[Federal Register Volume 59, Number 225 (Wednesday, November 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28146]
[[Page Unknown]]
[Federal Register: November 23, 1994]
_______________________________________________________________________
Part III
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 2, et al.
Public Information and Confidentiality Regulations; Proposed Rule
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 2, 57, 85, 86, 122, 123, 145, 233, 260, 270, 271, 281,
350, 403, 704, 707, 710, 712, 716, 717, 720, 723, 750, and 790
[FRL-4736-2]
RIN 2020-AA21
Public Information and Confidentiality Regulations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to modify certain regulations governing the
Freedom of Information Act confidential business information. This
proposal makes numerous changes intended to simplify and expedite
handling of confidential data.
DATES: Comments will be accepted until January 23, 1995.
ADDRESSES: Send or deliver written comments to Donald A. Sadowsky,
General and Information Law Division (2379), Office of General Counsel,
Environmental Protection Agency, 401 M Street, SW., Washington, DC
20460.
FOR FURTHER INFORMATION CONTACT: Donald A. Sadowsky, Office of General
Counsel. Telephone 202/260-5469.
SUPPLEMENTARY INFORMATION: On May 20, 1975 EPA published in the Federal
Register (40 FR 21987) a proposed rule concerning procedures for the
treatment of confidential business information (CBI) submitted under
various environmental statutes. This final rule was published on
September 1, 1976 (41 FR 36902), and codified as 40 CFR part 2, subpart
B. Rules governing treatment of CBI submitted under additional
environmental statutes were promulgated on September 8, 1978 (43 FR
40003), December 18, 1985 (50 FR 51663), and July 29, 1988 (53 FR
28772). EPA published additional rules concerning confidentiality on
January 5, 1993 (58 FR 457) and February 5, 1993 (58 FR 7187).
The contents of today's preamble are listed in the following
outline:
A. Introduction
B. Up-front Assertion of and Definition of Confidentiality Claims
1. Assertion of Claims
2. Definition of Claims
3. Retroactivity
C. Sanitization and Aggregation of Data
D. Requirement to Make a Final Determination of Confidentiality When
Information Claimed as Confidential is Requested Pursuant to the
Freedom of Information Act
E. Up-front Substantiation of Confidentiality Claims Upon Submission
of Information to EPA
F. Expiration of Confidentiality Claims: Sunset Provisions
1. Rationale
2. Operation of Sunset Provisions
3. Authority
4. Other Issues
G. Eligibility of Voluntarily-submitted Information for Confidential
Treatment
1. Critical Mass
2. Definition of ``Voluntarily Submitted''
3. Requests for Substantiation
4. Advance Confidentiality Determinations
5. Class Determinations
H. Implementation of Final Determinations by Program Offices
I. Delegation of Authority to Perform Functions Under part 2
1. Final Confidentiality Determinations With Respect to Data
Submitted Under the Toxic Substances Control Act (TSCA), the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Federal
Food, Drug and Cosmetic Act (FFDCA)
2. Delegation of Part 2, Subpart B Functions to Part-time Attorneys
J. Definition of Legal Office
K. Class Determinations
L. Effect of Previous Confidentiality Determinations
1. Previous Determinations by a Federal Court or EPA Legal Office
That Information Is Not Entitled to Confidentiality
2. Previous Determinations by a Federal Agency or by a State or
Local Government Entity
M. Agency Requirements When Requesting Comments Justifying a
Confidentiality Claim; Untimely Responses
1. Agency Requirements to Verify Receipt and Response
2. Codification of Class Determination 1-85
N. Advance Notice of Disclosure of CBI to Persons Authorized to
Receive It; Recordkeeping of Disclosures
1. Form of Notice
2. Contract or Subcontract Number
3. Response to Comments
4. Records of Disclosures
O. Disclosure to Foreign Governments and International Organizations
P. Safeguarding of Confidential Information by Enrollees Under the
Senior Environmental Employment (SEE) Program
Q. Disclosure to Federal Agencies for Law Enforcement Purposes
R. Reconciliation of Program-Specific Confidentiality Provisions
with Part 2
S. Changes to Rules Governing Certain Information Obtained Under the
Clean Air Act
1. Applicability of 40 CFR 2.301, Special Rules for the Clean Air
Act
2. Basic Rules Which Apply Without Change and Assertion of Claims
3. Changes to Specific Clean Air Act Regulations Under Parts 57, 85,
and 86
4. Substantive Criteria for Confidentiality Determinations:
Production and Consumption Allowances Under Title VI
5. Confidentiality of Certain Emission Data
6. Confidentiality of Gasoline Performance Baselines
T. Changes to Rules Governing Certain Information Obtained Under the
Clean Water Act
1. Substantive Criteria for Use in Confidentiality Determinations
2. Changes to Specific Clean Water Act Regulations Under Parts 122,
123, 233, and 403
U. Changes to Rules Governing Certain Information Obtained Under the
Safe Drinking Water Act
1. Substantive Criteria Used in Confidentiality Determinations
2. Changes to Specific Safe Drinking Water Act Regulations Under
Part 145
V. Changes to Rules Governing Certain Information Obtained Under the
Solid Waste Disposal Act
1. Disclosure of Hazardous Waste Export Information
2. Changes to Specific Resource Conservation and Recovery Act
Regulations Under Parts 270, 271, and 281
3. Change to List of Authorities
W. Changes to Rules Governing Certain Information Obtained Under the
Toxic Substances Control Act
1. Signature of a Senior Management Official for Some
Confidentiality Claims and Substantiations
2. Up-front Substantiation of Confidentiality Claims for Chemical
Identity
3. Definition of Health and Safety Data
4. Disclosure of Health and Safety Data
5. Reconciliation of TSCA Program-specific Rules With Part 2 Rules
6. Sunset Provisions
X. Changes to Rules Governing Certain Information Obtained Under the
Federal Insecticide, Fungicide, and Rodenticide Act
1. Codification of 1978 Interim Procedures
2. Incorporation of FIFRA Program Provisions Regarding CBI
3. Release in Emergency Situations
4. Pesticide Export Policy
Executive Order 12866
Paperwork Reduction Act
Regulatory Flexibility Act
A. Introduction
EPA, in its data collection and information disclosure needs,
administers a variety of statutes pertaining to the protection of the
environment (e.g., the Toxic Substances Control Act, Resource
Conservation and Recovery Act, Comprehensive Environmental Response,
Compensation, and Liability Act, Clean Air Act, and Federal Water
Pollution Control Act), each with differing data collection
requirements and differing requirements for disclosure of information
to the public. The Agency collects chemical, process, waste stream,
financial, and other data from tens of thousands of facilities in many
sectors of American business. Companies frequently consider this
information vital to their competitive position, and claim it as
confidential business information (CBI).
In the course of its daily business, the Agency often has a need to
communicate CBI during the process of rulemaking, to its contractors,
in response to requests under the Freedom of Information Act (FOIA), in
litigation, etc. In particular, EPA receives a large number of FOIA
requests for an agency its size (exceeded only by three other Federal
agencies). The Agency receives upwards of 40,000 FOIA requests
annually, and the number of requests grows each year. A large number of
these requests encompass information claimed as CBI (although obtaining
CBI may not necessarily be the objective of the requestor; see section
D., below).
To manage this volume of confidential information while protecting
both the confidentiality of competitively valuable information and the
rights of FOIA requestors, EPA instituted in 40 CFR part 2, subpart B,
a set of procedures for handling and disclosing information claimed as
CBI. Although these regulations have succeeded in protecting business
information, changes in case law and in Agency workload, practice, and
statutory authority require changes in the existing part 2 regulations
in order that they may continue to effectively and efficiently guide
the Agency in its stewardship of business information. EPA proposes to
modify these regulations to eliminate unnecessary procedures, and to
streamline and expedite activities involving confidential business
information. These proposals are detailed below.
B. Up-front Assertion of and Definition of Confidentiality Claims
EPA proposes to modify Sec. 2.203 so that the Agency would protect
only information explicitly claimed as confidential.
1. Assertion of Claims
Before releasing business information to the public, either in
response to a FOIA request or otherwise, 40 CFR 2.204 requires that the
Agency determine whether the submitter of the information has claimed
the information as confidential. If the Agency's records reveal a CBI
claim for the information, part 2 provides a series of procedures
governing whether and how such information may be disclosed.
Moreover, under existing regulations, even if the submitter has not
previously asserted a CBI claim, EPA must inquire whether the submitter
wishes to assert a claim if the information is such that the submitter
might be expected to object to its release (unless, pursuant to
Sec. 2.203(a), the submitter was furnished notice when EPA requested
the information that if no CBI claim was asserted when the information
was received, EPA may make the information available to the public
without further notice). Current regulations thus frequently put Agency
employees in the position of having to guess whether a submitter would
object to disclosure of the information.
EPA believes that the submitter is in the best position to know
whether there would be an objection to disclosure, and that it is
unreasonable to expect Agency employees to, in effect, read the mind of
the submitter. Therefore, the Agency is proposing to modify Sec. 2.203
so that CBI claims are made upon submission of the information. If
review of the Agency's records revealed no claim, the Agency would have
no duty to inquire whether the submitter wished to assert a claim.
However, if it were obvious that a document not associated with a CBI
claim did in fact contain commercially valuable information, the Agency
would look into the matter.
This change would not preclude a submitter from filing a CBI claim
subsequent to submission of the information, although to the extent
that EPA has already disclosed the information or widely disseminated
it in the interim may mean that such a claim would in practical effect
be too late. This is in fact the Agency's present policy with respect
to late claims, as provided in 40 CFR 2.203(c).
One class of submitters which would need to pay close attention to
this change is third-party submitters (e.g., Company A, which provides
CBI to Company B, which then submits it to EPA). Currently, when the
Agency has possession of information developed by Company A and
submitted to EPA by Company B, the Agency must determine whether both
Company A and Company B are affected businesses that might wish to
assert confidentiality claims. Under this change, if the information
was submitted by Company B without any indication that it was claimed
as CBI, EPA would assume that the information was nonconfidential.
Thus, submitters in the position of Company A would as a matter of
course need to ensure that, when they provide CBI to someone who may in
turn provide the information to EPA, the confidentiality claim is
asserted when the information is submitted to EPA. The Agency believes
that this is consistent with prudent business practice.
Section 2.203(c) currently provides that, with respect to
information submitted before October 1, 1976, EPA must verify with the
submitter that no claim is asserted before releasing business
information, without regard to whether the submitter knew that
information not claimed as confidential may be disclosed to the public.
(For information submitted after that date, the Agency need not make
such an inquiry if the submitter has received notice that information
not claimed as confidential may be disclosed without further notice.)
The purpose for this distinction was to protect companies who had
submitted information before EPA's regulatory policies for protecting
CBI were originally established.
EPA proposes to eliminate the distinction for information submitted
before October 1, 1976. The practical effect of this change would be
that persons who submitted information prior to October 1, 1976 and who
were given written notice at the time that information not claimed as
confidential may be disclosed to the public would no longer be asked at
a later date whether they wished to assert a CBI claim. If, with
respect to such information, the Agency had no record that such notice
had been given, EPA would continue to inquire, where appropriate,
whether the person wished to assert a CBI claim for the information.
The Agency believes that when data 17 years old or older were not
originally claimed as confidential, and the submitter was given notice
that a confidentiality claim must be asserted in order to protect the
information, further inquiry is not required.
2. Definition of Claims
Even where a submitter has asserted a confidentiality claim, the
claim is frequently asserted merely by claiming an entire submission as
confidential, even though very few documents are composed entirely of
confidential business information. Where such a blanket claim has been
made, the Agency has no way of knowing what specific information in the
submission is claimed as confidential. Consequently, Agency employees
may be faced with great difficulty in redacting (sanitizing) the
documents, or must ask the submitter in each case which information in
the submission is subject to a CBI claim. When EPA is dealing with
masses of data from hundreds or thousands of submitters, uncertainty as
to what specific confidentiality claims are being asserted can be a
significant barrier to Agency action. It is therefore important that
all CBI claims be asserted with specificity. Nonetheless, the Agency
recognizes that there are rare situations in which an entire document
may be entitled to confidentiality.
EPA is therefore proposing to modify Sec. 2.203(b) to provide that
any confidentiality claim for an entire document be deemed ineffective
(i.e., EPA would treat the document as if it were not claimed as CBI)
unless at the time of assertion the submitter substantiates why the
entire document (as opposed to portions of the document) should be
maintained as confidential.
3. Retroactivity
The proposed provisions governing up-front assertion of claims and
substantiation of blanket claims for an entire document would apply
only to data submitted on or after the date of the final rule.
C. Sanitization and Aggregation of Data
The Agency proposes to modify Sec. 2.202(f) to clarify that a
submitter's consent is not required for disclosure of sanitized or
aggregated data.
EPA frequently needs to disclose to the public (e.g., pursuant to a
FOIA request or in discussions of the bases for Agency decisions) non-
confidential information derived from data supplied by businesses and
claimed as confidential. Such releases might take the form of industry-
wide data aggregated into a non-confidential figure, or sanitized
documents where all information that could identify the submitters has
been removed.
Sanitization and aggregation of submissions require care to ensure
that the information released to the public cannot be used by a
knowledgeable person to back-calculate to information claimed as CBI.
EPA employees releasing such information frequently have questions
concerning the steps to be taken to ensure that CBI is not disclosed.
Existing Agency regulations at 40 CFR 2.202(f) provide an uncertain
guide, merely stating that EPA ``should consider whether it is possible
to obtain the affected business's consent'' to this kind of disclosure.
However, releasing properly sanitized or aggregated data does not
disclose information claimed as confidential, and the consent of the
submitter to such release is not necessary.
The Agency has long disclosed aggregated data submitted pursuant to
the Toxic Substances Control Act (TSCA), without the consent of the
submitter, in accordance with published protocols. See e.g., 48 FR 6539
(February 14, 1983). Such disclosures have successfully protected
confidential data.
EPA desires to clarify its policy with respect to sanitized and
aggregated data. The Agency believes it should provide the public with
useful information while ensuring that data claimed as confidential is
given sufficient protection. Therefore, the proposed rule contains
language modifying Sec. 2.202(f) to clarify that the submitter's
consent is not required for disclosure of aggregated or sanitized
information, but that: (1) When disclosing sanitized copies, EPA
offices must ensure that the portions of the documents which are
disclosed do not contain information claimed as confidential; and (2)
all disclosures of aggregated numerical data must be made using a
procedure on which an EPA legal office (Office of General Counsel or
Office of Regional Counsel) has been consulted. In consultation with an
EPA legal office, a program would develop and subsequently follow a set
of principles involving confidentiality safeguards and allowing
scientific or technical adaptability to specific aggregation needs.
D. Requirement to Make a Final Determination of Confidentiality
When Information Claimed as Confidential is Requested Pursuant to
the Freedom of Information Act
EPA proposes to modify its public information and confidentiality
regulations to require final confidentiality determinations only where
the requestor has expressly requested information claimed as
confidential.
When EPA receives a request pursuant to FOIA which encompasses
information claimed as confidential, existing regulations at 40 CFR
2.204(d)(1) require that the request be initially denied with respect
to information subject to a confidentiality claim (unless the
information is clearly not entitled to confidentiality), pending a
final determination by an Agency legal office of the eligibility of the
information for confidential treatment under exemption 4 of FOIA. This
determination must be made irrespective of whether the requestor
appeals the initial denial. Such treatment of exemption 4 denials is in
contrast to legal determinations made with respect to denials of
records pursuant to other exemptions of FOIA, which under 40 CFR 2.115
(contained in subpart A of part 2, governing requests for information)
are made only upon appeal of the denial. The Agency originally devised
this process as a means of meeting its obligations under FOIA to make a
determination of releasability and adhere to the response times in FOIA
of ten days to the extent possible: for most CBI claims, detailed
information from the submitter is necessary to make a determination of
confidentiality, and making such a final determination requires far
more than ten days.
However, making a final determination of confidentiality can be
time-consuming and resource intensive for EPA, and requires the
submitter to prepare a justification of why the information is entitled
to confidentiality. The Agency's experience in responding to such FOIA
requests is that requestors are frequently not interested in
information claimed as confidential, and the exercise of determining
confidentiality in such cases is unnecessary.
EPA is therefore proposing to modify its subpart A provisions so as
to require final determinations of confidentiality only where the
requestor has expressly indicated a desire for information claimed as
confidential. Under the proposed change, Sec. 2.111 (subpart A) and
Sec. 2.204(a)(1) (subpart B) would be modified to create a presumption,
rebuttable by the FOIA request itself, that the requestor does not
desire access to information claimed as CBI. In other words, if a FOIA
request which would otherwise encompass information claimed as business
confidential is silent as to whether information claimed as CBI is
desired by the requestor, EPA would presume that the requestor does not
desire such information. If, however, the request states that access to
information claimed as CBI is desired, the Agency would treat such
requests as it has in the past, i.e., making an initial denial with a
subsequent determination as to whether the subject information is
entitled to confidential treatment.
EPA realizes that some requestors might not be aware of the
necessity to specify that they desire access to information claimed as
confidential, or might not know, without first learning what records
are in EPA's possession, whether they do in fact require access to
information claimed as CBI. Thus, if the Agency merely ignored the
portion of the request pertaining to information claimed as CBI, some
requestors might never learn that there is pertinent information in the
Agency's files which is claimed as confidential. Therefore, Sec. 2.111
would provide that the response to such a FOIA request must state that
the Agency is presuming that the request does not encompass information
claimed as CBI, and must include in the response a list or description
of that information claimed as CBI which EPA was presuming not to be
subject to the FOIA request. The requestor could then choose to submit
another FOIA request for that information.
Authority to create such a presumption can be found in FOIA itself.
Although it is commonly believed that FOIA requires Federal agencies to
respond to every request under FOIA which reasonably describes the
records sought, FOIA requires that such requests be made ``in
accordance with published rules stating the * * * procedures to be
followed.'' 5 U.S.C. 552(a)(3)(B). The rebuttable presumption that CBI
is not requested would be a procedure under 5 U.S.C. 552(a)(3)(B) which
is intended to save both EPA and CBI submitters time and resources, as
well as to improve responsiveness to FOIA requests by eliminating
unnecessary determinations of confidentiality.
EPA considered a second alternative which adheres more closely to
current Agency procedures. Under this alternative, EPA would not make
any presumptions as to the scope of the request, and would continue to
issue denials with respect to information claimed as CBI, solely on the
basis of the confidentiality claim. However, the Agency would not
request substantiation or issue a final confidentiality determination
unless the requestor appealed the denial. The Agency considers this
alternative less desirable because even for those requestors who
specifically state a desire for CBI in their request, the lengthy
process of substantiation and determination would not begin until the
request was appealed. Additionally, this alternative raises a question
as to whether EPA would be meeting its obligations under paragraph
(a)(3) of FOIA to make non-exempt records available to requestors if it
denied requested records merely on the basis of a claim of
confidentiality without determining whether in fact such records
qualify for withholding under exemption 4 of FOIA.
A third alternative consists of implementing the presumption
discussed above and, with respect to those FOIA requests which
specifically request CBI, only making a final confidentiality
determination if the request is appealed (under the theory that
requestors who initially indicate a desire for CBI may decide not to
appeal once they see a list of what information is actually claimed).
This alternative would be the least burdensome for the Agency, but
suffers from the same difficulties as the previous alternative; it also
would only be worthwhile if a significant proportion of those
requestors specifically asking for CBI would in fact not appeal the
initial denial.
A fourth alternative is making no change to the present procedures.
EPA requests comments on all alternatives.
E. Up-front Substantiation of Confidentiality Claims Upon Submission of
Information to EPA
EPA proposes to amend Sec. 2.203(b) to provide a framework for more
specific regulatory requirements that CBI claims for specified types of
information must be accompanied by a substantiation at the time of
submission.
Pursuant to Sec. 2.204, when the Agency either; (1) Is required by
a FOIA request, or (2) desires for any purpose, to determine whether
information in its possession is entitled to confidentiality, EPA
requires the submitter to substantiate its confidentiality claim. The
submitter must submit information which, among other things, sets
forth:
(1) What portion of the information the submitter believes is
entitled to confidential treatment;
(2) The length of time for which confidential treatment is desired;
(3) Measures taken by the business to prevent undesired disclosure
to others;
(4) The extent to which the information has already been disclosed
to others; and
(5) Why release of the information would result in substantial
harmful effects to the business' competitive position in the
marketplace. 40 CFR 2.204(e)(4).
EPA's general confidentiality regulations at 40 CFR part 2 do not
require a CBI claim to be substantiated upon submission of the
information, although some program-specific regulations contain an up-
front substantiation requirement. See, e.g., 40 CFR 710.38 and
720.90(b)(2), implementing the Toxic Substances Control Act.
Submission of substantiation material at a later date can be
somewhat problematic, both for the submitter and the Agency. It may be
more difficult for the submitter to compile responsive information when
requested to do so by the Agency long after the information claimed as
confidential has been submitted to EPA. Not having this information on
hand can impair the Agency's ability to perform some of its functions
(especially responding to FOIA requests which seek information that
contains CBI) in an expeditious manner.
The Agency is proposing to amend Sec. 2.203(b) to explicitly
provide that up-front substantiation requirements may be promulgated on
a program-by-program basis by specific regulation. Existing up-front
substantiation requirements would not be affected by this change. The
need for such a requirement varies among programs and data collections,
dependent in part upon the public interest in the information, the
frequency of CBI claims, and the frequency of insupportable claims. For
example, in programs where CBI claims are infrequent, the impact of
confidentiality claims on both the Agency and FOIA requestors is low.
Therefore, the proposed amendment would not be self-executing: up-front
substantiation requirements would be imposed for specified classes of
information by notice and comment rulemaking. This approach would give
the Agency the flexibility to impose such a requirement only where
necessary.
The Agency believes that such a provision would be beneficial for
two principal reasons. First, it would enable EPA to deal in a more
expeditious fashion with FOIA requests which seek information
containing CBI. In general, such requests can take a long time to
resolve, in part due to the process of requesting (and receiving) a
substantiation from the submitter. Having the substantiation on file
would expedite the process.
Second, the Agency believes that an up-front substantiation
requirement would help reduce those CBI claims made as a matter of
course and induce submitters to be more selective in their CBI claims
by requesting CBI protection only for specific information that truly
needs to be protected. The Agency is not seeking to limit the type of
information which a party may claim as CBI. Rather, EPA believes that
the introduction of a requirement to justify a CBI claim upon
submission of the underlying material would induce submitters to
request CBI treatment only for information which is truly confidential,
thereby reducing the amount of confidentiality claims actually
submitted to the Agency. EPA anticipates that this will expedite review
of data provided to the Agency, allowing EPA to make determinations
concerning CBI claims and respond to FOIA requests more expeditiously.
Finally, the Agency does not believe that this amendment would chill a
submitter's assertion of a claim for information which is truly
entitled to confidential treatment. If information is important enough
to be worth confidential protection, it is worth substantiating the
claim. The proposed amendment does not codify uniform substantiation
questions, but requires all up-front substantiations to address at the
least the factors in 40 CFR 2.208 (criteria for confidentiality).
Authority for an up-front substantiation requirement stems both
from the statutes administered by EPA (e.g., section 308 of the Clean
Water Act provides that all information collected under this section
``shall be available to the public, except that upon a showing
satisfactory to the Administrator'' the information is entitled to
confidential protection), and the Agency's inherent authority to
promulgate regulations governing disclosure under the Freedom of
Information Act, the Trade Secrets Act, and other statutes (cf.
discussion of sunset provisions in section F., below).
F. Expiration of Confidentiality Claims: Sunset Provisions
EPA proposes to add a new Sec. 2.216, which would allow selected
CBI claims to expire unless reasserted.
1. Rationale
The commercial utility of information will usually decrease over
time: new processes are developed, and market forces change. As the
proprietary value of information lessens, at a certain point in time
the information may no longer be entitled to confidentiality. It is
then appropriate to end confidential treatment. EPA is proposing to
allow the promulgation of sunset provisions to identify such points in
time.
EPA has long taken the position that ``[p]ublic participation
cannot be effective unless meaningful information is made available to
the interested persons.'' 48 FR 21737 (May 13, 1983). Information
submitted to the Agency under a claim of confidentiality interferes
with EPA's ability to inform the public. EPA recognizes its duty to
safeguard confidential business information, but believes there are
confidentiality claims that are no longer valid. Where there is no
longer a reason for a confidentiality claim, the subject information
should be declassified to maximize the amount of information publicly
available to facilitate public participation in the regulatory process.
2. Operation of Sunset Provisions
EPA proposes to add a new section, Sec. 2.216, to establish a
framework within which the Agency may promulgate regulations requiring
that a previously asserted confidentiality claim be reasserted during a
specified period. The period could follow either submission of the
information or the occurrence of a specified event. Examples of
hypothetical periods are five years after submission of the
information, or within 90 days of granting of a United States patent
protecting the information. Because this framework would be implemented
by program-specific regulations, Sec. 2.216 would not in itself cause
any confidentiality claims to expire. Rather, the provision is intended
to establish the necessary components of a regulation which provides
for expiration of confidentiality claims.
All submitters asserting confidentiality claims subject to a sunset
provision would be given an opportunity to reassert the claim. In
addition, the provision would only be applied prospectively.
A regulation with a sunset provision would establish the various
parameters of the provision. These include the class of information to
which the sunset applies, the period of time or event to occur before
the confidentiality claim expires, and the procedures to follow to
reassert the claim. A claim which is not reasserted in accordance with
the stated procedures would be deemed waived. A specific sunset
provision might include, along with a requirement to reassert the
claim, a requirement to substantiate (or resubstantiate) the claim at
the time of reassertion.
Submitters would be expected to know what information is subject to
a sunset provision and the time when reassertion is due. Since the
existence of the sunset provision in Agency regulations would itself
provide submitters with notice of the reassertion requirement, the
Agency would not be required to provide further notice of either the
sunset provision or the opportunity to reassert the claim. However,
program offices would not be precluded from establishing a policy of
routinely providing such further notice.
Where the same information was submitted several times to the
Agency, each submission which is subject to a sunset provision would
carry its own sunset period. An expired confidentiality claim on one
submission would not automatically eliminate the confidentiality claim
for a second submission, because the link between the information and
the second submission might itself be protectible information,
notwithstanding the fact that the information in the first submission
is now public. Nonetheless, such situations are unlikely, and the
expiration of the claim for the first submission, causing that
information to enter the public domain, would play a significant role
in determining whether the second submission was now also in the public
domain.
3. Authority
EPA believes that the authority to promulgate requirements for
maintaining confidentiality claims is inherent in the environmental
statutes administered by the Agency which provide that information may
be protected upon a showing made to the Administrator that the
information is entitled to confidentiality (see, e.g., section 308 of
the Clean Water Act). EPA administers numerous statutes which require
information to be submitted to the Agency. These statutes contain
provisions which either specify the procedures for claiming
confidential status or generally describe confidential treatment for
information, in concert with general rulemaking authority to implement
the statute. These statutory authorities form the basis for the current
EPA confidentiality regulations.
For example, the Toxic Substances Control Act (TSCA) states that
``[a] designation (of confidentiality) under this chapter shall be made
in writing and in such manner as the Administrator may prescribe''. 15
U.S.C. 2613(c)(1)(B). EPA has previously construed this provision to
authorize a sunset provision which causes certain confidentiality
claims associated with Premanufacture Notifications to expire upon
submission of a Notice of Commencement, unless the claim is reasserted
at that time. See 40 CFR 720.85.
Implicit in the prohibition on disclosing confidential information
without authority to do so (contained in many of the statutes
administered by the Agency and the Trade Secrets Act, 18 U.S.C. 1905)
is the authority to provide for assertion of claims and to take those
steps necessary to determine which information claimed as CBI is
actually entitled to confidentiality. Because information may lose its
eligibility for confidential treatment over time, it is a legitimate
exercise of statutory authority to reexamine confidentiality claims in
a systematic manner via regulations which allow confidentiality claims
to expire.
In addition, EPA seeks to more fully embrace the policy stated in
Executive Order 12600 Sec. 3(b), 3 CFR, 1987 Comp., p. 236, which
explicitly contemplates that Federal agencies may provide for the
expiration of confidentiality claims on information submitted to the
Federal Government on or after January 1, 1988. The order provides that
``agency procedures may provide for the expiration, after a specified
period of time or change in circumstances, of designations of
competitive harm made by submitters.''
4. Other Issues
EPA has considered a number of different issues before arriving at
this proposal. First, EPA has considered how broadly a sunset provision
should apply. Specifically, the Agency considered whether regulations
should provide for a uniform sunset requirement for all submissions,
Agency-wide, or for a program-by-program sunset requirement based on
the individual program's needs. The Agency has concluded that, at a
minimum, the need for a sunset provision and the determination of the
appropriate sunset period depend upon, among other things, the nature
of the information, the public interest in the information, and the
frequency of confidentiality claims, all of which vary according to the
type of information involved. Therefore, the Agency has decided that it
is more appropriate that sunset provisions be put into place on a
program-by-program basis. The purpose of proposed Sec. 2.216 is to
establish a regulatory framework for how sunset provisions would
operate.
EPA has also considered whether the Agency should be required to
remind submitters when their claims are about to expire. EPA is
proposing not to provide such a reminder, but is placing on submitters
the responsibility for ensuring that they reassert the confidentiality
claim at the appropriate time. EPA believes that putting the burden on
the Agency to notify the submitter before expiration of the claim would
be little different than what is provided under existing regulations,
because EPA can already in effect give a submitter notice that a claim
will expire unless the submitter responds to the notice. Under current
Sec. 2.204(e) EPA can require a submitter to substantiate a claim; if
the submitter does not respond in a timely manner, under Sec. 2.205(d)
the claim is deemed waived. Although making submitters responsible for
determining when action must be taken would require them to maintain
the necessary information to make such a determination, it is a matter
of sound business practice to keep track of what information has been
submitted to EPA and what actions are required to safeguard the
information (and when to take such actions). Those claims which are
worth asserting for a significant period of time are also worth the
associated recordkeeping.
Finally, EPA has considered whether submitters should be required
to substantiate a reasserted claim at the time of the reassertion. EPA
believes that the answer to this question depends upon factors such as
the nature of the data, the likelihood that old data would continue to
need confidential treatment, and the uses made by the Agency and the
public of such data. Therefore, EPA proposes to leave that issue to be
decided on a case-by-case basis during promulgation of specific sunset
provisions. However, such a requirement could be placed in an
individual regulation, where appropriate.
G. Eligibility of Voluntarily-submitted Information for
Confidential Treatment
EPA proposes to amend several sections in part 2 to make the
regulations consistent with the recent decision in Critical Mass v.
Nuclear Regulatory Commission, 975 F.2d 871 (D.C. Cir. 1992), cert.
denied, 113 S. Ct. 1579 (1993).
1. Critical Mass
At the time of the Agency's original promulgation of its
confidentiality regulations at 40 CFR part 2, subpart B, the applicable
standard for whether information was entitled to confidential treatment
under Exemption 4 of the Freedom of Information Act was set forth in
National Parks and Conservation Association v. Morton, 498 F.2d 765
(D.C. Cir. 1974). In National Parks, the Court set forth a two-part
test, stating that ``[c]ommercial or financial matter is `confidential'
* * * if disclosure of the information is likely * * * either * * * (1)
to impair the Government's ability to obtain necessary information in
the future; or (2) to cause substantial harm to the competitive
position of the person from whom the information was obtained.'' 498
F.2d at 770.
In Critical Mass, the D.C. Circuit revisited the definition of
``confidential'' set forth in the National Parks case. The Court did
not abandon the definition of ``confidential'' presented in National
Parks, but chose to modify its application. The categorical rule
developed by the Court states that ``financial or commercial
information provided to the Government on a voluntary basis is
confidential for the purpose of Exemption 4 if it is of a kind that
would customarily not be released to the public by the person from whom
it was obtained.'' 975 F.2d at 879. Therefore, if commercial or
financial information obtained from a person is submitted voluntarily
and would not customarily be disclosed by the submitter, it is presumed
confidential without requiring any examination of the competitive harm
portion of the National Parks test. EPA proposes to amend the criteria
for confidentiality in Sec. 2.208 accordingly.
Note that information which under Critical Mass is entitled to
confidentiality pursuant to exemption 4 of FOIA may still be required
to be disclosed to the public via independent statutory authority. For
example, emission data which could have been collected pursuant to
section 114 of the Clean Air Act but was in fact voluntarily submitted
to EPA would not be eligible for confidential treatment, due to the
requirement in section 114 that emission data be available to the
public.
2. Definition of ``Voluntarily Submitted''
Section 2.201(i) currently provides that for information to be
considered voluntarily submitted it must be information whose
submission EPA had no statutory or contractual authority to require.
However, in Critical Mass, information which the court called
voluntarily submitted was within the statutory authority of the Nuclear
Regulatory Commission to require from the regulated industry, although
the Commission had not in fact required its submission; rather, the
Commission had obtained the information on a voluntary basis from an
industry association. 975 F.2d at 880. Because the Sec. 2.201(i)
definition appears to conflict with Critical Mass, and the courts have
only begun to determine when information is submitted voluntarily, EPA
proposes to delete Sec. 2.201(i) altogether.
3. Requests for Substantiation
Because the confidentiality of voluntarily submitted information is
not dependent on competitive harm, there is no need for the Agency to
require submitters to justify why disclosure of such information is
likely to cause substantial competitive harm. Therefore, EPA proposes
to modify the substantiation requirements at Sec. 2.204(e)(4) to allow
the action office to not request substantiation on competitive harm
when the action office believes the information was submitted
voluntarily. The Agency would ask questions eliciting information which
pertains to whether such information would customarily be disclosed to
the public by the submitter. If the EPA legal office which subsequently
determines the information's eligibility for confidential treatment
believes that the information is in fact not voluntarily submitted, the
legal office would request the submitter to substantiate the likelihood
of competitive harm, pursuant to the procedures of Sec. 2.204(e).
4. Advance Confidentiality Determinations
Under Sec. 2.206, EPA may make an advance determination of
confidentiality before information is officially submitted to the
Agency, provided that: (1) EPA has requested or demanded that a
business furnish business information to the Agency, (2) the submitter
asserts that the information would constitute voluntarily submitted
information, and (3) the submitter will voluntarily submit the
information for use by EPA only if EPA first determines that the
information is entitled to confidential treatment. Section 2.206
currently cites the definition of voluntarily submitted in
Sec. 2.201(i), and requires substantiation of competitive harm. EPA
proposes to delete both the reference to Sec. 2.201(i) and the
requirement to substantiate competitive harm.
EPA also proposes to remove the words ``or demanded'' from
Sec. 2.206(a)(1). This change would clarify that where EPA demands
submission of information pursuant to its authority, the information
cannot be deemed voluntarily submitted.
5. Class Determinations
Under Sec. 2.207, EPA may make determinations pertaining to, among
other things, whether information is submitted voluntarily (for a more
detailed discussion of class determinations, see section K., below).
Section 2.207 currently refers to the Sec. 2.201(i) definition of
voluntarily submitted information; this reference would be deleted.
H. Implementation of Final Determinations by Program Offices
EPA proposes to amend Sec. 2.205(f) to permit program offices to
grant extensions of time and release information pursuant to final
confidentiality determinations made by those offices under
Sec. 2.204(d)(2).
Final determinations of confidentiality are normally made by a
legal office (General Counsel or Regional Counsel) under Sec. 2.205.
However, when information is clearly not entitled to confidentiality,
under Sec. 2.204(d)(2) any office may make a final confidentiality
determination. Section 2.205(f) provides procedures to follow any
determination that information is not entitled to confidentiality
(either under Sec. 2.205 or Sec. 2.204(d)(2)): advance notification to
the submitter of disclosure of the information within a certain period
(normally ten days), extension of the time period in certain cases, and
disclosure of the information if the submitter does not file suit
during this period to enjoin disclosure.
Section 2.205(f) does not clearly state that a program office may
grant extensions of the time period and ultimately disclose the
information upon its expiration when the final determination was
drafted by the program office, although such a practice would be
logical and efficient. EPA proposes to amend Sec. 2.205(f) accordingly.
I. Delegation of Authority to Perform Functions Under Part 2
EPA proposes to amend several sections to give the General Counsel
greater flexibility in delegating part 2 functions.
40 CFR 2.205(i), as supplemented by Sec. 2.306(e)(1) (governing
TSCA confidentiality), Sec. 2.307(e)(1) (governing confidentiality
under the Federal Insecticide, Fungicide, and Rodenticide Act), and
Sec. 2.308(f)(1) (governing confidentiality under the Federal Food,
Drug and Cosmetic Act), sets limits on who can take certain actions
under part 2, such as issuing final determinations of confidentiality
under Sec. 2.205. Following are proposals to amend these limitations to
give EPA more flexibility in its internal operations.
1. Final Confidentiality Determinations With Respect to Data Submitted
Under the Toxic Substances Control Act (TSCA), the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), and the Federal Food, Drug and
Cosmetic Act (FFDCA)
Section 2.205(i) provides that final confidentiality determinations
may be made by EPA legal offices (Office of General Counsel or Offices
of Regional Counsel). However, Secs. 2.306(e)(1), 2.307(e)(1), and
2.308(f)(1) provide that ``the General Counsel (or his designee),
rather than the Regional Counsel,'' may make confidentiality
determinations for data submitted pursuant to TSCA, FIFRA, or FFDCA,
respectively. The Office of General Counsel has consistently
interpreted these provisions to allow the General Counsel to designate
the Regional Counsels to make TSCA, FIFRA and FFDCA confidentiality
determinations. EPA proposes to amend these provisions to provide that
Regional Counsels may make final determinations under TSCA, FIFRA, and
FFDCA. (Note: under revisions discussed below, Sec. 2.306(e) would be
redesignated as Sec. 2.306(f).)
2. Delegation of Part 2, Subpart B Functions to Part-time Attorneys
Section 2.205(i) provides that the General Counsel ``may redelegate
any or all of his authority under this subpart to any attorney employed
by EPA on a full-time basis under the General Counsel's supervision.''
The section contains similar language regarding Regional Counsels. The
limitation to full-time attorneys was originally promulgated to be an
internal management tool for the Agency. However, the Agency now
believes that the decision as to the ability of part-time attorneys to
fill a function is best left to the judgment of the delegating official
rather than being constrained by regulation, and proposes to remove
this limitation.
J. Definition of Legal Office
EPA proposes to amend Sec. 2.201(n) to reflect the reorganization
of 1990 involving the reporting relationships of Regional Counsels to
the Office of Enforcement and Compliance Assurance and the Office of
General Counsel.
Under part 2 regulations, some actions may be taken by any office
(e.g., initially denying a FOIA request encompassing CBI), while some
actions may only be taken by a ``legal office'' (e.g., final
confidentiality determinations pursuant to Sec. 2.205(a)). Section
Sec. 2.201(n) defines an EPA legal office as ``the EPA General Counsel,
and any EPA office over which the General Counsel exercises supervisory
authority, including the various Offices of Regional Counsel.''
Since 1990, the Offices of Regional Counsel (ORC) have reported to
EPA's Office of Enforcement (now the Office of Enforcement and
Compliance Assurance), rather than the Office of General Counsel,
although ORC maintains the same functions with respect to EPA's
confidentiality regulations. Therefore, EPA proposes to amend
Sec. 2.201(n) to reflect this organizational change.
K. Class Determinations
EPA proposes to modify Sec. 2.207 to require publication in the
Federal Register of future class determinations.
Under Sec. 2.207, EPA may issue a class determination finding that
there is a class of information such that one or more characteristics
common to all items in the class will necessarily result in identical
treatment for each such item under one or more of the provisions in
EPA's confidentiality regulations. EPA has issued seventeen class
determinations.
Most commonly, a class determination states whether the class is
entitled to confidentiality. When the Agency is contemplating
disclosure of information subject to a class determination, the notice
of opportunity to submit comments referred to in Secs. 2.204(d)(1)(ii)
and 2.205(b) may be modified to reflect the fact that the class
determination has made unnecessary the submission of materials
pertinent to one or more issues.
EPA has generally published such class determinations in the
Federal Register, and Sec. 2.207(d) provides that ``[t]he purpose of a
class determination is simply to make known the Agency's position
regarding the manner in which information within the class will be
treated.'' Nonetheless, Sec. 2.207 currently does not require
publication. Although class determinations are not rules subject to the
notice and comment requirements of the Administrative Procedures Act,
EPA believes that publication of all future class determinations in the
Federal Register would be consistent with the purpose of making known
the Agency's position on the class, and is in the best interests of
submitters of confidential information, FOIA requestors, and the Agency
itself. Publication would also be consistent with the requirement in
the Freedom of Information Act, 5 U.S.C. 552(a)(1)(D), that agencies
publish in the Federal Register ``interpretations of general
applicability formulated and adopted by the agency.'' Therefore, EPA is
proposing to modify Sec. 2.207 to provide for publication in the
Federal Register of future class determinations.
L. Effect of Previous Confidentiality Determinations
EPA proposes to modify Sec. 2.204(b) to clarify (or in some
situations increase) the ability of the Agency to rely on previous
confidentiality determinations by EPA, Federal courts, and State and
local governments.
When EPA is determining whether information is entitled to
confidentiality, Sec. 2.204(b) requires the Agency to ascertain whether
there has been a previous confidentiality determination by a Federal
court or EPA legal office. The normal method of learning about previous
determinations is to ask the submitter, who would have the most
comprehensive file of relevant determinations. If the information has
previously been determined by a Federal court or EPA legal office to be
entitled to confidentiality, the Agency does not reexamine the issue.
Instead, the Agency denies any pending FOIA requests for the
information, and considers the matter closed, unless the previous
determination was issued by EPA and the Agency now believes that the
previous determination was erroneous. Pursuant to Sec. 2.205(h), a
legal office may modify a previous determination believed to be
erroneous.
The purpose of Sec. 2.204(b) is to save the time and resources
otherwise required to decide the issue anew. However, Sec. 2.204(b)
fails to provide for any effect of either (1) A previous determination
by a Federal court or EPA legal office that the information is not
entitled to confidentiality, or (2) a determination by a State or local
governmental body. Additional savings could be realized if such
determinations had similar effect.
1. Previous Determinations by a Federal Court or EPA Legal Office That
Information Is Not Entitled to Confidentiality
Arguably, such situations are already covered by existing
regulations. Section 2.204(d)(2) allows an EPA office to issue a
determination that information is clearly not entitled to
confidentiality, without giving the submitter an opportunity to
substantiate the claim. In the Federal Register of September 1, 1976
(41 FR 36920, discussion of comment #16) the Agency stated that such a
determination can be made where ``EPA's position on the matter is
already clear and there is nothing further to consider.'' A previous
confidentiality determination clearly falls within that category.
Furthermore, on page 36919, in response to comment #13, the Agency
stated that ``[e]ven if a prior determination states that information
of a certain type is not entitled to confidential treatment, a business
should be afforded the opportunity to seek judicial review.'' The
Agency did not in that sentence discuss an additional opportunity for
the submitter to substantiate the CBI claim, indicating that a
Sec. 2.204(d)(2) determination was contemplated by EPA as the
appropriate procedure when the Agency has previously determined that
the information was not entitled to confidentiality.
Nonetheless, in the interest of clarity, EPA now proposes to amend
Sec. 2.204(b) to make it explicit that a previous determination by an
EPA legal office or a Federal court denying confidentiality is grounds
for a Sec. 2.204(d)(2) determination.
2. Previous Determinations by a Federal Agency or by a State or Local
Government Entity
Confidentiality determinations by other Federal agencies or by
State and local governments are not binding upon EPA, and in the case
of State or local determinations may be based upon inapplicable State
or local laws. Thus, the legal opinion of another Federal agency or of
a State or local government as to whether information is entitled to
confidentiality could only be useful to EPA in an advisory capacity.
However, where the government entity has determined that the
information is not entitled to confidentiality and has released the
information to the public based upon that determination, the
information has now entered the public domain, and is no longer
entitled to confidentiality, regardless of whether EPA agrees with the
rationale for the original determination by the governmental entity.
Therefore, the Agency proposes to modify Sec. 2.204(b) to provide that,
where another Federal agency or a State or local government entity has
determined that information is not entitled to confidentiality and the
information is available from that entity (e.g., if the submitter has
exhausted all administrative remedies with the governmental entity),
the information is clearly not entitled to confidentiality under
Sec. 2.204(d)(2).
M. Agency Requirements When Requesting Comments Justifying a
Confidentiality Claim; Untimely Responses
EPA proposes to amend Sec. 2.205 to expedite procedures for sending
out requests for substantiation and to codify Class Determination 1-85,
regarding untimely responses to substantiation requests.
When EPA is determining whether information claimed as confidential
is entitled to confidentiality, and asks an affected business to
substantiate a CBI claim, the business is given a period (usually 15
working days) to submit its substantiation. 40 CFR 2.204(e). Failure to
submit the substantiation within this period (or any approved extension
of time) results in a finding that the submitter has waived its claim.
40 CFR 2.205(d)(1).
1. Agency Requirements to Verify Receipt and Response
Because of the adverse consequences of such failure, EPA's
regulations require the Agency to go to considerable lengths to ensure
that the submitter files a response to the substantiation request:
(1) EPA must send the substantiation request to the submitter via
certified mail (return receipt requested), by personal delivery, or by
other means which allows verification of the fact and date of receipt;
(2) The Agency must orally inform a responsible representative of
the business that the business should expect to receive the written
notice, and must request that the business contact the EPA office if
the written notice has not been received within a few days; and
(3) If the substantiation has not been received within the required
period, the Agency must contact the affected business, ask whether the
substantiation had been lost in transmission, and provide an
opportunity to resubmit the comments. 40 CFR 2.204(e) and 2.205(b).
Although EPA continues to believe it is appropriate to adequately
document receipt of the substantiation request and to verify that the
substantiation was indeed submitted (given the size of the Agency and
the chances that a submission might be significantly delayed in finding
its way to its intended recipient), the advance oral notification is
not necessary, since businesses as a matter of course do read and
respond to their mail. Therefore, EPA proposes to delete the
requirement in Sec. 2.204(e)(3) that submitters be notified orally of
the impending substantiation request. Note that EPA would continue to
send the request by means which allow verification of receipt.
2. Codification of Class Determination 1-85
Section 2.205(d)(1) provides that if an EPA legal office finds that
a submitter has not filed a timely substantiation, the claim is waived.
To avoid the necessity of a legal office making such a finding each
time a submitter fails to file a timely substantiation, in 1985 EPA
issued Class Determination 1-85. This class determination provides that
a business has waived its confidentiality claim, and therefore that no
confidentiality claim applies to the relevant information, if both of
the following conditions are met:
(1) The EPA office designated to receive the business' comments has
not received those comments within the specified time period or an
approved extension thereof (see 40 CFR 2.205(b)(2)) as defined by EPA's
regulations (40 CFR 2.205(b)(1)-(4)) (after making appropriate inquiry
on whether the comments were lost in transmission, as required by 40
CFR 2.205(b)(4)); and
(2) The business was notified in writing at the time comments were
solicited that failure to submit timely comments would be construed as
a waiver of the business' claim. The effect of such a waiver is that
(unless some other business has claimed the information as CBI) no
confidentiality claim applies, and the information may be made
available to the public.
Although the class determination, pursuant to Sec. 2.207, is
effective in allowing disclosure of such information without further
notice, it would be clearer if 1-85 were codified in Sec. 2.204(d),
instead of requiring an additional non-regulatory document. EPA
therefore proposes to modify Sec. 2.204(d)(3), and delete
Sec. 2.205(d)(1), accordingly.
N. Advance Notice of Disclosure of CBI to Persons Authorized To Receive
It; Recordkeeping of Disclosures
EPA proposes to modify Secs. 2.301(h), 350.23(b)(3), and 2.209(g)
to streamline and clarify procedures for disclosure of CBI where
authorized to do so.
Section 2.301(h)(2)(iii) requires that before CBI may be disclosed
to an Agency contractor or subcontractor, advance notice must be given
to all affected businesses of the nature of the information to be
disclosed, the identity of the contractor or subcontractor, the
contract or subcontract number, and the purpose of the disclosure.
Affected businesses must be given at least 5 days to comment on the
proposed disclosure. Similarly, Sec. 2.301(h)(3)(ii) provides for
advance notice of disclosures to State and local governmental entities.
In addition, Sec. 2.301(h)(2)(iv) requires EPA offices disclosing
CBI to contractors to create a record of each disclosure, showing the
contractor or subcontractor, the contract or subcontract number, the
information disclosed, the date(s) of disclosure, and each affected
business; this record must be kept for at least three years. Similarly,
under Sec. 2.209(g), such a record must be kept with respect to
disclosures to Congress, a committee or subcommittee of Congress, the
Comptroller General, or another Federal agency. The following
paragraphs discuss proposed modifications to these requirements.
1. Form of Notice
Although neither Sec. 2.301(h)(2)(iii) nor Sec. 2.301(h)(3)(ii)
state the medium of the notice, the Agency's long-standing practice and
interpretation is that such notice may be given at least by letter or
Federal Register notice. EPA proposes to amend these paragraphs to make
explicit that notice in the Federal Register is one method of meeting
the requirements of these provisions.
EPA is also proposing to similarly amend Sec. 350.23(b)(3)
(governing EPCRA trade secret information), a provision equivalent to
Sec. 2.301(h).
2. Contract or Subcontract Number
Because Secs. 2.301(h)(2)(iii) and 350.23(b)(3) require that the
notice include the contract number, whenever EPA enters into a new
contract with the same contractor to do the same work as under a pre-
existing contract, a new Federal Register notice must be published (or
set of letters sent out), because the contract number has changed. EPA
believes the additional notice is a waste of Agency resources without
benefit to submitters, who already have notice of what information is
being provided to which contractor. Therefore, the Agency proposes to
eliminate the requirement to give notice of the contract or subcontract
number.
3. Response to Comments
Although a period for comments is provided by
Sec. 2.301(h)(2)(iii), the provision does not stipulate EPA's
responsibilities when comments are received. The Agency proposes to
revise the provision to make explicit the requirement to respond to
comments by affected businesses. EPA proposes to similarly revise
Sec. 350.23(b)(3) (governing disclosure of EPCRA trade secret data to
authorized representatives).
4. Records of Disclosures
Offices administering several environmental statutes (e.g., the
Toxic Substances Control Act (TSCA) and the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)) have developed security manuals
requiring extensive document tracking activities. Those offices have
concluded that the sensitivity and volume of the business information
they handle require such procedures. However, EPA as a whole has not
determined that there is an Agency-wide need to track every piece of
paper it receives. The requirements of Secs. 2.209(g) and
2.301(h)(2)(iv) are most appropriate for a TSCA or FIFRA security
scheme, and are not necessary for the entire Agency, especially given
the good track record of the Agency, its contractors, and other Federal
agencies in handling CBI. Therefore, EPA proposes to delete
Secs. 2.209(g) and 2.301(h)(2)(iv); Agency offices would continue to
include such a requirement in their internal security procedures, where
appropriate.
O. Disclosure to Foreign Governments and International
Organizations
EPA proposes to amend Sec. 2.209 to provide for disclosure of CBI
to foreign governments and international organizations where authority
for such disclosure exists.
EPA may need to disclose confidential information to foreign
governments or international intergovernmental bodies, such as the
United Nations, e.g., to assist in law enforcement activities or
pursuant to statutory requirements (see, e.g., export regulations
implementing section 12(b) of the Toxic Substances Control Act at 40
CFR Part 707). 40 CFR 2.209, governing disclosures of CBI in general,
does not include a provision for disclosure to foreign governments or
international organizations, even though authority for such disclosure
might be found in treaties or other agreements entered into by the
United States.
EPA therefore proposes to include a provision in Sec. 2.209
allowing such disclosure where the Office of General Counsel finds that
there is authority for such disclosure. Disclosure to foreign
governments or international organizations would involve several
safeguards:
(1) A written request for disclosure would be required (unless EPA
made a written determination that such disclosure was necessary to
assist the Agency in carrying out one of its functions or to enable EPA
to assist the government or organization with a duly-authorized
function of that entity);
(2) The General Counsel would have to determine that the Agency has
authority for the disclosure requested;
(3) Disclosure must be pursuant to law and procedures which will
provide adequate protection to the interests of affected businesses;
and
(4) advance notice of disclosure would be provided to affected
businesses.
One exception to advance notice would exist: Notice would not be
provided of a disclosure in the course of a criminal or other law
enforcement investigation. EPA works in conjunction with other
governments and international law enforcement agencies, such as
INTERPOL, in an increasing number of transboundary environmental
investigations. The confidential exchange of information, without risk
of disclosure to possible subjects of the investigation, can be
essential in preventing an investigation from being compromised. To
ensure that disclosure to an international body without notice to the
submitter occurred only when necessary, the rule would require a
determination by the Director of the Office of Criminal Enforcement (in
the case of criminal investigations) or the Office of Regulatory
Enforcement or the appropriate Office of Regional Counsel (in the case
of civil investigations) that providing such notice would interfere
with a criminal or civil law enforcement investigation before
disclosure could be made without notice.
P. Safeguarding of Confidential Information by Enrollees Under the
Senior Environmental Employment (SEE) Program
EPA proposes to amend Sec. 2.211 to include SEE enrollees within
its coverage.
On February 5, 1993, EPA promulgated a rule (58 FR 7187),
authorizing disclosure of confidential data, submitted pursuant to
certain environmental statutes administered by the Agency, to persons
participating in the Senior Environmental Employment (SEE) Program.
This program is authorized by the Environmental Programs Assistance Act
of 1984 (Pub. L. 98-313), which provides that the Administrator may
``make grants or enter into cooperative agreements'' for the purpose of
``providing technical assistance to Federal, State, and local
environmental agencies for projects of pollution prevention, abatement,
and control.''
The rule treated grantees/cooperators under the SEE Program in the
same fashion as contractors, requiring that protective clauses be
inserted into the SEE grants and cooperative agreements.
However, the rule did not correspondingly amend 40 CFR 2.211, which
requires Federal employees, contractors, and contractor employees to
protect CBI (this requirement is in addition to that imposed by
contract and statute). EPA proposes to include SEE grantees and
enrollees within the ambit of Sec. 2.211.
Q. Disclosure to Federal Agencies for Law Enforcement Purposes
EPA proposes to amend Sec. 2.209(c) to provide that no notice is
required when the Agency discloses CBI to other Federal agencies for
law enforcement purposes.
Under 40 CFR 2.209(c), CBI may be disclosed to other Federal
agencies with advance notice to the submitter. The only existing
exception to the notice requirement is when the other agency is
performing a function on behalf of EPA, e.g., representation by the
Department of Justice. However, occasions may arise when EPA needs to
cooperate with other agencies on a law enforcement investigation, in
which the other agency would not be performing a function on behalf of
EPA, but would, primarily, be pursuing its own investigation. Examples
of such cases include the investigation of procurement fraud on
contracts with more than one Federal agency or the violations of
environmental laws by companies whose activities are under the
jurisdiction of more than one agency. In such cases, prematurely
notifying the submitter of the transfer of CBI might jeopardize the
investigation or discourage the other agency from cooperating with EPA.
Therefore, EPA is proposing to amend Sec. 2.209(c) to provide that
no notice need be given to affected businesses of disclosure of CBI to
another Federal agency in the course of a law enforcement
investigation.
R. Reconciliation of Program-Specific Confidentiality Provisions
With Part 2
EPA proposes to cross-reference part 2 to specific confidentiality
provisions currently contained in specific program regulations outside
of part 2.
40 CFR part 2, subpart B regulates treatment of confidential data
by the Agency, and includes special provisions for each major
environmental statute administered by EPA. However, many program-
specific regulations outside of part 2 (e.g., Clean Air Act regulations
in 40 CFR parts 57, 85 and 86, and Toxic Substances Control Act
regulations in parts 710 and 720) contain confidentiality provisions
which, in some cases, differ from those of part 2.
EPA has always considered the program specific confidentiality
regulations as supplemental to part 2. However, the lack of reference
to such regulations in part 2 can be confusing both for the Agency and
for persons attempting to understand and comply with EPA's
confidentiality regulations. In determining how to resolve such
confusion, the Agency had to deal with competing considerations. First,
the Agency should be as consistent as possible in its treatment of CBI.
On the other hand, each program within the Agency is working with a
different statute (with slightly or significantly varying
confidentiality provisions) and operates in a different milieu of data,
confidentiality claims, and public interest in the information.
EPA is proposing to cross-reference existing program specific
confidentiality regulations in part 2 (the original provisions would
also remain in their respective parts). In some cases, minor changes
would be made to the program specific regulations where tighter
conformance with part 2, subpart A general regulations is desirable.
These changes are discussed on a statute-specific basis below.
The proposed reconciliation of program-specific CBI provisions with
part 2 does not affect 40 CFR part 350, governing trade secrecy under
the Emergency Planning and Community Right-to Know Act of 1986.
S. Changes to Rules Governing Certain Information Obtained Under the
Clean Air Act
1. Applicability of 40 CFR 2.301, Special Rules for the Clean Air Act
EPA proposes to amend Sec. 2.301(b)(1)(ii) to comport with the
language of section 208(a) of the Clean Air Act, as amended in 1990. In
particular, the Clean Air Act Amendments expanded EPA's authority under
section 208(a) to obtain information ``to otherwise carry out the
provision of (part A) and part C'' of the Clean Air Act. Also, the
language makes clear that EPA's authority under section 208(a) relates
specifically to part A and part C of Subchapter II of the Clean Air
Act.
2. Basic Rules Which Apply Without Change and Assertion of Claims
Section 2.203(c) allows businesses as a general matter to assert
late confidentiality claims. Specific Clean Air Act regulations in
parts 57 and 85 of Title 40 differ by providing that confidentiality
claims must accompany the information at the time it is submitted to
EPA. In addition, certain Clean Air Act regulations require that a
sanitized version of the information must be provided and that CBI
claims must be indicated by bracketing, stamping, or otherwise
specifying the claimed information in order to assert that information
submitted is confidential. Finally, in 40 CFR 85.408, EPA's motor
vehicle regulations additionally require specific labelling and
numbering of documents claimed confidential. EPA is proposing changes
here to Sec. 2.301 (c) and (d) to incorporate these specific Clean Air
Act requirements into part 2.
3. Changes to Specific Clean Air Act Regulations Under Parts 57, 85 and
86
EPA is proposing additional minor changes to Clean Air Act
regulations to reconcile those regulations with the changes being
proposed for part 2. Specifically, EPA is proposing to amend references
to Sec. 2.204(c)(2)(i)(A). That provision currently specifies that in
certain cases where a submitter might have been expected to assert a
confidentiality claim but did not, the EPA office shall contact the
business to inquire whether the business asserts a claim covering the
information. Since EPA is proposing that this inquiry provision be
deleted (prospectively only, see section B., above), references to the
provision in Clean Air Act regulations should apply only to data
submitted before the date the change to Sec. 2.204(c)(2)(i)(A) becomes
final. Also, the provisions currently contain references to Federal
Register notices publishing outdated versions of part 2 rules; EPA
would delete these references.
4. Substantive Criteria for Confidentiality Determinations: Production
and Consumption Allowances Under Title VI
Section 602 of the Clean Air Act provides for additions to the
lists of class I and class II ozone depleting substances. Section 607
specifies that the Administrator shall promulgate regulations providing
for production and consumption allowances of these substances. As
explained in detail below, the Act without exception compels the public
disclosure of companies' production and consumption allowances for such
newly listed substances; such disclosure is likely to result in the
release of information otherwise regarded as confidential. Congress
specified that the allowances are to be based on companies' individual
production and consumption levels. Therefore, upon promulgation of a
final rule listing a new ozone depleting substance as a class I
substance, the Agency believes that this information should not be
entitled to treatment as CBI. This is consistent with the position the
Agency has taken in an information collection request for information
regarding production and consumption of methyl bromide. 58 FR 15014
(March 18, 1993).
It is unnecessary to treat information as CBI or to undertake
regulatory procedures to disclose CBI where the statute directly
requires that specific information be disclosed. As explained below,
the Clean Air Act compels the Agency to disclose specific information
related to the establishment of limits on ozone-depleting substances.
Therefore, the Agency believes that this information is not eligible
for confidential treatment.
The relevant provisions of Titles III and VI of the Clean Air Act
require the Agency to disclose company- and chemical-specific
production and consumption allowances for a newly listed substance, at
least where the company produces or consumes only one such newly listed
substance. Sections 604 and 607 together require that EPA issue
company- and chemical-specific allowances for production and
consumption of newly listed substances. Section 604 imposes production
and consumption limits on each company based on the company's baseline
year production and consumption of the newly listed substance. A
company is limited to a specified percentage of its baseline year
production and consumption of the particular chemical. Section 607
requires EPA to ``promulgate rules * * * providing for the issuance of
allowances'' for the production and consumption of listed substances.
Under this provision, EPA is to issue specific allowances in accordance
with production and consumption limits. Particularly where allowances
are issued for a single newly listed substance, disclosure of a
company's allowances based on baseline year production and consumption
levels would disclose what might ordinarily be considered CBI.
Congress enacted sections 604 and 607 against the regulatory
backdrop of EPA's regulations implementing the Montreal Protocol under
existing Clean Air Act authority (former section 151(b)). The Agency
implemented the Protocol production and consumption limits through
rulemaking establishing company-specific allowances. See 53 FR 30566
(August 12, 1988) (implementing the Montreal Protocol and allotting
production and consumption allowances to producers and importers). The
adoption of sections 604 and 607 in the 1990 Amendments indicates that
Congress intended to continue the Agency's company-specific approach.
Section 604 requires that production and consumption limits apply on a
company-specific basis. Section 607 requires that allowances be based
on these company-specific limits. The Agency's current regulations
under section 607 comport with this approach. See 56 FR 9518 (March 6,
1991) (temporary final rule implementing 1991 production and
consumption limits under section 604); 56 FR 49548 (Sept. 30, 1991)
(Notice of Proposed Rulemaking to implement 1992 and later production
and consumption limits under section 604). Title VI calls for issuance
of company- and chemical-specific allowances for listed substances.
Further, under section 307(d)(1), of the Clean Air Act, the public
participation and disclosure provisions of section 307(d) apply to
``promulgation or revision of regulations under Title VI.'' Therefore,
the allowances must be published for public comment to be legally
binding and enforceable. In addition, under section 307(d)(3), the
Agency is obligated to include the factual basis for the allowances in
the docket for the rulemaking and to include a summary of the factual
data in the statement of basis and purpose for the proposed and final
rule.
The Clean Air Act's citizen suit provision further confirms that
Congress intended Title VI production and consumption limits be
disclosed to the public. Section 304 authorizes ``any person'' to
commence a civil action alleging a violation of an emission standard or
limitation under the Act. Section 304(f) defines ``emission standard or
limitation under this Act'' to include, inter alia, ``a schedule or
timetable of compliance, emission limitation, standard of performance
or emission standard,'' and thus includes title VI production and
consumption limits. Public disclosure of company- and chemical-specific
production and consumption limits is necessary for citizens to
challenge violations of those limits.
Therefore, EPA proposes to amend Sec. 2.301(e) to provide that
production and consumption allowance information is not entitled to
confidential treatment.
5. Confidentiality of Certain Emission Data
EPA is proposing a new Sec. 2.301(e)(2) to specifically identify
emission data that are not entitled to confidential treatment and,
notwithstanding a confidentiality claim, may be disclosed without
further notice. This proposal would codify current EPA policy regarding
categories of data that may be excluded from the trade secret
definition. That policy was published at 56 FR 7042 (February 21,
1991). As EPA explained in that notice, EPA believes that some kinds of
data will always constitute emission data within the meaning of section
114(c) of the Act. The list of types of data specified here is not
intended to be a comprehensive list of those types of data which are
not entitled to confidential treatment, but is intended to facilitate
the use of these data without the need for further processing of
confidentiality claims. EPA believes that the information identified is
sufficiently specific that a case-by-case evaluation of whether data
submitted is covered by the new Sec. 2.301(e)(2) is not necessary.
6. Confidentiality of Gasoline Performance Baselines
On December 15, 1993, EPA issued final regulations for the Clean
Air Act's reformulated and conventional gasoline programs. This rule
was published on February 16, 1994 (59 FR 7716). The regulations
require that refiners and importers of gasoline submit certain
information to EPA concerning the quality of the gasoline they produced
or imported in 1990. From this, EPA establishes an individual baseline
for the refinery or importer. In large part, the individual baseline
then becomes the refiner's or importer's performance standard for
conventional gasoline. In effect, the quality of their gasoline must on
average meet or exceed specified standards set at their 1990 individual
baseline levels. A similar approach is used in the reformulated
gasoline program for certain standards, however, these standards only
apply to certain fuel parameters and only apply for the first three
years of that program.
The regulations concerning individual baselines include two
provisions relating to public disclosure of this information. First,
under 40 CFR 80.93(b)(6)(i) EPA will publish the individual standards
for each refinery and importer, including baseline emissions. In
addition, under 40 CFR 80.93(b)(6)(ii) EPA determined that certain
information provided by the refiner or importer in their individual
baseline submission would not be considered confidential, under the
theory that such information constitutes emission data.
Various interested parties have since sought judicial review of
these individual baseline regulations, including those provisions
governing confidentiality. In light of this litigation, and to avoid
confusion, EPA is not proposing today to cross reference these
individual baseline regulations in Sec. 2.301, but instead will
determine the appropriate revision to part 2 at a later time. In the
meantime, the confidentiality provisions in 40 CFR 80.93(b)(6) remain
in effect.
T. Changes to Rules Governing Certain Information Obtained Under the
Clean Water Act
The Agency is proposing amendments both to its supplemental CBI
regulations at Sec. 2.302 and to certain other regulations in Title 40
which relate to the handling of CBI under the Clean Water Act (CWA).
These changes are intended to make CWA confidentiality provisions
published in 40 CFR parts 122, 123, 233, 403 and 501 consistent with
the provisions, including the changes proposed today, in 40 CFR part 2.
1. Substantive Criteria for Use in Confidentiality Determinations
The Agency is proposing to amend the part 2 supplemental CWA
provision (Sec. 2.302) to incorporate, for purposes of consistency,
certain limitations on confidentiality currently provided by the CWA
regulatory provisions (Secs. 122.7, 233.3, and 501.15). These sections
provide that: (1) Effluent data, (2) the name and address of any permit
applicant or permittee, and (3) any permit application (including any
attachments used to supply information required by the application
forms) or permit are not eligible for confidential treatment. This
change to Sec. 2.302 would not substantively alter the Agency's
approach to CBI under the CWA.
2. Changes to Specific Clean Water Act Regulations
Under Parts 122, 123, 233 and 403
As discussed in section B., above, the Agency is proposing to amend
Sec. 2.203 to provide that any information submitted to EPA without a
claim of confidentiality may be disclosed to the public without
inquiring whether the submitter wishes to claim confidentiality. The
Agency proposes to amend Secs. 122.7, 123.41 and 403.14 of this part to
make those sections consistent with part 2 procedures, including
changes proposed today. Specifically, the Agency is proposing to amend
these sections to clarify that submitters are not prohibited from
asserting CBI claims subsequent to the time of submission, but that any
such late claims will be treated in accordance with Sec. 2.203.
Sections 122.7, 123.41 and 403.14 would continue to refer to the part 2
regulations as controlling the handling of CBI.
The Agency is proposing to amend Sec. 233.3, which relates to
confidentiality of information under the Section 404 State Program
Regulations (part 233). In its current form, Sec. 233.3 states that
information submitted under part 233 may be claimed as confidential and
that ``a final determination as to that claim will be made in
accordance with the procedures of 40 CFR part 2.'' This language could
be interpreted to mean that the Agency will make a final CBI
determination for all information submitted under part 233 for which a
CBI claim is asserted. Such an interpretation would be inconsistent
with both Agency practice and the procedures set forth in part 2. Part
2 does not require a CBI determination every time a CBI claim is
submitted. Rather, information so submitted is protected as CBI until
such time as the Agency has a need to disclose such information (for
example, when the information is needed as part of a proceeding, or
when responding to a Freedom of Information Act Request). Therefore,
the Agency proposes to amend Sec. 233.4 to conform with standard Agency
CBI procedures, as set forth in part 2.
Finally, the Agency proposes to amend the discussion in Sec. 123.42
concerning disclosure of CBI to States to include a reference to the
part 2 confidentiality regulations. This change would clarify that
disclosures of information under that section are subject to part 2.
U. Changes to Rules Governing Certain Information Obtained Under the
Safe Drinking Water Act
The Agency is proposing amendments both to its supplemental CBI
regulations at Sec. 2.304 and to certain regulations in 40 CFR part 145
which relate to the handling of CBI under the Safe Drinking Water Act
(SDWA). These changes are intended to make parts 144, 145 and 147
confidentiality provisions consistent with the provisions, including
the changes proposed today, in 40 CFR part 2.
1. Substantive Criteria Used in Confidentiality Determinations
The Agency is proposing to amend the part 2 supplemental SDWA
provision (Sec. 2.304) to incorporate, for purposes of consistency,
certain limitations on confidentiality currently provided by the SDWA
regulatory provisions (Secs. 144.5 and 147.2907). These sections
provide that neither (1) the name and address of any permit applicant
or permittee nor (2) information which deals with the existence,
absence, or level of contaminants in drinking water are eligible for
confidential treatment. This change to Sec. 2.304(e) would not
substantively alter the Agency's approach to CBI under the SDWA.
2. Changes to Specific Safe Drinking Water Act Regulations Under Part
145
As discussed in section B., above, the Agency is proposing to amend
Sec. 2.203 to provide that any information submitted to EPA without a
claim of confidentiality may be disclosed to the public without
inquiring whether the submitter wishes to claim confidentiality. The
Agency proposes to amend Sec. 145.14 of this part to make that section
consistent with part 2 procedures, including those changes proposed
today. Specifically, the Agency is proposing to amend Sec. 145.14 to
clarify that submitters are not prohibited from asserting CBI claims
subsequent to the time of submission, but that any such late claims
will be treated in accordance with Sec. 2.203. Section 145.14 would
continue to refer to the part 2 regulations as controlling the handling
of CBI.
V. Changes to Rules Governing Certain Information Obtained Under the
Solid Waste Disposal Act
The Agency is proposing amendments both to its supplemental CBI
regulations at Sec. 2.305 and to certain regulations in 40 CFR parts
270, 271 and 281 which relate to the handling of CBI under the Solid
Waste Disposal Act, as amended by the Resource Conservation and
Recovery Act (RCRA). These changes are intended to make all RCRA
confidentiality provisions consistent with the provisions, including
the changes proposed today, in 40 CFR part 2.
1. Disclosure of Hazardous Waste Export Information
40 CFR 260.2 and 262.53 provide that certain information submitted
in notifications of intent to export a hazardous waste will be provided
to the Department of State and the appropriate authorities in a
receiving country, regardless of any claims of confidentiality.
Consistent with the Agency's intent to integrate the part 2
supplemental CBI regulations with regulations relating to CBI found
under other Agency program regulations, EPA is proposing to amend the
supplemental RCRA CBI regulation at Sec. 2.305 to include, as a new
paragraph Sec. 2.305(f), this already existing limitation on
confidentiality treatment.
2. Changes to Specific Resource Conservation and Recovery Act
Regulations Under Parts 270, 271, and 281
As discussed in section B., above, the Agency is proposing to amend
Sec. 2.203 to provide that any information submitted to EPA without a
claim of confidentiality may be disclosed to the public without
inquiring whether the submitter wishes to claim confidentiality. The
Agency proposes to amend Secs. 270.12, 271.17, 271.132 and 281.43 to
make those sections consistent with part 2 procedures, including the
changes proposed today. Specifically, the Agency is proposing to amend
these sections to clarify that submitters are not prohibited from
asserting CBI claims subsequent to the time of submission, but that any
such late claims will be treated in accordance with Sec. 2.203. These
sections would continue to refer to the part 2 regulations as
controlling the handling of CBI.
3. Change to List of Authorities
In the authority section for part 2 and in Sec. 2.305, section 9005
of RCRA is incorrectly cited as 42 U.S.C. 6995. The citation will be
corrected to 42 U.S.C. 6991d.
W. Changes to Rules Governing Certain Information Obtained Under the
Toxic Substances Control Act
The Agency is proposing amendments to its supplemental CBI
regulations at Sec. 2.306 which relate to the handling of CBI under the
Toxic Substances Control Act (TSCA). These changes are intended to make
all TSCA confidentiality provisions consistent with the provisions,
including the changes proposed today, in 40 CFR part 2, and to clarify
the scope of health and safety data under TSCA.
1. Signature of a Senior Management Official for Some Confidentiality
Claims and Substantiations
EPA proposes to make several amendments to require that a senior
management official sign all assertions and substantiations of
confidentiality claims for information submitted pursuant to the
following provisions, which constitute the core TSCA program: 40 CFR
part 704, subpart A (Reporting and Recordkeeping Requirements--General
Reporting and Recordkeeping Provisions for Section 8(a) Information-
Gathering Rules); 40 CFR part 704, subpart C (Reporting and
Recordkeeping Requirements--CAIR: Comprehensive Assessment Information
Rule--General Reporting and Recordkeeping Provisions); 40 CFR part 707,
subpart D (Chemical Imports and Exports--Notices of Export Under
Section 12(b)); 40 CFR part 710, subpart A (Inventory Reporting
Regulations--Compilation of the Inventory); 40 CFR part 710, subpart B
(Inventory Reporting Regulations--Partial Updating of the Inventory
Data Base); 40 CFR part 712 (Chemical Information Rules); 40 CFR part
716 (Health and Safety Data Reporting); 40 CFR part 717 (Records and
Reports of Allegations that Chemical Substances Cause Significant
Adverse Reactions to Health or the Environment); 40 CFR part 720
(Premanufacture Notification); 40 CFR part 723, subpart B
(Premanufacture Notice Exemptions--Specific Exemptions); 40 CFR part
750, subpart B (Procedures for Rulemaking Under Section 6 of the Toxic
Substances Control Act--Interim Procedural Rules for Manufacturing
Exemptions); 40 CFR part 750, subpart C (Procedures for Rulemaking
Under Section 6 of the Toxic Substances Control Act--Interim Procedural
Rules for Processing and Distribution in Commerce Exemptions) ; and 40
CFR part 790, subpart A (Procedures Governing Testing Consent
Agreements and Test Rules--General Provisions).
First, EPA proposes to amend Sec. 2.306(a) to include a definition
of ``senior management official''. Second, EPA proposes to amend
Sec. 2.306(d) and the applicable portions of the TSCA implementing
rules to require that assertions and substantiations of confidentiality
in the core TSCA program be signed by such a senior management
official.
The definition of senior management official is taken nearly
verbatim from the implementing regulations of the Emergency Response
and Community Right-To-Know Act (EPCRA), 42 U.S.C. 11001 et seq., at 40
CFR 350.1. As incorporated, this definition of senior management
official has been codified since 1988 and is well understood.
Submitters of information pursuant to EPCRA have made the determination
of who a senior management official is. Most submitters of information
pursuant to TSCA also submit information pursuant to EPCRA. The choice
to use very similar language was made to simplify reporting burdens for
submitters by imposing very similar reporting requirements. This will
also have the effect of providing consistency between the TSCA and
EPCRA programs administered by EPA which will become more important as
the Agency seeks to enhance the compatibility of its data bases.
EPA believes that one situation in which submitters assert
unsupportable confidentiality claims occurs when there is an inadequate
review of claims at the corporate level. Individual staff and less
senior management officials often lack the organizational perspective
to view confidentiality claims in the context of an entire corporate
policy and are unaware of the actions of other business units regarding
confidentiality claims.
Based on a limited sampling of submissions pursuant to TSCA, it
appears that a majority of TSCA submissions containing confidentiality
claims already conform with a senior management signatures requirement.
EPA believes that this wide-spread industry practice provides for
needed management oversight and seeks, by this rule, to
institutionalize the practice.
EPA believes that requiring all confidentiality claims and
substantiations for submissions subject to this requirement to be
signed by a senior management official is the most effective way to
ensure that sufficient deliberation and consideration is made when
claiming confidential status. As discussed in section W.3, below, EPA
seeks to increase the amount of accurate TSCA derived chemical
information available to the public. The Agency believes that
prescribing a senior level of scrutiny will help alleviate
unsupportable confidentiality claims. Also, EPA treats information
claimed confidential very carefully at significant cost and expects the
cooperation of industry to assure that such costs are incurred only
where necessary.
Authority for a senior management official signature requirement
exists in Sec. 14(c) of the Act which states that ``[a] designation * *
* shall be made in writing and in such a manner as the Administrator
may prescribe''. This authority to impose a similar signature
requirement has been previously exercised. See, e.g., 40 CFR
710.32(c)(2).
2. Up-front Substantiation of Confidentiality Claims for Chemical
Identity
EPA proposes to amend Secs. 2.306(d), 716.55 and 717.19 to require
that claims of confidentiality for chemical identity in Records and
Reports of Allegations that Chemical Substances Cause Significant
Adverse Reactions to Health or the Environment, submitted pursuant to
section 8(c) of TSCA, Health and Safety Data Reports, submitted
pursuant to section 8(d), and notices of substantial risk, submitted
pursuant to section 8(e), must be accompanied by a substantiation at
the time of submission. This requirement will apply only to chemicals
listed on either the public or confidential portions of the TSCA
Chemical Inventory. Chemicals not on the inventory, i.e., those not
available in commerce, will not be subject to this requirement.
EPA would prospectively require submitters to substantiate the
confidentiality claims described above at the time of filing by
responding to a series of questions. These substantiation questions are
designed to address with particularity the issues generally framed by
Secs. 2.204(e)(4) and 2.208 which set forth, among other factors, the
criteria of:
(1) What portion of the information the submitter believes is
entitled to confidential treatment;
(2) The length of time for which confidential treatment is desired;
(3) Measures taken by the business to prevent undesired disclosure
to others;
(4) The extent to which the information has already been disclosed
to others; and
(5) Why release of the information would result in substantial
harmful effects to the business' competitive position in the
marketplace. 40 CFR 2.204(e)(4).
EPA has, for several years, consistently reviewed confidentiality
claims for chemical identity asserted in submissions pursuant to
sections 8(d) and 8(e) of TSCA. This heightened scrutiny has occurred
contemporaneously with a decision by EPA's Office of Pollution
Prevention and Toxics to increase the amount of accurate TSCA-derived
chemical information available to the public. The major focus of these
dissemination activities has been on making available health and safety
data.
EPA considers chemical identity to be part of, or underlying data
to, a health and safety study in health and safety data reports. See,
40 CFR 716.3. Furthermore, this definition of health and safety data
will be formalized for all TSCA submissions (See the revision to
Sec. 2.306(a)(3) and accompanying preamble discussion, infra). As a
result, claims of confidentiality for chemical identity in such filings
are considered carefully. Nevertheless, there are situations where
chemical identity in a health and safety study may be entitled to
confidentiality.
Any inquiry into a confidentiality claim is a fact-specific
exercise. In this particular circumstance, EPA has determined that
there is a data gap when reviewing confidentiality claims for chemical
identity in health and safety studies. Necessary facts regarding
competitive market forces, the nature of the potential harm perceived
by the submitter, the submitter's treatment of the information and
other vital factors are not available to properly evaluate the claim.
This requires the Agency to contact by telephone the submitter each
time a claim is considered. Often, it is necessary to follow up the
telephone call with a written substantiation request pursuant to 40 CFR
2.204(d)(1).
There are, however, significant problems with the current practice.
First, it is inefficient for submitters. A submitter must carefully
consider a confidentiality claim prior to asserting it to the Agency.
The questions and issues so considered are substantially similar to the
questions a submitter must answer and the issues a submitter must
consider when responding to a substantiation request pursuant to 40 CFR
2.204(d)(1). When responding to such a substantiation request, the
submitter is simply considering for a second time and recording the
same thought processes as before. By requiring the submitter to take
one look at the issues implicated by a confidentiality claim, and
eliminating the duplicative two-step consideration process for
submitters, the up-front substantiation requirement will be less
burdensome on submitters.
Second, the current process lacks rigor, and is time-inefficient
for EPA. Decisions are sometimes based on insufficient information or
resources are expended gathering data which would be collected by the
up-front substantiation requirement. Through imposing this new
requirement, EPA seeks to improve the quality and speed of
decisionmaking on confidentiality claims for chemical identity.
At the same time, EPA wishes to minimize the burden placed on
submitters by the imposition of this new requirement. For this reason,
the Agency has decided to impose an up-front substantiation requirement
only for chemicals listed on the TSCA Chemical Inventory.
The rationale for this limitation is as follows. The intended
result of the confidentiality claim review process is to make more and
more useful chemical information available to the public. Chemicals
which are not listed on the TSCA Chemical Inventory may not legally
enter commerce, except in extraordinarily limited circumstances. There
is a lesser risk of exposure, and therefore, a lesser utility for
chemical information for public information purposes, if a chemical
substance is not available in commerce.
The implementation of an up-front substantiation requirement for
confidentiality claims for chemical identity in the limited
circumstances above is carefully sculpted to address the information
needs of the Agency while minimizing the burden placed on industry.
Authority for an up-front substantiation requirement exists in the
Freedom of Information Act, the Trade Secrets Act, and section 14(c) of
TSCA, which states that ``[a] designation * * * shall be made in
writing and in such a manner as the Administrator may prescribe''. (cf.
discussion of sunset provisions in section F., above). This authority
to impose an up-front substantiation requirement has been exercised
numerous times in the past, including for confidentiality claims for
chemical identity. See, e.g., 40 CFR 710.38(c)(1); 40 CFR
720.85(b)(3)(iv).
3. Definition of Health and Safety Data
EPA is proposing to clarify the definition of ``health and safety
data'' in Sec. 2.306(a)(3) (the term ``health and safety data'' would
be used interchangeably with ``health and safety study'') by adding
additional language to the definition to indicate that the term
encompasses not only data from a formal study but also any data
pertaining to the effects of a chemical on health or the environment.
The language is taken directly from the definition of ``health and
safety study'' in 40 CFR 716.3(e), which implements health and safety
data reporting pursuant to TSCA section 8(d), and in 40 CFR 720.3(k),
which implements premanufacture notification procedures pursuant to
TSCA section 5. EPA would include this clarification to ensure
regulatory consistency under TSCA.
4. Disclosure of Health and Safety Data
TSCA section 14(b) provides that data from health and safety
studies are not eligible for confidential protection unless disclosure
of such data would further disclose process information or proportions
of a mixture. As a means of implementing section 14(b),
Sec. 2.306(a)(3) currently defines health and safety data to exclude
data whose disclosure would further disclose process information or
proportions of a mixture. This definition achieves the result intended
by TSCA section 14(b), that process and mixture information are not
automatically exempt from confidential treatment.
However, Sec. 2.306(a)(3) as currently written does not properly
reflect the structure imposed by section 14(b). Therefore, EPA is
proposing to: (1) Modify Sec. 2.306(a)(3) to indicate that information
pertaining to process and mixture data may still be health and safety
data, and (2) revise Sec. 2.306(g) (criteria for confidential
treatment, redesignated in this proposal as Sec. 2.306(h) for reasons
unrelated to the discussion here) such that health and safety data
whose disclosure would further disclose process information or
proportions of a mixture may be eligible for confidential treatment if
they meet the standard criteria for confidentiality articulated in
Sec. 2.208. No substantive change in the eligibility of such data for
confidentiality is intended.
5. Reconciliation of TSCA Program-Specific Rules With Part 2 Rules
EPA proposes to incorporate various confidentiality provisions in
the TSCA implementing regulations (subchapter R of title 40) into part
2. Subchapter R contains several program specific confidentiality rules
tailored to the individual needs of the program. This amendment will
clarify the provisions that apply to information submitted pursuant to
TSCA.
Section 2.306(c) currently provides that Sec. 2.203 of the part 2
basic rules (the basic rules are those which apply over all programs,
except where otherwise indicated) applies without change to information
covered by Sec. 2.306. Section 2.203 governs procedures for asserting
claims of confidentiality. Because (1) subchapter R rules which contain
provisions governing confidentiality would be incorporated into
Sec. 2.306, and (2) many of these provisions differ from those in
Sec. 2.203, EPA would include a new paragraph, Sec. 2.306(d), detailing
the extent to which Sec. 2.203 and subchapter R provisions govern
assertion of CBI claims.
Similarly, those subchapter R provisions pertaining to disclosure
of CBI in special circumstances (normally governed by Sec. 2.209) would
be incorporated into Sec. 2.306(i) (currently Sec. 2.306(h)). Section
2.306(i) would also incorporate provisions for disclosure of
confidential chemical identities to bona fide requestors under 40 CFR
parts 710, 720, 721, and 723, and for disclosure to foreign governments
of export information under Sec. 707.75(c).
Current provisions under the Pre-manufacture Notification (PMN) and
Polymer Exemption Rules require reassertion and substantiation of a CBI
claim for chemical identity upon filing of a Notice of Commencement
(NOC). The rules also provide for expiration of the chemical identity
CBI claims for the underlying PMN and Polymer Exemption Application
should the NOC be filed without such reassertion and substantiation.
These provisions would be incorporated into a new paragraph
Sec. 2.306(m), a sunset provision consistent with proposed Sec. 2.216.
6. Sunset Provisions
EPA has considered proposing a sunset provision (see section F.,
above) for all confidentiality claims for information collected
pursuant to TSCA, or for some discrete subset of claims. At this time,
the Agency has decided to defer proposal of a TSCA sunset provision.
EPA believes that a sunset provision is appropriate only with respect
to those data collections where there is an identified need for
information to be publicly available after the passage of time (or
occurrence of an event). The Agency may reconsider TSCA sunset
provisions after appropriate analysis and articulation of need.
In order to evaluate the issues identified above, EPA solicits
comments on the following with respect to TSCA sunset provisions:
A. What information collected pursuant to TSCA would be most
appropriate for application of a sunset provision? Should the sunset
provision apply to all TSCA submissions of a specified type of
information (e.g., all submitter identities) or only with respect to
individual data collections (e.g., all submitter identities in
submissions pursuant to the Partial Updating of the Inventory Data
Base, 40 CFR 710.23 et seq.)? What information collected pursuant to
TSCA would be least appropriate for application of a sunset provision?
B. How long should the period be before sunset occurs?
C. Are any mechanisms in place for industry to periodically review
and relinquish confidentiality claims whose rationales for assertion
have disappeared? If so, is there any vehicle for the dissemination of
information no longer claimed as confidential?
X. Changes to Rules Governing Certain Information Obtained Under the
Federal Insecticide, Fungicide, and Rodenticide Act
The Agency is proposing amendments to its supplemental CBI
regulations at Sec. 2.307 which relate to the handling of CBI under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). These
changes are intended to: (1) Make all FIFRA confidentiality provisions
consistent with the provisions, including the changes proposed today,
in 40 CFR part 2;
(2) Codify procedures regarding handling of FIFRA CBI previously
announced in Federal Register notices; and
(3) Clarify procedures for release of FIFRA CBI in emergency
situations.
1. Codification of 1978 Interim Procedures
In 1978, Congress amended FIFRA to include new provisions for the
treatment and release of CBI. On December 19, 1978, EPA published in
the Federal Register a Notice of Interim Procedures for the treatment
of such information (43 FR 59060). At that time, EPA stated that the
interim procedures would remain in effect pending issuance of
amendments to the Agency's regulations at 40 CFR part 2. EPA is
proposing to amend the part 2 regulations applicable to information
submitted under FIFRA to incorporate the 1978 interim procedures as
permanent procedures. For more information on the rationale behind
specific provisions, please refer to the Notice of Interim Procedures
at 43 FR 59060.
Specifically, this proposed rule would establish procedures for
handling FIFRA CBI under the following circumstances:
a. Disclosure of CBI relating to formulas of products in public
hearings and in findings of fact issued by the Administrator.
The term ``findings of fact'' includes, but is not limited to, the
process of reviewing pesticides in order to decide whether to register,
reregister, or cancel those products, particularly notices published
during the Special Review process under 40 CFR part 154 (formerly known
as the RPAR or ``rebuttable presumption against registration''
process). The term also applies in cases where an inert ingredient of a
pesticide is the subject of a Special Review notice.
b. Disclosure of test data relating to registered or previously
registered pesticides pursuant to FIFRA.
The proposed Sec. 2.307(g) would clarify that, pursuant to FIFRA
section 10(d)(1), where safety and efficacy data (defined in proposed
Sec. 2.307(a)(5)) are submitted with regard to ``a registered or
previously registered pesticide or its separate ingredients,
impurities, or degradation products'' (language from FIFRA section
10(d)(1)), EPA will deny any claim of confidentiality for that data
unless the submitter can show that it would disclose one or more of the
three types of information specifically protected by FIFRA section
(10)(d)(1) (A)-(C), relating to manufacturing and quality control
processes, the identity and quantity of inert ingredients, and methods
of testing, detecting or measuring the quantities of inert ingredients.
Where data are submitted with regard to a pesticide which is not yet
registered, EPA will continue to follow the general procedures for
determining confidentiality of information under the general part 2,
subpart B rules. Section 2.307(a)(5) would also embody EPA's
interpretation that the language in section 10(d)(1) concerning ``a
registered or previously registered pesticide'' means that data
pertaining to pesticides which have never been registered (i.e., data
from applicants) is not subject to mandatory section 10(d)(1)
disclosure.
c. Disclosure of FIFRA CBI to contractors.
The 1978 Notice of Interim Procedures stated that the Office of
Pesticide Programs (OPP) and its contractors would follow the security
procedures listed in the EPA TSCA Confidential Business Information
Security Manual pending development of procedures specific to the
pesticides program. Since then OPP has completed its FIFRA Information
Security Manual. This document contains the procedures EPA and its
contractors follow when handling FIFRA CBI and is available through the
Information Services Branch of OPP. Therefore, EPA proposes that
Sec. 2.307(h)(3)(v) state that contractors who are allowed access to
FIFRA CBI will be required to follow the security procedures detailed
in that manual.
d. Disclosure of data to foreign or multinational pesticide
producers.
The 1978 amendments to FIFRA included a provision, section 10(g),
which prohibits EPA from providing data submitted by a registrant or an
applicant for registration (without the submitter's consent) to any
employee or agent of any business or other entity engaged in the
production, sale, or distribution of pesticides in countries other than
the United States or in addition to the United States, or to any other
person who intends to deliver such data to any such foreign or
multinational entity. In addition, FIFRA section 10(g) compels the
Administrator to require that every person requesting data affirm that
such person does not seek access to the data in order to deliver it or
offer it for sale to any foreign or multinational entity described
above, and that such person will not purposefully deliver it nor
negligently cause it to be delivered to any such entity. This proposed
rule would codify the procedures by which EPA implements this section
and the affirmation which must be made by all persons seeking access to
data submitted by registrants or applicants under FIFRA.
The text of FIFRA section 10(g) uses the terms ``information'' and
``data'' interchangeably. EPA has historically interpreted this section
to apply only to test data submitted by registrants and applicants for
registration. This is because section 10(g) was designed to prevent
companies from obtaining proprietary data from EPA under FOIA and FIFRA
section 10(d)(1) and using it to gain market entry in foreign countries
without contributing to the costs of developing the data, as FIFRA
section 3(c)(1)(F) requires of domestic market entrants. The term
``information'' could be read to include items which EPA routinely
makes available such as registration applications, product labeling,
and general offers to pay data compensation. Because EPA believes that
Congress intended to restrict foreign companies' access to registration
data, EPA interprets section 10(g) to apply only to test data.
On September 24, 1985, EPA issued Class Determination 3-85, stating
that reviews of data submitted by applicants or registrants which were
prepared by EPA personnel or under an EPA-funded contract and which do
not reveal the full methodology and complete results of the study,
test, or experiment, and all explanatory information necessary to
understand the methodology or interpret the results are not subject to
FIFRA section 10(g). Class Determination 3-85 noted that section 10(g)
``is intended to prevent a person from obtaining, under FIFRA, data
generated at another person's expense and then using the data to obtain
the approval of another country's government to manufacture, sell, or
use pesticides in that country * * * Disclosure of EPA reviews of data
(provided that they are truly reviews, and not essentially complete
reports) will not be useful in obtaining approvals by governments of
other countries. To the extent that such a country requires data to
evaluate the request, it is unlikely to be satisfied with a review of
data conducted by EPA; to the extent that such a country is willing to
accept an EPA review in lieu of data, it is just as likely to accept
other readily available information indicating EPA's position, such as
evidence that EPA has registered the product.'' EPA proposes to codify
this interpretation of FIFRA section 10(g) in Sec. 2.307(i)(1).
Class Determination 3-85 also stated that reviews of safety and
efficacy data which contain neither the three types of information
specifically protected by FIFRA section (10)(d)(1) (A)-(C) nor
unpublished information concerning the production, distribution, sale,
or inventories of a pesticide are not eligible for confidential
treatment. This would be codified in proposed Sec. 2.307(k)(2).
2. Incorporation of FIFRA Program Provisions Regarding CBI
In addition to the procedures proposed above, EPA is proposing to
amend the part 2 regulations to reference various regulations
promulgated under FIFRA at 40 CFR parts 152, 154, 155, and 158, which
contain specific provisions regarding CBI submitted under those
regulations. This amendment would not change the substance of those
provisions, but would merely incorporate them into Sec. 2.307. These
provisions pertain mainly to assertion of business confidentiality
claims when submitting particular types of information; also
incorporated (in Sec. 2.307(k)(1)) is a provision currently in
Sec. 152.119(b), governing public inspection of materials submitted to
comply with section 3(c)(1)(D) of FIFRA.
In addition, the Agency is proposing to add a new paragraph
Sec. 2.307(j), regarding designation by a business of an addressee for
notices and inquiries. This provision would incorporate the
requirements of 40 CFR 152.50(b) (2) and (3) for businesses which are
registrants or applicants for registration of a pesticide. For parties
other than registrants or applicants, Sec. 2.213(a) would still apply.
3. Release in Emergency Situations
EPA is proposing two amendments intended to clarify what personnel
could be allowed access to CBI in the event of an emergency under
Sec. 2.307(h)(2). First, EPA proposes to define the term ``qualified
persons'' to include any person whose presence or services are required
for the prevention or mitigation of imminent harm to persons, property,
or the environment, and who requires access to confidential information
in order to perform his or her duties in that capacity. Second, EPA
proposes to clarify that the term ``governmental agencies'' in that
section include federal, State, and local governments.
4. Pesticide Export Policy
On January 12, 1990 EPA published a Federal Register notice (55 FR
1261) indicating the Agency's position that the producer identity,
exporter identity, name of unregistered pesticide, and name of active
ingredient in export notifications under FIFRA section 17(a)(2) were
not entitled to confidentiality. On April 25, 1991 EPA issued Class
Determination 1-91, which provided that the identities of importing
countries in purchaser acknowledgement statements were not entitled to
confidentiality. This Class Determination was published in the February
18, 1993 policy statement governing exported pesticides (58 FR 9062).
That policy statement also refined the Agency's position with respect
to confidentiality of data concerning research and development
products, stating that these products may in some cases be eligible for
confidential treatment. EPA proposes to codify this position in
Sec. 2.307(g)(2). For details concerning this position, see 55 FR 1261.
Executive Order 12866
Under Executive Order 12866 (58 FR 51735 (October 4, 1993)) the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to Office of Management and Budget (OMB) review
and the requirements of the Executive Order. The Order defines
``significant regulatory action'' as one that is likely to result in a
rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
It has been determined that this rule is not a ``significant
regulatory action'' under the terms of Executive Order 12866 and is
therefore not subject to OMB review.
Paperwork Reduction Act
The information collection requirements in this proposed rule have
been submitted for approval to OMB under the Paperwork Reduction Act,
44 U.S.C. 3501 et seq. An Information Collection Request (ICR) has been
prepared by EPA (ICR No. 1667.01) and a copy may be obtained from Sandy
Farmer, Information Policy Branch (2136); U.S. Environmental Protection
Agency; 401 M Street, SW., Washington, DC 20460 or by calling (202)
260-2740.
The public reporting burden for this collection of information is
estimated to average 3.3 hours per response, including the time for
rule familiarization, gathering necessary data, drafting a
substantiation, submitting the substantiation, and recordkeeping for
the information collection. Send comments regarding the burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden, to Chief, Information Policy
Branch (2136); U.S. Environmental Protection Agency; 401 M Street, SW.,
Washington, DC 20460; and to the Office of Information and Regulatory
Affairs, Office of Management and Budget, Washington, DC 20503, marked
``Attention: Desk Officer for EPA.'' The final rule will respond to any
OMB or public comments on the information collection requirements
contained in this proposal.
Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act, 5
U.S.C. 605(b), the Administrator certifies that this rule would not
have a significant economic impact on a substantial number of small
entities. The Act requires identification of those regulations which
are likely to have a ``significant economic impact on a substantial
number of small entities,'' i.e., small governments, small businesses,
and small non-profit organizations. Under the requirements of the Act,
such regulations must be subjected to a regulatory flexibility
analysis. This analysis must address the likely economic impacts on
small entities and must consider any significant alternatives to the
rule which accomplish the objectives of applicable statutes and which
minimize any significant economic impact of the rulemaking on small
entities. In April 1992, EPA adopted a new policy which goes beyond the
minimum requirements of the Act (this policy applies to rulemaking
initiated after April 8, 1992). For rules subject to this new policy,
EPA will perform a regulatory flexibility analysis if the rule is
likely to have any economic impact on any small entity.
EPA has performed an Initial Regulatory Flexibility Analysis for
the changes in Agency confidentiality regulations proposed here. It is
available for comment from Donald A. Sadowsky, General and Information
Law Division (2379), Office of General Counsel, Environmental
Protection Agency, 401 M Street SW., Washington, DC 20460. The Agency
has identified as an impact the reporting burden discussed in the
Information Collection Request (see Paperwork Reduction Act discussion
above), deriving from (1) the requirement (discussed in section B.2.,
above) to substantiate claims of confidentiality asserted for an entire
document (as opposed to portions of the document), and (2) new proposed
TSCA-specific signature and up-front substantiation requirements
(discussed in sections W.1 and W.2, above). The estimated burdens for
respondents would be $347.53 (general provisions), $157.36 (TSCA-
specific signature), and $212.47 (TSCA-specific up-front
substantiation). EPA estimates that 285 respondents per year would
incur the burden pertaining to general provisions, 5,313 for TSCA-
specific signature, and 360 for TSCA-specific up-front substantiation.
An unknown number of these respondents would be small entities. The
Agency made the burden for the general provisions as low as possible,
choosing not to require respondents to answer the full series of
questions posed when the Agency must make a determination of
confidentiality when information is requested under FOIA. Any submitter
may avoid this burden completely by merely identifying which portions
of the submitted document should be protected as confidential. With
respect to the TSCA-specific provisions, flexibility in the TSCA-
specific regulations exists for small entities because small entities
are largely exempt from TSCA reporting requirements.
List of Subjects
40 CFR Part 2
Administrative practice and procedure, Confidential business
information, Courts, Freedom of information, Government employees.
40 CFR Part 57
Administrative practice and procedure, Air pollution control,
Metals, Reporting and recordkeeping requirements, Research, Sulfur
oxides.
40 CFR Part 85
Confidential business information, Imports, Labeling, Motor vehicle
pollution, Reporting and recordkeeping requirements, Research,
Warranties.
40 CFR Part 86
Administrative practice and procedure, Confidential business
information, Labeling, Motor vehicle pollution, Reporting and
recordkeeping requirements.
40 CFR Part 122
Administrative practice and procedure, Confidential business
information, Hazardous substances, Reporting and recordkeeping
requirements, Water pollution control.
40 CFR Part 123
Administrative practice and procedure, Confidential business
information, Hazardous substances, Indians--lands, Intergovernmental
relations, Penalties, Reporting and recordkeeping requirements, Water
pollution control.
40 CFR Part 145
Confidential business information, Indians--lands,
Intergovernmental relations, Penalties, Reporting and recordkeeping
requirements, Water supply.
40 CFR Part 233
Administrative practice and procedure, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Water pollution
control.
40 CFR Part 260
Administrative practice and procedure, Confidential business
information, Hazardous waste.
40 CFR Part 270
Administrative practice and procedure, Confidential business
information, Hazardous materials transportation, Hazardous waste,
Reporting and recordkeeping requirements, Water pollution control,
Water supply.
40 CFR Part 271
Administrative practice and procedure, Confidential business
information, Hazardous materials transportation, Hazardous waste,
Indians-lands, Intergovernmental relations, Penalties, Reporting and
recordkeeping requirements, Water pollution control, Water supply.
40 CFR Part 281
Administrative practice and procedure, Hazardous substances,
Insurance, Intergovernmental relations, Oil pollution, Reporting and
recordkeeping requirements, Surety bonds, Water pollution control,
Water supply.
40 CFR Part 350
Administrative practice and procedure, Chemicals, Confidential
business information, Disaster assistance, Hazardous substances,
Hazardous waste, Intergovernmental relations, Natural resources,
Reporting and recordkeeping requirements, Superfund, Water pollution
control, Water supply.
40 CFR Part 403
Confidential business information, Reporting and recordkeeping
requirements, Waste treatment and disposal, Water pollution control.
40 CFR Part 704
Environmental protection, Chemicals, Confidential business
information, Hazardous substances, Imports, Reporting and recordkeeping
requirements.
40 CFR Part 707
Environmental protection, Chemicals, Exports, Hazardous substances,
Imports, Confidential business information, Reporting and recordkeeping
requirements.
40 CFR Part 710
Environmental protection, Chemicals, Inventory, Partial Updating of
the inventory data base, Confidential business information, Reporting
and recordkeeping requirements.
40 CFR Part 712
Environmental protection, Chemicals, Confidential business
information, Reporting and recordkeeping requirements.
40 CFR Part 716
Environmental protection, Chemicals, Hazardous substances, Health
and safety, Confidential business information, Reporting and
recordkeeping requirements.
40 CFR Part 717
Environmental protection, Chemicals, Confidential business
information, Reporting and recordkeeping requirements, Significant
adverse reactions.
40 CFR Part 720
Environmental protection, Chemicals, Premanufacture notification,
Hazardous materials, Confidential business information, Reporting and
recordkeeping requirements.
40 CFR Part 723
Environmental protection, Chemicals, Premanufacture notification,
Hazardous materials, Confidential business information, Reporting and
recordkeeping requirements.
40 CFR Part 750
Administrative practice and procedure, Chemicals, Confidential
business information, Reporting and recordkeeping requirements.
40 CFR Part 790
Environmental protection, Chemicals, Testing, Hazardous substances,
Confidential business information, Reporting and recordkeeping
requirements.
Dated: November 3, 1994.
Carol M. Browner,
Administrator.
Therefore 40 CFR parts 2, 57, 85, 86, 122, 123, 145, 233, 260, 270,
271, 281, 350, 403, 704, 707, 710, 712, 716, 717, 720, 723, 750 and 790
are proposed to be amended as follows:
PART 2--[AMENDED]
The authority citation for part 2 is revised to read as follows:
Authority: 5 U.S.C. 301, 552 (as amended), 553; secs. 114, 206,
208, 301, and 307, Clean Air Act, as amended (42 U.S.C. 7414, 7525,
7542, 7601, 7607); secs. 308, 501 and 509(a), Clean Water Act, as
amended (33 U.S.C. 1318, 1361, 1369(a)); sec. 13, Noise Control Act
of 1972 (42 U.S.C. 4912); secs. 1445 and 1450, Safe Drinking Water
Act (42 U.S.C. 300j-4, 300j-9); secs. 2002, 3007, and 9005, Solid
Waste Disposal Act, as amended (42 U.S.C. 6912, 6927, 6991d); secs.
8(c), 11, 12(b), and 14, Toxic Substances Control Act (15 U.S.C.
2607(c), 2610, 2611(b), 2613); secs. 10, 12, and 25, Federal
Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C.
136h, 136j, 136w); sec. 408(f), Federal Food, Drug and Cosmetic Act,
as amended (21 U.S.C. 346(f)); secs. 104(f) and 108, Marine
Protection, Research and Sanctuaries Act of 1972 (33 U.S.C. 1414(f),
1418); secs. 104, 115, Comprehensive Environmental Response,
Compensation, and Liability Act of 1980, as amended (42 U.S.C. 9604,
9615); sec. 505, Motor Vehicle Information and Cost Savings Act, as
amended (15 U.S.C. 2005).
2. Section 2.111 is amended by revising paragraph (a)(4) to read as
follows:
Sec. 2.111 Action by office responsible for responding to request.
(a) * * *
(4) If any located records contain business information, as defined
in Sec. 2.201(c), comply with subpart B of this part. However, if the
request encompasses information claimed as business confidential
pursuant to subpart B of this part but is silent on whether the
requestor desires information subject to a claim of confidentiality,
the office shall presume that such information is excluded from the
scope of the request, and need not take the actions required by
Sec. 2.204(d). Nonetheless the office shall provide the requestor with
a description of those records claimed as confidential which would have
been within the scope of the request had the presumption in this
paragraph not been applied;
* * * * *
3. Section 2.113 is amended by revising paragraph (a)(1) to read as
follows:
Sec. 2.113 Initial denial of requests.
(a) * * *
(1) A statutory provision, provision of this part, or court order
requires that the information not be disclosed (information withheld
pursuant to section 10(g) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136h(g)) will be handled pursuant to
procedures in Sec. 2.307(j) of this part);
* * * * *
4. Part 2, subpart B is revised to read as follows:
Subpart B--Confidential Business Information.
Sec.
2.201 Definitions.
2.202 Applicability of subpart; priority where provisions conflict;
records containing more than one kind of information.
2.203 Notice to be included in EPA requests, demands, and forms;
method of asserting business confidentiality claim; effect of
failure to assert claim at time of submission.
2.204 Initial action by EPA office.
2.205 Final confidentiality determination by EPA legal office.
2.206 Advance confidentiality determinations.
2.207 Class determinations.
2.208 Substantive criteria for use in confidentiality
determinations.
2.209 Disclosure in special circumstances.
2.210 Nondisclosure for reasons other than business confidentiality
or where disclosure is prohibited by other statute.
2.211 Safeguarding of business information; penalty for wrongful
disclosure.
2.212 Establishment of control offices for categories of business
information.
2.213 Designation by business of addressee for notices and
inquiries.
2.214 Defense of Freedom of Information Act suits; participation by
affected business.
2.215 Confidentiality agreements.
2.216 Sunset Provisions for Confidentiality Claims.
2.217-2.300 [Reserved].
2.301 Special rules governing certain information obtained under
the Clean Air Act.
2.302 Special rules governing certain information obtained under
the Clean Water Act.
2.303 Special rules governing certain information obtained under
the Noise Control Act of 1972.
2.304 Special rules governing certain information obtained under
the Safe Drinking Water Act.
2.305 Special rules governing certain information obtained under
the Solid Waste Disposal Act, as amended.
2.306 Special rules governing certain information obtained under
the Toxic Substances Control Act.
2.307 Special rules governing certain information obtained under
the Federal Insecticide, Fungicide and Rodenticide Act.
2.308 Special rules governing certain information obtained under
the Federal Food, Drug and Cosmetic Act.
2.309 Special rules governing certain information obtained under
the Marine Protection, Research and Sanctuaries Act of 1972.
2.310 Special rules governing certain information obtained under
the Comprehensive Environmental Response, Compensation, and
Liability Act of 1980, as amended.
2.311 Special rules governing certain information obtained under
the Motor Vehicle Information and Cost Savings Act.
Sec. 2.201 Definitions.
For the purposes of this subpart:
(a) Person means an individual, partnership, corporation,
association, or other public or private organization or legal entity,
including Federal, State or local governmental bodies and agencies and
their employees.
(b) Business means any person engaged in a business, trade,
employment, calling or profession, whether or not all or any part of
the net earnings derived from such engagement by such person inure (or
may lawfully inure) to the benefit of any private shareholder or
individual.
(c) Business information (sometimes referred to simply as
information) means any information which pertains to the interests of
any business, which was developed or acquired by that business, and
(except where the context otherwise requires) which is possessed by EPA
in recorded form.
(d) Affected business means, with reference to an item of business
information, a business which has asserted (and not waived or
withdrawn) a business confidentiality claim covering the information,
or a business which could be expected to make such a claim if it were
aware that disclosure of the information to the public was proposed.
(e) Reasons of business confidentiality include the concept of
trade secrecy and other related legal concepts which give (or may give)
a business the right to preserve the confidentiality of business
information and to limit its use or disclosure by others in order that
the business may obtain or retain business advantages it derives from
its rights in the information. The definition is meant to encompass any
concept which authorizes a Federal agency to withhold business
information under 5 U.S.C. 552(b)(4), as well as any concept which
requires EPA to withhold information from the public for the benefit of
a business under 18 U.S.C. 1905 or any of the various statutes cited in
Secs. 2.301 through 2.311.
(f) [Reserved]
(g) Information which is available to the public is information in
EPA's possession which EPA will furnish to any member of the public
upon request and which EPA may make public, release or otherwise make
available to any person whether or not its disclosure has been
requested.
(h) Business confidentiality claim (or, simply, claim) means a
claim or allegation that business information is entitled to
confidential treatment for reasons of business confidentiality, or a
request for a determination that such information is entitled to such
treatment.
(i) [Reserved]
(j) Recorded means written or otherwise registered in some form for
preserving information, including such forms as drawings, photographs,
videotape, sound recordings, punched cards, and computer tape or disk.
(k) [Reserved]
(l) Administrator, Regional Administrator, General Counsel,
Regional Counsel, and Freedom of Information Officer mean the EPA
officers or employees occupying the positions so titled (or designated
to act in such position).
(m) EPA office means any organizational element of EPA, at any
level or location. (The terms EPA office and EPA legal office are used
in this subpart for the sake of brevity and ease of reference. When
this subpart requires that an action be taken by an EPA office or by an
EPA legal office, it is the responsibility of the officer or employee
in charge of that office to take the action or ensure that it is
taken.)
(n) EPA legal office means the EPA General Counsel, any EPA office
over which the General Counsel exercises supervisory authority, and the
various Offices of Regional Counsel. (See paragraph (m) of this
section.)
(o) A working day is any day on which Federal government offices
are open for normal business. Saturdays, Sundays, and official Federal
holidays are not working days; all other days are.
Sec. 2.202 Applicability of subpart; priority where provisions
conflict; records containing more than one kind of information.
(a) Sections 2.201 through 2.216 establish basic rules governing
business confidentiality claims, the handling by EPA of business
information which is or may be entitled to confidential treatment, and
determinations by EPA of whether information is entitled to
confidential treatment for reasons of business confidentiality.
(b) Various statutes (other than 5 U.S.C. 552) under which EPA
operates contain special provisions concerning the entitlement to
confidential treatment of information gathered under such statutes.
Sections 2.301 through 2.311 prescribe rules for treatment of certain
categories of business information obtained under the various statutory
provisions. Paragraph (b) of each of those sections should be consulted
to determine whether any of those sections applies to the particular
information in question.
(c) The basic rules of Secs. 2.201 through 2.216 govern except to
the extent that they are modified or supplanted by the special rules of
Secs. 2.301 through 2.311. In the event of a conflict between the
provisions of the basic rules and those of a special rule which is
applicable to the particular information in question, the provision of
the special rule shall govern.
(d) If two or more of the sections containing special rules apply
to the particular information in question, and the applicable sections
prescribe conflicting special rules for the treatment of the
information, the rule which provides greater or wider availability to
the public of the information shall govern.
(e) For most purposes, a document or other record may usefully be
treated as a single unit of information, even though in fact the
document or record is comprised of a collection of individual items of
information. However, in applying the provisions of this subpart, it
will often be necessary to separate the individual items of information
into two or more categories, and to afford different treatment to the
information in each such category. The need for differentiation of this
type may arise, e.g., because a business confidentiality claim covers
only a portion of a record, or because only a portion of the record is
eligible for confidential treatment. EPA offices taking action under
this subpart must be alert to this problem.
(f) In taking actions under this subpart, EPA offices are not
required to obtain the affected business' consent to disclosure of
useful portions of records while protecting the information which is or
may be entitled to confidentiality (e.g., by withholding such portions
of a record as would identify a business, or by disclosing data in the
form of industry-wide aggregates, multi-year averages or totals, or
some similar form). However, when disclosing portions of a record,
offices must ensure that the portions disclosed do not contain
information claimed as confidential under this subpart. Offices may not
disclose aggregated numerical data except where the aggregate was
calculated using a methodology on which an EPA legal office has been
consulted.
(g) This subpart does not apply to questions concerning entitlement
to confidential treatment or information which concerns an individual
solely in his personal, as opposed to business, capacity.
Sec. 2.203 Notice to be included in EPA requests, demands, and forms;
method of asserting business confidentiality claim; effect of failure
to assert claim at time of submission.
(a) Notice to be included in certain requests and demands for
information, and in certain forms. Whenever an EPA office makes a
written request or demand that a business furnish information which, in
the office's opinion, is likely to be regarded by the business as
entitled to confidential treatment under this subpart, or whenever an
EPA office prescribes a form for use by businesses in furnishing such
information, the request, demand, or form shall include or enclose a
notice which--
(1) States that the business may, if it desires, assert a business
confidentiality claim covering part or all of the information, in the
manner described by paragraph (b) of this section, and that information
covered by such a claim will be disclosed by EPA only to the extent,
and by means of the procedures, set forth in this subpart;
(2) States that if no such claim accompanies the information when
it is received by EPA, it may be made available to the public without
further notice to the business; and
(3) Furnishes a citation of the location of this subpart in the
Code of Federal Regulations.
(b) Method and time of asserting business confidentiality claim.
(1) A business which is submitting information to EPA may assert a
business confidentiality claim covering the information by placing on
(or attaching to) the information, at the time it is submitted to EPA,
a cover sheet, stamped or typed legend, or other suitable form of
notice employing language such as trade secret, proprietary, or company
confidential. Allegedly confidential portions of otherwise non-
confidential documents must be clearly identified by the business, and
may be submitted separately to facilitate identification and handling
by EPA. If the business desires confidential treatment only until a
certain date or until the occurrence of a certain event, the notice
should so state.
(2) A confidentiality claim asserted on or after [insert effective
date of final rule] which does not identify those portions of the
document which are allegedly confidential will not be recognized by EPA
unless the claim is accompanied by a substantiation of why the entire
document (as opposed to portions of the document) meets the criteria
for confidentiality set forth in Sec. 2.208. Section 2.205(c) applies
to substantiations submitted under this paragraph.
(3) Where a specific submission to EPA is claimed as confidential
and is subject to an EPA regulation which requires that documentation
substantiating a confidentiality claim (addressing or expanding upon
the criteria for confidentiality in Sec. 2.208) be submitted to the
Agency at the same time the business submits the information claimed to
be confidential, and a business fails to provide the same, EPA will not
recognize the confidentiality claim.
(c) Effect of failure to assert claim at time of submission of
information. (1) Where information received by EPA is unaccompanied by
a business confidentiality claim, the inquiry to the business required
by Sec. 2.204(c)(2) need not be made provided that EPA does not have
substantial reason to believe that disclosure would result in
competitive harm if either--
(i) The information was submitted by a business to EPA before
[insert effective date of final rule] in response to an EPA request or
demand (or on an EPA-prescribed form) which contained the substance of
the notice required by paragraph (a) of this section; or
(ii) The information was submitted by a business to EPA on or after
[insert effective date of final rule].
(2) If a claim covering the information is received after the
information itself is received, EPA will make such efforts as are
administratively practicable to associate the late claim with copies of
the previously-submitted information in EPA files (see
Sec. 2.204(c)(1)). However, EPA cannot assure that such efforts will be
effective, in light of the possibility of prior disclosure or
widespread prior dissemination of the information.
Sec. 2.204 Initial action by EPA office.
(a) Situations requiring action. This section prescribes procedures
to be used by EPA offices in making initial determinations of whether
business information is entitled to confidential treatment for reasons
of business confidentiality. Action shall be taken under this section
whenever an EPA office:
(1) Learns that it is responsible for responding to a request under
5 U.S.C. 552 for the release of business information; in such a case,
the office shall issue an initial determination within the period
specified in Sec. 2.112. However, if pursuant to Sec. 2.111(a)(4) the
request is presumed not to include information claimed as confidential,
the office shall take those actions required by paragraph (c) of this
section to determine the existence of confidentiality claims, but shall
not take action under paragraph (b) or (d) of this section;
(2) Desires to determine whether business information in its
possession is entitled to confidential treatment, even though no
request for release of the information has been received; or
(3) Determines that it is likely that EPA eventually will be
requested to disclose the information at some future date and thus will
have to determine whether the information is entitled to confidential
treatment. In such a case this section's procedures should be initiated
at the earliest practicable time, in order to increase the time
available for preparation and submission of comments and for issuance
of determinations, and to make easier the task of meeting response
deadlines if a request for release of the information is later received
under 5 U.S.C. 552.
(b) Previous confidentiality determination. The EPA office shall
first ascertain whether there has been a previous determination, issued
by a Federal court or by an EPA legal office acting under this subpart,
as to whether the information in question is entitled to confidential
treatment for reasons of business confidentiality. The office shall
also take into account any determination of confidentiality (of which
the office is aware) issued by a State or local government entity.
(1) If a determination issued by a Federal court or by an EPA legal
office holds that the information is entitled to confidential
treatment, the EPA Office shall furnish any person whose request for
the information is pending under 5 U.S.C. 552 an initial determination
(see Secs. 2.111 and 2.113) that the information has previously been
determined to be entitled to confidential treatment, and that the
request is therefore denied. The office shall furnish such person the
appropriate case citation or EPA determination. If the EPA office
believes that a previous determination which was issued by an EPA legal
office may be improper or no longer valid, the office shall so inform
the EPA legal office, which shall consider taking action under
Sec. 2.205(h).
(2) If a determination issued by a Federal court or by an EPA legal
office holds that the information is not entitled to confidential
treatment, the EPA office may proceed pursuant to Sec. 2.204(d)(2).
(3) If a determination issued by a Federal agency or by a State or
local government entity holds that the information is not entitled to
confidential treatment, and the information is available to the public
from the State or local government entity, the EPA office may proceed
pursuant to Sec. 2.204(d)(2).
(4) With respect to all information not known to be covered by any
of paragraphs (b) (1)-(3) of this section, the EPA office shall take
action under paragraph (c) of this section.
(c) Determining existence of business confidentiality claims.
(1) Whenever action under this paragraph is required by paragraph
(a)(1) or (b)(4) of this section, the EPA office shall examine the
information and the office's records to determine which businesses, if
any, are affected businesses (see Sec. 2.201(d)), and to determine
which businesses, if any, have asserted business confidentiality claims
which remain applicable to the information. If any business is found to
have asserted an applicable claim (and the request, if any, under 5
U.S.C. 552 has not been presumed to exclude information claimed as
confidential pursuant to Sec. 2.111(a)(4)), the office shall take
action under paragraph (d) of this section with respect to each such
claim.
(2)(i) If the examination conducted under paragraph (c)(1) of this
section discloses the existence of any business which, although it has
not asserted a claim, might be expected to assert a claim if it knew
EPA proposed to disclose the information, the EPA office shall contact
a responsible official of each such business to learn whether the
business asserts a claim covering the information. However, unless EPA
has substantial reason to believe that disclosure of the information
would result in competitive harm, no such inquiry need be made--
(A) To any business which failed to assert a claim covering the
information when responding to an EPA request or demand, or supplying
information on an EPA form, which contained the substance of the
statements prescribed by Sec. 2.203(a);
(B) To any business which otherwise failed to assert a claim
covering the information after being informed by EPA that such failure
could result in disclosure of the information to the public;
(C) To any business which has otherwise waived or withdrawn a claim
covering the information; or
(D) With respect to information submitted on or after [insert
effective date of final rule].
(ii) If a request for release of the information under 5 U.S.C. 552
is pending at the time inquiry is made under this paragraph (c)(2), the
inquiry shall be made by telephone or equally prompt means, and the
responsible official contacted shall be informed that any claim the
business wishes to assert must be brought to the EPA office's attention
no later than the close of business on the third working day after such
inquiry.
(iii) A record shall be kept of the results of any inquiry under
this paragraph (c)(2) of this section. If any business makes a claim
covering the information, and the request, if any, under 5 U.S.C. 552
has not been presumed to exclude information claimed as confidential
pursuant to Sec. 2.111(a)(4)), the EPA office shall take further action
under paragraph (d) of this section.
(3) If, after the examination under paragraph (c)(1) of this
section, and after any inquiry made under paragraph (c)(2) of this
section, the EPA office knows of no claim covering the information and
the time for response to any inquiry has passed, the information shall
be treated for purposes of this subpart as not entitled to confidential
treatment.
(d) Preliminary determination. Whenever action under this paragraph
is required by paragraph (c) (1) or (2) of this section on any
business' claim, the EPA Office shall make a determination with respect
to each such claim. Each determination shall be made after
consideration of the provisions of Sec. 2.203, the applicable
substantive criteria in Sec. 2.208 or elsewhere in this subpart, and
any previously-issued determinations under this subpart which are
applicable.
(1) If, in connection with any business' claim, the office
determines that the information may be entitled to confidential
treatment, the office shall--
(i) Furnish the notice of opportunity to submit comments prescribed
by paragraph (e) of this section to each business which is known to
have asserted an applicable claim and which has not previously been
furnished such notice with regard to the information in question;
(ii) Furnish, to any person whose request for release of the
information is pending under 5 U.S.C. 552, a determination (in
accordance with Sec. 2.113) that the information may be entitled to
confidential treatment under this subpart and 5 U.S.C. 552(b)(4), that
further inquiry by EPA pursuant to this subpart is required before a
final determination on the request can be issued, that the person's
request is therefore initially denied, and that after further inquiry a
final determination will be issued by an EPA legal office; and
(iii) Refer the matter to the appropriate EPA legal office,
furnishing the information required by paragraph (f) of this section
after the time has elapsed for receipt of comments from the affected
business.
(2) If, in connection with all applicable claims, the office
determines that the information clearly is not entitled to confidential
treatment, the office shall take the actions required by Sec. 2.205(f).
However, if a business has previously been furnished notice under
Sec. 2.205(f) with respect to the same information, no further notice
need be furnished to that business. A copy of each notice furnished to
a business under this paragraph (d)(2) and Sec. 2.205(f) shall be
forwarded promptly to the appropriate EPA legal office.
(3)(i) A business has waived its confidentiality claim if--
(A) The EPA office designated to receive the business' comments
(pursuant to paragraph (d)(1)(i)) has not received those comments
within the specified time, including any approved extension, (after
making appropriate inquiry on whether the comments were lost in
transmission) under Sec. 2.205(b); and
(B) The business was notified in writing at the time comments were
solicited that failure to submit timely comments would be construed as
a waiver of the business' claim.
(ii) If, after application of the preceding paragraph (i), no
confidentiality claim applies to the information, the office shall
determine that the information is not entitled to confidential
treatment under this subpart and, subject to Sec. 2.210, is available
to the public and may be disclosed without notice to any business.
(e) Notice to affected businesses; opportunity to comment. (1)
Whenever required by paragraph (d)(1) of this section, the EPA office
shall promptly furnish each business a written notice stating that EPA
is determining under this subpart whether the information is entitled
to confidential treatment, and affording the business an opportunity to
comment. The notice shall be furnished by certified mail (return
receipt requested), by personal delivery, or by other means which
allows verification of the fact and date of receipt. The notice shall
state the address of the office to which the business' comments shall
be addressed (the EPA office furnishing the notice, unless the General
Counsel has directed otherwise), the time allowed for comments, and the
method for requesting a time extension under Sec. 2.205(b)(2). The
notice shall further state that EPA will construe a business' failure
to furnish timely comments as a waiver of the business' claim.
(2) If action under this section is occasioned by a request for the
information under 5 U.S.C. 552, the period for comments shall be 15
working days after the date of the business' receipt of the written
notice. In other cases, the EPA office shall establish a reasonable
period for comments (not less than 15 working days after the business'
receipt of the written notice). The time period for comments shall be
considered met if the business' comments are postmarked or hand
delivered to the office designated in the notice by the date specified.
In all cases, the notice shall call the business' attention to the
provisions of Sec. 2.205(b).
(3) The written notice required by paragraph (e)(1) of this section
shall invite the business' comments on the following points (subject to
paragraph (e)(4) of this section):
(i) The portions of the information which are alleged to be
entitled to confidential treatment;
(ii) The period of time for which confidential treatment is desired
by the business (e.g., until a certain date, until the occurrence of a
specified event, or permanently);
(iii) The purpose for which the information was furnished to EPA
and the approximate date of submission, if known;
(iv) Whether a business confidentiality claim accompanied the
information when it was received by EPA;
(v) Measures taken by the business to guard against undesired
disclosure of the information to others;
(vi) The extent to which the information has been disclosed to
others, and the precautions taken in connection therewith;
(vii) Pertinent confidentiality determinations, if any, by EPA or
other Federal agencies, as well as by State and local governmental
entities, and a copy of any such determination, or reference to it, if
available;
(viii) Whether the business asserts that disclosure of the
information would be likely to result in substantial harmful effects on
the business' competitive position, and if so, what those harmful
effects would be, why they should be viewed as substantial, and an
explanation of the causal relationship between disclosure and such
harmful effects; and
(ix) Whether and why disclosure of the information would tend to
lessen the availability to EPA of similar information in the future.
(4)(i) To the extent that the EPA office already possesses the
relevant facts, the notice need not solicit responses to the matters
addressed in paragraph (e)(3) (i) through (ix) of this section,
although the notice shall request confirmation of EPA's understanding
of such facts where appropriate.
(ii) If the EPA office believes that the information submitted to
EPA was submitted voluntarily, the notice need not solicit responses to
the matters addressed in paragraph (e)(3)(viii) of this section. If,
upon examination of the information provided to an EPA legal office
pursuant to paragraph (f) of this section, the legal office believes
that the information was not voluntarily submitted, the legal office
shall solicit responses to the matters addressed in paragraph
(e)(3)(viii) of this section, pursuant to the procedures of this
paragraph (e).
(5) The notice shall refer to Sec. 2.205(c) and shall include the
statement prescribed by Sec. 2.203(a).
(f) Materials to be furnished to EPA legal office. When a matter is
referred to an EPA legal office under paragraph (d)(1) of this section,
the EPA office taking action under this section shall forward promptly
to the EPA legal office the following items:
(1) A copy of the information in question, or (where the quantity
or form of the information makes forwarding a copy of the information
impractical) representative samples, a description of the information,
or both;
(2) A description of the circumstances and date of EPA's
acquisition of the information;
(3) The name, address, and telephone number of the EPA employee(s)
most familiar with the information;
(4) The name, address and telephone number of each business which
asserts an applicable business confidentiality claim;
(5) A copy of each applicable claim (or the record of the assertion
of the claim), and a description of when and how each claim was
asserted;
(6) Comments concerning each business' compliance or noncompliance
with applicable requirements of Sec. 2.203;
(7) A copy of any request for release of the information pending
under 5 U.S.C. 552;
(8) A copy of the business' comments on whether the information is
entitled to confidential treatment;
(9) The office's comments concerning the appropriate substantive
criteria under this subpart, and information the office possesses
concerning the information's entitlement to confidential treatment; and
(10) Copies of other correspondence or memoranda which pertain to
the matter.
Sec. 2.205 Final confidentiality determination by EPA legal office.
(a) Role of EPA legal office. (1) The appropriate EPA legal office
(see paragraph (i) of this section) is responsible for making the final
administrative determination of whether or not business information
covered by a business confidentiality claim is entitled to confidential
treatment under this subpart.
(2) When a request for release of the information under 5 U.S.C.
552 is pending, the EPA legal office's determination shall serve as the
final determination on appeal from an initial denial of the request.
(i) If the initial denial was issued under Sec. 2.204(b)(1), a
final determination by the EPA legal office is necessary only if the
requestor has actually filed an appeal.
(ii) If the initial denial was issued under Sec. 2.204(d)(1),
however, the EPA legal office shall issue a final determination in
every case, unless the request has been withdrawn. (Initial denials
under Sec. 2.204(d)(1) are of a procedural nature, to allow further
inquiry into the merits of the matter, and a requestor is entitled to a
decision on the merits.) If an appeal from such a denial has not been
received by the EPA Freedom of Information Officer on the tenth working
day after issuance of the denial, the matter shall be handled as if an
appeal had been received on that day, for purposes of establishing a
schedule for issuance of an appeal decision under Sec. 2.117 of this
part.
(b) Comment period; extensions. (1) Each business which has been
furnished the notice and opportunity to comment prescribed by
Secs. 2.204(d)(1) and 2.204(e) shall furnish its comments to the office
specified in the notice in time to be postmarked or hand delivered to
that office not later than the date specified in the notice (or the
date established in lieu thereof under this section).
(2) The period for submission of comments may be extended if,
before the comments are due, a request for an extension of the comment
period is made by the business and approved by the EPA legal office.
Except in extraordinary circumstances, the EPA legal office will not
approve such an extension without the consent of any person whose
request for release of the information under 5 U.S.C. 552 is pending.
(3) The period for submission of comments by a business may be
shortened in the manner described in paragraph (g) of this section.
(4) If a business' comments have not been received by the specified
EPA office by the date they are due (including any approved extension),
that office shall promptly inquire whether the business has complied
with paragraph (b)(1) of this section. If the business has complied
with paragraph (b)(1) of this section but the comments have been lost
in transmission, duplicate comments shall be requested.
(c) Confidential treatment of comments from business. If
information is submitted to EPA by a business as part of its comments
under this section or as part of a substantiation pursuant to
Sec. 2.203(b)(2), pertains to the business' claim, is not otherwise
possessed by EPA, and is marked when received in accordance with
Sec. 2.203(b)(1), it will be regarded by EPA as entitled to
confidential treatment and will not be disclosed by EPA without the
business' consent, unless its disclosure is duly ordered by a Federal
court, notwithstanding other provisions of this subpart to the
contrary.
(d) Types of final determinations; matters to be considered. (1)
The EPA legal office shall consider each business' claim and comments
(provided that the claim is not waived or otherwise rendered
ineffective by any provision of this subpart), the various provisions
of this subpart, any previously-issued determinations under this
subpart which are pertinent, the materials furnished it under
Sec. 2.204(f), and such other materials as it finds appropriate. With
respect to each claim, the office shall determine whether or not the
information is entitled to confidential treatment for the benefit of
the business that asserted the claim, and the period of any such
entitlement (e.g., until a certain date, until the occurrence of a
specified event, or permanently), and shall take further action under
paragraph (e) or (f) of this section, as appropriate.
(2) Whenever the claims of two or more businesses apply to the same
information, the EPA legal office shall take action appropriate under
the particular circumstances to protect the interests of all persons
concerned (including any person whose request for the information is
pending under 5 U.S.C. 552).
(e) Determination that information is entitled to confidential
treatment. If the EPA legal office determines that the information is
entitled to confidential treatment for the full period requested by the
business which made the claim, EPA shall maintain the information in
confidence for such period, subject to paragraph (h) of this section,
Sec. 2.209, and the other provisions of this subpart which authorize
disclosure in specified circumstances, and the office shall so inform
the business. If any person's request for the release of the
information is then pending under 5 U.S.C. 552, the EPA legal office
shall issue a final determination denying that request.
(f) Determination that information is not entitled to confidential
treatment; notice; waiting period; release of information. (1) Notice
of denial (or partial denial) of a business confidentiality claim, in
the form prescribed by paragraph (f)(2) of this section, shall be
furnished--
(i) By the EPA office taking action under Sec. 2.204, to each
business on behalf of which a claim has been made, whenever
Sec. 2.204(d)(2) requires such notice; and
(ii) By the EPA legal office taking action under this section, to
each business which has asserted a claim applicable to the information
and which has furnished timely comments under paragraph (b) of this
section, whenever the EPA legal office determines that the information
is not entitled to confidential treatment under this subpart for the
benefit of the business, or determines that the period of any
entitlement to confidential treatment is shorter than that requested by
the business.
(2) The notice prescribed by paragraph (f)(1) of this section shall
be written, and shall be furnished by certified mail (return receipt
requested), by personal delivery, or by other means which allows
verification of the fact of receipt and the date of receipt. The notice
shall state the basis for the determination, that it constitutes final
agency action concerning the business confidentiality claim, and that
such final agency action may be subject to judicial review under
Chapter 7 of Title 5, United States Code. With respect to EPA's
implementation of the determination, the notice shall state that
(subject to Sec. 2.210) EPA will make the information available to the
public on the tenth working day after the date of the business' receipt
of the written notice (or on such later date as is established in lieu
thereof by the EPA legal office under paragraph (f)(3) of this
section), unless the EPA legal office has first been notified of the
business' commencement of an action in a Federal court to obtain
judicial review of the determination and to obtain preliminary
injunctive relief against disclosure. The notice shall further state
that if such an action is timely commenced, EPA may nonetheless make
the information available to the public (in the absence of an order by
the court to the contrary) once the court has denied a motion for a
preliminary injunction in the action or has otherwise upheld the EPA
determination, or whenever it appears to the EPA legal office, after
reasonable notice to the business, that the business is not taking
appropriate measures to obtain a speedy resolution of the action. If
the information has been found to be temporarily entitled to
confidential treatment, the notice shall further state that the
information will not be disclosed prior to the end of the period of
such temporary entitlement to confidential treatment.
(3) The period established in a notice under paragraph (f)(2) of
this section for commencement of an action to obtain judicial review
may be extended if, before the expiration of such period, a request for
an extension is made by the business and approved by the EPA legal
office, or by any office acting pursuant to Sec. 2.204(d)(2). Except in
extraordinary circumstances, the EPA office will not approve such an
extension without the consent of any person whose request for release
of the information under 5 U.S.C. 552 is pending.
(4) After the expiration of any period of temporary entitlement to
confidential treatment, a determination under this paragraph (f) of
this section shall be implemented by the EPA legal office, or by any
office acting pursuant to Sec. 2.204(d)(2) (after consultation with the
appropriate legal office) by making the information available to the
public (in the absence of a court order prohibiting disclosure)
whenever--
(i) The period provided for commencement by a business of an action
to obtain judicial review of the determination has expired without
notice to the EPA legal office of commencement of such an action;
(ii) The court, in a timely-commenced action, has denied the
business' motion for a preliminary injunction, or has otherwise upheld
the EPA determination; or
(iii) The EPA legal office, after reasonable notice has been
provided to the business, finds that the business is not taking
appropriate measures to obtain a speedy resolution of the timely-
commenced action.
(5) Any person whose request for release of the information under 5
U.S.C. 552 is pending at the time notice is given under paragraph
(f)(2) of this section shall be furnished a determination under 5
U.S.C. 552 stating the circumstances under which the information will
be released.
(g) Emergency situations. If the General Counsel finds that
disclosure of information covered by a claim would be helpful in
alleviating a situation posing an imminent and substantial danger to
public health or safety, he may prescribe and make known to interested
persons such shorter comment period (paragraph (b) of this section),
post-determination waiting period (paragraph (f) of this section), or
both, as he finds necessary under the circumstances.
(h) Modification of prior determinations. A determination that
information is entitled to confidential treatment for the benefit of a
business, made under this subpart by an EPA legal office, shall
continue in effect in accordance with its terms until an EPA legal
office taking action under this section, or under Sec. 2.206 or
Sec. 2.207, issues a final determination stating that the earlier
determination no longer describes correctly the information's
entitlement to confidential treatment because of a change in the
applicable law, newly-discovered or changed facts, or because the
earlier determination was clearly erroneous. If an EPA legal office
tentatively concludes that such an earlier determination is of
questionable validity, it shall so inform the business, and shall
afford the business an opportunity to furnish comments on pertinent
issues in the manner described by Sec. 2.204(e) and paragraph (b) of
this section. If, after consideration of any timely comments submitted
by the business, the EPA legal office makes a revised final
determination that the information is not entitled to confidential
treatment, or that the period of entitlement to such treatment will end
sooner than it would have ended under the earlier determination, the
office will follow the procedure described in paragraph (f) of this
section. Determinations under this section may be made only by, or with
the concurrence of, the General Counsel.
(i) Delegation and redelegation of authority. Unless the General
Counsel otherwise directs, or this subpart specifically provides,
determinations and actions required by this subpart to be made or taken
by an EPA legal office shall be made or taken by the appropriate
Regional Counsel whenever the EPA office taking action under Sec. 2.204
or Sec. 2.206(b) is under the supervision of a Regional Administrator,
and by the General Counsel in all other cases. The General Counsel may
redelegate any or all of his authority under this subpart to any
attorney employed by EPA under the General Counsel's supervision. A
Regional Counsel may redelegate any or all of his authority under this
subpart to any attorney employed by EPA under the Regional Counsel's
supervision.
Sec. 2.206 Advance confidentiality determinations.
(a) An advance determination under this section may be issued by an
EPA legal office if--
(1) EPA has requested that a business furnish business information
to EPA;
(2) The business asserts that the information, if submitted, would
constitute voluntarily submitted information;
(3) The business will voluntarily submit the information for use by
EPA only if EPA first determines that the information is entitled to
confidential treatment under this subpart; and
(4) The EPA office which desires submission of the information has
requested that the EPA legal office issue a determination under this
section.
(b) The EPA office requesting an advance determination under this
section shall--
(1) Arrange to have the business furnish directly to the EPA legal
office a copy of the information (or, where feasible, a description of
the nature of the information sufficient to allow a determination to be
made), as well as the business' comments concerning the matters
addressed in Sec. 2.204(e)(3), excluding, however, matters addressed in
Sec. 2.204 (e)(3)(iii) and (e)(3)(iv); and
(2) Furnish to the EPA legal office the materials referred to in
Sec. 2.204(f) (3), (7), (8), and (9).
(c) In making a determination under this section, the EPA legal
office shall first determine whether the information would constitute
voluntarily submitted information. If the information would constitute
voluntarily submitted information, the legal office shall further
determine whether the information is entitled to confidential
treatment.
(d) If the EPA legal office determines that the information would
not constitute voluntarily submitted information, or determines that it
would constitute voluntarily submitted information but would not be
entitled to confidential treatment, it shall so inform the business and
the EPA office which requested the determination, stating the basis of
the determination, and shall return to the business all copies of the
information which it may have received from the business (except that
if a request under 5 U.S.C. 552 for release of the information is
received while the EPA legal office is in possession of the
information, the legal office shall retain a copy of the information,
but shall not disclose it unless ordered by a Federal court to do so).
The legal office shall not disclose the information to any other EPA
office or employee and shall not use the information for any purpose
except the determination under this section, unless otherwise directed
by a Federal court.
(e) If the EPA legal office determines that the information would
constitute voluntarily submitted information and that it is entitled to
confidential treatment, it shall so inform the EPA office which
requested the determination and the business which submitted it, and
shall forward the information to the EPA office which requested the
determination.
Sec. 2.207 Class determinations.
(a) The General Counsel may make and issue a class determination
under this section if he finds that--
(1) EPA possesses, or is obtaining, related items of business
information;
(2) One or more characteristics common to all such items of
information will necessarily result in identical treatment for each
such item under one or more of the provisions in this subpart, and that
it is therefore proper to treat all such items as a class for one or
more purposes under this subpart; and
(3) A class determination would serve a useful purpose.
(b) A class determination shall clearly identify the class of
information to which it pertains.
(c) A class determination may state that all of the information in
the class--
(1) Is, or is not, voluntarily submitted information;
(2) Is, or is not, governed by a particular section of this
subpart, or by a particular set of substantive criteria under this
subpart;
(3) Fails to satisfy one or more of the applicable substantive
criteria, and is therefore ineligible for confidential treatment;
(4) Satisfies one or more of the applicable substantive criteria;
or
(5) Satisfies one or more of the applicable substantive criteria
during a certain period, but will be ineligible for confidential
treatment thereafter.
(d) The purpose of a class determination is simply to make known
the Agency's position regarding the manner in which information within
the class will be treated under one or more of the provisions of this
subpart. Accordingly, a class determination issued on or after [insert
effective date of final rule] must be published in the Federal Register
before it may be applied. The notice of opportunity to submit comments
referred to in Sec. 2.204(d)(1)(ii) and Sec. 2.205(b), and the list of
materials required to be furnished to the EPA legal office under
Sec. 2.204(d)(1)(iii), may be modified to reflect the fact that the
class determination has made unnecessary the submission of materials
pertinent to one or more issues. Moreover, in appropriate cases, action
based on the class determination may be taken under Sec. 2.204(b)(1),
Sec. 2.204(d), Sec. 2.205(d), or Sec. 2.206. However, the existence of
a class determination shall not, of itself, affect any right a business
may have to receive any notice under Sec. 2.204(d)(2) or Sec. 2.205(f).
Sec. 2.208 Substantive criteria for use in confidentiality
determinations.
Determinations issued under Secs. 2.204 through 2.207 shall hold
that business information is entitled to confidential treatment for the
benefit of a particular business if--
(a) The business has asserted a business confidentiality claim
which has not expired by its terms, nor been waived nor withdrawn;
(b) The business has satisfactorily shown that it has taken
reasonable measures to protect the confidentiality of the information,
and that it intends to continue to take such measures;
(c) The information is not, and has not been, reasonably obtainable
without the business' consent by other persons (other than governmental
bodies) by use of legitimate means (other than discovery based on a
showing of special need in a judicial or quasi-judicial proceeding);
(d) No statute specifically requires disclosure of the information;
and
(e) Either--
(1) The information has been voluntarily submitted and the business
has shown that it is of a kind that would not customarily be released
to the public by the party from whom it was obtained; or
(2) The information has not been voluntarily submitted and either--
(i) The business has satisfactorily shown that disclosure of the
information is likely to cause substantial harm to the business'
competitive position; or
(ii) Disclosure of the information would be likely to impair the
Government's ability to obtain necessary information in the future.
Sec. 2.209 Disclosure in special circumstances.
(a) General. Information which, under this subpart, is not
available to the public may nonetheless be disclosed to the persons,
and in the circumstances, described by paragraphs (b) through (g) of
this section. (This section shall not be construed to restrict the
disclosure of information which has been determined to be available to
the public. However, business information for which a claim of
confidentiality has been asserted shall be treated as being entitled to
confidential treatment until there has been a determination in
accordance with the procedures of this subpart that the information is
not entitled to confidential treatment.)
(b) Disclosure to Congress or the Comptroller General. (1) Upon
receipt of a written request by the Speaker of the House, President of
the Senate, chairman of a committee or subcommittee, or the Comptroller
General, as appropriate, EPA will disclose business information to
either House of Congress, to a committee or subcommittee of Congress,
or to the Comptroller General, unless a statute forbids such
disclosure.
(2) If the request is for business information claimed as
confidential or determined to be confidential, the EPA office
processing the request shall provide notice to each affected business
of the type of information disclosed and to whom it is disclosed.
Notice shall be given at least ten days prior to disclosure, except
where it is not possible to provide notice ten days in advance of any
date established by the requesting body for responding to the request.
Where ten days advance notice cannot be given, as much advance notice
as possible shall be provided. Where notice cannot be given before the
date established by the requesting body for responding to the request,
notice shall be given as promptly after disclosure as possible. Such
notice may be given by notice published in the Federal Register or by
letter sent by certified mail, return receipt requested, or telegram.
However, if the requesting body asks in writing that no notice under
this subsection be given, EPA will give no notice.
(3) At the time EPA discloses the business information, EPA will
inform the requesting body of any unresolved business confidentiality
claim known to cover the information and of any determination under
this subpart that the information is entitled to confidential
treatment.
(c) Disclosure to other Federal agencies. EPA may disclose business
information to another Federal agency if--
(1) EPA receives a written request for disclosures of the
information from a duly authorized officer or employee of the other
agency or on the initiative of EPA when such disclosure is necessary to
enable the other agency to carry out a function on behalf of EPA;
(2) The request, if any, sets forth the official purpose for which
the information is needed;
(3) When the information has been claimed as confidential or has
been determined to be confidential, the responsible EPA office provides
notice to each affected business of the type of information to be
disclosed and to whom it is to be disclosed. At the discretion of the
office, such notice may be given by notice published in the Federal
Register at least 10 days prior to disclosure, or by letter sent by
certified mail return receipt requested or telegram, either of which
must be received by the affected business at least 10 days prior to
disclosure. However, no notice shall be required when EPA furnishes
business information to another Federal agency--
(i) To perform a function on behalf of EPA, including but not
limited to--
(A) Disclosure to the Department of Justice for purposes of
investigation or prosecution of civil or criminal violations of Federal
law related to EPA activities;
(B) Disclosure to the Department of Justice for purposes of
representing EPA in any matter; and
(C) Disclosure to any Federal agency for purposes of performing an
EPA statutory function under an interagency agreement; or
(ii) In connection with a law enforcement investigation by the
other Federal agency;
(4) EPA notifies the other agency of any unresolved business
confidentiality claim covering the information and of any determination
under this subpart that the information is entitled to confidential
treatment, and that further disclosure of the information may be a
violation of 18 U.S.C. 1905; and
(5) The other agency agrees in writing not to disclose further any
information designated as confidential unless--
(i) The other agency has statutory authority both to compel
production of the information and to make the proposed disclosure, and
the other agency has, prior to disclosure of the information to anyone
other than its officers and employees, furnished to each affected
business at least the same notice to which the affected business would
be entitled under this subpart;
(ii) The other agency has obtained the consent of each affected
business to the proposed disclosure; or
(iii) The other agency has obtained a written statement from the
EPA General Counsel or an EPA Regional Counsel that disclosure of the
information would be proper under this subpart.
(d) Court-ordered disclosure. EPA may disclose any business
information in any manner and to the extent ordered by a Federal court.
Where possible, and when not in violation of a specific directive from
the court, the EPA office disclosing information claimed as
confidential or determined to be confidential shall provide as much
advance notice as possible to each affected business of the type of
information to be disclosed and to whom it is to be disclosed, unless
the affected business has actual notice of the court order. At the
discretion of the office, subject to any restrictions by the court,
such notice may be given by notice in the Federal Register, letter sent
by certified mail return receipt requested, or telegram.
(e) Disclosure within EPA. An EPA office, officer, or employee may
disclose any business information to another EPA office, officer, or
employee with an official need for the information.
(f) Disclosure with consent of business. EPA may disclose any
business information to any person if EPA has obtained the prior
consent of each affected business to such disclosure.
(g) Disclosures to foreign governments and international
organizations. (1) EPA may disclose business information to a foreign
government or to an international organization if--
(i) Either--
(A) EPA receives a written request for disclosure of the
information from a duly authorized officer or employee of the foreign
government or international organization (or from a duly authorized
officer or employee of another agency of the United States Government);
or
(B) The EPA office making such disclosure determines in writing
that disclosure is necessary to enable the foreign government or
international organization to assist EPA in carrying out a function of
EPA, or to enable EPA to assist the foreign government or international
organization with a duly-authorized function of that foreign government
or international organization;
(ii) The request, if any, sets forth the official purpose for which
the information is needed;
(iii) The General Counsel, after consideration of applicable
statutes, treaties, and other international agreements, has determined
that EPA has authority to make such disclosure;
(iv) At least 10 days prior to disclosure, the responsible EPA
office provides notice to each affected business by Federal Register,
certified mail, return receipt requested, or other appropriate means of
the type of information to be disclosed and to whom it is to be
disclosed, and an opportunity to comment on the intended disclosure
(except where the Director of the Office of Criminal Enforcement has
determined that providing such notice would interfere with an ongoing
or contemplated criminal investigation, or the Director of the Office
of Regulatory Enforcement or a Regional Counsel has determined that
providing such notice might compromise an ongoing or contemplated civil
law enforcement investigation);
(v) EPA notifies the foreign government or international
organization of any unresolved business confidentiality claim covering
the information and of any determination under this subpart that the
information is entitled to confidential treatment; and
(vi) The General Counsel has determined that the foreign
government's or international organization's use and disclosure of such
information will be governed by law and procedures or other binding
commitments which will provide adequate protection to the interests of
affected businesses.
(2) The General Counsel may waive any requirement in this paragraph
(g) if the General Counsel determines that a statute, treaty, or other
international agreement prohibits EPA from implementing the
requirement.
(3) For purposes of this paragraph (g), the term foreign government
means any foreign government or any department, agency, or other unit
of a foreign government, and the term international organization means
any public international organization, subdivision of a public
international organization or public international organization
preparatory commission, whether or not the United States is a member of
the public international organization, the subdivision, or the
preparatory commission in question.
Sec. 2.210 Nondisclosure for reasons other than business
confidentiality or where disclosure is prohibited by other statute.
(a) Information which is not entitled to confidential treatment
under this subpart shall be made available to the public (using the
procedures set forth in Secs. 2.204 and 2.205) if its release is
requested under 5 U.S.C. 552, unless EPA determines (under subpart A of
this part) that, for reasons other than reasons of business
confidentiality, the information is exempt from mandatory disclosure
and cannot or should not be made available to the public. Any such
determination under subpart A shall be coordinated with actions taken
under this subpart for the purpose of avoiding delay in responding to
requests under 5 U.S.C. 552.
(b) Notwithstanding any other provision of this subpart, if any
statute not cited in this subpart appears to require EPA to give
confidential treatment to any business information for reasons of
business confidentiality, the matter shall be referred promptly to an
EPA legal office for resolution. Pending resolution, such information
shall be treated as if it were entitled to confidential treatment.
Sec. 2.211 Safeguarding of business information; penalty for wrongful
disclosure.
(a) No EPA officer or employee may disclose, or use for his or her
private gain or advantage, any business information which came into his
or her possession, or to which he or she gained access, by virtue of
his or her official position or employment, except as authorized by
this subpart.
(b) Each EPA officer or employee who has custody or possession of
business information shall take appropriate measures to properly
safeguard such information and to protect against its improper
disclosure.
(c) Violation of paragraph (a) or (b) of this section shall
constitute grounds for dismissal, suspension, or other adverse
personnel action. Willful violation of paragraph (a) of this section
may result in criminal prosecution under 18 U.S.C. 1905 or other
applicable statute.
(d) Each contractor or subcontractor with the United States
Government, and each employee of such contractor or subcontractor, who
is furnished business information by EPA under Secs. 2.301(h),
2.302(h), 2.304(h), 2.305(h), 2.306(j), 2.307(h), 2.308(i), or
Sec. 2.310(h) shall use or disclose that information only as permitted
by the contract or subcontract under which the information was
furnished. Contractors or subcontractors shall take steps to properly
safeguard business information including following any security
procedures for handling and safeguarding business information which are
contained in any manuals, procedures, regulations, or guidelines
provided by EPA. Any violation of this paragraph shall constitute
grounds for suspension or debarment of the contractor or subcontractor
in question. A willful violation of this paragraph may result in
criminal prosecution under an applicable statute.
(e) Each grantee or cooperator under the Senior Environmental
Employment Program (pursuant to the Environmental Programs Assistance
Act of 1984 (Pub.L. 98-313)), and each enrollee associated with a
grantee or cooperator, who is furnished business information by EPA
under Secs. 2.301(h), 2.302(h), 2.304(h), 2.305(h), 2.307(h), 2.308(i),
or Sec. 2.310(h) shall use or disclose that information only as
permitted by the grant or cooperative agreement under which the
information was furnished. Grantees, cooperators, and enrollees shall
take steps to properly safeguard business information including
following any security procedures for handling and safeguarding
business information which are contained in any manuals, procedures,
regulations, or guidelines provided by EPA. If an enrollee under the
program violates this paragraph, EPA may terminate the enrollee's
eligibility for the program. A willful violation of this paragraph may
result in criminal prosecution under an applicable statute.
Sec. 2.212 Establishment of control offices for categories of business
information.
(a) The Administrator, by order, may establish one or more mutually
exclusive categories of business information, and may designate for
each such category an EPA office (hereinafter referred to as a control
office) which shall have responsibility for taking actions (other than
actions required to be taken by an EPA legal office) with respect to
all information within such category.
(b) If a control office has been assigned responsibility for a
category of business information, no other EPA office, officer, or
employee may make available to the public (or otherwise disclose to
persons other than EPA officers and employees) any information in that
category without first obtaining the concurrence of the control office.
Requests under 5 U.S.C. 552 for release of such information shall be
referred to the control office.
(c) A control office shall take the actions and make the
determinations required by Sec. 2.204 with respect to all information
in any category for which the control office has been assigned
responsibility.
(d) A control office shall maintain a record of the following, with
respect to items of business information in categories for which it has
been assigned responsibility:
(1) Business confidentiality claims;
(2) Comments submitted in support of claims;
(3) Waivers and withdrawals of claims;
(4) Actions and determinations by EPA under this subpart;
(5) Actions by Federal courts; and
(6) Related information concerning business confidentiality.
Sec. 2.213 Designation by business of addressee for notices and
inquiries.
(a) A business which wishes to designate a person or office as the
proper addressee of communications from EPA to the business under this
subpart may do so by furnishing in writing to the Freedom of
Information Officer (1105), Environmental Protection Agency, 401 M St.
SW., Washington, DC 20460, the following information: The name and
address of the business making the designation; the name, address, and
telephone number of the designated person or office; and a request that
EPA inquiries and communications (oral and written) under this subpart,
including inquiries and notices which require reply within deadlines if
the business is to avoid waiver of its rights under this subpart, be
furnished to the designee pursuant to this section. Only one person or
office may serve at any one time as a business' designee under this
subpart.
(b) If a business has named a designee under this section, the
following EPA inquiries and notices to the business shall be addressed
to the designee:
(1) Inquiries concerning a business' desire to assert a business
confidentiality claim under Sec. 2.204(c)(2)(i)(A);
(2) Notices affording opportunity to substantiate confidentiality
claims under Sec. 2.204(d)(1) and Sec. 2.204(e);
(3) Inquires concerning comments under Sec. 2.205(b)(4);
(4) Notices of denial of confidential treatment and proposed
disclosure of information under Sec. 2.205(f);
(5) Notices concerning shortened comment and/or waiting periods
under Sec. 2.205(g);
(6) Notices concerning modifications or overrulings of prior
determinations under Sec. 2.205(h);
(7) Notices to affected businesses under Secs. 2.301(g) and
2.301(h) and analogous provisions in Secs. 2.302, 2.303, 2.304, 2.305,
2.306, 2.307, 2.308 and 2.310; and
(8) Notices to affected businesses under Sec. 2.209.
(c) The Freedom of Information Officer shall, as quickly as
possible, notify all EPA offices that may possess information submitted
by the business to EPA, the Regional Freedom of Information Offices,
the Office of General Counsel, and the offices of Regional Counsel of
any designation received under this section. Businesses making
designations under this section should mind that several working days
may be required for dissemination of this information within EPA and
that some EPA offices may not receive notice of such designations.
Sec. 2.214 Defense of Freedom of Information Act suits; participation
by affected business.
(a) In making final confidentiality determinations under this
subpart, the EPA legal office relies to a large extent upon the
information furnished by the affected business to substantiate its
claim of confidentiality. The EPA legal office may be unable to verify
the accuracy of much of the information submitted by the affected
business.
(b) If the EPA legal office makes a final confidentiality
determination under this subpart that certain business information is
entitled to confidential treatment, and EPA is sued by a requester
under the Freedom of Information Act for disclosure of that
information, EPA will:
(1) Notify each affected business of the suit within 10 days after
service of the complaint upon EPA;
(2) Where necessary to preparation of EPA's defense, call upon each
affected business to furnish assistance; and
(3) Not oppose a motion by any affected business to intervene as a
party to the suit under rule 24(b) of the Federal Rules of Civil
Procedure.
(c) EPA will defend its final confidentiality determination, but
EPA expects the affected business to cooperate to the fullest extent
possible in this defense.
Sec. 2.215 Confidentiality agreements.
(a) No EPA officer, employee, contractor, or subcontractor shall
enter into any agreement with any affected business to keep business
information confidential unless such agreement is consistent with this
subpart. No EPA officer, employee, contractor, or subcontractor shall
promise any affected business that business information will be kept
confidential unless the promise is consistent with this subpart.
(b) If an EPA office has requested information from a State, local,
or Federal agency and the agency refuses to furnish the information to
EPA because the information is or may constitute confidential business
information, the EPA office may enter into an agreement with the agency
to keep the information confidential, notwithstanding the provisions of
this subpart. However, no such agreement shall be made unless the
General Counsel determines that the agreement is necessary and proper.
(c) To determine that an agreement proposed under paragraph (b) of
this section is necessary, the General Counsel must find:
(1) The EPA office requesting the information needs the information
to perform its functions;
(2) The agency will not furnish the information to EPA without an
agreement by EPA to keep the information confidential; and
(3) Either:
(i) EPA has no statutory power to compel submission of the
information directly from the affected business, or
(ii) While EPA has statutory power to compel submission of the
information directly from the affected business, compelling submission
of the information directly from the business would--
(A) Require time in excess of that available to the EPA office to
perform its necessary work with the information,
(B) Duplicate information already collected by the other agency and
overly burden the affected business, or
(C) Overly burden the resources of EPA.
(d) To determine that an agreement proposed under paragraph (b) of
this section is proper, the General Counsel must find that the
agreement states--
(1) The purpose for which the information is required by EPA;
(2) The conditions under which the agency will furnish the
information to EPA;
(3) The information subject to the agreement;
(4) That the agreement does not cover information acquired by EPA
from another source;
(5) The manner in which EPA will treat the information; and
(6) That EPA will treat the information in accordance with the
agreement subject to an order of a Federal court to disclose the
information.
(e) EPA will treat any information acquired pursuant to an
agreement under paragraph (b) of this section in accordance with the
procedures of this subpart except where the agreement specifies
otherwise.
Sec. 2.216 Sunset Provisions for Confidentiality Claims.
(a) Any claim of confidentiality asserted under this subpart will
expire if--
(1) The claim is subject to a regulation meeting the requirements
of paragraph (b) of this section;
(2) No affected business has met the requirements of paragraphs (c)
and (d) of this section during the period of time specified in
paragraph (c) of this section; and
(3) The sunset period or event set by the regulation referred to in
paragraph (a)(1) of this section has passed or occurred.
(b) Any regulation which causes a confidentiality claim to expire
must specify--
(1) The class of information subject to the sunset provision; and
(2) The period of time which must pass or the event which must
occur to cause the confidentiality claim to expire.
(c) A claim of confidentiality subject to a regulation meeting the
requirements of paragraph (b) of this section will not expire if an
affected business reasserts the confidentiality claim within 90
calendar days prior to the expiration of the period, or within 90 days
subsequent to the occurrence of the event, set forth in paragraph (b)
of this section. A regulation under paragraph (b) of this section may
provide for a reassertion period of less than 90 days.
(d) An officer of the affected business must sign the reassertion
of confidentiality submitted pursuant to paragraph (c) of this section
and must certify to the truth of the following statements concerning
the information reasserted to be confidential:
(1) My company has continually taken measures to protect the
confidentiality of the information, and intends to continue to take
such measures.
(2) The information is not, and has not been, reasonably obtainable
without our consent by other persons (other than governmental bodies)
by use of legitimate means (other than discovery based on a showing of
special need in a judicial or quasi-judicial proceeding).
(3) The information is not publicly available elsewhere.
(4) If the information was not submitted voluntarily to EPA,
disclosure of the information would cause substantial harm to our
competitive position.
(e) A confidentiality claim which has expired pursuant to paragraph
(a) of this section is deemed waived, and the information subject to
that claim may be disclosed to the public without further notice to the
affected business.
Sec. 2.217-2.300 [Reserved]
Sec. 2.301 Special rules governing certain information obtained under
the Clean Air Act.
(a) Definitions. For the purpose of this section:
(1) Act means the Clean Air Act, as amended, 42 U.S.C. 7401 et seq.
(2)(i) Emission data means, with reference to any source of
emission of any substance into the air--
(A) Information necessary to determine the identity, amount,
frequency, concentration, or other characteristics (to the extent
related to air quality) of any emission which has been emitted by the
source (or of any pollutant resulting from any emission by the source),
or any combination of the foregoing;
(B) Information necessary to determine the identity, amount,
frequency, concentration, or other characteristics (to the extent
related to air quality) of the emissions which, under an applicable
standard or limitation, the source was authorized to emit (including,
to the extent necessary for such purposes, a description of the manner
or rate of operation of the source); and
(C) A general description of the location and/or nature of the
source to the extent necessary to identify the source and to
distinguish it from other sources (including, to the extent necessary
for such purposes, a description of the device, installation, or
operation constituting the source).
(ii) Notwithstanding paragraph (a)(2)(i) of this section, the
following information shall be considered to be emission data only to
the extent necessary to allow EPA to disclose publicly that a source is
(or is not) in compliance with an applicable standard or limitation, or
to allow EPA to demonstrate the feasibility, practicability, or
attainability (or lack thereof) of an existing or proposed standard or
limitation:
(A) Information concerning research, or the results of research, on
any project, method, device or installation (or any component thereof)
which was produced, developed, installed, and used only for research
purposes; and
(B) Information concerning any product, method, device, or
installation (or any component thereof) designed and intended to be
marketed or used commercially but not yet so marketed or used.
(3) Standard or limitation means any emission standard or
limitation (including a standard or limitation that must be disclosed
under subchapter VI of the Act in connection with allocation of
production and consumption allowances for ozone depleting substances)
established or publicly proposed pursuant to the Act or pursuant to any
regulation under the Act.
(4) Proceeding means any rulemaking, adjudication, or licensing
conducted by EPA under the Act or under regulations which implement the
Act, except for determinations under this subpart.
(5) Manufacturer has the meaning given it in section 216(1) of the
Act, 42 U.S.C. 7550(1).
(b) Applicability. (1) This section applies to business information
which was--
(i) Provided or obtained under section 114 of the Act, 42 U.S.C.
7414, by the owner or operator of any stationary source, for the
purpose:
(A) of developing or assisting in the development of any
implementation plan under section 110 or 111(d) of the Act, 42 U.S.C.
7410, 7411(d), any standard of performance under section 111 of the
Act, 42 U.S.C. 7411, or any emission standard under section 112 of the
Act, 42 U.S.C. 7412;
(B) of determining whether any person is in violation of any such
standard or any requirement of such a plan; or
(C) of carrying out any provision of the Act (except a provision of
Part II of the Act with respect to a manufacturer of new motor vehicles
or new motor vehicle engines);
(ii) Provided or obtained under section 208 of the Act, 42 U.S.C.
7542, for the purpose of enabling the Administrator to determine
whether a manufacturer has acted or is acting in compliance with part A
and part C of Subchapter II of the Act and regulations thereunder, or
to otherwise carry out the provisions of part A and part C of
Subchapter II of the Act, or provided or obtained under section 206(c)
of the Act, 42 U.S.C. 7525(c); or
(iii) Provided in response to a subpoena for the production of
papers, books, or documents issued under the authority of section
307(a) of the Act, 42 U.S.C. 7607(a).
(2) Information will be considered to have been provided or
obtained under section 114 of the Act if it was provided in response to
a request by EPA made for any of the purposes stated in section 114, or
if its submission could have been required under section 114,
regardless of whether section 114 was cited as the authority for any
request for the information, whether an order to provide the
information was issued under section 113(a) of the Act, 42 U.S.C.
7413(a), whether an action was brought under section 113(b) of the Act,
42 U.S.C. 7413(b), or whether the information was provided directly to
EPA or through some third person.
(3) Information will be considered to have been provided or
obtained under section 208 of the Act if it was provided in response to
a request by EPA made for any of the purposes stated in section 208, or
if its submission could have been required under section 208,
regardless of whether section 208 was cited as the authority for any
request for the information, whether an action was brought under
section 204 of the Act, 42 U.S.C. 7523, or whether the information was
provided directly to EPA or through some third person.
(4) Information will be considered to have been provided or
obtained under section 206(c) of the Act if it was provided in response
to a request by EPA made for any of the purposes stated in section
206(c), or if its submission could have been required under section
206(c) regardless of whether section 206(c) was cited as authority for
any request for the information, whether an action was brought under
section 204 of the Act, 42 U.S.C. 7523, or whether the information was
provided directly to EPA or through some third person.
(5) Information will be considered to have been provided or
obtained under section 307(a) of the Act if it was provided in response
to a subpoena issued under section 307(a), or if its production could
have been required by subpoena under section 307(a), regardless of
whether section 307(a) was cited as the authority for any request for
the information, whether a subpoena was issued by EPA, whether a court
issued an order under section 307(a), or whether the information was
provided directly to EPA or through some third person.
(c) Basic rules which apply without change. Sections 2.201, 2.202,
2.204 through 2.207, Sec. 2.209 and Sec. Sec. 2.211 through 2.216 apply
without change to information to which this section applies.
(d) Section 2.203 applies to information to which this section
applies, except that:
(1) Information submitted pursuant to 40 CFR part 57, Primary
Nonferrous Smelter Orders, shall be subject to the requirements of
Sec. 57.203(a) and Appendix A of this chapter, instruction 1.3;
(2) Information submitted pursuant to 40 CFR part 85, Control of
Air Pollution from Motor Vehicles and Motor Vehicle Engines, shall be
subject to the requirements of Secs. 85.1514, 85.1712, 85.1808,
85.1909, 85.2123, and 85.408 of this chapter; and
(3) Information submitted pursuant to 40 CFR part 86, Control of
Air Pollution from New and In-Use Motor Vehicles and New and In-Use
Motor Vehicle Engines: Certification and Test Procedures, shall be
subject to the requirements of Secs. 86.1015, 86.1116-87 and 86.615-84
of this chapter.
(e) Substantive criteria for use in confidentiality determinations.
(1) Section 2.208 applies to information to which this section applies,
except that information which is emission data, a standard or
limitation (including a standard or limitation that must be disclosed
under subchapter VI of the Act in connection with allocation of
production and consumption allowances for ozone depleting substances),
or is collected pursuant to section 211(b)(2)(A) of the Act is not
eligible for confidential treatment.
(2) The following information, when submitted pursuant to a request
for information under section 114 of the Act, constitutes emission data
(but is not an exhaustive list of information which is emission data)
and, notwithstanding any claims of confidentiality, may be disclosed to
the public without notice to affected businesses:
(i) Plant name and related point identifiers, including address,
city, county, Air Quality Control Region (AQCR), Metropolitan
Statistical Area (MSA, PMSA, CMSA), State, zip code;
(ii) Ownership and point of contact information locational
identifiers, including latitude and longitude, or Universal Transverse
Mercator (UTM) grid coordinates, standard industrial classification
(SIC), emission point, device or operation description information, and
source classification codes (SCC); and
(iii) Emissions parameters, including emission type, emission rate,
release height, description of terrain and surrounding structures,
stack or vent diameter at point of emissions, release velocity, release
temperature, frequency of release, duration of release, concentration,
density of emissions stream or average molecular weight, boiler or
process design capacity, emission estimation method, percent space
heat, and hourly maximum design rate.
(f) Availability of information not entitled to confidential
treatment. Section 2.210 does not apply to information to which this
section applies. Emission data, standards or limitations, and any other
information provided under section 114 or 208 of the Act which is
determined under this subpart not to be entitled to confidential
treatment, shall be available to the public notwithstanding any other
provision of this part. Emission data and standards or limitations
provided in response to a subpoena issued under section 307(a) of the
Act shall be available to the public notwithstanding any other
provision of this part. Information (other than emission data and
standards or limitations) provided in response to a subpoena issued
under section 307(a) of the Act, which is determined under this subpart
not to be entitled to confidential treatment, shall be available to the
public, unless EPA determines that the information is exempt from
mandatory disclosure under 5 U.S.C. 552(b) for reasons other than
reasons of business confidentiality and cannot or should not be made
available to the public.
(g) Disclosure of information relevant to a proceeding. (1) Under
sections 114, 208 and 307 of the Act, any information to which this
section applies may be released by EPA because of the relevance of the
information to a proceeding, notwithstanding the fact that the
information otherwise might be entitled to confidential treatment under
this subpart. Release of information because of its relevance to a
proceeding shall be made only in accordance with this paragraph (g).
(2) In connection with any proceeding other than a proceeding
involving a decision by a presiding officer after an evidentiary or
adjudicatory hearing, information to which this section applies which
may be entitled to confidential treatment may be made available to the
public under this paragraph (g)(2). No information shall be made
available to the public under this paragraph (g)(2) until any affected
business has been informed that EPA is considering making the
information available to the public under this paragraph (g)(2) in
connection with an identified proceeding, and has afforded the business
a reasonable period for comment (such notice and opportunity to comment
may be afforded in connection with the notice prescribed by
Secs. 2.204(d)(1) and 2.204(e)). Information may be made available to
the public under this paragraph (g)(2) only if, after consideration of
any timely comments submitted by the business, the General Counsel
determines that the information is relevant to the subject of the
proceeding and the EPA office conducting the proceeding determines that
the public interest would be served by making the information available
to the public. Any affected business shall be given at least 5 days
notice by the General Counsel prior to making the information available
to the public.
(3) In connection with any proceeding involving a decision by a
presiding officer after an evidentiary or adjudicatory hearing,
information to which this section applies which may be entitled to
confidential treatment may be made available to the public, or to one
or more parties of record to the proceeding, upon EPA's initiative,
under this paragraph (g)(3). An EPA office proposing disclosure of
information under this paragraph (g)(3), shall so notify the presiding
officer in writing. Upon receipt of such a notification, the presiding
officer shall notify each affected business that disclosure under this
paragraph (g)(3) has been proposed, and shall afford each such business
a period for comment found by the presiding officer to be reasonable
under the circumstances. Information may be disclosed under this
paragraph (g)(3) only if, after consideration of any timely comments
submitted by the business, the EPA office determines in writing that,
for reasons directly associated with the conduct of the proceeding, the
contemplated disclosure would serve the public interest, and the
presiding officer determines in writing that the information is
relevant to a matter in controversy in the proceeding. The presiding
officer may condition disclosure of the information to a party of
record on the making of such protective arrangements and commitments as
the presiding officer finds to be warranted. Disclosure to one or more
parties of record, under protective arrangements or commitments, shall
not, of itself, affect the eligibility of information for confidential
treatment under the other provisions of this subpart. Any affected
business shall be given at least 5 days notice by the presiding officer
prior to making the information available to the public or to one or
more of the parties of record to the proceeding.
(4) In connection with any proceeding involving a decision by a
presiding officer after an evidentiary or adjudicatory hearing,
information to which this section applies may be made available to one
or more parties of record to the proceeding, upon request of a party,
under this paragraph (g)(4). A party of record seeking disclosure of
information shall direct its request to the presiding officer. Upon
receipt of such a request, the presiding officer shall notify each
affected business that disclosure under this paragraph (g)(4) has been
requested, and shall afford each such business a period for comment
found by the presiding officer to be reasonable under the
circumstances. Information may be disclosed to a party of record under
this paragraph (g)(4) only if, after consideration of any timely
comments submitted by the business, the presiding officer determines in
writing that: the party of record has satisfactorily shown that with
respect to a significant matter which is in controversy in the
proceeding, the party's ability to participate effectively in the
proceeding will be significantly impaired unless the information is
disclosed to him; and any harm to an affected business that would
result from the disclosure is likely to be outweighed by the benefit to
the proceeding and to the public interest that would result from the
disclosure. The presiding officer may condition disclosure of the
information to a party of record on the making of such protective
arrangements and commitments as he finds to be warranted. Disclosure to
one or more parties of record, under protective arrangements or
commitments, shall not, of itself, affect the eligibility of
information to confidential treatment under the other provisions of
this subpart. Any affected business shall be given at least 5 days
notice by the presiding officer prior to making the information
available to one or more of the parties of record to the proceeding.
(h) Disclosure to authorized representatives. (1) Under sections
114, 208 and 307(a) of the Act, EPA possesses authority to disclose to
any authorized representative of the United States any information to
which this section applies, notwithstanding the fact that the
information might otherwise be entitled to confidential treatment under
this subpart. Such authority may be exercised only in accordance with
paragraph (h) (2) or (3) of this section.
(2)(i) A person under contract or subcontract to the United States
Government to perform work in support of EPA in connection with the Act
or regulations which implement the Act may be considered an authorized
representative of the United States for purposes of this paragraph (h).
For purposes of this section, the term ``contract'' includes grants and
cooperative agreements under the Environmental Programs Assistance Act
of 1984 (Pub. L. 98-313), and the term ``contractor'' includes grantees
and cooperators under the Environmental Programs Assistance Act of
1984. Subject to the limitations in this paragraph (h)(2), information
to which this section applies may be disclosed--
(A) To a contractor or subcontractor with EPA, if the EPA program
office managing the contract first determines in writing that such
disclosure is necessary in order that the contractor or subcontractor
may carry out the work required by the contract or subcontract; or
(B) To a contractor or subcontractor with an agency other than EPA,
if the EPA program office which provides the information to that
agency, contractor, or subcontractor first determines in writing, in
consultation with the General Counsel, that such disclosure is
necessary in order that the contractor or subcontractor may carry out
the work required by the contract or subcontract.
(ii) No information shall be disclosed under this paragraph (h)(2),
unless this contract or subcontract in question provides:
(A) That the contractor or subcontractor and the contractor's or
subcontractor's employees shall use the information only for the
purpose of carrying out the work required by the contract or
subcontract, shall refrain from disclosing the information to anyone
other than EPA without the prior written approval of each affected
business or of an EPA legal office, and shall return to EPA all copies
of the information (and any abstracts or extracts therefrom) upon
request by the EPA program office whenever the information is no longer
required by the contractor or subcontractor for the performance of the
work required under the contract or subcontract or upon completion of
the contract or subcontract (where the information was provided to the
contractor or subcontractor by an agency other than EPA, the contractor
may disclose or return the information to that agency);
(B) That the contractor or subcontractor shall obtain a written
agreement to honor such terms of the contract or subcontract from each
of the contractor's or subcontractor's employees who will have access
to the information, before such employee is allowed such access; and
(C) That the contractor or subcontractor acknowledges and agrees
that the contract or subcontract provisions concerning the use and
disclosure of business information are included for the benefit of, and
shall be enforceable by, both the United States Government and any
affected business having an interest in information concerning it
supplied to the contractor or subcontractor by the United States
Government under the contract or subcontract.
(iii) No information shall be disclosed under this paragraph (h)(2)
until each affected business has been furnished notice (by letter,
Federal Register, or other means) of the contemplated disclosure by the
EPA program and has been afforded a period found reasonable by that
office (not less than 5 working days) to submit its comments. Such
notice shall include a description of the information to be disclosed,
the identity of the contractor or subcontractor, and the purposes to be
served by the disclosure. The office preparing the notice must respond
in writing to all comments.
(3) A State or local governmental agency which has duties or
responsibilities under the Act, or under regulations which implement
the Act, may be considered an authorized representative of the United
States for purposes of this paragraph (h). Information to which this
section applies may be furnished to such an agency at the agency's
written request, but only if--
(i) The agency has first furnished to the EPA office having custody
of the information a written opinion from the agency's chief legal
officer or counsel stating that under applicable State or local law the
agency has the authority to compel a business which possesses such
information to disclose it to the agency; or
(ii) Each affected business is informed (by letter, Federal
Register, or other means) of those disclosures under this paragraph
(h)(3) which pertain to it, and the agency has shown to the
satisfaction of an EPA legal office that the agency's use and
disclosure of such information will be governed by State or local law
and procedures which will provide adequate protection to the interests
of affected businesses.
Sec. 2.302 Special rules governing certain information obtained under
the Clean Water Act.
(a) Definitions. For the purposes of this section:
(1) Act means the Clean Water Act, as amended, 33 U.S.C. 1251 et
seq.
(2)(i) Effluent data means, with reference to any source of
discharge of any pollutant (as that term is defined in section 502(6)
of the Act, 33 U.S.C. 1362 (6))--
(A) Information necessary to determine the identity, amount,
frequency, concentration, temperature, or other characteristics (to the
extent related to water quality) of any pollutant which has been
discharged by the source (or of any pollutant resulting from any
discharge from the source), or any combination of the foregoing;
(B) Information necessary to determine the identity, amount,
frequency, concentration, temperature, or other characteristics (to the
extent related to water quality) of the pollutants which, under an
applicable standard or limitation, the source was authorized to
discharge (including, to the extent necessary for such purpose, a
description of the manner or rate of operation of the source); and
(C) A general description of the location and/or nature of the
source to the extent necessary to identify the source and to
distinguish it from other sources (including, to the extent necessary
for such purposes, a description of the device, installation, or
operation constituting the source).
(ii) Notwithstanding paragraph (a)(2)(i) of this section, the
following information shall be considered to be effluent data only to
the extent necessary to allow EPA to disclose publicly that a source is
(or is not) in compliance with an applicable standard or limitation, or
to allow EPA to demonstrate the feasibility, practicability, or
attainability (or lack thereof) of an existing or proposed standard or
limitation:
(A) Information concerning research, or the results of research, on
any product, method, device, or installation (or any component thereof)
which was produced, developed, installed, and used only for research
purposes; and
(B) Information concerning any product, method, device, or
installation (or any component thereof) designed and intended to be
marketed or used commercially but not yet so marketed or used.
(3) Standard or limitation means any prohibition, any effluent
limitation, or any toxic, pre-treatment or new source performance
standard established or publicly proposed pursuant to the Act or
pursuant to regulations under the Act, including limitations or
prohibitions in a permit issued or proposed by EPA or by a State under
section 402 of the Act, 33 U.S.C. 1342.
(4) Proceeding means any rulemaking, adjudication, or licensing
conducted by EPA under the Act or under regulations which implement the
Act, except for determinations under this part.
(b) Applicability. (1) This section applies only to business
information--
(i) Provided to or obtained by EPA under section 308 of the Act, 33
U.S.C. 1318, by or from the owner or operator of any point source, for
the purpose of carrying out the objective of the Act (including but not
limited to developing or assisting in the development of any standard
or limitation under the Act, or in determining whether any person is in
violation of any such standard or limitation); or
(ii) Provided to or obtained by EPA under section 509(a) of the
Act, 33 U.S.C. 1369(a).
(2) Information will be considered to have been provided or
obtained under section 308 of the Act if it was provided in response to
a request by EPA made for any of the purposes stated in section 308, or
if its submission could have been required under section 308,
regardless of whether section 308 was cited as the authority for any
request for the information, whether an order to provide the
information was issued under section 309(a)(3) of the Act, 33 U.S.C.
1319(a)(3), whether a civil action was brought under section 309(b) of
the Act, 33 U.S.C. 1319(b), and whether the information was provided
directly to EPA or through some third person.
(3) Information will be considered to have been provided or
obtained under section 509(a) of the Act if it was provided in response
to a subpoena issued under section 509(a), or if its production could
have been required by subpoena under section 509(a), regardless of
whether section 509(a) was cited as the authority for any request for
the information, whether a subpoena was issued by EPA, whether a court
issued an order under section 307(a), or whether the information was
provided directly to EPA or through some third person.
(4) This section specifically does not apply to information
obtained under section 310(d) or 312(g)(3) of the Act, 33 U.S.C.
1320(d), 1322(g)(3).
(c) Basic rules which apply without change. Sections 2.201 through
2.207, 2.209, 2.211 through 2.216 apply without change to information
to which this section applies.
(d) [Reserved]
(e) Substantive criteria for use in confidentiality determinations.
Section 2.208 applies to information to which this section applies,
except that the following information is not eligible for confidential
treatment:
(1) Information which is effluent data or a standard or limitation;
(2) Name and address of any permit applicant or permittee under
part 122 of this chapter, part 501 of this chapter, or Section 404 of
the Act; and
(3) Any permit application (including any attachments used to
supply information required by the applications forms) or permit under
part 122 of this chapter, part 501 of this chapter, or Section 404 of
the Act.
(f) Availability of information not entitled to confidential
treatment. Section 2.210 does not apply to information to which this
section applies. Effluent data, standards or limitations, or any other
information provided or obtained under section 308 of the Act which is
determined under this subpart not to be entitled to confidential
treatment, shall be available to the public notwithstanding any other
provision of this part. Effluent data and standards or limitations
provided in response to a subpoena issued under section 509(a) of the
Act shall be available to the public notwithstanding any other
provision of this part. Information (other than effluent data and
standards or limitations) provided in response to a subpoena issued
under section 509(a) of the Act, which is determined under this subpart
not to be entitled to confidential treatment, shall be available to the
public, unless EPA determines that the information is exempt from
mandatory disclosure under 5 U.S.C. 552(b) for reasons other than
reasons of business confidentiality and cannot or should not be made
available to the public.
(g) Disclosure of information relevant to a proceeding. (1) Under
sections 308 and 509(a) of the Act, any information to which this
section applies may be released by EPA because of the relevance of the
information to a proceeding, notwithstanding the fact that the
information otherwise might be entitled to confidential treatment under
this subpart. Release of information to which this section applies
because of its relevance to a proceeding shall be made only in
accordance with this paragraph (g).
(2) The provisions of Sec. 2.301(g) (2), (3), and (4) must be
followed when making disclosures pursuant to this paragraph (g).
(h) Disclosure to authorized representatives. (1) Under sections
308 and 509(a) of the Act, EPA possesses authority to disclose to any
authorized representative of the United States any information to which
this section applies, notwithstanding the fact that the information
might otherwise be entitled to confidential treatment under this
subpart. Such authority may be exercised only in accordance with
paragraph (h)(2) or (h)(3) of this section.
(2) The provisions of Sec. 2.301(h) (2) and (3) must be followed
when making disclosures pursuant to this paragraph (h).
Sec. 2.303 Special rules governing certain information obtained under
the Noise Control Act of 1972.
(a) Definitions. For the purposes of this section:
(1) Act means the Noise Control Act of 1972, 42 U.S.C. 4901 et seq.
(2) Manufacturer has the meaning given it in 42 U.S.C. 4902(6).
(3) Product has the meaning given it in 42 U.S.C. 4902(3).
(4) Proceeding means any rulemaking, adjudication, or licensing
conducted by EPA under the Act or under regulations which implement the
Act, except for determinations under this subpart.
(b) Applicability. This section applies only to information
provided to or obtained by EPA under section 13 of the Act, 42 U.S.C.
4912, by or from any manufacturer of any product to which regulations
under section 6 or 8 of the Act (42 U.S.C. 4905, 4907) apply.
Information will be deemed to have been provided or obtained under
section 13 of the Act, if it was provided in response to a request by
EPA made for the purpose of enabling EPA to determine whether the
manufacturer has acted or is acting in compliance with the Act, or if
its submission could have been required under section 13 of the Act
regardless of whether section 13 was cited as authority for the
request, whether an order to provide such information was issued under
section 11(d) of the Act, 42 U.S.C. 4910(d), and whether the
information was provided directly to EPA by the manufacturer or through
some third person.
(c) Basic rules which apply without change. Sections 2.201 through
2.216 apply without change to information to which this section
applies.
(d) [Reserved]
(e) [Reserved]
(f) [Reserved]
(g) Disclosure of information relevant to a proceeding. (1) Under
section 13 of the Act, any information to which this section applies
may be released by EPA because of its relevance to a matter in
controversy in a proceeding, notwithstanding the fact that the
information otherwise might be entitled to confidential treatment under
this subpart. Release of information because of its relevance to a
proceeding shall be made only in accordance with this paragraph (g).
(2) The provisions of Sec. 2.301(g) (2), (3), and (4) must be
followed when making disclosures pursuant to this paragraph (g).
Sec. 2.304 Special rules governing certain information obtained under
the Safe Drinking Water Act.
(a) Definitions. For the purposes of this section:
(1) Act means the Safe Drinking Water Act, 42 U.S.C. 300f et seq.
(2) Contaminant means any physical, chemical, biological, or
radiological substance or matter in water.
(3) Proceeding means any rulemaking, adjudication, or licensing
process conducted by EPA under the Act or under regulations which
implement the Act, except for any determination under this part.
(b) Applicability. (1) This section applies only to information--
(i) Which was provided to or obtained by EPA pursuant to a
requirement of a regulation which was issued by EPA under the Act for
the purpose of--
(A) Assisting the Administrator in establishing regulations under
the Act;
(B) Determining whether the person providing the information has
acted or is acting in compliance with the Act; or
(C) Administering any program of financial assistance under the
Act; and
(ii) Which was provided by a person--
(A) Who is a supplier of water, as defined in section 1401(5) of
the Act, 42 U.S.C. 300f(5);
(B) Who is or may be subject to a primary drinking water regulation
under section 1412 of the Act, 42 U.S.C. P300g-1;
(C) Who is or may be subject to an applicable underground injection
control program, as defined in section 1422(d) of the Act, 42
U.S.C.300h-1(d);
(D) Who is or may be subject to the permit requirements of section
1424(b) of the Act, 42 U.S.C. 300h-3(b);
(E) Who is or may be subject to an order issued under section
1441(c) of the Act, 42 U.S.C. 300j(c); or
(F) Who is a grantee, as defined in section 1445(e) of the Act, 42
U.S.C. 300j-4(e).
(2) This section applies to any information which is described by
paragraph (b)(1) of this section if it was provided in response to a
request by EPA or its authorized representative (or by a State agency
administering any program under the Act) made for any purpose stated in
paragraph (b)(1) of this section, or if its submission could have been
required under section 1445 of the Act, 42 U.S.C. 300j-4, regardless of
whether such section was cited in any request for the information, or
whether the information was provided directly to EPA or through some
third person.
(c) Basic rules which apply without change. Sections 2.201 through
2.207, 2.209, and 2.211 through 2.216 apply without change to
information to which this section applies.
(d) [Reserved]
(e) Substantive criteria for use in confidentiality determinations.
Section 2.208 applies to information to which this section applies,
except that the following information is not eligible for confidential
treatment: the name and address of any permit applicant or permittee
and information which pertains to the existence, absence, or level of
contaminants in drinking water is not eligible for confidential
treatment.
(f) Nondisclosure for reasons other than business confidentiality
or where disclosure is prohibited by other statute. Section 2.210
applies to information to which this section applies, except that
information which deals with the existence, absence, or level of
contaminants in drinking water shall be available to the public
notwithstanding any other provision of this part.
(g) Disclosure of information relevant to a proceeding. (1) Under
section 1445(d) of the Act, any information to which this section
applies may be released by EPA because of the relevance of the
information to a proceeding, notwithstanding the fact that the
information otherwise might be entitled to confidential treatment under
this subpart. Release of information to which this section applies
because of its relevance to a proceeding shall be made only in
accordance with this paragraph (g).
(2) The provisions of Sec. 2.301(g) (2), (3), and (4) must be
followed when making disclosures pursuant to this paragraph (g).
(h) Disclosure to authorized representatives. (1) Under section
1445(d) of the Act, EPA possesses authority to disclose to any
authorized representative of the United States any information to which
this section applies, notwithstanding the fact that the information
otherwise might be entitled to confidential treatment under this
subpart. Such authority may be exercised only in accordance with
paragraph (h)(2) of this section.
(2) The provisions of Sec. 2.301(h) (2) and (3) must be followed
when making disclsoures pursuant to this paragraph (h).
Sec. 2.305 Special rules governing certain information obtained under
the Solid Waste Disposal Act, as amended.
(a) Definitions. For purposes of this section:
(1) Act means the Solid Waste Disposal Act, as amended, including
amendments made by the Resource Conservation and Recovery Act of 1976,
as amended, 42 U.S.C. 6901 et seq.
(2) Person has the meaning given it in section 1004(15) of the Act,
42 U.S.C. 6903(15).
(3) Hazardous waste has the meaning given it in section 1004(5) of
the Act, 42 U.S.C. 6903(5).
(4) Proceeding means any rulemaking, adjudication, or licensing
conducted by EPA under the Act or under regulations which implement the
Act including the issuance of administrative orders and the approval or
disapproval of plans (e.g. closure plans) submitted by persons subject
to regulation under the Act, but not including determinations under
this subpart.
(b) Applicability. This section applies to information provided to
or obtained by EPA under section 3001(b)(3)(B), 3007, or 9005 of the
Act, 42 U.S.C 6921(b)(3)(B), 6927, or 6991d. Information will be
considered to have been provided or obtained under sections
3001(b)(3)(B), 3007, or 9005 of the Act if it was provided in response
to a request from EPA made for any of the purposes stated in the Act or
if its submission could have been required under those provisions of
the Act regardless of whether a specific section was cited as the
authority for any request for the information or whether the
information was provided directly to EPA or through some third person.
(c) Basic rules which apply without change. Sections 2.201 through
2.216 apply without change to information to which this section
applies.
(d) [Reserved]
(e) [Reserved]
(f) Disclosure of hazardous waste export information. Information
that is required by 40 CFR 262.53(a) which is submitted in notification
of intent to export a hazardous waste will be provided to the
Department of State and the appropriate authorities in a receiving
country regardless of any claims of confidentiality.
(g) Disclosure of information relevant in a proceeding. (1) Under
sections 3007(b) and 9005(b) of the Act (42 U.S.C. 6927(b) and
6991d(b)), any information to which this section applies may be
disclosed by EPA because of the relevance of the information in a
proceeding under the Act, notwithstanding the fact that the information
otherwise might be entitled to confidential treatment under this
subpart. Disclosure of information to which this section applies
because of its relevance in a proceeding shall be made only in
accordance with this paragraph (g).
(2) The provisions of Sec. 2.301(g) (2), (3), and (4) must be
followed when making disclosures pursuant to this paragraph (g).
(h) Disclosure to authorized representatives. (1) Under sections
3001(b)(3)(B), 3007(b), and 9005(b) of the Act (42 U.S.C.
6921(b)(3)(B), 6927(b), and 6991d(b)), EPA possesses authority to
disclose to any authorized representative of the United States any
information to which this section applies, notwithstanding the fact
that the information might otherwise be entitled to confidential
treatment under this subpart. Such authority may be exercised only in
accordance with paragraph (h)(2) or (h)(3) of this section.
(2) The provisions of Sec. 2.301(h) (2) and (3) must be followed
when making disclosures pursuant to this paragraph (h).
(3) At the time any information is furnished to a contractor,
subcontractor, or State or local government agency under this paragraph
(h), the EPA office furnishing the information to the contractor,
subcontractor, or State or local government agency shall notify the
contractor, subcontractor, or State or local government agency that the
information may be entitled to confidential treatment and that any
knowing and willful disclosure of the information may subject the
contractor, subcontractor, or State or local government agency and its
employees to penalties in section 3001(b)(3)(B), 3007(b)(2), or
9005(b)(1) of the Act (42 U.S.C. 6921(b)(3)(B), 6927(b), or 6991d(b)).
Sec. 2.306 Special rules governing certain information obtained under
the Toxic Substances Control Act.
(a) Definitions. For the purposes of this section:
(1) Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et
seq.
(2) Chemical substance has the meaning given it in section 3(2) of
the Act, 15 U.S.C. 2602(2).
(3) Health and safety data (sometimes referred to in this section
as health and safety study) means the information described in
paragraphs (a)(3) (i), (ii), and (iii) of this section with respect to
any chemical substance or mixture offered for commercial distribution
(including for test marketing purposes and for use in research and
development), including but not limited to any chemical substance
included on the inventory of chemical substances under section 8 of the
Act (15 U.S.C. 2607), or any chemical substance or mixture for which
testing is required under section 4 of the Act (15 U.S.C. 2603) or for
which notification is required under section 5 of the Act (15 U.S.C.
2604).
(i) Any study of any effect of a chemical substance or mixture on
health, on the environment, or on both, including underlying data and
epidemiological studies; studies of occupational exposure to a chemical
substance or mixture; and toxicological, clinical, and ecological
studies of a chemical substance or mixture;
(ii) Any test performed under the Act; and
(iii) Any data reported to, or otherwise obtained by, EPA from a
study described in paragraph (a)(3)(i) of this section or a test
described in paragraph (a)(3)(ii) of this section. It is intended that
the term ``health and safety study'' be interpreted broadly. Not only
is information which arises as a result of a formal, disciplined study
included, but other information relating to the effects of a chemical
on health or the environment is also included. Any data that bear on
the effects of a chemical substance on health or environment would be
included. Chemical identity is part of, or underlying data to, a health
and safety study.
(4) [Reserved]
(5) Mixture has the meaning given it in section 3(8) of the Act, 15
U.S.C. 2602(8).
(6) Proceeding means any rulemaking, adjudication, or licensing
conducted by EPA under the Act or under regulations which implement the
Act, except for determinations under this subpart.
(7) Senior Management Official means an official with management
responsibilities for the affected business, such as officials with
management responsibilities for the person or persons completing the
report, or the manager of environmental programs for the facility or
establishments, or for the corporation owning or operating the facility
or establishment responsible for certifying similar reports under other
environmental regulatory requirements.
(8) TSCA Inventory means EPA's comprehensive list of chemical
substances which constitute the Chemical Substances Inventory compiled
under section 8(b) of the Act. It includes substances reported under 40
CFR part 710, subpart A and substances reported under 40 CFR part 720
for which a Notice of Commencement of Manufacture or Import has been
received under 40 CFR 720.120.
(b) Applicability. This section applies to all information
submitted to EPA for the purpose of satisfying some requirement or
condition of the Act or of regulations which implement the Act,
including information originally submitted to EPA for some other
purpose and either relied upon to avoid some requirement or condition
of the Act or incorporated into a submission in order to satisfy some
requirement or condition of the Act or of regulations which implement
the Act. Information will be considered to have been provided under the
Act if the information could have been obtained under authority of the
Act, whether the Act was cited as authority or not, and whether the
information was provided directly to EPA or through some third person.
(c) Basic rules which apply without change. Sections 2.201, 2.202,
2.206, 2.207, and Secs. 2.210 through 2.216 apply without change to
information to which this section applies.
(d) Method of asserting business confidentiality claim; effect of
failure to assert claim at time of submission. Section 2.203 applies,
except that--
(1) An owner, operator or senior management official, as defined in
paragraph (a)(7) of this section, shall sign all business
confidentiality claims to which this section applies;
(2) With respect to confidentiality claims for specific chemical
identity in submissions of Records and Reports of Allegations that
Chemical Substances Cause Significant Adverse Reactions to Health or
the Environment in accordance with section 8(c) of the Act and 40 CFR
part 717, Health and Safety Data Reports in accordance with section
8(d) of the Act and 40 CFR part 716, or notices of substantial risk in
accordance with section 8(e) of the Act, where the chemical substance
is listed on the TSCA Inventory--
(i) The affected business must file with the document submission
detailed written answers to the following 11 questions signed and dated
by a senior management official, as defined in paragraph (a)(7) of this
section:
(A) What harmful effects to your competitive position, if any, do
you think would result from the identity of the chemical substance
being disclosed in connection with reporting under this subpart?
(B) How long should confidential treatment be given? Until a
specific date, the occurrence of a specific event, or permanently? Why?
(C) Has the chemical substance been patented? If so, have you
granted licenses to others with respect to the patent as it applies to
the chemical substance? If the chemical substance has been patented and
therefore disclosed through the patent, why should it be treated as
confidential?
(D) Has the identity of the chemical substance been kept
confidential to the extent that your competitors do not know it is
being manufactured or imported for a commercial purpose by anyone?
(E) Is the fact that the chemical substance is being manufactured
or imported for a commercial purpose publicly available, for example in
technical journals, libraries, or State, local, or Federal agency
public files?
(F) What measures have you taken to prevent undesired disclosure of
the fact that this chemical substance is being manufactured or imported
for a commercial purpose?
(G) To what extent has the fact that this chemical substance is
manufactured or imported for commercial purposes been revealed to
others? What precautions have been taken regarding these disclosures?
Have there been public disclosures or disclosures to competitors?
(H) Does this particular chemical substance leave the site of
manufacture in any form, as product, effluent, emission, etc.? If so,
what measures have you taken to guard against discovery of its
identity?
(I) If the chemical substance leaves the site in a product that is
available to the public or your competitors, can the substance be
identified by analysis of the product?
(J) For what purpose do you manufacture or import the substance?
(K) Has EPA, another Federal agency, or any Federal court made any
pertinent confidentiality determinations regarding this chemical
substance? If so, please attach copies of such determinations.
(ii) If any of the information contained in the answers to the
questions is asserted to contain confidential business information, the
submitter must mark that information as ``trade secret,''
``confidential'' or other appropriate designation.
(iii) If the substantiation required under paragraph (d)(2)(i) of
this section is not submitted at the time a confidentiality claim is
asserted, EPA will deem the claim for chemical identity waived and may
make the identity public without further notice to the submitter.
(3) With respect to information collected pursuant to the following
provisions from subchapter R of this chapter, the provisions of
Sec. 2.203 are modified as provided below. (Each provision is
identified by subject matter and states the subject of the difference
from Sec. 2.203.)
(i) Information submitted pursuant to 40 CFR part 704, subpart A
(Reporting and Recordkeeping Requirements--General Reporting and
Recordkeeping Provisions for Section 8(a) Information-Gathering Rules)
is subject to Sec. 704.7 of this chapter (method of asserting claims;
certification requirement; effect of failure to properly assert
claims).
(ii) Information submitted pursuant to 40 CFR part 704, subpart C
(Reporting and Recordkeeping Requirements--CAIR: Comprehensive
Assessment Information Rule--General Reporting and Recordkeeping
Provisions) is subject to Sec. 704.219 (method of asserting claims;
substantiating claims; effect of failure to properly assert or
substantiate claims).
(iii) Information submitted pursuant to 40 CFR part 710, subpart A
(Inventory Reporting Regulations--Compilation of the Inventory) is
subject to Sec. 710.7 (method of asserting claims; substantiating
claims; effect of failure to properly assert or substantiate claims).
(iv) Information submitted pursuant to 40 CFR part 710, subpart B
(Inventory Reporting Regulations--Partial Updating of the Inventory
Data Base) is subject to Sec. 710.38 of this chapter (method of
asserting claims; limitation on claims for chemical identity;
substantiating claims; effect of failure to properly assert or
substantiate claims).
(v) Information submitted pursuant to 40 CFR part 712 (Chemical
Information Rules--General Provisions) is subject to Sec. 712.15 of
this chapter (certification requirement; effect of failure to properly
assert or certify claims).
(vi) Information submitted pursuant to 40 CFR part 716 (Health and
Safety Data Reporting) is subject to Sec. 716.55 (method of asserting
claims; sanitized version of document required; effect of failure to
provide sanitized copy).
(vii) Information submitted pursuant to 40 CFR part 717 (Records
and Reports of Allegations that Chemical Substances Cause Significant
Adverse Reactions to Health or the Environment) is subject to
Sec. 717.19 of this chapter (method of asserting claims; sanitized copy
of document required; effect of failure to provide sanitized copy).
(viii) Information submitted pursuant to 40 CFR part 720
(Premanufacture Notification) is subject to--
(A) Section 720.80 of this chapter (method of asserting claims;
effect of failure to assert claim);
(B) Section 720.85(a) of this chapter (claims for confidentiality
of chemical identity applicable to the period prior to commencement of
manufacture or import; generic name requirement);
(C) Section 720.85(b) of this chapter (claims for confidentiality
of chemical identity applicable to the period after commencement of
manufacture or import; method of asserting claims; substantiation
requirement; effect of failure to substantiate properly; generic name
requirement);
(D) Section 720.87 of this chapter (method of asserting claims;
generic use requirement);
(E) Section 720.90 of this chapter (method of asserting claims;
substantiation requirement); and
(F) Section 720.102 of this chapter (reassertion and substantiation
of claims for chemical identity; effect of failure to reassert or
substantiate claims).
(ix) Information submitted pursuant to 40 CFR 723.50
(Premanufacture Notice Exemptions--Chemical Substances Manufactured in
Quantities of 1,000 Kilograms or Less per Year--Exemption Notice) is
subject to Sec. 723.50 (e)(1)(E) and (k)(2) of this chapter (generic
name requirement).
(x) Information submitted pursuant to 40 CFR 723.250
(Premanufacture Notice Exemptions--Polymers) is subject to paragraph
(d)(3)(viii)(A)-(F) of Sec. 2.306.
(xi) Information submitted pursuant to 40 CFR part 761
(Polychlorinated Biphenyls (PCBs) Manufacturing, Processing,
Distribution in Commerce, and Use Prohibitions--Notification of PCB
Waste Activity) is subject to Sec. 761.205(a)(4)(viii) (certain
information will not be afforded confidential treatment unless the
submitter makes a sufficient showing of reasons for confidential
treatment; timing of asserting claims).
(xii) Information submitted pursuant to 40 CFR part 763, subpart D
(Reporting Commercial and Industrial Uses of Asbestos) is subject to
Sec. 763.74 (method of asserting claims: certification requirement).
(xiii) Information submitted pursuant to 40 CFR part 763, subpart I
(Asbestos--Prohibition on The Manufacture, Importation, Processing and
Distribution in Commerce of Certain Asbestos-Containing Products;
Labeling Requirements) is subject to Sec. 763.179 (method of asserting
claims; timing of asserting claims; sanitized copy of document
required; effect of failure to submit a sanitized copy; substantiation
requirement; effect of failure to substantiate).
(xiv) Information submitted pursuant to 40 CFR part 790 (Procedures
Governing Testing Consent Agreements and Test Rules) is subject to
Sec. 790.7 (method of asserting claims; timing of asserting claims;
substantiation requirement; effect of failure to substantiate).
(e) Initial action by EPA office. Section 2.204 applies to
information to which this section applies, except that the provisions
of paragraph (e)(3) of this section regarding the time allowed for
seeking judicial review shall be reflected in any notice furnished to a
business under Sec. 2.204(d)(2).
(f) Final confidentiality determination by EPA legal office.
Section 2.205 applies to information to which this section applies,
except that--
(1) In addition to the statement prescribed by the second sentence
of Sec. 2.205(f)(2), the notice of denial of a business confidentiality
claim shall state that under section 20(a) of the Act, 15 U.S.C. 2619,
the business may commence an action in an appropriate Federal district
court to prevent disclosure.
(2) The following sentence is substituted for the third sentence of
Sec. 2.205(f)(2): ``With respect to EPA's implementation of the
determination the notice shall state that (subject to Sec. 2.210) EPA
will make the information available to the public on the thirty-first
(31st) calendar day after the date of the business' receipt of the
written notice (or on such later date as is established in lieu thereof
under paragraph (f)(3) of this section), unless the EPA legal office
has first been notified of the business' commencement of an action in a
Federal court to obtain judicial review of the determination and to
obtain preliminary injunctive relief against disclosure.''; and
(3) Notwithstanding Sec. 2.205(g), the 31 calendar day period
prescribed by Sec. 2.205(f)(2), as modified by paragraph (e)(3) of this
section, shall not be shortened without the consent of the business.
(g) [Reserved]
(h) Substantive criteria for use in confidentiality determinations.
Section 2.208 applies without change to information to which this
section applies, except that health and safety data are not eligible
for confidential treatment. Notwithstanding the preceding sentence,
Sec. 2.208 applies to--
(1) Health and safety data governed by Sec. 716.55(a) (3) or (4),
Sec. 720.85(a)(ii), Sec. 720.90, or Sec. 723.250(g)(9) of subchapter R
of this chapter; and
(2) Health and safety data whose disclosure would--
(i) In the case of a chemical substance or mixture, disclose
processes used in the manufacturing or processing of the chemical
substance or mixture; or
(ii) In the case of a mixture, disclose the portion of the mixture
comprised by any of the chemical substances in the mixture.
(i) Disclosure in special circumstances. Section 2.209 applies to
information to which this section applies, except that--
(1) The following two additional provisions apply to Sec. 2.209(c):
(i) The official purpose for which the information is needed must
be in connection with the agency's duties under any law for protection
of health or the environment or for specific law enforcement purposes;
and
(ii) EPA notifies the other agency that the information was
acquired under authority of the Act and that any knowing disclosure of
the information may subject the officers and employees of the other
agency to the penalties in section 14(d) of the Act (15 U.S.C.
2613(d)).
(2) Information governed by part 707, subpart D of this chapter
(Chemical Imports and Exports--Notices of Export Under section 12(b) of
the Act) may be disclosed to foreign governments pursuant to
Sec. 707.75(c) of this chapter.
(3) Information submitted pursuant to part 710, subpart A of this
chapter (Inventory Reporting Regulations--Compilation of the Inventory)
may be disclosed to a bona fide requestor pursuant to Sec. 710.7 of
this chapter.
(4) Information submitted pursuant to part 720 of this chapter
(Premanufacture Notification) may be disclosed to a bona fide requestor
pursuant to Sec. 720.85 of this chapter.
(5) Information submitted pursuant to part 721 of this chapter
(Significant New Uses of Chemical Substances) may be disclosed to a
bona fide requestor pursuant to Secs. 721.555, 721.557, and 721.575 of
this chapter.
(6) Information submitted pursuant to part 723 of this chapter
(Premanufacture Notice Exemptions--Polymers) may be disclosed to a bona
fide requestor pursuant to Sec. 723.250(g)(7) of this chapter.
(j) Disclosure of information relevant in a proceeding. (1) Under
section 14(a)(4) of the Act (15 U.S.C. 2613(a)(4)), any information to
which this section applies may be disclosed by EPA when the information
is relevant in a proceeding under the Act, notwithstanding the fact
that the information otherwise might be entitled to confidential
treatment under this subpart. However, any such disclosure shall be
made in a manner that preserves the confidentiality of the information
to the extent practicable without impairing the proceeding. Disclosure
of information to which this section applies because of its relevance
in a proceeding shall be made only in accordance with this paragraph
(j).
(2) The provisions of Sec. 2.301(g) (2), (3), and (4) must be
followed when making disclosures pursuant to this paragraph (j).
(k) Disclosure of information to contractors and subcontractors.
(1) Under section 14(a)(2) of the Act (15 U.S.C. 2613(a)(2)), any
information to which this section applies may be disclosed by EPA to a
contractor or subcontractor of the United States performing work under
the Act, notwithstanding the fact that the information otherwise might
be entitled to confidential treatment under this subpart. Subject to
the limitations in this paragraph (j), information to which this
section applies may be disclosed
(i) To a contractor or subcontractor with EPA, if the EPA program
office managing the contract first determines in writing that such
disclosure is necessary for the satisfactory performance by the
contractor or subcontractor of the contract or subcontract; or
(ii) To a contractor or subcontractor with an agency other than
EPA, if the EPA program office which provides the information to that
agency, contractor, or subcontractor first determines in writing, in
consultation with the General Counsel, that such disclosure is
necessary for the satisfactory performance by the contractor or
subcontractor of the contract or subcontract.
(2) The provisions of Sec. 2.301(h)(2) (ii) and (iii) must be
followed when making disclosures pursuant to this paragraph (k).
(3) At the time any information is furnished to a contractor or
subcontractor under this paragraph (k), the EPA office furnishing the
information to the contractor or subcontractor shall notify the
contractor or subcontractor that the information was acquired under
authority of the Act and that any knowing disclosure of the information
may subject the contractor or subcontractor and its employees to the
penalties in section 14(d) of the Act (15 U.S.C. 2613(d)).
(l) Disclosure of information when necessary to protect health or
the environment against an unreasonable risk of injury. (1) Under
section 14(a)(3) of the Act (15 U.S.C. 2613(a)(3)), any information to
which this section applies may be disclosed by EPA when disclosure is
necessary to protect health or the environment against an unreasonable
risk of injury to health or the environment. However, any disclosure
shall be made in a manner that preserves the confidentiality of the
information to the extent not inconsistent with protecting health or
the environment against the unreasonable risk of injury. Disclosure of
information to which this section applies because of the need to
protect health or the environment against an unreasonable risk of
injury shall be made only in accordance with paragraph (k) of this
section.
(2) If any EPA office determines that there is an unreasonable risk
of injury to health or the environment and that to protect health or
the environment against the unreasonable risk of injury it is necessary
to disclose information to which this section applies that otherwise
might be entitled to confidential treatment under this subpart, the EPA
office shall notify the General Counsel in writing of the nature of the
unreasonable risk of injury, the extent of the disclosure proposed, how
the proposed disclosure will serve to protect health or the environment
against the unreasonable risk of injury, and the proposed date of
disclosure. Such notification shall be made as soon as practicable
after discovery of the unreasonable risk of injury. If the EPA office
determines that the risk of injury is so imminent that it is
impracticable to furnish written notification to the General Counsel,
the EPA office shall notify the General Counsel orally.
(3) Upon receipt of notification under paragraph (k)(2) of this
section, the General Counsel shall make a determination in writing
whether disclosure of information to which this section applies that
otherwise might be entitled to confidential treatment is necessary to
protect health or the environment against an unreasonable risk of
injury. The General Counsel shall also determine the extent of
disclosure necessary to protect against the unreasonable risk of injury
as well as when the disclosure must be made to protect against the
unreasonable risk of injury.
(4) If the General Counsel determines that disclosure of
information to which this section applies that otherwise might be
entitled to confidential treatment is necessary to protect health or
the environment against an unreasonable risk of injury, the General
Counsel shall furnish notice to each affected business of the
contemplated disclosure and of the General Counsel's determination.
Such notice shall be made in writing by certified mail, return receipt
requested, at least 15 days before the disclosure is to be made. The
notice shall state the date upon which disclosure will be made.
However, if the General Counsel determines that the risk of injury is
so imminent that it is impracticable to furnish such notice 15 days
before the proposed date of disclosure, the General Counsel may provide
notice by means that will provide receipt of the notice by the affected
business at least 24 hours before the disclosure is to be made. This
may be done by telegram, telephone, or other reasonably rapid means.
(m) Sunset provisions. (1) Pursuant to Secs. 2.216, 720.85, 720.90,
and 720.102, claims for confidentiality of chemical identity in
Premanufacture Notifications expire upon commencement of manufacture or
export unless reasserted in the Notice of Commencement.
(2) Pursuant to Secs. 2.216 and 723.250(g) (7), (9), and (11),
claims for confidentiality of chemical identity in Polymer Exemption
Applications expire upon commencement of manufacture or export unless
reasserted in the Notice of Commencement.
(3) Notwithstanding Sec. 2.216(a), the provisions of this paragraph
(m) apply to claims for confidentiality of chemical identity in
Premanufacture Notifications and Polymer Exemption Applications,
regardless of whether they were submitted on or after [insert effective
date of final rule].
Sec. 2.307 Special rules governing certain information obtained under
the Federal Insecticide, Fungicide and Rodenticide Act.
(a) Definitions. For the purposes of this section:
(1) Act means the Federal Insecticide, Fungicide and Rodenticide
Act, as amended, 7 U.S.C. 136 et seq., and its predecessor, 7 U.S.C.
135 et seq.
(2) Applicant means any person who has submitted to EPA (or to a
predecessor agency with responsibility for administering the Act) a
registration statement or application for registration under the Act of
a pesticide or of an establishment.
(3) Registrant means any person who has obtained registration under
the Act either of a pesticide or of an establishment.
(4) Qualified person means any person whose presence or services
are required for the prevention or mitigation of imminent harm to
persons, property or the environment, and who requires access to
confidential information in order to perform his or her duties in that
capacity.
(5) Safety and efficacy data means all information concerning the
objectives, methodology, results, or significance of any test or
experiment performed on or with a registered or previously registered
pesticide or its separate ingredients, impurities, or degradation
products, and any information concerning the effects of such pesticide
on any organism or the behavior of such pesticide in the environment,
including, but not limited to, data on safety to fish and wildlife,
humans and other mammals, plants, animals, and soil, and studies on
persistence, translocation and fate in the environment, and metabolism.
Data concerning a pesticide which has never been registered do not
constitute safety and efficacy data.
(b) Applicability. This section applies to all information
submitted to EPA by an applicant or registrant for the purpose of
satisfying some requirement or condition of the Act or of regulations
which implement the Act, including information originally submitted to
EPA for some other purpose but incorporated by the applicant or
registrant into a submission in order to satisfy some requirement or
condition of the Act or of regulations which implement the Act. This
section does not apply to information supplied to EPA by a petitioner
in support of a petition for a tolerance under 21 U.S.C. 346a(d),
unless the information is also described by the first sentence of this
paragraph.
(c) Basic rules which apply without change. Sections 2.201 through
2.203, 2.206, 2.207, 2.210 through 2.212, and 2.214 through 2.216 apply
without change to information to which this section applies.
(d) Method of asserting business confidentiality claim. Section
2.203 applies to information to which this section applies, except
that--
(1) Information submitted pursuant to part 154, Special Review
Procedures, shall be subject to the requirements of Sec. 154.15(c) of
this chapter.
(2) Information submitted pursuant to part 155, Registration
Standards, shall be subject to the requirements of Sec. 155.30(c) of
this chapter.
(3) Information submitted pursuant to part 158, Data Requirements
for Registration, shall be subject to the requirements of Sec. 158.33
of this chapter.
(4) Analytical methods submitted pursuant to Sec. 158.240 of this
chapter and used to enforce residue limits for emergency exemptions,
temporary tolerances and permanent tolerances must be available for use
by enforcement agencies and thus may not be claimed as confidential
business information.
(e) Initial action by EPA office. Section 2.204 applies to
information to which this section applies, except that the provisions
of paragraph (e) of this section regarding the time allowed for seeking
judicial review shall be reflected in any notice furnished to a
business under Sec. 2.204(d)(2).
(f) Final confidentiality determination by EPA legal office.
Section 2.205 applies to information to which this section applies,
except that--
(1) In addition to the statement prescribed by the second sentence
of Sec. 2.205(f)(2), the notice of denial of a business confidentiality
claim shall state that under section 10(c) of the Act, 7 U.S.C.
136h(c), the business may commence an action in an appropriate Federal
district court for a declaratory judgment;
(2) The following sentence is substituted for the third sentence of
Sec. 2.205(f)(2): ``With respect to EPA's implementation of the
determination, the notice shall state that (subject to Sec. 2.210) EPA
will make the information available to the public on the thirty-first
(31st) calendar day after the date of the business' receipt of the
written notice (or on such later date as is established in lieu thereof
under paragraph (f)(3) of this section), unless the EPA legal office
has first been notified of the business' commencement of an action in a
Federal court to obtain judicial review of the determination or to
obtain a declaratory judgment under section 10(c) of the Act and to
obtain preliminary injunctive relief against disclosure.''; and
(3) Notwithstanding Sec. 2.205(g), the 31 calendar day period
prescribed by Sec. 2.205(f)(2), as modified by paragraph (e)(3) of this
section, shall not be shortened without the consent of the business.
(g) Substantive criteria for use in confidentiality determinations.
Section 2.208 applies without change to information to which this
section applies except as provided in this paragraph (g). No
information to which this section applies is voluntarily submitted
information.
(1) Safety and efficacy data are not eligible for confidential
treatment. Notwithstanding the preceding sentence, Sec. 2.208 applies
where an affected business has shown that disclosure of the information
would disclose one or more of the following types of information:
(i) Manufacturing or quality control processes;
(ii) Details of any methods for testing, detection, or measuring
the quantity of any deliberately added inert ingredient of a pesticide;
or
(iii) The identity or percentage quantity of any deliberately added
inert ingredient of a pesticide.
(2) The following information on the purchaser acknowledgement
statement submitted pursuant to section 17(a)(2) of the Act is not
eligible for confidential treatment, unless the purchaser
acknowledgement statement pertains to a research and development
product (in which case Sec. 2.208 applies):
(i) The identity of the importing country;
(ii) The identity of the producer of the unregistered pesticide;
(iii) The identity of the exporting company;
(iv) The name of the unregistered pesticide product; and
(v) The name of the active ingredient.
(h) Disclosure in special circumstances. (1) Section 2.209 applies
without change to information to which this section applies. In
addition, under section 12(a)(2)(D) of the Act, 7 U.S.C. 136j(a)(2)(D),
EPA possesses authority to disclose any information to which this
section applies to physicians, pharmacists, and other qualified persons
needing such information for the performance of their duties,
notwithstanding the fact that the information might otherwise be
entitled to confidential treatment under this subpart. Such authority
under section 12(a)(2)(D) of the Act may be exercised in accordance
with paragraph (h)(2) or (h)(3) of this section.
(2) Information to which this section applies may be disclosed
(notwithstanding the fact that it might otherwise be entitled to
confidential treatment under this subpart) to physicians, pharmacists,
hospitals, veterinarians, law enforcement personnel, or Federal, State,
or local governmental agencies with responsibilities for protection of
public health, and to employees of any such persons or agencies, or to
other qualified persons, when and to the extent that disclosure is
necessary in order to treat illness or injury or to prevent imminent
harm to persons, property, or the environment, in the opinion of the
Administrator or his designee.
(3)(i) Information to which this section applies may be disclosed
(notwithstanding the fact that it otherwise might be entitled to
confidential treatment under this subpart)--
(A) To a contractor or subcontractor with EPA, if the EPA program
office managing the contract first determines in writing that such
disclosure is necessary for the satisfactory performance of a contract
or subcontract in connection with the Act; or
(B) To a contractor or subcontractor with a Federal agency other
than EPA, if the EPA program office which provides the information to
that agency, contractor, or subcontractor first determines in writing,
in consultation with the General Counsel, that such disclosure is
necessary for the satisfactory performance of a contract or subcontract
in connection with the Act.
(ii) The provisions of Sec. 2.301(h)(2) (ii) and (iii) must be
followed when making disclosures pursuant to this paragraph (h)(3).
(iii) At the time any information is furnished to a contractor or
subcontractor under this paragraph (h)(3), the EPA office furnishing
the information to the contractor or subcontractor shall notify the
contractor or subcontractor that the information was acquired under
authority of the Act and that any knowing disclosure of the information
may subject the contractor or subcontractor and its employees to the
penalties in section 10(f) of the Act (7 U.S.C. 136h(f)).
(iv) Contractors receiving information to which this section
applies will be required to follow the security procedures established
in the ``FIFRA Information Security Manual,'' which is available
through the Office of Pesticide Programs, Information Services Branch.
(v) For purposes of this section, the term ``contract'' includes
grants and cooperative agreements under the Environmental Programs
Assistance Act of 1984 (Pub. L. 98-313), and the term ``contractor''
includes grantees and cooperators under the Environmental Programs
Assistance Act of 1984.
(4) Information to which this section applies, and which relates to
formulas of products, may be disclosed at any public hearing under the
Act. Prior to such disclosure, EPA will follow the procedures set forth
in Sec. 2.301(g)(3) and (4), which are incorporated here by reference.
(5) Information to which this section applies, and which relates to
formulas of products, may be disclosed in findings of fact issued by
the Administrator under the Act. No information shall be made available
to the public under this paragraph (h)(5) until
(i) The official responsible for issuing the findings of fact has
made a written finding that disclosure is necessary to carry out the
provisions of the Act;
(ii) EPA has notified the affected business by certified mail,
return receipt requested, of the Agency's intent to disclose the
information; and
(iii) Thirty calendar days have passed since the business' receipt
of the notice required under paragraph (h)(5)(ii) of this section.
(6) Information to which this section applies, and which concerns
production, sale, or inventories of a pesticide that is otherwise
entitled to confidential treatment may be disclosed in connection with
a public proceeding to determine whether a pesticide, or any ingredient
of a pesticide, causes unreasonable adverse effects on health or the
environment. In proposing to disclose such information, EPA will follow
the procedures set forth in Sec. 2.301(g)(2)-(4), except that before
disclosing the information, EPA will make a determination that the
disclosure is necessary in the public interest, and will give all
affected businesses thirty days advance notice by certified mail,
return receipt requested. During the thirty day period, the submitter
will have the opportunity to seek judicial review.
(7)(i) Under section 10(d)(1) of the Act (7 U.S.C 136(d)(1)), any
safety and efficacy data (as defined in paragraph (a)(5) of this
section) to which this section applies and which falls within one of
the classes of information defined by paragraph (g) (1), (2), or (3) of
this section may be disclosed by EPA when disclosure is necessary to
protect against an unreasonable risk of injury to health or the
environment. However, any disclosure shall be made in a manner that
preserves the confidentiality of the information to the extent not
inconsistent with protecting health or the environment against the
unreasonable risk of injury. Disclosure of information to which this
section applies because of the need to protect health or the
environment against an unreasonable risk of injury shall be made only
in accordance with this paragraph (h)(7).
(ii) The provisions of Sec. 2.306(l) (2) and (3) must be followed
when making disclosures pursuant to this paragraph (h)(7).
(iii) If the General Counsel determines that disclosure of
information to which this section applies that otherwise might be
entitled to confidential treatment is necessary to protect health or
the environment against an unreasonable risk of injury, the General
Counsel shall furnish notice to each affected business of the
contemplated disclosure and of the General Counsel's determination.
Such notice shall be made in writing by certified mail, return receipt
requested, at least 30 days before the disclosure is to be made. The
notice shall state the date upon which disclosure will be made.
However, if the General Counsel determines that the risk of injury is
so imminent that it is impracticable to furnish such notice 30 days
before the proposed date of disclosure, the General Counsel may provide
notice by means that will provide receipt of the notice by the affected
business at least 10 days before the disclosure is to be made. This may
be done by telegram, telephone, or other reasonably rapid means.
(8) Information required to be produced pursuant to part 164 (rules
of practice governing regulatory hearings under the Act) and which any
party to the proceeding claims is a trade secret or commercial or
financial information (other than information relating to the formulas
of a pesticide) shall be subject to the requirements of Sec. 164.4(c).
(i) Restriction on disclosure to foreign or multinational entities
(1) A request (including any request submitted pursuant to subpart
A of this part) for data obtained from an applicant or registrant under
the Act must be made in writing, and must be accompanied by a signed
affirmation as required by section 10(g)(1) of the Act. The affirmation
must contain the language specified in paragraph (i)(2) of this
section. If EPA receives a request that is not accompanied by a signed
affirmation, EPA will return the request unprocessed (if the request
also includes information not within the scope of this paragraph (i),
the remainder of the request will be handled pursuant to the procedures
in subpart A of this part). This paragraph (i) does not apply to
reviews of data which were prepared by EPA personnel or under an EPA-
funded contract and which do not reveal the full methodology and
complete results of the study, test, or experiment, and all explanatory
information necessary to understand the methodology or interpret the
results.
(2) The requestor must sign the following affirmation:
I have requested access to data submitted by an applicant or
registrant under the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 136 et seq.) to the Environmental Protection Agency. I
hereby affirm:
That I do not seek access to the data for the purpose of
delivering it or offering it for sale to any business or other
entity engaged in the production, sale, or distribution of
pesticides in countries other than the United States or in addition
to the United States or its agents or employees; and
That I will not purposefully deliver or negligently cause the
data to be delivered to any such business or entity or its agents or
employees. I am aware that I may be subject to criminal penalties
under 18 U.S.C 1001 if I have made any statement of material facts
knowing that such statement is false or if I willfully conceal any
material fact.
(Signature, Name, Address, Organization or Affiliation, Client.)
(3) The first time EPA discloses data submitted by a specific
applicant or registrant under the Act in response to a written request
by a member of the public, EPA will provide written notice to the
applicant or registrant. The notice will include a copy of the
affirmation and a listing of the data disclosed, and will advise the
applicant or registrant that EPA maintains a file of affirmations and
data disclosure listings. Copies of future affirmations and data
disclosure listings may be obtained by the appropriate registrants and
applicants by request to EPA.
(4) Notwithstanding any other provision of this paragraph (i), data
submitted by an applicant or registrant under the Act which is not
subject to a claim of confidentiality may be disclosed to any person in
connection with a public proceeding where the information is relevant
to a determination by the Administrator as to whether a pesticide, or
an ingredient of a pesticide, causes unreasonable adverse effects on
health or the environment. EPA will disclose the information only after
a finding by the appropriate official that the information is relevant
to such a determination. No advance notice will be given of such
disclosures.
(j) Designation by business of addressee for notices and inquiries.
Section 2.213 applies to information to which this section applies,
except that designations by registrants and applicants submitting
information pursuant to part 152 of this chapter shall be made pursuant
to Sec. 152.50(b) (2) and (3) of this chapter.
(k) Availability of material in support of registration and reviews
of pesticide data. Regardless of any claims of confidentiality--
(1) Within 30 days after registration under the Act, EPA will make
available for public inspection, by request, and without notice to
affected businesses, the materials required by subpart E of part 152 of
this chapter to be submitted with an application for registration.
Materials that will be publicly available include an applicant's list
of data requirements, the method used by the applicant to demonstrate
compliance for each data requirement, and the applicant's citations of
specific studies in the Agency's possession if applicable; and
(2) EPA may make available to the public, without notice to
affected businesses, reviews of safety and efficacy data which do not
contain (or from which has been deleted) any information, the
disclosure of which would in turn disclose--
(i) Information described in paragraphs (g)(1) (i)-(iii) of this
section; or
(ii) Unpublished information concerning the production,
distribution, sale, or inventories of a pesticide.
Sec. 2.308 Special rules governing certain information obtained under
the Federal Food, Drug and Cosmetic Act.
(a) Definitions. For the purposes of this section:
(1) Act means the Federal Food, Drug and Cosmetic Act, as amended,
21 U.S.C. 301 et seq.
(2) Petition means a petition for the issuance of a regulation
establishing a tolerance for a pesticide chemical or exempting the
pesticide chemical from the necessity of a tolerance, pursuant to
section 408(d) of the Act, 21 U.S.C. 346a(d).
(3) Petitioner means a person who has submitted a petition to EPA
(or to a predecessor agency).
(b) Applicability. (1) This section applies only to business
information submitted to EPA (or to an advisory committee established
under the Act) by a petitioner, solely in support of a petition which
has not been acted on by the publication by EPA of a regulation
establishing a tolerance for a pesticide chemical or exempting the
pesticide chemical from the necessity of a tolerance, as provided in
section 408(d) (2) or (3) of the Act, 21 U.S.C. 346a(d) (2) or (3).
(2) Section 2.307, rather than this section, applies to information
described by the first sentence of Sec. 2.307(b) (material incorporated
into submissions in order to satisfy the requirements of the Federal
Insecticide, Fungicide and Rodenticide Act, as amended), even though
such information was originally submitted by a petitioner in support of
a petition.
(3) This section does not apply to information gathered by EPA
under a proceeding initiated by EPA to establish a tolerance under
section 408(e) of the Act, 21 U.S.C. 346a(e).
(c) Basic rules which apply without change. Sections 2.201, 2.202,
2.206, 2.207, and 2.210 through 2.216 apply without change to
information to which this section applies.
(d) Effect of submission of information without claim. Section
2.203 (a), (b), and (c)(1) apply without change to information to which
this section applies, except that summaries of petitions required under
Sec. 177.102(j) of this chapter may not be claimed as confidential.
Section 2.203(c)(2) does not apply to information to which this section
applies. A petitioner's failure to assert a claim when initially
submitting a petition shall not constitute a waiver of any claim the
petitioner may have.
(e) Initial action by EPA office. Section 2.204 applies to
information to which this section applies, except that--
(1) Unless the EPA office has on file a written waiver of
petitioner's claim, a petitioner shall be regarded as an affected
business, a petition shall be treated as if it were covered by a
business confidentiality claim, and an EPA office acting under
Sec. 2.204(d) shall determine that the information in the petition is
or may be entitled to confidential treatment and shall take action in
accordance with Sec. 2.204(d)(1);
(2) In addition to other required provisions of any notice
furnished to a petitioner under Sec. 2.204(e), such notice shall state
that--
(i) Section 408(f) of the Act, 21 U.S.C. 346a(f), affords absolute
confidentiality to information to which this section applies, but after
publication by EPA of a regulation establishing a tolerance (or
exempting the pesticide chemical from the necessity of a tolerance)
neither the Act nor this section affords any protection to the
information;
(ii) Information submitted in support of a petition which is also
incorporated into a submission in order to satisfy a requirement or
condition of the Federal Insecticide, Fungicide and Rodenticide Act, as
amended, 7 U.S.C. 136 et seq., is regarded by EPA as being governed,
with respect to business confidentiality, by Sec. 2.307 rather than by
this section;
(iii) Although it appears that this section may apply to the
information at this time, EPA is presently engaged in determining
whether for any reason the information is entitled to confidential
treatment or will be entitled to such treatment if and when this
section no longer applies to the information; and
(iv) Information determined by EPA to be covered by this section
will not be disclosed for as long as this section continues to apply,
but will be made available to the public thereafter (subject to
Sec. 2.210) unless the business furnishes timely comments in response
to the notice.
(f) Final confidentiality determination by EPA legal office.
Section 2.205 applies to information to which this section applies,
except that--
(1) In addition to the circumstances mentioned in Sec. 2.205(f)(1),
notice in the form prescribed by Sec. 2.205(f)(2) shall be furnished to
each affected business whenever information is found to be entitled to
confidential treatment under section 408(f) of the Act but not
otherwise entitled to confidential treatment. With respect to such
cases, the following sentences shall be substituted for the third
sentence of Sec. 2.205(f)(2): ``With respect to EPA's implementation of
the determination, the notice shall state that (subject to Sec. 2.210)
EPA will make the information available to the public on the thirty-
first (31st) calendar day after the business' receipt of the written
notice (or on such later date as is established in lieu thereof under
paragraph (f)(3) of this section), unless the EPA legal office has
first been notified of the business' commencement of an action in a
Federal court to obtain judicial review of the determination and to
obtain preliminary injunctive relief against disclosure; provided, that
the information will not be made available to the public for so long as
it is entitled to confidential treatment under section 408(f) of the
Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a(f).''; and
(2) Notwithstanding Sec. 2.205(g), the 31 calendar day period
prescribed by Sec. 2.205(f)(2), as modified by paragraph (f)(2) of this
section, shall not be shortened without the consent of the business.
(g) [Reserved]
(h) Substantive criteria for use in confidentiality determinations.
Section 2.208 does not apply to information to which this section
applies. Such information shall be determined to be entitled to
confidential treatment for so long as this section continues to apply
to it.
(i) Disclosure in special circumstances. (1) Section 2.209 applies
to information to which this section applies. In addition, under
Section 408(f) of the Act, 21 U.S.C. 346a(f), EPA is authorized to
disclose the information to other persons. Such authority under section
408(f) of the Act may be exercised only in accordance with paragraph
(i)(2) or (i)(3) of this section.
(2) Information to which this section applies may be disclosed
(notwithstanding the fact that it otherwise might be entitled to
confidential treatment under this subpart) to a person under contract
to EPA to perform work for EPA in connection with the Act, with the
Federal Insecticide, Fungicide, and Rodenticide Act, as amended, or
regulations which implement either such Act, if the EPA program office
managing the contract first determines in writing that such disclosure
is necessary in order that the contractor may carry out the work
required by the contract. Any such disclosure to a contractor shall be
made only in accordance with the procedures and requirements of
Sec. 2.301(h)(2)(ii) and (h)(2)(iii).
(3) Information to which this section applies may be disclosed by
EPA to an advisory committee in accordance with section 408(d) of the
Act, 21 U.S.C. 346a(d).
Sec. 2.309 Special rules governing certain information obtained under
the Marine Protection, Research and Sanctuaries Act of 1972.
(a) Definitions. For the purposes of this section:
(1) Act means the Marine Protection, Research and Sanctuaries Act
of 1972, 33 U.S.C. 1401 et seq.
(2) Permit means any permit applied for or granted under the Act.
(3) Application means an application for a permit.
(b) Applicability. This section applies to all information provided
to or obtained by EPA as a part of any application or in connection
with any permit.
(c) Basic rules which apply without change. Sections 2.201 through
2.207 and 2.209 through 2.216 apply without change to information to
which this section applies.
(d) Substantive criteria for use in confidentiality determinations.
Section 2.208 does not apply to information to which this section
applies. Pursuant to section 104(f) of the Act, 33 U.S.C. 1414(f), no
information to which this section applies is eligible for confidential
treatment.
Sec. 2.310 Special rules governing certain information obtained under
the Comprehensive Environmental Response, Compensation, and Liability
Act of 1980, as amended.
(a) Definitions. For purposes of this section:
(1) Act means the Comprehensive Environmental Response,
Compensation, and Liability Act of 1980, as amended, including
amendments made by the Superfund Amendments and Reauthorization Act of
1986, 42 U.S.C. 9601, et seq.
(2) Person has the meaning given it in section 101(21) of the Act,
42 U.S.C. 9601(21).
(3) Facility has the meaning given it in section 101(9) of the Act,
42 U.S.C. 9601(9).
(4) Hazardous substance has the meaning given it in section 101(14)
of the Act, 42 U.S.C. 9601(14).
(5) Release has the meaning given it in section 101(22) of the Act,
42 U.S.C. 9601(22).
(6) Proceeding means any rulemaking or adjudication conducted by
EPA under the Act or under regulations which implement the Act
(including the issuance of administrative orders under section 106 of
the Act and cost recovery pre-litigation settlement negotiations under
sections 107 or 122 of the Act), any cost recovery litigation under
section 107 of the Act, or any administrative determination made under
section 104 of the Act, but not including determinations under this
subpart.
(b) Applicability. This section applies only to information
provided to or obtained by EPA under section 104 of the Act, 42 U.S.C.
9604, by or from any person who stores, treats, or disposes of
hazardous wastes; or where necessary to ascertain facts not available
at the facility where such hazardous substances are located, by or from
any person who generates, transports, or otherwise handles or has
handled hazardous substances, or by or from any person who performs or
supports removal or remedial actions pursuant to section 104(a) of the
Act. Information will be considered to have been provided or obtained
under section 104 of the Act if it was provided in response to a
request from EPA or a representative of EPA made for any of the
purposes stated in section 104, if it was provided pursuant to the
terms of a contract, grant or other agreement to perform work pursuant
to section 104, or if its submission could have been required under
section 104, regardless of whether section 104 was cited as authority
for any request for the information or whether the information was
provided directly to EPA or through some third person.
(c) Basic rules which apply without change. Sections 2.201 through
2.216 apply without change to information to which this section
applies.
(d) [Reserved]
(e) [Reserved]
(f) [Reserved]
(g) Disclosure of information relevant to a proceeding. (1) Under
section 104(e)(7)(A) of the Act (42 U.S.C. 9604(e)(7)(A)) any
information to which this section applies may be disclosed by EPA
because of the relevance of the information in a proceeding under the
Act, notwithstanding the fact that the information otherwise might be
entitled to confidential treatment under this subpart. Disclosure of
information to which this section applies because of its relevance in a
proceeding shall be made only in accordance with this paragraph (g).
(2) The provisions of Sec. 2.301(g)(2) must be followed when making
disclosures pursuant to paragraph (g) of this section.
(3) In connection with any proceeding involving a decision by a
presiding officer after an evidentiary or adjudicatory hearing, except
with respect to litigation conducted by a Federal court, information to
which this section applies which may be entitled to confidential
treatment may be made available to the public, or to one or more
parties of record to the proceeding, upon EPA's initiative, under this
paragraph (g)(3). An EPA office proposing disclosure of information
under this paragraph (g)(3), shall so notify the presiding officer in
writing. Upon receipt of such a notification, the presiding officer
shall notify each affected business that disclosure under this
paragraph (g)(3) has been proposed, and shall afford each such business
a period for comment found by the presiding officer to be reasonable
under the circumstances. Information may be disclosed under this
paragraph (g)(3) only if, after consideration of any timely comments
submitted by the business, the EPA office determines in writing that,
for reasons directly associated with the conduct of the proceeding, the
contemplated disclosure would serve the public interest, and the
presiding officer determines in writing that the information is
relevant to a matter in controversy in the proceeding. The presiding
officer may condition disclosure of the information to a party of
record on the making of such protective arrangements and commitments as
he finds to be warranted. Disclosure to one or more parties of record,
under protective arrangements or commitments, shall not, of itself,
affect the eligibility of information for confidential treatment under
the other provisions of this subpart. Any affected business shall be
given at least 5 days notice by the presiding officer prior to making
the information available to the public or to one or more of the
parties of record to the proceeding.
(4) In connection with any proceeding involving a decision by a
presiding officer after an evidentiary or adjudicatory hearing, except
with respect to litigation conducted by a Federal court, information to
which this section applies which may be entitled to confidential
treatment may be made available to one or more parties of record to the
proceeding, upon request of a party, under this paragraph (g)(4). A
party of record seeking disclosure of information shall direct his
request to the presiding officer. Upon receipt of such a request, the
presiding officer shall notify each affected business that disclosure
under this paragraph (g)(4) has been requested, and shall afford each
such business a period for comment found by the presiding officer to be
reasonable under the circumstances. Information may be disclosed to a
party of record under this paragraph (g)(4) only if, after
consideration of any timely comments submitted by the business, the
presiding officer determines in writing both that the party of record
has satisfactorily shown that with respect to a significant matter
which is in controversy in the proceeding, the party's ability to
participate effectively in the proceeding will be significantly
impaired unless the information is disclosed to him, and that any harm
to an affected business that would result from the disclosure is likely
to be outweighed by the benefit to the proceeding and the public
interest that would result from the disclosure. The presiding officer
may condition disclosure of the information to a party of record on the
making of such protective arrangements and commitments as he finds to
be warranted. Disclosure to one or more parties of record, under
protective arrangements or commitments, shall not, of itself, affect
the eligibility of information for confidential treatment under the
other provisions of this subpart. Any affected business shall be given
at least 5 days notice by the presiding officer prior to making the
information available to one or more of the parties of record to the
proceeding.
(5) In connection with cost recovery pre-litigation settlement
negotiations under section 107 or 122 of the Act (42 U.S.C. 9607,
9622), any information to which this section applies that may be
entitled to confidential treatment may be made available to potentially
responsible parties pursuant to a contractual agreement to protect the
information.
(6) In connection with any cost recovery proceeding under section
107 of the Act involving a decision by a presiding officer after an
evidentiary or adjudicatory hearing, any information to which this
section applies that may be entitled to confidential treatment may be
made available to one or more parties of record to the proceeding, upon
EPA's initiative, under this paragraph (g)(6). Such disclosure must be
made pursuant to a stipulation and protective order signed by all
parties to whom disclosure is made and by the presiding officer.
(h) Disclosure to authorized representatives. (1) Under section
104(e)(7) of the Act (42 U.S.C. 9604(e)(7)), EPA possesses authority to
disclose to any authorized representative of the United States any
information to which this section applies, notwithstanding the fact
that the information might otherwise be entitled to confidential
treatment under this subpart.
(2) The provisions of Sec. 2.301(h)(2) and (h)(3) must be followed
when making disclosures pursuant to paragraph (h) of this section.
(3) At the time any information is furnished to a contractor,
subcontractor, or State or local government agency under this paragraph
(h), the EPA office furnishing the information to the contractor,
subcontractor, or State or local government agency shall notify the
contractor, subcontractor, or State or local government agency that the
information may be entitled to confidential treatment and that any
knowing and willful disclosure of the information may subject the
contractor, subcontractor, or State or local government agency and its
employees to penalties in section 104(e)(7)(B) of the Act (42 U.S.C.
9604(e)(7)(B)).
Sec. 2.311 Special rules governing certain information obtained under
the Motor Vehicle Information and Cost Savings Act.
(a) Definitions. For the purposes of this section:
(1) Act means the Motor Vehicle Information and Cost Savings Act,
as amended, 15 U.S.C. 1901 et seq.
(2) Average fuel economy has the meaning given it in section 501(4)
of the Act, 15 U.S.C. 2001(4).
(3) Fuel economy has the meaning given it in section 501(6) of the
Act, 15 U.S.C. 2001(6).
(4) Fuel economy data means any measurement or calculation of fuel
economy for any model type and average fuel economy of a manufacturer
under section 503(d) of the Act, 15 U.S.C. 2003(d).
(5) Manufacturer has the meaning given it in section 501(9) of the
Act, 15 U.S.C. 2001(9).
(6) Model type has the meaning given it in section 501(11) of the
Act, 15 U.S.C. 2001(11).
(b) Applicability. This section applies only to information
provided to or obtained by EPA under Title V, Part A of the Act, 15
U.S.C. 2001 through 2012. Information will be considered to have been
provided or obtained under Title V, Part A of the Act if it was
provided in response to a request from EPA made for any purpose stated
in Title V, Part A, or if its submission could have been required under
Title V, Part A, regardless of whether Title V, Part A was cited as the
authority for any request for information or whether the information
was provided directly to EPA or through some third person.
(c) Basic rules which apply without change. Sections 2.201 through
2.207 and Secs. 2.209 through 2.216 apply without change to information
to which this section applies.
(d) [Reserved]
(e) Substantive criteria for use in confidentiality determinations.
Section 2.208 applies without change to information to which this
section applies, except that information that is fuel economy data is
not eligible for confidential treatment.
(f) [Reserved]
(g) Disclosure of information relevant to a proceeding.
(1) Under section 505(d)(1) of the Act, any information to which
this section applies may be released by EPA because of the relevance of
the information to a proceeding under Title V, Part A of the Act,
notwithstanding the fact that the information otherwise might be
entitled to confidential treatment under this subpart. Release of
information to which this section applies because of its relevance to a
proceeding shall be made only in accordance with this paragraph (g).
(2) The provisions of Sec. 2.301(g)(2), (g)(3), and (g)(4) must be
followed when making disclosures pursuant to paragraph (g) of this
section.
PART 57--[AMENDED]
5. The authority citation for part 57 continues to read as follows:
Authority: Secs. 110, 114, 119, 301, Clean Air Act as amended
(42 U.S.C. 7410, 7414, 7419, and 7601); sec. 406 of Pub. L. 95-95.
6. Section 57.203 is amended by revising the first sentence of
paragraph (a) to read as follows:
Sec. 57.203 Contents of the application.
(a) Claim of confidentiality. The smelter owner may make a business
confidentiality claim covering all or part of the information in the
NSO application in accordance with 40 CFR part 2, subpart B. * * *
* * * * *
7. Appendix A of part 57 is amended by revising the second sentence
of instruction 1.3 to read as follows:
Appendix A to Part 57--Primary Nonferrous Smelter Order (NSO)
Application
* * * * *
1.3 Confidentiality. * * * Agency regulations concerning claims of
confidentiality of business information are contained in 40 CFR part 2,
subpart B. * * *
* * * * *
PART 85--[AMENDED]
8. The authority citation for part 85 continues to read as follows:
Authority: Secs. 202, 208, and 301(a), Clean Air Act, as amended
(42 U.S.C. 7521, 7542 and 7601(a)).
9. Section 85.1712 is amended by revising paragraph (e) to read as
follows:
Sec. 85.1712 Treatment of confidential information.
* * * * *
(e) Information provided without a claim of confidentiality at the
time of submission may be made available to the public by EPA without
further notice to the submitter.
10. Section 85.1808 is amended by revising paragraph (e) to read as
follows:
Sec. 85.1808 Treatment of confidential information.
* * * * *
(e) Information provided without a claim of confidentiality at the
time of submission may be made available to the public by EPA without
further notice to the submitter.
11. Section 85.1909 is amended by revising paragraph (e) to read as
follows:
Sec. 85.1909 Treatment of confidential information.
* * * * *
(e) Information provided without a claim of confidentiality at the
time of submission may be made available to the public by EPA without
further notice to the submitter.
12. Section 85.2123 is amended by revising paragraph (e) to read as
follows:
Sec. 85.2123 Treatment of confidential information.
* * * * *
(e) Information provided without a claim of confidentiality at the
time of submission may be made available to the public by EPA without
further notice to the submitter.
PART 86--[AMENDED]
13. The authority citation for part 86 continues to read as
follows:
Authority: Secs. 202, 203, 206, 207, 208, 215, 301(a), Clean Air
Act, as amended (42 U.S.C. 7521, 7522, 7524, 7525, 7541, 7549, 7550,
7552, and 7601(a)), unless otherwise noted.
14. Section 86.615-84 is amended by revising paragraph (e) to read
as follows:
Sec. 86.615-84 Treatment of confidential information.
* * * * *
(e) Information provided without a claim of confidentiality at the
time of submission may be made available to the public by EPA without
further notice to the submitter.
15. Section 86.1015 is amended by revising paragraph (e) to read as
follows:
Sec. 86.1015 Treatment of confidential information.
* * * * *
(e) Information provided without a claim of confidentiality at the
time of submission may be made available to the public by EPA without
further notice to the submitter.
16. Section 86.1116-87 is amended by revising paragraph (e) to read
as follows:
Sec. 86.1116-87 Treatment of confidential information.
* * * * *
(e) Information provided without a claim of confidentiality at the
time of submission may be made available to the public by EPA without
further notice to the submitter.
PART 122--[AMENDED]
17. The authority citation for part 122 continues to read as
follows:
Authority: The Clean Water Act, 33 U.S.C. 1251 et seq.
18. Section 122.7 is amended by revising paragraph (a) to read as
follows:
Sec. 122.7 Confidentiality of information.
(a) In accordance with 40 CFR part 2, any information submitted to
EPA pursuant to these regulations may be claimed as confidential by the
submitter. Any such claim must be asserted at the time of submission in
the manner prescribed in the application form or instructions or, in
the case of other submission, by stamping the words ``confidential
business information'' on each page containing such information. If no
claim is made at the time of submission, EPA may make the information
available to the public without further notice. If a claim covering the
information is received after the information itself is received, EPA
will make such efforts as are administratively practicable to associate
the late claim with copies of the previously-submitted information in
EPA files. However, EPA cannot assure that such efforts will be
effective, in light of the possibility of prior disclosure or
widespread prior dissemination of the information. If a claim is
asserted, the information will be treated in accordance with the
procedures in 40 CFR part 2 (Public Information).
* * * * *
PART 123--[AMENDED]
19. The authority citation for part 123 continues to read as
follows:
Authority: Clean Water Act, 33 U.S.C. 1251 et seq.
20. Section 123.41 is amended by revising paragraph (a) to read as
follows:
Sec. 123.41 Sharing of information.
(a) Any information obtained or used in the administration of a
State program shall be available to EPA upon request without
restriction. If the information has been submitted to the State under a
claim of confidentiality, the State must submit that claim to EPA when
providing information under this section. Any information obtained from
a State and subject to a claim of confidentiality will be treated in
accordance with the regulations in 40 CFR part 2. If EPA obtains from a
State information that is not claimed to be confidential, EPA may make
that information available to the public without further notice. If a
claim covering the information is received after the information itself
is received, EPA will make such efforts as are administratively
practicable to associate the late claim with copies of the previously-
submitted information in EPA files. However, EPA cannot assure that
such efforts will be effective, in light of the possibility of prior
disclosure or widespread prior dissemination of the information.
* * * * *
21. Section 123.42 is amended by revising the first sentence of the
introductory text to read as follows:
Sec. 123.42 Receipt and use of Federal information.
Upon approving a State permit program, EPA shall send to the State
agency administering the permit program, subject to the conditions in
40 CFR part 2, any relevant information which was collected by EPA. * *
*
* * * * *
PART 145--[AMENDED]
22. The authority citation for part 145 continues to read as
follows:
Authority: 42 U.S.C. 300f et seq.
23. Section 145.14 is amended by revising paragraph (a) to read as
follows:
Sec. 145.14 Sharing of information.
(a) Any information obtained or used in the administration of a
State program shall be available to EPA upon request without
restriction. If the information has been submitted to the State under a
claim of confidentiality, the State must submit that claim to EPA when
providing information under this section. Any information obtained from
a State and subject to a claim of confidentiality will be treated in
accordance with the regulations in 40 CFR part 2. If EPA obtains from a
State information that is not claimed to be confidential, EPA may make
that information available to the public without further notice. If a
claim covering the information is received after the information itself
is received, EPA will make such efforts as are administratively
practicable to associate the late claim with copies of the previously-
submitted information in EPA files. However, EPA cannot assure that
such efforts will be effective, in light of the possibility of prior
disclosure or widespread prior dissemination of the information.
* * * * *
PART 233--[AMENDED]
24. The authority citation for part 233 continues to read as
follows:
Authority: Clean Water Act, 33 U.S.C. 1251 et seq.
25. Section 233.3 is amended by revising paragraph (a) to read as
follows:
Sec. 233.3 Confidentiality of information.
(a) Any information submitted to EPA pursuant to these regulations
may be claimed as confidential by the submitter at the time of
submittal. Information so claimed will be treated in accordance with
the procedures in 40 CFR part 2.
* * * * *
PART 260--[AMENDED]
26. The authority citation for part 260 continues to read as
follows:
Authority: 42 U.S.C. 6905, 6912(a), 6921-6927, 6930, 6934, 6935,
6937, 6938, 6939, and 6974.
27. Section 260.2 is amended by revising paragraph (b) to read as
follows:
Sec. 260.2 Availability of information; confidentiality of
information.
* * * * *
(b) Any person who submits information to EPA in accordance with
parts 260 through 266 and 268 of this chapter may assert a claim of
business confidentiality covering part or all of that information by
following the procedures set forth in Sec. 2.203(b) of this chapter.
Information covered by such a claim will be disclosed by EPA only to
the extent, and by means of the procedures, set forth in part 2,
subpart B, of this chapter. However, if no such claim accompanies the
information when it is received by EPA, it may be made available to the
public without further notice to the person submitting it. If a claim
covering the information is received after the information itself is
received, EPA will make such efforts as are administratively
practicable to associate the late claim with copies of the previously-
submitted information in EPA files. However, EPA cannot assure that
such efforts will be effective, in light of the possibility of prior
disclosure or widespread prior dissemination of the information.
Pursuant to Sec. 2.305(f) of this chapter, information required by
Sec. 262.53(a) which is submitted in notification of intent to export a
hazardous waste will be provided to the Department of State and the
appropriate authorities in a receiving country regardless of any claims
of confidentiality.
PART 270--[AMENDED]
28. The authority citation for part 270 continues to read as
follows:
Authority: 42 U.S.C. 6905, 6912, 6924, 6925, 6927, 6939, and
6974.
29. Section 270.12 is amended by revising paragraph (a) to read as
follows:
Sec. 270.12 Confidentiality of information.
(a) In accordance with 40 CFR part 2, any information submitted to
EPA pursuant to these regulations may be claimed as confidential by the
submitter. Any such claim must be asserted at the time of submission in
the manner prescribed in the application form or instructions or, in
the case of other submissions, by stamping the words ``confidential
business information'' on each page containing such information. If no
claim is made at the time of submission, EPA may make the information
available to the public without further notice. If a claim covering the
information is received after the information itself is received, EPA
will make such efforts as are administratively practicable to associate
the late claim with copies of the previously-submitted information in
EPA files. However, EPA cannot assure that such efforts will be
effective, in light of the possibility of prior disclosure or
widespread prior dissemination of the information. If a claim is
asserted, the information will be treated in accordance with the
procedures in 40 CFR part 2 (Public Information).
* * * * *
PART 271--[AMENDED]
30. The authority citation for part 271 continues to read as
follows:
Authority: 42 U.S.C. 9602; 33 U.S.C. 1321 and 1361.
31. Section 271.17 is amended by revising paragraph (a) to read as
follows:
Sec. 271.17 Sharing of information.
(a) Any information obtained or used in the administration of a
State program shall be available to EPA upon request without
restriction. If the information has been submitted to the State under a
claim of confidentiality, the State must submit that claim to EPA when
providing information under this subpart. Any information obtained from
a State and subject to a claim of confidentiality will be treated in
accordance with the regulations in 40 CFR part 2. If EPA obtains from a
State information that is not claimed to be confidential, EPA may make
that information available to the public without further notice. If a
claim covering the information is received after the information itself
is received, EPA will make such efforts as are administratively
practicable to associate the late claim with copies of the previously-
submitted information in EPA files. However, EPA cannot assure that
such efforts will be effective, in light of the possibility of prior
disclosure or widespread prior dissemination of the information.
* * * * *
32. Section 271.132 is amended by revising paragraph (a) to read as
follows:
Sec. 271.132 Sharing of information.
(a) Any information obtained or used in the administration of a
State program shall be available to EPA upon request without
restriction. If the information has been submitted to the State under a
claim of confidentiality, the State must submit that claim to EPA when
providing information under this subpart. Any information obtained from
a State and subject to a claim of confidentiality will be treated in
accordance with the regulations in 40 CFR part 2. If EPA obtains from a
State information that is not claimed to be confidential, EPA may make
that information available to the public without further notice. If a
claim covering the information is received after the information itself
is received, EPA will make such efforts as are administratively
practicable to associate the late claim with copies of the previously-
submitted information in EPA files. However, EPA cannot assure that
such efforts will be effective, in light of the possibility of prior
disclosure or widespread prior dissemination of the information.
* * * * *
PART 281--[AMENDED]
33. The authority citation for part 281 continues to read as
follows:
Authority: Sections 2002, 9004, 9005, 9006 of the Solid Waste
Disposal Act, as amended by the Resource Conservation and Recovery
Act of 1976, as amended (42 U.S.C. 6912, 6991 (c), (d), (e).
34. Section 281.43 is amended by revising paragraph (a)(1) to read
as follows:
Sec. 281.43 Sharing of information.
(a) * * *
(1) Any information submitted to the State under a claim of
confidentiality. The State must submit that claim to EPA when providing
such information. If a claim covering the information is received after
the information itself is received, EPA will make such efforts as are
administratively practicable to associate the late claim with copies of
the previously-submitted information in EPA files. However, EPA cannot
assure that such efforts will be effective, in light of the possibility
of prior disclosure or widespread prior dissemination of the
information. Any information obtained from a State and subject to a
claim of confidentiality will be treated in accordance with federal
regulations in 40 CFR part 2; and
* * * * *
PART 350--[AMENDED]
35. The authority citation for part 350 continues to read as
follows:
Authority: 42 U.S.C. 11042, 11043 and 11048 Pub. L. 99-499, 100
Stat. 1747.
36. Section 350.23 is amended by revising paragraph (b)(3) and
removing paragraph (b)(4) to read as follows:
Sec. 350.23 Disclosure to authorized representatives.
* * * * *
(b) * * *
(3) No information shall be disclosed under this Sec. 350.23(b)
until each affected submitter has been furnished notice (by letter,
Federal Register, or other means) of the contemplated disclosure by the
EPA program office and has been afforded a period found reasonable by
that office (not less than 5 working days) to submit its comments. Such
notice shall include a description of the information to be disclosed,
the identity of the contractor, subcontractor or grantee, and the
purposes to be served by the disclosure. The office preparing the
notice must respond in writing to all comments submitted by affected
businesses.
PART 403--[AMENDED]
37. The authority citation for part 403 continues to read as
follows:
Authority: Sec. 54(c)(2) of the Clean Water Act of 1977 (Pub. L.
95-217), sections 204(b)(1)(C), 208(b)(2)(C)(iii), 301(b)(1)(A)(ii),
301(b)(2)(A)(ii), 301(b)(2)(C), 301(h)(5), 301(i)(2), 304(e),
304(g), 307, 308, 309, 402(b), 405 and 501(a) of the Federal Water
Pollution Control Act (Pub. L. 92-500) as amended by the Clean Water
Act of 1977 and the Water Quality Act of 1987 (Pub. L. 100-4).
38. Section 403.14 is amended by revising paragraph (a) to read as
follows:
Sec. 403.14 Confidentiality.
(a) EPA Authorities. In accordance with 40 CFR part 2, any
information submitted to EPA pursuant to these regulations may be
claimed as confidential by the submitter. Any such claim must be
asserted at the time of submission in the manner prescribed in the
application form or instructions, or, in the case of other submission,
by stamping the words ``confidential business information'' on each
page containing such information. If no claim is made at the time of
submission, EPA may make the information available to the public
without further notice. If a claim covering the information is received
after the information itself is received, EPA will make such efforts as
are administratively practicable to associate the late claim with
copies of the previously-submitted information in EPA files. However,
EPA cannot assure that such efforts will be effective, in light of the
possibility of prior disclosure or widespread prior dissemination of
the information. If a claim is asserted, the information will be
treated in accordance with the procedures in 40 CFR part 2 (Public
Information).
* * * * *
PART 704--[AMENDED]
39. The authority citation for part 704 is revised to read as
follows:
Authority: 15 U.S.C. 2607(a) and 2613.
40. Section 704.7 is amended by revising paragraphs (a) and (d)
introductory text to read as follows:
Sec. 704.7 Confidential business information claims.
(a) Any person submitting a notice under this rule may assert a
business confidentiality claim covering all or any part of the
information. A senior management official, as defined in 40 CFR
2.306(a)(7), shall sign all business confidentiality claims. Any
information covered by a claim will be disclosed by EPA only to the
extent and by means of the procedures set forth in part 2 of this
chapter.
* * * * *
(d) In submitting a claim of confidentiality, a senior management
official, as defined in 40 CFR 2.306(a)(7), attests to the truth of the
following four statements concerning all the information claimed
confidential:
* * * * *
41. Section 704.219 is amended by adding paragraph (c)(2) and
revising paragraph (d) to read as follows:
Sec. 704.219 Confidential business information claims.
* * * * *
(c) * * *
(2) A senior management official, as defined in 40 CFR 2.306(a)(7),
shall sign all reports containing confidentiality claims.
(d) Submitters must substantiate all claims of confidentiality at
the time the submitter asserts the claim (i.e., when the reporting form
is submitted). A senior management official, as defined in 40 CFR
2.306(a)(7), shall sign all substantiations of claims of
confidentiality. Failure to provide substantiation of a claim at the
time the submitter submits the reporting form will result in a waiver
of the confidentiality claim, and the information may be disclosed to
the public without further notice to the submitter.
* * * * *
PART 707--[AMENDED]
42. The authority citation for part 707 is revised to read as
follows:
Authority: 15 U.S.C. 2611(b), 2612 and 2613.
43. Section 707.75 is amended by revising paragraph (a) to read as
follows:
Sec. 707.75 Confidentiality.
(a) A person may assert a claim of confidentiality for any
information which is submitted to EPA in a notice. A senior management
official, as defined in 40 CFR 2.306(a)(7), shall sign all claims of
confidentiality.
* * * * *
PART 710--[AMENDED]
44. The authority citation for part 710 is revised to read as
follows:
Authority: 15 U.S.C. 2607(a) and 2613.
45. Section 710.7 is amended by revising paragraph (b) to read as
follows:
Sec. 710.7 Confidentiality.
* * * * *
(b) Any claims of confidentiality must accompany the information at
the time it is submitted to EPA. The claims must appear on the form on
which the information is submitted to EPA and in the manner prescribed
on the form. In addition, any claims of confidentiality must be
substantiated at the time the information is submitted to EPA in the
manner specified in the form instructions. A senior management
official, as defined in 40 CFR 2.306(a)(7), shall sign all claims of
confidentiality and substantiations.
* * * * *
46. Section 710.38 is amended by revising paragraph (a) and the
introductory text of paragraph (c)(1) to read as follows:
Sec. 710.38 Confidentiality.
(a) Any person submitting information under this subpart may assert
a business confidentiality claim for the information. A senior
management official, as defined in 40 CFR 2.306(a)(7), shall sign all
business confidentiality claims. The procedures for asserting
confidentiality claims are described in the instruction booklet
identified in Sec. 710.39. Information claimed as confidential in
accordance with this section and those instructions will be treated and
disclosed in accordance with the procedures in part 2 of this chapter.
* * * * *
(c) * * *
(1) The person must submit with the report detailed written answers
to the following questions signed and dated by a senior management
official, as defined in 40 CFR 2.306(a)(7).
* * * * *
PART 712--[AMENDED]
47. The authority citation for part 712 is revised to read as
follows:
Authority: 15 U.S.C. 2607(a) and 2613.
48. Section 712.15 is amended by revising paragraph (b) to read as
follows:
Sec. 712.15 Confidentiality.
* * * * *
(b) A senior management official, as defined in 40 CFR 2.306(a)(7),
must certify to the validity of the claim of confidentiality asserted
for information reported under this part, as specified on the reporting
form.
* * * * *
PART 716--[AMENDED]
49. The authority citation for part 716 is revised to read as
follows:
Authority: 15 U.S.C. 2607(d) and 2613.
50. Section 716.55 is amended by adding paragraphs (a)(5) and
(a)(6) to read as follows:
Sec. 716.55 Confidentiality claims.
(a) * * *
(5) Any respondent who wishes to assert a claim of confidentiality
for chemical identity must substantiate such claim in accordance with
40 CFR 2.306(d)(2). A senior management official, as defined in 40 CFR
2.306(a)(7), shall sign all substantiations. If no claim of
confidentiality for chemical identity accompanies the submission or if
the substantiation required under this paragraph (a)(5) is not
submitted at the time of assertion of the claim, EPA will deem the
claim for chemical identity waived and may make the identity public
without further notice to the submitter.
(6) A senior management official, as defined in 40 CFR 2.306(a)(7),
shall sign all submissions containing confidentiality claims.
* * * * *
PART 717--[AMENDED]
51. The authority citation for part 717 is revised to read as
follows:
Authority: 15 U.S.C. 2607(c) and 2613.
52. Section 717.19 is amended by adding paragraphs (c)(5) and
(c)(6) to read as follows:
Sec. 717.19 Confidentiality.
* * * * *
(c) * * *
(5) Any respondent who wishes to assert a claim of confidentiality
for chemical identity must substantiate such claim in accordance with
40 CFR2.306(d)(2). A senior management official, as defined in 40 CFR
2.306(a)(7), shall sign all substantiations. If no claim of
confidentiality for chemical identity accompanies the submission or if
the substantiation required under this subparagraph is not submitted at
the time of assertion of the claim, EPA will deem the claim for
chemical identity waived and may make the identity public without
further notice to the submitter.
(6) A senior management official, as defined in 40 CFR 2.306(a)(7),
shall sign all submissions containing confidentiality claims.
PART 720--[AMENDED]
53. The authority citation for part 720 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607 and 2613.
54. Section 720.80 is amended by adding paragraph (b)(3) to read as
follows:
Sec. 720.80 General provisions.
* * * * *
(b) * * *
(3) A senior management official, as defined in 40 CFR 2.306(a)(7),
shall sign all notice forms containing any claims of confidentiality.
* * * * *
55. Section 720.85 is amended by revising paragraph (b)(3)(iv),
introductory text, to read as follows:
Sec. 720.85 Chemical identity.
* * * * *
(b) * * *
(3) * * *
(iv) Provide a detailed written substantiation of the claim, signed
by a senior management official, as defined in 40 CFR 2.306(a)(7), by
answering the following questions:
* * * * *
56. Section 720.90 is amended by adding a sentence after the first
sentence of paragraph (b)(2) to read as follows:
Sec. 720.90 Data from health and safety studies.
* * * * *
(b) * * *
(2) Claims applicable to period after commencement of manufacture
or import for commercial purposes. * * * A senior management official,
as defined in 40 CFR 2.306(a)(7), shall sign such reassertions and
substantiations of claims of confidentiality for chemical identity.
* * * * *
PART 723--[AMENDED]
57. The authority citation for part 723 is revised to read as
follows:
Authority: 15 U.S.C. 2604 and 2613.
58. Section 723.50 is amended by revising paragraph (k)(1) to read
as follows:
Sec. 723.50 Chemical substances manufactured in quantities of 1,000
kilograms or less per year.
* * * * *
(k) Confidentiality. (1) If the manufacturer submits to EPA under
this section information which it claims to be confidential business
information, the manufacturer must clearly identify the information at
the time of submission to EPA by bracketing, circling, or underlining
it and stamping it with ``CONFIDENTIAL'' or some other appropriate
designation. A senior management official, as defined in 40 CFR
2.306(a)(7), shall sign all business confidentiality claims. Any
information so identified will be treated in accordance with the
procedures in part 2 of this chapter. Any information not claimed as
confidential at the time of submission may be made available to the
public without further notice.
* * * * *
59. Section 723.175 is amended by revising paragraph (k) to read as
follows:
Sec. 723.175 Chemical substances used in or for the manufacture or
processing of instant photographic and peel-apart film articles.
* * * * *
(k) Confidentiality. If the manufacturer submits to EPA under
paragraph (i) or (j) of this section information which it claims to be
confidential business information, the manufacturer must clearly
identify the information at the time of submission to EPA by
bracketing, circling, or underlining it and stamping it with
``CONFIDENTIAL'' or some other appropriate designation. A senior
management official, as defined in 40 CFR 2.306(a)(7), shall sign all
business confidentiality claims. Any information so identified will be
treated in accordance with the procedures in part 2 of this chapter.
Any information not claimed as confidential at the time of submission
will be made available to the public without further notice to the
submitter.
* * * * *
PART 750--[AMENDED]
60. The authority citation for part 750 is revised to read as
follows:
Authority: 15 U.S.C. 2605 and 2613.
61. Section 750.16 is revised to read as follows:
Sec. 750.16 Confidentiality.
The Agency encourages the submission of nonconfidential information
by petitioners and commenters. The Agency does not wish to have
unnecessary restrictions on access to the rulemaking record. However,
if a petitioner or commenter believes that he can only state his
position through the use of information claimed to be confidential, he
may submit it. Such information must be separately submitted for the
rulemaking record and marked ``confidential'' by the submitter. A
senior management official, as defined in 40 CFR 2.306(a)(7), shall
sign all business confidentiality claims. For information claimed to be
confidential, the Agency will list only the date and the name and
address of the petitioner or commenter in the public file, noting that
the petitioner or commenter has requested confidential treatment. The
information claimed to be confidential will be placed in a confidential
file. A petitioner must also file a nonconfidential petition with a
nonconfidential summary of the confidential information to be placed in
the public file. Similarly, a commenter must supply a nonconfidential
summary of the information claimed to be confidential to be placed in
the public file. Any information not marked as confidential will be
placed in the public file. Information marked as confidential will be
treated in accordance with the procedures in part 2, subpart B of this
chapter.
62. Section 750.36 is revised to read as follows:
Sec. 750.36 Confidentiality.
EPA encourages the submission of non-confidential information by
petitioners and commenters. EPA does not wish to have unnecessary
restrictions on access to the rulemaking record. However, if a
petitioner or commenter believes that he can only state his position
through the use of information claimed to be confidential, he may
submit it. Such information must be separately submitted for the
rulemaking record and marked ``confidential'' by the submitter. A
senior management official, as defined in 40 CFR 2.306(a)(7), shall
sign all business confidentiality claims. For information claimed to be
confidential, EPA will list only the date and the name and address of
the petitioner or commenter in the public file, noting that the
petitioner or commenter has requested confidential treatment. The
information claimed to be confidential will be placed in a confidential
file. A petitioner must also file a non-confidential petition with a
non-confidential summary of the confidential information to be placed
in the public file. Similarly, a commenter must supply a non-
confidential summary of the information claimed to be confidential to
be placed in the public file. Any information not marked as
confidential will be placed in the public file. Information marked
confidential will be treated in accordance with the procedures in part
2, subpart B of this chapter.
PART 790--[AMENDED]
63. The authority citation for part 790 is revised to read as
follows:
Authority: 15 U.S.C. 2603 and 2613.
64. Section 790.7 is amended by revising paragraphs (a), (b) and
(c), introductory text, to read as follows:
Sec. 790.7 Confidentiality.
(a) Any person subject to a consent agreement or test rule under
section 4 of the Act may assert a claim of confidentiality claim for
certain information submitted to EPA in response to the consent
agreement or test rule. A senior management official, as defined in 40
CFR 2.306(a)(7), shall sign all business confidentiality claims. Any
information claimed as confidential will be treated in accordance with
the procedures in part 2 of this chapter and section 14 of the Act.
Failure to assert a claim of confidentiality at the time the
information is submitted will result in the information being made
available to the public without further notice to the submitter.
(b) A claim of confidentiality must be asserted by circling or
otherwise marking the specific information claimed as confidential and
designating it with the words ``confidential business information,''
``trade secret,'' or another appropriate phrase indicating its
confidential character. Any respondent who wishes to assert a claim of
confidentiality for chemical identity must substantiate such claim in
accordance with 40 CFR 2.306(d)(2). A senior management official, as
defined in 40 CFR 2.306(a)(7), shall sign all substantiations. If no
claim of confidentiality for chemical identity accompanies the document
submission or if the substantiation required under this paragraph (b)
is not submitted at the time of assertion of the claim, EPA will deem
the claim for chemical identity waived and may make the identity public
without further notice to the submitter.
(c) If a person asserts a claim of confidentiality for study plan
information described in Sec. 790.50(c)(1) (iii)(D), (iv), (v), and
(vi) and Sec. 790.62(b) (6), (7), (8), (9) and (10), the person must
provide a detailed written substantiation of the claim by answering the
questions in this paragraph. A senior management official, as defined
in 40 CFR 2.306(a)(7), shall sign all substantiations. Failure to
provide written substantiation at the time the study plan information
is submitted will be considered a waiver of the claim of
confidentiality, and the study plan information will be disclosed to
the public without further notice.
* * * * *
[FR Doc. 94-28146 Filed 11-22-94; 8:45 am]
BILLING CODE 6560-50-P
