[Federal Register Volume 60, Number 60 (Wednesday, March 29, 1995)]
[Rules and Regulations]
[Pages 16298-16311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7709]
[[Page 16297]]
_______________________________________________________________________
Part III
Environmental Protection Agency
_______________________________________________________________________
40 CFR Parts 704, 720, 721, and 723
Revisions of Premanufacture Notification Regulations; Expedited Process
to Issue Significant New Use Rules for Selected New Chemical
Substances; Revisions of Exemptions for Polymers; and Revision of
Exemptions for Chemical Substances Manufactured in Small Quantities-Low
Release and Exposure Exemptions; Final Rules
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 /
Rules and Regulations
[[Page 16298]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 704, 720 and 721
[OPPTS-50593B; FRL-4921-8]
RIN 2070-AC14
Premanufacture Notification; Revisions of Premanufacture
Notification Regulations; Final Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule.
-----------------------------------------------------------------------
SUMMARY: Pursuant to section 5 of the Toxic Substances Control Act
(TSCA), EPA is promulgating procedural amendments to the premanufacture
notification (PMN) rule to incorporate a number of regulatory
initiatives designed to streamline and reduce the administrative costs
and burdens of the section 5 new chemicals program. These actions will
allow EPA to concentrate its limited resources on identifying and
controlling those new chemical substances most likely to present an
unreasonable risk of injury to human health and the environment.
DATES: This rule will become effective May 30, 1995. In accordance with
40 CFR 23.5, this rule shall be promulgated for purposes of judicial
review at 1:00 p.m. eastern savings time on April 12, 1995.
FOR FURTHER INFORMATION CONTACT: James B. Willis, Acting Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 554-0551.
SUPPLEMENTARY INFORMATION: EPA published its final PMN rule (40 CFR
part 720) on May 13, 1983 (48 FR 21722) and subsequently amended
certain parts of the rule on September 13, 1983 (48 FR 41132) and April
22, 1986 (51 FR 15096). On February 8, 1993, EPA proposed additional
amendments to the PMN rule (58 FR 7661). Please consult those documents
for further information on the PMN rule and the proposed amendments.
The docket control number for this action is OPPTS-50593B.
I. Background
A. Statutory Authority
Section 5(a)(1) of TSCA requires that persons notify EPA at least
90 days before they manufacture or import a new chemical substance for
commercial purposes. For the purposes of TSCA, a new chemical substance
is one that is not listed in the Master File of the TSCA Chemical
Substance Inventory (``the Inventory'') compiled under TSCA section
8(b), which consists of substances originally reported under the
Inventory reporting regulations (40 CFR part 710) and substances added
via notices of commencement of manufacture or import (NOCs)(40 CFR
720.102) from submitters of PMNs.
B. History
Since 1979, EPA has reviewed over 25,000 section 5 notices for new
chemical substances. During the intervening years, EPA has implemented
a number of initiatives which have enabled the Agency to review a
growing number of new chemical substances more efficiently. As
discussed in the February 8, 1993 proposed rule (58 FR 7661), EPA is
amending the PMN rule at 40 CFR part 720 to further reduce the costs of
administering the Agency's new chemicals program and to implement other
efficiencies for EPA and submitters. Please consult the proposed rule
for a more detailed discussion of the objectives and rationale for
these amendments.
II. Discussion of Final Amendments and Response to Comments
The final rule adopts the proposed amendments with minor revisions.
The Agency reviewed and considered all comments received on the
proposed amendments. A complete copy of all comments received is
available in the public docket for this rulemaking, along with EPA's
response to comments not addressed in this document. A discussion of
the final amendments including a summary of significant comments and
the Agency's response follows:
A. Correct Chemical Identity
EPA is amending Sec. 720.45(a) of the PMN rule to require that
submitters of section 5 notices provide the currently correct Chemical
Abstracts (CA) Index Name or CA Preferred Name for each chemical
substance included in the notice (``reported substance'') that is
consistent with TSCA Inventory listings for similar substances. Persons
who request a search of the confidential Inventory by demonstrating a
bona fide intent to manufacture or import a chemical substance for
commercial purposes (``bona fide'') will also be required to provide CA
nomenclature and chemical identity information in accordance with
amended Sec. 720.25, as discussed later in this document. The rule also
requires that a currently valid Chemical Abstracts Service (CAS)
Registry Number (CASRN) consistent with the CA name be reported for the
substance if a CASRN already exists for that substance. Until now, the
PMN rule has indicated that CA nomenclature is the preferred, but not
required chemical nomenclature system for PMN reporting. Therefore,
submitters were able in the past to identify the PMN substance using
alternative nomenclature. Having the currently correct CA
identification for a substance is important to EPA because the
reporting of incorrect, inconsistent, ambiguous, or obsolete chemical
names, molecular formulae, or chemical structure information, or names
that are not CA Index or CA Preferred Names, causes extra resources to
be spent by EPA in establishing the best descriptions for substances
under TSCA for searching the Inventory.
Although a CASRN has not been routinely required for a reported
substance if a CASRN is not already available and the amendment only
requires that CASRNs be reported for substances that already have them,
EPA strongly recommends that submitters provide CASRNs for all reported
substances, especially when the chemical identity is not being claimed
as confidential business information (CBI). The fact that a CASRN
exists does not prohibit a submitter from claiming this information as
confidential. Having more substances reported with CASRNs will save EPA
resources involved with chemical review and Inventory searching.
Submitters must provide a CA Index Name or CA Preferred Name that
is consistent with the application of the Ninth Collective Index (9CI)
of CA nomenclature rules and conventions. (This definitive guide to CA
nomenclature has been used since 1972.) Whether to report a CA Index
Name or Preferred Name for a substance depends on whether the chemical
identity of the substance is well-defined or poorly defined.
For well-defined substances appropriately named using CA Index
nomenclature, the specific chemical name chosen as most accurately
describing the substance should be based on all information that the
submitter can reasonably ascertain about its chemical structure,
including, where applicable, the degree of structural specificity of
the substance (e.g., whether specific isomers are intended to be
manufactured in the reaction that produces the substance). For poorly
defined substances properly named using CA Preferred nomenclature, the
specific name of choice should be based on the
[[Page 16299]] submitter's knowledge of the identities of the chemical
precursors used, the sources of the reactants (synthetic, isolated by
processing from certain naturally occurring materials, etc.), the
nature of the reaction, and the types of chemical substances
constituting the product combination, etc. For naming any kind of
substance, the submitter's knowledge of impurities or byproducts is
also a consideration.
When more than one substance results from a reaction, one should
determine whether the product combination can be viewed for TSCA
purposes as a mixture of separately reportable substances. For example,
when the intended product combination is known to always be completely
composed of a specific number of identified substances that do not
react with one another, the combination can be represented as a mixture
of individual components. If this is not the case, a single chemical
name must be used to collectively describe the product combination as
one substance. Where the chemical components can be represented as a
mixture, they may be reported in a single PMN as long as the components
are not intended to be separated. Otherwise, multiple PMNs or a
consolidated PMN (requiring pre-approval by EPA) must be submitted.
The PMN rule retains all of the other chemical identity information
required at Sec. 720.45(a), including molecular formula and chemical
structure information. However, for substances not able to be
characterized by a single chemical structure, the amendments require
the submitted representative or partial structural diagram to be as
complete as known to or reasonably ascertainable by the submitter.
Failure to fully comply with the chemical identification elements of
this requirement will result in the notice being declared incomplete by
EPA pursuant to Sec. 720.65(c)(1). Such incomplete notices will not be
processed or reviewed by the Agency until the chemical identification
requirement is satisfied.
Concerning the degree of chemical structure information that can be
reasonably ascertained for a given substance, submitters should
understand that, for TSCA Inventory purposes, all substances are
categorized by EPA into two groups according to the degree of certainty
about the chemical structure of a substance: Class 1 and Class 2. Class
1 substances are those of precisely known chemical composition for
which a single, complete structural diagram can be drawn. Class 2
substances are those having chemical compositions not completely
definite or known; therefore, they cannot be characterized by definite,
complete chemical structure diagrams. This rule amendment requires
complete structural diagrams to be provided for Class 1 substances; for
Class 2 substances, partial structure diagrams are required that are as
complete as can be reasonably ascertained from the Class 2 chemical
identity.
All of the chemical identification requirements described above
should be satisfied if the submitter uses the CAS Registry Services
Inventory Expert Service, which is a special extension of CAS for
identifying substances to be submitted under TSCA. Submitters may also
choose to use the services of another chemical information service or
consultant that the submitter considers capable of generating correct
CA names, chemical structure diagrams or molecular formulae where
appropriate, and obtaining existing CASRNs. Alternatively, the
submitter can search publicly available databases to retrieve this
information, if available, or attempt to generate a name without
assistance from another person or organization, if the submitter has
sufficient knowledge about the Ninth Collective (9CI) Index of CA
nomenclature rules and conventions and about how similar substances are
named for the Inventory.
Information describing CA nomenclature rules and conventions can be
obtained from CAS. In addition, the Agency is preparing a series of
Inventory nomenclature papers that are intended to generate better
understanding of how various classes of substances or types of complex
product combinations are identified for TSCA purposes. The Inventory
papers provide informal technical guidance that is intended solely to
illustrate how various types of substances are represented on the TSCA
Inventory based on the information provided by the submitters. The
papers are not intended to be used for identifying substances for
reporting purposes or for determining the need to report. Generally,
EPA has attempted to maintain a consistent Inventory by closely
following the guidance contained in the papers. However, EPA cannot
guarantee that the guidance discussed in these papers has been applied
to all substances listed on the Inventory. The initial Inventory
reporting utilized four types of reporting forms with very different
format and data requirements, making it difficult to ensure complete
consistency. The Inventory papers will be available from the TSCA
Assistance Information Service at (202) 554-1404; TTD (202) 554-0551;
on line service modem (202) 554-5603.
An information sheet on the CAS Registry Services is also available
from the TSCA Assistance Information Service. Printed copies of the
non-confidential Inventory can be purchased from the Government
Printing Office; computer tapes, CD ROM, and PC diskettes, (up-dated
semi-annually) containing this Inventory information can be purchased
from the National Technical Information Service (NTIS).
Regardless of how submitters determine correct CA chemical
nomenclature, submitters should provide the party generating the CA
nomenclature with the same chemical identity information that the
submitter would have to send to EPA if reporting the substance in a
PMN: the same types of information, levels of detail, degrees of
specificity, byproduct and impurity information, etc. The party
assigning a chemical identity should ensure that the name choice
reflects the current CA nomenclature rules and conventions, as well as
how similar substances are named for the Inventory, or the chemical
name will be incorrect and the notice may be declared incomplete by the
Agency.
The final rule at Sec. 720.45(a)(3)(i) and (ii) sets forth the
required mechanism for obtaining CA nomenclature directly from CAS or
alternative sources, as follows:
Method 1. A submitter using this method obtains the correct
chemical identification directly from the CAS Registry Services
Inventory Expert Service prior to submitting a notice to EPA. CAS will
provide such services pursuant to arrangements between CAS and persons
informing CAS that their substances will be reported to EPA in a
notice. Submitters should call or write to the CAS Registry Services
for information. Submitters must provide EPA with a copy of the
chemical identification report obtained from CAS along with the
completed notice, to verify that they obtained the information directly
from CAS.
EPA believes that most submitters will find it advantageous to
utilize the services of CAS to meet this requirement. As discussed in
the proposed rule, due to CAS' authoritative position in the field of
chemical identification and its familiarity with TSCA Inventory and
nomenclature policies, EPA believes that chemical names and other
chemical identity information assigned by CAS according to this method
should be acceptable to the Agency. For these reasons, EPA strongly
recommends that submitters use the services of CAS to satisfy the
amended provisions. [[Page 16300]]
Submitters should note, however, that if EPA disagrees with the
identification assigned by CAS to a given substance, the Agency
reserves the final authority to designate how a reported substance
should be named and represented for the Inventory. This will not delay
processing of the PMN by EPA. In the event EPA does not agree with a
chemical name, CASRN, chemical structure or molecular formula provided
to a submitter by CAS for TSCA purposes according to Method 1, EPA will
work with CAS to either modify the submitted chemical identity when
necessary or confirm that CAS' identification is most appropriate, to
ensure that a correct TSCA description is assigned. Using Method 1,
there will be no delay in EPA review or additional cost to the
submitter resulting from an identification error by CAS or an identity
verification request by EPA provided that the submitter has given
complete chemical information to CAS that is identical to the chemical
identity information contained in the section 5 notice to EPA. EPA will
assume responsibility for resolving chemical identity problems
occurring when Method 1 is used. However, if EPA determines that the
chemical identity information submitted to EPA is not identical to that
provided CAS, the notice may be deemed incomplete in accordance with
Sec. 720.65(c)(1).
Method 2. Using this method, a submitter may obtain the required
chemical identity information from any chemical information service or
consultant, or can retrieve or develop the proper CA identifications
without assistance. EPA emphasizes that with this method submitters
will need to provide for each substance a correct CA Index or Preferred
Name and other chemical identity information, as required under
Sec. 720.45(a)(1) and (2), that is consistent with Inventory listings
for similar substances. It will be the submitter's responsibility under
Method 2 to seek the required information from a source the submitter
believes to be sufficiently knowledgeable about CA nomenclature
conventions and TSCA Inventory listings.
In contrast to Method 1, if a submitter uses Method 2 and reports
any chemical identity information that is considered incorrect by EPA,
the submitter, not the Agency, will be considered responsible for
correcting the chemical identification. EPA will declare such a notice
incomplete under Sec. 720.65(c)(1) and will not further process or
review it until the submitter provides the fully correct chemical
identity information specified in this amendment.
Concerning the task of generating correct CA nomenclature, it
should be noted that there are many chemical names on the CAS Registry
File, particularly CA names for indefinitely described substances, that
are not appropriate for uniquely identifying substances on the
Inventory. Thus, the application of just the CA nomenclature rules to
name a new substance may not necessarily guarantee an acceptable
chemical name for TSCA purposes. One must also be familiar with the
ways in which similar substances are listed in the Inventory. As stated
above, EPA is developing papers on specific Inventory nomenclature
issues for public distribution.
Whether a submitter uses CAS or another method to obtain CA
nomenclature, EPA will assume that upon sending a notice to the Agency,
the submitter agrees with the chemical identity information provided by
the source. Regardless of which method is chosen by a submitter for
properly identifying a reported substance, EPA remains the final
authority for naming new substances for the TSCA Inventory.
For submitters to have ample time to become familiar with the
process of obtaining chemical identity information from CAS, another
chemical information service, or a consulting party for obtaining
chemical identifications, submitters should contact their chosen source
at least 1 or 2 months before the intended submission date of a notice.
This is especially important the first time one would have to report
under this amendment.
EPA anticipates that many submitters would consider chemical
identity information and/or submitter identity information given to CAS
(by Method 1) or another third party (by Method 2) to be CBI. Until
submitted to EPA under a provision of TSCA, CBI is not subject to EPA's
procedural and security protections under TSCA. Therefore, provisions
for handling any CBI first submitted to CAS or another outside party
must be arranged directly with that party. Submitters should not assume
that CAS or another outside party is required to adhere to EPA's TSCA-
CBI procedures regarding the possession, handling, labelling, storage,
tracking, auditing, or other processing of this information.
However, based on currently available information, it is EPA's
understanding that any confidential, proprietary, or trade secret
information that CAS would receive according to Method 1 of this rule
amendment prior to the information being reported to EPA would be
handled in accordance with the long-established security procedures and
policies that CAS has implemented to safeguard any confidential
information provided by its customers.
When submitting chemical substance identity information to CAS or
any other information service, a submitter who indicates that the
substance identity is CBI should be aware that a CASRN for that
substance may already exist due to CAS's prior knowledge of the
existence of that substance from another source. In such a case, the
chemical identity would already have been assigned a CASRN and placed
by CAS in its publicly accessible files.
Based on its knowledge of CAS's procedures, EPA believes that CAS
currently does not place the substance identity into the publicly
available CAS Registry File, if not already present there, when a
submitter has requested confidential treatment of the information.
However, EPA cannot ensure that CAS will continue this practice in the
future, nor can EPA ensure how other services handle this type of
information. As always, it is the submitter's responsibility to ensure
that the information service it uses properly protects the
confidentiality of its data. Submitters choosing to use either Method 1
or Method 2 should inquire how the information service, consultant, or
party receiving their confidential information will handle, protect,
and use such information.
The final rule at Sec. 720.45(a)(4) and (5) sets forth procedures
for importers and manufacturers who do not possess the complete
chemical identity information required to submit a notice to EPA about
a substance they intend to import or manufacture because of proprietary
claims by the U.S. or foreign supplier of the new chemical substance or
a reactant used to manufacture the new chemical substance. Section
720.45(a)(4) requires that the importer of a proprietary new chemical
substance have the foreign supplier follow the procedures for obtaining
CAS nomenclature for the new chemical substance from CAS or alternative
sources as specified in Sec. 720.45(a)(3). The foreign supplier would
provide the chemical identity information on the new chemical substance
specified in Secs. 720.45 (a)(1) and (2) directly to EPA as part of a
joint submission or letter of support clearly referencing the
importer's notice and in the case of PMNs, the user fee identification
number of the PMN submission established by the U.S. submitter (see 40
CFR 700.45(e)(3)).
Section 720.45(a)(5) contains provisions for manufacturers who
cannot provide complete chemical [[Page 16301]] identity information
because the new chemical substance is manufactured using a reactant
whose identity is claimed confidential by its supplier. In this
situation, however, due to logistical obstacles to generating correct
CA nomenclature and other chemical identity information for a substance
based on multiple submissions from different sources, each containing
part of the overall chemical identity, EPA will not require the
submitter to first develop or obtain a correct CA chemical
identification for the given substance before submitting a section 5
notice. Instead, the final rule requires that the manufacturer provide
all the information known by the manufacturer about the chemical
identity of the reported substance and the proprietary reactant. This
would typically include tradename, generic chemical name, or partial
composition information about the confidential reactant such as that
listed in a Material Safety Data Sheet (MSDS) or in other product
literature and any other chemical identity information the submitter
may know or reasonably ascertain about the confidential reactant or
reported substance. In addition, the manufacturer must ensure that the
supplier of the proprietary reactant sends a letter of support directly
to EPA providing the specific chemical identity of the confidential
reactant, including the CAS number, if available, and the appropriate
PMN or exemption number, if applicable. This should be information
known to or reasonably ascertainable by the supplier since that person
is responsible for determining that the proprietary reactant is either
on the Inventory or being manufactured under terms of an applicable
section 5 exemption.
As indicated above, Secs. 720.45(a)(4) and (5) require that persons
providing information as part of a joint submission or letter of
support clearly reference the importer or manufacturer's notice and
user fee identification number (See 40 CFR 700.45(c)(3)), if
appropriate so that EPA can be sure of properly linking the two
submissions. In addition, any CBI claims must be clearly marked in the
notice or letter of support along with a statement that this
information must not be shared with the notice submitter. The statutory
review period for a section 5 notice will not begin until EPA receives
all parts of a joint notice, or all necessary supporting documents
providing chemical identity information for a notice.
Comment. EPA should resolve nomenclature issues leading to
inconsistency (1) within the TSCA Inventory, (2) between CAS and TSCA
nomenclature and (3) between how a substance is named for TSCA purposes
and how it is named by the chemical industry for marketing purposes.
Response. Basically, there is only one set of nomenclature rules
used for the TSCA Inventory; the CA nomenclature system has always been
utilized by EPA to represent and name substances for Inventory
purposes. However, recognizing the complexity of the various types of
commercial chemical substances that would be reported under TSCA and
the need for accurately representing these substances on the Inventory,
EPA held numerous meetings with trade associations at the time the
Initial Inventory was compiled to develop guidelines for identifying
these substances. Before the Inventory was initially compiled, EPA
worked with CAS to refine some of the nomenclature policies for certain
categories of chemical substances, such as (1) substances of variable
composition, (2) natural fats, and (3) polymers.
The TSCA Inventory was initially compiled from information
submitted by chemical manufacturers, importers, and processors.
Perceived Inventory inconsistencies reflect the different ways in which
similar substances were described and reported by submitters.
Differences in commercial intent, author emphasis, and level of detail
or knowledge of composition resulted in some variation in names. This
flexibility in nomenclature was considered necessary by the chemical
industry at the time of the Initial Inventory reporting. The Agency
checked the original 160,000 reports for the Initial Inventory using a
computer program that was designed to identify obvious discrepancies;
the Agency then worked with the submitters of problem substances to
correct the Inventory reports. If there were no obvious discrepancies,
the Agency was not able to identify substances that were identified
incorrectly by the submitters, and consequently, some incorrectly
identified substances might have been added to the Inventory. However,
when the Agency adds substances to the Inventory through the PMN
program, it works with the submitters and CAS to attempt to ensure that
consistent nomenclature is used.
The Agency will continue using its current nomenclature system,
striving to maintain consistency. As discussed above, a series of
Inventory nomenclature guidance papers (that will be available through
TSCA's Assistance Information Service) is under development at the
Agency to publicly articulate Agency nomenclature practices used for
Inventory representation of various types of chemical substances.
Comment. CA nomenclature should not be required for TSCA
submissions; CAS should not have an exclusive interest.
Response. EPA developed the TSCA Inventory using CA nomenclature
and numbers; CAS has been assisting EPA in compiling, maintaining and
updating the Inventory since 1977. CA nomenclature and numbers are used
by all major industrial countries for their chemical inventories. This
form of international harmonization enhances international trade and
conserves the resources of chemical industries and governments. Many
major chemical manufacturers now utilize CA nomenclature, too. The use
of one nomenclature system minimizes confusion in regulatory matters
and trade, and facilitates compliance monitoring. Moreover, the Agency
has the authority to specify the form of nomenclature for TSCA
purposes. Therefore, the Agency believes that the use of CA
nomenclature is appropriate. Submitters have the choice of which
nomenclature service to use, as long as names are consistent with TSCA
nomenclature requirements.
Comment. Problems with nomenclature not provided by CAS should not
delay Agency review.
Response. Chemical identification errors by submitters result in
wasted resources and significant delays for both EPA and submitters.
For this reason, the Agency has determined that it will consider
submissions incomplete and thus delay their review if the incorrect
nomenclature is received from a source other than CAS. The Agency
believes, as a result of its years of experience using CAS
nomenclature, that chemical substance identities provided by CAS
specifically for TSCA purposes will rarely be in error and that any
errors would be relatively minor. EPA has insufficient experience with
other chemical nomenclature services to allow EPA to assume that the
nomenclature provided by such services would normally be consistent
with Inventory nomenclature requirements.
Comment. The burden of supplying CA nomenclature is significant,
both in terms of time and financial resources.
Response. The Agency disagrees with this comment. The Agency
recognizes that the time and cost of submitting a notice will increase
to some extent because of the requirement to use CAS nomenclature. This
will be true for those who utilize the TSCA nomenclature services of
CAS or other providers or choose to develop CAS nomenclature on their
own. EPA does [[Page 16302]] not believe that this requirement will
present significant problems because, in EPA's experience under the
section 5 program, some submitters already use CAS private registry
services, despite the absence of a requirement to do so under the
previous PMN regulations, apparently with minimal added cost or delay.
The Agency recognizes that the lead time required to prepare a PMN
may increase. In most cases, submitters can be preparing other sections
of their notices pending nomenclature assignments. The added up-front
time in compiling a PMN should not be a major factor. According to EPA
records many PMN substances are not manufactured until a month or more
after the PMN review period ends. The Agency believes that submitters
should always take the time necessary to ensure that their chemical
substance is correctly identified upfront. The practice of relying on
EPA to correct submitter errors, after the fact, has over the years
consumed significant Agency resources. The Agency believes that this
change in the procedural rule will place this responsibility where it
legitimately belongs.
Comment. The burden imposed on small manufacturers and importers is
too large.
Response. EPA does not consider this burden to be unreasonable,
especially because small companies already save $2,400 on each of their
PMN submissions compared with larger companies. Small companies have
historically been responsible for a disproportionately large number of
errors in chemical identities. The burden of generating CA nomenclature
will be offset, in many cases, because with the inclusion of proper
chemical names in the initial section 5 notice the review period will
not be suspended for problems with chemical identity. Small companies
may also benefit significantly from an early knowledge of the correct
chemical identity, which may enhance their customer service, Inventory
search efforts, and regulatory compliance.
Comment. Requirements to generate CA nomenclature will create
problems in protecting confidentiality.
Response. The Agency does not believe that the requirement for CA
nomenclature will create undue problems with confidentiality for
submitters. All submitters must be responsible for the confidentiality
of their information prior to submission to the Agency.
Comment. EPA should not require CA nomenclature for polymers and
for bona fide inquiries (bona fides).
Response. While submitters must report all monomers and other
reactants used to manufacture reported polymers, CA nomenclature is
required for polymers, in part, because in certain cases the
appropriate CA name for the polymer is based on more than just the
names of the monomers and other reactants. CA nomenclature for certain
polymeric substances may be based on structural repeating units or
other important structural features of the polymeric material. Examples
include certain block polymers, certain post-treated or functionalized
polymers, and siloxanes and silicones. The Agency has chosen to
maintain a consistent policy for nomenclature using CA names for all
substances, avoiding the potential confusion and compliance problems
which could occur if only some substances required CA names.
In a separate rulemaking published concurrently with this document,
the Agency has decided not to require CAS nomenclature for polymers
that are manufactured under terms of the polymer exemption in
accordance with 40 CFR 723.250, since the Agency will no longer review
exemption notices for exempted polymers. However, since chemical
identity information is required as part of the recordkeeping
requirements, persons who are manufacturing polymers under terms of the
polymer exemption are encouraged to use standard CA nomenclature in
their records.
The Inventory search process is the same for both PMNs and for bona
fides. In the case of bona fides, chemical identity issues frequently
have interfered with the Agency's ability to give an accurate response
to submitters within the 30-day period to which the Agency has
committed itself. In general, there have been more problems with
chemical identity for bona fides than for PMNs, in part because much
less chemical information has been required for bona fides than for PMN
submissions. Once a correct chemical name is developed for purposes of
a bona fide, the same name can be used for a subsequent PMN submission
without further expense.
B. Revised Requirements for Bona Fides
The Agency is amending Sec. 720.25 by revising certain provisions
of the procedures to establish a bona fide intent to manufacture or
import a substance. This amendment reduces or simplifies existing
analytical information requirements, modifies and/or clarifies other
existing information requirements, and requires some additional types
of information in bona fides.
The amendments eliminate the need for elemental analysis data
[former Sec. 720.25(b)(2)(iv)] as well as reduce and simplify other
analytical information requirements [former Sec. 720.25(b)(2)(v)] by
identifying an infrared spectrum as the usual practice for
characterizing the new chemical substance. Two other parts of this
section, regarding chemical identity information, and the description
of research and development (R&D) activities and use [former
Sec. 720.25(b)(2)(i) and (iii), respectively] were modified and/or
clarified. There are three new information requirements regarding the
most probable manufacturing site and process to be used, as well as an
approximate date when the submitter would be likely to submit a section
5 notice for the substance if it is not found in the Inventory. EPA
believes that the amendments represent a balanced trade-off of
requirements between the former and amended provisions. The amendments
will enable submitters to better demonstrate a bona fide intent while
the Agency will be better able to protect the CBI of the original
submitters of Inventory substances. The additional information or data
required in the amendment is considered reasonably ascertainable by the
submitter, and generally would have been determined already by the time
the submitter has developed a bona fide intent to manufacture or import
a substance for a commercial purpose. Under the amended
Sec. 720.25(b)(2)(i), submitters of a bona fide must provide, as
described in the amended provisions of Sec. 720.45(a) discussed in unit
II.A above, a currently correct CA Index Name or CA Preferred Name,
whichever is appropriate, and a currently correct CASRN (if the
substance already has a CASRN assigned to it). In addition, the Agency
requires a molecular formula and a complete or partial chemical
structure diagram if these are known or reasonably ascertainable.
Failure to fully comply with the chemical identification elements of
this requirement will result in the bona fide being declared incomplete
by EPA and returned to the submitter.
The amendments modify the requirement for a description of R&D
activities conducted to date on the substance and the purpose for
manufacture or import [former Sec. 720.25(b)(2)(iii)]. Since in the
past many submitters have inadvertently omitted one of these two
different pieces of information in their notices, EPA is making the
requirements clearer by separating the requests for the description of
R&D activities and the [[Page 16303]] purpose for which the submitter
will manufacture or import the substance into different subparagraphs
of the amended rule [amended Sec. 720.25(b)(2)(iii) and (iv),
respectively]. In addition, in the amended Sec. 720.25(b)(2)(iii)(A),
EPA elaborates on the information required by listing some of the
general types of R&D activities to be reported. Also, the year in which
R&D was started by the submitter on the substance is required. EPA
believes that these modifications will enable the submitter to indicate
the scope and length of its commitment towards developing the substance
for commercial use. EPA expects that this information be briefly
stated.
In the amended Sec. 720.25(b)(2)(iii)(B), EPA provides an
alternative reporting requirement for importers who do not perform R&D
activities on the substance and have no knowledge of R&D activities
that may have been conducted outside of the United States. Such
importers will be allowed, in lieu of presenting R&D information, to
indicate for how long, and in which country a given substance has been
in commerce outside the United States, as well as to state whether they
believe that the substance has already been used outside of the United
States for the same commercial applications intended by the submitter.
This alternative requirement is similar to the informal EPA practice in
the past of allowing such a prospective importer to satisfy the former
Sec. 720.25(b)(2)(iii) by providing certain information on foreign
commercial activity of the substance.
In the amended Sec. 720.25(b)(2)(iv), for clarity, the term
``purpose'' used in the former Sec. 720.25(b)(iii) has been replaced by
the phrase ``major intended application or use'' because some
submitters have misunderstood the type of information required and have
not provided a description of the intended end use.
EPA has simplified the analytical data requirements in the amended
Sec. 720.25(b)(2)(v) to reflect the usual practice of submitters
providing an infrared spectrum to characterize the chemical substance.
An infrared spectrum is required, unless infrared analysis is not
suitable for the substance or does not yield good structural
information about the substance. In such cases, the amendment requires
a spectrum or instrumental readout from another method of spectral or
instrumental analysis that yields better structural or compositional
information.
Amended Sec. 720.25(b)(2)(vi) consists of a minor but new
information requirement to estimate the month and year in which the
person would intend to submit a section 5 notice for the substance if
it is not found in the Inventory. EPA believes that submitters with a
bona fide interest in a substance would have already considered a
future timeframe for reporting the substance under section 5 if in fact
it is a new chemical substance. The intent of this requirement is not
to legally bind the submitter to a certain date for submission of a
PMN. In addition to using this information to determine a demonstration
of a bona fide intent to manufacture or import the substance, if EPA
can anticipate how many bona fide submitters may report their
substances in PMNs in a given year, the Agency may be able to better
allocate resources for reviewing the expected PMNs.
Amended Sec. 720.25(b)(2)(vii) requires the address of the facility
under the submitter's control where the substance is most likely be
manufactured or processed in the future for a commercial purpose. For
imported substances it requires the facility at which processing is
most likely to occur, if any.
Amended Sec. 720.25(b)(2)(viii) requires a manufacturer to briefly
describe either in words or with a process flow diagram the
manufacturing process that the submitter would most likely use to
produce commercial quantities of the substance. The process description
does not have to be detailed or comprehensive. Importers are required
to briefly describe how the substance would most likely be processed or
used at a site controlled by them, or, if no processing or use of the
substance is anticipated to occur at a submitter-controlled facility,
an importer may state that such commercial activity is not expected to
occur. This information is not intended to be legally binding, but
rather to assist EPA in determining whether the submitter appears to
have serious intentions for commercializing the substance in question.
The Agency has also clarified the procedure for a foreign
manufacturer or supplier to provide confidential chemical identity
information directly to EPA, to complete a notice when the chemical
identity is considered proprietary information by the foreign party and
will not be disclosed to the bona fide submitter. As amended, it is the
importer's responsibility at Sec. 720.25(b)(3)(i) to ensure that the
foreign supplier provides the required chemical identity information in
accordance with Secs. 720.45(a)(1), (2), and (3) to EPA in a timely
manner so that EPA can easily link the information to the importer's
bona fide.
The amendments at Sec. 720.25(b)(3)(ii) indicate how to meet
chemical identification requirements when submitters of substances to
be manufactured or imported do not possess full knowledge of the
chemical identity of the substance to be reported because a purchased
reactant or component used in the reported material has a confidential
chemical identity that is the proprietary information of the supplier.
Similar to the procedures specified at Sec. 720.45(a)(5) for section 5
notices involving confidential (often trademarked or tradenamed
products) reactants or starting materials, the bona fide submitter
reports all the information known by the submitter about the substance
identity. In addition, the supplier must submit a letter of support to
EPA providing the specific chemical identity of the proprietary
reactant, including the CAS number, if available, and referencing the
submitter's bona fide. As previously discussed in this Unit under
Correct Chemical Identity, correct CA nomenclature is not required when
a reported substance involves the use of a purchased proprietary
reactant. This is due to logistical obstacles involved in generating
correct CA identifications for substances based on multiple submissions
of parts of the overall identity from different sources. However, the
submitter must coordinate with the supplier to ensure that the
remaining specific chemical identity information is sent by the
chemical supplier directly to EPA in a timely manner, to complete the
bona fide request and initiate review by EPA. If the appropriate
supporting document from the supplier is not received within 30 days
after EPA receives the submitter's bona fide, the bona fide will be
considered incomplete.
Further, EPA has included language in amended Sec. 720.25(b)(9) to
describe what constitutes an incomplete bona fide, and how EPA will
handle incomplete ones. When an incomplete bona fide is received and
identified as such, EPA will immediately return the bona fide (minus
any supplier-confidential portions) directly to the submitter. The
submitter will then have to resubmit the completed bona fide, in its
entirety, to have EPA perform the Inventory search and respond to the
inquiry.
Comment. Appropriate bona fide intent exists even though many bona
fide substances are never submitted as PMNs.
Response. Each bona fide request requires a certification statement
about commercial intent. As a result, the Agency believes it is
reasonable to expect that most bona fide submissions involving
substances not found to be on the Inventory would result in
[[Page 16304]] subsequent PMNs. This judgment takes into account the
types of factors that could legitimately cause submitters to change
their minds. The Agency expects that once the new requirements are in
place, a larger percentage of bona fides will eventually result in
submission of PMNs.
Comment. The proposed bona fide requirements are burdensome and the
existing requirements need not be changed; EPA should not require
process information, specific manufacturing site, the year that
research and development started (or the length of foreign use), or the
estimated date of PMN submission in order to establish bona fide
intent.
Response. EPA believes that the information requested does not
cause a significant burden because it should be known to or reasonably
ascertainable by the submitter without developing or collecting
additional data. EPA believes that submitters who have not yet
considered these topics or developed this information are not at a
commercial development stage consistent with showing bona fide intent.
Comment. EPA should focus on abusers of the bona fide process
rather than increasing the reporting burdens on all submitters.
Response. The Agency believes that the perceived problem of
submitter abuse of the bona fide process involves more than a few
submitters. EPA believes that the best solution is to improve the
integrity of the entire process through the new requirements so that
all submitters will demonstrate a serious bona fide intent prior to
receiving confidential Inventory information.
Comment. Greatly increased requirements for bona fide intent may
lead to more PMN submissions.
Response. Rather than increasing the number of PMNs, EPA believes
that the revised procedures will reduce the number of bona fides from
persons who do not have a bona fide intent to manufacture the
substance. In any event, persons who intend to manufacture or import a
new chemical substance for a commercial purpose are free to submit a
PMN without submitting a prior bona fide.
C. ``Two percent rule'' for Polymers
Section 720.45(a)(2)(iii) allows submitters to indicate on the PMN
form which monomers and other reactants used at 2 weight percent or
less (based on the dry weight of the polymer) should be included as
part of the polymer description on the Inventory. This gives a
manufacturer the flexibility of increasing the weight percent above the
2 percent level without submitting another PMN, but also requires that
the monomer or reactant always be present at some level in the polymer.
In practice, many polymer manufacturers currently request Agency pre-
approval of a consolidated PMN to allow the manufacture of a new
polymer with levels of monomers above and below the two percent level
(i.e., with and without the monomer in the polymer's chemical
identity). As a general rule, if the weight of monomer or reactant
charged to the reaction vessel is 2 percent or less, the monomer or
reactant is not considered part of the chemical identity of the
polymer, unless indicated by the submitter on the PMN form. The 2
percent limit for polymers, referred to as the ``two percent rule'',
has been in place since the Inventory reporting regulations were
published on December 23, 1977 (see 40 CFR 710.5(c)) and was adopted
because the Agency and the regulated community believed it would be
difficult to identify the exact amount of monomers or other reactants
actually incorporated in the final polymer. Accordingly, polymer
manufacturers can use other monomers or reactants at 2 percent or less
without changing the chemical identity of an Inventory-listed polymer.
Under the final rule, persons may continue to determine the weight
percentage of monomer or other reactant based on the weight of monomer
or other reactant actually ``charged'' to the reaction vessel. However,
Sec. 720.45(a)(iii)(B) now allows persons the flexibility, where
technically feasible, to determine the minimum weight of monomer or
other reactant required in theory to account for the actual weight of
monomer or other reactant molecules or fragments chemically
``incorporated'' (chemically combined) in the polymeric substance
manufactured. Consequently, a PMN submitter or a person relying on
existing polymer Inventory listings may determine which monomers or
other reactants constitute the polymer identity on the basis of either
method.
During the compilation of the Inventory, the method of reporting
the percent composition of monomers and other reactants ``as charged''
was viewed as a reasonable approach by chemical and polymer industries.
However, due to advanced analytical capabilities developed over the
intervening years, certain polymer manufacturers asked EPA to revise
the ``two percent rule'' to allow manufacturers the option of
determining the amounts of monomers and other reactants that are
present ``in chemically combined form'' (incorporated) in a polymer as
an alternative to the practice of requiring reporting based on the
amounts added (charged) to the reaction vessel. The final rule allows
this option. The Agency believes that allowing submitters to report on
the basis of amounts incorporated in the polymer will provide a better
indicator of physical, chemical, and toxicological properties of
polymers. At the same time, this action will allow manufacturers
greater flexibility in commercial innovation, reduce the number of
unnecessary PMNs representing slight variations in polymer composition,
and provide greater consistency with international reporting policies.
However, the Agency believes that manufacturers should be aware that
there may be certain drawbacks and burdens involved in using the method
of computation based on incorporated amounts of monomers and other
reactants. For example, use of the ``incorporated'' method may have
regulatory consequences if process modifications (such as a change in
catalyst or solvent used or method and/or order of charging the
reactants) affect the degree of chemical incorporation such that the 2
percent level is exceeded for a monomer or other reactant not specified
as part of the chemical identity for the polymer, as discussed in the
proposed rule (58 FR 7664).
If a person determines those monomers or other reactants used at 2
percent or less on the basis of the amount incorporated in the polymer,
EPA believes that it is reasonable to require that such manufacturers
maintain in their records analytical data or appropriate theoretical
calculations (if it can be documented that an analytical determination
is not feasible or not necessary) to demonstrate that the amounts of
monomers and other reactants incorporated in the manufactured polymer
have been accurately determined [Sec. 720.45(a)(2)(iv)]. Additional
guidance on appropriate measurements or theoretical calculations is
available in EPA's Draft Technical Guidance Document on the Polymer
Exemption Rule. That document is in the docket for that rulemaking
(OPPTS 50594B) and is available through the TSCA Assistance Information
Service.
EPA recognizes that it was a matter of convenience, rather than one
of science, to have thus far required reporting of the amounts of
polymer reactants charged rather than the amounts incorporated; the
former method requires only ``bookkeeping'', while the latter may
require extensive and expensive analytical work. After 16 years of
experience with the Inventory and PMN [[Page 16305]] reporting rules,
however, EPA has come to realize that the ``amount charged'' approach
has drawbacks. In particular, this approach of identifying many
polymers based on monomers and other reactants charged to the reactor
in quantities significantly larger than the amounts found to be
incorporated in the polymer may not adequately represent the physical,
chemical, and toxicological properties of the polymer.
Until now under the PMN rule, inefficiently incorporated reactants,
reactants charged in large excess, and reactants with other functions
besides their reactant ones were often likely to produce reportable
polymers, even though the degree of chemical incorporation may have
been less than or equal to two percent. For example, free-radical
initiators are often charged in quantities greater than two percent to
start many polymer chains simultaneously and limit the amount of high-
molecular-weight polymer produced. Chemical incorporation of these
initiators is inefficient, since many processes other than chain
initiation can consume the initiator. The weight of the final polymer
that can be attributed to fragments originating from the initiator is
often less than 2 percent by weight. In the past, a manufacturer may
have used many different initiators, all charged at greater than 2
percent, to produce what would be the same polymer if the
``incorporated'' method of computation was used. The result represented
what many manufacturers believed to be excess reporting. Similar
problems arose with solvents that have reactive functions, and with
neutralizing agents used in excess of their salt-forming capacities.
Technical details concerning the ``two percent rule'' are contained in
EPA's Draft Technical Guidance Document on the Polymer Exemption Rule,
which is available in the public docket for this rulemaking [OPPTS-
50593B].
The Agency has always believed the actual content of a polymer is a
better indicator of its physical, chemical, and toxicological
properties, but adopted the ``amount charged'' method of computation as
a matter of convenience to industry. The Agency believes that, in light
of advanced analytical capabilities, it is now reasonable to also allow
the submitter to optionally use the amounts of monomers and other
reactants incorporated, as an alternative to the ``amounts-charged''
method.
Comment. Several comments supported EPA's proposal to modify the
``two percent rule'' by allowing polymer manufacturers to determine the
amounts of monomers and other reactants that are ``incorporated'' in
the polymer, as an alternative to the current practice of reporting
based on the ``amounts charged'' to the reaction vessel. One comment
stated that the use of the incorporation method, where the technology
is available and feasible, more accurately represents the actual
properties of the polymer. Commenters also stated that PMN submitters
and/or manufacturers relying on existing listings of polymers on the
Inventory should be able to use either method as long as they are in
compliance with the ``two percent rule.''
Response. The proposed amendment was intended to allow this
flexibility. Persons relying on existing Inventory listings of polymers
or persons submitting PMNs may use either method as long as they can
demonstrate the percentage of monomers or other reactants either
charged to the reaction vessel or incorporated in the polymer.
Comment. The amendment to the ``two percent rule'' should be
clearly stated to be an option rather than a regulatory requirement.
EPA should abandon the proposed rule's arbitrary distinction and
clarify that, for purposes of TSCA compliance, a polymer should be
described either by analysis or by calculation.
Response. EPA has clearly indicated in this preamble and in the
regulatory text that a manufacturer may use either method to determine
which monomers or other reactants constitute the polymer identity.
Comment. EPA should establish a ``five percent rule'' for non-
monomer reactants such as free radical initiators, chain transfer
reagents, and pH neutralizing agents. These reactants are known to
correlate poorly with the amounts charged and incorporated. Routine
analytical testing would be inconclusive.
Response. EPA continues to believe, as stated in the preamble to
the proposed rule (58 FR 7672), that a 5 percent rule would create a
larger potential variation in those physical and chemical properties of
a polymer that may have toxicological implications. Further, adopting a
``five percent rule'' would not be consistent with the Agency's goal of
harmonizing, to the extent possible, the reporting of polymers with
other international reporting practices that use a 2 percent standard.
In the past, industry has asserted that free radical initiators
were not expected to be incorporated, so allowing a company to use the
``incorporated'' method should already provide a greater measure of
flexibility. Manufacturers who are unable to develop reliable
analytical data or reasonable theoretical calculations to support their
use of the ``incorporated'' method should continue to follow the
current practice of calculating 2 percent based on the monomers and
other reactants ``charged'' to the reaction vessel.
Comment. EPA should allow use of any scientifically sound and
technically appropriate incorporation measurement or theoretical
calculation method. The proposal should be modified so that analytical
and recordkeeping requirements for the incorporation method are not so
onerous as to virtually negate the advantage of its use. A company that
uses the ``incorporated'' method would be required to maintain
analytical data to support this determination at the site of
manufacture.
Response. The rule does not specify any particular analytical
methodology for the ``incorporated'' method. The Agency would also
allow theoretical calculations if it can be documented that an
analytical determination is not technically feasible or not necessary
as discussed above. Further, EPA believes that it is reasonable to
require that manufacturers who use the ``incorporated'' method maintain
records of analytical data or appropriate theoretical calculations that
demonstrate compliance with the ``two percent rule'' at the site of
manufacture to verify compliance in a straightforward manner.
D. Multiple photocopies of section 5 submissions
The Agency is amending Sec. 720.40(d)(2) to require submitters to
provide EPA with one original and two complete copies of section 5
notices, in addition to a sanitized copy in which CBI has been deleted
under Sec. 720.80. Submitters are also required to provide one original
and two additional copies of any test data.
Comment. EPA should not require the submission of copies of test
data. Test reports range from hundreds to thousands of pages and
submitting extra copies would result in excessive volumes of material
for EPA to handle.
Response The two extra copies of test data will reduce the Agency's
administrative burden and will facilitate scientific reviews of the
data submitted. The Agency's request for these test results falls
clearly within the General Information Collection Guidelines, 5 CFR
1320.6 of the rules on the Paperwork Reduction Act of May 10, 1988
promulgated by the Office of Management and Budget. Under these
guidelines, the Agency is allowed to request an original and two copies
of [[Page 16306]] any document that satisfies its statutory
requirements.
E. Electronic Transmission of Section 5 Notices; Removal of PMN from
the CFR
EPA is amending the PMN rule at Sec. 720.40(a) to allow for future
reporting via magnetic or other electronic media. This amendment is
designed to promote the use of electronic media for data submission.
EPA is investigating the use of magnetic tape, floppy diskettes, and
electronic data interchange as means to submit information, and is
participating in a nation-wide trend toward reducing reliance on paper
for information transfer. EPA has already taken steps in TSCA and other
program areas to encourage electronic submission, and intends to expand
this effort to the PMN review program.
Information may be submitted electronically (on magnetic or other
media) once EPA publishes a format for electronic submissions. Pilot
projects using electronic submissions for the Inventory Update Rule (40
CFR part 710) and Toxic Release Inventory Rule (40 CFR part 372) will
be used as a baseline for enhancements to developing a standard Agency-
wide format. Such submissions will have to meet this format and all
other media specifications published by EPA.
EPA is taking this opportunity to remove the full text of EPA form
7710-25 (PMN form) from the Code of Federal Regulations (CFR)(40 CFR
part 720, Appendix A) and also correct the address for availability (40
CFR 720.40). The PMN form, which has been printed each year in the CFR,
requires approximately 10 pages of publication and does not represent
the most current document in use by PMN submitters. Removing the form
from the CFR reflects standard Agency policy of not printing the full
text of final forms in the CFR and will result in a significant cost
savings for the Agency. In general, EPA has determined that it is not
legally obligated to publish forms in full text. Under the
Administrative Procedure Act (APA), 5 U.S.C. 552(a)(1)(c), EPA is
obligated to describe forms and give a source of availability. In
addition to removing the form, EPA is making conforming amendments to
those sections that reference part 720, Appendix A to remove reference
to Appendix A.
In addition, the PMN form that appears in the CFR has been photo
reduced and cannot be used in a practical sense by those who must
comply with the reporting requirements. More importantly, the Agency
has continued to implement editorial revisions to the form since it was
first published as part of the final rule in 1983. These revisions are
intended to reflect PMN regulations and the policy initiatives
implemented during the intervening years. Any substantive removal or
addition of reporting requirements is accomplished by notice and
comment rulemaking.
Comment. Comments were generally supportive of developing an
electronic data interchange (EDI) with the Agency, although some
reservations and concerns were expressed. Comments questioned (1) how
practical it might be to submit some information, such as toxicity
studies, electronically, (2) signature certification and (3) the
security of CBI submissions. One comment suggested holding a workshop
to address CBI concerns.
Response. EPA will not implement an EDI application for TSCA
section 5 submissions until an Agency policy is developed for EDI
standard practices. Thus, submitters would not have to develop unique
interchange devices for section 5.
Electronic authentification technology is commercially available to
address signature certification concerns and general security concerns.
The Agency is required to protect CBI, and any EDI practices will
ensure the confidentiality of data transmissions. The Agency is
receptive to working with industry and other concerned parties to
develop an EDI application for the New Chemicals Program, including CBI
procedures. In the interim, the Agency encourages the use of PMN
software developed by industry and approved for use by the Agency for
generating hardcopy section 5 notices.
In addition to EDI, the Agency is analyzing other electronic
reporting media to determine which is most appropriate for these
submissions, given the variety of documents and materials involved. All
comments on electronic reporting are welcome.
F. Mandatory Form for Notice of Commencement of Manufacture or Import
(NOC)
Under this amendment, all PMN submitters are required to use a
standard one-page form to submit a NOC. In addition, the NOC
information requirements at Sec. 720.102(c) have been slightly
expanded; however, all information can be provided on the one-page
standard form (EPA Form 7710-56).
Every NOC received at EPA on or after the effective date of these
final rule amendments must contain the required information on the new
standard NOC reporting form. This form will automatically be provided
to each PMN submitter as an attachment to EPA's letter acknowledging
PMN receipt letter sent to submitters shortly after each PMN is
received. Persons who have not submitted NOCs for PMNs that have been
previously submitted to EPA can obtain copies of the NOC form from the
TSCA Assistance Information Office. Many submitters are already
reporting voluntarily using a similar form.
Previous NOC information reporting requirements, which are
unaffected by these amendments, include specific chemical identity of
the PMN substance, PMN number, the date manufacture or import
commenced, and substantiation of CBI claims for chemical identity,
which is required at the time a NOC is submitted. The amendment at
Sec. 720.102(c)(ix) requests a clear indication of whether the
submitter identity and/or other information on the form are also
claimed as confidential. Confidentiality claims can only be asserted by
the submitter if corresponding claims were made in the PMN.
EPA is amending NOC reporting to require that complete submitter
identity information be provided on the form. This would include the
name and address of the submitter, the name and dated signature of the
authorized official, and the name and telephone number of a technical
contact in the United States.
The amended NOC provisions also require a generic chemical name for
a substance whose chemical identity is claimed as CBI. This name could
either be (1) the same generic name provided in the PMN, (2) a generic
name as revised by the submitter, as long as it masks no more of the
chemical identity than the original generic name provided, or (3) an
improved or corrected generic name agreed to via negotiation with EPA.
Because the initial intention to manufacture or import a substance
sometimes changes between the time of PMN submission and the NOC,
submitters are required to specify in the NOC whether commencement
occurred via manufacture or import and the address of the site(s) at
which manufacture commenced.
All of the above amendments to information requirements for NOCs
involve information that the submitter will already know by the time
manufacture or importation of the substance has commenced.
Consequently, providing this information in the NOC will not constitute
a significant reporting burden. EPA will not process a NOC that does
not contain the chemical [[Page 16307]] identity, the date of
commencement, and the PMN number.
Comment. EPA needs to define in the regulations or form the ``date
of commencement.'' Is this the first date that a chemical reaction
occurs in the manufacturing operation; the date that the last amount of
final product is produced in a batch operation; the first date that the
PMN chemical is drummed off; or another date?
Response. The Agency considers the date of commencement to mean the
date of completion of manufacture for non-exempt commercial purposes of
the first amount (e.g., batch, drum, etc.) of the chemical substance
identified in the PMN. The Agency chose not to use the date on which
the manufacturing process is started because that particular process
may in some instances not result in the successful manufacture of the
PMN substance. For importers, the date of commencement is the date the
new chemical substance clears United States Customs. The final rule
contains this definition.
Comment. The information required for an NOC duplicates that
already submitted in the PMN: site of manufacture, name and telephone
number of technical contact. This information should not be required,
since a manufacturer is free to change any of these items after the PMN
review period has expired. The Inventory Update Rule is the appropriate
vehicle for the Agency to gather this information.
Response. An NOC may be filed years after the PMN was submitted. In
the interim, the information provided in the original PMN may have
changed due to change of location, change in ownership, etc. Up-to-date
telephone numbers are important when problems need to be resolved. The
Agency believes that the site of first manufacture or import is an
important compliance monitoring tool. Although the Agency recognizes
that a company may switch from import to domestic manufacture (or vice
versa) after the PMN review period has expired, the Agency may find
cause to investigate such changes that occur shortly after the
expiration of the PMN review period.
Comment. The NOC form should be made available for public comment
prior to finalization.
Response Although the form was not published in the Federal
Register as part of the proposed rulemaking, it was available in the
public docket and at the public hearings for this rulemaking held on
April 26-27, 1993. Draft copies of the form have been available through
the TSCA Assistance Information Office. The form has also been
routinely distributed to all PMN submitters for use on a voluntary
basis during the past year.
Comment. EPA should clarify its statement that an NOC will be
declared incomplete if any required information is missing. It is
possible that EPA could declare an NOC incomplete past the 30-day
period, potentially resulting in a compliance problem. EPA should
provide that the original NOC filing date will be considered the
effective date for determining compliance with the requirement that the
NOC be filed within 30 days after the first day of commercial
manufacture or importation. For example, if EPA determines that
responses to CBI claims are inadequate, the NOC should not be declared
untimely because it is considered incomplete.
Response. EPA will continue its practice of adding a PMN substance
to the Inventory as of the date the Agency receives the NOC from the
PMN submitter with the correct chemical identity, date of commencement
and PMN number. Further, EPA does not believe it is a significant
burden for companies to submit a completed standard one-page NOC form
that requests information that should be known to the submitter when
manufacture or importation commences.
Comment. The NOC form should be computer compatible or the
submitter should be allowed to use a computer facsimile as long as it
has the same format as the NOC form. Companies should not be required
to receive advance approval of computer facsimiles.
Response. The Agency will allow submitters to use a computer
generated form, as long as the form is readable by Agency staff.
Comment. EPA should allow an ``authorized official or designated
representative'' to sign the NOC form. The term ``authorized official''
might be construed to mean a corporate vice president. This type of
form should not require a corporate vice president's signature.
Response. The ``authorized official'' has always been designated by
the submitting company and should be a person that the submitting
company deems responsible for the truth and accuracy of each statement
in the certification.
Comment. The NOC form and/or accompanying instructions should
indicate clearly that a sanitized version must be submitted if any
information is claimed confidential and that all submitter
identification information will be treated as CBI. Furthermore, the
submitter must be permitted to claim the signature of the authorized
official as CBI.
Response. EPA does not require submission of a sanitized copy of
the NOC form because NOC submissions are not placed in the public
files. Information on the NOC form that was claimed confidential in the
original PMN submission may also be claimed confidential on the NOC
form, although new confidentiality claims cannot be made in an NOC for
information not claimed as confidential in the original PMN submission.
G. Comments on Other Issues
The Agency also discussed certain issues relating to CBI claims in
the proposed rule (58 FR 7665) but did not propose any additional PMN
rule amendments at that time. The Public Docket for this rulemaking
contains a complete set of comments on this issue, as well as comments
received in response to a discussion on use of geographic locators by
section 5 reporting facilities. Several industry commenters expressed
concern about the discussion in the proposal regarding enhanced review
of all confidential claims. Specifically, some commenters were
concerned that the discussion signalled a change of rules on making CBI
claims in the PMN process. As stated in the proposal, the purpose
behind the discussion of CBI claims filed in PMNs was to remind the
regulated community of its obligations concerning CBI claims. As noted
at that time, there are no changes to the CBI procedures included in
the PMN rule amendments.
Industry submitters have an obligation to insure that only that
information which needs to be kept confidential is claimed as CBI.
Further, CBI claims are routinely reviewed and submitters who make
broad, indiscriminate CBI claims will be contacted and requested to
substantiate their claims pursuant to 40 CFR part 2.
III. Economic Analysis
EPA has evaluated the potential costs of the amendments for
potential submitters of section 5 notices. The Agency's complete
economic analysis is available in the public record for this rule
(OPPTS-50593B).
The regulatory impact analysis estimates the costs and benefits
attributable to the regulation. In this case, the analysis also
contains estimates for the three additional amendments to section 5
regulations that are published elsewhere in this Federal Register.
These new provisions amend the PMN Exemptions for Polymers, Chemical
Substances [[Page 16308]] Manufactured in Quantities of 1,000 Kilograms
or Less per Year (40 CFR part 723), and the Expedited Process for
Issuing Significant New Use Rules (40 CFR part 721). Because these
regulations are amendments to current regulations, their costs and
benefits are incremental as compared to the current regulations.
The costs and benefits associated with these amendments are
partially quantified; many of the benefits are unquantified but are of
significant importance. Considering only the quantified costs and
benefits, there is a slight cost increase for industry and a slight
cost savings for EPA. Assuming either 1,000, 2,000, or 3,000 annual
section 5 submissions, the savings as compared to the current
regulation are estimated to be:
------------------------------------------------------------------------
Annual Cost Savings ($ Million)
Annual Number of ------------------------------------------------
Submissions Industry Government
------------------------------------------------------------------------
1,000.................. -0.1 0.1
2,000.................. -0.3 0.2
3,000.................. -0.4 0.2 - 0.3
------------------------------------------------------------------------
The aspects of the amendments that have the greatest quantified
cost impact on industry are the change in requirements for a bona fide
TSCA Inventory search request and the requirement to provide correct
chemical identification. Both requirements are expected to enable the
Agency to utilize resources more effectively, thereby providing better
service to industry. One of the major unquantified benefits of this
amendment is increased flexibility under the ``two percent rule,''
allowing industry to make minor compositional changes, providing more
manufacturing latitude to the submitter and possibly reducing the
number of section 5 submissions. Another unquantified change is the
requirement to use a standardized form for NOCs, the impact of which is
expected to be minimal as many submitters are already using a similar
form.
IV. Rulemaking Record
EPA has established a record for this rulemaking (docket control
number OPPTS-50593B). The record includes basic information including
public comments considered by the Agency in developing this rule
amendment. A public version of the record without any confidential
information is available in the TSCA Public Docket Office from 12 noon
to 4 p.m., Monday through Friday, except legal holidays. The TSCA
Public Docket Office is located in Rm. NE-G307 (Northeast Mall), 401 M
St., SW., Washington, DC.
V. Other Regulatory Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51835, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the Order defines a ``significant regulatory action'' as an action that
is likely to (1) have an annual effect on the economy of $100 million
or more, or adversely and materially affect a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local or tribal governments or communities (also
referred to as ``economically significant'') (2) create serious
inconsistency or otherwise interfere with an action taken or planned by
another agency; (3) materially alter the budgetary impacts of
entitlement, 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 this Executive Order.
Pursuant to Executive Order 12866, it has been determined that this
rule is not a ``significant regulatory action'' under section 3 (f) of
the Order. This action is therefore not subject to OMB review.
B. Regulatory Flexibility Act
Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.),
the Agency has determined that this regulatory action will not impose
any adverse economic impacts on small entities. EPA believes that, even
if all of the section 5 notice submitters were small firms, the number
of small businesses affected by this action will not be substantial.
C. Paperwork Reduction Act
The information collection requirements in this rule have been
approved by the OMB under the provisions of the Paperwork Reduction
Act, 44 U.S.C. 3502 et seq and have been assigned OMB control number
2070-0012. The public reporting burden for this collection of
information is estimated to vary from 18 to 21 hours per response, with
an average of 20 hours per response, including time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
List of Subjects
40 CFR Part 704
Chemicals, Confidential business information, Environmental
protection, Hazardous substances, Imports, Reporting and recordkeeping
requirements.
40 CFR Part 720
Chemicals, Environmental protection, Premanufacture notification,
Hazardous materials, Reporting and recordkeeping requirements.
40 CFR Part 721
Administrative practice and procedure, Chemicals, Environmental
protection, Hazardous substances, Imports, Labeling, Occupational
Safety and Health, Reporting and Recordkeeping requirements.
Dated: March 21, 1995.
Carol M. Browner,
Administrator.
Therefore, 40 CFR chapter I, subchapter R, parts 704, 720 and 721
are amended as follows:
1. In part 704:
PART 704--[AMENDED]
a. The authority citation for part 704 continues to read as
follows:
Authority: 15 U.S.C. 2607(a).
b. Section 704.25 is amended by revising paragraph (d) to read as
follows:
Sec. 704.25 11-Aminoundecanoic acid.
* * * * *
(d) What information to report. Persons identified in paragraph (b)
of this section must submit a Premanufacture Notice Form (EPA Form
7710-25).
* * * * *
c. Section 704.104 is amended by revising paragraph (d) to read as
follows:
Sec. 704.104 Hexafluoropropylene oxide.
* * * * *
(d) What information to report. Persons identified in paragraph (b)
of this section must submit a Premanufacture Notice Form (EPA Form
7710-25).
* * * * *
2. In part 720:
PART 720 -- [AMENDED]
a. The authority citation for part 720 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2613.
b. Section 720.25 is amended by revising paragraphs (a), (b)(1),
(2)(i), [[Page 16309]] (2)(iii), (2)(iv), (2)(v), (3), and by adding
paragraphs (b)(2)(vi), (2)(vii), (2)(viii), and (b)(9) to read as
follows:
Sec. 720.25 Determining whether a chemical substance is on the
Inventory.
(a) A new chemical substance is any chemical substance that is not
currently listed on the Inventory.
(b)(1) A chemical substance is listed in the public portion of the
Inventory by a specific chemical name (either a Chemical Abstracts (CA)
Index Name or a CA Preferred Name) and a Chemical Abstracts Service
(CAS) Registry Number if its identity is not confidential. If its
identity is confidential, it is listed in the public portion of the
Inventory by a TSCA Accession Number and a generic chemical name that
masks the specific substance identity. The confidential substance is
listed by its specific chemical name only in the confidential portion
of the Inventory, which is not available to the public. A person who
intends to manufacture or import a chemical substance not listed by
specific chemical name in the public portion of the Inventory may ask
EPA whether the substance is included in the confidential Inventory.
EPA will answer such an inquiry only if EPA determines that the person
has a bona fide intent to manufacture or import the chemical substance
for commercial purposes.
(2) * * *
(i) Except as provided in paragraphs (b)((3)(i) and (ii) of this
section, the specific chemical identity of the substance that the
person intends to manufacture or import, using the currently, correct
CA name for the substance and the other correct chemical identity
information in accordance with Secs. 720.45(a)(1), (2)), and (3).
* * * * *
(iii)(A) A brief description of the research and development
activities conducted to date related to the substance, including the
year in which the person first started to conduct research or
development activity on the substance, and the general types of
research and development activities conducted thus far (e.g.,
synthesis, substance isolation/purification, formulating, product
development, process development, end-use application, toxicity
testing, etc.). The person must also indicate whether any pilot plant
or production-scale plant evaluations have been conducted involving the
manufacture or processing of the substance.
(B) If an importer is unable to provide the information requested
in paragraph (b)(2)(iii)(A) of this section from the foreign
manufacturer or supplier, the following information shall be submitted:
(1) A brief statement indicating how long the substance has been in
commercial use outside of the United States.
(2) The name of a country in which it has been commercially used.
(3) Whether the importer believes that the substance has already
been used commercially, in any country, for the same purpose or
application that the importer is intending.
(iv) A specific description of the major intended application or
use of the substance.
(v) An infrared spectrum of the substance, or alternative spectra
or other data which identify the substance if infrared analysis is not
suitable for the substance or does not yield a reasonable amount of
structural information. When using alternative spectra or instrumental
analysis, the person must submit a spectrum or instrumental readout for
the substance.
(vi) The estimated date (month/year) in which the person intends to
submit a Premanufacture Notice (PMN) for this substance if EPA informs
the notice submitter that the substance is not on the Inventory.
(vii) The address of the facility under the control of the
submitter at which the manufacture or processing of the substance would
most likely occur. For an imported substance, the facility under the
control of the importer at which processing of the substance would
likely occur, if any.
(viii)(A) For substances intended to be manufactured in the United
States, a description of the most probable manufacturing process that
would be used by the submitter to produce the substance for non-exempt
commercial purposes.
(B) For substances intended to be imported, a brief description of
how the submitter is most likely to process or use the substance for a
commercial purpose. If the substance is not expected to be processed or
used at any facility under the importer's control, a statement to this
effect must be included along with a description of how the substance
will be processed or used at sites controlled by others, if this
information is known or reasonably ascertainable.
(3)(i) If an importer cannot provide the chemical identity
information required by paragraph (b)(2)(i) and (v) of this section
because it is claimed confidential by its foreign manufacturer or
supplier, the foreign manufacturer or supplier must supply the required
information directly to EPA in accordance with Sec. 720.45(a)(1), (2),
and (3) and reference the importer's notice. If the appropriate
supporting document from the foreign party is not received within 30
days after EPA receives the importer's notice, the notice will be
considered incomplete.
(ii) If a manufacturer cannot provide all of the required
information in accordance with Sec. 720.45(a)(1), (2), and (3) because
the new chemical substance is manufactured using a reactant that has a
specific chemical identity claimed as confidential by its supplier, the
notice must contain chemical identity information that is as complete
as known by the manufacturer. In addition, a letter of support for the
notice must then be sent to EPA by the chemical supplier of the
confidential reactant, providing the specific chemical identity of the
proprietary reactant. The letter of support must reference the
manufacturer's notice. If the appropriate supporting document from the
supplier is not received within 30 days after EPA receives the
manufacturer's notice, the notice will be considered incomplete.
* * * * *
(9) If the required chemical identity information has not been
reported correctly or completely in the notice (except as provided
under paragraph (b)(3)(ii) of this section) or if any other required
data or information has been omitted or is incomplete, EPA will
consider the whole notice to be incomplete. As soon as an incomplete
notice is identified as such by EPA, the Agency will immediately return
the notice directly to the submitter. The submitter must then resubmit
the whole, completed bona fide notice to EPA in order to have the
Agency perform the desired Inventory search and respond to the notice.
c. Section 720.40 is amended by revising paragraphs (a) and (d) to
read as follows:
Sec. 720.40 General.
(a) Use of the notice form; electronic submissions. (1) Each person
who is required by subpart B of this part to submit a notice must
complete, sign, and submit a notice containing the information in the
form and manner specified in this paragraph. The information submitted
and all attachments (unless the attachment appears in the open
scientific literature) must be in English. All information submitted
must be true and correct.
(2) Information may be submitted on paper, or electronically, as
follows:
(i) Information submitted on paper must be submitted in the form
and manner set forth in EPA Form No. 7710-25, which is available from
the [[Page 16310]] Environmental Assistance Division (7408), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Information which is not submitted on
the EPA Form No. 7710-25 or a photocopy thereof (e.g., on a form
created by commercial form-making software) must be in a format pre-
approved by the Agency.
(ii) Information may be submitted electronically (on magnetic or
other media) pursuant to an EPA published format for electronic
submissions. Such submissions must comply with this format and all
other media specifications published by EPA. Persons submitting
electronically must still complete and submit on paper the
Certification and Submitter Identification sections of Form 7710-25.
* * * * *
(d) General notice requirements. (1) Each person who submits a
notice must provide the information described in Sec. 720.45 and
specified on the notice form, to the extent such information is known
to or reasonably ascertainable by the person. In accordance with
Sec. 720.50, the notice must also include any test data in the person's
possession or control, and descriptions of other data which are known
to or reasonably ascertainable by the person and which concern the
health and environmental effects of the new chemical substance.
(2) A person who submits a notice to EPA under this part must
provide EPA with an original and two complete copies of the notice,
including all test data and any other information attached to the
notice form. If information is claimed as confidential pursuant to
Sec. 720.80, a sanitized copy must also be provided.
* * * * *
d. Section 720.45 is amended by revising paragraph (a) to read as
follows:
Sec. 720.45 Information that must be included in the notice form.
* * * * *
(a)(1) The specific chemical identity of the substance that the
person intends to manufacture or import, which includes the following:
(i) The currently correct Chemical Abstracts (CA) name for the
substance, based on the Ninth Collective Index (9CI) of CA nomenclature
rules and conventions, and consistent with listings for similar
substances in the Inventory. For each substance having a chemical
composition that can be represented by a specific, complete chemical
structure diagram (a Class 1 substance), a CA Index Name must be
provided. For each chemical substance that cannot be fully represented
by a complete, specific chemical structure diagram (a Class 2
substance), or if the substance is a polymer, a CA Index Name or CA
Preferred Name must be provided (whichever is appropriate based on CA
9CI nomenclature rules and conventions). In addition, for a Class 2
substance, the notice must identify the immediate chemical precursors
and reactants by specific chemical name and Chemical Abstracts Service
Registry Number (CASRN), if the number is available. Tradenames or
generic names of chemical precursors or reactants are not acceptable as
substitutes for specific chemical names.
(ii) The currently correct CASRN for the substance if a CASRN
already exists for the substance.
(iii) For a Class 1 substance and for any Class 2 substance for
which a definite molecular formula is known or reasonably
ascertainable, the correct molecular formula.
(iv) For a Class 1 substance, a complete, correct chemical
structure diagram; for a Class 2 substance or polymer, a correct
representative or partial chemical structure diagram, as complete as
can be known, if one can be reasonably ascertained.
(2) For a polymer, the submitter must also report the following:
(i) The specific chemical name and CASRN, if the number is
available, of each monomer and other reactant used, at any weight
percent, to manufacture the polymer. Tradenames or generic names of
chemical reactants or monomers are not acceptable as substitutes for
specific chemical names.
(ii) The typical percent by weight of each monomer and other
reactant in the polymer (weight of the monomer or other reactant
expressed as a percentage of the weight of the polymeric chemical
substance manufactured), and the maximum residual amount of each
monomer present in the polymer.
(iii) For monomers and other reactants used at 2 weight percent or
less (based on the dry weight of the polymer manufactured), indicate on
the PMN form any such monomers and other reactants that should be
included as part of the polymer description on the Inventory, where the
weight percent is based on either (A) the weight of monomer or other
reactant actually charged to the reaction vessel, or (B) the minimum
weight of monomer or other reactant required in theory to account for
the actual weight of monomer or other reactant molecules or fragments
chemically incorporated (chemically combined) in the polymeric
substance manufactured.
(iv) For a determination that 2 weight percent or less of a monomer
or other reactant is incorporated (chemically combined) in a polymeric
substance manufactured, as specified in paragraphs (a)(2)(iii)(B) of
this section, analytical data or appropriate theoretical calculations
(if it can be documented that analytical measurement is not feasible or
not necessary) to support this determination must be maintained at the
site of manufacture or import of the polymer.
(v) Measured or estimated values of the minimum number-average
molecular weight of the polymer and the amount of low molecular weight
species below 500 and below 1,000 molecular weight, with a description
of how the measured or estimated values were obtained.
(3) The person must use one of the following two methods to develop
or obtain the specified chemical identity information reported under
paragraphs (a)(1) and (2) of this section and must identify the method
used in the notice:
(i) Method 1. Obtain the correct chemical identity information
required by paragraphs (a)(1) and (2) of this section directly from the
Chemical Abstracts Service (CAS), specifically from the CAS Registry
Services Inventory Expert Service, prior to submitting a notice to EPA.
A copy of the chemical identification report obtained from CAS must be
submitted with the notice.
(ii) Method 2. Obtain the correct chemical identity information
required by paragraphs (a)(1) and (2) from any source. The notice will
be incomplete according to Sec. 720.65(c)(1)(vi) if the person uses
Method 2 and any chemical identity information is determined to be
incorrect by EPA.
(4) If an importer submitting the notice cannot provide all the
information specified in paragraphs (a)(1) and (2) of this section
because it is claimed as confidential by the foreign supplier of the
substance, the importer must have the foreign supplier follow the
procedures in paragraph (a)(3) of this section and provide the correct
chemical identity information specified in paragraphs (a)(1) and (2) of
this section directly to EPA in a joint submission or as a letter of
support to the notice, which clearly references the importer's notice
and PMN User Fee Identification Number. The statutory review process
will commence upon receipt of both the notice and the complete, correct
information.
(5) If a manufacturer cannot provide all the information specified
in paragraphs (a)(1) and (2) of this section because the new chemical
substance is [[Page 16311]] manufactured using a reactant having a
specific chemical identity claimed as confidential by its supplier, the
manufacturer must submit a notice directly to EPA containing all the
information known by the manufacturer about the chemical identity of
the reported substance and its proprietary reactant. In addition, the
manufacturer must ensure that the supplier of the confidential reactant
submit a letter of support directly to EPA providing the specific
chemical identity of the confidential reactant, including the CAS
number, if available, and the appropriate PMN or exemption number, if
applicable. The letter of support must reference the manufacturer's
name and PMN User Fee Identification Number under Sec. 700.45(c)(3) of
this chapter. The statutory review period will commence upon receipt of
both the notice and the letter of support.
* * * * *
e. Section 720.80 is amended by revising paragraph (b)(2) to read
as follows:
Sec. 720.80 General provisions.
* * * * *
(b) * * *
(2) If any information is claimed as confidential, the person must
submit, in addition to the copies specified by Sec. 720.40, a sanitized
copy of the notice form (or electronic submission) and any attachments.
(i) The original and two copies of the notice, specified at
Sec. 720.40 (or electronic submission) and attachments must be
complete. The submitter must designate that information which is
claimed as confidential in the manner prescribed on the notice form (or
in EPA's electronic submission instructions).
(ii) The sanitized copy must be complete except that all
information claimed as confidential in the original must be deleted.
EPA will place this sanitized copy in the public file.
(iii) If the person does not provide the sanitized copy, or
information in a health and safety study (except information claimed as
confidential in accordance with Sec. 720.90), the submission will be
deemed incomplete and the notice review period will not begin until EPA
receives the sanitized copy or the health and safety study information
is included, in accordance with Sec. 720.65(c)(1)(vii).
* * * * *
f. Section 720.95 is amended by revising the third sentence to read
as follows:
Sec. 720.95 Public file.
* * * Any of the nonconfidential material described in this
subpart will be available for public inspection in the TSCA
Nonconfidential Information Center, Room B607, Northeast Mall, 401 M
St., SW., Washington, DC between the hours of 1 p.m. and 4 p.m.,
weekdays, excluding legal holidays.
g. Section 720.102 is amended by revising paragraphs (c) and (d) to
read as follows:
Sec. 720.102 Notice of commencement of manufacture or import.
* * * * *
(c) Information to be reported on form. (1) The notice must be
submitted on EPA (Form 7710-56), which is available from the
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. The form must be signed and dated by an
authorized official. All information specified on the form must be
provided. The notice must contain the following information:
(i) The specific chemical identity of the PMN substance.
(ii) A generic chemical name (if the chemical identity is claimed
as confidential by the submitter).
(iii) The premanufacture notice (PMN) number assigned by EPA.
(iv) The date of commencement for the submitter's manufacture or
import for a non-exempt commercial purpose (indicating whether the
substance was initially manufactured in the United States or imported).
The date of commencement is the date of completion of non-exempt
manufacture of the first amount (batch, drum, etc.) of new chemical
substance identified in the submitter's PMN. For importers, the date of
commencement is the date the new chemical substance clears United
States customs.
(v) The name and address of the submitter.
(vi) The name of the authorized official.
(vii) The name and telephone number of a technical contact in the
United States.
(viii) The address of the site where commencement of manufacture
occurred.
(ix) Clear indications of whether the chemical identity, submitter
identity, and/or other information are claimed as confidential by the
submitter.
(2) If the submitter claims the chemical identity confidential, and
wants the identity to be listed on the confidential portion of the
Inventory, the claim must be reasserted and substantiated in accordance
with Sec. 720.85(b). Otherwise, EPA will list the specific chemical
identity on the public Inventory. Submitters who did not claim the
chemical identity, submitter identity, or other information to be
confidential in the PMN cannot claim this information as confidential
in the notice of commencement.
(d) Where to submit. Notices of commencement of manufacture or
import should be submitted to:
TSCA Document Control Office (7407), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 401 M St.,
SW., Washington, DC 20460.
* * * * *
Appendix A [Removed]
h. Appendix A to part 720 is removed.
3. In part 721:
PART 721--[AMENDED]
a. The authority citation for part 721 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2652(c).
b. Section 721.25 is amended by revising the last sentence of
paragraph (a) to read as follows:
Sec. 721.25 Notice requirements and procedures.
(a)* * * The notice must be submitted on EPA Form 7710-25, and
must comply with the requirements of part 720 of this chapter, except
to the extent that they are inconsistent with this part 721.
* * * * *
[FR Doc. 95-7709 Filed 3-24-95; 3:32 pm]
BILLING CODE 6560-50-F
