[Federal Register Volume 63, Number 62 (Wednesday, April 1, 1998)]
[Rules and Regulations]
[Pages 15765-15774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-8425]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 716
[OPPTS-42188B; FRL-5750-4]
RIN 2070-AD17
Revisions to Reporting Regulations Under TSCA Section 8(d)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: As a part of EPA's 1994 regulatory review, the reporting
requirements under section 8(d) of the Toxic Substances Control Act
(TSCA) were reviewed for burden reduction opportunities. As a result of
this review, EPA is revising its TSCA section 8(d) health and safety
data reporting rule that requires chemical manufacturers (including
importers) and processors of listed substances and listed mixtures to
report unpublished health and safety studies. Revisions include changes
to the categories of persons required to report, the types of studies
and the grade/purity of the substance for which reporting is required,
the reporting period, and the measure of adequacy of the file search
needed to comply with the requirements of TSCA section 8(d).
Additionally, EPA is amending the sunset date for all chemical
substances and mixtures listed in 40 CFR 716.120, for which reporting
is currently required. Furthermore, because of this change in the
reporting period, EPA will no longer conduct a biennial review of the
chemical substances and mixtures listed in 40 CFR 716.120. The Agency's
goal is to streamline the reporting requirements while maintaining the
ability to protect human health and the environment through the
collection of data regarding potential risks.
DATES: Effective date: June 30, 1998. Comment date: All comments must
be received by EPA by May 1, 1998. If EPA receives adverse comments to
this direct final rule by May 1, 1998, EPA will issue a notice to
withdraw this direct final rule and seek comment on the issue raised.
After considering the comments submitted, EPA will respond to comments
received in a final rule that is published in the Federal Register. If
no adverse comments to this direct final rule are received, this rule
will become effective as a final rule on the date specified above.
ADDRESSES: Each comment must bear the docket control number OPPTS-
42188B. All comments should be sent in triplicate to: OPPT Document
Control Officer (7407), Office of Pollution Prevention and Toxics, U.S.
Environmental Protection Agency, 401 M St., SW., Room G-099, East
Tower, Washington, DC 20460.
Comments and data may also be submitted electronically to: oppt.
ncic@epamail.epa.gov. Follow the instructions under Unit IV. of this
document. No Confidential Business Information (CBI) should be
submitted through e-mail.
All comments which contain information claimed as CBI must be
clearly marked as such. Three sanitized copies of any comments
containing information claimed as CBI must also be submitted and will
be placed in the public record for this rulemaking. Persons submitting
information on any portion of which they believe is entitled to
treatment as CBI by EPA must assert a business confidentiality claim in
accordance with 40 CFR 2.203(b) for each such portion. This claim must
be made at the time that the information is submitted to EPA. If a
submitter does not assert a confidentiality claim at the time of
submission, EPA will consider this as a waiver of any confidentiality
claim and the information may be made available to the public by EPA
without further notice to the submitter.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Rm. ET-543B, Office of
Pollution Prevention and Toxics, USEPA, 401 M St., SW., Washington, DC
20460; telephone: (202) 554-1404; TDD: (202) 554-0551; e-mail: TSCA-
Hotline@epamail.epa.gov. For specific information regarding this rule,
contact Keith Cronin, Project Manager, Chemical Control Division
(7405), Office of Pollution Prevention and Toxics, U.S. Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone:
(202) 260-8157; fax: (202) 260-1096; e-mail:
cronin.keith@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
Electronic Availability:
Internet
Electronic copies of this document are available from the EPA Home
Page at the Federal Register - Environmental Documents entry for this
document under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/
TOX/).
Fax on Demand
Using a faxphone call 202-401-0527 and select item 4301 for a copy
of this document and select item 4057 for a copy of 40 CFR 716.120
revised in its entirety.
Regulated persons. Potentially regulated persons are those that
manufacture (including import) or process chemical substances and
mixtures. Regulated categories and entities include:
------------------------------------------------------------------------
Examples of regulated
Category persons
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Industry Chemical manufacturers
(including
importers),chemical
processors, and petroleum
refiners.
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This table is not exhaustive, but lists the types of persons that could
potentially be regulated by this action. Other types of persons may
also be regulated. To determine whether a person is regulated by this
action, carefully examine the applicability criteria in 40 CFR part
716. If you have questions regarding the applicability of this action
to a particular person, consult the person listed under ``FOR FURTHER
INFORMATION CONTACT'' at the beginning of this document.
EPA believes this revised rule will significantly decrease the
reporting burden by eliminating many of the file
[[Page 15766]]
searches conducted in compliance with TSCA section 8(d), eliminating
many of the reporting systems which have been designed to track TSCA
section 8(d) chemical substances, and eliminating the submission of
data that are typically unnecessary to determine data needs.
EPA is publishing this action as a direct final rule, without a
proposal and prior opportunity for comment, because the action
substantially reduces existing reporting requirements under TSCA
section 8(d), the Agency views the action as noncontroversial, and the
Agency anticipates there will be no significant adverse comments. EPA
believes that there will be no adverse reaction to this action because
it substantially reduces the reporting burden associated with TSCA
section 8(d) Health and Safety Data reporting requirements while still
providing EPA with the needed data. In addition, EPA discussed these
changes with a majority of the information providers and users, and
received a favorable response. It is in the interest of the regulated
community and EPA to avoid delaying the implementation of this action
due to the burden reduction that would be achieved from the time it
becomes effective as a final rule. The shared interest of EPA and the
regulated community in this action indicates that these revisions will
be received favorably and without adverse comment. Therefore, notice
and public procedure are unnecessary prior to the publication of this
direct final rule.
Nonetheless, adverse comments may be submitted on this action as
directed under ``ADDRESSES'' at the beginning of this document. If EPA
receives adverse comments, this direct final rule will be withdrawn
before the effective date through publication of a document in the
Federal Register. If this direct final rule is withdrawn, any public
comments received will be addressed in a subsequent proposed rule. Any
parties interested in commenting on this action must do so at this
time. If no adverse comments are received, the public is advised that
this action will become effective on June 30, 1998.
I. Introduction
The TSCA section 8(d) Health and Safety Data Reporting rule (40 CFR
part 716) sets forth requirements for the submission of lists and
copies of health and safety studies on chemical substances and mixtures
selected for priority consideration for testing rules under section
4(a) of TSCA and on other substances and mixtures for which EPA
requires health and safety information to identify data needs and/or to
support chemical risk assessment/management activities. The rule
requires manufacturers (including importers) and processors to submit
to EPA unpublished health and safety studies on the substances and
mixtures listed at 40 CFR 716.120. EPA is revising the categories of
persons required to report, the types of studies and the purity/grade
of the substance on which studies were performed for which reporting is
required, the reporting period, and the measure of adequacy of the file
search needed to comply with TSCA section 8(d).
A. Background
On October 11, 1976, the President signed the Toxic Substances
Control Act (TSCA), 15 U.S.C. 2601 et seq., to ``regulate commerce and
protect human health and the environment by requiring testing and
necessary use restrictions on certain chemical substances * * *.''
Section 8(d) of TSCA, 15 U.S.C. 2607(d), directs the EPA Administrator
to promulgate rules that require the submission of lists of health and
safety studies and copies of the studies pertaining to chemical
substances and mixtures in commerce. This section of TSCA requires
``any person who manufactures (includes imports), processes, or
distributes in commerce or who proposes to manufacture, process, or
distribute in commerce any chemical substance or mixture'' to submit to
EPA lists and copies of health and safety studies available to them.
The regulations implementing TSCA section 8(d) are found at 40 CFR part
716.
Under the current section 8(d) regulations, EPA requires the
submission of unpublished health and safety studies on specified
chemicals from manufacturers (including importers) and processors of
the chemicals. Studies of human health and environmental effects,
including studies of exposures to people and the environment, are the
fundamental ingredients of any assessment of chemical risk. EPA
requires reporting under these regulations for specific chemicals that
are under investigation either in the early stages of risk assessment
or when action to control exposure is being considered.
As TSCA section 8(d) rules are promulgated, chemicals and mixtures
are added and subtracted from the list in 40 CFR 716.120. The process
by which these modifications are made has evolved over the years.
Particularly significant changes in the process described at 40 CFR
part 716 occurred on October 4, 1982, when a rule (47 FR 38780) was
published that set up a process for adding chemicals recommended for
testing by the TSCA Interagency Testing Committee (ITC) without the
opportunity for prior notice and comment (40 CFR 716.105(b)). For such
chemicals, amendments made to 40 CFR 716.120, the list of chemicals
subject to section 8(d) reporting requirements, become effective as
direct final rules thirty days after publication of a document in the
Federal Register.
B. Role of the TSCA Interagency Testing Committee (ITC)
The TSCA Interagency Testing Committee (ITC) is an independent
committee that was created in 1976 under section 4(e) of TSCA, 15
U.S.C. 2603(e), to make recommendations to the Agency about chemicals
for which data are needed. The statute specifies that the ITC consists
of eight statutory members, appointed by and drawn from the following
organizations: Environmental Protection Agency (EPA), Department of
Labor (DOL) (appointee is drawn from the Occupational Safety and Health
Administration (OSHA)), Council on Environmental Quality (CEQ),
National Institute for Occupational Safety and Health (NIOSH), National
Institute of Environmental Health Sciences (NIEHS), National Cancer
Institute (NCI), National Science Foundation (NSF), and the Department
of Commerce (DOC). Currently, eight other Federal Agency members are
participating on a liaison basis: Agency for Toxic Substances and
Disease Registry (ATSDR), Consumer Product Safety Commission (CPSC),
Department of Agriculture (USDA), Department of Defense (DOD), Food and
Drug Administration (FDA), Department of the Interior (DOI), National
Library of Medicine (NLM), and the National Toxicology Program (NTP).
The chemical substances and mixtures recommended by the ITC to the
EPA for priority consideration for proposed test rules under TSCA
section 4(a) comprise a list called the Priority List. Chemical
substances and mixtures may be recommended to be added to the Priority
List based on the ITC's consideration of factors such as production
volume, exposure, and availability of data regarding health and
environmental effects. When the ITC recommends chemicals for testing,
EPA issues amendments in the Federal Register to add to the list of
recommended chemicals subject to reporting requirements under TSCA
section 8(a) (40 CFR 712.30) and TSCA section 8(d) (40 CFR 716.120).
The ITC provides an existing infrastructure to rapidly prioritize
inter-Agency data needs on many industrial chemicals. The ITC has the
authority to
[[Page 15767]]
designate chemical substances and mixtures on the Priority List with
respect to which the ITC determines the Administrator should initiate
rulemaking proceedings pursuant to TSCA section 4(a). Within 12 months
of the date of first inclusion on the Priority List of a chemical
substance or mixture designated by the ITC, TSCA directs the
Administrator to initiate rulemaking proceedings or publish in the
Federal Register the reasons for not doing so.
The ITC recommends chemicals to the Administrator to meet focused
Federal data needs under TSCA section 4(e). EPA plans to focus its TSCA
section 8(d) reporting requirements to reduce the resources that are
consumed to retrieve and submit section 8(d) studies (on the part of
industry), log-in, store and index studies (on the part of EPA), and
summarize and review studies (on the part of ITC). Further, in its 40th
Report to the Administrator, the ITC has recommended to EPA that
procedures be established by the Agency that offer industry
opportunities to submit voluntarily the types of data required under
TSCA section 8(a) and 8(d) and establish cooperative efforts with the
ITC to support ITC efforts in evaluating chemicals for testing under
TSCA (62 FR 30580, June 4, 1997).
C. The Need for Change
As one part of its regulatory reinvention initiative, EPA has
reviewed its reporting requirements under section 8(d) of TSCA. The
Agency's goal is to streamline the reporting requirements while
maintaining the availability of the data or its ability to acquire the
data necessary to protect human health and the environment. The current
opportunity to revise the section 8(d) rule is the result of the
``regulatory reform'' evaluation efforts undertaken as a result of a
Presidential regulatory reform initiative of March 16, 1995 entitled
``Reinventing Environmental Regulation.'' The rationales for
reinvention activities are manifold, however, a central principle is
that ``[r]egulation must be designed to achieve environmental goals in
a manner that minimizes costs to individuals, businesses, and other
levels of government.'' (Ref. 1)
Over the years, EPA has received a variety of comments concerning
the implementation of section 8(d). Extensive comments have been
received on many topics, including the definition of the term
``processor,'' reporting requirements for waste streams, and reporting
requirements for modeling and monitoring information. In December 1987,
the Chemical Manufacturers Association (CMA) developed a comprehensive
report (Ref. 2) suggesting a variety of revisions and, in June 1996,
provided the following list of suggested revisions in descending order
of importance to CMA and its members (Ref. 3):
(1) Reduce ten-year reporting period to one year for section 8(d)
related information.
(2) Revise reporting of monitoring and modeling studies.
(3) Revise processor reporting requirements.
(4) Reduce reporting of studies on mixtures.
(5) Exempt reporting requirements for waste streams.
(6) Eliminate study initiation reporting.
(7) Clarify file search issue.
(8) Clarify guidance on reporting of international studies.
(9) Establish a voluntary call-in prior to issuing TSCA section
8(d) reporting rules.
(10) Establish an electronic up-to-date list of TSCA section 8(d)
chemicals by CAS registry number.
(11) Exclude health and safety studies managed by other
environmental regulations to avoid duplicate reporting.
(12) Eliminate reporting of quantitative risk assessment and
structure-activity analysis.
(13) Eliminate less useful studies.
(14) Provide for alternative forms of required reporting.
D. The Public Meeting
On August 23, 1996, EPA published a Federal Register notice (61 FR
43546) inviting all interested parties to attend a public meeting in
Washington, DC on September 12, 1996, to discuss possible amendments to
the TSCA section 8(d) rule. The meeting was well attended with over 65
representatives of manufacturers, processors, trade associations, and
other interested parties. Each of the above issues was discussed and
time for comments was provided. At the meeting, EPA requested that
comments on the above or any other issues be submitted in writing for
consideration by the Agency. Additional comments were submitted,
especially relating to the issue of definition of the term
``processor'' and whether processors should be required to submit
health and safety data under section 8(d) of TSCA. The comments
received from all sources have been analyzed and evaluated (Ref. 4) and
the general issues are addressed in Unit II. of this document.
II. Revisions to TSCA Section 8(d) Regulations
A. Background
TSCA provides EPA with a variety of methods by which it can acquire
chemical substance and mixture data needed to protect human health and
the environment. Section 8(d) provides EPA with the authority to
promulgate rules requiring the submission of studies that are initiated
by the submitter, as well as studies conducted by the submitter in the
past and studies the submitter knows of or may reasonably ascertain.
A chemical substance or mixture that is not subject to an section
8(d) rule may still be subject to other TSCA reporting requirements.
Section 8(e) requires manufacturers, processors and distributors to
report any information regarding a chemical substance or mixture which
reasonably supports the conclusion that the substance or mixture
presents a substantial risk of injury to health or the environment.
Studies that are not otherwise required to be reported under section
8(e) are typically the kind of studies required to be reported under
section 8(d). Data relating to chemical substances and mixtures that
are not reportable under TSCA section 8 may be obtained by EPA through
the promulgation of a test rule under section 4 of TSCA. Once findings
are made by EPA under section 4(a), EPA must promulgate a rule
requiring the testing of chemical substances and mixtures to develop
health and environmental effects data.
B. Persons Who Must Report
Under the current TSCA section 8(d) regulations, any person who
manufacturers (including imports) or processes a chemical substance or
mixture listed under 40 CFR 716.120 must submit to EPA copies of
available health and safety studies upon request by EPA. Currently,
there is no category or sector limitation on reporting. By this
rulemaking, reporting of health and safety studies would be required
only by manufacturers (including importers) who fall under the North
American Industry Classification System (NAICS) in effect as of January
1, 1997, replacing the 1987 Standard Industrial Classification ((SIC);
62 FR 17288, April 9, 1997), Subsector 325 (chemical manufacturing and
allied products) and Industry Group 32411 (petroleum refiners), unless
otherwise required in a specific rule. EPA believes that this narrowing
of the scope of reporting, on a routine basis, will reduce the burden
imposed on industry to comply with TSCA section 8(d), while still
providing EPA and other Federal agencies with the
[[Page 15768]]
data necessary to protect human health and the environment.
A number of organizations have suggested that the definition of
the term ``processor'' under TSCA section 8(d) should be reevaluated.
Commentors suggested two options:
(1) Revise the definition to focus reporting requirements on
manufacturers (including importers), rather than on ``chemical users,''
who buy chemicals and mixtures and then use them to manufacture non-
chemical products, such as articles.
(2) Use appropriate Standard Industrial Classification (SIC) codes
(replaced by the North American Industry Classification System, NAICS,
in 1997).
At the present time, the term ``processor'' may be broadly defined to
include a far larger audience than intended on a routine basis.
EPA has analyzed the approximately 300 submitters of the roughly
11,000 submissions of TSCA section 8(d) information received to date,
and has categorized them by submitter type (Ref. 4). The vast majority
of submitters are individual chemical manufacturers or associations
representing chemical manufacturers falling under NAICS Subsector 325
and Industry Group 32411, which are heavily concentrated on the
chemical, allied products, and petroleum refining industries.
Examination of some of the processor submissions indicates very limited
data have been submitted by them and typically only in the form of
industrial hygiene/monitoring data. Thus, narrowing the overall scope
of persons who must report on a routine basis would likely have a
negligible impact on the type and comprehensiveness of the information
submitted under section 8(d). The rule's focus on those entities that
actually submit studies ensures that virtually all of the data that
have been reported in the past will continue to be reported. Health and
safety data submitted under section 8(d) are typically those studies
that are not otherwise reportable under section 8(e), the ``substantial
risk'' information reporting provision of TSCA. Further, studies
reportable under section 8(e) must be submitted within a specific time
frame by a broader range of persons, i.e., manufacturers, importers,
processors, and distributors.
In a specific section 8(d) rule, EPA may require reporting of
health and safety studies from all manufacturers (including importers)
and processors of a chemical substance. In this way, EPA reserves the
ability to require more information from a much wider audience in
exceptional circumstances, while reducing the burden to industry on a
routine basis.
C. Reporting Period
The reporting period for health and safety studies under TSCA
section 8(d) is currently 60 days for existing data, and 10 years for
new data, after the effective date on which a listed chemical substance
or listed mixture is added to 40 CFR 716.120, unless the listed
substance or listed mixture is removed from 40 CFR 716.120 prior to the
lapse of the standard reporting period. EPA is revising 40 CFR 716.65,
Reporting period, to only require a standard one-time reporting, which
will include the requirement that all existing studies be reported
within 60 days of the 40 CFR 716.120 listing, instead of the present 10
year reporting requirement. EPA believes this will provide a
significant burden reduction for industry while having little effect on
the availability of data to EPA and the ITC (Refs. 5 and 6).
When a substance from the TSCA section 4(e) Priority List is listed
at 40 CFR 716.120, existing studies are required to be reported within
60 days of the listing, then the ITC examines the submitted data,
usually within a year, to see if test data are already available in the
areas of concern. The ITC has only rarely used data that have been
submitted after the first year. Once the ITC recommends a chemical for
testing, EPA may write a rule requiring testing or obtain the test data
through specific enforceable consent agreements (ECA) with individual
companies or groups of companies who volunteer to conduct the needed
testing. This may take one to several years after the initial 40 CFR
716.120 listing. Although it is important for EPA to know about any
testing initiated after the first year, EPA expects this information to
still be forthcoming to EPA in a timely manner. Industry groups subject
to a test rule, or with which EPA is negotiating an ECA, are likely to
be knowledgeable about any relevant testing that is underway or will in
fact be the ones conducting the testing.
Examination of the EPA's Toxic Substances Control Act Test
Submissions (TSCATS) database (Ref. 4) indicates that most of the
section 8(d) submissions are made shortly after the initial listing of
a chemical substance. Any new studies that offer reasonable support for
a conclusion of substantial risk, would still be required to be
submitted immediately under TSCA section 8(e). In addition, many
companies submit to EPA other new studies on a ``For Your Information''
(FYI) basis. The present revisions to the rule leave section 8(d) as
the primary mechanism to obtain older studies, not new studies, and
require that industry track the chemical for 60 days to make sure that
any data that should be submitted under section 8(d) are collected and
transmitted to EPA, within this new time frame. Should this direct
final rule become effective, EPA will sunset all current reporting
requirements for all chemicals listed at 40 CFR 716.120 for which
reporting is currently required, except for those chemicals about which
EPA was notified that a study had been initiated or is underway. For
those chemicals, reporting is required until receipt of the final
report is received by EPA. At the present time, the 60-day reporting
period for all chemicals and mixtures listed at 40 CFR 716.120 has
elapsed. Experience has shown prospective reporting to be very limited
and therefore, it is likely that EPA has received all relevant data
except for chemicals for which EPA has received notice of studies
initiated during the initial 60-day period or those studies underway at
that time.
D. Initiated Studies
The existing regulations at 40 CFR 716.35(a)(2) and 40 CFR
716.60(b)(1) require that EPA be notified within 30 days about studies
initiated during the current 10-year reporting period and that the
Agency be provided with information including the date on which the
study was commenced, the purpose of the study, the types of data to be
collected, the anticipated date of completion, and the name and address
of the laboratory conducting the study. EPA is revising 40 CFR 716.65
to only require notification of study initiation that occurs during the
60-day reporting period. EPA believes that this revision will reduce
the burden imposed on industry without reducing the data available to
EPA and other Federal agencies to protect human health and the
environment.
Several comments (Ref. 4) received in response to the public
meeting held on September 12, 1996, have suggested that for short-term
toxicity studies, any notification is of little value because within a
short time the final versions of these studies would be submitted. It
was also suggested that it would require considerable effort to track
the initiation of other types of studies, such as monitoring studies.
In addition, it was suggested by some industry groups that it would be
to their benefit to voluntarily notify EPA of these planned studies in
order to ensure the completeness of data known to EPA, as
[[Page 15769]]
the Agency will make decisions on required testing of a chemical
substance or mixture under section 4 of TSCA based upon the data
available.
Historically, few studies have been initiated during the TSCA
section 8(d) reporting period. Thus, the revisions made in this
rulemaking should result in a reduction in burden related to reporting
by industry and in burden of reviewing by EPA. Persons who are subject
to the rule under 40 CFR 716.35 (a)(2) or (a)(3) and who have submitted
to EPA lists of ongoing or initiated studies under 40 CFR 716.35 (a)(1)
or (a)(2) must still submit the final report of the study within 30
days after its completion regardless of the study's completion date.
E. Studies to be Reported
A present general requirement of 40 CFR part 716 is that all health
and safety data available on a listed chemical substance or listed
mixture must be reported when requested by EPA. EPA is narrowing the
focus of the reporting requirements to specifically identify data needs
on listed chemical substances or listed mixtures which meet or exceed
certain grade/purity requirements. EPA believes that this approach
reduces the amount of routine reporting of health effects studies and
mixture studies which are in many cases of little value in Agency and
ITC decision making.
Following the September 12, 1996, public meeting, EPA met with the
ITC to discuss potential revisions to the Agency's regulations under
TSCA section 8(d). The ITC recommended that the Agency focus its needs
for section 8(d) data to reduce the resources that are spent by:
industry to submit section 8(d) studies, EPA to computerize and store
studies, and ITC to review studies. In order to facilitate such focused
requests for information, EPA will require reporting of studies on
particular effects of a chemical recommended by the ITC.
In order to facilitate the identification of data needs, the EPA
will specify the type(s) of health and safety data needed by the ITC
(see the following table for sample of effects data; environmental fate
and exposure data may also be requested by the ITC). By being as
specific as possible in identifying data needs, EPA will allow some
companies that have indexed their health and safety studies to quickly
identify relevant information for submission. Also, there may be some
instances when the ITC cannot specifically identify the type of health
and safety data needed (e.g., when a chemical has high exposure and
little toxicity data). In such a situation, the reporting requirement
may be significantly broader in scope. In all cases, the ITC will
provide the rationale to EPA for its requests for studies of interest.
EPA will also specify the chemical grade/purity for which reporting
is required. If studies meeting the EPA's chemical/grade purity
specifications are not reported, the ITC may consider requesting
studies on mixtures containing the recommended chemical, and EPA will
reserve the ability to require that mixtures containing a listed
chemical substance are subject to reporting under a specific TSCA
section 8(d) rule. In the past, the ITC has typically only reviewed
studies on mixtures if there were no available studies on the
relatively pure chemical. The reduction in the routine reporting of
studies on mixtures that would occur upon promulgation of this direct
final rule should provide significant burden relief to industry, not
because of the quantity of studies that are typically reported on
mixtures, but because of the difficulty in identifying the mixtures
that contain a listed substance. By no longer routinely requesting
mixture studies, EPA will expend fewer resources computerizing and
storing studies and ITC will spend less time reviewing studies that are
in many cases of little value in Agency and ITC decision-making.
The following table is a hypothetical example of the types of
existing studies for which EPA may be interested in obtaining for a
chemical or mixture which meets or exceeds certain grade/purity
criteria. This table should not be interpreted as setting forth future
reporting requirements for a given chemical substance or mixture;
rather it is a sample of the type of table which could be printed in
the Federal Register setting forth certain identified data needs
necessary for risk characterization for a specific chemical substance
or mixture meeting specified grade/purity criteria in a new section of
rules issued under section 8(d). Data needs and grade/purity would be
indicated in the appropriate boxes. Data needs may include health,
ecological, and/or environmental fate studies. A particular organism
(e.g., rat) or route of exposure (e.g., inhalation) may provide the
most relevant data for decision-making purposes, therefore,
identification of a particular test species or route of exposure will
be made where applicable.
Examples of Health, Ecological, and/or Environmental Effects Studies Which Can Be Requested Under TSCA Section 8(d)
--------------------------------------------------------------------------------------------------------------------------------------------------------
CAS registry Grade/purity of test
Chemical name no. substance Study types Test species Route of exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
1,chemical name xxx-xx-x technical grade or HE\1\/subchronic Mammals Dermal/oral
2,chemical name xxx-xx-x 99.9% EE/reproductive Fish-Marine na
toxicity
3,chemical name xxx-xx-x mixtures 75% or greater EF/octanol na na
Water partition
Coefficient
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ HE, health effects.
\2\ EE, ecological effects.
\3\ EF, environmental fate.
\4\ na, not applicable.
F. Adequate File Search
The former approach for reporting TSCA section 8(d) studies
requires searching all ``active'' files or records kept by the company
personnel responsible for keeping such records or providing advice on
health and environmental effects of chemicals. In this rulemaking, EPA
is limiting 40 CFR 716.25 to require file searches only for reportable
information dated on or after January 1, 1977, the effective date of
TSCA, unless a subsequent section 8(d) rule requires a more extensive
search.
[[Page 15770]]
EPA believes that this revision will also result in an additional
reduction in burden to both industry and EPA.
Over the years, commenters have suggested that file searches have
resulted in considerable burden due to the reporting of some rather old
studies which are less likely to meet current needs due to changing
protocols to achieve state-of-the-art science and lack of application
of Good Laboratory Practice Standards (GLPS). The GLPS were promulgated
in 1978 (Food and Drug Administration) and the mid 1980's (EPA, 40 CFR
part 792). For example, in earlier studies, fewer animals were used for
oncogenicity, developmental, reproductive, and subchronic studies;
monitoring of animals' health status by breeders was less rigorous; and
chemical analytical methods were not as sensitive. However, limiting
reporting of studies to only a certain time frame preceding the date of
the listing of the substance could result in useful studies not being
reported to EPA and ITC. Consequently, EPA would reserve the right to
request such studies through a more extensive search.
EPA believes that in all but exceptional circumstances,
establishing a single date after which all files should be searched
will remove the confusion that currently exists with respect to
``active'' and ``retired'' files. EPA will continue to accept the
submissions of older studies that may meet the regulatory needs of EPA
and ITC, but these would be submitted on a voluntary rather than
obligatory basis by industry, unless a rule makes submission mandatory.
However, because studies conducted prior to the effective date of TSCA
may be the only source of relevant data on a chemical, EPA may, under
certain circumstances, require file searches for reportable information
dated before January 1, 1977. Industry will have a considerable
incentive to voluntarily submit older ``good'' studies, because the
alternative is that EPA may require testing under section 4 of TSCA if
sufficient relevant test data are not forthcoming. Additionally,
section 8(e) would remain applicable to studies, regardless of age,
required to be reported pursuant to that section.
III. Refinements to the TSCA Section 8(d) Information Collection
Program
A. The Voluntary Program
For over twenty years, the ITC has received voluntary data
submissions from manufacturers, importers, processors and users of
chemicals recommended by the ITC and has engaged in dialogue with
several chemical industry trade associations and their members to
discuss the needs for these data. Such dialogue provides opportunities
to discuss in a more focused way data needed by ITC member
organizations, and may in some cases result in the ITC obtaining
sufficient information to remove a chemical from the Priority List
provided by the ITC to EPA. The following are examples that illustrate
the significance of these activities:
(1) Discussions between the ITC and CMA's Propylene Glycol Ethers
Panel resulted in the provision of data and facilitated the removal of
propylene glycol ethers from the Priority List (60 FR 42982, August 17,
1995).
(2) Discussions between the ITC and Silicones Environmental Health
and Safety Council (SEHSC) resulted in the provision of data and
facilitated the removal of many siloxanes from the Priority List (61 FR
4188, February 2, 1996).
Recently, most additions to the list of chemical substances and
mixtures subject to TSCA section 8(d) reporting requirements (40 CFR
716.120) have been the result of additions by the ITC to the TSCA
section 4(e) Priority List. Voluntary data submissions by numerous
chemical companies and trade associations to the ITC have been helpful
in identifying the important commercial chemicals that require testing
and identifying the types of tests that need to be conducted. A request
for the voluntary submission of health and safety data prior to the
promulgation of a section 8(d) rule for a recommended chemical was
issued by the ITC in its 40th Report to the EPA Administrator (62 FR
30580, June 4, 1997). Such requests provide an opportunity for industry
representatives to voluntarily submit information related to the ITC's
testing or informational needs. When responding to requests, a letter
(or e-mail) of intent to submit the information must be received by the
ITC no later than 30 days after the date the ITC Report is published in
the Federal Register. If the ITC receives a ``letter of intent,''
followed by a voluntary information submission, the ITC will make a
decision regarding the need for additional information following its
review of all relevant information. If no ``letter of intent'' (or e-
mail) is received, the ITC will request in its next Report that EPA
promulgate a TSCA section 8(d) rule requiring the reporting of health
and safety studies on the recommended chemical substance or mixture.
B. Electronic Submissions
The EPA, ITC, and industry have had an interest for a number of
years in the development of a means for providing electronic
submissions of TSCA section 8(d)-related data. This interest was
stimulated for the following reasons:
(1) Electronic submissions would reduce costs to industry and the
EPA by eliminating copying time and charges.
(2) Electronic submissions would cut the large amount of paper
generated with each submission.
(3) Electronic submissions could be linked to tracking systems to
ease document management efforts by EPA, ITC, and industry.
(4) Electronic submissions would have the potential to be
searchable and permit easier review.
(5) Electronic submissions could be more easily and rapidly
transferred to end users allowing potential real time assessment of
submissions.
(6) Electronic submissions could be ``uploaded'' to existing
databases.
(7) Electronic submissions may be readily made publicly available
through existing and new information dissemination vehicles.
Currently, three areas related to electronic submissions of TSCA
section 8(d) data are under consideration:
(1) Cover sheets for section 8(d) documents.
(2) Bibliographic data and abstracts of section 8(d) documents.
(3) Electronic copies of full text section 8(d) documents.
Documents containing confidential business information (CBI) must not
be submitted electronically. Electronic submissions of section 8(d)
data are considered public information by the Agency.
The current status of the above efforts is as follows:
Coversheets, bibliographic data and abstract submittal.
Standardized coversheets have been designed by a committee consisting
of members from EPA and industry. These coversheets provide the
information required for entry of data into EPA's Toxic Substances
Control Act Test Submissions (TSCATS) database as well as some
additional data desired by the Agency. Currently EPA is investigating
the possibility of placing templates of this coversheet on a World Wide
Web page to permit easy access and a means for transmitting completed
cover sheets to EPA, and matching transmitted coversheets to the paper
copies of the section 8(d) documents when they are received by EPA.
These coversheets will provide a standardized form for submittal of
data whether used in
[[Page 15771]]
electronic form or as a paper attachment to a section 8(d) document.
As part of this effort, industry would submit bibliographic data
(title, submitter, laboratory), indexing terms (as they are used in the
TSCATS database) and abstracts of section 8(d) documents submitted.
Some industry groups have indicated that there is little incentive to
develop the means to submit these data electronically if they normally
only submit a few studies or if their files are not currently in
electronic form. EPA agrees that current incentives are lacking, but
feels that, with time, industry (particularly large corporations) will
have ``computerized'' file structures, and electronic filing may
provide industry with a cost savings. If EPA establishes its data needs
now, industry can accommodate them, at little expense, when developing
electronic files. With advance knowledge of these data elements,
industry can ensure that any database developed will be compatible with
electronic submission of section 8(d) information.
Full text electronic documents. The development of systems to
accommodate submission of full text documents in electronic form will
assist in reducing storage space, providing easily read documents, and
potentially allowing the searching of documents for specific subjects.
EPA anticipates that electronic documents would be provided in a
variety of file formats including, but not limited to, standard word
processing files, images, and combinations of these, and any system
developed would need to accommodate all formats. Information from
laboratory studies, particularly raw data, is still typically
maintained in handwritten form, and unless a specific company has its
own reason for converting this material to electronic form, there is
little incentive to convert for submission to EPA. In addition,
industries who submit relatively few documents may initially prefer
paper submission. For these reasons, industry has encouraged EPA to
develop means for receiving submissions in electronic form, while also
maintaining the current process for receiving paper copies of TSCA
section 8(d) submissions.
EPA believes there are a number of advantages to developing the
means to submit section 8(d) information in electronic form, thus the
development of these procedures will continue. The current system of
paper submissions will be continued because of the cost of converting
to electronic submissions, particularly for those who submit relatively
few documents or do not currently have their files computerized. It is
anticipated, however, that in the future, more companies will have
electronic files and that there will be a cost savings associated with
the submission of section 8(d) documents by electronic filing. As the
means to submit documents electronically progresses, EPA will address
issues concerning document security, integrity, and authenticity.
C. Updated List of Chemicals for which TSCA Section 8(d) Reporting is
Required
Currently, when a chemical or chemical class appears on the section
4(e) Priority List, an amendment to the section 8(d) regulations at 40
CFR 716.120, effective thirty days after publication in the Federal
Register, requires submission of all health and safety studies for 10
years after the notice is published. EPA has also made the section 8(d)
list at 40 CFR 716.120 available on EPA's Home Page through a World
Wide Web Site (http://www.epa.gov). Under the revised section 8(d)
rule, EPA has reduced the reporting period, in general, from 10 years
to 60 days. Because of this change in the reporting period, EPA will no
longer conduct biennial review of chemical substances and mixtures
listed at 40 CFR 716.120. EPA is amending the sunset date for all
chemical substances and mixtures listed at 40 CFR 716.120, for which
reporting is currently required, to June 30, 1998. Nevertheless, EPA
will continue to publish each chemical or mixture on the list at 40 CFR
716.120, including the sunset date, for a period of 5 years.
In a specific section 8(d) rule, EPA may, in certain circumstances
in which it has identified a continuing need for information, continue
to list chemical substances and mixtures at 40 CFR 716.120 for a period
of time not to exceed 2 years. In this way, EPA reserves the ability to
require the reporting of information during periods longer than 60 days
where EPA believes that new and potentially significant data may be
generated beyond the 60 day period, while reducing the burden of
industry on a routine basis.
IV. Public Record and Electronic Submissions
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number OPPTS-42188B (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 12 noon to 4 p.m., Monday through Friday, excluding legal
holidays. The official rulemaking record is located in the TSCA
Nonconfidential Information Center, Rm. NE-B607, 401 M St., SW.,
Washington, DC.
Electronic comments can be sent directly to EPA at:
oppt.ncic@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number OPPTS-42188B. Electronic comments on this
proposed rule may be filed online at many Federal Depository Libraries.
A. Supporting Documentation
This record contains the basic information considered in
developing this Rule and includes the following information:
Federal Register notice of Public Meeting for TSCA Section 8(d)
Revision, (August 23, 1996, 61 FR 43546).
Communications consisting of:
(a) Written letters.
(1) AAMA & AIAM. 1996. Comments of the American Automobile
Manufacturers Association and the Association of International
Automobile Manufacturers on EPA's TSCA Section 8(d) Reinvention
Initiative, November 1, 1996, Washington, DC.
(2) AIA. 1996. Letter from Roundtree, G. to Frank Kover, OPPT, EPA
for TSCA Section 8(d) Revision Project, Aerospace Industries
Association, October 15, 1996, Washington, DC.
(3) API. 1996. Comments of the American Petroleum Institute on
EPA's Review of Reporting Requirements Under Section 8(d) of the Toxic
Substances Control Act, November 1, 1996, Washington, DC.
(4) Adams, G.L. 1992. Letter to TSCA Public Document Office.
``OPPTS-82038 TSCA Section 8(d) Guidance on Modeling Health and Safety
Studies.'' March 4, 1992, 3M, St. Paul, MN 55144.
(5) Adams, G.L. 1995. Letter to TSCA Public Document Office.
``OPPTS-84030 TSCA Section 8(d).'' October 19, 1995, 3M, St. Paul, MN
55144.
(6) Christman, M.H. 1992. Letter to TSCA Public Document Office.
Comments on Docket Control Number OPPTS-82038: ``Questions and Answers:
Applicability of the Toxic Substances Control Act (TSCA) Section 8(d)
Model Health and Safety Reporting Rule (40 CFR Part 716) to Modeling
[[Page 15772]]
Studies.'' 57 FR 1723 (January 15, 1992), April 1, 1992, DuPont,
Wilmington, Delaware 19898.
(7) CMA. 1988. Letter to Joseph Merenda, Director, Existing
Chemical Assessment Division, EPA, May 2, 1988, Washington, DC.
(8) CMA. 1991. Letter to Mark Greenwood, Director, Office of Toxic
Substances, EPA, August 26, 1991, Washington, DC.
(9) CMA. 1996. Recommendations of the Chemical Manufacturers
Association for Reform in EPA's Reporting Requirements Under Section
8(d) of the Toxic Substances Control Act, October 15, 1996, Washington,
DC.
(10) Green, D.H. 1994. Letter to Patricia A. Roberts, Office of
General Counsel, EPA, for Regulations of Wastes Under TSCA, October 6,
1994, Piper & Marbury, Washington, DC.
(11) Green, D.H. 1996A. Letter to Patricia A. Roberts, Office of
General Counsel, EPA, for TSCA section 4 Test Rules and Waste Imports,
April 5, 1996, Piper & Marbury, Washington, DC.
(12) Green, D.H. 1996B. Letter to Keith Cronin, Chemical Control
Division, OPPT, for Comments on Issues Raised at EPA Public Meeting on
TSCA Section 8(d) Amendments (OPPTS-4218), October 15, 1996, Piper &
Marbury, Washington, DC.
(13) Greenwood, M.A. 1996. Letter to Frank Kover, OPPT, US EPA for
TSCA Section 8(d) Revision Project, Ropes & Gray, Washington, DC.
(14) Harvey, S.K. 1996. Letter to TSCA Docket Contol Number 42188
for Comments on Section 8(d) Notice, October 14, 1996, FMC Corporation,
Philadelphia, PA.
(15) Kuryla, W.C. 1990. Letter to Charles Auer, Acting Director,
Existing Chemical Assessment Division, Office of Toxic Substances, for
Request for Interpretation of TSCA Section 8(d), March 29, 1990, Union
Carbide Corporation, Danbury, CT 06817.
(16) Kuryla, W.C. 1995. Letter to Frank Kover, OPPT, US EPA for
TSCA Section 8(d) Revision, December 21, 1995, Union Carbide
Corporation, Danbury, CT 06817.
(17) Petke, F. D. 1996. Letter to Frank Kover, OPPT, US EPA,
Comments on Revisions to TSCA Section 8(d), October 10, 1996, Eastman
Chemical Company, Kingsport, TN 37662.
(18) Robinson, R.H. 1995A. Letter to Regulatory Coordination Staff,
OPPTS, EPA, for Regulations Reinvention Initiative--Opportunity to
Submit Comments in OPPTS, May 16, 1995, Hazardous Waste Management
Association.
(19) Robinson, R.H. 1995B. Letter to Denise Keehner, Deputy
Director, Chemical Control Division, OPPTS, EPA, for Meeting Concerning
Applicability of TSCA to Wastes, May 31, 1995, Hazardous Waste
Management Association.
(20) Sanders, W.H. III. Undated. Letter to Gary King, Regulatory
Program Manager, Safety-Kleen Corporation, Elgin, Illinois, Office of
Pollution Prevention and Toxics, EPA, Washington, DC.
(21) Wilson, J.D. 1992. Letter to TSCA Public Document Office.
Comments on Docket Control Number OPPTS-82038: ``Questions and answers:
Applicability of the Toxic Substances Control Act (TSCA) Section 8(d)
model health and safety reporting rule to modeling studies.'' 57 FR
1723 (January 15, 1992), July 20, 1992, Monsanto Co., St. Louis, MO
63167.
(22) Zoll, D.F. 1988A. Letter to Charles L. Elkins, Director of
Office of Toxic Substances. May 24, 1988, Guidance on Application of
TSCA Section 8(d) to Community Health Standards and Modeling and
Monitoring Reports Developed in Connection With Section 313 of EPCRA,
Chemical Manufacturers Association, Washington, DC.
(23) Zoll, D.F. 1988B. Letter to Joseph J. Merenda, Director of the
Assessment Division, EPA, June 28, 1988, Application of TSCA Section
8(d) to Modeling and Other Materials Developed in Connection With
Section 313 of EPCRA, Chemical Manufacturers Association, Washington,
DC.
(b) Meeting summary.
EPA. Agenda and Presentation; Public Meeting for Revisions's in
EPA's Reporting Requirements under Section 8(d) of the Toxic Substances
Control Act, September 12, 1996, Washington, DC.
B. References
(1) ``Reinventing Environmental Regulation,'' Clinton Regulatory
ReformInitiative, Washington, DC (March 16, 1995).
(2) CMA. 1987. Recommendations of the Chemical Manufacturers
Association for Modification of EPA's Regulations Under Section 8(d) of
TSCA. December 28, 1987. Washington, DC.
(3) CMA. 1996. Regulatory Priorities of the Chemical Manufacturers
Association for Modification of EPA's Regulations Under Section 8(d) of
TSCA (Draft). June, 1996. Washington, DC.
(4) Syracuse Research Corporation. ``Support Document for Proposed
Revisions to Section 8(d) of TSCA,'' Syracuse NY (April 30, 1997).
(5) Chemical Manufacturers Association. ``Recommendations of the
Chemical Manufacturers Association for Reforms in EPA's Reporting
Requirements Under Section 8(d) of the Toxic Substances Control Act''
(October 15, 1996).
(6) EPA. ``Analysis of the Proposed Streamlining of Section 8(d)
Rule Requirements,'' Washington, DC (April 30, 1997).
V. Regulatory Assessment Requirements
The Office of Management and Budget (OMB) has exempted actions
issued pursuant to section 8(d) of TSCA from OMB review under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993). In addition, this direct final rule is expected to
provide significant reductions in the burden and costs associated with
reporting under TSCA section 8(d) for those subject to reporting (i.e.,
manufacturers, importers, and processors of chemicals), as well as
those who use the information reported (i.e., the ITC and EPA), and is
not expected to result in any adverse impacts.
As a result, this action does not impose any enforceable duty or
contain any unfunded mandate as described in the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation with
State officials as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993). Moreover, it does not involve special considerations of
environmental justice related issues as required by Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994), or require OMB review in accordance with Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997).
According to the Paperwork Reduction Act (PRA), 44 USC 3501 et
seq., an agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations, after initial display in the preamble of the final rules,
are listed in 40 CFR part 9. The information collection requirements
related to reporting under TSCA section 8(d) have already been approved
by OMB pursuant to the PRA under OMB control number 2070-0004 (EPA ICR
No. 575). This action does not impose
[[Page 15773]]
any new collections or burden requiring additional OMB approval.
The annual public burden for the existing requirements ranged
between 2 and 23 hours per response (depending upon the individual
respondent activities). The changes made to the requirements through
this direct final rule reduce the annual public burden by 5,000 hours,
for a new annual public burden of between 1 and 12 hours per response.
If the Agency does not receive any adverse comments so that this direct
final rule can become effective, EPA will then amend the total burden
hours approved under OMB Control number 2070-0004 to reflect this
reduction.
Under the PRA, burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
Send any comments about the accuracy of this burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
OPPE Regulatory Information Division, U.S. Environmental Protection
Agency (Mail Code 2137), 401 M Street, SW., Washington, DC 20460, with
a copy to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th St., NW., Washington, DC 20503, marked
``Attention: Desk Officer for EPA.'' Please remember to include the OMB
control number in any correspondence, but do not submit any reports to
these addresses.
In addition, pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby
certifies that this action does not have a significant economic impact
on a substantial number of small entities.
VI. Submission to Congress and the Comptroller General
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, EPA submitted a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in today's Federal
Register. This rule is not a ``major rule'' as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 716
Environmental Protection, Chemicals, Hazardous substances, Health
and Safety, Reporting and recordkeeping requirements.
Dated: March 18, 1998.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
PART 716--[AMENDED]
1. The authority for part 716 continues to read as follows:
Authority: 15 U.S.C. 2607(d).
2. By revising Sec. 716.5 to read as follows:
Sec. 716.5 Persons who must report.
(a) Except as provided in paragraphs (b) and (c) of this section,
only those persons described in this section are required to report
under this part. Persons who must report include manufacturers
(including importers) who fall within the North American Industry
Classification System (NAICS) (in effect as of January 1, 1997)
Subsector 325 (chemical manufacturing and allied products) or Industry
Group 32411 (petroleum refineries), who:
(1) In the 10 years preceding the effective date on which a
substance or mixture is added to Sec. 716.120, either had proposed to
manufacture (including import), or had manufactured (including
imported) the listed substance or listed mixture (including as a known
byproduct), are required to report during the reporting period
specified in Sec. 716.65.
(2) As of the effective date on which a substance or mixture is
added to Sec. 716.120, and who propose to manufacture (including
import), or who are manufacturing (including importing) the listed
substance or listed mixture (including as a known byproduct), are
required to report during the reporting period specified in
Sec. 716.65.
(3) After the effective date on which a substance or mixture is
added to Sec. 716.120, and who propose to manufacture (including
import) the listed substance or listed mixture (including as a known
byproduct), are required to report during the reporting period
specified in Sec. 716.65.
(b) A rule promulgated under the authority of 15 U.S.C. 2607(d) may
require that any person who does not fall within NAICS (in effect as of
January 1, 1997) Subsector 325 or Industry Group 32411, and who had
proposed to manufacture (including import) or process, had manufactured
(including imported) or processed, proposes to manufacture (including
import) or process, or is manufacturing (including importing) or
processing a substance or mixture listed in Sec. 716.120 must report
under this part.
(c) Processors and persons who propose to process a substance or
mixture otherwise subject to the reporting requirements imposed by this
part are not subject to this part unless EPA specifically states
otherwise in a particular notice or rule promulgated under the
authority of 15 U.S.C. 2607(d).
3. By adding Sec. 716.20(b)(5) to read as follows:
Sec. 716.20 Studies not subject to reporting requirements.
* * * * *
(b) * * *
(5) Rulemaking proceedings that add substances and mixtures to
Sec. 716.120 will specify the types of health and/or environmental
effects studies that must be reported and will specify the chemical
grade/purity requirements that must be met or exceeded in individual
studies. Chemical grade/purity requirements will be specified on a per
chemical basis or for a category of chemicals for which reporting is
required.
4. By revising Sec. 716.25 to read as follows:
Sec. 716.25 Adequate file search.
The scope of a person's responsibility to search records is limited
to records in the location(s) where the required information is
typically kept, and to records kept by the person or the person's
individual employee(s) who is/are responsible for keeping such records
or advising the person on the health and environmental effects of
chemicals. Persons are not required to search for reportable
information dated before January 1, 1977, to comply with this subpart
unless specifically required to do so in a rule.
5. By revising the first sentence in Sec. 716.30(a)(1) to read as
follows:
Sec. 716.30 Submission of copies of studies.
(a)(1) Except as provided in Secs. 716.5, 716.20, and 716.50,
persons must send to EPA copies of any health and safety studies in
their possession for the
[[Page 15774]]
substances or mixtures listed in Sec. 716.120. * * *
* * * * *
6. By revising Sec. 716.35(a), introductory text, to read as
follows:
Sec. 716.35 Submission of lists of studies.
(a) Except as provided in Secs. 716.5, 716.20, and 716.50, persons
subject to this rule must send lists of studies to EPA for each of the
listed substances or listed mixtures (including as a known byproduct)
in Sec. 716.120 which they are manufacturing, importing, or processing,
or which they propose to manufacture (including import) or process.
* * * * *
7. By revising Sec. 716.45(c)(3) to read as follows:
Sec. 716.45 How to report on substances and mixtures.
* * * * *
(c) * * *
(3) The substance of the grade/purity specified in each rule
promulgated under 15 U.S.C. 2607(d).
8. By revising Sec. 716.60(a) to read as follows:
Sec. 716.60 Reporting schedule.
(a) General requirements. Except as provided in Sec. 716.5 and
paragraphs (b) and (c) of this section, submissions under Secs. 716.30
and 716.35 must be postmarked on or before 60 days after the effective
date of the listing of a substance or mixture in Sec. 716.120 or within
60 days of proposing to manufacture (including import) or process a
listed substance or listed mixture (including as a known byproduct) if
first done after the effective date of the substance or mixture being
listed in Sec. 716.120.
* * * * *
9. By revising the Sec. 716.65 to read as follows:
Sec. 716.65 Reporting period.
Unless otherwise required in a rule promulgated under 15 U.S.C.
2607(d) relating to a listed chemical substance or listed mixture
[hereinafter ``rule''], the reporting period for a listed chemical
substance or listed mixture will terminate 60 days after the effective
date on which the listed chemical substance or listed mixture is added
to 40 CFR 716.120. EPA may require reporting for a listed chemical
substance or listed mixture beyond the 60 day period in a rule
promulgated under 15 U.S.C. 2607(d), however EPA will not extend any
reporting period later than 2 years after the effective date on which a
listed chemical substance or listed mixture is added to 40 CFR 716.120.
After the applicable reporting period terminates, any person subject to
the rule under 40 CFR 716.5 (a)(2) or (a)(3) and who has submitted to
EPA lists of ongoing or initiated studies under 40 CFR 716.35 (a)(1) or
(a)(2) must submit a copy of any such study within 30 days after its
completion, regardless of the study's completion date.
Sec. 716.120 [Amended]
10. The tables in Sec. 716.120 (a), (c), and (d) are amended by
revising the dates in the ``Sunset date'' column that have not yet
occurred as of April 1, 1998, to read ``June 30, 1998''.
[FR Doc. 98-8425 Filed 3-31-98; 8:45 am]
BILLING CODE 6560-50-F
