[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report unpublished health and safety studies.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. 
[email protected]. 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-
H[email protected]. 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: 
[email protected].
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          
------------------------------------------------------------------------
Industry                                    Chemical manufacturers      
                                             (including                 
                                             importers),chemical        
                                             processors, and petroleum  
                                             refiners.                  
------------------------------------------------------------------------


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:
    [email protected]

    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