TSCA Section 8(e); Notification of Substantial Risk; Policy Clarification and Reporting Guidance

 
[Federal Register: June 3, 2003 (Volume 68, Number 106)]
[Notices]
[Page 33129-33140]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn03-73]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
[OPPT-2002-0067; FRL-7287-4]
 
TSCA Section 8(e); Notification of Substantial Risk; Policy 
Clarification and Reporting Guidance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: EPA is hereby finalizing revisions to certain parts of EPA's 
``Statement of Interpretation and Enforcement Policy; Notification of 
Substantial Risk'' (policy statement) issued March 16, 1978, concerning 
the reporting of ``substantial risk'' information pursuant to section 
8(e) of the Toxic Substances Control Act (TSCA). EPA is making these 
revisions after having considered public comments that were solicited 
in 1993 and 1995. Specifically, the revisions address the reporting of 
information on the release of chemical substances to, and the detection 
of chemical substances in, environmental media, the reporting deadline 
for written ``substantial risk'' information, and the circumstances 
under which certain information need not be reported to EPA under 
section 8(e) of TSCA. EPA is republishing the policy statement in its 
entirety in this document, including both those portions of the policy 
statement that are revised and those portions that are not affected by 
any revisions. Since the policy statement was published in 1978, this 
republication is intended to ensure that a single reference source for 
the TSCA section 8(e) policy and guidance is easily available to the 
regulated community and other interested parties.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Barbara Cunningham, Director, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
    For technical information contact: Richard Hefter, Chief, High 
Production Volume Chemicals Branch, Risk Assessment Division, Office 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-7649; e-mail address: hefter.richard@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
process, import, or distribute in commerce chemical substances and 
mixtures. Potentially affected entities may include, but are not 
limited to:
    ? Chemical manufacturers, processors, and distributors (NAICS 
325)
    ? Petroleum refiners and distributors (NAICS 324)
    ? Manufacturers of plastic parts and components (NAICS 
325211)
    ? Paints and coatings and adhesive manufacturing (NAICS 3255)
    ? Cleaning compounds and similar products manufacturing 
(NAICS 3256)
    ? Electronics manufacturing (NAICS 334 and 335)
    ? Automobiles manufacturing (NAICS 3361)

[[Page 33130]]

    ? Aircraft manufacturing (NAICS 336411)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Unit VIII., Part II., 
of this document. If you have any questions regarding the applicability 
of this action to a particular entity, consult the technical person 
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPPT-2002-0067. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the EPA Docket Center, Rm. 
B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, 
DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays. The EPA Docket Center Reading 
Room telephone number is (202) 566-1744 and the telephone number for 
the OPPT Docket, which is located in EPA Docket Center, is (202) 566-
0280.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. Information about the Office 
of Prevention, Pesticides and Toxic Substances (OPPTS) and OPPTS-
related programs is available from http://www.epa.gov/opptsmnt/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background

A. What Action is the Agency Taking?

    The Agency is revising and clarifying certain provisions of the 
TSCA section 8(e) policy statement issued in 1978. Specifically the 
Agency is changing the interpretation that section 8(e) notices should 
be submitted within 15 working days by lengthening the reporting period 
to 30 calendar days. The Agency is revising and clarifying the guidance 
regarding the release and detection of chemical substances in 
environmental media, which includes previously unsuspected chemical 
contamination such as in soil and ground water, and emergency incidents 
of environmental contamination such as spills to water and releases to 
the atmosphere. Also, the Agency is expanding the types of information 
that it believes need not be reported under section 8(e) and changing 
the reporting periods to provide additional time for industry 
compliance with TSCA section 8(e). In addition, EPA is updating certain 
reporting contact phone numbers and the address for reporting section 
8(e) notices.
    While the Agency is only revising portions of the 1978 guidance it 
has issued in earlier documents, EPA is including in this Federal 
Register document, along with the revised guidance, those portions of 
earlier guidance documents that are not being changed. In that way, 
members of the regulated community will be able to find all current EPA 
guidance on compliance with section 8(e) in this Federal Register 
document, without having to consult older documents as well.
    The Agency is including in this guidance document its preferences 
for how and where section 8(e) notices should be submitted. Although 
these preferences could be codified in procedural rules under the 
Administrative Procedures Act (APA), 5 U.S.C. 551 et seq., EPA is not 
at this time adopting them as rules. While submitters of section 8(e) 
notices are not therefore obligated to comply with the preferences 
articulated in this document, EPA encourages submitters to consider and 
follow them when preparing and submitting TSCA section 8(e) notices.
    Finally, the bulk of this document contains EPA's guidance on 
certain types of information it currently believes generally meet the 
statutory standard of ``information which reasonably supports the 
conclusion that such substance or mixture presents a substantial risk 
of injury to health or the environment.'' Some of this guidance is new, 
and reflects public comment following the Agency's requests for 
comments in 1993 and 1995. As noted earlier, this document also 
contains earlier guidance issued on section 8(e) that has not been 
changed and that is being reprinted here for the convenience of all 
interested persons.
    During the Compliance Audit Program (CAP) (see Unit II.C.), EPA 
reviewed the provisions in the reporting guidance for incidents 
involving chemical contamination of the environment. The changes set 
out in this document were developed as a result of that review. In 
1993, EPA issued a Federal Register notice (58 FR 37735, July 13, 1993) 
that proposed changes to the reporting guidance. In 1995, after 
consideration of comments received on the 1993 proposal, EPA sought 
additional public comment on proposed changes to the reporting guidance 
(60 FR 14756, March 20, 1995) (FRL-4937-6). Unit III. describes the 
changes EPA proposed, the comments received on the proposed changes, 
and the Agency's resolution of the issues raised by the comments.

B. What is the Agency's Authority for Taking this Action?

    TSCA section 8(e) states, ``Any person who manufactures, [imports,]
processes, or distributes in commerce a chemical substance or mixture 
and who obtains information which reasonably supports the conclusion 
that such substance or mixture presents a substantial risk of injury to 
health or the environment shall immediately inform the [EPA]
Administrator of such information unless such person has actual 
knowledge that the Administrator has been adequately informed of such 
information.'' 15 U.S.C. 2607(e).
    EPA hopes and expects that this guidance will be useful to 
manufacturers, including importers, processors, and distributers of 
chemical substances in fulfilling their responsibilities under section 
8(e). This guidance is not, however, a substitute for rulemaking and it 
does not impose any binding requirements upon either the regulated 
community or the Agency. In any particular set of circumstances, any 
person who has a question about

[[Page 33131]]

the applicability of section 8(e) to certain information is welcome to 
contact EPA. In responding to such person, the Agency will consider the 
guidance contained in this document, but the guidance will not be 
determinative. It is also important to point out that the guidance 
provided will not be unalterable, and that the Agency may revise this 
guidance without notice or an opportunity to comment. EPA has sought 
public comment on this guidance so that it can ensure the utility of 
the guidance for the intended audience. If it becomes necessary, the 
Agency will revise this guidance.

C. What is the Agency's Current Policy on and Interpretation of the 
TSCA Section 8(e) Reporting Requirements?

    The section 8(e) reporting requirements became effective on January 
1, 1977, the effective date of TSCA. The statutory language of section 
8(e) requires the exercise of a certain degree of judgment in 
determining what information must be reported. Although section 8(e) is 
self-implementing, EPA issued a proposed policy statement in the 
Federal Register of September 9, 1977 (42 FR 45362), and sought public 
comment with regard to the Agency's interpretation and implementation 
of section 8(e). Following receipt and consideration of public 
comments, on March 16, 1978 (43 FR 11110) (FRL-849-2), EPA issued a 
final TSCA section 8(e) policy statement hereinafter cited as the 
``1978 Policy Statement.'' The 1978 Policy Statement described the 
types of information that EPA considers reportable under section 8(e) 
and described the procedures for reporting such information to EPA.
    In the Federal Register of February 1, 1991 (56 FR 4128), the 
Agency announced a one-time voluntary TSCA section 8(e) CAP. The CAP 
was designed primarily to: (1) Obtain any section 8(e) information that 
was required to have been submitted to EPA before the CAP, and (2) 
encourage companies to voluntarily search (``audit'') their files for 
data reportable under section 8(e). The TSCA section 8(e) CAP 
established a schedule of monetary penalties for failure to submit 
section 8(e) data before the CAP, and also established a ceiling on 
penalties that would be collected from any single company.

D. The Reason for Issuing Revised Guidance

    Companies considering whether to participate in the CAP had raised 
questions about Parts V.(b)(1) and V.(c) of the 1978 Policy Statement. 
Those sections outlined the reportability of data on ``widespread and 
previously unsuspected distribution in environmental media'' and 
``emergency incidents of environmental contamination,'' respectively. 
In order to answer the questions raised by the companies, the Agency 
reviewed existing section 8(e) guidance and determined that Parts 
V.(b)(1) and V.(c) of the 1978 Policy Statement needed clarification 
and refinement. Therefore, in the Federal Register of June 20, 1991 (56 
FR 28458), EPA announced that the Agency was suspending application of 
Parts V.(b)(1) and V.(c) of the 1978 Policy Statement.
    That Federal Register document also stated that EPA was going to 
provide more specific guidance about the types of information on 
environmental releases and detection of environmental contamination 
that should be submitted under section 8(e). Phase 2 of the CAP, which 
was to deal with data on environmental contamination, would be 
triggered by publication of that revised guidance (phase 1 of the CAP 
had dealt with studies of ``effects'' of toxic substances on health or 
the environment.). On July 13, 1993, EPA issued a Federal Register 
document (58 FR 37735) that proposed changes to the 1978 Policy 
Statement, clarifying the types of environmental contamination data 
that EPA believes are subject to section 8(e) reporting.
    Comments received on the proposed changes took issue with a number 
of the revisions proposed by the Agency as well as with the original 
guidance. Based on the comments received, it became apparent that any 
final guidance would likely be significantly different from previous 
guidance and should therefore be applied prospectively. Since the CAP 
was essentially a retrospective exercise, the decision to make 
substantial revisions in the guidance for reporting on environmental 
contamination called into question the utility of carrying out phase 2. 
Consequently, the Agency, in consultation with CAP participants, 
decided to conclude the CAP after phase 1 ``effects'' reporting. 
Letters were sent to CAP participants announcing the change in the 
program, and the CAP was terminated on May 15, 1996. EPA reached final 
settlements with CAP participants, announced those settlements on 
October 15, 1996, and collected payment for stipulated penalties.

III. Section 8(e) Policy Clarifications and Revisions

    EPA's interpretation of section 8(e) is that it requires the 
reporting of certain ``substantial risk'' information concerning the 
release of chemical substances to, and the detection of chemical 
substances in, any environmental medium. In order to enhance 
implementation of TSCA section 8(e), EPA is, in this Federal Register 
document, publishing a complete version of the policy statement which 
reflects comments received on proposed refinements to the policy 
statement published on July 13, 1993 (58 FR 37735), and March 20, 1995 
(60 FR 14756). EPA has also decided to reinstate application of Part 
V.(c) relating to ``emergency incidents of environmental 
contamination,'' which was suspended on June 20, 1991 (56 FR 28458).

A. What Changes were Proposed in 1993?

    In a notice published in the Federal Register on July 13, 1993 (58 
FR 37735), EPA proposed the following changes to the 1978 Policy 
Statement:
    1. Revise the 1978 reporting guidance as to when the discovery of 
``widespread and previously unsuspected [chemical]
distribution in 
environmental media'' would trigger a substantial risk notice under 
section 8(e). EPA indicated that the key elements to consider would be 
the known hazard potential of the contaminant, how ``widespread'' the 
substance is in the environment, and the potential for actual human or 
environmental exposure. EPA further stated that the weight to be given 
exposure considerations would be judged in light of hazard potential, 
i.e., the more hazardous the chemical the less one would weigh exposure 
considerations.
    2. Expand the categories of information cited in the 1978 reporting 
guidance that EPA believed no longer need to be reported to under 
section 8(e). The major change proposed was intended to reduce the 
potential for TSCA section 8(e) submissions to be duplicative of 
reporting under other mandates, by allowing an exemption for 
information reported under other EPA reporting requirements (including 
those delegated to the states). Also, a clarification of what would 
constitute ``corroborative'' data not subject to reporting was 
proposed.
    3. Change the interpretation that section 8(e) notices for 
information other than ``emergency incidents of environmental 
contamination'' should be submitted within 15 working days by 
lengthening the reporting period to 30 calendar days.

[[Page 33132]]

    4. Eliminate the need to follow up an emergency release 
notification under Part V.(c) with a written report.
    5. Clarify standards for claiming CBI in section 8(e) notices.
    6. Correct the address under Part IX. of the 1978 Policy Statement.

B. Summary of Public Comments on the 1993 and 1995 Proposed Revisions 
and EPA's Responses

    In addition to the brief summaries of public comments and Agency 
responses presented in this Federal Register document, EPA has prepared 
a ``response to comments'' document that addresses in greater detail 
the significant comments it received on the proposed changes. The 
public version of the ``response to comments'' document, which does not 
contain any CBI information, is publicly available in the docket 
described in Unit I.B.1 of this document.
    1. Comments on the 1993 proposed changes. EPA received comments 
from 49 companies and industry associations in response to the 1993 
Federal Register document. Commenters suggested that EPA's proposed 
plan for environmental reporting lacked criteria that were sufficiently 
clear to enable companies to separate ``routine'' releases, which need 
not be reported, from the ``extraordinary'' releases, which were to be 
reported under section 8(e). Commenters stated that EPA should provide 
clearer criteria for determining when a situation presents a 
``substantial risk,'' and should provide as many ``bright lines'' as 
possible to indicate what would and would not be reportable under 
section 8(e). Specifically, commenters:
    ? Questioned EPA's interpretation of when contamination would 
be ``widespread.''
    ? Stated that only a contaminant's ``known'' toxicity should 
be considered.
    ? Stated that for contamination to be reportable, it must be 
``previously unsuspected'' contamination.
    ? Stated that the contamination must result in actual or high 
probability of significant exposure to humans or non-human organisms.
    ? Stated that any contamination to be reported under section 
8(e) must ``present'' a substantial risk rather than only a speculative 
``may present.''
    ? Proposed that EPA establish a decision tree that companies 
could follow to determine whether to report incidents involving 
environmental contamination under section 8(e). Commenters stated that 
if companies had sequential criteria, they would be in a much better 
position to comply with the reporting requirements of section 8(e).
    ? Supported the change to the section 8(e) notice reporting 
period from 15 working days to 30 calendar days.
    The bulk of the remaining comments concerned circumstances under 
which companies need not report information to EPA. EPA had proposed to 
exempt from reporting under TSCA section 8(e) information companies 
were required to report under other EPA authorities (including those 
delegated to the States). However, the exemption would only apply if 
the information was submitted under the other authorities within 30 
days of obtaining the information. Commenters believed that this would 
offer little relief because many of the other authorities have 
reporting periods longer than 30 days. The companies would either have 
to accelerate their reporting under authorities other than TSCA section 
8(e) or submit two reports, one within 30 days under section 8(e) and 
another within the time frame of the other requirement. The commenters 
suggested allowing a longer time frame, i.e., 90 days or longer, for 
that information submitted under authorities other than TSCA section 
8(e).
    Commenters also suggested expanding the ``other authorities'' 
exemption to include reporting under all Federal environmental statutes 
as well as State laws and regulations, especially when a site is 
undergoing remediation for contamination with hazardous waste and any 
environmental or health threats associated with those contaminants are 
being addressed in the course of the remediation.
    Finally, EPA received comments on the relationship of the revised 
guidance to phase 2 of the CAP. The sentiment expressed by all those 
who commented on this issue was that, given the limited guidance in the 
1978 Policy Statement, EPA's suspension of the guidance section on 
environmental contamination, and the likelihood that EPA's final 
guidance would be essentially ``new,'' the final guidance should only 
be enforced prospectively. Consequently, companies should not be 
subject to any liability for past failures to report under the criteria 
of the ``new'' guidance.
    2. EPA's response to comments on the 1993 proposed changes; the 
1995 proposed draft guidance. In response to the comments received on 
the 1993 proposed changes to the 1978 guidance, on March 20, 1995, EPA 
issued revised proposed guidance to address the commenters' concerns.
    First, in the 1995 notice, EPA proposed clarifications to the 
situations involving environmental contamination which EPA believes 
would need to be reported. Language suggested in comments to the 1993 
notice was adopted, specifying that the contamination must be 
``previously unsuspected,'' that ``exposure'' has occurred or there is 
a substantial likelihood that it will occur, and that the chemical(s) 
in question is ``known'' to cause serious adverse effects. EPA stated 
that information on those effects could be obtained from several 
sources:
    ? Databases available to the public (online or in paper 
versions), such as the National Library of Medicine (NLM) databases 
(Toxline, Medline, Hazardous Substances Data Bank, etc.), National 
Institute for Occupational Safety and Health (NIOSH) Registry of Toxic 
Effects of Chemical Substances (RTECS), EPA's Aquatic Toxicity 
Information Retrieval database (AQUIRE) (Now the Ecotoxicology (ECOTOX) 
database) www.epa.gov/ecotox/.
    ? Reports to EPA or other government agencies.
    ? Unpublished data known to the person or entity subject to 
reporting.
    As regards the issue of what is meant by ``known'' to cause serious 
adverse effects, EPA did not mean that the effects must be conclusively 
shown and did not intend a higher standard of certainty than for the 
``effects'' reporting part of the 1978 Policy Statement. In that 
notice, EPA stated that all that is needed for an effect to be 
``known'' is that the information reasonably supports that the chemical 
can cause the effect(s) of concern. This issue is addressed in the 1978 
Policy Statement in EPA's response to comments that questioned the use 
of ``may suggest'' language regarding information obtained and the 
reporting of substantial risk information (see Supplementary 
Information paragraph (3) of the 1978 Policy Statement).
    In addition, EPA agreed to allow the use of ``benchmark levels'' to 
help determine if the information should be reported. EPA has 
established benchmark levels for various substances. Benchmark levels 
are concentrations that either trigger a regulatory response, or 
concentrations above which a substance is presumed to present a risk to 
health and/or the environment. For instance, the Agency has developed 
Reference Doses (RfD's) for numerous substances under its Integrated 
Risk Information System (IRIS). Reference doses establish a level of 
exposure where no adverse effects would be expected to be manifested. 
Thus, if a person found groundwater contaminated with a chemical at a 
level that did not exceed the RfD for that

[[Page 33133]]

substance, the person could assume that a substantial risk does not 
exist. It should be noted that benchmark levels are often medium-
specific, so their use should be limited accordingly. Examples of 
certain benchmark levels can be found at the following EPA Web sites: 
http://www.epa.gov/iris/ and http://www.epa.gov/ost/drinking/standards/
dwstandards.pdf

    Second, EPA increased the number of types of information that it 
believed need not be reported under TSCA section 8(e). The types of 
information proposed to be exempted included:
    ? Draft and final reports made available to the public by 
other Federal agencies.
    ? Data obtained from scientific journals and databases, 
including, but not limited to, those to which EPA subscribes.
    ? Information obtained from news publications and radio/
television broadcasts.
    ? Information obtained at scientific meetings or conferences 
where EPA is the sponsor, where the information is presented by an EPA 
employee or contractor acting on behalf of EPA, and at other similar 
meetings, provided that such information is cited or abstracted in a 
scientific journal or database within 90 days of a person subject to 
reporting under section 8(e) obtaining such information.
    The rationale for these proposed changes was to relieve persons who 
are potentially subject to reporting under section 8(e) from the burden 
of considering information from secondary sources when the secondary 
source does not provide sufficient information for a person to judge 
whether the information should be reported. For instance, a 
manufacturer of a chemical might obtain a news article about research 
done by another company. A person reading the article would need the 
underlying study to evaluate the true significance of the results of 
the research and, based on that evaluation, make a judgment as to 
whether there is a substantial risk of injury to human health or the 
environment. In such a case, the potential reporting obligation falls 
on the company that generated the research discussed in the news 
article.
    Third, EPA retained the interpretation proposed in the 1993 Federal 
Register notice that section 8(e) notices for information other than 
``emergency incidents of environmental contamination,'' should be 
submitted within 30 calendar days. EPA continues to believe that the 
change from 15 working days to 30 calendar days would significantly 
relieve the burden on persons subject to section 8(e) reporting without 
substantially affecting EPA's ability to appropriately evaluate and 
respond in a timely manner to the reported information.
    Fourth, EPA identified the group of statutes for which exemptions 
would be granted from reporting of non-emergency information under TSCA 
section 8(e), specifying the other statutes administered by EPA and 
those for which implementation was delegated to the States. The maximum 
allowable reporting period, in lieu of reporting under section 8(e), 
under those other authorities was increased from 30 to 90 days from the 
date reportable non-emergency situations of chemical contamination was 
obtained by a person subject to section 8(e), i.e, persons reporting to 
the other authorities within the 90-day time frame would be exempt from 
reporting the information under section 8(e). EPA believed that 
extending the time for reporting non-emergency situations of chemical 
contamination would allow for those instances where assembling several 
types of information in order to determine whether section 8(e) applies 
could take more than 30 days and was consistent with the majority of 
the reporting periods under the other statutes.
    Fifth, if the Federal government or a State requires that 
information be submitted on a site remediation program carried out 
under Federal or State regulations, that information would not have to 
be separately submitted under section 8(e) beyond an initial section 
8(e) notification. The Agency believed that once the chemical 
contamination situation has been identified, such as by a notice under 
section 8(e), and the site is undergoing remediation, little if any 
additional benefit is gained by subsequent section 8(e) reporting 
concerning that chemical contamination situation at the same site.
    Sixth, usually only the person who operates or owns a site at which 
environmental contamination has occurred would have the responsibility 
to report under section 8(e). It is unlikely that a person not 
associated with a site as an owner or operator would have access to a 
sufficiently wide range of information about an environmental 
contamination situation to determine whether data on the contamination 
meet the test for section 8(e) reporting. This is unlike the 
acquisition of effects test data, because data on effects are not site-
specific and have general applicability for production and use of the 
chemical of interest in the United States. Similarly, persons subject 
to section 8(e) would not have to report information obtained about a 
site outside the United States unless there is potential for 
contamination from that site to enter the United States.
    Seventh, because of the number of changes made to the proposed 
guidance in the 1995 Federal Register notice and the fact that it 
represented a significant change from the original guidance suspended 
on June 20, 1991, the Agency concluded that the revised guidance when 
issued should be applied prospectively. This eliminates the need for 
companies to review files currently in their possession for information 
that may be subject to section 8(e) reporting in accordance with the 
revised guidance. However, data in such files could be subject to 
section 8(e) reporting if data obtained by a company after issuance of 
the revised guidance triggered a review of such preexisting data and in 
doing so the combination of preexisting and new data met the section 
8(e) reporting criteria.
    Eighth, the Agency stated that it would develop, in cooperation 
with interested parties, a ``question and answer'' (Q. and A.) document 
that would provide further detail and ``real world'' examples to 
further assist persons in fulfilling their section 8(e) reporting 
responsibilities as regards the revised guidance. The Agency stated 
that it intends to work with interested parties to prepare such a Q. 
and A. document, which EPA expects to have available several months 
from the issuance of the final reporting guidance. At that time, the 
Agency intends to post the Q. and A. document on the TSCA section 8(e) 
homepage (http://www.epa.gov/oppt/tsca8e). A copy may also be obtained 
from the contacts listed under FOR FURTHER INFORMATION CONTACT. As 
additional examples, or questions and answers are identified as being 
of potential value to share broadly, the Agency will refine this Q. and 
A. document.
    Finally, some commenters requested an additional opportunity to 
review the revised draft guidance developed in response to the 
extensive comments of the proposed revisions in the July 13, 1993 
Federal Register notice. On March 20, 1995 (58 FR 37735), the Agency 
published a notice of availability in the Federal Register of the 
revised draft guidance and allowed 45 days for comment. The 1995 draft 
guidance substantially responded to the comments received on the 1993 
proposed revisions.
    3. Comments on the 1995 proposed changes and EPA's response. In 
response to the Agency's request for comment on the revised draft 
guidance published in 1995, EPA received

[[Page 33134]]

comments from 22 companies and trade associations. The commenters 
generally agreed that the changes made by EPA addressed most of their 
major comments on the 1993 proposed guidance, and that the 1995 revised 
guidance was a significant improvement. For example, the Monsanto 
Company stated: ``The reproposed guidance, as summarized in the draft 
policy text for public comment dated March 9, 1995, is a significant 
improvement over the guidance published July 13, 1993. The reproposed 
guidance significantly minimizes the duplicative over-reporting burden 
that characterized the earlier guidance document. We support the 
reproposed guidance document and believe it is generally consistent 
with the Congressional intent of the original drafters of TSCA, as well 
as current Agency and Congressional efforts to reform government 
reporting requirements to minimize duplicative and unneeded over-
reporting. The reproposed guidance document on environmental release/
contamination is a significant move in the direction of clarifying the 
Agency's need for information that reasonably supports a conclusion of 
substantial risk.'' (Ref. 1).
    In addition to their statements of support for the proposed 
changes, the commenters requested a number of clarifications/
definitions of terms, editorial rewordings, and other less substantive 
changes that are addressed in a ``response-to-comments'' document that 
can be found in the docket as described in Unit I.B.1. Commenters 
expressed strong support for making the new guidance prospective, 
ending the CAP at phase 1, and developing a Q. and A. document. As 
previously discussed, EPA is in agreement with those comments.
    One major area where industry commenters requested further changes 
was the exemption from reporting under section 8(e) for data submitted 
to EPA or other agencies under other authorities. The commenters were 
concerned about the extent to which exemptions from reporting under 
section 8(e) would be granted for reporting under authorities other 
than EPA statutes administered either by the Agency or, where 
implementation of an EPA statute has been delegated to the States. EPA 
had proposed to reduce the potential for duplicative submission under 
TSCA section 8(e) authorities by allowing an exemption to reporting 
under section 8(e) for all information which is required to be reported 
under other EPA statutes including where implementation had been 
delegated to the States, and where such reporting was required to be 
submitted within 90 days of being obtained. Industry commenters also 
questioned the length of the time period for reporting proposed by EPA. 
Industry commenters requested that the exemption be expanded to: (1) 
Include any mandatory reporting requirement whether Federal, State, or 
local, and (2) allow reporting within the time frame provided by the 
individual reporting authorities.
    Regarding expanding the section 8(e) policy statement list of 
reporting authorities that would fall under a reporting exemption in 
Part VII. of the policy statement, the July 1993 and March 1995 
proposals included an exemption to reporting only if the information 
was to be submitted under EPA statutes, including statutes such as the 
Clean Air Act, where implementation has been delegated in large part to 
the States. Delegation of implementation allowed a clear ``nexus'' to 
be shown between a State reporting requirement and EPA, thus following 
the statutory language of section 8(e) which does not require reporting 
if a company has ``actual knowledge that the Administrator has been 
adequately informed of such information.'' The commenters would have 
EPA expand the reporting exemption by including any Federal, State, or 
local reporting requirements.
    The issue of expanding the reporting authorities is problematic 
because of the statutory language in section 8(e). However, it is also 
relevant to look to the purpose of TSCA, and section 8(e) in 
particular, in light of the legislative history concerning how TSCA 
should be implemented. TSCA was designed to fill a number of regulatory 
gaps. Those included review of ``new'' chemicals, collection of test 
data on new and existing chemicals, and regulation of chemicals to 
address risks associated with chemicals' production, use, or disposal. 
Specifically, regarding the submission of test data, Congress wanted to 
avoid the potential for industry to withhold ``information which would 
have revealed hazards associated with these chemicals at a much earlier 
date'' (Ref. 2). Thus, the reporting requirement of section 8(e) of 
TSCA was established so that the Agency would be ``adequately 
informed'' to enable it to take corrective action if necessary. While 
Congress envisioned TSCA as filling a major gap in the regulatory 
framework protecting human health and the environment, it also directed 
the Administrator to avoid duplicating existing (and future) regulatory 
and enforcement authorities.
    Given the statutory language of section 8(e), it is hard to make a 
case that the Administrator is adequately informed of reporting under 
State or local authorities, other than those reporting requirements 
that originate in laws administrated by EPA in which the United States 
Congress has provided for delegation to the States, and such delegation 
has occurred. Except where such delegation of EPA authority has 
occurred, the Agency believes reporting to a state government may not 
result in EPA getting important information in a timely manner and, 
therefore, EPA does not believe it is appropriate to exempt from 
section 8(e), information that is reported to state governments.
    However, at least some information reported under other Federal 
authorities could be viewed differently. While there is not a direct 
statutory ``nexus,'' often there is a considerable amount of 
interagency cooperation in dealing with environmental contamination 
situations, e.g., the National Response Center. To the extent EPA 
Headquarters and the Regions become involved in joint cleanups, 
assessments, etc., or act in advisory roles with other Federal 
agencies, the Administrator could reasonably be considered to be 
adequately informed. The Agency believes that information reported 
under other Federal authorities for site-specific contamination within 
90 calendar days or immediately pursuant to a mandatory reporting 
requirement qualifies for exemption from section 8(e) reporting.
    While this approach reduces the role of section 8(e) in the 
reporting of site-specific release/contamination information, Congress' 
goal in passing TSCA to ensure that important health and environmental 
related information are reported in a timely fashion will still be met. 
Further, since there is now a considerable array of Federal health and 
environmental reporting requirements, including section 8(e), which 
provide such information and for which there is enhanced public access, 
Congress's goal is not considered to be compromised by some of the 
expanded exemptions.
    However, product contamination information that could be required 
to be submitted to the Consumer Product Safety Commission (CPSC) under 
their regulations is not analogous. CPSC has a more narrow purview 
(i.e., consumer product safety) and could not adequately assess or 
address chemical contamination from a product that may also have 
industrial/commercial applications or may present potential 
environmental risks during its manufacture and processing. In such 
instances, reporting to EPA, as well as CPSC would allow EPA, 
consistent with the intent of TSCA, to address all the potential risks 
presented, where appropriate. Consequently, EPA has

[[Page 33135]]

concluded that section 8(e) reporting will continue to be required for 
chemical product contamination, because EPA, uniquely among Federal 
agencies, has the authority to address all potential health and 
environmental risk aspects of a chemical's life cycle.
    Regarding the issue of expanding the reporting exemption in Part 
VII. of the section 8 policy statement to allow reporting within the 
time frame provided by the individual reporting authorities, as 
originally proposed in 1993, companies would not be required to report 
information under section 8(e) if the information was required to be 
submitted under other EPA or EPA-delegated authorities, so long as the 
other statute required reporting within 30 days from the day a person 
who was required to report obtained information required to be 
submitted. Commenters noted that only a few of the regulations required 
reporting within 30 days, so the exemption would be of limited value 
given that companies would still be required to report the information 
under section 8(e) as well as under the other regulations. To address 
this concern, the reporting policy is being changed. Companies would be 
exempt from reporting information under section 8(e) as long as the 
company complies with the relevant reporting requirement of another 
statute, as described in Part VII. of the TSCA section 8(e) policy and 
guidance, that requires reporting within 90 days from the day a person 
obtained information required to be submitted. This change was based on 
information submitted by industry showing that roughly 70 percent of 
the reporting requirements have reporting periods of 90 days or less 
(see Ref. 3 at page 29, Table 1). Further, an examination of the cited 
reporting requirements shows that the 90-day period will capture 
reports that otherwise would be required under section 8(e), namely 
newly found environmental contamination from spills, leaking tanks, and 
other types of releases. By and large, the types of reporting for which 
the statutory time limits for filing of mandatory reports are longer 
than 90 days include periodic summary reports, minor operating changes 
allowed by permits, etc.
    It appears that most or all of the exposure-related or site-
specific release/detection information that might be considered 
reportable under section 8(e) would be required to be reported under 
other authorities within 90 days of such information being obtained. 
Therefore, there would be a negligible reduction of the reporting 
burden if authorities whose reporting time limits exceed 90 days were 
also exempted from reporting under section 8(e). Also, such a change 
seems inconsistent with the statutory language that substantial risk 
information be ``immediately'' reported. Given that a 90-day limit 
appears to resolve most of the problem with potentially duplicative 
reporting, and that longer limits may not be consistent with the 
statutory directive for ``immediate reporting,'' EPA has decided to 
keep the reporting time limit at 90 days as proposed in the 1995 draft 
guidance.
    Additionally, as proposed in the 1993 and reproposed 1995 draft 
guidance, EPA is adopting the interpretation that section 8(e) notices 
for information other than ``emergency incidents of environmental 
contamination'' should be submitted within 30 calendar days. Thus the 
Agency is changing in this guidance document its interpretation of the 
term ``immediately'' in this context. EPA believes the term should be 
interpreted more flexibly based upon the Agency's experience of 
processing and use of data reported under section 8(e) and comments 
received from interested parties. EPA has concluded that, with the 
exception of reporting related to emergency incidents of environmental 
contamination, section 8(e) reports should be submitted to EPA within 
30 calendar days of obtaining the reportable information, instead of 
the 15 working days that was articulated in previous guidance. The 
Agency believes that application of this interpretation for the 
statutory term ``immediately'' will not adversely impact section 8(e)'s 
purpose of assuring that the Agency becomes aware of important risk-
related information in a timely manner. In addition, providing 30 
calendar days for reporting to the Agency is consistent with the 
regulations under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., which provides that agencies should not require a written 
response in fewer than 30 days after receipt without demonstrating that 
it is necessary to satisfy a statutory requirement or other substantial 
need (5 CFR 1320.5(d)(2)(ii)). Although TSCA section 8(e) clearly 
provides the necessary statutory justification to require a shorter 
response time, the Agency is using the minimum time frame established 
under the PRA to respond to the commenters who indicated the need for 
additional time to process a submission.

C. EPA's reinstatement of Part V.(c)

    ``Emergency incidents of environmental contamination.'' Part V.(c) 
of the 1978 Policy Statement, which addresses what constitutes a 
``substantial risk'' in the context of emergency incidents of 
environmental contamination, was suspended on June 20, 1991 (56 FR 
28458). EPA has decided, for the following reasons, to reinstate Part 
V.(c):
    ? EPA is making a number of changes to the reporting guidance 
that would affect emergency incident reporting. Changes include 
reporting to the National Response Center, elimination of follow-up 
written section 8(e) reports, and expansion of the list of authorities 
persons could report under in lieu of section 8(e).
    ? Part V.(c) includes the basic elements of the new Part 
V.(b)(1) guidance: The adverse effect(s) in question have been ascribed 
to the chemical; human or environmental exposure may occur; exposure 
(in this case, an emergency release) threatens humans and/or non-human 
organisms with serious adverse effects.
    ? EPA believes such reporting under section 8(e) is still 
necessary. Although many release incidents are covered under other 
statutes, there may be instances where chemicals that have not yet been 
reviewed for release reporting under other EPA programs have the 
requisite hazard characteristics to require a response/notification if 
there is a release to the environment. In this regard, EPA agrees with 
a comment from the Chemical Manufacturers Association (CMA--CMA is now 
the American Chemistry Council) indicating that, if EPA retains the 
distinction between emergency and non-emergency situations of 
environmental contamination, ``emergency'' should be defined. CMA 
stated: ``CMA believes an `emergency' should be defined as a situation 
in which a significant threat to human health or the environment is 
imminent or already present, and where immediate action is necessary to 
abate the hazard. Such an approach would be consistent with the 
Agency's previous description of non-emergency situations of 
environmental contamination as situations which do not require 
immediate action, but nevertheless reasonably support the conclusion of 
`substantial risk.''' (Ref. 4). EPA believes that revised Part 
V.(b)(1), the reinstated Part V.(c), and the reporting procedures 
adequately make the distinction described by CMA in that a 
``substantial risk'' in this context is an ``emergency incident of 
environmental contamination'' that ``seriously threatens'' humans or 
the environment.

IV. Claims of Confidentiality for Data Submitted under TSCA Section 
8(e)

    In general, health and safety information submitted to EPA--even as 
confidential--may be released to the

[[Page 33136]]

public, except as noted below. EPA considers information contained in a 
notice of substantial risk under TSCA section 8(e) to be health and 
safety information and, therefore, covered by the term ``health and 
safety study,'' as defined in section 3(6) of TSCA. TSCA section 3(6) 
defines a ``health and safety study'' as ``any study of any effect of a 
chemical substance or mixture on health or the environment or on both, 
including the underlying data and epidemiological studies, studies of 
occupational exposure to a chemical substance or mixture, 
toxicological, clinical, and ecological studies of a chemical substance 
or mixture, and any test performed pursuant to this Act.''
    Under TSCA section 14(b), health and safety information may be 
disclosed to the public (i.e., may not be protected as confidential). 
However, the section does not authorize public release of information 
concerning the manufacturing process of a chemical substance or mixture 
which is the subject of submitted health and safety information, 
including data ``disclosing the portion of the mixture comprised by any 
of the chemical substances in the mixture.''
    In the legislative history of TSCA, the Conference Committee stated 
that ``[i]t is intended that the term (health and safety studies) be 
interpreted broadly. Not only is information which arises as a result 
of a formal, disciplined study included, but other information relating 
to the effects of a chemical substance or mixture on health and the 
environment is also included. Any data that bears on the effects of a 
chemical substance on health or the environment would be included.'' 
(Ref. 5). EPA believes that TSCA section 8(e) information, such as 
information or underlying data from studies carried out to investigate 
the effects of a chemical (or a mixture of chemicals) on health or the 
environment, or reports concerning the effects of unintentional or 
accidental releases or exposures, is information that ``bears on the 
effects of a chemical substance on health or the environment.''
    Therefore, incident information, exposure studies, and their 
underlying data should be considered covered under the term ``health 
and safety study.'' To the extent that information contained in a 
section 8(e) substantial risk report falls within the meaning of the 
term ``health and safety study'' under TSCA, it will not be afforded 
TSCA ``Confidential Business Information'' (CBI) protection except as 
noted in the following paragraph.
    EPA considers chemical identity to be part of, the underlying data 
to, a health and safety study. See, for example, 40 CFR 716.3 and 40 
CFR 720.3(k). Consequently, the confidential identity of a chemical 
substance will not be protected by EPA unless otherwise provided for 
under section 14 of TSCA and the interpreting regulations in 40 CFR 
part 2.
    EPA urges persons submitting data under TSCA section 8(e) to 
observe the limitations imposed on CBI claims by section 14 and the 
applicable regulations at 40 CFR part 2, subpart B, in order to save 
both Agency and submitter resources.

V. References

    The following is a listing of the documents that are specifically 
cited in this guidance document, and which are available as part of the 
public docket described in Unit I.B.1.:
    1. Monsanto Company. Letter from J. Ronald Condray. Comment 
#12. May 3, 1995.
    2. United States Congress. (1976) Report of the Senate Committee on 
Commerce on S. 3149, No. 94-698: 8.
    3. Chemical Manufacturers Association (CMA). Comments of the 
Chemical Manufacturers Association on TSCA Section 8(e) Notice of 
Clarification. October 28, 1993.
    4. Chemical Manufacturers Association (CMA). Comments of the 
Chemical Manufacturers Association on TSCA Section 8(e) draft policy 
statement. Comment #6, p. 24. May 4, 1995.
    5. United States Congress. (1976) House of Representatives, 94th 
Congress, 2d Session. H.R. Report 94-1679 (Conference Report and 
Debates): 58.

VI. Statutory and Executive Order Reviews

    As discussed in Unit II.B., the guidance document articulates EPA's 
preferences for how and where TSCA section 8(e) notices should be 
submitted. The guidance document is not a regulation, and submitters of 
TSCA section 8(e) notices are not obligated to comply with the 
preferences. Since this document is not a regulation and does not 
impose any new binding requirements it is not subject to review by the 
Office of Management and Budget (OMB) under Executive Order 12866, 
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997), or Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001). For the same reason, the requirements 
of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not 
apply.
    Pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., an agency may not conduct or sponsor, and a person is not 
required to respond to, an information collection request as defined by 
the PRA, unless it displays a currently valid OMB control number. The 
OMB control numbers for EPA's regulations, after appearing in the 
Federal Register, are listed in 40 CFR part 9 and 48 CFR chapter 15, 
and included on the related collection instrument or form, if 
applicable.
    This document does not contain any new information collection 
requirements that would require additional OMB review and approval 
under the PRA. The information collection activities related to the 
submission of information pursuant to TSCA section 8(e) have been 
approved by OMB under OMB control number 2070-0046 (EPA ICR No. 0794). 
The annual respondent burden for this information collection activity 
is estimated to average 27 hours per initial section 8(e) submission 
and 5 hours per follow-up/supplemental section 8(e) submission, which 
includes the average time for processing, compiling and reviewing the 
requested data, generating the request, follow-up correspondence with 
EPA, storing, filing, and maintaining the data.
    As defined by the PRA and 5 CFR 1320.3(b), ``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.
    This document will have a negligible impact on States, local or 
Tribal governments because they do not generally engage in activities 
that would subject them to reporting requirements under TSCA section 
8(e). Further this guidance document imposes no requirements on any 
entities, and instead is announcing Agency policies

[[Page 33137]]

and interpretations that generally will ease the reporting burdens 
under section 8(e). This action will not have substantial direct 
effects on State or tribal governments, on the relationship between the 
Federal government and States or Indian tribes, or on the distribution 
of power and responsibilities between the Federal government and States 
or Indian tribes. As a result, no action is required under Executive 
Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), or 
under Executive Order 13175, entitled Consultation and Coordination 
with Indian Tribal Governments (59 FR 22951, November 6, 2000). Nor 
does it impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4).
    This action requires no special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or Executive Order 12630, entitled Governmental 
Actions and Interference with Constitutionally Protected Property 
Rights (53 FR 8859, March 15, 1988).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Specific Revisions to the Policy Statement

    For the reasons discussed in Unit III., EPA is making the following 
specific changes to the 1978 Policy Statement:
    1. Part II. Persons Subject to the Requirement is amended by 
revising the note at the end of Part II.
    2. Part IV. Requirement That a Person ``Immediately Inform'' the 
Administrator, Part VII. Information Which Need Not Be Reported, and 
Part IX. Reporting Requirements are revised.
    3. Part V. What Constitutes Substantial Risk is amended by revising 
the heading of paragraph (b) and paragraph (b)(1) and adding the 
paragraph heading ``Environmental effects.'' to the beginning of 
paragraphs (b)(2) through (b)(5).

VIII. Republication of TSCA Section 8(e) Policy Statement and Guidance

    As discussed previously, the following is a republication of the 
entire TSCA section 8(e) Policy Statement and Guidance, as amended:
I. Definitions
    The definitions set forth in TSCA section 3 apply to this policy 
statement. In addition, the following definitions are provided for 
purposes of this policy statement:
    The term manufacture or process for commercial purposes means to 
manufacture or process: (1) For distribution in commerce, including for 
test marketing purposes, (2) for use as a catalyst or an intermediate, 
(3) for the exclusive use by the manufacturer or processor, or (4) for 
product research and development.
    The term person includes any natural person, corporation, firm, 
company, joint-venture, partnership, sole proprietorship, association, 
or any other business entity, any State or political subdivision 
thereof, any municipality, any interstate body and any department, 
agency, or instrumentality of the Federal Government.
    The term substantial-risk information means information which 
reasonably supports the conclusion that a chemical substance or mixture 
presents a substantial risk of injury to health or the environment.
II. Persons Subject to the Requirement
    Persons subject to section 8(e) requirements include both natural 
persons and business entities engaged in manufacturing, processing, or 
distributing in commerce a chemical substance or mixture. In the case 
of business entities, the president, chief executive officer, and any 
other officers responsible and having authority for the organization's 
execution of its section 8(e) obligations should ensure that the 
organization reports substantial risk information to EPA. The business 
organization is considered to have obtained any information which any 
officer or employee capable of appreciating the significance of that 
information has obtained. It is therefore incumbent upon business 
organizations to establish procedures for expeditiously processing 
pertinent information consistent with the schedule set forth in Part 
IV.
    Those officers and employees of business organizations who are 
capable of appreciating the significance of pertinent information are 
also subject to these reporting requirements. An employing organization 
may relieve its individual officers and employees of any responsibility 
for reporting substantial-risk information directly to EPA by 
establishing, internally publicizing, and affirmatively implementing 
procedures for employee submission and corporate processing of 
pertinent information. These procedures, at a minimum, should: (1) 
Specify the information that officers and employees must submit; (2) 
indicate how such submissions are to be prepared and the company 
official to whom they are to be submitted; (3) note the Federal 
penalties for failing to report; and (4) provide a mechanism for 
promptly advising officers and employees in writing of the company's 
disposition of the report, including whether or not the report was 
submitted to EPA (and if not reported, informing employees of their 
right to report to EPA, as protected by TSCA section 23). An employee 
of any company that has established and publicized such procedures, who 
has internally submitted pertinent information in accordance with them, 
shall have discharged his section 8(e) obligation. Establishment of 
such procedures notwithstanding, all officials responsible and having 
authority for the organization's execution of its section 8(e) 
obligations retain personal liability for ensuring that the appropriate 
substantial-risk information is reported to EPA.
    Business organizations that do not establish such procedures cannot 
relieve their individual officers and employees of the responsibility 
for ensuring that substantial-risk information they obtain is reported 
to EPA. While officers and employees of such organizations may also 
elect to submit substantial-risk information to their superiors, for 
corporate processing and reporting, rather than to EPA directly, they 
have not discharged their individual section 8(e) obligation until EPA 
has received the information.
    Note: Irrespective of a business organization's decision to 
establish and publicize procedures described above, the business 
organization is responsible for becoming cognizant of any 
``substantial risk'' information obtained by its officers, 
employees, and agents, and for ensuring that such information is 
properly reported to EPA.

III. When a Person Will Be Regarded as Having Obtained Information
    A person obtains substantial-risk information at the time he first 
comes into possession of or knows of such information.
    Note: This includes information of which a prudent person 
similarly situated could reasonably be expected to possess or have 
knowledge. An establishment obtains information at the time any 
officer or employee capable of appreciating the significance of such 
information obtains it.


[[Page 33138]]


IV. Requirement That a Person ``Immediately Inform'' the Administrator
    With the exception of certain information on emergency incidents of 
environmental contamination (see Part V.(c)) and information submitted 
under Part VII. (c), (d) and (e), a person has ``immediately informed'' 
the Administrator if information is received by EPA not later than the 
30th calendar day after the date the subject person obtained such 
information. Supplementary information generated after a section 8(e) 
notification should, if appropriate, be immediately reported (within 30 
calendar days of a person obtaining the information). This also applies 
to submitter responses to EPA requests for additional information 
related to submitted section 8(e) data. Section 8(e) reporting must be 
submitted to EPA and should be made as described under Part IX. For 
emergency incidents of environmental contamination, a person should 
report by telephone to the appropriate contact as directed in Part IX. 
as soon as the person has knowledge of the incident. The emergency 
incident report should contain as much of the information specified in 
Part IX. as is possible. A follow-up written report is not required.
    Note: Preexisting information (i.e., of the kind described under 
Part V. (b)(1) and (c)) that predates June 3, 2003, is not subject 
to section 8(e) reporting unless its review is triggered by a person 
obtaining new information and that in combination with the 
preexisting information meets the criteria for section 8(e) 
reporting.

V. What Constitutes Substantial Risks
    A ``substantial risk of injury to health or the environment'' is a 
risk of considerable concern because of (a) the seriousness of the 
effect (see subparts (a), (b), and (c) of this part for an illustrative 
list of effects of concern), and (b) the fact or probability of its 
occurrence. (Economic or social benefits of use, or costs of 
restricting use, are not to be considered in determining whether a risk 
is ``substantial.'') These two criteria are differentially weighted for 
different types of effects. The human health effects listed in subpart 
(a) of this part, for example, are so serious that relatively little 
weight is given to exposure: The mere fact the implicated chemical is 
in commerce constitutes sufficient evidence of exposure. In contrast, 
the remaining effects listed in subparts (b) and (c) of this part must 
involve, or be accompanied by the potential for, significant levels of 
exposure (because of general production levels, persistence, typical 
uses, common means of disposal, or other pertinent factors).
    Note that information on the effects outlined below should not be 
reported: (i) If the respondent has actual knowledge that the 
Administrator is already informed of them, or (ii) information 
respecting these effects can be obtained either directly by observation 
of their occurrence, or inferred from designed studies as discussed in 
Part VI.
    The Agency considers effects for which substantial-risk information 
should be reported to include the following.
    (a) Human health effects. (1) Any instance of cancer, birth 
defects, mutagenicity, death, or serious or prolonged incapacitation, 
including the loss of or inability to use a normal bodily function with 
a consequent relatively serious impairment of normal activities, if one 
(or a few) chemical(s) is strongly implicated.
    (2) Any pattern of effects or evidence which reasonably supports 
the conclusion that the chemical substance or mixture can produce 
cancer, mutation, birth defects or toxic effects resulting in death, or 
serious or prolonged incapacitation.
    (b) Non-emergency situations involving environmental contamination; 
environmental effects--(1) Non-emergency situations of chemical 
contamination involving humans and/or the environment. Information that 
pertains to widespread and previously unsuspected distribution in 
environmental media of a chemical substance or mixture known to cause 
serious adverse effects, when coupled with information that widespread 
or significant exposure to humans or non-human organisms has occurred 
or that there is a substantial likelihood that such exposure will 
occur, is subject to reporting. The mere presence of a chemical in an 
environmental media, absent the additional information noted above, 
would not trigger reporting under section 8(e). Information concerning 
the detection of chemical substances contained within appropriate 
disposal facilities such as treatment, storage and disposal facilities 
permitted under RCRA should not be reported under this part.
    Note: From time to time EPA establishes concentrations of 
various substances in different media that trigger a regulatory 
response or establish levels that are presumed to present no risk to 
human health or the environment. For example, EPA establishes 
Maximum Contaminant Levels (MCLs) in drinking water, Ambient Water 
Quality Criteria for receiving bodies of water, and Reference Doses 
(RfDs) or Concentrations (RfCs). For the purposes of section 8(e), 
information about contamination found at or below these kinds of 
benchmarks would not be reportable. Conversely, information about 
contamination found at or above benchmarks that trigger regulatory 
requirements, such as Resource Conservation and Recovery Act (RCRA) 
Toxicity Characteristic Limits, is to be considered for possible 
reporting, based on potential exposure to humans and/or non-human 
organisms and other relevant factors.

    (2) Environmental effects. Measurements and indicators of 
pronounced bioaccumulation heretofore unknown to the Administrator 
(including bioaccumulation in fish beyond 5,000 times water 
concentration in a 30-day exposure or having an n-octanol/water 
partition coefficient greater than 25,000) should be reported when 
coupled with potential for widespread exposure and any non-trivial 
adverse effect.
    (3) Environmental effects. Any non-trivial adverse effect, 
heretofore unknown to the Administrator, associated with a chemical 
known to have bioaccumulated to a pronounced degree or to be widespread 
in environmental media, should be reported.
    (4) Environmental effects. Ecologically significant changes in 
species' interrelationships; that is, changes in population behavior, 
growth, survival, etc. that in turn affect other species' behavior, 
growth, or survival, should be reported.
    Examples include: (i) Excessive stimulation of primary producers 
(algae, macrophytes) in aquatic ecosystems, e.g., resulting in nutrient 
enrichment, or eutrophication, of aquatic ecosystems.
    (ii) Interference with critical biogeochemical cycles, such as the 
nitrogen cycle.
    (5) Environmental effects. Facile transformation or degradation to 
a chemical having an unacceptable risk as defined above should be 
reported.
    (c) Emergency incidents of environmental contamination. Any 
environmental contamination by a chemical substance or mixture to which 
any of the above adverse effects has been ascribed and which because of 
the pattern, extent, and amount of contamination (1) seriously 
threatens humans with cancer, birth defects, mutation, death or serious 
or prolonged incapacitation, or (2) seriously threatens non-human 
organisms with large-scale or ecologically significant population 
destruction, should be reported.
VI. Nature and Sources of Information Which ``Reasonably Supports the 
Conclusion'' of Substantial Risk
    Information attributing any of the effects described in Part V. of 
this policy statement to a chemical substance or

[[Page 33139]]

mixture should be reported if it is one of the types listed below and 
if it is not exempt from the reporting requirement by reason of Part 
VII. of this policy statement. A person should not delay reporting 
until he obtains conclusive information that a substantial-risk exists, 
but should immediately report any evidence which ``reasonably 
supports'' that conclusion. Such evidence will generally not be 
conclusive as to the substantiality of the risk; it should, however, 
reliably ascribe the effect to the chemical.
    Information from the following sources concerning the effects 
described in Part V. will often ``reasonably support'' a conclusion of 
substantial risk. Consideration of corroborative information before 
reporting can only occur where it is indicated below.
    (1) Designed controlled studies. In assessing the quality of 
information, the respondent should consider whether it contains 
reliable evidence ascribing the effect to the chemical. Not only should 
final results from such studies be reported, but also preliminary 
results from incomplete studies where appropriate. Designed, controlled 
studies include:
    (i) In vivo experiments and tests.
    (ii) In vitro experiments and tests. Consideration may be given to 
the existence of corroborative information, if necessary to reasonably 
support the conclusion that a chemical presents a substantial risk.
    (iii) Epidemiological studies.
    (iv) Environmental monitoring studies.
    (2) Reports concerning and studies of undesigned, uncontrolled 
circumstances. It is anticipated here that reportable effects will 
generally occur in a pattern, where a significant common feature is 
exposure to the chemical. However, a single instance of cancer, birth 
defects, mutation, death, or serious incapacitation in a human would be 
reportable if one (or a few) chemicals) was strongly implicated. In 
addition, it is possible that effects less serious than those described 
in Part V.(a) may be preliminary manifestations of the more serious 
effects and, together with another triggering piece of information, 
constitute reportable information; an example would be a group of 
exposed workers experiencing dizziness together with preliminary 
experimental results demonstrating neurological dysfunctions. Reports 
and studies of undesigned circumstances include:
    (i) Medical and health surveys.
    (ii) Clinical studies.
    (iii) Reports concerning and evidence of effects in consumers, 
workers, or the environment.
VII. Information Which Need Not Be Reported
    ``Substantial risk'' information need not be reported under section 
8(e) if it:
    (a) Is obtained in its entirety from one of the following sources:
    (1) An EPA study or report.
    (2) An official publication or official report (draft or final) 
published or made available to the general public by another Federal 
agency and any information developed by another Federal Agency as a 
result of a toxicological testing/study program, or site evaluation for 
chemical contamination, in which EPA is collaborating in the design, 
review, or evaluation of testing/sampling plans or resultant data.
    (3) Scientific publications, including bibliographic databases, 
available electronically or in hard copy (e.g., Science, Nature, New 
England Journal of Medicine, Medline, Toxline, NIOSH RTECS, 
International Uniform Chemical Information Database (IUCLID), etc.).
    (4) Scientific databases (e.g., Agricola, Biological Abstracts, 
Chemical Abstracts, Dissertation Abstracts, Index Medicus, etc).
    (5) A news publication (i.e., newspaper, news magazine, trade 
press) with circulation in the United States.
    (6) A radio or television news report broadcast in the United 
States.
    (7) A public scientific conference or meeting held within the 
United States, provided that the information is captured accurately by 
way of a meeting transcript, abstract, or other such record, and has 
been cited in a bibliographic/abstract computerized data base, 
publication, or report of the type cited in paragraphs (a) (1), (2), 
(3), or (4) of this part within 90 days of a subject person obtaining 
such information.
    (8) A public scientific conference sponsored or co-sponsored by EPA 
or at a conference where the subject information is presented by an EPA 
employee or contractor acting on behalf of EPA.
    (b) Corroborates (i.e., substantially duplicates or confirms) in 
terms of, for example, route of exposure, dose, species, strain, sex, 
time to onset of effect, nature and severity of effect, a well-
recognized/well-established serious adverse effect for the chemical(s) 
under consideration, unless such information concerns effects observed 
in association with emergency incidents of environmental contamination 
as described in Part V.(c) and thus should be considered for reporting 
under section 8(e).
    (c) Is information that will be reported to EPA within 90 calendar 
days of obtaining the information for non-emergency information under 
Part V.(b)(1), immediately (i.e., as soon as the subject person has 
knowledge of the incident) for emergency information under Part V.(c), 
or within 30 calendar days of obtaining the information for the other 
types of information specified under Part V., pursuant to a mandatory 
reporting requirement of any statutory authority that is administered 
by EPA (including, but not limited to, the Toxic Substances Control 
Act; the Federal Water Pollution Control Act; the Clean Air Act; the 
Federal Insecticide, Fungicide, and Rodenticide Act; the Safe Drinking 
Water Act; the Marine Protection, Research, and Sanctuaries Act; the 
Comprehensive Environmental Response, Compensation, and Liability Act; 
the Resource Conservation and Recovery Act, the Pollution Prevention 
Act; the Emergency Planning and Community Right-to-Know Act).
    (d) Is information that will be reported to a State within 90 
calendar days of obtaining the information for non-emergency 
information under Part V.(b)(1), immediately (i.e., as soon as the 
subject person has knowledge of the incident) for emergency information 
under Part V.(c), or within 30 calendar days of obtaining the 
information for the other types of information specified under Part V., 
pursuant to a mandatory reporting requirement under any Federal statute 
administered by EPA for which implementation has been delegated to that 
State (e.g., National Pollutant Discharge Elimination System (NPDES) 
permit requirements), or pursuant to a mandatory reporting provision of 
an EPA-authorized State program established under a Federal statute 
administered by EPA, e.g., state RCRA programs.
    (e) Is information that will be reported to the Federal government 
within 90 calendar days of obtaining the information for non-emergency 
site-specific contamination information under Part V.(b)(1) or 
immediately (i.e., as soon as the subject person has knowledge of the 
incident) for emergency information under Part V.(c), pursuant to a 
mandatory reporting requirement under any Federal statute.
    (f) Is information of the kind under Part V. (b)(1) and (c) 
submitted to the Federal government or a state that is developed in 
connection with an authorized (by the relevant Federal or state 
authority) site remediation program.
    (g) Is information of the kind under Part V. (b)(1) and (c) 
concerning a site under the control of another person who is subject to 
the section 8(e) reporting authority.

[[Page 33140]]

    (h) Is information of the kind under Part V.(b)(1) and (c) 
concerning a non-United States site provided the person who obtains the 
information does not have reason to believe that there is a substantial 
likelihood that the contamination will cause environmental 
contamination, of a nature that would be reportable under Part V. 
(b)(1) and (c), to occur in an area in the United States.
VIII. Information First Received By a Person Prior to the Effective 
Date of TSCA
    Any substantial risk information possessed by a person prior to 
January 1,1977, of which he is aware after that date should be reported 
within 60 days of publication of this policy statement. The Agency 
considers that a person is aware of:
    (a) Any information reviewed after January 1, 1971, including not 
only written reports, memoranda and other documents examined after 
January 1, 1971, but also information referred to in discussions and 
conferences in which the person participated after January 7, 1977;
    (b) Any information the contents of which a person has been alerted 
to by date received after January 1, 1977, including any information 
concerning a chemical for which the person is presently assessing 
health and environmental effects;
    (c) Any other information of which the person has actual knowledge.
IX. Reporting Requirements
    Notices should be delivered to the Document Processing Center 
(7407M), (Attn: TSCA Section 8(e) Coordinator), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Avenue, NW., Washington, DC 20460-0001
    A notice should:
    (a) Be sent by certified mail, or in any other way permitting 
verification of its receipt by the Agency.
    (b) State that it is being submitted in accordance with section 
8(e).
    (c) Contain the job title, name, address, telephone number, and 
signature of the person reporting and the name and address of the 
manufacturing, processing, or distribution establishment with which the 
person is associated.
    (d) Identify the chemical substance or mixture (including, if 
known, the Chemical Abstract Service (CAS) Registry Number).
    (e) Summarize the adverse effect(s) or risk(s) being reported, 
describing the nature and the extent of the effect(s) or risk(s) 
involved.
    (f) Contain the specific source of the information together with a 
summary and the source of any available supporting technical data.
    For emergency incidents of environmental contamination (see Part 
V.(c)), a person should report the incident to the Administrator or the 
National Response Center by telephone as soon as he/she has knowledge 
of the incident. The report should contain as much of the information 
specified by paragraphs (c) through (f) of this part as possible. If 
any new substantial risk information concerning the incident and 
reportable under TSCA section 8(e) is obtained, supplementary reporting 
by the person is required. A twenty-four hour emergency telephone 
number is:
    The National Response Center, (800) 424-8802 or (202) 267-2675 in 
the Washington, DC metropolitan area.
    Region I (Maine, Rhode Island, Connecticut, Vermont, Massachusetts, 
New Hampshire), (617) 223-7265.
    Region II (New York, New Jersey, Puerto Rico, Virgin Islands), 
(201) 548-8730.
    Region III (Pennsylvania, West Virginia, Virginia, Maryland, 
Delaware, District of Columbia), (215) 814-3255.
    Region IV (Kentucky, Tennessee, North Carolina, South Carolina, 
Georgia, Alabama, Mississippi, Florida), (404) 562-8700.
    Region V (Wisconsin, Illinois, Indiana, Michigan, Ohio, Minnesota), 
(312) 353-2318.
    Region VI (New Mexico, Texas, Oklahoma, Arkansas, Louisiana), (214) 
655-6428.
    Region VII (Nebraska, Iowa, Missouri, Kansas), (913) 281-0991.
    Region VIII (Colorado, Utah, Wyoming, Montana, North Dakota, South 
Dakota), (800) 227-8917.
    Region IX (California, Nevada, Arizona, Hawaii, Guam), (415) 972-
4400.
    Region X (Washington, Oregon, Idaho, Alaska), (206) 553-1263.
X. Confidentiality Claims
    (a) EPA may release to the public health and safety data claimed 
confidential, including information submitted in a notice of 
substantial risk under section 8 (e) of TSCA. EPA will disclose any 
information claimed confidential only to the extent, and by means of 
the procedures, set forth in 40 CFR part 2 (41 FR 36902, September 1, 
1976)
    (b) If no claim accompanies the notice at the time it is submitted 
to EPA, the notice will be placed in an open file to be available to 
the public without further notice to the submitter.
    (c) To assert a claim of confidentiality for information contained 
in a notice, the submitter must submit two copies of the notice.
    (1) The first copy should be complete and unedited, clearly 
reflecting what specific information is being claimed confidential. 
This should be done on each page by placing brackets around the 
specific information in question together with a label such as 
``confidential,'' ``proprietary,'' or ``trade secret.''
    (2) The second copy should be identical to the first copy, but with 
all bracketed information blanked out within the brackets.
    (3) Information within the first confidential copy of the notice 
will be disclosed by EPA only to the extent, and by means of the 
procedures, set forth in 40 CPR part 2. The second copy will be placed 
in an open file to be available to the public
    (d) Any person submitting a notice containing information for which 
they are asserting a confidentiality claim should send the notice in a 
double envelope.
    (1) The outside envelope should bear the same address outlined in 
Part IX. of this policy statement.
    (2) The inside envelope should be clearly marked ``To be opened 
only by the OPPT Document Control Officer.''
    (e) The submitter should substantiate any CBI claims by answering 
substantiation questions according to the instructions located in the 
TSCA section 8(e) website: http://www.epa.gov/opptintr/tsca8e/doc/
cbi.htmXI. Failure to Report Information
    Section 15(3) of TSCA makes it unlawful for any person to fail or 
refuse to submit information required under section 8(e). Section 16 
provides that a violation of section 15 renders a person liable to the 
United States for a civil penalty and possible criminal prosecution. 
Pursuant to section 17, the Government may seek judicial relief to 
compel submittal of section 8(e) information and to otherwise restrain 
any violation of section 8(e).

List of Subjects

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: May 15, 2003.
Stephen L. Johnson,
Assistant Administrator for Prevention, Pesticides, and Toxic 
Substances.
[FR Doc. 03-13888 Filed 6-2-03; 8:45 am]
BILLING CODE 6560-50-S
Notices For
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994
TSCA Section 8(e); Notification of Substantial Risk; Policy Clarification and Reporting Guidance

Local Navigation
