Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices 33129

may not conduct or sponsor, and a 

person is not required to respond to a 

collection of information unless it 

displays a currently valid OMB control 

number. The OMB control number for 

EPA’s regulations, after initial display in 

the final rule, are listed in 40 CFR part 

9. 

VI. References 

1. U.S. EPA, OPPT. I. Ethylene 

Dichloride (107–06–2). Pp 24–27 In: 

‘‘TSCA Section 4 Findings for 21 

Hazardous Air Pollutants: A Supporting 

Document for Proposed Hazardous Air 

Pollutants (HAPs) Test Rule.’’ (June 25, 

1996). 

2. The HAP Task Force. Letter from 

Peter E. Voytek to Charles M. Auer with 

attachment entitled: ‘‘Proposal for 

Pharmacokinetics Study of Ethylene 

Dichloride, November 22, 1996.’’

(November 22, 1996). 

3. U.S. EPA. Letter from Charles M. 

Auer to Peter E. Voytek with attachment 

entitled: ‘‘Preliminary EPA Technical 

Analysis of Proposed Industry 

Pharmacokinetics (PK) Strategy for 

Ethylene Dichloride, June, 1997.’’ (June 

26, 1997). 

4. The HAP Task Force. Letter from 

Peter E. Voytek to Charles M. Auer, U.S. 

EPA. (March 19, 1999). 

5. U.S. EPA. Letter from Charles M. 

Auer to Peter E. Voytek, HAP Task 

Force, Re: ECA Development of 

Ethylene Dichloride (EDC) (OPPTS 

42197C, with attachment: ‘‘EDC ECA—

DRAFT, dated February, 2001.’’

(February 13, 2001). 

6. Final Enforceable Consent 

Agreement for Ethylene Dichloride and 

Accompanying Testing Consent Order, 

signed by EPA on May 13, 2003. 

7. D’Souza, R.W., Francis, W.R., Bruce 

R.D., and Andersen, M.E. 

Physiologically based phamacokinetic 

model for ethylene dichloride and its 

application in risk assessment. Pp 286–

301, In: Pharmacokinetics in Risk 

Assessment. National Academy Press. 

Washington, D.C. (1987). 

8. D’Souza, R.W., Francis, W.R., and 

Andersen, M.E. Physiological model for 

tissue glutathione depletion and 

increased resynthesis after ethylene 

dichloride exposure. Journal of 

Pharmacology and Experimental 

Therapeutics 245(2):563–568. 1988. 

9. Daniel, F.B., Robinson, M., Olson, 

G.R., York, R.G., and Condie, L.W. Ten 

and ninety-day toxicity studies of 1,2-

dichloroethane in Sprague-Dawley rats. 

Drug and Chemical Toxicology 17: 463–

477. 1994. 

10. Alumot, E., Nachtomi, E., Mandel, 

E., Holstein, P., Bondi, A., and Herzberg, 

M. Tolerance and acceptable daily 

intake of chlorinated fumigants in the 

rat diet. Food, Cosmetics and 

Toxicology 14: 105–110. (1976). 

11. Rao, K.S., Murray, J.S., Deacon, 

M.M., John, J.A., Calhoun, L.L., and 

Young, J.T. Teratogenicity and 

reproduction studies in animals 

inhaling ethylene dichloride. Banbury 

Report 5: 149–166. (1980). 

12. Lane, R.W., Riddle, B.L., and 

Borzelleca, J.F. Effects of 1,2-

dichloroethane and 1,1,1-

trichloroethane in drinking water on 

reproduction and development in mice. 

Toxicology and Applied Pharmacology 

63: 409–421. 1982. 

13. Payan, J.P., Saillenfait, A.M., 

Bonnet, P., Fabry, J.P., Langonne, I., and 

Sabate J.P. Assessment of the 

developmental toxicity and placental 

transfer of the 1,2-dichloroethane in 

rats. Fundamental and Applied 

Toxicology 28: 187–198. 1995. 

14. Sherwood, R.L., O’Shea, W., 

Thomas, P.T., Ratajczak, H.V., and 

Aranyi, C. Effects of inhalation of 

ethylene dichloride on pulmonary 

defenses of mice and rats. Toxicology 

and Applied Pharmacology 91: 491–496. 

1987. 

15. U.S. EPA, OPPTS. ‘‘Burden 

Estimates for the Enforceable Consent 

Agreement for Ethylene Dichloride.’’

(January 31, 2002).

List of Subjects 

Environmental protection, Hazardous 

chemicals.

Dated: May 13, 2003. 

Stephen Johnson, 

Assistant Administrator for Prevention, 

Pesticides and Toxic Substances.

[FR Doc. 03–13721 Filed 6–2–03; 8:45 am]

BILLING CODE 6560–50–S

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: TSCAHotline@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) 

33130 Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices 

• 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 

Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices 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. 

33132 Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices 

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 nonhuman 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 

Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices 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 nonemergency 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 

33134 Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices 

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 sitespecific 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 

Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices 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 EPAdelegated 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 

33136 Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices 

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 

Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices 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 (65 FR 

67249, 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.

33138 Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices 

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) Nonemergency 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 nonhuman 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 nonhuman 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 noctanol/water partition coefficient 

greater than 25,000) should be reported 

when coupled with potential for 

widespread exposure and any nontrivial adverse effect. 

(3) Environmental effects. Any nontrivial 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 

Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices 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 nonemergency 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 sitespecific 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. 

33140 Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices 

(h) Is information of the kind under 

Part V.(b)(1) and (c) concerning a nonUnited 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.htm 

XI. 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