[Federal Register Volume 59, Number 189 (Friday, September 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24250]
[[Page Unknown]]
[Federal Register: September 30, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-42052P; FRL-4756-5]
Notice of Opportunity to Initiate Negotiations for TSCA Section 4
Enforceable Consent Agreements; Solicitation of Testing Proposals for
ATSDR Chemicals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice invites manufacturers and processors of certain
chemical substances who wish to participate in testing negotiations for
various chemicals to develop and submit testing program proposals to
EPA. The chemicals are hazardous substances identified for data needs
by the Agency for Toxic Substances and Disease Registry (ATSDR),
National Toxicological Program (NTP) and EPA pursuant to section
104(i)(5) of the Comprehensive Environmental Response, Compensation and
Liability Act of 1980 (CERCLA or Superfund)(42 U.S.C. 9601-9675). These
12 chemical substances are vinyl chloride, benzene, trichloroethylene,
tetrachloroethylene, hydrogen cyanide, sodium cyanide, toluene,
methylene chloride, chloroethane, mercury, chromium, and beryllium.
These substances and associated data needs appear in Table 1 below. The
specific forms of the metals mercury, chromium, and beryllium to be
tested are yet to be determined; EPA will solicit testing proposals for
the specific forms of these metals at a later date. Testing proposals
should cover all identified data needs of a substance (or multiple
substances) in order to be considered for Enforceable Consent Agreement
(ECA) negotiation. If, after receiving testing proposals, EPA elects to
pursue negotiations for one or more ECAs applicable to specific
chemicals, EPA will solicit requests to be designated an interested
party at that point. EPA has authority to require testing for these 12
chemical substances under section 4 of the Toxic Substances Control Act
(TSCA)(15 U.S.C. 2601-2692) and if an ECA-based approach does not prove
viable, EPA would proceed with rulemaking to require the needed
testing.
DATES: Written testing proposals must be received by November 29, 1994.
EPA may extend the deadline for receipt of testing proposals upon a
showing of good faith efforts to develop testing proposals by the
initial deadline.
ADDRESSEES: Submit three copies of written testing proposals to TSCA
Docket Receipts (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. NE B607, 401 M St., SW.,
Washington, DC 20460. Submissions should bear the document control
number (OPPTS-42052P; FRL-4756-5). The public record supporting this
action, including comments, is available for public inspection at the
above address from 12 noon to 4 p.m., Monday through Friday, except
legal holidays.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Rm. E-543B, 401 M St., SW.,
Washington, DC 20460, (202) 554-1404, TDD (202) 554-0551. For specific
information regarding this action or related activities, contact Brian
P. Riedel, Project Manager, Chemical Testing and Information Branch
(7405), Rm. NE-1606, 401 M St., SW., Washington, DC 20460, (202) 260-
0321.
SUPPLEMENTARY INFORMATION:
I. Background
A. Solicitation for Testing Proposals
EPA's procedures for requiring the testing of chemical substances
under section 4 of TSCA include the adoption of ECAs and the
promulgation of test rules. On numerous occasions, chemical companies
have approached EPA to negotiate ECAs for testing chemicals which are
likely to become the subject of proposed test rules. EPA will follow
the procedures outlined in unit II of this notice to develop ECAs.
B. Chemical Data Needs
The data needs which are the subject of this notice were
determined in accordance with the requirements of the Superfund
Amendments and Reauthorization Act (SARA) of 1986 which amended and
extended CERCLA.
Section 104(i) of CERCLA requires ATSDR and EPA to prepare and
revise a list of hazardous substances which are most commonly found at
facilities on the CERCLA National Priorities List (NPL) and which ATSDR
and EPA, in their sole discretion, determine are posing the most
significant potential threat to human health. The lists of these 275
hazardous substances were published in the Federal Register on April
17, 1987 (52 FR 12866); October 20, 1988 (53 FR 41280); October 26,
1989 (54 FR 43615); October 17, 1990 (55 FR 42067); October 17, 1991
(55 FR 52166); October 28, 1992 (57 FR 48801); and October 18, 1993 (58
FR 53739).
Section 104(i) of CERCLA also directs ATSDR to prepare
toxicological profiles of each listed hazardous substance. Section
104(i)(3) outlines the content of these profiles. Each profile is
required to include an examination, summary and interpretation of
available toxicological information and epidemiologic evaluations in
order to ascertain the levels of significant human exposure for the
substance and the associated health effects. The profiles must also
include a determination of whether adequate information on the health
effects of each substance is available or in the process of
development. ATSDR has prepared 110 toxicological profiles covering 195
substances. (One toxicological profile may cover several related
substances).
Under CERCLA, section 104(i)(5), when adequate information is not
available on the health effects of each substance, ATSDR, in
cooperation with the National Toxicology Program (NTP), is required to
assure the initiation of a research program designed to determine such
health effects (and techniques for developing methods to determine such
health effects).
As the first step in developing its health effects research
program, ATSDR identified data needs for each substance in the
toxicological profiles. These data needs were reviewed by scientists
from ATSDR, NTP, EPA and the Centers for Disease Control, peer reviewed
by an external review panel, and made available for public comment.
Prior to final publication of the toxicological profiles, ATSDR
considered all public comments it received regarding identification of
data needs for the substances.
The next step in the development of the health effects research
program (or the substance-specific research program) involved the
creation of the ``Decision Guide for Identifying Substance-Specific
Data Needs Related to Toxicological Profiles'' (Decision Guide),
published in the Federal Register on September 11, 1989 (54 FR 37618).
Applying the principles discussed in the Decision Guide, ATSDR
published the ``Identification of Priority Data Needs for 38 Priority
Hazardous Substances'' in the Federal Register on October 17, 1991 (56
FR 52178). As required by CERCLA, section 104(i)(5), ATSDR considered
recommendations from the Interagency Testing Committee (ITC), and, with
EPA, coordinated development of these priority data needs with NTP and
with programs of toxicological testing established under TSCA and the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)(7 U.S.C.
136). The purpose of such coordination is to avoid duplication of
effort and to assure that the listed hazardous substances are tested
thoroughly at the earliest practicable date. ATSDR also considered
public comments on identification of the priority data needs. On
November 16, 1992, ATSDR published the ``Announcement of Final Priority
Data Needs for 38 Priority Hazardous Substances'' in the Federal
Register (57 FR 54150). Copies of the FR actions cited above are
available in the docket established for this action (OPPTS-42052P; FRL-
4756-5).
CERCLA, section 104(i)(5)(C) provides that TSCA authorities may be
used to carry out the health effects research program. CERCLA, section
104(i)(5)(D) declares that:
[i]t is the sense of the Congress that the costs of [conducting
health effects research programs] be borne by the manufacturers and
processors of the hazardous substances in question, as required in
programs of toxicological testing under the Toxic Substances Control
Act.
In October 1992, ATSDR requested that EPA test 38 substances using
authorities under TSCA and FIFRA. EPA coordinated extensively with
other Federal agencies (including the Occupational Safety and Health
Administration, National Institute for Occupational Safety and Health,
Mine Safety and Health Administration, and the Consumer Product Safety
Commission) and among its own programs (including Office of Air and
Radiation, Office of Water, Office of Solid Waste and Emergency
Response, and Office of Research and Development) to evaluate ATSDR's
request for testing. In addition, EPA, ATSDR, and the National
Institute of Environmental Health Sciences (NIEHS) met as members of
the Tri-Agency Superfund Applied Research Committee (TASARC) to discuss
ATSDR's data needs and EPA's response. Copies of the minutes of the
TASARC meetings are available in the docket established for this
action.
In response to ATSDR's initial request to test 38 substances, EPA
deleted substances from the initial list and deleted and added
associated data needs based on various factors including, but not
limited to, the appropriateness of using TSCA authority to require
testing of certain substances and the needs of other Federal Agencies
and EPA programs for certain test data. Relevant correspondence between
EPA and ATSDR regarding these selections is available in the docket
established for this action. In a letter dated November 9, 1993, EPA
informed ATSDR that EPA would pursue testing of ATSDR substances under
section 4 of TSCA. The ATSDR list of 38 substances was modified to
contain the 12 substances shown in Table 1 below with a summary
description of data needs. These substances will be added to the next
edition of the Office of Pollution Prevention and Toxics' Master
Testing List scheduled for release in FY '95. Further description of
the data needs are available in the docket established for this action.
Note that TASARC has set up a workgroup to identify the specific
forms of the metals mercury, chromium and beryllium to be tested. This
workgroup will consider the needs of other Federal Agencies and EPA
programs. In addition, EPA will solicit testing proposals for the
specific forms of these metals at a later date. Note also that EPA has
not yet developed testing guidelines for certain endpoints indicated in
Table 1 below. EPA particularly encourages submission of testing
guidelines for these endpoints which may be used as part of a testing
proposal.
EPA realizes that under certain circumstances, as outlined below,
route-to-route extrapolation based on valid pharmacokinetic (PK) data
can offer a useful and less expensive alternative to retesting by
another route of exposure to chemical substances that have already been
tested by one route. Therefore, EPA will consider entering into ECAs
for PK testing under protocols proposed by prospective test sponsors.
EPA will consider route-to-route extrapolation of toxicity data
from routes other than those proposed in Table 1 below when it is
scientifically reasonable to empirically derive the risk. Derivation of
the risk is only reasonable when portal-of-entry effects and first-pass
effects can be ruled out or adequately characterized. Regardless of the
toxic endpoint considered, EPA's ability to perform quantitative route-
to-route extrapolation is critically dependent on the amount and type
of data available. The minimum information needed includes both the
nature of the toxic effects and a description of the relationship
between exposure and the toxic effect.
The preferred method for performing route-to-route extrapolation
involves the development of a physiologically-based pharmacokinetic
(PBPK) model that describes the disposition (deposition, absorption,
distribution, metabolism, and elimination) of the chemical for the
routes of interest. PBPK models must be used in conjunction with
toxicity and mechanistic studies in order to relate the effective dose
associated with an effect for the test species and conditions to other
scenerios.
The primary purpose of this ASTDR/EPA health effects testing
program is to meet the substance-specific information needs of the
public and the scientific community, and, consistent with the
guidelines discussed in the Decision Guide, this testing program will
supply toxicity and exposure information which will assist in the
development of Superfund health assessments by ASTDR. In addition,
because of the involvement by other Federal Agencies and EPA offices in
reviewing the testing needs identified for these chemicals, this
testing program will supply test data which will also meet the needs of
other Federal Agencies and EPA programs.
Table 1.--Data Needs and Testing Guidelines
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Chemical and CAS No. Proposed Testing Guideline (40 CFR)
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Vinyl chloride (75-01- Reproductive inhalation... R
4).
Developmental inhalation.. D
Neurotoxicity inhalation.. N
Benzene (71-43-2).... Subchronic oral........... 798.2650
Subchronic inhalation..... 798.2450
Neurotoxicity inhalation.. N
Functional observational
battery
Motor activity
Neuropathology .....................
Reproductive inhalation... R
Trichloroethylene (79- Acute oral................ 798.1175
01-6).
Subchronic oral........... 798.2650
Immunotoxicity oral....... I
Tetrachloroethylene Acute inhalation.......... A
(127-18-4).
Reproductive inhalation... R
Neurotoxicity subchronic N
inhalation.
Functional observational
battery
Motor activity
Neuropathology
Developmental inhalation.. D
Immunotoxicity inhalation. I
Hydrogen cyanide (74- Acute inhalation.......... A
90-8).
Subchronic inhalation..... 798.2450
Developmental inhalation.. D
Neurotoxicity subchronic N
inhalation.
Functional observational
battery
Motor activity
Neuropathology
Sodium cyanide (143- Developmental oral........ D
33-9).
Toluene (108-88-3)... Comparative PK
pharmacokinetic.
Immunotoxicity oral....... I
Methylene chloride Subchronic oral........... 798.2650
(75-09-2).
Developmental oral........ D
Neurotoxicity subchronic N
oral.
Functional observational
battery
Motor activity
Neuropathology
Immunotoxicity oral....... I
Chloroethane* (Ethyl Comparative PK
chloride) (75-00-3). pharmacokinetic.
Mercury**(TBD)....... .......................... .....................
Chromium**(TBD)...... .......................... .....................
Beryllium**(TBD)..... .......................... .....................
------------------------------------------------------------------------
Notes:
*Note that a soon-to-be-published proposed test rule on
hazardous air pollutants (HAPs) will cover chloroethane.
**A workgroup set up by TASARC is in the process of identifying
the specific forms of these metals.
TBD -- The Chemical Abstract Service Registry Number(s) for the
chemical(s) to be tested is yet to be determined.
R -- Proposed revised EPA guidelines for reproductive toxicity
testing are under development and are anticipated to be finalized in
the near future. Copies of the latest draft to date are available in
the docket established for this action.
D -- Proposed revised EPA guidelines for developmental toxicity
testing are under development and are anticipated to be finalized in
the near future. Copies of the latest draft to date are available in
the docket established for this action.
N -- EPA intends for parties subject to neurotoxicity testing
requirements under this rule to follow the 1991 Neurotoxicology
Testing Guidelines which are available in the docket established for
this action.
I -- A workgroup established by the Tri-Agency Superfund Applied
Research Committee (TASARC) is developing immunotoxicity testing
guidelines.
A -- Revised EPA guidelines for acute inhalation testing are
under development and will soon be published with a proposed test
rule on HAPs. Copies of the latest draft to date are available in
the docket established for this action.
PK -- EPA has developed testing guidelines which may be used
for conducting comparative pharmokinetic testing. These final
guidelines are awaiting publication and are available in the docket
established for this action.
II. Procedures for Development of ECAs
EPA will follow the procedures outlined below to develop ECAs for
the chemical substances listed in Table 1 above.
1. Submission of testing proposals for ECA negotiations. Following
publication of this Notice, manufacturers and processors have 60 days
to develop testing proposals for the chemical substances listed in
Table 1 above that they wish EPA to consider as candidates for ECA
negotiations. EPA may extend the deadline for receipt of testing
proposals upon a showing of good faith efforts to develop testing
proposals by the initial deadline. The testing proposals should
describe the testing to be performed in detail (test guideline or
protocol, including route of administration, species, etc.) and explain
in detail where there are deviations from tests proposed by EPA in
Table 1 above. The Agency suggests as a model the testing proposal
submitted on N-methylpyrrolidone (NMP) by the NMP Producers Group on
September 11, 1992 found in the docket established for this action. In
order for a testing proposal to be eligible for consideration, the
proposal should cover all identified data needs of a substance (or
multiple substances).
2. Agency selection of most likely candidates for the ECA program.
EPA will review the submissions and select the most promising
submissions as candidates for negotiation. Submissions which fully
address EPA's concerns will have a higher chance of success than those
which do not fully address all data needs issues.
3. Formal solicitation of ``interested parties'' in the Federal
Register. If EPA selects a proposal as a candidate for negotiations,
such negotiations will be conducted pursuant to procedures described in
40 CFR 790.28. Accordingly, EPA will publish a notice in the Federal
Register soliciting persons interested in participating in or
monitoring negotiations for the development of an ECA, to so notify the
Agency in writing. Those individuals and groups who respond to EPA's
notice by the deadline established in the notice will have the status
of ``interested parties'' and will be afforded opportunities to
participate in the negotiation process. Designation as an ``interested
party'' will not incur any obligations. Submitters of testing proposals
will be considered interested parties with regard to the subject(s) of
their proposals and need not respond to the solicitation notice.
4. Negotiation of testing program and development of an ECA.
Negotiations will be conducted in meetings open to the public.
Notification of meetings will be given only to persons identified as
interested parties. The first negotiation meeting will establish the
period for negotiation. If agreement is not reached within this
prescribed time limit and EPA chooses not to extend the negotiation
period, negotiations will be terminated and testing will be required
under a rule.
5. Approval of the ECA by interested parties and EPA and
publication of a notice in the Federal Register. After EPA and
interested parties have agreed in principle on the terms of the ECA,
the ECA text will be sent for approval to interested parties who are
actual participants in the negotiation. Subsequent to approval of the
ECA, EPA will publish a notice in the Federal Register summarizing the
testing program and announcing that in lieu of a test rule, the Agency
has issued a testing Consent Order that incorporates the ECA.
III. Public Record
EPA has established a record for this action (docket control
number OPPTS-42052P; FRL-4756-5). The record includes basic information
considered by EPA in developing this action. EPA will supplement the
record with additional information as it is received.
A public version of this record is available in the TSCA
Nonconfidential Information Center (NCIC) from 12 noon to 4 p.m.,
Monday through Friday, except legal holidays. The NCIC is located in
Rm. NE-B607, Mail Code 7407, 401 M St., SW., Washington, DC, 20460.
Written requests for copies of documents contained in this record may
be sent to the above address or faxed to (202) 260-9555.
Authority: 15 U.S.C. 2603.
Dated: September 21, 1994.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 94-24250 Filed 9-29-94; 8:45 am]
BILLING CODE 6560-50-P
