[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]


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

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.

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

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               
------------------------------------------------------------------------
 Chemical and CAS No.       Proposed Testing         Guideline (40 CFR) 
------------------------------------------------------------------------
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