[Federal Register Volume 60, Number 112 (Monday, June 12, 1995)]
[Notices]
[Pages 30874-30876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14344]



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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-42052R; FRL-4938-2]
RIN 2070-033


Solicitation of Testing Proposals for 1,6-Hexamethylene 
Diisocyanate for Negotiation of a TSCA Section 4 Enforceable Consent 
Agreement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice invites manufacturers and processors of 1,6-
hexamethylene diisocyanate (HDI) and other interested parties to 
develop and submit to EPA specific toxicity testing program proposals 
for this chemical. In addition, EPA is also interested in the 
development of a voluntary product stewardship program for HDI as a 
complement to the testing effort.

DATES: Written testing proposals must be received by August 11, 1995. 
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.

ADDRESSES: 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-42052R; FRL-4938-2). The public docket 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.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic comments 
must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number (OPPTS-42052R; FRL-4938-2). No CBI should be 
submitted through e- [[Page 30875]] mail. Electronic comments on this 
notice may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found in Unit 
II of this document.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
Environmental Assistance Division (7408), Rm. E543B, 401 M St., SW., 
Washington, DC 20460, (202) 554-1404, TDD (202) 554-0551. For specific 
information regarding this action or related activities, contact Keith 
Cronin, Project Manager, Chemical Testing and Information Branch 
(7405), Rm. E201E, 401 M St., SW., Washington, DC 20460, (202) 260-
8157.

SUPPLEMENTARY INFORMATION:

I. Background

A. Enforceable Consent Agreement Solicitation

    One, 6-hexamethylene diisocyanate (HDI) is an aliphatic 
diisocyanate. HDI is used in the manufacture of higher molecular biuret 
polyisocyanate resins and trimer polyisocyanate resins used in 
polyurethane paint systems. The production and uses of HDI in 
polyurethane paint systems results in potential exposures to 
substantial numbers of workers. The greatest potential for occupational 
exposures to HDI is in coating application operations, with an 
estimated 153,000 auto body repair workers having a potential for some 
exposure to paints containing HDI biuret and trimer. This potential for 
substantial exposure forms the foundation for the Agency's concern for 
the potential health risk that may be posed to workers by HDI.
    In the Federal Register of May 20, 1988 (53 FR 18196), the 
Interagency Testing Committee (ITC) designated HDI for health effects 
testing for chronic toxicity, oncogenicity, and reproductive and 
developmental effects. EPA responded to the ITC's designation of HDI by 
issuing a proposed test rule in the Federal Register of May 17, 1989 
(54 FR 21240), requiring that HDI be tested for oncogenicity, 
mutagenicity, reproductive toxicity, developmental toxicity, 
neurotoxicity, pharmacokinetics, and hydrolysis under section 4 of the 
Toxic Substances Control Act (TSCA) (15 U.S.C. 2603). The proposed rule 
contains a chemical profile of HDI, a discussion of EPA's TSCA section 
4(a) findings, and the proposed test standards and reporting 
requirements. EPA based its proposal on section 4(a)(1)(B) of TSCA, 
finding that HDI is produced in substantial quantities and that there 
is or may be substantial human exposure from its manufacture, 
processing, and use.
    EPA has recently reviewed significant new scientific data developed 
since publication of the proposed rule in 1989. The new data -- which 
address chronic toxicity, subchronic toxicity, and mutagenicity -- 
significantly affect the final scope of testing needs for this chemical 
substance. In view of these developments' impact on the scope of needed 
HDI testing, EPA is considering negotiating an Enforceable Consent 
Agreement (ECA) as an alternative to finalizing the proposed test rule 
to acquire the data identified in table 1. In the past, EPA, chemical 
manufacturers and other interested parties have frequently found that 
in some circumstances, the ECA process provides a more efficient, more 
flexible and less resource-intensive means of obtaining needed test 
data than the rulemaking process.
    To be considered for ECA negotiation, testing proposals for HDI 
should address all data needs identified in table 1. If, after 
receiving testing proposals, EPA decides to pursue negotiations for 
HDI, EPA will solicit requests from individuals and others to be 
designated interested parties to the negotiation. EPA maintains its 
authority to require testing for HDI under TSCA section 4 and if 
negotiations do not produce an ECA, EPA intends to proceed with 
rulemaking to obtain the needed HDI data. EPA is also interested in 
receiving indications of interest in product stewardship programs as a 
compliment to the testing effort. Depending on what can be developed, 
it may be possible to offset some of the testing identified in this 
notice.

B. Chemical Data Needs

    The ITC designated HDI for health effects testing, including 
chronic toxicity, oncogenicity, and reproductive and developmental 
effects on May 20, 1988 (53 FR 18196). EPA responded to the ITC's 
designation of HDI by issuing a proposed test rule in the Federal 
Register of May 17, 1989 (54 FR 21240), which would require that HDI be 
tested for oncogenicity, mutagenicity, reproductive toxicity, 
developmental toxicity, neurotoxicity, pharmacokinetics, and 
hydrolysis. The proposed rule contained a chemical profile of HDI, a 
discussion of EPA's TSCA section 4(a) findings, and the proposed test 
standards and reporting requirements. EPA based its proposal on section 
4(a)(1)(B) of TSCA, finding that HDI is produced in substantial 
quantities and that there is or may be substantial human exposure from 
its manufacture, processing, and use.
    EPA has reviewed new significant scientific data developed since 
publication of the proposed rule in 1989. The new data addressed 
chronic toxicity and subchronic toxicity which impacts the final scope 
of testing needs for this chemical substance. EPA believes the testing 
identified in table 1 is both appropriate and needed for HDI.


                              Table 1.--Proposed Testing and Test Standards For HDI                             
----------------------------------------------------------------------------------------------------------------
 Description of Tests         Species             Exposure Route         Test Duration         Guideline/Notes  
----------------------------------------------------------------------------------------------------------------
Oncogenicity.........  1 species other than   Inhalation...........  2 years..............  40 CFR 798.3300     
                        rat.                                                                                    
2 generation           1 species............  Inhalation...........  2 generation.........  40 CFR 798.4700 as  
 reproductive study.                                                                         proposed for       
                                                                                             revision (59 FR    
                                                                                             42272, August 17,  
                                                                                             1994)              
Developmental          2 species............  Inhalation...........  .....................  40 CFR 798.4900 as  
 toxicity study.                                                                             proposed for       
                                                                                             revision (59 FR    
                                                                                             42272, August 17,  
                                                                                             1994)              
Acute neurotoxicity..  1 species............  Inhalation...........  .....................  1991 Neurotoxicity  
                                                                                             Testing Guidelines 
Subchronic             1 species............  Inhalation...........  90 days..............  1991 Neurotoxicity  
 neurotoxicity.                                                                              Testing Guidelines 
Mammalian cells in     NA...................  NA...................  NA...................  40 CFR 798.5300     
 culture.                                                                                                       
Salmonella             NA...................  NA...................  NA...................  40 CFR 798.5265     
 typhimurium.                                                                                                   
in vivo cytogenetics.  NA...................  NA...................  NA...................  40 CFR 798.5385     
Hydrolysis...........  NA...................  NA...................  NA...................  Holdren, et al.     
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[[Page 30876]] II. Public Docket

    EPA has established a docket for this action under docket control 
number OPPTS-42052R, FRL-4938-2 (including comments and data submitted 
electronically as described below). The docket contains basic 
information considered by EPA in developing this action and includes:
    1. Notice containing the ITC designation of HDI to the Priority 
List (53 FR 18196, May 20, 1988).
    2. 1,6-Hexamethylene Diisocyanate proposed test rule (54 FR 21240, 
May 17, 1989).
    3. Notice containing the proposed revision to the Reproductive and 
Developmental Toxicity Studies (59 FR 42272, August 17, 1994).
    EPA will supplement the docket with additional information as it is 
received.
    A record has been established for this notice under docket control 
number OPPTS-42052R, FRL-4938-2 (including comments and data submitted 
electronically as described below). A public version of this docket, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as confidential business 
information (CBI), is available for inspection from 12 noon to 4 p.m., 
Monday through Friday, excluding legal holidays. The public docket is 
located in the TSCA Nonconfidential Information Center, Rm NE-B607, 401 
M St., SW., Washington, DC 20460. Written requests for copies of 
documents contained in this docket may be sent to the above address or 
faxed to (202) 260-9555.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this notice, as well as the public version, 
as described above will be kept in paper form. Accordingly, EPA will 
transfer all comments received electronically into printed, paper form 
as they are received and will place the paper copies in the official 
notice record which will also include all comments submitted directly 
in writing. The official notice record is the paper record maintained 
at the address in ``ADDRESSES'' at the beginning of this document.

    Authority: 15 U.S.C. 2603.

    Dated: June 5, 1995.

Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
[FR Doc. 95-14344 Filed 6-9-95; 8:45 am]
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