[Federal Register Volume 62, Number 189 (Tuesday, September 30, 1997)]
[Notices]
[Pages 51107-51108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25893]



[[Page 51107]]

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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-42107E; FRL-5744-3]
RIN 2070-AB94


Testing Consent Order for 1,6-Hexamethylene Diisocyanate (HDI)

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of consent agreement.

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SUMMARY: Pursuant to section 4 of the Toxic Substances Control Act 
(TSCA), EPA has issued a testing consent order (Order) that 
incorporates an enforceable consent agreement (ECA) with ARCO Chemical 
Company, Bayer Corporation, and Rhone-Poulenc Inc. (collectively, the 
Companies). The Companies have agreed to perform certain health effects 
tests on 1,6-hexamethylene diisocyanate (HDI) (CAS No. 822-06-0). This 
notice announces the ECA and Order for HDI and summarizes the terms of 
the ECA.

EFFECTIVE DATES: The effective date of the ECA and Order is September 
30, 1997.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Rm. ET-543B, U.S. Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460; telephone: (202) 554-
1404; TDD: (202) 554-0551; e-mail: TSCA-H[email protected]. For 
specific information regarding this notice, or the ECA and Order, 
contact Keith J. Cronin, Project Manager, Chemical Control Division 
(7405), Office of Pollution Prevention and Toxics, U.S. Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone: 
(202) 260-8157; fax: (202) 260-1096; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:
    Electronic Availability: Electronic copies of this document and 
various support documents are available from the EPA Home Page at the 
Federal Register - Environmental Documents entry for this document 
under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/).
    This notice announces the ECA and Order for HDI and summarizes the 
terms of the ECA.

I. Introduction

    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 use of 
HDI in polyurethane paint systems result in potential exposures to 
substantial numbers of workers. The greatest potential for occupational 
exposure to HDI is 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.
    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 
TSCA. 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 reviewed significant new scientific data developed since 
publication of the proposed rule in 1989. The new data--which address 
chronic toxicity, subchronic toxicity, mutagenicity, and hydrolysis--
significantly affect the final scope of testing needs for this chemical 
substance. In view of the impact of these developments on the scope of 
needed HDI testing, EPA published a notice on June 12, 1995 (60 FR 
30874) (FRL-4938-2) soliciting testing proposals for HDI.

II. Enforceable Consent Agreement Negotiations

    In response to EPA's offer to negotiate an ECA, the Chemical 
Manufacturers Association (CMA) HDI Panel submitted a proposal for a 
testing program (Ref. 1).
    EPA held a public meeting to negotiate an ECA for HDI on September 
25, 1996. This meeting was attended by representatives of the Companies 
and other interested parties. During the public meeting, consensus was 
reached on the ECA, and on the tests to be included in the ECA. On 
August 26, 1997, EPA received the ECA signed by the Companies. On 
September 23, 1997, EPA signed the ECA and accompanying Order.

III. Proposed Test Rule

    EPA has decided not to finalize the proposed test rule for HDI (54 
FR 21240, May 17, 1989). EPA has instead reached agreement with the 
Companies that the testing requirements for HDI in the proposed rule 
will be met by implementing the ECA and Order, and that the issuance of 
the ECA and Order constitutes final EPA action for purposes of 5 U.S.C. 
704. Should EPA decide in the future that it requires additional data 
on HDI, EPA will initiate a separate action.

IV. Testing Program

    The following table 1 describes the required testing, test 
standards, and reporting requirements under the ECA for HDI. This 
testing program will allow EPA to characterize further the potential 
health hazards resulting from exposure to HDI. The appendices 
referenced in this table are specific to the enforceable consent 
agreement and are not appendices in 40 CFR part 798.

                  Table 1.--Required Testing, Test Standards and Reporting Requirements for HDI                 
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                                                                               Deadline for         Interim     
             Description of test                      Test standard          final report\1\       reports\2\   
                                                                                 (months)      required (number)
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Genotoxicity:                                                                                                   
1. Mammalian cells in culture                           798.5300                                                
                                                        (40 CFR)                    12                 1        
                                                                                                                
2. Salmonella Typhimurium                               798.5265                                                
                                                        (40 CFR)                    12                 1        

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3. In vivo Cytogenetics                                 798.5385                                                
                                                        (40 CFR)                                                
                                                      (Appendix I)                  12                 1        
                                                                                                                
Developmental Toxicity: One species (rat),                                                                      
 inhalation                                             798.4900                                                
                                                        (40 CFR)                                                
                                                      (Appendix II)                 21                 3        
                                                                                                                
Reproductive developmental screen with                                                                          
 functional observational battery; One                                                                          
 species (rat), via inhalation                          OECD 422                                                
                                                     (Appendix III)                 21                 3        
                                                                                                                
2-generation reproductive study\3\                      798.4700                                                
                                              as proposed for revision (59                                      
                                               FR 42272, August 17, 1994)                                       
                                                      (Appendix IV)               24\4\                3        
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\1\ Number of months after the effective date of the testing consent order.                                     
\2\ Interim reports are required every 6 months from the effective date until the final report is submitted.    
  This column shows the number of interim reports required for each test.                                       
\3\ This study must be conducted if the Agency determines that the results of the reproductive/developmental    
  screening test show statistically or biologically significant adverse reproductive or developmental effects.  
  If the results of the reproductive/developmental screening test are equivocal, the 2-generation reproductive/ 
  developmental study will not be required unless the Agency concludes that the use of HDI may present an       
  unreasonsable risk to human health or the environment in light of (1) a weight-of-the-evidence evaluation of  
  HDI's reproductive/developmental effects, and (2) worker exposure practices and/or manufacturer product       
  stewardship activities. The Agency shall, in any event, provide the Panel with an opportunity to meet and     
  discuss the screening test results with the Agency before making a determination under this paragraph.        
\4\ Figure indicates the reporting deadline, in months, calculated from the date of notification to the test    
  sponsor by certified letter of Federal Register notice that the Agency has determined this required testing   
  must be performed.                                                                                            


V. Export Notification

    At a later date EPA will propose to amend 40 CFR 799.5000 by adding 
HDI to the list of chemicals subject to testing consent orders, thereby 
subjecting all persons who export or who intend to export HDI, of any 
purity, to the export notification requirements of section 12(b) of 
TSCA.

VI. Public Record

    EPA has established an official record for this ECA and Order under 
docket number OPPTS-42107E, which is available for inspection from 12 
noon to 4 p.m., Monday through Friday, excluding legal holidays. The 
official record is located in the TSCA Nonconfidential Information 
Center in Rm. NE-B607, 401 M St., SW., Washington, DC 20460. 
Information claimed as Confidential Business Information (CBI), while 
part of the record, is not available for public review. This record 
contains the basic information considered in developing this ECA and 
Order and includes the following information.

A. Supporting Documentation

    (1) Testing Consent Order for HDI, with incorporated Enforceable 
Consent Agreement and associated testing protocols attached as 
appendices.
    (2) Federal Register notices pertaining to this notice, the Testing 
Consent Order and the Enforceable Consent Agreement, consisting of:
    (a) Notice of Proposed Rulemaking for HDI (54 FR 21240, May 17, 
1989).
    (b) Notice of Solicitation of Testing Proposals for 1,6-
Hexamethylene Diisocyanate for Negotiation of a TSCA Section 4 
Enforceable Consent Agreement (60 FR 30874, June 12, 1995).
    (3) Communications consisting of:
    (a) Written letters.
    (b) Meeting summaries.
    (4) Reports--published and unpublished factual materials.

B. References

    1. The Hexamethylene Diisocyanate Panel of the Chemical 
Manufacturers Association. Letter from Langley A. Spurlock to EPA. 
Enforceable Testing Agreement Proposal for 1,6-Hexamethylene 
Diisocyanate. Washington, DC (August 11, 1995).

List of Subjects

    Environmental protection.

    Dated: September 23, 1997.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides, and Toxic 
Substances.

[FR Doc. 97-25893 Filed 9-29-97; 8:45 am]
BILLING CODE 6560-50-F