[Federal Register Volume 60, Number 17 (Thursday, January 26, 1995)]
[Rules and Regulations]
[Pages 5138-5141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1856]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799

[OPPTS-42178; FRL-4925-9]
RIN 2070-AB94


Testing Consent Order for Glycidyl Methacrylate

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Consent Agreement and Order; Final Rule.

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SUMMARY: EPA has issued a Testing Consent Order (Order) that 
incorporates an Enforceable Consent Agreement (ECA) pursuant to the 
Toxic Substances Control Act (TSCA) with Air Products and Chemicals, 
Inc., The Dow Chemical Company, Mitsubishi Gas Chemical America, Inc., 
NOF America Corporation, and San Esters Corporation (the Companies). 
The Companies have agreed to perform certain health effects tests on 
glycidyl methacrylate (GMA; CAS No. 106-91-2). This document summarizes 
the ECA, adds GMA to the list of chemical substances and mixtures 
subject to testing consent orders, and announces that export 
notification requirements apply to GMA.

EFFECTIVE DATE: January 26, 1995.

FOR FURTHER INFORMATION CONTACT: Jim Willis, Acting Director, 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Rm. E-543B, 401 M St., SW., Washington, DC 
20460, (202) 554-1404, TDD (202) 554-0551.

SUPPLEMENTARY INFORMATION: This document amends 40 CFR 799.5000 by 
adding GMA to the list of chemical substances and mixtures subject to 
testing consent orders and export notification requirements.

I. Background

    GMA, a glycidol derivative, is an epoxy resin additive used in 
paint coating formulations and adhesive applications. Its annual 
production volume is less than 5 million pounds. Approximately 42,000 
workers may be exposed to GMA.
    In its third report to the EPA Administrator, published in the 
Federal Register on October 30, 1978 (43 FR 50630), the Interagency 
Testing Committee (ITC) designated the category of glycidol and its 
derivatives [[Page 5139]] (collectively referred to as ``glycidyls'') 
for priority consideration for health effects testing with regard to 
the following endpoints: carcinogenicity, mutagenicity, teratogenicity, 
and other adverse health effects, with particular emphasis on the 
reproductive system. Epidemiological studies were also recommended. The 
rationale for the original designation is discussed in the same Federal 
Register notice. This chemical category was defined by the ITC as all 
substances with the general formula:

[GRAPHIC][TIFF OMITTED]TR26JA95.022



where R is a hydrogen atom or any alkyl, aryl, or acyl group. R is 
unrestricted as to the number and type of substituents it may carry.
    On December 30, 1983, EPA published an advance notice of proposed 
rulemaking (ANPR) in the Federal Register (48 FR 57562) to require 
testing glycidyls under section 4(a) of TSCA.
    In the November 7, 1991 Federal Register (56 FR 57144), EPA 
published the Notice of Proposed Rulemaking for Glycidol and its 
Derivatives. EPA evaluated the testing needs for glycidyls as described 
in Unit I.D. of the Notice of Proposed Rulemaking for Glycidol and its 
Derivatives. In this notice, EPA proposed that GMA manufacturers test 
GMA for subchronic toxicity, developmental toxicity, and subchronic 
neurotoxicity (functional observation battery, motor activity, and 
neuropathology). Mutagenicity testing (a sex-linked recessive lethal 
assay and a rodent dominant lethal assay) was proposed for glycidyl 
acrylate as a representative test substance for Subgroup VII-B of the 
glycidyls, of which GMA was the other member.

II. Enforceable Consent Agreement Negotiations

    On July 17, 1992, EPA published a Federal Register notice (57 FR 
31714) announcing an ``open season.'' The ``open season'' was a time 
during which manufacturers could submit to EPA proposals for testing 
chemical substances which had been proposed for testing by EPA but had 
not been subject to a final test rule. In that notice, EPA indicated 
that it would review the submissions and select candidates for 
negotiation of ECAs pursuant to 40 CFR part 790. EPA also indicated 
that it would later publish a Federal Register notice soliciting 
persons interested in participating in or monitoring negotiations for 
the development of ECAs on the chemical substances selected.
    On September 15, 1992, the Companies submitted a proposal for 
testing GMA under an ECA (Ref. 1). The Companies proposed subchronic 
toxicity testing (including an evaluation of male reproductive 
function), subchronic neurotoxicity testing (functional observational 
battery, motor activity, neuropathology, and electrophysiology), and 
reproductive toxicity testing.
    On March 30, 1993, EPA published a Federal Register notice (58 FR 
16669) establishing EPA's priority for initiating ECA negotiations on 
certain chemical substances. The notice identified GMA as a Tier II 
chemical substance for which some factors were considered favorable to 
proceed towards negotiating an ECA. This notice and another Federal 
Register notice (58 FR 19253, April 13, 1993) gave manufacturers the 
opportunity to supplement their test proposals for Tier II chemical 
substances, including GMA.
    In response to the April 13, 1993 Federal Register notice, on April 
26, 1993, the Companies submitted a supplement to their September 15, 
1992 proposal (Ref. 2).
    On August 18, 1993, EPA published a Federal Register notice (58 FR 
43893) that solicited interested parties to participate in or monitor 
ECA negotiations on GMA.
    On November 18, 1993, the Companies submitted a draft proposed ECA 
package for GMA (Ref. 3) that offered subchronic toxicity testing 
(including an evaluation of male reproductive function), subchronic 
neurotoxicity testing (functional observational battery, motor 
activity, neuropathology, and electrophysiology), and developmental 
toxicity testing.
    EPA held a public meeting attended by representatives of the 
Companies and other interested parties on July 27, 1994. During the 
public meeting and following the meeting (Refs. 4, 5, and 6), consensus 
was reached on the tests to be included in the ECA (See Table 1, 
``Required Testing, Test Standards and Reporting Requirements for 
GMA'', below.).
    On October 18, 1994, EPA received the ECA signed by the Companies. 
On January 13, 1995, EPA's Assistant Administrator for Prevention, 
Pesticides and Toxic Substances signed the ECA and accompanying Order.

III. Proposed Test Rule

    EPA has decided not to finalize the proposed test rule for GMA 
contained in the proposed test rule for the category glycidol and its 
derivatives (56 FR 57144, November 7, 1991). EPA has instead reached 
agreement with the companies that the GMA testing requirements 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 in the future decide that it 
requires additional data on GMA, the Agency will initiate a separate 
action.

IV. Testing Program

    Table 1 describes the required testing, test standards, and 
reporting requirements for GMA under the ECA. This testing program will 
allow EPA to further characterize the potential health hazards 
resulting from exposure to GMA.

  Table 1.--Required Testing, Test Standards and Reporting Requirements 
                                 for GMA                                
------------------------------------------------------------------------
                                        Deadline for         Interim    
  Description of   Test Standard (40   Final Report\1\     Reports\2\   
      Tests          CFR citation)         Months        Required Number
------------------------------------------------------------------------
90 Day Subchronic  (Appendix I.)      24                3               
 Toxicity Study                                                         
 (Inhalation in                                                         
 rats).                                                                 
Functional         (Appendix II.)     24                3               
 Observation                                                            
 Battery:                                                               
 Subchronic                                                             
 (Inhalation in                                                         
 rats).                                                                 
Motor Activity     (Appendix II.)     24                3               
 Test: Subchronic                                                       
 (Inhalation in                                                         
 rats).                                                                 
Neuropathology:    (Appendix II)      24                3               
 Subchronic                                                             
 (Inhalation in                                                         
 rats).                                                                 
Functional         798.6050           12\4\             1               
 Observation                                                            
 Battery: Acute                                                         
 (Inhalation in                                                         
 rats)\3\.                                                              
Motor Activity     798.6200           12\4\             1               
 Test: Acute                                                            
 (Inhalation in                                                         
 rats)\3\.                                                              
Neuropathology:    798.6400           12\4\             1               
 Acute                                                                  
 (Inhalation in                                                         
 rats)\3\.                                                              
Developmental      (Appendix III.)    15                2               
 Toxicity                                                               
 (Inhalation in                                                         
 New Zealand                                                            
 White Rabbits).                                                        
Mutagenicity:....                                                       
[[Page 5140]]                                                           
                                                                        
  In vivo          798.5385 OR        24                3               
   Mammalian Bone   798.5395                                            
   Marrow                                                               
   Cytogenetics                                                         
   Analysis--IP                                                         
   OR In vivo                                                           
   Mammalian Bone                                                       
   Marrow                                                               
   Cytogenetics                                                         
   Test:                                                                
   Micronucleus                                                         
   Assay--IP.                                                           
                                                                        
  Gene Mutations   798.5300           10                1               
   in Somatic                                                           
   Cells in                                                             
   Culture.                                                             
------------------------------------------------------------------------
\1\ Number of months after the effective date of the 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\ If EPA determines that the results of the subchronic neurotoxicity  
  studies are not negative, then the acute neurotoxicity studies must be
  performed.                                                            
\4\ Figure indicates the reporting deadline, in months, calculated from 
  the date of notification to the test sponsor by certified letter or   
  Federal Register notice that the Agency has determined this required  
  testing must be performed.                                            

V. Export Notification

    The issuance of the ECA and Order subjects any persons who export 
or intend to export the chemical substance GMA (CAS No. 106-91-2), of 
any purity, to the export notification requirements of section 12(b) of 
TSCA. The listing of a chemical substance or mixture at 40 CFR 799.5000 
serves as notification to persons who export or intend to export such 
chemical substance or mixture that the substance or mixture is the 
subject of an ECA and Order and that 40 CFR part 707 applies.

VI. Public Record

    EPA has established a record for this ECA and Order under docket 
number OPPTS-42178, which is available for inspection Monday through 
Friday, excluding legal holidays, in Rm. NE B607, 401 M St., SW., 
Washington, DC, 20460 from Noon to 4 p.m. 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 consists 
of the following information:

A. Supporting Documentation

    (1) Testing Consent Order for GMA, 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) ``Third Report of the Interagency Testing Committee; Receipt of 
the Report and Request for Comments'' (43 FR 50630, October 30, 1978).
    (b) Advance Notice of Proposed Rulemaking for Glycidol and its 
Derivatives (48 FR 57562, December 30, 1983).
    (c) Notice of Proposed Rulemaking for Glycidol and its Derivatives 
(56 FR 57144, November 7, 1991).
    (d) Notice of Opportunity to Initiate Negotiations for TSCA Section 
4 Testing Consent Agreements (57 FR 31714, July 17, 1992).
    (e) Notice of Testing Consent Agreement Development for Tier I 
Chemical Substances; Solicitation for Interested Parties (58 FR 16669, 
March 30, 1993).
    (f) Notice of Testing Consent Agreement Development for Tiers II 
and III Chemical Substances; Reopening of Comment Period (58 FR 19253, 
April 13, 1993).
    (g) Notice of Testing Consent Agreement Development for Listed 
Chemical Substances; Solicitation for Interested Parties (58 FR 43893, 
August 18, 1993).
    (3) Communications consisting of:
    (a) Written Letters.
    (b) Telephone contact reports.
    (c) Meeting summaries.
    (4) Reports - published and unpublished factual materials.

B. References

    1. Glycidyl Methacrylate Manufacturers Group. Letter from 
Patrick J. Hurd to Gary E. Timm. Proposed Testing Program for 
Glycidyl Methacrylate. Washington, DC. (September 15, 1992).
    2. Glycidyl Methacrylate Industry Group. Letter from Patrick J. 
Hurd to TSCA Public Docket Office. Supplement to Glycidyl 
Methacrylate Testing Proposal. Washington, DC. (April 26, 1993).
    3. Glycidyl Methacrylate Industry Group. Letter from Patrick J. 
Hurd to Charles M. Auer. Draft Enforceable Consent Agreement 
Proposal for Glycidyl Methacrylate. Washington, DC. (November 18, 
1993).
    4. EPA. Memorandum from Deborah O. Norris to Charles M. Auer. 
Use of Subchronic Neurotoxicity Testing as a Trigger for Acute 
Testing as Suggested by Industry Panel on GMA. Washington, DC. 
(August 4, 1994).
    5. Glycidyl Methacrylate Industry Group. Letter from Patrick J. 
Hurd to Charles M. Auer. Use of Acute Tests and Subchronic 
Neurotoxicity Testing as Triggers for Acute Neurotoxicity Testing. 
Washington, DC. (September 1, 1994).
    6. EPA. Letter from Charles M. Auer to Patrick J. Hurd. Glycidyl 
Methacrylate Enforceable Consent Agreement; Final Draft for Test 
Sponsors' Signatures. Washington, DC. (September 28, 1994).

VII. Regulatory Assessment Requirements

    The Office of Management and Budget (OMB) has approved the 
information collection requirements contained in the ECA under the 
provisions of the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et 
seq., and has assigned OMB control 2070-0033.
    Public reporting burden for this collection of information is 
estimated to average 586 hours per response. The estimates include time 
for reviewing instructions, searching existing data sources, gathering 
and maintaining the data needed, and completing and reviewing the 
collection of information.

List of Subjects in 40 CFR Part 799

    Chemicals, Chemical export, Environmental protection, Hazardous 
substances, Health effects, Laboratories, Reporting and recordkeeping 
requirements, Testing.

    Dated: January 13, 1995.

Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

    Therefore, 40 CFR chapter I, subchapter R, part 799 is amended as 
follows:

PART 799--[AMENDED]

    1. The authority citation for part 799 continues to read as 
follows:

    Authority: 15 U.S.C. 2603, 2611, 2625.


    2. Section 799.5000 is amended by adding glycidyl methacrylate to 
the table in CAS Number order, to read as follows:


Sec. 799.5000   Testing Consent Orders for Substances and Mixtures with 
Chemical Abstract Service Registry Numbers.

*    *     *     *     *     *

                                                                        
[[Page 5141]]                                                           
------------------------------------------------------------------------
                  Substance or mixture                    FR Publication
   CAS Number             name              Testing            Date     
------------------------------------------------------------------------
                                                                        
       *                  *                  *                  *       
          *                  *                  *                       
106-91-2........  Glycidyl              Health effects   January 26,    
                   Methacrylate                           1995          
                                                                        
       *                  *                  *                  *       
          *                  *                  *                       
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[FR Doc. 95-1856 Filed 1-25-95; 8:45 am]
BILLING CODE 6560-50-F