[Federal Register Volume 61, Number 57 (Friday, March 22, 1996)]
[Rules and Regulations]
[Pages 11740-11743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7040]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799

[OPPTS-42185; FRL-5356-7]
RIN 2070-0033


Testing Consent Order For Alkyl Glycidyl Ethers

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final consent agreement and order; final rule.

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SUMMARY: Pursuant to the Toxic Substances Control Act (TSCA), EPA has 
issued a testing consent order (Order) that incorporates an enforceable 
consent agreement (ECA) with Air Products and Chemicals, Inc., Callaway 
Chemical Company, Ciba-Geigy Corporation, CVC Specialty Chemicals, and 
Shell Chemical Company (the Companies). The Companies have agreed to 
perform certain health effects tests on alkyl (C12-C13) 
glycidyl ether (CAS No. 120547-52-6), as a representative of the alkyl 
glycidyl ethers subcategory of EPA's proposed test rule for glycidol 
and its derivatives. This notice summarizes the ECA, adds alkyl 
(C12-C13) glycidyl ether to the list of chemical substances 
and mixtures subject to testing consent orders, and announces that 
export notification requirements apply to alkyl (C12-C13) 
glycidyl ether.

EFFECTIVE DATE: March 22, 1996.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Rm. ET-543B, USEPA, 401 M St., SW., Washington, 
DC 20460; telephone: (202) 554-1404, TDD: (202) 554-0551; e-mail: TSCA-
H[email protected].

SUPPLEMENTARY INFORMATION: This notice amends 40 CFR 799.5000 by adding 
alkyl (C12-C13) glycidyl ether to the list of chemical 
substances and mixtures subject to testing consent orders and export 
notification requirements.

I. Background

    Alkyl glycidyl ethers (AGEs) are epoxy resin additives derived from 
glycidol and are used as modifiers for other epoxides in flooring and 
adhesives. Their annual production volume is approximately 7 million 
pounds. Approximately 37,000-69,000 workers may be exposed to AGEs.
    In its Third Report to the EPA Administrator, published in the 
Federal Register on October 30, 1978 (43 FR 50630), the TSCA section 4 
Interagency Testing Committee (ITC) designated the category glycidol 
and its derivatives (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:

            R-O-CH2CH(O)CH2

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 advanced notice of proposed 
rulemaking (ANPRM) (FRL-2480-7) in the Federal Register (48 FR 57562) 
to require testing glycidyls under section 4(a) of TSCA.
    In the November 7, 1991 issue of the Federal Register (56 FR 
57144), EPA published a notice of proposed rulemaking (FRL-3736-2) for 
testing the category glycidol and its derivatives. Unit I.D. of the 
notice described EPA's evaluation of the testing needs for glycidyls. 
The proposal contained testing requirements for, among others, the 
following chemical substances: lauryl glycidyl ether (CAS No. 2461-18-
9); hexadecyl glycidyl ether (CAS No. 15965-99-8); n-octadecyl glycidyl 
ether (CAS No. 16245-97-9); tetradecyl glycidyl ether (CAS No. 38954-
75-5); alkyl (C10-C16) glycidyl ether (CAS No. 68081-84-5); 
and alkyl (C12-C14) glycidyl ether (CAS No. 68609-97-2). The 
proposal designated these chemical substances as subcategory II-A.
    The November 7, 1991, notice proposed that manufacturers of 
subcategory II-A chemical substances conduct tests on a representative 
member of the subcategory for the following endpoints: Subchronic 
toxicity, developmental toxicity, subchronic neurotoxicity (functional 
observational battery, motor activity, and neuropathology), and genetic 
toxicology (immediately required testing--the salmonella typhimurium 
reverse mutation assay; in vitro mammalian bone marrow cytogenetics; 
and in vivo mammalian bone marrow cytogenetics tests: chromosomal 
analysis or micronucleus assay).

II. Enforceable Consent Agreement Negotiations

    On July 17, 1992, EPA published a Federal Register notice (57 FR 
31714) (FRL-4078-9) announcing an ``open season''. The open season was 
a time during which industry and other interested parties could submit 
to EPA proposals for enforceable consent agreements (ECAs) to test 
chemical substances for which the Agency had not issued final test 
rules. In that notice, EPA indicated that it would review the 
submissions and select candidates for negotiation of ECAs pursuant to 
40 CFR 790.22. EPA also indicated that it would, at a future date, 
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 (Ref. 1) 
for a categorization scheme and a testing program that would be an 
alternative to that described in the proposed test rule for the 
category glycidol and its derivatives. The Companies proposed a testing 
program for, among others, a representative of the subcategory II-A 
chemical substances. On April 26, 1993, the Companies made another 
proposal (Ref. 2) that expanded the scope of the testing program.
    On August 18, 1993, EPA published a Federal Register notice (58 FR 
43893) (FRL-4639-5) that solicited interested parties to participate in 
or monitor ECA negotiations on subcategory II-A chemical substances.
    On November 30, 1994, the Companies submitted a draft proposed ECA 
(Ref. 3) that revised the material that they had previously submitted 
in this matter. The Companies proposed as the test substance alkyl 
(C12-C13) glycidyl ether (CAS No. 120547-52-6) which is 
subsumed within the six subcategory II-A substances (60 FR 31154, June 
13, 1995) (FRL-4960-3). These seven chemicals are referred to as alkyl 
glycidyl ethers (AGEs). The Companies proposed the following tests--
subchronic toxicity (with an

[[Page 11741]]
assessment of testicular toxicity), developmental toxicity, subchronic 
neurotoxicity (functional observational battery, motor activity, 
neuropathology, and electrophysiology), and genetic toxicity (in vivo 
mammalian bone marrow cytogenetics test: micronucleus assay). In 
addition, the Companies offered to undertake voluntarily a product 
stewardship program to address the potential health and environmental 
hazards associated with AGEs in the workplace.
    On June 13, 1995, EPA published a Federal Register notice (60 FR 
31154) (FRL-4960-3) that resolicited interested parties to negotiate an 
ECA for AGEs, and announced a public meeting for this negotiation. EPA 
held the public meeting, which was attended by representatives of the 
Companies and other interested parties, on July 26, 1995. During the 
public meeting and following the meeting (Refs. 4, 5, 6, and 7), 
consensus was reached on the ECA, with alkyl (C12-C13) 
glycidyl ether to be tested as a representative of AGEs, and on the 
tests to be included in the ECA (see table 1 in Unit IV of this 
preamble). On January 22, 1996, EPA received the ECA and a memorandum 
of understanding (MOU) for a product stewardship program, both signed 
by the Companies.
    On March 15, 1996, EPA signed the ECA and accompanying Order, and 
the MOU.

III. Proposed Test Rule

    EPA has decided not to finalize the proposed test rule for AGEs 
contained in the proposed test rule for the category glycidol and its 
derivatives (56 FR 57144, November 7, 1991) (FRL-3736-2). EPA has 
instead reached agreement with the Companies that the testing 
requirements for AGEs 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 AGEs, the 
Agency will initiate a separate action.

IV. Testing Program

    Table 1 describes the required testing, test standards, and 
reporting requirements under the ECA for alkyl (C12-C13) 
glycidyl ether as a representative of AGEs. This testing program will 
allow EPA to characterize further the potential health hazards 
resulting from exposure to AGEs.

  Table 1.--Required Testing, Test Standards and Reporting Requirements 
     for Alkyl (C12-C13) Glycidyl Ether as a Representative of AGEs     
------------------------------------------------------------------------
                                     Test        Deadline      Interim  
                                 standard (40   for final    reports\2\ 
      Description of test             CFR       report\1\     required  
                                   citation)     (months)     (number)  
------------------------------------------------------------------------
Subchronic Toxicity:             (Appendix I)       21            3     
  1. 90-day dermal subchronic                                           
   toxicity study in rats with                                          
   assessment of testicular                                             
   toxicity.                                                            
Developmental Toxicity:            (Appendix        21            3     
                                      II)                               
  1. Dermal developmental                                               
   toxicity screen in rats.                                             
Neurotoxicity:                     (Appendix        21            3     
                                      III)                              
  1. Dermal subchronic                                                  
   functional observational                                             
   battery in rats.                                                     
  2. Dermal subchronic motor                                            
   activity test in rats.                                               
  3. Dermal subchronic                                                  
   neuropathology in rats.                                              
  4. Dermal subchronic                                                  
   electrophysiology in rats.                                           
Genetic Toxicity:                  798.5395         12            1     
  1. In vivo mammalian bone                                             
   marrow cytogenetics test:                                            
   Micronucleus assay in mice.                                          
  2. The salmonella typhimurium    798.5265         12            1     
   reverse mutation assay.                                              
  3. Detection of gene             798.5300         12            1     
   mutations in somatic cells                                           
   in culture.                                                          
------------------------------------------------------------------------
\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.                               

V. Export Notification

    The issuance of the ECA and Order subjects any persons who export 
or intend to export alkyl (C12-C13) glycidyl ether, 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-42185 (FRL-5356-7), which is available for inspection 
Monday through Friday, excluding legal holidays, in Rm. NE B607, 401 M 
St., SW., Washington, DC 20460, from 12 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 
includes the following information.

A. Supporting Documentation

    (1) Testing Consent Order for Alkyl Glycidyl Ethers, with 
incorporated Enforceable Consent Agreement and associated testing 
protocols attached as appendices.

[[Page 11742]]

    (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) (FRL-2480-7).
    (c) Notice of proposed rulemaking for glycidol and its derivatives 
(56 FR 57144, November 7, 1991) (FRL-3736-2).
    (d) Notice of Opportunity to Initiate Negotiations for TSCA Section 
4 Testing Consent Agreements (57 FR 31714, July 17, 1992) (FRL-4078-9).
    (e) Notice of Testing Consent Agreement Development for Listed 
Chemical Substances; Solicitation for Interested Parties (58 FR 43893, 
August 18, 1993) (FRL-4639-5).
    (h) Testing Consent Agreement Development for Alkyl Glycidyl 
Ethers; Solicitation of Interested Parties and Notice of Public Meeting 
(60 FR 31154, June 13, 1995) (FRL-4960-3).
    (3) Communications consisting of:
    (a) Written letters.
    (b) Meeting summaries.
    (4) Reports - published and unpublished factual materials.

B. References

    1. The Epoxy Resin Systems Task Group of The Society of the 
Plastics Industry, Inc. Letter from Lynne R. Harris to Gary E. Timm. 
Proposed Testing Program for the Chemical Category Glycidol and Its 
Derivatives. Washington, DC (September 15, 1992).
    2. The Epoxy Resin Systems Task Group of The Society of the 
Plastics Industry, Inc. Letter from Lynne R. Harris to TSCA Public 
Docket Office. Testing Consent Agreement Development. Washington, DC 
(April 26, 1993).
    3. The Epoxy Resin Systems Task Group of The Society of the 
Plastics Industry, Inc. Letter from Lynne R. Harris to Charles M. Auer. 
Draft Enforceable Consent Agreement Proposed for Alkyl Glycidyl Ethers 
and Product Stewardship Program. Washington, DC (November 30, 1994).
    4. EPA. Letter from Frank D. Kover to Lynne R. Harris. Dermal 
Absorption Study--ECA for Alkyl Glycidyl Ethers. Washington, DC (August 
16, 1995).
    5. EPA. Letter from Charles M. Auer to Lynne R. Harris. Enforceable 
Consent Agreement for Alkyl Glycidyl Ethers; Final Draft for Test 
Sponsors Signatures. Washington, DC (September 21, 1995).
    6. The Epoxy Resin Systems Task Group of The Society of the 
Plastics Industry, Inc. Letter from Lynne R. Harris to Keith Cronin. 
Draft Protocols for Studies Required Under Enforceable Consent 
Agreement. Washington, DC (December 21, 1995).
    7. The Epoxy Resin Systems Task Group of the Plastics Industry, 
Inc. Letter from Lynne R. Harris to Keith Cronin. Revisions to Draft 
Protocols for Studies Required Under Enforceable Consent Agreement. 
Washington, DC (February 9, 1996).

VII. Regulatory Requirements

A. Regulatory Assessments

    This notice announces a testing consent order incorporating a 
negotiated enforceable consent agreement between EPA and the Companies. 
Since the action announced is not a ``regulation'', ``rule'' or 
``regulatory action'' as these terms are defined by sections 3(d) and 
(e) of Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Executive Order is not applicable. The current action is not a ``rule'' 
as defined by section 601(2) of the Regulatory Flexibility Act, 5 
U.S.C. 601 et seq.; therefore, this statute does not apply. Similarly, 
because the action is not a ``regulation'' or a ``rule'' within the 
meaning of section 101(a) of the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4), the act is not applicable.

B. Paperwork Reduction Act

    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information, unless it displays a 
currently valid control number assigned by the Office of Management and 
Budget (OMB). The information collection requirements related to the 
action announced in this notice have already been approved by OMB 
pursuant to the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., under 
OMB control number 2070-0033 (EPA ICR No. 1139). This action does not 
impose any burdens requiring additional OMB approval.
    The public reporting burden for this collection of information is 
estimated to average 586 hours per response. The estimate includes time 
for reviewing the test protocols attached to the ECA and gathering and 
analyzing the data generated by the tests.

List of Subjects in 40 CFR Part 799

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

    Dated: March 15, 1996.

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

    Therefore, title 40 of the Code of Federal Regulations, 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 alkyl (C12-C13) 
glycidyl ether 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.

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                                         Substance or mixture                                                   
              CAS Number                         name                   Testing            FR publication date  
----------------------------------------------------------------------------------------------------------------
                                                                                                                
  *                 *                 *                 *                 *                 *                *  
120547-52-6                            Alkyl (C12-C13)          Health Effects.........  March 22, 1996         
                                        Glycidyl Ether.                                                         
                                                                                                                
  *                 *                 *                 *                 *                 *                *  
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[FR Doc. 96-7040 Filed 3-21-96; 8:45 am]
BILLING CODE 6560-50-F