[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-
Hotline@epamail.epa.gov.
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
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Test Deadline Interim
standard (40 for final reports\2\
Description of test CFR report\1\ required
citation) (months) (number)
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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.
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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.
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
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* * * * * * *
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
