[Federal Register Volume 59, Number 146 (Monday, August 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18560]
[[Page Unknown]]
[Federal Register: August 1, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-42168; FRL 4642-3]
Testing Consent Order For Bisphenol A Diglycidyl Ether
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 that incorporates an
Enforceable Consent Agreement (ECA) pursuant to the Toxic Substances
Control Act (TSCA), with the Dow Chemical Company, Shell Oil Company,
and Ciba-Geigy Corporation, (the Companies) who have agreed to perform
certain health effects tests and an exposure evaluation test with
bisphenol A diglycidyl ether (DGEBPA; CAS No. 1675-543). This document
summarizes the ECA, amends 40 CFR 799.5000 by adding DGEBPA to the list
of chemical substances and mixtures subject to ECAs and deletes DGEBPA
from the proposed test rule for the category glycidol and its
derivatives. Accordingly, the export notification requirements of 40
CFR part 707 apply to DGEBPA.
EFFECTIVE DATE: August 1, 1994.
FOR FURTHER INFORMATION CONTACT: Susan Hazen, 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 DGEBPA to the list of chemical substances and mixtures subject
to ECAs and export notification requirements.
I. Regulatory History
A. ITC Designation
In its Third Report to the Administrator of the Environmental
Protection Agency, 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'' for priority
consideration for health effects testing in the following areas:
mutagenicity, carcinogenicity, and other adverse health effects, with
particular emphasis on the reproductive system. Epidemiology studies
were also recommended. The rationale for the original designation is
discussed in the Federal Register of October 30, 1978 (43 FR 50630).
This chemical category was defined by the ITC as all substances of the
general formula:
TR01AU94.012
where R is a hydrogen atom or any alkyl, aryl, or acyl group. R is
unrestricted as to the number and type of substitutes it may carry.
In evaluating the testing needs for glycidyls, EPA considered all
relevant information, including the following: information presented in
the ITC's report; information regarding production volume, use,
exposure, and release reported by manufacturers of glycidyls under the
TSCA section 8(a) Preliminary Assessment Information Rule (40 CFR part
712); health and safety studies submitted under TSCA section 8(d)
Health and Safety Reporting Rule (40 CFR part 716) for glycidyls; and
published and unpublished information available to EPA. On December 30,
1983, EPA published an advanced notice of proposed rulemaking (ANPR) in
the Federal Register (48 FR 57562) to require testing glycidyls under
section 4(a) of TSCA.
EPA evaluated and responded to public comments on the ANPR in a
document (Ref. 1), entitled ``Support Document for Glycidol and its
Derivatives: Responses to Public Comments on the Advance Notice of
Proposed Rulemaking'' (December, 1989).
In addition, EPA developed a technical support document for
glycidol and its derivatives (Ref. 2). This document includes data on
the identity and chemical/physical properties of the substances
contained in this chemical category, as well as information on the
production, uses, chemical fate, human exposure, and health effects for
these substances. Subsequently, EPA summarized the information in this
technical support document, as well as more recent information from
other sources, in an additional support document for glycidyls (Ref. 3)
outlining the data supporting EPA's findings under section 4(a)(1) of
TSCA for certain substances contained in the category.
A meeting was held on May 17, 1984, between representatives from
the Epoxy Resins Program Panel of the Chemical Manufacturers
Association (CMA) and EPA personnel concerning this chemical category.
Meetings were also held on January 25, 1989, and May 17, 1989, between
EPA and representatives of various working units of the Society of the
Plastics Industry, Inc. (SPI). An Epoxides Workshop was held on April
25, 1990, at which EPA personnel and representatives of SPI were
scheduled to discuss, among other topics, the glycidyls testing
category as it relates to the broader issues concerning epoxides in
general. Copies of the overhead slides, which were supplied in advance
to SPI, have been placed in the record for the proposed rulemaking,
along with summaries of the meetings held and copies of all support
documents.
B. Proposed Test Rule
EPA published a proposed test rule for the category glycidol and
its derivatives (56 FR 57144, November 7, 1991). EPA proposed health
effects testing which included testing for subchronic toxicity,
developmental toxicity, reproductive toxicity, neurotoxicity,
mutagenicity, and oncogenicity.
EPA evaluated the public comments submitted after the test rule was
proposed and responded to these comments in a document entitled
``Support Document for Glycidol and its Derivatives: Responses to
Public Comments on the Proposed Rulemaking; DGEBPA'' (July, 1993) (Ref.
4).
C. 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 period
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 chemicals selected.
On March 30, 1993, EPA published a Federal Register notice (58 FR
16669) announcing candidates selected for ECA negotiations and
requesting that interested parties identify themselves to EPA. One of
the glycidyls, DGEBPA, was selected. The notice established EPA's
priority for initiating negotiations on the chemicals selected, and
DGEBPA was among the chemicals assigned a high priority. The notice
announced tentative dates for starting negotiations on DGEBPA and the
other high-priority chemicals.
The Dow Chemical Company, Shell Oil Company, and Ciba-Geigy
Corporation identified themselves through their agent, SPI, as
interested parties. On May 18, 1993, EPA held a public meeting attended
by representatives of interested parties. At the public meeting, SPI,
on behalf of its member companies, presented a proposed testing plan
and provided test protocols (Ref. 5) which would characterize the
potential of DGEBPA for oncogenicity, neurotoxicity, male reproductive
toxicity, and mutagenicity. In addition, SPI offered to undertake a
glove permeability study and to implement a product stewardship program
as a means of assessing and reducing worker exposure to DGEBPA. EPA
also made available its draft proposal for testing on DGEBPA.
On June 1, 1993, EPA requested additional information from SPI to
be used in conjunction with evaluating the testing plan (Ref. 6). In
response to EPA's request, SPI submitted information (Refs. 7 through
15) and requested an opportunity to meet with EPA again.
On June 29, 1993, EPA convened a second public meeting attended by
representatives of interested parties. At the public meeting, SPI, on
behalf of its member companies, presented a testing proposal and test
protocols (Ref. 16). Protocols were presented for a 2-year bioassay, a
subchronic study (with satellite studies for testing for reproductive
toxicity, neurotoxicity, and mutagenicity); all studies would be
conducted via the dermal route of exposure. In addition, SPI reiterated
its offer to perform a glove permeability study and implement a product
stewardship program for DGEBPA.
EPA proposed that all testing of DGEBPA be conducted via the oral
route of administration. After consideration of SPI's proposed testing
plan and review of new information (Refs. 17, 18 and 19) submitted to
EPA by SPI, EPA has determined that testing via the dermal route of
exposure is consistent with DGEBPA's physical properties and the
typical route of human exposure to DGEBPA, that significant systemic
absorption occurs when DGEBPA is applied dermally, and that a higher
percentage of parent compound will be absorbed if administered dermally
than if given orally and extensively hydrolyzed at acid pH of the
stomach. For these reasons, testing via the dermal route of exposure is
appropriate.
EPA proposed testing DGEBPA for developmental toxicity. After
considering new information presented to EPA by SPI (Refs. 20, 21 and
22), EPA has determined that sufficient information already exists to
evaluate the potential for developmental toxicity from exposure to
DGEBPA. For this reason, further tests are not needed at this time.
EPA proposed testing DGEBPA for mutagenicity1. After
consideration of SPI's proposed testing plan and new information
presented to EPA by SPI (Ref. 7), EPA has determined that for many of
the tests proposed, information has already been developed; thus these
tests are no longer necessary.
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\S\pecifically, EPA proposed the salmonella typhimurium, reverse
mutation assay, detection of gene mutations in somatic cells in
culture, sex linked recessive lethal test in drosophila
melanogaster, a mouse specific-locus assay or mouse biochemical
specific assay, in vitro mammalian cytogenetics assay, in vivo
mammalian cytogenetics assay, rodent dominant lethal assay, and a
rodent heritable translocation assay for DGEBPA.
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The Companies have agreed to perform testing for oncogenicity,
subchronic toxicity, reproductive toxicity, and neurotoxicity, and
glove permeability by specified dates according to test standards
described below. In addition, the Companies are voluntarily developing
and implementing a DGEBPA product stewardship program (PSP) that
includes the following primary elements: application and communication
of health and safety data; new data development; pollution prevention,
waste minimization, and other exposure reduction actions; and
continuous improvement in measurement and reporting activities. EPA
believes that this PSP makes significant progress toward reducing the
potential risk of injury to health and the environment posed by
exposure to DGEBPA. The results of the testing program in the DGEBPA
ECA are expected to aid in the periodic EPA and industry evaluation of
the PSP to determine its adequacy and effectiveness.
II. Production, Use, and Exposure
DGEBPA and other glycidyl derivatives are produced by reacting
epichlorohydrin with a compound having one or more active hydrogen
atoms, followed by dehydrohalogenation (Ref. 23). On the basis of the
Inventory Update Rule (40 CFR part 710, subpart B) or from other
sources, EPA estimates annual production volume for DGEBPA to be
approximately 400 million pounds (Ref. 5). The production volume of
DGEBPA, represents greater than 95 percent of the total volume of
production for the entire category of glycidol and its derivatives.
The uses for all glycidyls are listed in the technical support
document developed after the ANPR was published (Ref. 2). Primarily,
DGEBPA is the principal component in epoxy resins. Other glycidyl
compounds are used as reactive diluents. Resins which are then reacted
with curing agents to yield high performance thermosetting plastics,
used in a large variety of application such as strong adhesives or
coatings.
Glycidol and its esters and ethers are produced within ``closed
systems'' (Refs. 24 and 25); however, EPA believes that some worker
exposure may occur during this production process, due to intermittent
high-level exposures during maintenance operations, or resulting from
spills or leaks from the ``closed systems.''
In addition, workers may be exposed by the dermal and inhalation
routes to glycidyl derivatives during the processing of glycidyl ethers
and esters for various uses, particularly since these processes are
generally conducted in an open system (Ref. 24). The National Institute
for Occupational Safety and Health (NIOSH) has estimated the number of
workers potentially exposed to glycidol and its derivatives, and these
estimates appear in an exposure support document prepared for the
proposed rulemaking (Ref. 24). NIOSH has estimated that 36,697 workers
in the United States are potentially exposed to glycidol, that 52,838
workers may be exposed to glycidyl ethers, and that 42,469 workers may
be exposed to glycidyl esters. Furthermore, recent estimates suggest
that up to 3 million people in the United States may be exposed to
DGEBPA through the consumer and commercial use of epoxy resins (Ref.
25).
III. Testing Program
The Companies have agreed to complete the following testing:
Table 1.--Testing Required For DGEBPA
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Deadline for
Description of Test Standard (40 Final Reports Final Report
Tests CFR citation) Months\1\ Date\2\
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2-year Bioassay.. 798.3320 as 53 8
amended
(Appendix I)
Subchronic 798.2250 as 21 3
Toxicity Study. amended
(Appendix II)
Functional 798.6050 as 21 3
Observation amended
Battery: (Appendix III)
subchronic.
Motor Activity 798.6200 as 21 3
Test: subchronic. amended
(Appendix III)
Neuropathology: 798.6400 as 21 3
subchronic. amended
(Appendix III)
Functional 798.6050 as 12\4\ 1
Observation amended
Battery: (Appendix IV)
acute\3\.
Motor Activity 798.6200 as 12\6\ 1
Test: acute\5\. amended
(Appendix IV)
Neuropathology 798.6400 as 12\8\ 1
Test: acute\7\. amended
(Appendix IV)
Reproductive 798.4700 as 21 3
Toxicity Test. amended
(Appendix V)
Glove ASTM as amended 12 1
Permeability (Appendix VI)
Test.
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\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 the Agency determines that the results of the subchronic study
are not negative, then this required testing must be performed.
\4\ Figure indicates that reporting deadline, in months, calculated from
the date of notification of the test sponsor by certified letter or
Federal Register notice, that the Agency has determined that this
required testing must be performed.
\5\ If the Agency determines that the results of the subchronic study
are not negative, then this required testing must be performed.
\6\ Figure indicates that reporting deadline, in months, calculated from
the date of notification of the test sponsor by certified letter or
Federal Register notice, that the Agency has determined that this
required testing must be performed.
\7\ If the Agency determines that the results of the subchronic study
are not negative, then this required testing must be performed.
\8\ Figure indicates that reporting deadline, in months, calculated from
the date of notification of the test sponsor by certified letter or
Federal Register notice, that the Agency has determined that this
required testing must be performed.
IV. Export Notification
The issuance of the ECA and Order subjects any persons who export
or intend to export the chemical substance, DGEBPA (CAS No. 1675-54-3),
of any purity, to the export notification requirements of section 12(b)
of TSCA and the regulations promulgated pursuant to it at 40 CFR part
707. The listing of the chemical substance or mixture at 40 CFR
799.5000 serves as a notification to persons who intend to export such
chemical substance or mixture that the substance or mixture is the
subject of an ECA and Order and 40 CFR part 707 applies.
V. Deletion from Proposed Rule
EPA and the Companies have agreed that the DGEBPA testing
requirements in the proposed rule will be met by implementing the ECA
and Order, and the issuance of the ECA and Order by EPA constitutes
final EPA action for purposes of 5 U.S.C. 704. Therefore, the proposed
testing rule of DGEBPA, in the proposed test rule for the category
glycidol and its derivatives, published at 56 FR 57144, November 7,
1991, will not be adopted as final.
VI. Public Record
A. Supporting Documentation
EPA has established a record for this ECA and Order, under docket
number OPPTS-42168, which is available for inspection Monday through
Friday, excluding legal holidays, in the TSCA Nonconfidential
Information Center, NE B607 401 M St., SW., Washington, DC., 20460,
from 1 p.m. to 4 p.m. Information claimed as Confidential Business
Information (CBI) while a 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:
(1) Testing Consent Order for DGEBPA, with incorporated Enforceable
Consent Agreement and associated testing protocols attached as
appendices.
(2) Federal Register notices pertaining to this notice and the
Testing Consent Order incorporating the ECA consisting of:
(a) Notice of Proposed Rulemaking for Glycidol and its Derivatives,
(November 7, 1991, 56 FR 57144).
(b) Notice announcing opportunity to initiate negotiations for TSCA
section 4 testing consent agreements (July 17, 1992, 57 FR 31714).
(3) Communications consisting of:
(a) Written letters.
(b) Contact reports of telephone summaries.
(c) Meeting summaries.
(4) Reports - published and unpublished factual materials.
B. References
(1) USEPA, U.S. Environmental Protection Agency. Test Rules
Development Branch. ``Support Document for Glycidol and its
Derivatives: Responses to Comments on the Advance Notice of Proposed
Rulemaking.'' (December, 1989).
(2) Syracuse Research Corporation. ``Draft Final Technical
Support Document: Glycidol and its Derivatives.'' (November 11,
1986).
(3) USEPA. U.S. Environmental Protection Agency. Test Rules
Development Branch. ``Support Document for Glycidol and its
Derivatives: Review of Available Health Effects Data.'' (October,
1987).
(4) USEPA. U.S. Environmental Protection Agency. Chemical
Testing and Information Branch. ``Support Document for Glycidol and
its Derivatives: Responses to Comments on the Proposed Rulemaking;
Bisphenol A diglycidyl ether.'' (September, 1993).
(5) The Society of the Plastics Industry, Inc. ``DGEBPA
Enforceable Consent Agreement Presentation.'' (May 18, 1993).
(6) USEPA. U.S. Environmental Protection Agency. ``Diglycidyl
ether of Bisphenol A, Review of Testing Proposal,'' letter from
Keith J. Cronin to Lynn R. Harris (Society of the Plastics Industry
Inc.). (June, 1993).
(7) Pullin, Terry, G. Report to the Dow Chemical Company
entitled: ``Integrated Mutagenicity Testing Program on Several Epoxy
Compounds.'' (December 28, 1977).
(8) Bently, et al., ``Hydrolysis of bisphenol A diglycidyl ether
by epoxide hydrolases in cytosolic and microsomal fractions of mouse
liver and skin: inhibition by bis epoxycyclopentylether and the
effects upon the covalent binding to mouse skin DNA.''
Carcinogenesis, vol. 10, no. 2 pp. 321-327, 1989.
(9) Magdalou, J., and Hammock, B. ``1,2 Epoxycycloalkanes:
Substrates and Inhibitors of Microsomal and Cytosolic Epoxide
Hydrolases in Mouse Liver.'' Biochemical Pharmacology, vol. 37, no.
14, pp. 2717-2722, 1988.
(10) DiGiovanni, J. ``Multistage Carcinogenesis in Mouse Skin.''
Pharmacology Therapeutics, vol. 54, pp. 63-128, 1992
(11) Li, D., and Randerath, K. ``Strain differences of I-
compounds in relation to organ sites of spontaneous tumorigenesis
and non-neoplastic renal diseases in mice.'' Carcinogenesis, vol.
11, no. 2 pp. 251-255, 1990.
(12) Rao, et al. ``Mouse Strains for Chemical Carcinogenicity
Studies: Overview of Workshop.'' Fundamental and Applied Toxicology,
vol. 10, pp. 385-394, 1988.
(13) USEPA. U.S. Environmental Protection Agency. Summary of:
``Workshop on Carcinogenesis Bioassay via the Dermal Route.'' (April
29, 1987).
(14) USEPA. U.S. Environmental Protection Agency. Summary of:
``Second EPA Workshop on Carcinogenesis via the Dermal Route.'' (May
18, 1988).
(15) USEPA. U.S. Environmental Protection Agency. Office of
Pesticides and Toxic Substances. Atlas of Dermal Lesions (August,
1990).
(16) The Society of the Plastics Industry, Inc. ``DGEBPA
Enforceable Consent Agreement Presentation.'' (June 29, 1993).
(17) Nolan, R., and Unger, L. Report to the Dow Chemical Company
entitled: ``Diglycidyl Ether of Bisphenol A (DGEBPA): Fate in Male
Fischer 344 Rats (Probe).'' (December 15, 1981).
(18) Climie, et al. ``Metabolism of the epoxy resin component
2,2-bis[4-(2,3-epoxypropoxy)phenyl]propane, the diglycidyl ether of
bisphenol A (DGEBPA) in the mouse.'' Part I ``A comparison of the
fate of a single oral dose of 14C-DGEBPA.'' Xenobiotica, vol. 11,
no.6, pps 391-300, 1981.
(19) Climie, et al. ``Metabolism of the epoxy resin component
2,2-bis[4-(2,3-epoxypropoxy)phenyl]propane, the diglycidyl ether of
bisphenol A (DGEBPA) in the mouse.'' Part II - ``Identification of
metabolites in urine and faeces following a single oral dose of 14C-
DGEBPA.'' Xenobiotica, vol.11, no.6, pps 401-424, 1981.
(20) Smith, et al. Report to Ciba-Geigy Ltd., entitled: ``A
Study of the Effect of TK 10490 on the Pregnancy of the Rat.'' (July
19, 1988).
(21) Smith, et al. Report to Ciba-Geigy Ltd., entitled: ``A
Study of the Effect of TK 10490 on the Pregnancy of the Rabbit.''
(July 19, 1988).
(22) Smith, et al. Report to Ciba-Geigy Ltd., entitled: ``A
Study of the Effect of TK 10490 on Reproductive Function of One
Generation in the Rat.'' (February 2, 1989).
(23) Lee, H., and Neville, K. ``Epoxy Resins.'' In: Encyclopedia
of Polymer Science and Technology, vol. 6. N.M. Bikales, and J.
Conrad, eds. New York, NY: Interscience Publishers, pp. 209-271.
(1967).
(24) JRB Associates. ``TSCA Section 4 Human Exposure Assessment:
Glycidol and its Derivatives (Final Report).'' (February 4, 1982).
(25) Versar, Inc. ``Consumer Exposure to the Glycidols (Draft
Final Report).'' (December 1, 1983).
VII. Regulatory Assessment Requirements
The Office of Management and Budget (OMB) has approved the
information collection requirements contained in this Consent Order
under the provisions of the Paperwork Reduction Act of 1980, 44 U.S.C.
3501 et seq., and has assigned OMB control number 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 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, and Testing.
Dated: July 8, 1994.
Susan H. Wayland,
Acting 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 continues to read as follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
2. Section 799.5000 is amended by revising the section heading to
read as set forth below and by adding bisphenol A diglycidyl 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.
* * * * *
------------------------------------------------------------------------
Substance or FR Publication
CAS Number Mixture name Testing date
------------------------------------------------------------------------
* * * * * * *
4675-54-3........ Bisphenol A Health effects August 1, 1994
diglycidyl ether Exposure
evaluation
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 94-18560 Filed 7-29-94; 8:45 am]
BILLING CODE 6560-50-F
