[Federal Register Volume 62, Number 12 (Friday, January 17, 1997)]
[Rules and Regulations]
[Pages 2607-2611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1263]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-42150B; FRL-5570-2]
RIN 2070-AB94
Testing Consent Order For Phenol
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final consent agreement and order; direct final rule.
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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 AlliedSignal
Inc., Aristech Chemical Corporation, The Dow Chemical Company, Dakota
Gasification Company, Georgia Gulf Corporation, General Electric
Company, GIRSA, Inc., JLM Chemicals, Inc., Kalama Chemical, Inc.,
Merichem Company, Mitsubishi International Corporation, Mitsui Co.
(U.S.A.), Inc., Shell Chemical Company, and Texaco Refining Marketing
Inc. (collectively the Companies). The Companies have agreed to perform
certain health effects tests on phenol (CAS No. 108-95-2). This notice
summarizes the ECA and adds phenol to the list of chemicals subject to
testing consent orders and hence subject to export notification
requirements.
EFFECTIVE DATE: The effective date of the ECA and Order (including the
export notification requirements) is January 17, 1997. The effective
date for the addition of phenol to the list of chemicals in 40 CFR
799.5000 subject to testing consent orders, and thus, the effective
date of the export notification requirements contained in this notice
for those entities not party to the ECA is March 18, 1997.
If EPA receives any adverse comments on the addition of phenol to
the list of chemicals contained in 40 CFR 799.5000, which makes the
export notification requirements in this notice applicable to all
exporters of phenol, EPA will withdraw this rule. Instead, EPA will
issue a proposed rule addressing this issue and will provide a 30-day
period for public comment. If no adverse comments are received, the
rule will become effective as a final rule on the date specified.
ADDRESSES: Each comment must bear the docket control number OPPTS-
42150B. All comments should be sent in triplicate to: OPPT Document
Control Officer (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 401 M Street, SW., Room G-099, East
Tower, Washington, DC 20460.
Persons submitting information any portion of which they believe is
entitled to treatment as confidential business information (CBI) by EPA
must assert a business confidentiality claim in accordance with 40 CFR
2.203(b) for each such portion. This claim must be made at the time
that the information is submitted to EPA. If a submitter does not
assert a confidentiality claim at the time of submission, EPA will
treat the information as non-confidential and may make it available to
the public without further notice to the submitter. Three sanitized
copies of any comments
[[Page 2608]]
containing information claimed as CBI must also be submitted and will
be placed in the public record for this action.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: [email protected]. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by the
docket number OPPTS-42150B. No CBI should be submitted through e-mail.
Electronic comments on this direct final rule may be filed online at
many Federal Depository Libraries. Additional information on electronic
submissions can be found in Unit VII of this document.
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 direct final rule 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: This notice announces the ECA and Order for
phenol and amends 40 CFR 799.5000 by adding phenol to the list of
chemical substances and mixtures subject to testing consent orders and
export notification requirements.
I. Introduction
TSCA section 12(b)(1) requires persons who export or intend to
export a chemical substance for which the submission of data is
required under section 4 of TSCA to notify EPA of such export or intent
to export. Section 799.5000 of title 40 of the Code of Federal
Regulations contains a list of chemical substances and mixtures that
are subject to testing consent orders and for which export notification
is required under 40 CFR 799.19. This notice adds phenol to the list
contained in 40 CFR 799.5000, thus making all persons who export or
intend to export phenol subject to the export notification requirements
contained in 40 CFR part 707 (see Unit VI of this document). EPA is
amending 40 CFR 799.5000 by direct final rulemaking. However, EPA does
not expect adverse comments on this rule because the burden of
compliance with the export notification requirements (set forth at Unit
VIII. A. of this notice) is minimal.
II. Chemical-Specific Background
At the request of EPA, the Interagency Testing Committee (ITC)
received a subset of chemicals included on EPA's Integrated Risk
Information System (IRIS) data base for which the Agency believed there
is inadequate data. The ITC designated six chemicals included in IRIS
(acrylic acid addressed in a separate rulemaking at 57 FR 7656, March
4, 1992), acetophenone, phenol, N,N-dimethylaniline, ethyl acetate, and
2,6-dimethylphenol for priority consideration as candidates for
chemical fate, health effects, and environmental effects testing. The
reasons for these recommendations by the ITC are further discussed in
the Federal Register of March 6, 1991 (56 FR 9534), and in the chemical
specific sections of the November 22, 1993 (58 FR 61654) Federal
Register notice.
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 industry and other interested parties could submit to EPA
proposals for enforceable consent agreements (ECAs) to test 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.
After evaluating the testing proposals submitted during the open
season (57 FR 31714), EPA issued a Federal Register notice on March 30,
1993 (58 FR 16669), which identified a three tier priority ranking of
the testing proposals received from manufacturers, solicited parties
interested in monitoring or participating in ECA negotiations of tier I
chemicals to identify themselves to EPA, and extended the opportunity
for manufacturers to supplement their test proposals for tier I, tier
II, tier III and unranked chemicals.
In response to the March 30, 1993, notice EPA received, among other
items, a request for removing carbon disulfide from the open season
program, a testing proposal for brominated flame retardants, and a
request for adding phenol to tier I.
On November 22, 1993 (58 FR 61654), EPA proposed a test rule under
section 4(a) of TSCA that would require manufacturers and processors of
five chemicals (phenol, acetophenone, N,N-dimethylaniline, ethyl
acetate, and 2,6-dimethylphenol) to conduct testing for certain
chemical fate, health and environmental effects. In addition, in this
proposed rulemaking, EPA also invited manufacturers and/or processors
of these chemical substances to participate in consent agreement
negotiations for the chemicals proposed for testing to develop and
submit consent agreement proposals to EPA.
In evaluating the ITC's testing recommendations for phenol in the
proposed test rule, EPA considered the information provided by the ITC,
the on-line IRIS data base, and supplemental information developed by
EPA. In developing the testing requirements, EPA has also considered
the status of phenol under the Clean Air Act amendments of 1990. These
considerations have influenced the testing routes of administration
selected.
EPA believes that phenol is used in a wide variety of industrial
and consumer activities. The annual production volume is estimated to
exceed 3.5 billion pounds. Approximately 320,000 workers may be exposed
to phenol. In addition, phenol is used in numerous consumer products
indicating a potential for exposure to consumers.
In the November 22, 1993 proposal, EPA proposed that phenol be
tested, by the inhalation route of administration, for subchronic
toxicity, toxicokinetics, neurotoxicity (acute and subchronic), and
reproductive toxicity. In addition, EPA proposed that toxicokinetics
testing by the oral route of administration and both reproductive and
developmental toxicity testing be conducted by gavage.
EPA also proposed, in the Hazardous Air Pollutants (HAPS) test rule
(61 FR 33178, June 26, 1996) (FRL-4869-1) that phenol be tested for
acute toxicity and immunotoxicity in addition to the testing proposed
earlier (58 FR 61654). On the basis of information provided by the
Phenol Panel, EPA requested that manufacturers conduct a 14-day
inhalation study so that inhalation risks of phenol exposure could be
extrapolated from the oral test data and pharmacokinetics data that the
Panel members had agreed to conduct, rather than the acute study. The
inhalation study is necessary to determine portal-of-entry effects from
inhalation
[[Page 2609]]
exposure which can only be obtained from a well conducted inhalation
study. The pharmacokinetics data can be used to calculate the
inhalation exposures that correspond to the doses used in the oral
studies for the systemic effects, thus permitting an estimation of the
inhalation doses that would be required to produce the responses
observed in the oral studies. The Panel provided EPA with test data
which are sufficient to characterize the immunotoxicity of phenol.
III. Enforceable Consent Agreement Negotiations
In response to EPA's proposed rule and offer to negotiate an ECA,
The Chemical Manufacturer's Association (CMA) Phenol Panel submitted a
proposal for a testing program (Ref. 1).
EPA held a public meeting to negotiate an ECA for phenol on October
26, 1995. 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
September 6, 1996, EPA received the ECA signed by the Companies. On
January 9, 1997, EPA signed the ECA and accompanying Order.
IV. Proposed Test Rule
EPA has decided not to finalize the proposed test rules for phenol
(58 FR 61654, November 22, 1993; 61 FR 33178, June 26, 1996). EPA has
instead reached agreement with the Companies that the testing
requirements for phenol in both proposed rules, 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 phenol,
the EPA will initiate a separate action.
V. Testing Program
Table 1 describes the required testing, test standards, and
reporting requirements under the ECA for phenol. This testing program
will allow EPA to characterize further the potential health hazards
resulting from exposure to phenol.
Table 1.--Required Testing, Test Standards and Reporting Requirements
for Phenol
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Test Deadline Interim
standard for final reports
Description of test (40 CFR report\1\ required\2\
citation) (months) (number)
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Respiratory toxicity:
1. 14-day, inhalation. Appendix I 12 1
Reproductive toxicity:
1. Reproductive toxicity, 798.4700 29 4
drinking water. (40 CFR)
(Appendix
II)
Neurotoxicity:
1. Subchronic neurotoxicity, 91-154617 21 3
functional observational (National
battery, motor activity, Technical
neuropathology, drinking Informatio
water. n Service)
(Appendix
III)
2. Developmental 91-154617 \4\21 3
neurotoxicity,\3\ drinking (National
water. Technical
Informatio
n Service)
(Appendix
III)
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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\ If the Agency determines that the results of the neuropathology
study are not negative, then this required testing must be performed.
\4\ Figure indicates the reporting deadline, in months, calculated from
the date the notification to the test sponsor by certified letter or
Federal Register notice that the Agency has determined this required
testing must be performed.
VI. Export Notification
Upon publication of this notice, the ECA and Order subject any of
the Companies who export or intend to export phenol, of any purity, to
the export notification requirements of section 12(b) of TSCA. Upon the
effective date of the rule, any other persons who export or intend to
export phenol, of any purity, will be subject 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.
VII. Public Record
EPA has established a record for this ECA and Order under docket
number OPPTS-42150B, 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.
Electronic comments can be sent directly to EPA at: oppt-
[email protected]. Electronic comments must be submitted as an ASCII
file avoiding the use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which also include all comments submitted
directly in writing. The official rulemaking record is the paper record
maintained at the address in ``ADDRESSES'' at the beginning of this
document.
A. Supporting Documentation
This record contains the basic information considered in developing
this ECA and Order and includes the following information.
(1) Testing Consent Order for Phenol, with incorporated Enforceable
Consent
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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 Acetophenone, Phenol, N,N-
dimethylaniline, ethyl acetate, and 2,6-dimethylphenol (58 FR 61654;
November 22, 1993).
(b) Notice of Opportunity to Initiate Negotiations for TSCA Section
4 Testing Consent Agreements (57 FR 31714; July 17, 1992).
(c) 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) Meeting summaries.
(4) Reports--published and unpublished factual materials.
B. References
1. The Phenol Regulatory Task Group of the Chemical Manufacturers
Association. Letter from Gordon D. Strickland to EPA. Enforceable
Testing Consent Agreement Proposal for Phenol. Washington, DC.
(February 22, 1994).
VIII. Regulatory Requirements
A. Regulatory Assessment Requirements
For regulatory assessment purposes, the ECA and Order for phenol
announced in this notice do not constitute a rule as defined by
sections 3 (d) and (e) of Executive Order 12866 (58 FR 51735, October
4, 1993) or section 601(2) of the Regulatory Flexibility Act, 5 U.S.C.
601 et seq. The Order incorporates the ECA and the ECA is an agreement
between and among EPA and the Companies. This notice, however, is a
rule because it amends 40 CFR 799.5000, thereby subjecting all persons
who export or intend to export phenol to export notification
requirements.
Under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., EPA has
determined that few, if any, entities which currently export phenol, or
are likely to export phenol in the future, are small as defined by 40
CFR 704.3. Furthermore, the exporter is required only to include the
following information in the notice to EPA: The name of the chemical
substance (i.e., in this case, phenol); the name and address of the
exporter; the country (ies) of import; the date(s) of export or
intended export; and the section of TSCA under which EPA has taken
action (i.e., in this case, TSCA section 4). The cost of compliance
with these routine administrative requirements is minimal. Therefore, I
certify that this rule will not have a significant economic impact on a
substantial number of small entities.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.
L. 104-4, establishes requirements for Federal agencies to assess the
effects of certain regulatory actions on State, local, and tribal
governments and the private sector. Under sections 202 and 205 of UMRA,
EPA generally must prepare a written statement of economic and
regulatory alternatives analyses for proposed and final rules with
Federal mandates, as defined by UMRA, that may result in expenditures
to State, local, and tribal governments, in the aggregate, or to the
private sector, of $100 million or more in any one year.
This rule will not result in annual expenditures of $100 million or
more for State, local, and/or tribal governments in the aggregate, or
the private sector. As described above, the export notification
procedure is a routine administrative act and the cost of compliance is
minimal. The requirements of section 203 of UMRA which relate to
regulatory requirements that may significantly or uniquely affect small
governments also do not apply to today's rule because the rule affects
only the private sector, i.e., those who export or intend to export
phenol.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
rule is not a ``significant regulatory action'' subject to review by
the Office of Management and Budget (OMB), nor does it involve special
considerations of environmental justice related issues as required by
Executive Order 12898 (59 FR 7629, February 16, 1994).
An agency may not conduct or sponsor, and a person is not required
to respond to, an information collection request unless it displays a
currently valid control number assigned by OMB. The OMB control numbers
for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter
15. The information collection requirements related to this action 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) for implementation of the ECA and Order, and OMB control number
2070-0030 (EPA ICR No. 0795) for compliance with export notification
requirements. This action does not impose any burdens requiring
additional OMB approval.
The public reporting burden for the collection of information
relating to the ECA and Order is estimated to average 388 hours per
response. This estimate includes the time for reviewing the test
protocols attached to the ECA, generating and analyzing the test
results, and submitting the results to EPA. The public reporting burden
for the collection of information relating to the export notification
requirements is estimated to average 0.55 hours per response.
B. Submission to Congress and the General Accounting Office
This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).
Pursuant to 5 U.S.C. 801(a)(1)(A), EPA submitted this action to the
U.S. Senate, the U.S. House of Representatives and the Comptroller
General of the General Accounting Office prior to its publication in
today's Federal Register.
List of Subjects in 40 CFR Part 799
Environmental Protection, Chemicals, Chemical export, Hazardous
substances, Health effects, Laboratories, Reporting and recordkeeping
requirements, Testing.
Dated: January 9, 1997.
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 phenol to the table in CAS
number order, effective March 18, 1997, 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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* * * * * *
108-95-2 Phenol................. Health Effects......... January 17, 1997
* * * * * *
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[FR Doc. 97-1263 Filed 1-16-97; 8:45 am]
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