[Federal Register: September 16, 2010 (Volume 75, Number 179)]
[Rules and Regulations]
[Page 56472-56477]
[DOCID:fr16se10-4]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 790

[EPA-HQ-OPPT-2009-0894; FRL-8832-8]
RIN 2070-AJ59

Amendments to Enforceable Consent Agreement Procedural Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revising the procedures for developing Enforceable
Consent Agreements (ECAs) to generate test data under the Toxic
Substances Control Act (TSCA). The main features of the ECA process
that EPA is changing include when and how to initiate negotiations and
inserting a firm deadline at which negotiations will terminate. EPA is
also deleting, modifying, or consolidating several sections of 40 CFR
part 790 to place the ECA provisions in one section and the Interagency
Testing Committee (ITC) provisions in a separate section, to make it
clearer that there is one ECA negotiation procedure applicable to all
circumstances when an ECA would be appropriate, and to make conforming
changes in other sections that reference the ECA procedures.

DATES: This final rule is effective October 18, 2010.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2009-0894. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket
Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave.,
NW., Washington, DC. The EPA/DC Public Reading Room hours of operation
are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number of the EPA/DC Public Reading Room is
(202) 566-1744, and the telephone number for the OPPT Docket is (202)
566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Jessica Barkas, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 250-8880; e-mail address<EMAIL_ADDRESS>     For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture
(defined by statute to include import) or process chemical substances
or mixtures (defined as ``chemical'' in 40 CFR part 790). Potentially
affected entities may include, but are not limited to:
     Manufacturers (defined by statute to include importers) of
chemical substances (NAIC codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
     Processors of chemical substances (NAIC codes 325 and
324110), e.g., chemical manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

II. Background

A. What is the Agency's Authority for Taking this Action?

    Section 4 of TSCA authorizes EPA to require manufacturers and
processors of chemical substances and mixtures to test these chemical
substances to generate data that is relevant to determining whether the
chemical substances present an unreasonable risk. Section 4(a) of TSCA
empowers the Agency to promulgate rules which require such testing.
Section 4 of TSCA provides implied authority to enter into ECAs
requiring testing where such agreements provide procedural safeguards
equivalent to those that apply where testing is conducted by rule.

B. What Action is the Agency Taking?

    EPA is finalizing a rule revising the procedures for initiating and
negotiating an ECA. ECAs are enforceable agreements between EPA and one
or more chemical manufacturers or processors to conduct specific
testing on a particular chemical substance. These agreements are
designed to provide EPA with data identified as necessary to evaluate a
particular chemical substance without the need for EPA to first make
the risk- or exposure-based findings for, or promulgate, a TSCA section
4 test rule, and without introducing delays inherent in the rulemaking
process. ECAs were intended to permit EPA to obtain test data more
quickly than test rules, while preserving opportunity for input from
the public and the affected manufacturer(s).
    The main features of the ECA process that EPA is changing include
when and how to initiate negotiations and inserting a firm deadline at
which negotiations will terminate. EPA is also deleting, modifying, or
consolidating several parts of 40 CFR part 790 to place the ECA
provisions in one section and the ITC provisions in a separate section,
to make it clearer that there is one ECA negotiation procedure
applicable to all circumstances when an ECA would be appropriate, and
to make conforming changes in other sections that reference the ECA
procedures.
    The proposed rule was published in the Federal Register of February
19, 2010 (75 FR 7428) (FRL-8802-6). Additional detail about ECAs, the
specific changes, and the rationale for those changes can be found in
that Federal Register document. One comment was received on the
proposed rule. No changes have been made to the rule since it was
proposed.

C. What Was EPA's Response to Comment?

    The comment period for the proposed rule ended on March 22, 2010.
One comment was received, from the American Chemistry Council (ACC).
The ACC comments indicated support for the ECA procedural changes, and
had a few specific suggestions:
    Comment 1: EPA should include in the ECA rule what ``office or
program and level of management within EPA will have the organizational
authority to officially speak on behalf of the Agency on such perceived
[testing] needs, and how EPA will communicate this request to industry
and through what vehicle.''
    EPA response: Under the current delegation, the EPA Assistant
Administrator for the Office of Chemical Safety and Pollution
Prevention (OCSPP) (formerly the Office of Prevention, Pesticides and
Toxic Substances (OPPTS)) has the authority to make the final decision
on whether testing is necessary under TSCA section 4. As explained in
the preamble to the proposed rule, EPA will invite testing proposals
through Federal Register documents, EPA's website, and other forms of
public communication. Depending on the circumstances (e.g., the size
and geographical distribution of the group potentially required to
conduct testing), EPA may use more than one of these methods, as
necessary to reach the affected companies. For instance, one of the
public forms of communication that EPA may use is speeches or
presentations by Agency officials at industry conferences, where
representatives from individual companies and trade associations will
be present, and able to pass the word along to their companies and
members. Of course, individual companies, trade associations and other
organizations, and their representatives can always

contact EPA, using the contact information provided in the Federal
Register document, EPA website, or other public communication of
testing needs, with questions about specific testing requirements and
other details for individual chemical substances.
    Comment 2: EPA should describe in greater detail what EPA believes
should be contained in the proposed consent agreement.
    EPA response: The testing needs, timeline, and other details will
necessarily vary for each individual chemical substance, so it is
impossible for EPA to generalize about what will form an adequate
proposal in each circumstance. The standard provisions that must be
included in all consent agreements are listed in 40 CFR 790.60,
``Contents of consent agreements,'' which this action will not change.
Again, individual companies, trade associations, and other
organizations, and their representatives can always contact EPA, using
the contact information provided in the Federal Register document, EPA
website, or other public communication of testing needs, with questions
about specific testing requirements and other details for individual
chemicals. In addition, as stated in the rule, ``EPA may request
additional clarifications of or revisions to the proposal(s).'' This
statement in the rule makes it explicit that submitters will have an
opportunity to clarify, correct, and otherwise revise their
proposal(s), if EPA decides that clarification is needed, or the
proposal needs expansion or elaboration to adequately meet testing
needs.
    Comment 3: The ECA procedures should include a provision that would
permit the Agency to agree to an ECA where some or most, but not all,
data needs might be filled.
    EPA response: There is nothing in the original or revised ECA
procedural rules that would prohibit EPA from agreeing to an ECA that
covers some, but not all, needed testing, then pursuing a test rule or
follow-up ECA, to fill remaining data needs--if no other interested
parties submit a timely written objection, and if EPA concludes that
such a multi-part process is likely to be an efficient and successful
means of obtaining the needed test data.

III. Statutory and Executive Order Reviews

A. Regulatory Review

    Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that this final rule is not a ``significant
regulatory action'' subject to review under Executive Order 12866,
because it does not meet the criteria in section 3(f)(4) of the
Executive Order. Accordingly, EPA did not submit this final rule to OMB
for review under Executive Order 12866.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden,
because the development of the ECA regulations does not involve
information collection activities as defined by the Paperwork Reduction
Act (PRA), 44 U.S.C. 3501 et seq. However, the information collection
requirements contained in an ECA are already approved by OMB pursuant
to PRA under OMB control number 2070-0033 (EPA ICR No. 1139). Under
PRA, 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 in title 40 of the CFR are listed in 40 CFR part
9, and will be included in the individual ECAs.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), after considering the potential economic
impacts of this final rule on small entities, the Agency hereby
certifies that this final rule would not have a significant adverse
economic impact on a substantial number of small entities.
    Small entities include small businesses, small organizations, and
small governmental jurisdictions. For purposes of assessing the impacts
of this final rule on small entities, small entity is defined as:
    1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201.
    2. A small governmental jurisdiction that is a government of a
city, county, town, school district, or special district with a
population of less than 50,000.
    3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
    This action will not have a significant economic impact on a
substantial number of small entities. In determining whether a final
rule has a significant economic impact on a substantial number of small
entities, the impact of concern is any significant adverse economic
impact on small entities, since the primary purpose of regulatory
flexibility analysis is to identify and address regulatory alternatives
``which minimize any significant economic impact of the rule on small
entities.'' 5 U.S.C. 603 and 604. Thus, an agency may certify that a
final rule will not have a significant economic impact on a substantial
number of small entities if the final rule relieves regulatory burden,
or otherwise has a positive economic effect on all of the small
entities subject to the final rule.
    The changes discussed in this document are expected to streamline
and improve the ECA procedures in a way that will benefit all
participants. EPA has therefore concluded that this final rule will not
have any adverse impacts on affected small entities. EPA did not
receive any comments on the proposed rule regarding the impact on small
entities.

D. Unfunded Mandates Reform Act

    This action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), (2 U.S.C. 1531-1538). Therefore, this action
is not subject to the requirements of UMRA.

E. Federalism

    Pursuant to Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999), EPA has determined that this final rule does
not have ``federalism implications,'' because it will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. Thus, Executive Order 13132 does
not apply to this final rule.

F. Tribal Implications

    Under Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has
determined that this final rule does not have tribal implications
because it will not have any effect on tribal governments, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in the Order. Thus,
Executive Order 13175 does not apply to this action.

G. Children's Health Protection

    Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997), does not apply to this action because this is not designated as
an

``economically significant'' regulatory action as defined by Executive
Order 12866 (see Unit III.A.), nor does this action establish an
environmental standard that is intended to have a disproportionate
effect on children. To the contrary, this action will revise procedures
which will facilitate the development of data and information that EPA
and others can use to assess the risks of chemical substances,
including potential risks to children.

H. Energy Effects

    This action is not subject to Executive Order 13211, entitled
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001), because this action
is not expected to affect energy supply, distribution, or use.

I. Technology Standards

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), section 12(d) (15 U.S.C. 272 note), directs EPA to
use voluntary consensus standards in its regulatory activities unless
to do so would be inconsistent with applicable law or otherwise
impractical. Voluntary consensus standards are technical standards
(e.g., materials specifications, test methods, sampling procedures, and
business practices) that are developed or adopted by voluntary
consensus standards bodies. The NTTAA directs EPA to provide Congress,
through OMB, explanations when the Agency decides not to use available
and applicable voluntary consensus standards.
    This final rule does not involve technical standards. Therefore,
EPA is not considering the use of any voluntary consensus standards.

J. Environmental Justice

    This action does not involve special considerations of
environmental justice related issues as delineated by Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994).

IV. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 790

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: September 8, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.

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Therefore, 40 CFR chapter I is amended as follows:

PART 790--[AMENDED]

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1. The authority citation for part 790 continues to read as follows:

    Authority: 15 U.S.C. 2603.

Sec.  790.1  [Amended]

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2. Section 790.1 is amended by removing the last sentence of paragraph
(c) and by removing paragraph (d).
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3. Section 790.20 is revised to read as follows:

Sec. 790.20  Recommendation, recommendation with an intent to
designate, and designation of testing candidates by the ITC.

    (a) ITC recommendations and recommendations with intent to
designate. The ITC has advised EPA that it will discharge its
responsibilities under section 4(e) of TSCA in the following manner:
    (1) When the ITC identifies a chemical substance or mixture that it
believes should receive expedited consideration by EPA for testing, the
ITC may add the substance or mixture to its list of chemicals
recommended for testing and include a statement that the ITC intends to
designate the substance or mixture for action by EPA in accordance with
section 4(e)(1)(B) of TSCA.
    (2) Chemical substances or mixtures selected for expedited review
under paragraph (a)(1) of this section may, at a later time, be
designated for EPA action within 12 months of such designation. The
ITC's subsequent decision would be based on the ITC's review of TSCA
sections 8(a) and 8(d) data and other relevant information.
    (3) Where the ITC concludes that a chemical substance or mixture
warrants testing consideration but that expedited EPA review of testing
needs is not justified, the ITC will add the substance or mixture to
its list of testing recommendations without expressing an intent to
designate the substance or mixture for EPA action in accordance with
section 4(e)(1)(B) of TSCA.
    (4) The ITC reserves its right to designate any chemical substance
or mixture that it determines the Agency should, within 12 months of
the date first designated, initiate a proceeding under section 4(a) of
TSCA.
    (b) Preliminary EPA evaluation of ITC recommendations with intent
to designate. Following receipt of an ITC report containing a
recommendation with an intent to designate, EPA will use the following
procedure for completing a preliminary evaluation of testing needs on
those chemical substances that the ITC has recommended with intent to
designate:
    (1) EPA will publish the ITC report in the Federal Register and
announce that interested persons have 30 days to submit comments on the
ITC's testing recommendations.
    (2) EPA will publish a Federal Register document adding all ITC-
recommended chemicals to the automatic reporting provisions of its
rules under sections 8(a) and 8(d) of TSCA (40 CFR parts 712 and 716).
    (3) EPA will hold a public ``focus meeting'' to discuss the ITC's
testing recommendations and obtain comments and information from
interested parties.
    (4) EPA will evaluate submissions received under TSCA sections 8(a)
and 8(d) reporting requirements, comments filed on the ITC's
recommendations, and other information and data compiled by the Agency.
    (5) EPA will make a preliminary staff determination of the need for
testing and, where testing appears warranted, will tentatively select
the studies to be performed.
    (6) EPA will hold a public meeting to announce its preliminary
testing determinations.
    (c) EPA response to ITC designations and recommendations--(1) Where
a chemical substance or mixture is designated for EPA action under
section 4(e)(1)(B) of TSCA, the Agency will take either one of the
following actions within 12 months after receiving the ITC designation:
    (i) Initiate rulemaking proceedings under section 4(a) of TSCA.
Where the testing recommendations of the ITC raise unusually complex
and novel issues that require additional Agency review and opportunity
for public comment, the Agency may initiate rulemaking by publishing an
Advance Notice of Proposed Rulemaking (ANPRM).
    (ii) Publish a Federal Register notice explaining the Agency's
reasons for not initiating such rulemaking proceedings. EPA may
conclude that rulemaking

proceedings under section 4(a) of TSCA are unnecessary if it determines
that the findings specified in section 4(a) of TSCA cannot be made or
if the Agency entered into a consent agreement requiring the testing
identified by the ITC.
    (2) Where a chemical substance or mixture has been recommended for
testing by the ITC, whether with or without an intent to designate, EPA
will use its best efforts to act on the ITC's recommendations as
rapidly as possible consistent with its other priorities and
responsibilities. EPA may respond to the ITC's recommendations with
action such as:
    (i) Initiating rulemaking proceedings under section 4(a) of TSCA,
     (ii) Publishing a Federal Register notice explaining the Agency's
reasons for concluding that testing is unnecessary, or
    (iii) Entering into a consent agreement in accordance with this
subpart.
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4. Section 790.22 is revised to read as follows:

Sec.  790.22  Procedures for developing consent agreements.

    (a) Preliminary EPA evaluation of proposed consent agreement. Where
EPA believes that testing of a chemical substance or mixture may be
needed, and wishes to explore whether a consent agreement may satisfy
the identified testing needs, EPA will invite manufacturers and/or
processors of the affected chemical substance or mixture to submit a
proposed consent agreement to EPA. EPA will evaluate the proposal(s)
and may request additional clarifications of or revisions to the
proposal(s).
    (b) Negotiation procedures for consent agreements. If, after
evaluating the proposed consent agreement(s), EPA believes it is likely
that proceeding with negotiation of a consent agreement would be an
efficient means of developing the data, EPA will use the following
procedures to conduct such negotiations:
    (1) In the Federal Register, EPA will give notice of the
availability of the proposal(s) that is the basis for negotiation,
invite persons interested in participating in or monitoring
negotiations to contact the Agency in writing, set a deadline for
interested parties to contact the Agency in writing, and set a date for
the negotiation meeting(s).
     (2) The Agency will meet with interested parties at the
negotiation meeting(s) for the purpose of attempting to negotiate a
consent agreement. Only the submitter(s) of the proposal(s) that is the
basis for negotiation and those persons who submit written requests to
participate in or monitor negotiations by the deadline established
under paragraph (b)(1) of this section will be deemed ``interested
parties'' for purposes of this section.
    (3) All negotiation meetings will be open to members of the public,
but only interested parties will be permitted to participate in
negotiations. The minutes of each meeting will be prepared by EPA.
Meeting minutes, the proposed consent agreement(s), background
documents, and other materials distributed at negotiation meetings will
be placed in an Internet-accessible public docket established by EPA.
    (4) If EPA concludes at any time that negotiations are unlikely to
produce a final agreement, EPA will terminate negotiations and may
proceed with rulemaking. If EPA terminates negotiations, no further
opportunity for negotiations will be provided. EPA will notify all
interested parties of the termination.
    (5) The period between the first negotiation meeting and final
agreement, if any (``the negotiation period''), will be no longer than
6 months, unless extended prior to its expiration in accordance with
paragraph (b)(7) of this section. This period will include all
negotiation meetings, and the processes discussed in paragraphs (b)(6)
and (b)(9) of this section. If the negotiation period passes without
the production of a final agreement, negotiations and development of
the subject ECA will terminate automatically.
    (6) EPA will circulate a draft of the consent agreement to all
interested parties if EPA concludes that such draft is likely to
achieve final agreement. A period of 30 days will be provided for
submitting comments or written objections under paragraph (b)(8)(i)(B)
of this section.
    (7) If, prior to the expiration of the negotiation period, final
agreement has not been reached, EPA may at its discretion provide one
or more extensions, each of which may be up to 60 days, if it seems
likely to EPA that a final agreement will be reached during that time.
EPA will notify all interested parties of any extension(s).
    (8) (i) EPA will enter into consent agreements only where there is
a consensus among the Agency, one or more manufacturers and/or
processors who agree to conduct or sponsor the testing, and all other
interested parties who identify themselves in accordance with paragraph
(b)(2) of this section. EPA will not enter into a consent agreement in
either of the following circumstances:
    (A) EPA and affected manufacturers and/or processors cannot reach a
consensus in the timeframe described in paragraph (b)(5) of this
section.
    (B) A draft consent agreement is considered inadequate by other
interested parties who have submitted timely written objections to the
draft consent agreement, which provide a specific explanation of the
grounds on which the draft agreement is objectionable.
    (ii) EPA may reject objections described in paragraph (b)(8)(i)(B)
of this section only where the Agency concludes the objections:
    (A) Are not made in good faith;
    (B) Are untimely;
    (C) Do not involve the adequacy of the proposed testing program or
other features of the agreement that may affect EPA's ability to
fulfill the goals and purposes of TSCA; or
    (D) Are not accompanied by a specific explanation of the grounds on
which the draft agreement is considered objectionable.
    (iii) The unwillingness of some manufacturers and/or processors to
sign the draft consent agreement does not, in itself, establish a lack
of consensus if EPA concludes that those manufacturers and/or
processors who are prepared to sign the agreement are capable of
accomplishing the testing to be required and that the draft agreement
will achieve the purposes of TSCA in all other respects.
    (9) Where a consensus exists, as described in paragraph (b)(8) of
this section, concerning the contents of a draft consent agreement, the
draft consent agreement will be circulated to EPA management and the
parties that are to conduct or sponsor testing under the agreement, for
final approval and signature.
    (10) Upon final approval and signature of a consent agreement, EPA
will publish a Federal Register document announcing the availability of
the consent agreement and codifying (in subpart C of 40 CFR part 799)
the name of the chemical substance(s) and/or mixture(s) to be tested
and the citation to the Federal Register document.

Sec. Sec.  790.24, 790.26, and 790.28   [Removed]

0
5. Remove Sec. Sec.  790.24, 790.26, and 790.28.

Sec.  790.68   [Amended]

0
6. Remove the cross-reference ``Sec.  790.24'' in ``Sec.
790.68(a)(2)'' and add in its place ``Sec.  790.22(b)(8).''

Appendix A to subpart E of part 790   [Removed]

0
7. Remove Appendix A to subpart E of part 790.

[FR Doc. 2010-23131 Filed 9-15-10 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 233 (Tuesday, December 6, 2022)]
[Notices]
[Pages 74609-74610]
[FR Doc No: 2022-26477]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: PR23-12-000.
    Applicants: Dow Pipeline Company.
    Description: Sec.  284.123 Rate Filing: Petition for Rate Approval
to be effective 12/1/2022.
    Filed Date: 11/29/22.
    Accession Number: 20221129-5139.
    Comment Date: 5 p.m. ET 12/20/22.

    Docket Numbers: PR23-13-000.
    Applicants: The East Ohio Gas Company.
    Description: Sec.  284.123(g) Rate Filing: Operating Statement of
The East Ohio Gas Company 11/2/2022 to be effective 11/2/2022.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5003.
    Comment Date: 5 p.m. ET 12/21/22.
    184.123(g) Protest: 5 p.m. ET 1/30/23.

    Docket Numbers: PR23-14-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  284.123(g) Rate Filing: Statement of Rates &
Statement of Op.

Conditions_eff 11.1.22 to be effective 11/1/2022.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5063.
    Comment Date: 5 p.m. ET 12/21/22.
    184.123(g) Protest: 5 p.m. ET 1/30/23.

    Docket Numbers: RP23-213-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: REX 2022-11-29 Negotiated Rate
Agreement Amendment to be effective 11/28/2022.
    Filed Date: 11/29/22.
    Accession Number: 20221129-5123.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-214-000.
    Applicants: Chandeleur Pipe Line, LLC.
    Description: Compliance filing: Chandeleur FLLA Filing to be
effective N/A.
    Filed Date: 11/29/22.
    Accession Number: 20221129-5186.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-215-000.
    Applicants: Kinder Morgan Louisiana Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Fuel Adjustment Effective
January 1, 2023 to be effective 1/1/2023.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5000.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-216-000.
    Applicants: Southern Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Spire Negotiated Rate Dec 2022
to be effective 12/1/2022.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5022.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-217-000.
    Applicants: MountainWest Overthrust Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Company Contact Information to
be effective 1/1/2023.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5061.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-218-000.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: ATC Update Filing--Totem 2022-
2023 to be effective 12/1/2022.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5062.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-219-000.
    Applicants: White River Hub, LLC.
    Description: Sec.  4(d) Rate Filing: Company Contact Information to
be effective 1/1/2023.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5066.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-220-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agmt Update
(Conoco--Dec 22) to be effective 12/1/2022.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5072.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-221-000.
    Applicants: MountainWest Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Company Contact Information to
be effective 1/1/2023.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5076.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-222-000.
    Applicants: MountainWest Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: FGRP Report for 2023 to be
effective 1/1/2023.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5079.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-223-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement
Filing (MIECO #618189) to be effective 12/1/2022.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5086.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-224-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreements
Update (Red Willow #FT3HM000 and EOG #617664)) to be effective 1/1/
2023.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5097.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-225-000.
    Applicants: Young Gas Storage Company, Ltd.
    Description: Sec.  4(d) Rate Filing: Annual Fuel Filing 2022 to be
effective 1/1/2023.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5110.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-226-000.
    Applicants: TransColorado Gas Transmission Company LLC.
    Description: Sec.  4(d) Rate Filing: TC Quarterly FL&U Update Nov.
2022 to be effective 1/1/2023.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5125.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-227-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Cherokee
AGL--Replacement Shippers--Dec 2022 to be effective 12/1/2022.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5142.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-228-000.
    Applicants: UGI Sunbury, LLC.
    Description: Annual Report of Operational Purchases and Sales of
UGI Sunbury, LLC.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5153.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: RP23-229-000.
    Applicants: Gulf Run Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: NRA--Golden Pass LNG Terminal
LLC to be effective 1/1/2023.
    Filed Date: 11/30/22.
    Accession Number: 20221130-5167.
    Comment Date: 5 p.m. ET 12/12/22.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP22-823-000.
    Applicants: Wyoming Interstate Company, L.L.C.
    Description: Refund Report: WIC's Refund Report in Docket No. RP22-
823-000 to be effective N/A.
    Filed Date: 11/8/22.
    Accession Number: 20221108-5131.
    Comment Date: 5 p.m. ET 12/7/22.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 30, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-26477 Filed 12-5-22; 8:45 am]
BILLING CODE 6717-01-P


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EPA REGISTRATION DIVISION - COMPANY NOTICE OF FILING FOR PESTICIDE PETITION

EPA Contact: Registration Division

Interregional Research Project Number 4 (IR-4)

Petition Number: 6E8472

EPA has received a pesticide petition (PP# 6E8472) from Interregional Research Project Number 4 (IR-4 Project), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W., Princeton, NJ  08540, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a (d), to amend 40 CFR part 180.345 by increasing the existing tolerance for the combined residues of the herbicide ethofumesate, (2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate) and its metabolites, 2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate both calculated as the parent compound in or on the food commodities, as follows: Beet, sugar, molasses at 2.5 parts per million (ppm), Beet, sugar, refined sugar at 1.0 ppm; Beet, sugar, roots at 1.5 ppm; and Beet, sugar, tops at 30.0 ppm.

IR-4 also proposed, upon the approval of the aforementioned tolerances, to remove established tolerances for the combined residues of the herbicide ethofumesate, in or on the food commodities: Beet, sugar, molasses at 0.5 ppm; Beet, sugar, refined sugar at 0.2 ppm; Beet, sugar, roots at 0.3 ppm; and Beet, sugar, tops at 4.0 ppm. EPA has determined that this petition contains data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism.  The metabolism of ethofumesate in plants is adequately understood based on metabolism studies with sugar beets, annual ryegrass, cabbage, wheat, and radish.  All studies showed similar routes of metabolism for ethofumesate. The major metabolites are 2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate (the lactone analog), NC 20645 (the carboxy analogue) together with small amounts of the unchanged parent. Metabolite NC 20645 exists in equilibrium with the lactone analog and all recovered NC 20645 are derivatized and reported as the lactone analog. From the studies, the residues of concern are the combined residues of ethofumesate and its metabolites 2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate.

2. Analytical method.  Analytical methods have been developed and validated for the determination of ethofumesate and its metabolites 2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate in sugar beet (roots and tops).  Ethofumesate and its related residues are extracted in a two-part process and quantified using LC-MS/MS analysis. The limit of quantification for ethofumesate and metabolites is 0.05 ppm. Therefore, adequate analytical methodology is available for enforcement purposes and it allows detection of residues at or above the proposed tolerances.

3. Magnitude of residues.

a. Plant residues.
i. Sugar Beets:  The IR-4 Project received requests from the states of Idaho, North Dakota, and Oregon for the use of ethofumesate to control waterhemp, glyphosate-resistant waterhemp, kochia, redroot pigweed, Powell amaranth, common lambsquarters, and volunteer Roundup-Ready canola in glyphosate-resistant sugar beets at one application at 4 lb AI/A or multiple applications totaling 4 lb AI/A at 10 day re-treatment intervals with a pre-harvest interval of 45 days.
Glyphosate-resistant waterhemp has become a serious problem in Roundup Ready sugar beet in North Dakota and Minnesota.  Currently, only the herbicides UpBeet, Betamix, and Ethofumesate 4SC applied postemergence have activity on waterhemp.  However waterhemp plants may also be resistant to UpBeet, an ALS herbicide, and Betamix provides variable control of waterhemp.  Also, Betamix is no longer registered, leaving Ethofumesate 4SC the only remaining postemergence herbicide to provide average to excellent control of glyphosate-resistant waterhemp when mixed with glyphosate.  Field research conducted in Minnesota and North Dakota showed that adding ethofumesate to glyphosate postemergence controlled most glyphosate-resistant waterhemp and improved the control of kochia and lambsquarters.  Waterhemp, kochia, Powell amaranth, and lambsquarters control is maximized when multiple applications of ethofumesate + glyphosate were applied. Glyphosate-resistant waterhemp control can also be improved when Ethofumesate 4SC is applied preemergence followed by applications of tank mixes of Ethofumesate 4SC plus glyphosate.

In support of the requests, magnitude of residue data were collected from a total of thirteen sugar beet field trials conducted in North Dakota, New Mexico, Washington, Idaho, Michigan, Wisconsin and California.  Samples were analyzed for residues of ethofumesate and metabolites, 2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate.  In sugar beet tops, the residues measured for total ethofumesate ranged from about 1.0 ppm to 21 ppm. In sugar beet roots, the residues measured for total ethofumesate ranged from about 0.15 to 1.1 ppm. The data support the proposed increase in tolerances for sugar beet tops at 30.0 ppm and sugar beet roots at 1.5 ppm.

b. Animal residues: EPA established tolerances of 0.05 ppm for residues of ethofumesate and its metabolites in meat, meat byproducts and fat from the following animals: cattle, goats, sheep, hogs and horses.

B. Toxicological Profile

1. Acute toxicity.  In an acute oral toxicity study conducted in rats, the oral LD50 value for technical ethofumesate was determined to be >6400 mg/kg (Toxicity Category IV). The dermal LD50 in rats was established at >20,050 mg/kg (Toxicity Category IV).  An inhalation four hour exposure of rats to ethofumesate resulted in a LC50 of >0.49 mg/L (maximum achievable concentration; Toxicity Category II).  Application of ethofumesate to the rabbit eye resulted in no irritation (Toxicity Category IV). A primary dermal irritation study in rabbits demonstrated that application of ethofumesate produced no irritation (Toxicity Category IV). No dermal sensitization occurred with ethofumesate in guinea pigs.

2. Genotoxicity. No evidence of genotoxicity was observed in a battery of tests including an in vivo mouse bone marrow micronucleus assay and four in vitro studies:  Ames Salmonella assay, gene mutation assay in mammalian cells (mouse lymphoma 6TG cells), chromosomal aberration assay in human lymphocytes, and unscheduled DNA synthesis in primary rat hepatocytes.

3. Reproductive and developmental toxicity.

i. Prenatal Developmental Toxicity - Rat
Groups of 24 time-mated female rats received ethofumesate by daily gavage at dose levels of 0, 10, 100, or 1000 mg/kg/day from day 6 to day 15 of gestation. No maternal or developmental toxicity was observed up to a limit dose of 1,000 mg/kg/day.  There were no unscheduled deaths during the study and no effects of treatment on maternal body weight gains, food efficiency or gross pathology.  There were no effects of treatment at 10 or 100 mg/kg.  The maternal NOAEL is 1000 mg/kg/day.  There were no treatment-related effects on the numbers of fetuses (live or dead), resorptions (early or late), post-implantation loss, sex ratio, fetal weight or fetal external, visceral or skeletal examinations.  The developmental NOAEL is 1000 mg/kg/day.

ii. Prenatal Developmental Toxicity - Rabbit
In a developmental toxicity study, ethofumesate was administered daily via oral gavage to 25 female New Zealand White rabbits/group at dose levels of 0, 30, 300 or 3000 mg/kg/day, on gestation days (GD) 6 through 18.  The maternal NOAEL was 300 mg/kg/day based on increased mortality, decreased body weights, abortion and litter resorptions at the highest dose tested, 3000 mg/kg/day.  Developmental toxicity was observed at 300 and 3000 mg/kg/day as evidenced by increased resorptions, post-implantation loss and incomplete ossification of vertebral arches.  The NOAEL was 30 mg/kg/day indicating increased prenatal susceptibility in rabbits.

iii. Three-Generation Reproduction  -  Rat
In a three-generation reproduction toxicity study ethofumesate was administered continuously in the diet to CD:Crl albino rats (30/sex/dose) at nominal dose levels of 0, 200, 1000 or 5000 ppm.  No parental, offspring or reproductive toxicity was observed at the highest dose tested, 5000 ppm (equivalent to 396.8 mg/kg/day in males and 462.5 mg/kg/day in females).

4. Subchronic toxicity

i. 90 Day Dietary  -  Rat
Male and female Crl:CD(SD) rats were administered ethofumesate in the diet at concentrations of 0, 300, 3000 or 30000 ppm for 90-days.  These dose levels were equivalent to 0, 23.4, 230 and 2309 mg/kg/day in females and 0, 18.2, 190 and 1900 mg/kg/day in males, respectively.  Body weight was 8% lower in males and 17% lower in females at the high dose at study termination when compared to the controls.  Overall body weight gain was depressed 15% in males and 47% in females at 30000 ppm.  Food consumption was unaffected in males, but decreased 10% in females at the high dose and food efficiency was increased in both males and females.  Hematology and clinical chemistry parameters were unaffected by treatment.  Absolute liver weight was increased in males at 30000 ppm which was accompanied with liver microscopic findings including eosinophilic periportal hepatocytes and periportal fat deposition.  Absolute kidney weights were also increased in males as well as the incidence of tubular basophilia, dilation, inflammation and/or fibrosis.  Although kidney weights were increased in females, no histopathology findings were observed.  No adverse findings were observed at the low and mid dose.  The NOAEL was considered to be 3000 ppm based on effects on body weight and weight gain and microscopic findings in the liver and kidney.

ii. 90 Day Dietary - Mouse
In the 90-day mouse study, Crl:CD-1(ICR)BR (VAF plus) male and female mice were administered 0, 300, 3000 or 10000 ppm in the diet.  These dietary concentrations were equivalent to 0, 45, 450 and 1500 mg/kg/day using the Lehman conversion factor of 0.15.  No adverse effects were observed in the study and the NOAEL was considered to be greater than 10000 ppm or 1500 mg/kg/day.

5. Chronic toxicity.

i. Chronic Toxicity  -  Dog
Male and female beagle dogs were fed diets containing 0, 800, 4000 or 20000 ppm in the diet for 104 weeks.  These dose levels were equivalent to 0, 24.5, 117.8 and 632.4 mg/kg/day in males and 0, 23.7, 109.0 and 618.9 mg/kg/day in females.  No effects were observed on mortality, body weight and weight gain, incidence of clinical signs, food consumption, hematology and urinalysis parameters, or upon macroscopic and microscopic pathology.  At the high dose, alkaline phosphatase and alanine aminotransferase were statistically increased in males and females combined.  In addition, absolute liver weights were increased in males and females at 20000 ppm.  There were no microscopic correlates in the liver.  The NOAEL was considered to be 4000 ppm (117.8/109.0 mg/kg/day) based on the effects observed on alkaline phosphatase and alanine transferase and absolute liver weights observed at 20000 ppm (632.4/618.9 mg/kg/day).

ii. Combined Chronic Toxicity/Oncogenicity  -  Rat
A chronic toxicity/carcinogenicity study was conducted in Sprague-Dawley rats at dietary concentrations of 0, 2000, 7000 or 20000 ppm.  The chronic toxicity phase of the study was 52 weeks in duration and the carcinogenicity phase was 104 weeks.  In the chronic phase of the study, dietary concentrations were equivalent to, 0, 115, 398 and 1135 mg/kg/day in males and 0, 144, 577 and 1697 mg/kg/day in females.  Body weights were statistically decreased in the mid and high dose group throughout the study in females and at the high dose in males.  Relative liver weight was statistically increased in females at the high dose group compared to the control group.  The following microscopic findings were statistically increased compared to the control group:  hepatic focal cellular alteration with vascular changes at the mid and high dose in males; hepatocellular vacuolation and periportal cellular changes at the high dose in males; periportal hepatocyte enlargement in females at the mid and high dose; dilated/cystic follicles in the thyroid in males at the high dose; and cystic ducts in the thymus of high dose females.  The NOAEL was considered to be 2000 ppm (115 and 144 mg/kg/day in males and females, respectively) based on decreased body weight (females) and liver histopathology (males) observed at 7000 ppm.

In the carcinogenicity phase of the rat study, body weights were statistically decreased compared to the controls in females at the mid and high dose levels throughout the study and in males at the high dose.  Body weight gain was also reduced primarily at the high dose.  The following microscopic findings were statistically increased at the high dose compared to the control group: centrilobular hypertrophy in the liver of males and females; periportal cellular alteration in the liver of males; tubular pigment deposition in the kidney in females; focal hypertrophy in the pancreas of females; and retinal atrophy in females.  In the carcinogenicity phase of the study the 2000, 7000 and 20,000 ppm levels were equivalent to 127, 469 and 1003 mg/kg/day in males and 97, 332 and 1003 mg/kg/day in females. The NOAEL is 2000 ppm (127 mg/kg/day) in females based on decreased body weights/body weight gain observed at 7000 ppm, and 7000 ppm (332 mg/kg/day) in males based on decreased body weights/body weight gain and liver lesions observed at 20000 ppm.

iii. Oncogenicity - Mouse
In a carcinogenicity study, ethofumesate was administered to Crl:CD-1(ICR)BR (VAF plus) mice in the diet for 80 weeks at doses of 0, 1000, 3000 or 10000 ppm (equivalent to of 161, 477 and 1601 mg/kg/day for males and 204, 644 and 2145 mg/kg/day for females, respectively).  Mortality, body weights, body weight gains, food consumption/efficiency, clinical observations and differential leukocyte counts were unaffected by treatment.  Although absolute and/or relative liver weights were increased in all groups of treated mice the increases were not clearly dose-related and there were no supporting histopathology findings in the liver.  No significant gross or microscopic pathological lesions were found in either sex of mice.  The NOAEL was greater than 10000 ppm (1601 mg/kg/day in males and 2145 mg/kg/day in females).

6. Neurotoxicity

An overall weight of the evidence evaluation of the available information on ethofumesate and one other benzofuranyl alkanesulfonate herbicide indicates that ethofumesate has no neurotoxic potential.  The liver is the primary target organ for the toxicity of ethofumesate with effects on the liver or reduced body weight driving many no observed adverse effect levels (NOAEL) in the studies conducted.  Ethofumesate is a long chain fatty acid synthesis inhibitor and does not have a neurotoxic mode of action.  A careful review of the available toxicity studies on ethofumesate indicates that there are no indicators of neurotoxicity.  An examination of the available toxicology database of the other benzofuranyl alkanesulfonate herbicide (benfuresate) does not raise any concern for neurotoxicity.  An extensive search of the literature indicates no reports of neurotoxicity associated with benzofuranyl alkanesulfonate pesticides, including ethofumesate.  EPA concluded in the Toxicology Chapter of the Reregistration Eligibility Document that "the available studies in rat, mouse, dog and rabbit show no clinical evidence or pathological indication of neurotoxicity".

7.  Immunotoxicity

An overall weight of the evidence evaluation of the available information on ethofumesate and one other benzofuranyl alkanesulfonate herbicide indicates that ethofumesate has no immunotoxic potential.  The liver is the primary target organ for the toxicity of ethofumesate with effects on the liver or reduced body weight driving many no observed adverse effect levels (NOAEL) in the studies conducted.  The available toxicity studies on ethofumesate indicate that any potential indicators of immunotoxicity occur only at dose levels that result in other systemic toxicity (chronic rat study) or were considered unrelated to treatment (21-day rabbit study).  An examination of the available toxicology database of the other benzofuranyl alkanesulfonate herbicide (benfuresate) does not raise any concern for immunotoxicity.  An extensive search of the literature indicates no reports of immunotoxicity associated with benzofuranyl alkanesulfonate pesticides, including ethofumesate.

8.  Dermal Absorption

In a dermal absorption rat study, [14-C]-ethofumesate was applied to Sprague-Dawley Crl:CD (SD) rats at dose levels of 3, 9 and 20 μg/cm[2]. A single dermal application of the test material in aqueous methyl cellulose was made to the shaved dorsal skin (12 cm[2] area) of a total of 48 animals (4 per time group/16 per dose) and the animals were monitored for absorption at 1, 10, 24 and 168 hours after dosing. The 168 hour group underwent skin wash at 10 hours and was carried to 168 hours before termination.  Mean recoveries of applied radioactivity from all dose groups ranged from 86 to 102%.   Mean absorption based on urinary/fecal excretion, blood, carcass, and cage wash ranged from 1.68 to 32.51%.  Total radioactivity absorbed clearly increased with increasing exposure time for all doses and the highest absorption rate consistently occurred at the 24 hour exposure duration. Absorbed radioactivity decreased with increasing dose for the 10 and 24 hour exposure durations indicating that the skin was approaching saturation of penetration for these exposure durations. The majority of the absorbed radioactivity was consistently found in the urine for all doses and durations. Absorbed dose found in the urine and feces increased with increasing exposure duration indicating that absorbed test material is increasingly absorbed and eliminated over time. Negligible amounts were present in blood samples analyzed for all dose/duration groups. The amount of radioactivity present in the carcass at 1, 10 and 24 hour exposure durations ranged from 1.5-6.2%. The amount of radioactively found in the carcass was significantly reduced at 168 hr post-wash exposure duration. Most of the unabsorbed radioactivity was found in the skin washes from each dose/duration (48-88%). Amount of radioactive dose on the treated skin after wash and termination ranged from 0.3 to 7%. Although there was no clearly discernable pattern of radioactivity remaining in/on treated skin indicating the extent to which skin residues continue to be absorbed post-wash, it is reasonable to assume that that test material remaining in/on skin is absorbed.  A dermal absorption factor of 27% is based on the combined radioactivity absorbed and that remaining in/on the skin at the 10 hour exposure duration for the low dose.

9.  Animal metabolism.

i.  Rats - The metabolism of ethofumesate has been extensively studied in rats, ruminants and hens.  In the rat, ethofumesate is rapidly and extensively absorbed and metabolized to the water soluble acid metabolite NC 20645 which is excreted mainly in the urine. At higher dose levels an increase in excretion via the feces was observed.  Within the first 24 hours after dosing, most of the ethofumesate was eliminated from the body. Very low residue levels were detected in tissues five or seven days after dosing. No evidence of accumulation in any tissue or organ was observed.

ii. Ruminants - A dairy cow received two oral doses of [14C]-ethofumesate every day for four consecutive days.  The mean daily dose was 2.945 g (equivalent to 5.0 mg/kg body weight/day) with the total dose equivalent to 274 ppm in the diet.  Edible tissue residue levels ranged from 0.033 and 1.863 mg equivalents/kg tissue. Milk residue levels rose rapidly and peaked at 0.134 mg equivalents/kg 32 hours after the initial dose.  Kidney and liver residue levels were the highest at 1.863 mg equivalents/kg and 0.661 mg/equivalents/kg, respectively. Unmetabolized ethofumesate was the major residue in tissues.  Low levels of the metabolites NC 8493, NC 9607 (the lactone analogue) and NC 20645 were also detected in tissues.

iii.  Poultry - [14C]-Ethofumesate was orally dosed to three laying hens at 1.50 mg (approximately 12 ppm in the diet) per bird each day for ten consecutive days. After the initial dose, residues were rapidly excreted with 82% of the [14C] recovered within 24 hours. Total residues (ethofumesate and/or metabolites) in the edible tissues of the hen were low.  Ethofumesate was the major component identified in egg yolks, fat and skin. The metabolite NC 9607 was detected in all tissues while the metabolite NC 20645 was identified in the muscle, liver, skin and egg yolks.

10. Endocrine disruption.

No special studies have been conducted to investigate the potential of ethofumesate to induce estrogenic or other endocrine effects. However, no evidence of estrogenic or other endocrine effects has been noted in any of the standard toxicology studies that have been conducted with this product and there is no reason to suspect that any such effects would be likely.

C. Aggregate Exposure

1. Dietary exposure.

i. Acute and chronic combined dietary (food + drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model-FCID(TM) software (Version 4.02) which uses food consumption data from the 2005-2010 National Health and  Nutrition Examination Survey (NHANES), What We Eat in America (WWEIA).  Dietary exposure estimates were based on the current tolerances that have been established (40 CFR 180.345) for combined residues of ethofumesate and metabolites in or on onions, garlic and shallots (0.25 ppm), carrots (7.0 ppm), garden beets (0.5 ppm), animal commodities including fat, meat and meat byproducts (0.05 ppm), and the proposed higher tolerance for sugar beet roots (1.5 ppm), sugar beet molasses (2.5 ppm), and sugar beet refined sugar (1.0 ppm). It was assumed that 100% of the crops were treated with ethofumesate. Although the carrot tolerance is restricted to use in the states of Washington and Oregon, the assessment assumed a national consumption of treated carrots by all population subgroups.

There is no appropriate single-dose endpoint available for acute oral exposure of the general population to ethofumesate and therefore a quantitative acute dietary risk assessment is not needed.  An acute reference dose (RfD) of 0.3 mg/kg body weight/day for Females 13-39 years old is based on the results from a prenatal developmental toxicity study in rabbits (LOEL 300 mg/kg/day) and an uncertainty factor of 100 (10X for interspecies extrapolation and 10X for intraspecies variation).

A chronic RfD was established for the general population including infants and children at 1.3 mg/kg/day based on the results from the combined chronic toxicity/oncogenicity study in the rat (NOAEL 127 mg/kg/day) and an uncertainty factor of 100 (10X for interspecies extrapolation and 10X for intraspecies variation).  The chronic RfD for Females 13-49 years of age was established separately from the general population because the developmental toxicity observed at 30 mg/kg/day in the developmental toxicity study in rabbits resulted in an acute RfD (0.300 mg/kg/day) which is lower than the chronic RfD (1.30 mg/kg/day) established from the combined chronic toxicity/carcinogenicity study in rats.

An exposure assessment for the purpose of assessing cancer risk is not required because EPA classified ethofumesate as "not likely to be a human carcinogen".

ii. Drinking water. For ethofumesate, no monitoring data are available.  Estimated drinking water concentrations in surface water were calculated using the USEPA tool Pesticide Water Calculator (PWC v1.5).  Groundwater estimates were calculated from the USEPA screening level tool SCIGROW and PRZMGW.  Drinking water residues were then incorporated into DEEM-FCIDTM under the food categories "water, direct, all sources" and "water, indirect, all sources."  The highest drinking water exposure concentration was used in the DEEM model and was derived from the PRZMGW WI Sands scenario using the application scenario for carrots.  The peak value for that scenario is 782 μ/L and that value was used in the acute dietary exposure estimates.  The highest chronic value is 685 μ/L based on the application to carrots on coarse soil from PRZMGW WI sands scenario.

For the most sensitive sub-population, Females 13-49 years of age, acute dietary (food + water) exposure was estimated to be 0.04342 mg/kg/day.  This exposure represents 14.5% (95[th] percentile) of the aPAD which is well below 100% of the aPAD.  The contribution of food and food forms to the estimate, at the 95[th] percentile, is 1.9%.

Using a chronic water concentration of 685 ppb, none of the exposures from food and drinking water together resulted in a cPAD over 6% the reference dose for the general population or any other population subgroup.  Chronic dietary exposure for Females 13-49 years of age was estimated to be 0.014686 mg/kg/day which occupies 4.9% of the chronic reference dose.  The most highly exposed subpopulation was Non-Nursing Infants at 5.9% (0.076806 mg/kg/day) of the chronic reference dose.  There is no concern for exposures occupying 100% or less of the RfD. Therefore, the acute and chronic dietary exposures for both the U.S. population and infants and children are well within acceptable levels.

2. Non-dietary exposure. There are no residential uses of ethofumesate and it is not intended for use by homeowners.  Ethofumesate may be applied to residential lawns by professional lawn care operators.  Therefore, there is no exposure of homeowners to ethofumesate during the mixing, loading, and application of ethofumesate to residential lawns. However, post-application exposure to adults and toddlers on lawns treated with ethofumesate is possible. Exposure of adults to ethofumesate is from the dermal route only. In addition to dermal exposure, toddlers may have oral exposure to ethofumesate during post-application activities on treated turf via hand-to-mouth, object-to-mouth, and soil ingestion routes.

Turf transferable residues were not empirically determined from study data and default assumptions were used.  Other assumptions included immediate contact with turf after treatment after the maximum application rate was applied. EPA Standard Operating Procedures (SOPs) for Residential Exposure Assessment were used to complete the residential exposure estimates for adults and toddlers.

Tier I residential reentry assessments were prepared for adults, females 14-39 years of age, and toddlers following treatment of residential lawns with ethofumesate.  Estimates were made for the worst case scenario: a single application of ethofumesate at a rate of 1.5 lb ai/A, 3 lb ai/A, or 4 lb ai/A.

Risk was estimated by calculating dermal margins of exposure (MOEs) for adults, females 13-49 years of age, and toddlers, and an oral MOE for toddlers.  Dermal margins of exposure (MOEs) for adults were based on the rat 90-day oral toxicity study in which the no-observable adverse effect level (NOAEL) was 190 mg/kg/day.  Dermal margins of exposure (MOEs) for females 13-49 years of age were based on the oral NOAEL of 30 mg/kg/d from the rabbit developmental toxicity study.  Oral MOEs for children were based on a rat 90-day oral NOAEL of 190 mg/kg/day.  A dermal absorption factor of 27% was applied.

Dermal MOEs for short- and intermediate-term exposure to adults ranged from 470 to 1300 for application rates of between 1.5 and 4.0 lb ai/A applied to turf.  Dermal MOEs for toddlers 1 to <2 years old ranged from 240 to 630 for short- and intermediate-term high contact lawn activities.  Oral MOEs for toddlers 1 to <2 years old ranged from 240 for short- to intermediate-term high contact lawn activities to 3100 for hand-to-mouth exposures from applications of ethofumesate at 4.0 lb ai/A to lawns.  The oral MOE for toddlers 1 to <2 years old for incidental ingestion of granules/pellets was 640 (1.5 lb ai/A).

The short- and intermediate-term post-application exposure MOEs for females 13-49 years of age were 64, 85, and 170 from high contact lawn activities at application rates of ethofumesate to lawns at 1.5 lb ai/A, 3 lb ai/A, or 4 lb ai/A, respectively.  Except for Females 13-49 years old, the MOEs for adult and toddler activities on residential lawns following treatment with the maximum application of ethofumesate are well above the target MOE of 100 when conservative Tier I assumptions were used in the assessment.  Although the MOEs for Females 13-49 years old are below the target MOE of 100, the scenarios used in these calculations are very conservative.  The developmental endpoint used to estimate the risk for Females 13-49 years old was based on a study with a NOAEL (30 mg/kg/d) that is 10X lower than the LOAEL (300 mg/kg/d); the NOAEL may be an artifact of dose selection.  For residential post-application exposure, the endpoint is oral while assessed exposures are dermal.  Conservative default assumptions were used.  Exposures are assumed to be immediately after application, at the maximum level of contact, from the maximum application rate, and maximum levels dermal exposure area.  Most turf uses of ethofumesate are for golf courses and sod farms where high levels of post-application exposures are not expected.  Ethofumesate residues resulting from sod farm application would likely dissipate significantly before sod was transplanted to residential areas.

This assessment indicates that there is a reasonable certainty of no harm to adults or toddlers from potential residential exposure to ethofumesate after application to homeowner lawns.

D. Cumulative Effects.

There is no reliable information to indicate that toxic effects of ethofumesate would be cumulative with those of another pesticide chemical.  Ethofumesate does not appear to produce a toxic metabolite produced by other substances.  Thus, it is appropriate to consider only the potential risks of ethofumesate in an aggregate exposure assessment.

E. Safety Determination.

1. U.S. population. Acute dietary (food + water) exposure for the most sensitive population subgroup, Females 13-49 years old, to residues of ethofumesate from current and proposed uses was estimated to occupy 14.5% of the acute RfD, which is well below levels expected to pose any appreciable risk to human health. Therefore, aggregate acute exposure to ethofumesate for proposed and current uses is within acceptable levels.

Ethofumesate may be applied to residential lawns by professional lawn care operators which may result in post-application exposure to adults on lawns treated with ethofumesate.  Aggregate short-term exposures were determined by combining chronic dietary (food + drinking water) exposures with short term residential exposures.  The short-term aggregate MOE for the general population of adults was calculated to be 445 which is well above the acceptable level of 100.  Therefore, aggregate short-term exposure and risk for adults is expected to be well within acceptable levels.
Using conservative exposure assumptions previously described, chronic dietary (food + drinking water) exposure to residues of ethofumesate from current and proposed uses was estimated to occupy 1.2% of the chronic RfD for the general U.S. population, 4.9% for Females 13-49 years of age, and 5.9% for the most sensitive population subgroup, Non-nursing Infants.  Thus, based on the completeness and reliability of the toxicity data and the conservative exposure assessment it is concluded that there is a reasonable certainty that no harm will result to the general U.S. population from acute, short-term or chronic aggregate exposures to ethofumesate residues from current and proposed uses.

2. Infants and children.  No appropriate single-dose endpoint is available for acute oral exposure of the general population to ethofumesate and no acute dietary risk assessment is needed for this population group.  Therefore no acute dietary exposure is needed for the infants and children subpopulations.  Infants and children may experience short-term dermal and oral exposure to ethofumesate as a result of post-application activities on treated residential turf.  Aggregate short-term exposures were determined by combining chronic dietary (food and water) exposures with short-term residential exposures.  The short-term aggregate MOE for non-nursing infants 1 to < 2 years old was 158, which is above the acceptable level of 100.  Using conservative exposure assumptions previously described, chronic dietary exposure to residues of ethofumesate from current and proposed uses including drinking water was estimated to occupy 5.9% of the chronic RfD for the most highly exposed subpopulation, non-nursing infants.  Drinking water was estimated to occupy 5.2% of the chronic RfD for non-nursing infants.  Thus, based on the completeness and reliability of the toxicity data and the conservative exposure assessment it is concluded that there is a reasonable certainty that no harm will result to infants and children from acute, short-term or chronic aggregate exposures to ethofumesate residues from current and proposed uses.

F. International Tolerances.

European Union Maximum Residue Level (MRL) for sugar beet root is established at 0.5 ppm for ethofumesate.  Maximum Residue Levels (MRL's) have been established in Canada for ethofumesate in sugar beet roots at 0.3 ppm and sugar beet molasses at 0.5 ppm.