Acephate, Fenbutatin-Oxide (Hexakis), MCPA, Pyrethrins, and Triallate; Tolerance Actions, 5104-5109 [E8-1535]
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Federal Register / Vol. 73, No. 19 / Tuesday, January 29, 2008 / Rules and Regulations
Federal Government and Indian tribes,
as specified by Executive Order 13175
(65 FR 67249, November 9, 2000).
Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
This rule also is not subject to
Executive Order 13045 ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), because it is not
economically significant.
Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
Because it is not a ‘‘significant
regulatory action’’ under Executive
Order 12866 or a ‘‘significant regulatory
action,’’ this action is also not subject to
Executive Order 13211, ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001).
National Technology Transfer
Advancement Act
List of Subjects in 40 CFR Part 52
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (NTTAA), 15 U.S.C. 272,
requires Federal agencies to use
technical standards that are developed
or adopted by voluntary consensus to
carry out policy objectives, so long as
such standards are not inconsistent with
applicable law or otherwise impractical.
In reviewing SIP submissions, EPA’s
role is to approve state choices,
provided that they meet the criteria of
the Clean Air Act. Absent a prior
existing requirement for the state to use
voluntary consensus standards, EPA has
no authority to disapprove a SIP
submission for failure to use such
standards, and it would thus be
inconsistent with applicable law for
EPA to use voluntary consensus
standards in place of a program
submission that otherwise satisfies the
provisions of the Clean Air Act.
Therefore, the requirements of section
12(d) of the NTTA do not apply.
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping
requirements.
Dated: January 11, 2008.
Gary Gulezian,
Acting Regional Administrator, Region 5.
I
40 CFR part 52 is amended as follows:
PART 52—[AMENDED]
1. The authority citation for part 52
continues to read as follows:
I
Authority: 42 U.S.C. 7401, et seq.
Subpart X—Michigan
2. In § 52.1170, the table in paragraph
(c) entitled ‘‘EPA—Approved Michigan
Regulations’’ is amended by adding an
entry in Part 8 for ‘‘R 336.1818’’ to read
as follows:
I
§ 52.1170
*
Identification of plan.
*
*
(c) * * *
*
*
EPA-APPROVED MICHIGAN REGULATIONS
Michigan
citation
State effective
date
Title
*
*
*
EPA approval date
*
*
Comments
*
*
*
*
Part 8. Emission Limitations and Prohibitions—Oxides of Nitrogen
*
*
R 336.1818 .......
*
*
*
*
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[FR Doc. E8–1415 Filed 1–28–08; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
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[EPA–HQ–OPP–2007–0445; FRL–8348–8]
Acephate, Fenbutatin-Oxide (Hexakis),
MCPA, Pyrethrins, and Triallate;
Tolerance Actions
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
16:22 Jan 28, 2008
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11/20/06
1/29/08 [Insert page number where the document begins].
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SUMMARY: EPA is revoking certain
tolerances for the insecticides acephate
and pyrethrins. Also, EPA is modifying
certain tolerances for the insecticides
acephate and pyrethrins. In addition,
EPA is establishing new tolerances for
the herbicides MCPA and triallate, and
the insecticides fenbutatin-oxide
(hexakis) and pyrethrins. The regulatory
actions finalized in this document are in
follow-up to the Agency’s reregistration
program under the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), and tolerance reassessment
program under the Federal Food, Drug,
and Cosmetic Act (FFDCA) section
408(q).
This regulation is effective
January 29, 2008. Objections and
DATES:
Final rule.
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combustion engines.
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requests for hearings must be received
on or before March 31, 2008, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007–0445. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
ADDRESSES:
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the docket index available in
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
https://www.regulations.gov or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT: Jane
Smith, Special Review and
Reregistration Division (7508P), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 308–
0048; e-mail address:smith.janescott@epa.gov.
SUPPLEMENTARY INFORMATION:
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I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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. To determine whether
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you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
Unit II.A. If you have any questions
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket athttps://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the Federal Register listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2007–0445 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before March 31, 2008.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2007–0445, by one of
the following methods.
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
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Protection Agency, Rm. S–4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
II. Background
A. What Action is the Agency Taking?
In the Federal Register of August 8,
2007 (72 FR 44439) (FRL–8138–8), EPA
issued a proposal to revoke, modify, and
establish specific tolerances for residues
of the herbicides MCPA and triallate;
and the insecticides acephate,
fenbutatin-oxide (hexakis), and
pyrethrins. Also, the proposal of August
8, 2007 provided a 60–day comment
period which invited public comment
for consideration and for support of
tolerance retention under FFDCA
standards.
In this final rule, EPA is revoking,
modifying, and establishing specific
tolerances for residues of acephate,
fenbutatin-oxide (hexakis), MCPA,
pyrethrins, and triallate in or on
commodities listed in the regulatory text
of the proposal published August 8,
2007.
EPA is finalizing these tolerance
actions in order to implement the
tolerance recommendations made
during the reregistration and tolerance
reassessment processes (including
follow-up on canceled or additional
uses of pesticides). As part of these
processes, EPA is required to determine
whether each of the amended tolerances
meets the safety standard of the Food
Quality Protection Act (FQPA). The
safety finding determination of
‘‘reasonable certainty of no harm’’ is
discussed in detail in each
Reregistration Eligibility Decision (RED)
and Report of the Food Quality
Protection Act (FQPA) Tolerance
Reassessment Progress and Risk
Management Decision (TRED) for the
active ingredient. REDs and TREDs
recommend certain tolerance actions to
be implemented to reflect current use
patterns, to meet safety findings, and
change commodity names and
groupings in accordance with new EPA
policy. Printed copies of many REDs
and TREDs may be obtained from EPA’s
National Service Center for
Environmental Publications (EPA/
NSCEP), P.O. Box 42419, Cincinnati,
OH 45242–2419; telephone: 1 (800)
490–9198; fax: 1 (513) 489–8695;
internet at https://www.epa.gov/
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ncepihom/ and from the National
Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA
22161; telephone: 1 (800) 553–6847 or
(703) 605–6000; internet at: https://
www.ntis.gov/. Electronic copies of
REDs and TREDs are available on the
Internet and in the public dockets EPA–
HQ–OPP–2007–0445 and EPA–HQ–
OPP–2004–0154 (fenbutatin-oxide/
hexakis), EPA–HQ–OPP–2004–0156
(MCPA), EPA–HQ–OPP–2005–0043
(pyrethrins), and EPA–HQ–OPP–2006–
0586 (triallate) at https://
www.regulations.gov and https://
www.epa.gov/pesticides/reregistration/
status.htm.
In this final rule, EPA is revoking
certain tolerances and tolerance
exemptions because these specific
tolerances and exemptions correspond
to uses no longer current or registered
under FIFRA in the United States. The
tolerances revoked by this final rule are
no longer necessary to cover residues of
the relevant pesticides in or on
domestically treated commodities or
commodities treated outside but
imported into the United States. It is
EPA’s general practice to revoke those
tolerances and tolerance exemptions for
residues of pesticide active ingredients
on crop uses for which there are no
active registrations under FIFRA, unless
any person in comments on the
proposal indicates a need for the
tolerance or tolerance exemption to
cover residues in or on imported
commodities or legally treated
domesticcommodities.
EPA has historically been concerned
that retention of tolerances that are not
necessary to cover residues in or on
legally treated foods may encourage
misuse of pesticides within the United
States.
Generally, EPA will proceed with the
revocation of these tolerances on the
grounds discussed in Unit II.A. if one of
the following conditions applies:
1. Prior to EPA’s issuance of a section
408(f) order requesting additional data
or issuance of a section 408(d) or (e)
order revoking the tolerances on other
grounds, commenters retract the
comment identifying a need for the
tolerance to be retained.
2. EPA independently verifies that the
tolerance is no longer needed.
3. The tolerance is not supported by
data that demonstrate that the tolerance
meets the requirements under FQPA.
This final rule does not revoke those
tolerances for which EPA received
comments stating a need for the
tolerance to be retained. In response to
the proposal published in the Federal
Register of August 8, 2007 (72 FR
44439), EPA received comments during
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the 60–day public comment period, as
follows:
General. Comment by Pat Duggan,
Editor of the Pesticide Chemical News
Guide. The commenter questions why
the Agency is retaining the postharvest
designation on many of the pyrethrin
tolerances when in a previous notice for
the chemical thiophanate-methyl it was
stated that ‘‘the Agency has determined
that the timings of treatment should not
be included as part of these tolerances
because the enforcement agency
analyzing samples would not know
whether a commodity bore residues
resulting from a seed treatment.’’
Agency Response. Currently, residues
of pyrethrin are regulated in two
sections of the 40 CFR part 180.
Residues of pyrethrins resulting from
preharvest applications are regulated
under the exemption in 40 CFR
180.905(a)(6). Residues of pyrethrins
resulting from postharvest applications
are regulated by tolerances in 40 CFR
180.128. Since there is an exemption in
place for pyrethrins, there are
deficiencies in the residue data used to
support some tolerances. As part of the
reregistration decision, the residue
studies that were not previously
conducted on crop groups and other
commodities are being required and/or
are underway. Although there are some
residue data deficiencies, EPA was able
to make a safety finding using
conservative assumptions in the risk
assessment, which indicated no dietary
risks, and to consider the tolerances
reassessed. Therefore, the Agency is
retaining the postharvest terminology on
an interim basis until these data for
preharvest uses are received from the
registrants and to prevent confusion in
the 40 CFR part 180 between
§ 180.905(a)(6) and § 180.128 (unlike
thiophanate-methyl which appears in
only one section of the CFR.) Once the
preharvest data are evaluated, and the
Agency confirms that the tolerances in
§ 180.128 are reflective of the pre- and
postharvest residue levels, the Agency
intends to remove the postharvest
designation to be consistent with
current Agency practice.
The Agency did not receive comments
on the following chemicals: acephate,
fenbutatin-oxide (hexakis), MCPA, and
triallate. Therefore, the Agency is
finalizing, with the exception of the
chlorpyrifos and metolachlor tolerances,
the amendments proposed in the
Federal Register of August 8, 2007 (72
FR 44439) (FRL–8138–8). The Agency
received comments on chlorpyrifos and
metolachlor which require additional
time to address. The Agency will
publish the response to comment and
final tolerance rule for chlorpyrifos and
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metolachlor in the future. For a detailed
discussion of the Agency’s rationale for
the establishments, revocations, and
modifications to the tolerances, refer to
the August 8, 2007 proposed rule.
B. What is the Agency’s Authority for
Taking this Action?
EPA may issue a regulation
establishing, modifying, or revoking a
tolerance under FFDCA section 408(e).
In this final rule, EPA is establishing,
modifying, and revoking tolerances to
implement the tolerance
recommendations made during the
reregistration and tolerance
reassessment processes, and as followup on canceled uses of pesticides. As
part of these processes, EPA is required
to determine whether each of the
amended tolerances meets the safety
standards under FQPA. The safety
finding determination is found in detail
in each RED and TRED for the active
ingredient. REDs and TREDs
recommend the implementation of
certain tolerance actions, including
modifications to reflect current use
patterns, to meet safety findings, and
change commodity names and
groupings in accordance with new EPA
policy. Printed and electronic copies of
the REDs and TREDs are available as
provided in Unit II.A.
EPA has issued post-FQPA REDs for
pyrethrins, MCPA, triallate, and TREDs
for acephate and fenbutatin-oxide
whose REDs were completed prior to
FQPA. REDs and TREDs contain the
Agency’s evaluation of the data base for
these pesticides, including statements
regarding additional data on the active
ingredients that may be needed to
confirm the potential human health and
environmental risk assessments
associated with current product uses,
and REDs state conditions under which
these uses and products will be eligible
for reregistration. The REDs and TREDs
recommended the establishment,
modification, and/or revocation of
specific tolerances. RED and TRED
recommendations such as establishing
or modifying tolerances, and in some
cases revoking tolerances, are the result
of assessment under the FQPA standard
of ‘‘reasonable certainty of no harm.’’
However, tolerance revocations
recommended in REDs and TREDs, that
are made final in this document, do not
need such assessment when the
tolerances are no longer necessary.
EPA’s general practice is to propose
revocation of tolerances for residues of
pesticide active ingredients on crops for
which FIFRA registrations no longer
exist and on which the pesticide may
therefore no longer be used in the
United States. Nonetheless, EPA will
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establish and maintain tolerances even
when corresponding domestic uses are
canceled if the tolerances, which EPA
refers to as ‘‘import tolerances,’’ are
necessary to allow importation into the
United States of food containing such
pesticide residues. However, where
there are no imported commodities that
require these import tolerances, the
Agency believes it is appropriate to
revoke tolerances for unregistered
pesticides in order to prevent potential
misuse.
When EPA establishes tolerances for
pesticide residues in or on raw
agricultural commodities, the Agency
gives consideration to possible pesticide
residues in meat, milk, poultry, and/or
eggs produced by animals that are fed
agricultural products (for example, grain
or hay) containing pesticides residues
(40 CFR 180.6). If there is no reasonable
expectation of finite pesticide residues
in or on meat, milk, poultry, or eggs,
then tolerances do not need to be
established for these commodities (40
CFR 180.6(b) and180.6(c)).
C. When Do These Actions Become
Effective?
These actions become effective on the
date of publication of this final rule in
the Federal Register. The tolerances
revoked in this rule are associated with
uses that have been canceled for several
years. The Agency believes that treated
commodities have had sufficient time
for passage through the channels of
trade.
Any commodities listed in the
regulatory text of this document that are
treated with the pesticides subject to
this final rule, and that are in the
channels of trade following the
tolerance revocations, shall be subject to
FFDCA section 408(1)(5), as established
by FQPA. Under this section, any
residues of these pesticides in or on
such food shall not render the food
adulterated so long as it is shown to the
satisfaction of the Food and Drug
Administration that:
1. The residue is present as the result
of an application or use of the pesticide
at a time and in a manner that was
lawful under FIFRA.
2. The residue does not exceed the
level that was authorized at the time of
the application or use to be present on
the food under a tolerance or exemption
from a tolerance. Evidence to show that
food was lawfully treated may include
records that verify the dates that the
pesticide was applied to such food.
III. Are the Actions Consistent with
International Obligations?
The tolerance revocations in this final
rule are not discriminatory and are
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designed to ensure that both
domestically produced and imported
foods meet the food safety standard
established by FFDCA. The same food
safety standards apply to domestically
produced and imported foods.
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue levels
(MRLs) established by the Codex
Alimentarius Commission, as required
by section 408(b)(4) of the FFDCA. The
Codex Alimentarius is a joint U.N. Food
and Agriculture Organization/World
Health Organization food standards
program, and it is recognized as an
international food safety standardssetting organization in trade agreements
to which the United States is a party.
EPA may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level in a notice
published for public comment. EPA’s
effort to harmonize with Codex MRLs is
summarized in the tolerance
reassessment section of individual REDs
and TREDs, and in the Residue
Chemistry document which supports
the RED and TRED, as mentioned in
Unit II.A. Specific tolerance actions in
this final rule and how they compare to
Codex MRLs (if any) are discussed in
Unit II.A.
IV. Statutory and Executive Order
Reviews
In this final rule, EPA is establishing
tolerances under FFDCA section 408(e),
and modifying and revoking specific
tolerances established under FFDCA
section 408. The Office of Management
and Budget (OMB) has exempted these
types of actions (e.g., establishment and
modification of a tolerance and
tolerance revocation for which
extraordinary circumstances do not
exist) from review under Executive
Order 12866, entitledRegulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866 due to its lack of
significance, this final rule is not subject
to Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
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unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations as required by
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or
any other Agency action under
Executive Order 13045, entitled
Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Pursuant to
the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency
previously assessed whether
establishment of tolerances, exemptions
from tolerances, raising of tolerance
levels, expansion of exemptions, or
revocations might significantly impact a
substantial number of small entities and
concluded that, as a general matter,
these actions do not impose a significant
economic impact on a substantial
number of small entities. These analyses
for tolerance establishments and
modifications, and for tolerance
revocations were published on May 4,
1981 (46 FR 24950) and on December
17, 1997 (62 FR 66020), respectively,
and were provided to the Chief Counsel
for Advocacy of the Small Business
Administration. Taking into account
this analysis, and available information
concerning the pesticides listed in this
final rule, the Agency hereby certifies
that this action will not have a
significant negative economic impact on
a substantial number of small entities.
In a memorandum dated May 25, 2001,
EPA determined that eight conditions
must all be satisfied in order for an
import tolerance or tolerance exemption
revocation to adversely affect a
significant number of small entity
importers, and that there is a negligible
joint probability of all eight conditions
holding simultaneously with respect to
any particular revocation. (This Agency
document is available in the docket of
this final rule). Furthermore, for the
pesticides named in this final rule, the
Agency knows of no extraordinary
circumstances that exist as to the
present proposal that would change
EPA’s previous analysis. Any comments
about the Agency’s determination
should be submitted to EPA along with
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comments on the proposal, and will be
addressed prior to issuing a final rule.
In addition, the Agency has determined
that this action will not have a
substantial direct effect on 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,
entitledFederalism (64 FR 43255,
August 10, 1999). Executive Order
13132 requires EPA to develop an
accountable process to ensure
‘‘meaningful and timely input by State
and local officials in the development of
regulatory policies that have federalism
implications.’’ ‘‘Policies that have
federalism implications’’ is defined in
the Executive Order to include
regulations that 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.’’ This
final rule directly regulates growers,
food processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the
Agency has determined that this final
rule does not have any ‘‘tribal
implications’’ as described in Executive
Order 13175, entitled Consultation and
Coordination with Indian Tribal
Governments (65 FR 67249, November
6, 2000). Executive Order 13175,
requires EPA to develop an accountable
process to ensure ‘‘meaningful and
timely input by tribal officials in the
development of regulatory policies that
have tribal implications.’’ ‘‘Policies that
have tribal implications’’ is defined in
the Executive Order to include
regulations that have ‘‘substantial direct
effects on one or more Indian tribes, 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.’’ This
final rule will not have substantial
direct effects on tribal governments, on
the relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this final rule.
VerDate Aug<31>2005
16:22 Jan 28, 2008
Jkt 214001
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: January 17, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
(2) A food tolerance of 0.02 ppm is
established for residues of acephate per
se (O,S-dimethyl
acetylphosphoramidothioate) as follows:
*
*
*
*
*
(c) Tolerances with regional
registration. Tolerances with regional
registration, as defined in § 180.1(m),
are established for residues of acephate
per se (O,S-dimethyl
acetylphosphoramidothioate) in or on
the following food commodities:
Commodity
PART 180—[AMENDED]
Nut, macadamia .............
1. The authority citation for part 180
continues to read as follows:
I
2. Section 180.108 is amended by
revising paragraph (a)(1), paragragh
(a)(2) introductory text, and (c) to read
as follows:
I
§ 180.108 Acephate; tolerances for
residues.
(a) General. (1) Tolerances are
established for residues of acephate per
se (O,S-dimethyl
acetylphosphoramidothioate) in or on
the following food commodities1:
Parts per million
Bean, dry, seed ..............
Bean, succulent ..............
Brussels sprouts .............
Cattle, fat ........................
Cattle, meat ....................
Cattle, meat byproducts
Cauliflower ......................
Celery .............................
Cotton, hulls ....................
Cotton, meal ...................
Cotton, undelinted seed
Cranberry ........................
Egg .................................
Goat, fat ..........................
Goat, meat ......................
Goat, meat byproducts ...
Hog, fat ...........................
Hog, meat .......................
Hog, meat byproducts ....
Horse, fat ........................
Horse, meat ....................
Horse, meat byproducts
Lettuce, head ..................
Milk .................................
Peanut ............................
Pepper ............................
Peppermint, tops ............
Poultry, fat ......................
Poultry, meat ..................
Poultry, meat byproducts
Sheep, fat .......................
Sheep, meat ...................
Sheep, meat byproducts
Spearmint, tops ..............
Soybean, seed ................
3.0
3.0
3.0
0.1
0.1
0.1
2.0
10
1.0
1.0
0.5
0.5
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
10
0.1
0.2
4.0
27
0.1
0.1
0.1
0.1
0.1
0.1
27
1.0
1Residues
of the acephate metabolite,
methamidophos, are regulated under 40 CFR
180.315
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
0.05
*
Authority: 21 U.S.C. 321(q), 346a and 371.
Commodity1
Parts per million
*
*
*
*
3. Section 180.128 is amended by
revising paragraph (a) to read as follows:
I
§ 180.128 Pyrethrins; tolerances for
residues.
(a) General. (1) Tolerances for
residues of the insecticide pyrethrins
((1S)-2-methyl-4-oxo-3-(2Z)-2,4pentadienylcyclopenten-1-yl (1R,3R)2,2-dimethyl-3-(2-methyl-1propenyl)cyclopropanecarboxylate
(pyrethrin 1), (1S)-2-methyl-4-oxo-3(2Z)-2,4-pentadienyl-2-cyclopenten-1-yl
(1R,3R)-3-[(1E)-3-methoxy-2-methyl-3oxo-1-propenyl]-2,2dimethylcyclopropane-carboxylate
(pyrethrin 2), (1S)-3-(2Z)-2-butenyl-2methyl-4-oxo-2-cyclopenten-1-yl
(1R,3R)-2,2-dimethyl-3-(2-methyl-1propenyl)cyclopropanecarboxylate
(cinerin 1), (1S)-3-(2Z)-2-butenyl-2methyl-4-oxo-2-cyclopenten-1-yl
(1R,3R)-3-[(1E)-3-methoxy-2-methyl-3oxo-1-propenyl]-2,2dimethylcyclopropanecarboxylate
(cinerin 2), (1S)-2-methyl-4-oxo-3-(2Z)2-pentenyl-2-cyclopenten-1-yl (1R, 3R)2,2-dimethyl-3-(2-methyl-1propenyl)cyclopropanecarboxylate
(jasmolin 1), and (1S)-2-methyl-4-oxo-3(2Z)-pentenyl-2-cyclopenten-1-yl
(1R,3R)-3-[(1E)-3-methoxy-2-methyl-3oxo-1-propenyl]-2,2dimethylcyclopropanecarboxylate
(jasmolin 2)), the insecticidally active
principles of Chrysanthemum
cinerariaefolium, which are measured as
cumulative residues of pyrethrin 1,
cinerin 1, and jasmolin 1 are not to
exceed the following:
Commodity
Almond, postharvest .......
Apple, postharvest ..........
Barley, grain, postharvest
Bean, succulent,
postharvest ..................
Birdseed, mixtures,
postharvest ..................
Blackberry, postharvest ..
Blueberry, postharvest ....
E:\FR\FM\29JAR1.SGM
29JAR1
Parts per million
1.0
1.0
3.0
1.0
3.0
1.0
1.0
Federal Register / Vol. 73, No. 19 / Tuesday, January 29, 2008 / Rules and Regulations
Commodity
Parts per million
rwilkins on PROD1PC63 with RULES
Boysenberry, postharvest
Buckwheat, grain,
postharvest ..................
Cacao bean, roasted
bean, postharvest .......
Cattle, fat ........................
Cattle, meat ....................
Cattle, meat byproducts
Cherry, sweet,
postharvest ..................
Cherry, tart, postharvest
Coconut, copra,
postharvest ..................
Corn, field, grain,
postharvest ..................
Corn, pop, grain,
postharvest ..................
Cotton, undelinted seed,
postharvest ..................
Crabapple, postharvest ..
Currant, postharvest .......
Dewberry, postharvest ....
Fig, postharvest ..............
Flax, seed, postharvest ..
Goat, fat ..........................
Goat, meat ......................
Goat, meat byproducts ...
Gooseberry, postharvest
Grape, postharvest .........
Guava, postharvest ........
Hog, fat ...........................
Hog, meat .......................
Hog, meat byproducts ....
Horse, fat ........................
Horse, meat ....................
Horse, meat byproducts
Loganberry, postharvest
Mango, postharvest ........
Milk, fat (reflecting negligible residues in milk)
Muskmelon, postharvest
Oat, grain, postharvest ...
Orange, postharvest .......
Pea, dry, seed,
postharvest ..................
Peach, postharvest .........
Peanut, postharvest ........
Pear, postharvest ...........
Pineapple, postharvest ...
Plum, prune, fresh,
postharvest ..................
Potato, postharvest .........
Raspberry, postharvest ..
Rice, grain, postharvest ..
Rye, grain, postharvest ..
Sheep, fat .......................
Sheep, meat ...................
Sheep, meat byproducts
Sorghum, grain, grain,
postharvest ..................
Sweet potato,
postharvest ..................
Tomato, postharvest .......
Walnut, postharvest ........
Wheat, grain, postharvest
1.0
3.0
1.0
1.0
0.05
0.05
1.0
1.0
1.0
3.0
3.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
0.05
0.05
1.0
1.0
1.0
1.0
0.05
0.05
1.0
0.05
0.05
1.0
1.0
0.05
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
0.05
1.0
3.0
3.0
1.0
0.05
0.05
1.0
0.05
1.0
1.0
3.0
(2) A tolerance of 1.0 ppm is
established for residues of the
insecticide pyrethrins in or on milled
fractions derived from grain, cereal
when present as a result of its use in
cereal grain mills and in storage areas
for milled cereal grain products.
VerDate Aug<31>2005
16:22 Jan 28, 2008
Jkt 214001
(3) A tolerance of 1.0 ppm is
established for residues of the
insecticide pyrethrins in or on all food
items in food handling establishments
where food and food products are held,
processed, prepared and/or served.
Food must be removed or covered prior
to use.
(4) Where tolerances are established
on both the raw agricultural
commodities and processed foods made
there-from, the total residues of
pyrethrins in or on the processed food
shall not be greater than that permitted
by the larger of the two tolerances.
*
*
*
*
*
I 4. Section 180.314 is amended by
alphabetically adding the following
commodity to the table in paragraph (c)
to read as follows
*
*
*
*
5109
*
[FR Doc. E8–1535 Filed 1–28–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 716
[EPA–HQ–OPPT–2007–0487; FRL–8154–2]
RIN 2070–AB11
Health and Safety Data Reporting;
Addition of Certain Chemicals
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This final rule, issued
pursuant to section 8(d) of the Toxic
Substances Control Act (TSCA) and its
§ 180.314 Triallate; tolerance for residues.
regulations, requires manufacturers
*
*
*
*
*
(including importers) of consumer
(c) Tolerances with regional
products intended for use by children
registrations. * * *
who also manufacture (including
import) lead or lead compounds to
Commodity
Parts per million
report certain unpublished health and
*
*
*
*
*
safety data to EPA. This final rule adds
lead and lead compounds to 40 CFR
Wheat, forage .................
0.05 716.120 because the Interagency Testing
*
*
*
*
*
Committee (ITC) added the category of
lead and lead compounds to the Priority
Testing List through its 60th ITC Report.
*
*
*
*
*
The ITC was established under section
I 5. Section 180.339 is amended by
4(e) of TSCA to recommend chemicals
alphabetically adding the following
and chemical mixtures to EPA for
commodity to the table in paragraph
priority testing consideration; the ITC
(a)(1) to read as follows.
periodically amends the TSCA section
4(e) Priority Testing List through
§ 180.339 MCPA; tolerances for residues.
periodic reports submitted to EPA.
(a)(1) General. * * *
DATES: This final rule is effective on
February 28, 2008. For purposes of
Commodity
Parts per million
judicial review, this final rule shall be
*
*
*
*
*
promulgated at 1 p.m. eastern daylight/
standard time on February 12, 2008.
Grain, aspirated fractions
3.0 (See 40 CFR 23.5.)
*
*
*
*
*
A request to withdraw a chemical
from this final rule pursuant to 40 CFR
716.105(c) must be received on or before
*
*
*
*
*
February 12, 2008. (See Unit IV. of the
I 6. Section 180.362 is amended by
SUPPLEMENTARY INFORMATION.)
alphabetically adding the following
For dates for reporting requirements,
commodity to the table in paragraph
see Unit III.B. of the SUPPLEMENTARY
(a)(1) to read as follows.
INFORMATION.
§ 180.362 Hexakis (2-methyl-2ADDRESSES: Submit your comments,
phenylpropyl)distannoxane; tolerances for
identified by docket identification (ID)
residues.
number EPA–HQ–OPPT–2007–0487, by
(a) * * *
one of the following methods.
• Federal eRulemaking Portal: https://
(1) * * *
www.regulations.gov. Follow the on-line
Commodity
Parts per million
instructions for submitting comments.
• Mail: Document Control Office
*
*
*
*
*
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Pistachio .........................
0.5
Protection Agency, 1200 Pennsylvania
*
*
*
*
*
Ave., NW., Washington, DC 20460–
0001.
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
E:\FR\FM\29JAR1.SGM
29JAR1
Agencies
[Federal Register Volume 73, Number 19 (Tuesday, January 29, 2008)]
[Rules and Regulations]
[Pages 5104-5109]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-1535]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0445; FRL-8348-8]
Acephate, Fenbutatin-Oxide (Hexakis), MCPA, Pyrethrins, and
Triallate; Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is revoking certain tolerances for the insecticides
acephate and pyrethrins. Also, EPA is modifying certain tolerances for
the insecticides acephate and pyrethrins. In addition, EPA is
establishing new tolerances for the herbicides MCPA and triallate, and
the insecticides fenbutatin-oxide (hexakis) and pyrethrins. The
regulatory actions finalized in this document are in follow-up to the
Agency's reregistration program under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), and tolerance reassessment
program under the Federal Food, Drug, and Cosmetic Act (FFDCA) section
408(q).
DATES: This regulation is effective January 29, 2008. Objections and
requests for hearings must be received on or before March 31, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0445. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in
[[Page 5105]]
the docket index available in 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 https://www.regulations.gov or, if
only available in hard copy, at the OPP Regulatory Public Docket in Rm.
S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Jane Smith, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0048; e-mail
address:smith.jane-scott@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II.A. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket athttps://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the Federal Register
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2007-0445 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before March 31, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0445, by one of the following methods.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background
A. What Action is the Agency Taking?
In the Federal Register of August 8, 2007 (72 FR 44439) (FRL-8138-
8), EPA issued a proposal to revoke, modify, and establish specific
tolerances for residues of the herbicides MCPA and triallate; and the
insecticides acephate, fenbutatin-oxide (hexakis), and pyrethrins.
Also, the proposal of August 8, 2007 provided a 60-day comment period
which invited public comment for consideration and for support of
tolerance retention under FFDCA standards.
In this final rule, EPA is revoking, modifying, and establishing
specific tolerances for residues of acephate, fenbutatin-oxide
(hexakis), MCPA, pyrethrins, and triallate in or on commodities listed
in the regulatory text of the proposal published August 8, 2007.
EPA is finalizing these tolerance actions in order to implement the
tolerance recommendations made during the reregistration and tolerance
reassessment processes (including follow-up on canceled or additional
uses of pesticides). As part of these processes, EPA is required to
determine whether each of the amended tolerances meets the safety
standard of the Food Quality Protection Act (FQPA). The safety finding
determination of ``reasonable certainty of no harm'' is discussed in
detail in each Reregistration Eligibility Decision (RED) and Report of
the Food Quality Protection Act (FQPA) Tolerance Reassessment Progress
and Risk Management Decision (TRED) for the active ingredient. REDs and
TREDs recommend certain tolerance actions to be implemented to reflect
current use patterns, to meet safety findings, and change commodity
names and groupings in accordance with new EPA policy. Printed copies
of many REDs and TREDs may be obtained from EPA's National Service
Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419,
Cincinnati, OH 45242-2419; telephone: 1 (800) 490-9198; fax: 1 (513)
489-8695; internet at https://www.epa.gov/
[[Page 5106]]
ncepihom/ and from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161; telephone: 1 (800) 553-
6847 or (703) 605-6000; internet at: https://www.ntis.gov/. Electronic
copies of REDs and TREDs are available on the Internet and in the
public dockets EPA-HQ-OPP-2007-0445 and EPA-HQ-OPP-2004-0154
(fenbutatin-oxide/hexakis), EPA-HQ-OPP-2004-0156 (MCPA), EPA-HQ-OPP-
2005-0043 (pyrethrins), and EPA-HQ-OPP-2006-0586 (triallate) at https://
www.regulations.gov and https://www.epa.gov/pesticides/reregistration/
status.htm.
In this final rule, EPA is revoking certain tolerances and
tolerance exemptions because these specific tolerances and exemptions
correspond to uses no longer current or registered under FIFRA in the
United States. The tolerances revoked by this final rule are no longer
necessary to cover residues of the relevant pesticides in or on
domestically treated commodities or commodities treated outside but
imported into the United States. It is EPA's general practice to revoke
those tolerances and tolerance exemptions for residues of pesticide
active ingredients on crop uses for which there are no active
registrations under FIFRA, unless any person in comments on the
proposal indicates a need for the tolerance or tolerance exemption to
cover residues in or on imported commodities or legally treated
domesticcommodities.
EPA has historically been concerned that retention of tolerances
that are not necessary to cover residues in or on legally treated foods
may encourage misuse of pesticides within the United States.
Generally, EPA will proceed with the revocation of these tolerances
on the grounds discussed in Unit II.A. if one of the following
conditions applies:
1. Prior to EPA's issuance of a section 408(f) order requesting
additional data or issuance of a section 408(d) or (e) order revoking
the tolerances on other grounds, commenters retract the comment
identifying a need for the tolerance to be retained.
2. EPA independently verifies that the tolerance is no longer
needed.
3. The tolerance is not supported by data that demonstrate that the
tolerance meets the requirements under FQPA.
This final rule does not revoke those tolerances for which EPA
received comments stating a need for the tolerance to be retained. In
response to the proposal published in the Federal Register of August 8,
2007 (72 FR 44439), EPA received comments during the 60-day public
comment period, as follows:
General. Comment by Pat Duggan, Editor of the Pesticide Chemical
News Guide. The commenter questions why the Agency is retaining the
postharvest designation on many of the pyrethrin tolerances when in a
previous notice for the chemical thiophanate-methyl it was stated that
``the Agency has determined that the timings of treatment should not be
included as part of these tolerances because the enforcement agency
analyzing samples would not know whether a commodity bore residues
resulting from a seed treatment.''
Agency Response. Currently, residues of pyrethrin are regulated in
two sections of the 40 CFR part 180. Residues of pyrethrins resulting
from preharvest applications are regulated under the exemption in 40
CFR 180.905(a)(6). Residues of pyrethrins resulting from postharvest
applications are regulated by tolerances in 40 CFR 180.128. Since there
is an exemption in place for pyrethrins, there are deficiencies in the
residue data used to support some tolerances. As part of the
reregistration decision, the residue studies that were not previously
conducted on crop groups and other commodities are being required and/
or are underway. Although there are some residue data deficiencies, EPA
was able to make a safety finding using conservative assumptions in the
risk assessment, which indicated no dietary risks, and to consider the
tolerances reassessed. Therefore, the Agency is retaining the
postharvest terminology on an interim basis until these data for
preharvest uses are received from the registrants and to prevent
confusion in the 40 CFR part 180 between Sec. 180.905(a)(6) and Sec.
180.128 (unlike thiophanate-methyl which appears in only one section of
the CFR.) Once the preharvest data are evaluated, and the Agency
confirms that the tolerances in Sec. 180.128 are reflective of the
pre- and postharvest residue levels, the Agency intends to remove the
postharvest designation to be consistent with current Agency practice.
The Agency did not receive comments on the following chemicals:
acephate, fenbutatin-oxide (hexakis), MCPA, and triallate. Therefore,
the Agency is finalizing, with the exception of the chlorpyrifos and
metolachlor tolerances, the amendments proposed in the Federal Register
of August 8, 2007 (72 FR 44439) (FRL-8138-8). The Agency received
comments on chlorpyrifos and metolachlor which require additional time
to address. The Agency will publish the response to comment and final
tolerance rule for chlorpyrifos and metolachlor in the future. For a
detailed discussion of the Agency's rationale for the establishments,
revocations, and modifications to the tolerances, refer to the August
8, 2007 proposed rule.
B. What is the Agency's Authority for Taking this Action?
EPA may issue a regulation establishing, modifying, or revoking a
tolerance under FFDCA section 408(e). In this final rule, EPA is
establishing, modifying, and revoking tolerances to implement the
tolerance recommendations made during the reregistration and tolerance
reassessment processes, and as follow-up on canceled uses of
pesticides. As part of these processes, EPA is required to determine
whether each of the amended tolerances meets the safety standards under
FQPA. The safety finding determination is found in detail in each RED
and TRED for the active ingredient. REDs and TREDs recommend the
implementation of certain tolerance actions, including modifications to
reflect current use patterns, to meet safety findings, and change
commodity names and groupings in accordance with new EPA policy.
Printed and electronic copies of the REDs and TREDs are available as
provided in Unit II.A.
EPA has issued post-FQPA REDs for pyrethrins, MCPA, triallate, and
TREDs for acephate and fenbutatin-oxide whose REDs were completed prior
to FQPA. REDs and TREDs contain the Agency's evaluation of the data
base for these pesticides, including statements regarding additional
data on the active ingredients that may be needed to confirm the
potential human health and environmental risk assessments associated
with current product uses, and REDs state conditions under which these
uses and products will be eligible for reregistration. The REDs and
TREDs recommended the establishment, modification, and/or revocation of
specific tolerances. RED and TRED recommendations such as establishing
or modifying tolerances, and in some cases revoking tolerances, are the
result of assessment under the FQPA standard of ``reasonable certainty
of no harm.'' However, tolerance revocations recommended in REDs and
TREDs, that are made final in this document, do not need such
assessment when the tolerances are no longer necessary.
EPA's general practice is to propose revocation of tolerances for
residues of pesticide active ingredients on crops for which FIFRA
registrations no longer exist and on which the pesticide may therefore
no longer be used in the United States. Nonetheless, EPA will
[[Page 5107]]
establish and maintain tolerances even when corresponding domestic uses
are canceled if the tolerances, which EPA refers to as ``import
tolerances,'' are necessary to allow importation into the United States
of food containing such pesticide residues. However, where there are no
imported commodities that require these import tolerances, the Agency
believes it is appropriate to revoke tolerances for unregistered
pesticides in order to prevent potential misuse.
When EPA establishes tolerances for pesticide residues in or on raw
agricultural commodities, the Agency gives consideration to possible
pesticide residues in meat, milk, poultry, and/or eggs produced by
animals that are fed agricultural products (for example, grain or hay)
containing pesticides residues (40 CFR 180.6). If there is no
reasonable expectation of finite pesticide residues in or on meat,
milk, poultry, or eggs, then tolerances do not need to be established
for these commodities (40 CFR 180.6(b) and180.6(c)).
C. When Do These Actions Become Effective?
These actions become effective on the date of publication of this
final rule in the Federal Register. The tolerances revoked in this rule
are associated with uses that have been canceled for several years. The
Agency believes that treated commodities have had sufficient time for
passage through the channels of trade.
Any commodities listed in the regulatory text of this document that
are treated with the pesticides subject to this final rule, and that
are in the channels of trade following the tolerance revocations, shall
be subject to FFDCA section 408(1)(5), as established by FQPA. Under
this section, any residues of these pesticides in or on such food shall
not render the food adulterated so long as it is shown to the
satisfaction of the Food and Drug Administration that:
1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA.
2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from a tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates that the
pesticide was applied to such food.
III. Are the Actions Consistent with International Obligations?
The tolerance revocations in this final rule are not discriminatory
and are designed to ensure that both domestically produced and imported
foods meet the food safety standard established by FFDCA. The same food
safety standards apply to domestically produced and imported foods.
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue levels (MRLs) established
by the Codex Alimentarius Commission, as required by section 408(b)(4)
of the FFDCA. The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level in a notice published
for public comment. EPA's effort to harmonize with Codex MRLs is
summarized in the tolerance reassessment section of individual REDs and
TREDs, and in the Residue Chemistry document which supports the RED and
TRED, as mentioned in Unit II.A. Specific tolerance actions in this
final rule and how they compare to Codex MRLs (if any) are discussed in
Unit II.A.
IV. Statutory and Executive Order Reviews
In this final rule, EPA is establishing tolerances under FFDCA
section 408(e), and modifying and revoking specific tolerances
established under FFDCA section 408. The Office of Management and
Budget (OMB) has exempted these types of actions (e.g., establishment
and modification of a tolerance and tolerance revocation for which
extraordinary circumstances do not exist) from review under Executive
Order 12866, entitledRegulatory Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule has been exempted from review
under Executive Order 12866 due to its lack of significance, this final
rule is not subject to Executive Order 13211, Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations as required by Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any other Agency action under
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.), the Agency previously assessed whether establishment of
tolerances, exemptions from tolerances, raising of tolerance levels,
expansion of exemptions, or revocations might significantly impact a
substantial number of small entities and concluded that, as a general
matter, these actions do not impose a significant economic impact on a
substantial number of small entities. These analyses for tolerance
establishments and modifications, and for tolerance revocations were
published on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR
66020), respectively, and were provided to the Chief Counsel for
Advocacy of the Small Business Administration. Taking into account this
analysis, and available information concerning the pesticides listed in
this final rule, the Agency hereby certifies that this action will not
have a significant negative economic impact on a substantial number of
small entities. In a memorandum dated May 25, 2001, EPA determined that
eight conditions must all be satisfied in order for an import tolerance
or tolerance exemption revocation to adversely affect a significant
number of small entity importers, and that there is a negligible joint
probability of all eight conditions holding simultaneously with respect
to any particular revocation. (This Agency document is available in the
docket of this final rule). Furthermore, for the pesticides named in
this final rule, the Agency knows of no extraordinary circumstances
that exist as to the present proposal that would change EPA's previous
analysis. Any comments about the Agency's determination should be
submitted to EPA along with
[[Page 5108]]
comments on the proposal, and will be addressed prior to issuing a
final rule. In addition, the Agency has determined that this action
will not have a substantial direct effect on 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, entitledFederalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that 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.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this final rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, 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.'' This final rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this final rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: January 17, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.108 is amended by revising paragraph (a)(1), paragragh
(a)(2) introductory text, and (c) to read as follows:
Sec. 180.108 Acephate; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
acephate per se (O,S-dimethyl acetylphosphoramidothioate) in or on the
following food commodities1:
------------------------------------------------------------------------
Commodity\1\ Parts per million
------------------------------------------------------------------------
Bean, dry, seed...................................... 3.0
Bean, succulent...................................... 3.0
Brussels sprouts..................................... 3.0
Cattle, fat.......................................... 0.1
Cattle, meat......................................... 0.1
Cattle, meat byproducts.............................. 0.1
Cauliflower.......................................... 2.0
Celery............................................... 10
Cotton, hulls........................................ 1.0
Cotton, meal......................................... 1.0
Cotton, undelinted seed.............................. 0.5
Cranberry............................................ 0.5
Egg.................................................. 0.1
Goat, fat............................................ 0.1
Goat, meat........................................... 0.1
Goat, meat byproducts................................ 0.1
Hog, fat............................................. 0.1
Hog, meat............................................ 0.1
Hog, meat byproducts................................. 0.1
Horse, fat........................................... 0.1
Horse, meat.......................................... 0.1
Horse, meat byproducts............................... 0.1
Lettuce, head........................................ 10
Milk................................................. 0.1
Peanut............................................... 0.2
Pepper............................................... 4.0
Peppermint, tops..................................... 27
Poultry, fat......................................... 0.1
Poultry, meat........................................ 0.1
Poultry, meat byproducts............................. 0.1
Sheep, fat........................................... 0.1
Sheep, meat.......................................... 0.1
Sheep, meat byproducts............................... 0.1
Spearmint, tops...................................... 27
Soybean, seed........................................ 1.0
------------------------------------------------------------------------
\1\Residues of the acephate metabolite, methamidophos, are regulated
under 40 CFR 180.315
(2) A food tolerance of 0.02 ppm is established for residues of
acephate per se (O,S-dimethyl acetylphosphoramidothioate) as follows:
* * * * *
(c) Tolerances with regional registration. Tolerances with regional
registration, as defined in Sec. 180.1(m), are established for
residues of acephate per se (O,S-dimethyl acetylphosphoramidothioate)
in or on the following food commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Nut, macadamia....................................... 0.05
------------------------------------------------------------------------
* * * * *
0
3. Section 180.128 is amended by revising paragraph (a) to read as
follows:
Sec. 180.128 Pyrethrins; tolerances for residues.
(a) General. (1) Tolerances for residues of the insecticide
pyrethrins ((1S)-2-methyl-4-oxo-3-(2Z)-2,4-pentadienylcyclopenten-1-yl
(1R,3R)-2,2-dimethyl-3-(2-methyl-1-propenyl)cyclopropanecarboxylate
(pyrethrin 1), (1S)-2-methyl-4-oxo-3-(2Z)-2,4-pentadienyl-2-
cyclopenten-1-yl (1R,3R)-3-[(1E)-3-methoxy-2-methyl-3-oxo-1-propenyl]-
2,2-dimethylcyclopropane-carboxylate (pyrethrin 2), (1S)-3-(2Z)-2-
butenyl-2-methyl-4-oxo-2-cyclopenten-1-yl (1R,3R)-2,2-dimethyl-3-(2-
methyl-1-propenyl)cyclopropanecarboxylate (cinerin 1), (1S)-3-(2Z)-2-
butenyl-2-methyl-4-oxo-2-cyclopenten-1-yl (1R,3R)-3-[(1E)-3-methoxy-2-
methyl-3-oxo-1-propenyl]-2,2-dimethylcyclopropanecarboxylate (cinerin
2), (1S)-2-methyl-4-oxo-3-(2Z)-2-pentenyl-2-cyclopenten-1-yl (1R, 3R)-
2,2-dimethyl-3-(2-methyl-1-propenyl)cyclopropanecarboxylate (jasmolin
1), and (1S)-2-methyl-4-oxo-3-(2Z)-pentenyl-2-cyclopenten-1-yl (1R,3R)-
3-[(1E)-3-methoxy-2-methyl-3-oxo-1-propenyl]-2,2-
dimethylcyclopropanecarboxylate (jasmolin 2)), the insecticidally
active principles of Chrysanthemum cinerariaefolium, which are measured
as cumulative residues of pyrethrin 1, cinerin 1, and jasmolin 1 are
not to exceed the following:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond, postharvest.................................. 1.0
Apple, postharvest................................... 1.0
Barley, grain, postharvest........................... 3.0
Bean, succulent, postharvest......................... 1.0
Birdseed, mixtures, postharvest...................... 3.0
Blackberry, postharvest.............................. 1.0
Blueberry, postharvest............................... 1.0
[[Page 5109]]
Boysenberry, postharvest............................. 1.0
Buckwheat, grain, postharvest........................ 3.0
Cacao bean, roasted bean, postharvest................ 1.0
Cattle, fat.......................................... 1.0
Cattle, meat......................................... 0.05
Cattle, meat byproducts.............................. 0.05
Cherry, sweet, postharvest........................... 1.0
Cherry, tart, postharvest............................ 1.0
Coconut, copra, postharvest.......................... 1.0
Corn, field, grain, postharvest...................... 3.0
Corn, pop, grain, postharvest........................ 3.0
Cotton, undelinted seed, postharvest................. 1.0
Crabapple, postharvest............................... 1.0
Currant, postharvest................................. 1.0
Dewberry, postharvest................................ 1.0
Fig, postharvest..................................... 1.0
Flax, seed, postharvest.............................. 1.0
Goat, fat............................................ 1.0
Goat, meat........................................... 0.05
Goat, meat byproducts................................ 0.05
Gooseberry, postharvest.............................. 1.0
Grape, postharvest................................... 1.0
Guava, postharvest................................... 1.0
Hog, fat............................................. 1.0
Hog, meat............................................ 0.05
Hog, meat byproducts................................. 0.05
Horse, fat........................................... 1.0
Horse, meat.......................................... 0.05
Horse, meat byproducts............................... 0.05
Loganberry, postharvest.............................. 1.0
Mango, postharvest................................... 1.0
Milk, fat (reflecting negligible residues in milk)... 0.05
Muskmelon, postharvest............................... 1.0
Oat, grain, postharvest.............................. 1.0
Orange, postharvest.................................. 1.0
Pea, dry, seed, postharvest.......................... 1.0
Peach, postharvest................................... 1.0
Peanut, postharvest.................................. 1.0
Pear, postharvest.................................... 1.0
Pineapple, postharvest............................... 1.0
Plum, prune, fresh, postharvest...................... 1.0
Potato, postharvest.................................. 0.05
Raspberry, postharvest............................... 1.0
Rice, grain, postharvest............................. 3.0
Rye, grain, postharvest.............................. 3.0
Sheep, fat........................................... 1.0
Sheep, meat.......................................... 0.05
Sheep, meat byproducts............................... 0.05
Sorghum, grain, grain, postharvest................... 1.0
Sweet potato, postharvest............................ 0.05
Tomato, postharvest.................................. 1.0
Walnut, postharvest.................................. 1.0
Wheat, grain, postharvest............................ 3.0
------------------------------------------------------------------------
(2) A tolerance of 1.0 ppm is established for residues of the
insecticide pyrethrins in or on milled fractions derived from grain,
cereal when present as a result of its use in cereal grain mills and in
storage areas for milled cereal grain products.
(3) A tolerance of 1.0 ppm is established for residues of the
insecticide pyrethrins in or on all food items in food handling
establishments where food and food products are held, processed,
prepared and/or served. Food must be removed or covered prior to use.
(4) Where tolerances are established on both the raw agricultural
commodities and processed foods made there-from, the total residues of
pyrethrins in or on the processed food shall not be greater than that
permitted by the larger of the two tolerances.
* * * * *
0
4. Section 180.314 is amended by alphabetically adding the following
commodity to the table in paragraph (c) to read as follows
Sec. 180.314 Triallate; tolerance for residues.
* * * * *
(c) Tolerances with regional registrations. * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Wheat, forage........................................ 0.05
* * * * *
------------------------------------------------------------------------
* * * * *
0
5. Section 180.339 is amended by alphabetically adding the following
commodity to the table in paragraph (a)(1) to read as follows.
Sec. 180.339 MCPA; tolerances for residues.
(a)(1) General. * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Grain, aspirated fractions........................... 3.0
* * * * *
------------------------------------------------------------------------
* * * * *
0
6. Section 180.362 is amended by alphabetically adding the following
commodity to the table in paragraph (a)(1) to read as follows.
Sec. 180.362 Hexakis (2-methyl-2-phenylpropyl)distannoxane;
tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Pistachio............................................ 0.5
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-1535 Filed 1-28-08; 8:45 am]
BILLING CODE 6560-50-S