Pendimethalin; Pesticide Tolerances, 17571-17573 [2010-7740]
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Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations
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 Bldg.),
2777 S. Crystal Dr., 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: Jim
Commodity
Parts per million
Tompkins, Registration Division
Wheat, bran ....................
0.20 (7505P), Office of Pesticide Programs,
Wheat, forage .................
2.5 Environmental Protection Agency, 1200
Wheat, grain ...................
0.05 Pennsylvania Ave., NW., Washington,
Wheat, hay .....................
1.2 DC 20460–0001; telephone number:
Wheat, straw ...................
0.20 (703) 305–5697; e-mail address:
tompkins.jim@epa.gov.
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SUPPLEMENTARY INFORMATION:
[FR Doc. 2010–7624 Filed 4–6–10; 8:45 am]
flutolanil, N-(3-(1methylethoxy)phenyl)-2(trifluoromethyl)benzamide, including
its metabolites and degradates, in or on
the commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only flutolanil and its
metabolites converted to 2(trifluoromethyl) benzoic acid and
calculated as flutolanil, in or on the
following commodities.
I. General Information
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0673; FRL–8817–4]
Pendimethalin; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation amends the
current tolerance for combined residues
of pendimethalin and its metabolite,
expressed as pendimethalin equivalents,
in or on alfalfa forage. BASF
Corporation requested this tolerance
amendment under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April
7, 2010. Objections and requests for
hearings must be received on or before
June 7, 2010, 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–2009– 0673. All documents in the
docket are listed in the docket index
available at https://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.
WReier-Aviles on DSKGBLS3C1PROD with RULES
ADDRESSES:
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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 those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide 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 person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
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17571
objections. 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–2009–0673 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before June 7, 2010. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
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 this copy,
identified by docket ID number EPA–
HQ–OPP–2009–0673, 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 Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’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 Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of January 6,
2010 (75 FR 864) (FRL–8801–5), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 9F7576) by BASF
Corporation, 26 Davis Drive, Research
Triangle Park, NC 27709. The petition
requested that 40 CFR 180.361 be
amended by increasing the tolerance for
the combined residues of the herbicide
pendimethalin, [N-(1-ethylpropyl)-3,4dimethyl-2,6-dinitrobenzenamine], and
its metabolite 4-[(1-ethylpropyl)amino]2-methyl-3,5-dinitrobenzyl alcohol, in
or on alfalfa, forage from 3.0 parts per
million (ppm) to 3.5 (ppm). That notice
referenced a summary of the petition
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17572
Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations
WReier-Aviles on DSKGBLS3C1PROD with RULES
prepared by BASF Corporation, the
registrant, which is available in the
docket, https://www.regulations.gov.
Comments were received on the notice
of filing. EPA’s response to these
comments is discussed in Unit IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue....’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for combined
residues of pendimethalin and its
metabolite including exposure resulting
from the tolerance established by this
action. EPA’s assessment of exposures
and risks associated with
pendimethalin, [N-(1-ethylpropyl)-3,4dimethyl-2,6-dinitrobenzenamine] and
its metabolite 4-[(1-ethylpropyl)amino]2-methyl-3,5-dinitrobenzyl alcohol
follows.
On January 27, 2010, the Agency
published a final rule (75 FR 4279, FRL–
8804–2) establishing tolerances for
combined residues of pendimethalin
and its metabolite in or on various grass
commodities in crop group 17. When
the Agency conducted the risk
assessment in support of the January,
2010 tolerance action, it considered the
use of pendimethalin on alfalfa,
including potential residues of
pendimethalin and its metabolite in or
on alfalfa hay and forage. EPA also
considered the potential for secondary
residues of pendimethalin in livestock
commodities from consumption of
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treated alfalfa hay and forage and
determined that there was no reasonable
expectation of finite residues to occur.
Since alfalfa hay and alfalfa forage are
both categorized as roughage, EPA
assessed the pendimethalin dietary
burden of livestock using the higher
(more conservative) of the two
tolerances (alfalfa hay at 4.0 ppm).
Increasing the tolerance for alfalfa forage
to 3.5 ppm will not affect the estimated
livestock dietary burden or the
estimated aggregate risks resulting from
use of pendimethalin, as discussed in
the January 27, 2010 (75 FR 4279–4284,
FRL–8804–2) Federal Register. Refer to
this Federal Register document,
available at https://www.regulations.gov,
for a detailed discussion of the aggregate
risk assessments and determination of
safety. EPA relies upon those risk
assessments and the findings made in
the Federal Register document in
support of this action.
Therefore, based on the risk
assessments discussed in the final rule
published in the Federal Register of
January 27, 2010 (75 FR 4279, FRL–
8804–2), EPA concludes that there is a
reasonable certainty that no harm will
result to the general population, or to
infants and children from aggregate
exposure to pendimethalin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology,
using liquid chromatography/mass
spectrometry analysis (LC/MS/MS), is
available to enforce the tolerance
expression. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov
dinitrobenzenamine], and its metabolite
4-[(1-ethylpropyl)amino]-2-methyl-3,5dinitrobenzyl alcohol, calculated as the
stoichiometric equivalent of
pendimethalin.
EPA has determined that it is
reasonable to make this change final
without prior proposal and opportunity
for comment, because public comment
is not necessary, in that the change has
no substantive effect on the tolerance,
but rather is merely intended to clarify
the existing tolerance expression.
D. Response to Comments
EPA received comments from an
anonymous submitter objecting to
pesticides and other ‘‘toxic’’ chemicals
generally and recommending against
any tolerances greater than zero for this
product. The Agency understands the
commenter’s concerns and recognizes
that some individuals believe that
pesticides should be banned
completely. However, the existing legal
framework provided by section 408 of
the Federal Food, Drug and Cosmetic
Act (FFDCA) contemplates that
tolerances greater than zero may be set
when persons seeking such tolerances
or exemptions have demonstrated that
the pesticide meets the safety standard
imposed by that statute. This
submitter’s comments appear to be
directed at the underlying statute and
not EPA’s implementation of it; the
citizen has made no contention that
EPA has acted in violation of the
statutory framework.
C. Revisions to Petitioned-for Tolerances
V. Conclusion
Therefore, a tolerance is established
for residues of pendimethalin, including
its metabolites and degradates, in or on
the alfalfa, forage at 3.5 ppm.
Compliance with the tolerance level is
to be determined by measuring only
pendimethalin, [N-(1-ethylpropyl)-3,4dimethyl-2,6-dinitrobenzenamine], and
its metabolite, 4-[(ethylpropyl) amino]2-methyl-3,5-dinitrobenzyl alcohol,
calculated as the stoichiometric
equivalent of pendimethalin, in or on
alfalfa, forage.
EPA has revised the pendimethalin
tolerance expression for the new and
existing tolerances to clarify the
chemical moieties that are covered by
the tolerances and specify how
compliance with the tolerances is to be
measured. The revised tolerance
expression makes clear that the
tolerances cover residues of
pendimethalin and its metabolites and
degradates, but that compliance with
the tolerance levels will be determined
by measuring only pendimethalin, [N(1-ethylpropyl)-3,4-dimethyl-2,6-
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
B. International Residue Limits
There are no established or proposed
Codex maximum residue limits (MRLs)
for pendimethalin.
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Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule 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) (Public Law 104–4).
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).
VII. 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 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 this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: March 26, 2010.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.361, revise the
introductory text and the entry for
Alfalfa, forage in the table in paragraph
(a) to read as follows:
■
§ 180.361 Pendimethalin; tolerances for
residues.
(a) General. Tolerances are
established for residues of the herbicide
pendimethalin, including its
metabolites and degradates, in or on the
commodities. Compliance with the
tolerance levels specified in the
following table below is to be
determined by measuring only
pendimethalin, [N- (1-ethylpropyl)-3,4dimethyl-2,6-dinitrobenzenamine], and
its metabolite, 4-[(1-ethylpropyl)amino]2-methyl-3,5-dinitrobenzyl alcohol,
calculated as the stoichiometric
equivalent of pendimethalin, in or on
the following commodities:
Commodity
Parts per million
Alfalfa, forage ...................................................................................................................................................
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[FR Doc. 2010–7740 Filed 4–6–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
WReier-Aviles on DSKGBLS3C1PROD with RULES
[EPA–HQ–OPP–2009–0057; FRL–8818–4]
Nicosulfuron; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for residues of nicosulfuron
in or on cattle, fat; cattle, meat; cattle,
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meat byproducts; goat, fat; goat, meat;
goat, meat byproducts; grass, forage;
grass, hay; horse, fat; horse, meat; horse,
meat byproducts; milk; sheep, fat;
sheep, meat; and sheep, meat
byproducts. E. I. du Pont de Nemours
and Company requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA). This
regulation also removes the existing
tolerance for residues of nicosulfuron on
corn, forage.
DATES: This regulation is effective April
7, 2010. Objections and requests for
hearings must be received on or before
June 7, 2010, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
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3.5
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2009–0057. All documents in the
docket are listed in the docket index
available at https://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
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
E:\FR\FM\07APR1.SGM
07APR1
Agencies
[Federal Register Volume 75, Number 66 (Wednesday, April 7, 2010)]
[Rules and Regulations]
[Pages 17571-17573]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7740]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0673; FRL-8817-4]
Pendimethalin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends the current tolerance for combined
residues of pendimethalin and its metabolite, expressed as
pendimethalin equivalents, in or on alfalfa forage. BASF Corporation
requested this tolerance amendment under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective April 7, 2010. Objections and
requests for hearings must be received on or before June 7, 2010, 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-2009- 0673. All documents in the
docket are listed in the docket index available at https://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 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 Bldg.), 2777 S. Crystal Dr., 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: Jim Tompkins, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5697; e-mail address: tompkins.jim@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 those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide 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 person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR cite at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2009-0673 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 7, 2010. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
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 this copy, identified by docket ID number
EPA-HQ-OPP-2009-0673, 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
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility'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 Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of January 6, 2010 (75 FR 864) (FRL-8801-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9F7576) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.361 be amended by
increasing the tolerance for the combined residues of the herbicide
pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine],
and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl
alcohol, in or on alfalfa, forage from 3.0 parts per million (ppm) to
3.5 (ppm). That notice referenced a summary of the petition
[[Page 17572]]
prepared by BASF Corporation, the registrant, which is available in the
docket, https://www.regulations.gov. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit
IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for combined residues of
pendimethalin and its metabolite including exposure resulting from the
tolerance established by this action. EPA's assessment of exposures and
risks associated with pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-
2,6-dinitrobenzenamine] and its metabolite 4-[(1-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenzyl alcohol follows.
On January 27, 2010, the Agency published a final rule (75 FR 4279,
FRL-8804-2) establishing tolerances for combined residues of
pendimethalin and its metabolite in or on various grass commodities in
crop group 17. When the Agency conducted the risk assessment in support
of the January, 2010 tolerance action, it considered the use of
pendimethalin on alfalfa, including potential residues of pendimethalin
and its metabolite in or on alfalfa hay and forage. EPA also considered
the potential for secondary residues of pendimethalin in livestock
commodities from consumption of treated alfalfa hay and forage and
determined that there was no reasonable expectation of finite residues
to occur. Since alfalfa hay and alfalfa forage are both categorized as
roughage, EPA assessed the pendimethalin dietary burden of livestock
using the higher (more conservative) of the two tolerances (alfalfa hay
at 4.0 ppm). Increasing the tolerance for alfalfa forage to 3.5 ppm
will not affect the estimated livestock dietary burden or the estimated
aggregate risks resulting from use of pendimethalin, as discussed in
the January 27, 2010 (75 FR 4279-4284, FRL-8804-2) Federal Register.
Refer to this Federal Register document, available at https://www.regulations.gov, for a detailed discussion of the aggregate risk
assessments and determination of safety. EPA relies upon those risk
assessments and the findings made in the Federal Register document in
support of this action.
Therefore, based on the risk assessments discussed in the final
rule published in the Federal Register of January 27, 2010 (75 FR 4279,
FRL-8804-2), EPA concludes that there is a reasonable certainty that no
harm will result to the general population, or to infants and children
from aggregate exposure to pendimethalin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, using liquid chromatography/mass
spectrometry analysis (LC/MS/MS), is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov
B. International Residue Limits
There are no established or proposed Codex maximum residue limits
(MRLs) for pendimethalin.
C. Revisions to Petitioned-for Tolerances
EPA has revised the pendimethalin tolerance expression for the new
and existing tolerances to clarify the chemical moieties that are
covered by the tolerances and specify how compliance with the
tolerances is to be measured. The revised tolerance expression makes
clear that the tolerances cover residues of pendimethalin and its
metabolites and degradates, but that compliance with the tolerance
levels will be determined by measuring only pendimethalin, [N- (1-
ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite
4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, calculated
as the stoichiometric equivalent of pendimethalin.
EPA has determined that it is reasonable to make this change final
without prior proposal and opportunity for comment, because public
comment is not necessary, in that the change has no substantive effect
on the tolerance, but rather is merely intended to clarify the existing
tolerance expression.
D. Response to Comments
EPA received comments from an anonymous submitter objecting to
pesticides and other ``toxic'' chemicals generally and recommending
against any tolerances greater than zero for this product. The Agency
understands the commenter's concerns and recognizes that some
individuals believe that pesticides should be banned completely.
However, the existing legal framework provided by section 408 of the
Federal Food, Drug and Cosmetic Act (FFDCA) contemplates that
tolerances greater than zero may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. This submitter's comments
appear to be directed at the underlying statute and not EPA's
implementation of it; the citizen has made no contention that EPA has
acted in violation of the statutory framework.
V. Conclusion
Therefore, a tolerance is established for residues of
pendimethalin, including its metabolites and degradates, in or on the
alfalfa, forage at 3.5 ppm. Compliance with the tolerance level is to
be determined by measuring only pendimethalin, [N-(1-ethylpropyl)-3,4-
dimethyl-2,6-dinitrobenzenamine], and its metabolite, 4-[(ethylpropyl)
amino]-2-methyl-3,5-dinitrobenzyl alcohol, calculated as the
stoichiometric equivalent of pendimethalin, in or on alfalfa, forage.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211,
[[Page 17573]]
entitled Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). 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., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule 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) (Public Law 104-4).
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).
VII. 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 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 26, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
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 180.361, revise the introductory text and the entry for
Alfalfa, forage in the table in paragraph (a) to read as follows:
Sec. 180.361 Pendimethalin; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide pendimethalin, including its metabolites and degradates, in
or on the commodities. Compliance with the tolerance levels specified
in the following table below is to be determined by measuring only
pendimethalin, [N- (1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine], and its metabolite, 4-[(1-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenzyl alcohol, calculated as the stoichiometric
equivalent of pendimethalin, in or on the following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Alfalfa, forage..................... 3.5
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2010-7740 Filed 4-6-10; 8:45 am]
BILLING CODE 6560-50-S