Dicamba; Pesticide Tolerances, 55804-55807 [2011-23159]
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55804
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations
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).
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 31, 2011.
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 180.637 is amended by
revising paragraph (b) to read as follows:
■
Mandipropamid; tolerances for
*
*
*
*
*
(b) Section 18 emergency exemptions.
Time-limited tolerances specified in the
following table are established for
residues of the mandipropamid, 4chloro-N-[2-[3-methoxy-4-(2propynyloxy)phenyl]ethyl]-a-(2propynyloxy)-benzeneacetamide in or
on the specified agricultural
commodities, resulting from use of the
pesticide pursuant to FFIFRA section 18
emergency exemptions. The tolerances
expire on the date specified in the table.
Parts per
million
Commodity
Basil, dried ........
Basil, fresh ........
*
*
*
240
20
*
Expiration
date
12/31/12
12/31/12
*
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[FR Doc. 2011–22983 Filed 9–8–11; 8:45 am]
BILLING CODE 6560–50–P
40 CFR Part 180
[EPA–HQ–OPP–2010–0496; FRL–8881–6]
Dicamba; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of dicamba in or
on teff, forage; teff, grain; teff, straw; and
teff, hay. Interregional Research Project
Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
September 9, 2011. Objections and
requests for hearings must be received
on or before November 8, 2011, 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–2010–0496. 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:
Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7390; e-mail address: nollen.
laura@epa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
List of Subjects in 40 CFR Part 180
§ 180.637
residues.
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
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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
site at https://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl. To access the
harmonized test guidelines referenced
in this document electronically, please
go https://www.epa.gov/ocspp and select
‘‘Test Methods and Guidelines.’’
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 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–2010–0496 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 November 8, 2011. 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. Information not marked
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confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2010–0496, 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. Summary of Petitioned-For
Tolerance
In the Federal Register of October 22,
2010 (75 FR 65321) (FRL–8851–1), 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 0E7779) by IR–4,
500 College Rd. East, Suite 201W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.227 be
amended by establishing a tolerance for
residues of the herbicide dicamba, 3,6dichloro-o-anisic acid, and its
metabolite 3,6-dichloro-5-hydroxy-oanisic acid (5-OH dicamba), in or on
teff, forage at 90.0 parts per million
(ppm); teff, grain at 6.0 ppm; teff, straw
at 30.0 ppm; and teff, hay at 40.0 ppm.
That notice referenced a summary of the
petition prepared on behalf of IR–4 by
Helena Chemical Company, the
registrant, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon review of the data
supporting the petition, EPA has revised
the tolerance expression for all
established commodities to be
consistent with current Agency policy.
The reason for this change is explained
in Unit IV.C.
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
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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 dicamba
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with dicamba follows.
In the Federal Register of April 2,
2008 (73 FR 17914) (FRL–8356–6), EPA
published a final rule establishing
tolerances for combined residues of the
herbicide dicamba, 3,6-dichloro-o-anisic
acid, and its metabolite, 3,6-dichloro-5hydroxy-o-anisic acid in or on corn,
sweet, forage at 0.50 ppm; corn, sweet,
kernel plus cob with husks removed
0.04 ppm; and corn, sweet, stover at
0.50 ppm, based on EPA’s conclusion
that aggregate exposure to dicamba is
safe for the general population,
including infants and children. Since
2008, there have been no additional
tolerance actions for dicamba.
As noted in this unit, the current
action concerns a tolerance for dicamba
on teff. Teff is an intermediate grass that
is morphologically and taxonomically
similar to other cereal grains, including
wheat. It is used to make flour in a
manner similar to wheat and other
cereal grains. EPA recently assessed the
proposed use of dicamba on teff. In that
assessment, EPA determined that
aggregate dicamba exposures and risks
will not increase as a result of the
addition of the proposed teff uses to the
uses assessed as part of the 2008
rulemaking. Teff is not included in the
Continuing Survey of Food Intakes by
Individuals (CSFII). However, because it
is used to make flour in a manner
similar to wheat and other cereal grains,
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it will likely substitute in the diet for
cereal grain foods which will contain
similar residues of dicamba; therefore, a
significant increase in dietary exposure
to residues of dicamba from
consumption of teff-containing foods
will not occur. Furthermore, residues of
dicamba in teff livestock feeds will be
similar to those in other forages, hays,
and silages for which tolerances of
dicamba are currently established. As
such, there would be no increase in the
livestock dietary burden should teff be
substituted in the livestock diet for
other hays and silages; residues in meat,
milk, poultry and eggs will remain the
same.
Further information about EPA’s risk
assessment and determination of safety
for this action can be found at https://
www.regulations.gov in document ‘‘2,4D and Dicamba: Petition for the
Establishment of Tolerances on Teff;
Request for Registration of Latigo (EPA
Reg. No. 5905–564) on Teff.’’ in docket
ID number EPA–HQ–OPP–2010–0496.
Except as supplemented by the
information described in this unit, EPA
is relying on the safety finding in the
2008 rulemaking and the risk
assessment underlying that action in
establishing the tolerances for dicamba
on teff, forage; teff, grain; teff, straw; and
teff, hay. Further information regarding
the safety finding for the last rulemaking
can be found in the Federal Register of
April 2, 2008 (73 FR 17917) (FRL–8356–
6), at https://www.epa.gov/fedrgstr/EPAPEST/2008/April/Day-02/p6674.htm.
For the 2008 rulemaking, the toxicity
database was considered complete.
However, recent changes to 40 CFR part
158 imposed new data requirements for
immunotoxicity testing (OPPTS
Guideline 870.7800) and acute and
subchronic neurotoxicity testing
(OPPTS Guideline 870.6200) for
pesticide registration. The toxicity
database for dicamba includes
acceptable acute and subchronic
neurotoxicity studies; therefore, the
requirements for the neurotoxicity
screening battery have been met.
Additionally, an immunotoxicity study
was recently submitted and is currently
under review. A screening level review
of this study indicates that no effects,
including immunotoxic effects, were
observed at the highest dose tested of
approximately 307 milligrams/
kilograms(mg/kg/day). This value is
higher than the doses currently used for
risk assessment; therefore, risk
assessment endpoints will not change
and the toxicity database is considered
complete.
Based upon the 2008 rulemaking and
the other information discussed in this
unit, EPA concludes that there is a
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reasonable certainty that no harm will
result to the general population, and to
infants and children, from aggregate
exposure to dicamba residues. Refer to
the April 2, 2008 (73 FR 17914) (FRL–
8356–6) 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.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies,
Methods I and II—gas chromatography
with electron capture detection (GC/
ECD), are available to enforce the
tolerance expression. The methods are
published in the Pesticide Analytical
Manual (PAM) Volume II. 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; email address: residuemethods@epa.gov.
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B. International Residue Limits
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 limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
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.
The Codex has not established MRLs
for dicamba in or on commodities
associated with this action.
C. Revisions to Petitioned-For
Tolerances
The EPA has revised the tolerance
expression to clarify:
1. That, as provided in FFDCA section
408(a)(3), the tolerance covers
metabolites and degradates of dicamba
not specifically mentioned; and
2. That compliance with the specified
tolerance levels is to be determined by
measuring only the specific compounds
mentioned in the tolerance expression.
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V. Conclusion
Therefore, tolerances are established
for residues of dicamba, 3,6-dichloro-oanisic acid, including its metabolites
and degradates, in or on teff, forage at
90.0 ppm; teff, grain at 6.0 ppm; teff,
straw at 30.0 ppm; and teff, hay at 40.0
ppm.
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,
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
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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) (Pub. L. 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: August 31, 2011.
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 180.227 is amended by
revising the introductory text in
paragraphs (a)(1), (2), and (3); and
alphabetically adding the following
commodities to the table in paragraph
(a)(1) to read as follows:
■
§ 180.227 Dicamba; tolerances for
residues.
(a) General. (1) Tolerances are
established for the residues of the
herbicide dicamba (3,6-dichloro-o-anisic
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acid), including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels is to be determined by
measuring only the sum of the residues
of dicamba (3,6-dichloro-o-anisic acid)
and its metabolite, 3,6-dichloro-5hydroxy-o-anisic acid, calculated as the
stoichiometric equivalent of dicamba, in
or on the following commodities:
Drug, and Cosmetic Act (FFDCA) for
residues of novaluron in or on multiple
commodities which are identified and
discussed later in this document.
Additionally, the Agency is amending
existing tolerances for meat byproducts
and revising commodity terms for hog
and poultry byproducts. Interregional
Research Project Number 4 (IR–4)
requested the sweet corn tolerances;
Makhteshim-Agan of North America,
Parts per
Inc. requested the food and feed
Commodity
million
handling establishment tolerances.
DATES: This regulation is effective
September 9, 2011. Objections and
*
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*
*
*
Teff, forage .................................
90.0 requests for hearings must be received
Teff, grain ...................................
6.0 on or before November 8, 2011, and
Teff, hay ......................................
40.0 must be filed in accordance with the
Teff, straw ...................................
30.0 instructions provided in 40 CFR part
178 (see also Unit I.C. of the
*
*
*
*
*
SUPPLEMENTARY INFORMATION ).
ADDRESSES: EPA has established a
(2) Tolerances are established for
docket for this action under docket
residues of the herbicide dicamba, 3,6identification (ID) number EPA–HQ–
dichloro-o-anisic acid, including its
metabolites and degradates, in or on the OPP–2010–0466. All documents in the
docket are listed in the docket index
commodities in the table below.
available at https://www.regulations.gov.
Compliance with the tolerance levels is
to be determined by measuring only the Although listed in the index, some
information is not publicly available,
residues of dicamba (3,6-dichloro-oe.g., Confidential Business Information
anisic acid) and its metabolite, 3,6(CBI) or other information whose
dichloro-2-hydroxybenzoic acid,
disclosure is restricted by statute.
calculated as the stoichiometric
Certain other material, such as
equivalent of dicamba, in or on the
copyrighted material, is not placed on
following commodities:
the Internet and will be publicly
*
*
*
*
*
available only in hard copy form.
(3) Tolerances are established for
Publicly available docket materials are
residues of the herbicide dicamba, 3,6available in the electronic docket at
dichloro-o-anisic acid, including its
https://www.regulations.gov, or, if only
metabolites and degradates, in or on the
available in hard copy, at the OPP
commodities in the table below.
Regulatory Public Docket in Rm. S–
Compliance with the tolerance levels is
4400, One Potomac Yard (South Bldg.),
to be determined by measuring only the
2777 S. Crystal Dr., Arlington, VA. The
residues of dicamba, 3,6-dichloro-oDocket Facility is open from 8:30 a.m.
anisic acid, and its metabolites, 3,6to 4 p.m., Monday through Friday,
dichloro-5-hydroxy-o-anisic acid, and
excluding legal holidays. The Docket
3,6-dichloro-2-hydroxybenzoic acid,
Facility telephone number is (703) 305–
calculated as the stoichiometric
5805.
equivalent of dicamba, in or on the
FOR FURTHER INFORMATION CONTACT:
following commodities:
Jennifer Gaines, Registration Division
*
*
*
*
*
(7505P), Office of Pesticide Programs,
[FR Doc. 2011–23159 Filed 9–8–11; 8:45 am]
Environmental Protection Agency, 1200
BILLING CODE 6560–50–P
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5967; e-mail address:
ENVIRONMENTAL PROTECTION
gaines.jennifer@epa.gov.
AGENCY
SUPPLEMENTARY INFORMATION:
40 CFR Part 180
I. General Information
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[EPA–HQ–OPP–2010–0466; FRL–8882–1]
Novaluron; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances under the Federal Food,
SUMMARY:
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16:30 Sep 08, 2011
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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:
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55807
• 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
site at https://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl. To access the
harmonized test guidelines referenced
in this document electronically, please
go https://www.epa.gov/ocspp and select
‘‘Test Methods and Guidelines.’’
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 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–2010–0466 in the subject line on
the first page of your. All requests for a
hearing must be in writing, and must be
received by the Hearing Clerk on or
before November 8, 2011. 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. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
E:\FR\FM\09SER1.SGM
09SER1
Agencies
[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Rules and Regulations]
[Pages 55804-55807]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23159]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0496; FRL-8881-6]
Dicamba; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of dicamba
in or on teff, forage; teff, grain; teff, straw; and teff, hay.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 9, 2011. Objections and
requests for hearings must be received on or before November 8, 2011,
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-2010-0496. 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: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; e-mail address: nollen.laura@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 site at https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the
harmonized test guidelines referenced in this document electronically,
please go https://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 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-2010-0496 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
November 8, 2011. 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. Information not marked
[[Page 55805]]
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit a copy of your non-CBI objection or
hearing request, identified by docket ID number EPA-HQ-OPP-2010-0496,
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. Summary of Petitioned-For Tolerance
In the Federal Register of October 22, 2010 (75 FR 65321) (FRL-
8851-1), 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
0E7779) by IR-4, 500 College Rd. East, Suite 201W, Princeton, NJ 08540.
The petition requested that 40 CFR 180.227 be amended by establishing a
tolerance for residues of the herbicide dicamba, 3,6-dichloro-o-anisic
acid, and its metabolite 3,6-dichloro-5-hydroxy-o-anisic acid (5-OH
dicamba), in or on teff, forage at 90.0 parts per million (ppm); teff,
grain at 6.0 ppm; teff, straw at 30.0 ppm; and teff, hay at 40.0 ppm.
That notice referenced a summary of the petition prepared on behalf of
IR-4 by Helena Chemical Company, the registrant, which is available in
the docket, https://www.regulations.gov. There were no comments received
in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
revised the tolerance expression for all established commodities to be
consistent with current Agency policy. The reason for this change is
explained in Unit IV.C.
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 dicamba including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with dicamba
follows.
In the Federal Register of April 2, 2008 (73 FR 17914) (FRL-8356-
6), EPA published a final rule establishing tolerances for combined
residues of the herbicide dicamba, 3,6-dichloro-o-anisic acid, and its
metabolite, 3,6-dichloro-5-hydroxy-o-anisic acid in or on corn, sweet,
forage at 0.50 ppm; corn, sweet, kernel plus cob with husks removed
0.04 ppm; and corn, sweet, stover at 0.50 ppm, based on EPA's
conclusion that aggregate exposure to dicamba is safe for the general
population, including infants and children. Since 2008, there have been
no additional tolerance actions for dicamba.
As noted in this unit, the current action concerns a tolerance for
dicamba on teff. Teff is an intermediate grass that is morphologically
and taxonomically similar to other cereal grains, including wheat. It
is used to make flour in a manner similar to wheat and other cereal
grains. EPA recently assessed the proposed use of dicamba on teff. In
that assessment, EPA determined that aggregate dicamba exposures and
risks will not increase as a result of the addition of the proposed
teff uses to the uses assessed as part of the 2008 rulemaking. Teff is
not included in the Continuing Survey of Food Intakes by Individuals
(CSFII). However, because it is used to make flour in a manner similar
to wheat and other cereal grains, it will likely substitute in the diet
for cereal grain foods which will contain similar residues of dicamba;
therefore, a significant increase in dietary exposure to residues of
dicamba from consumption of teff-containing foods will not occur.
Furthermore, residues of dicamba in teff livestock feeds will be
similar to those in other forages, hays, and silages for which
tolerances of dicamba are currently established. As such, there would
be no increase in the livestock dietary burden should teff be
substituted in the livestock diet for other hays and silages; residues
in meat, milk, poultry and eggs will remain the same.
Further information about EPA's risk assessment and determination
of safety for this action can be found at https://www.regulations.gov in
document ``2,4-D and Dicamba: Petition for the Establishment of
Tolerances on Teff; Request for Registration of Latigo (EPA Reg. No.
5905-564) on Teff.'' in docket ID number EPA-HQ-OPP-2010-0496. Except
as supplemented by the information described in this unit, EPA is
relying on the safety finding in the 2008 rulemaking and the risk
assessment underlying that action in establishing the tolerances for
dicamba on teff, forage; teff, grain; teff, straw; and teff, hay.
Further information regarding the safety finding for the last
rulemaking can be found in the Federal Register of April 2, 2008 (73 FR
17917) (FRL-8356-6), at https://www.epa.gov/fedrgstr/EPA-PEST/2008/April/Day-02/p6674.htm.
For the 2008 rulemaking, the toxicity database was considered
complete. However, recent changes to 40 CFR part 158 imposed new data
requirements for immunotoxicity testing (OPPTS Guideline 870.7800) and
acute and subchronic neurotoxicity testing (OPPTS Guideline 870.6200)
for pesticide registration. The toxicity database for dicamba includes
acceptable acute and subchronic neurotoxicity studies; therefore, the
requirements for the neurotoxicity screening battery have been met.
Additionally, an immunotoxicity study was recently submitted and is
currently under review. A screening level review of this study
indicates that no effects, including immunotoxic effects, were observed
at the highest dose tested of approximately 307 milligrams/
kilograms(mg/kg/day). This value is higher than the doses currently
used for risk assessment; therefore, risk assessment endpoints will not
change and the toxicity database is considered complete.
Based upon the 2008 rulemaking and the other information discussed
in this unit, EPA concludes that there is a
[[Page 55806]]
reasonable certainty that no harm will result to the general
population, and to infants and children, from aggregate exposure to
dicamba residues. Refer to the April 2, 2008 (73 FR 17914) (FRL-8356-6)
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.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies, Methods I and II--gas
chromatography with electron capture detection (GC/ECD), are available
to enforce the tolerance expression. The methods are published in the
Pesticide Analytical Manual (PAM) Volume II. 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
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 limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). 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.
The Codex has not established MRLs for dicamba in or on commodities
associated with this action.
C. Revisions to Petitioned-For Tolerances
The EPA has revised the tolerance expression to clarify:
1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of dicamba not specifically
mentioned; and
2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.
V. Conclusion
Therefore, tolerances are established for residues of dicamba, 3,6-
dichloro-o-anisic acid, including its metabolites and degradates, in or
on teff, forage at 90.0 ppm; teff, grain at 6.0 ppm; teff, straw at
30.0 ppm; and teff, hay at 40.0 ppm.
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, 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) (Pub. L. 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: August 31, 2011.
Lois Rossi,
Director, Registration Division, 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 180.227 is amended by revising the introductory text in
paragraphs (a)(1), (2), and (3); and alphabetically adding the
following commodities to the table in paragraph (a)(1) to read as
follows:
Sec. 180.227 Dicamba; tolerances for residues.
(a) General. (1) Tolerances are established for the residues of the
herbicide dicamba (3,6-dichloro-o-anisic
[[Page 55807]]
acid), including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels is
to be determined by measuring only the sum of the residues of dicamba
(3,6-dichloro-o-anisic acid) and its metabolite, 3,6-dichloro-5-
hydroxy-o-anisic acid, calculated as the stoichiometric equivalent of
dicamba, in or on the following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Teff, forage................................................ 90.0
Teff, grain................................................. 6.0
Teff, hay................................................... 40.0
Teff, straw................................................. 30.0
* * * * *
------------------------------------------------------------------------
(2) Tolerances are established for residues of the herbicide
dicamba, 3,6-dichloro-o-anisic acid, including its metabolites and
degradates, in or on the commodities in the table below. Compliance
with the tolerance levels is to be determined by measuring only the
residues of dicamba (3,6-dichloro-o-anisic acid) and its metabolite,
3,6-dichloro-2-hydroxybenzoic acid, calculated as the stoichiometric
equivalent of dicamba, in or on the following commodities:
* * * * *
(3) Tolerances are established for residues of the herbicide
dicamba, 3,6-dichloro-o-anisic acid, including its metabolites and
degradates, in or on the commodities in the table below. Compliance
with the tolerance levels is to be determined by measuring only the
residues of dicamba, 3,6-dichloro-o-anisic acid, and its metabolites,
3,6-dichloro-5-hydroxy-o-anisic acid, and 3,6-dichloro-2-hydroxybenzoic
acid, calculated as the stoichiometric equivalent of dicamba, in or on
the following commodities:
* * * * *
[FR Doc. 2011-23159 Filed 9-8-11; 8:45 am]
BILLING CODE 6560-50-P