Glyphosate; Pesticide Tolerance, 27268-27271 [2011-11205]
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27268
Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations
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, 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 (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
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16:21 May 10, 2011
Jkt 223001
under Title II of the Unfunded Mandates
Reform Act of 1995 (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,
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).
*
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Bushberry, subgroup 13–07B ...
Caneberry, subgroup 13–07A ..
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Low growing berry subgroup
13–07G, except cranberry ....
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Onion, bulb subgroup 3–07A ...
Onion, green, subgroup 3–07B
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Peppermint, tops ......................
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10.0
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Spearmint, tops ........................
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10.0
*
Dated: May 2, 2011.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
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1.0
1.0
1.3
0.2
9.0
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(b) * * *
Avocado ........
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10
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*
Expiration/
revocation
date
Parts per
million
Commodity
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Parts per
million
Commodity
*
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12/31/13
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[FR Doc. 2011–11564 Filed 5–10–11; 8:45 am]
BILLING CODE 6560–50–P
Therefore, 40 CFR chapter I is
amended as follows:
ENVIRONMENTAL PROTECTION
AGENCY
PART 180—[AMENDED]
40 CFR Part 180
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Amend § 180.434 as follows:
i. In the table to paragraph (a), remove
the entries for ‘‘berry group 13,’’ ‘‘onion,
bulb,’’ ‘‘onion, green,’’ and ‘‘strawberry’’;
revise the entries for ‘‘peppermint, tops’’
and ‘‘spearmint, tops’’, and add
alphabetically entries for ‘‘bushberry,
subgroup 13–07B,’’ ‘‘caneberry,
subgroup 13–07A,’’ ‘‘low growing berry
subgroup 13–07G, except cranberry,’’
‘‘onion, bulb subgroup 3–07A,’’ and
‘‘onion, green, subgroup 3–07B.’’
■ ii. In the table to paragraph (b) add
alphabetically and entry for ‘‘avocado.’’
The added and revised text reads as
follows:
■
■
§ 180.434 Propiconazole; tolerances for
residues.
(a) * * *
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[EPA–HQ–OPP–2010–0938; FRL–8872–6]
Glyphosate; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation increases the
established tolerance for residues of
glyphosate in or on corn, field, forage.
Monsanto Company requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective May
11, 2011. Objections and requests for
hearings must be received on or before
July 11, 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–
SUMMARY:
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Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations
OPP–2010–0938. 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:
Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5218; e-mail address:
stanton.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
srobinson on DSKHWCL6B1PROD with RULES
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.
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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://www.gpoaccess.gov/ecfr.
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–2010–0938 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 July 11, 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
EPA–HQ–OPP–2010–0938, 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 February 4,
2011 (76 FR 6465) (FRL–8858–7), EPA
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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 0F7741) by
Monsanto Company, 1300 I St., NW.,
Suite 450 East, Washington, DC 20052.
The petition requested that 40 CFR
180.364 be amended by establishing a
tolerance for residues of the herbicide
glyphosate, N-(phosphonomethyl)
glycine, in or on corn, field, forage at 13
parts per million (ppm). That notice
referenced a summary of the petition
prepared by Monsanto Company, 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.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 glyphosate
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with glyphosate follows.
In the Federal Register of April 8,
2011 (76 FR 19701) (FRL–8866–8), EPA
issued a final rule establishing a
tolerance for residues of glyphosate in
or on sweet corn and reducing the
established tolerance for residues of
glyphosate and N-acetyl-glyphosate in
or on poultry meat. When the Agency
conducted the risk assessment in
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Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations
support of the April 8, 2011 tolerance
action, it considered secondary residues
of glyphosate in livestock commodities
from consumption of glyphosate-treated
feed items, including corn forage. The
Agency has determined that increasing
the tolerance on corn forage from 6 ppm
to 13 ppm will not increase residues of
glyphosate in livestock commodities
above those assumed in the previous
risk assessment. The livestock dietary
burdens for glyphosate were calculated
assuming the roughage portion of the
diet for beef and dairy cattle consisted
of nongrass animal feed and grass
forage, which have much higher
tolerances (400 and 300 ppm,
respectively) than corn forage.
Therefore, increasing the tolerance for
corn forage from 6 to 13 ppm will not
affect the estimated livestock dietary
burden or expected residues of
glyphosate in livestock commodities
and will not change the estimated
aggregate risks resulting from use of
glyphosate, as discussed in the April 8,
2011 (76 FR 19701; FRL–8866–8)
Federal Register. Refer to the Federal
Register document, available at https://
www.regulations.gov, for a detailed
discussion of the aggregate risk
assessment and determination of safety.
Therefore, based on the risk
assessment discussed in the final rule
published in the Federal Register of
April 8, 2011 (76 FR 19701; FRL–8866–
8) 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 glyphosate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(high-performance liquid
chromatography (HPLC) equipped with
a fluorescence detector method; LOQ =
0.05 ppm) 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.
srobinson on DSKHWCL6B1PROD with RULES
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).
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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 established an MRL for
residues of glyphosate in or on maize at
5 ppm. The MRL for maize would cover
residues of glyphosate on corn (maize)
forage. This MRL is different than the
tolerance being established for
glyphosate on field corn forage in the
United States due to differences in
Codex and U.S. residue definitions. The
U.S. tolerance of 13 ppm for corn, field,
forage is necessarily higher than the
Codex MRL to account for residues of
both glyphosate and its metabolite Nacetyl glyphosate. N-acetyl glyphosate is
found in genetically modified (GMO)
glyphosate-resistant commodities,
including corn, grown in the U.S.
Therefore, it is included in the U.S.
tolerance but not the Codex expression,
accounting for the difference in the
established MRLs.
C. Response to Comments
EPA received comments from two
individuals expressing concerns about
pesticides generally and objecting to the
presence of any pesticide residues in
food. The Agency understands the
commenters’ 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. The submitted
comments appear to be directed at the
underlying statute and not EPA’s
implementation of it; the commenters
made no contention that EPA has acted
in violation of the statutory framework.
D. Revisions to Petitioned-For
Tolerances
Monsanto Company proposed a
tolerance for residues of glyphosate on
corn, field, forage at 13 ppm. The
current tolerance is expressed in terms
of glyphosate, including its metabolites
and degradates; and compliance with
the tolerance level is determined by
measuring glyphosate and its N-acetylglyphosate metabolite. EPA is increasing
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the tolerance level from 6 ppm to 13
ppm, as proposed, but is retaining the
current tolerance expression to clarify
the chemical moieties that are covered
by the tolerance and specify how
compliance with the tolerance is to be
measured.
V. Conclusion
Therefore, the previously established
tolerance for residues of glyphosate,
including its metabolites and
degradates, in or on corn, field, forage
is amended as set forth in the regulatory
text.
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
E:\FR\FM\11MYR1.SGM
11MYR1
Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Rules and Regulations
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).
§ 180.364 Glyphosate; tolerances for
residues.
VII. Congressional Review Act
TSCA Inventory Update Reporting
Modifications; Submission Period
Suspension
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: May 2, 2011.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
srobinson on DSKHWCL6B1PROD with RULES
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 180.364 is amended by
revising the following entry in the table
in paragraph (a)(2) to read as follows:
■
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million
Commodity
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Corn, field, forage .......................
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[FR Doc. 2011–11205 Filed 5–10–11; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 710
[EPA–HQ–OPPT–2009–0187; FRL–8874–2]
RIN 2070–AJ43
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is amending the Toxic
Substances Control Act (TSCA) section
8(a) Inventory Update Reporting (IUR)
regulations by suspending the next IUR
submission period. The IUR requires
manufacturers (including importers) of
certain chemical substances included on
the TSCA Chemical Substance
Inventory (TSCA Inventory) to report
current data on the manufacturing,
processing, and use of the chemical
substances. In the Federal Register of
August 13, 2010, EPA published
proposed modifications to the IUR
regulations. EPA is suspending the next
submission period to allow additional
time to finalize the proposed
modifications to the IUR regulations,
and to avoid finalizing changes to the
reporting requirements in the midst of
the 2011 submission period. EPA
expects to finalize, in the near future,
changes to the IUR reporting
requirements which will supersede this
action.
DATES: This final rule is effective May
11, 2011.
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPPT–2009–0187. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
SUMMARY:
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27271
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 OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at
Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number of the EPA/DC Public Reading
Room is (202) 566–1744, and the
telephone number for the OPPT Docket
is (202) 566–0280. Docket visitors are
required to show photographic
identification, pass through a metal
detector, and sign the EPA visitor log.
All visitor bags are processed through
an X-ray machine and subject to search.
Visitors will be provided an EPA/DC
badge that must be visible at all times
in the building and returned upon
departure.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Chenise
Farquharson, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–7768; e-mail address:
farquharson.chenise@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; e-mail address: TSCAHotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
You may be potentially affected by
this action if you manufacture
(including manufacture as a byproduct)
or import chemical substances listed on
the TSCA Inventory. Potentially affected
entities may include, but are not limited
to:
• Chemical manufacturers and
importers (NAICS codes 325 and
324110; e.g., chemical manufacturing
and processing and petroleum
refineries).
• Chemical users and processors who
may manufacture a byproduct chemical
substance (NAICS codes 22, 322, 331,
and 3344; e.g., utilities, paper
manufacturing, primary metal
E:\FR\FM\11MYR1.SGM
11MYR1
]]>Agencies
[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Rules and Regulations]
[Pages 27268-27271]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11205]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0938; FRL-8872-6]
Glyphosate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation increases the established tolerance for
residues of glyphosate in or on corn, field, forage. Monsanto Company
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective May 11, 2011. Objections and
requests for hearings must be received on or before July 11, 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-
[[Page 27269]]
OPP-2010-0938. 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: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; e-mail address: stanton.susan@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://www.gpoaccess.gov/ecfr.
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-2010-0938 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
July 11, 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 EPA-HQ-OPP-2010-0938, 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 February 4, 2011 (76 FR 6465) (FRL-8858-
7), 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
0F7741) by Monsanto Company, 1300 I St., NW., Suite 450 East,
Washington, DC 20052. The petition requested that 40 CFR 180.364 be
amended by establishing a tolerance for residues of the herbicide
glyphosate, N-(phosphonomethyl) glycine, in or on corn, field, forage
at 13 parts per million (ppm). That notice referenced a summary of the
petition prepared by Monsanto Company, 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.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 glyphosate including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with glyphosate
follows.
In the Federal Register of April 8, 2011 (76 FR 19701) (FRL-8866-
8), EPA issued a final rule establishing a tolerance for residues of
glyphosate in or on sweet corn and reducing the established tolerance
for residues of glyphosate and N-acetyl-glyphosate in or on poultry
meat. When the Agency conducted the risk assessment in
[[Page 27270]]
support of the April 8, 2011 tolerance action, it considered secondary
residues of glyphosate in livestock commodities from consumption of
glyphosate-treated feed items, including corn forage. The Agency has
determined that increasing the tolerance on corn forage from 6 ppm to
13 ppm will not increase residues of glyphosate in livestock
commodities above those assumed in the previous risk assessment. The
livestock dietary burdens for glyphosate were calculated assuming the
roughage portion of the diet for beef and dairy cattle consisted of
nongrass animal feed and grass forage, which have much higher
tolerances (400 and 300 ppm, respectively) than corn forage. Therefore,
increasing the tolerance for corn forage from 6 to 13 ppm will not
affect the estimated livestock dietary burden or expected residues of
glyphosate in livestock commodities and will not change the estimated
aggregate risks resulting from use of glyphosate, as discussed in the
April 8, 2011 (76 FR 19701; FRL-8866-8) Federal Register. Refer to the
Federal Register document, available at https://www.regulations.gov, for
a detailed discussion of the aggregate risk assessment and
determination of safety.
Therefore, based on the risk assessment discussed in the final rule
published in the Federal Register of April 8, 2011 (76 FR 19701; FRL-
8866-8) 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 glyphosate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high-performance liquid
chromatography (HPLC) equipped with a fluorescence detector method; LOQ
= 0.05 ppm) 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
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 established an MRL for residues of glyphosate in or
on maize at 5 ppm. The MRL for maize would cover residues of glyphosate
on corn (maize) forage. This MRL is different than the tolerance being
established for glyphosate on field corn forage in the United States
due to differences in Codex and U.S. residue definitions. The U.S.
tolerance of 13 ppm for corn, field, forage is necessarily higher than
the Codex MRL to account for residues of both glyphosate and its
metabolite N-acetyl glyphosate. N-acetyl glyphosate is found in
genetically modified (GMO) glyphosate-resistant commodities, including
corn, grown in the U.S. Therefore, it is included in the U.S. tolerance
but not the Codex expression, accounting for the difference in the
established MRLs.
C. Response to Comments
EPA received comments from two individuals expressing concerns
about pesticides generally and objecting to the presence of any
pesticide residues in food. The Agency understands the commenters'
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. The
submitted comments appear to be directed at the underlying statute and
not EPA's implementation of it; the commenters made no contention that
EPA has acted in violation of the statutory framework.
D. Revisions to Petitioned-For Tolerances
Monsanto Company proposed a tolerance for residues of glyphosate on
corn, field, forage at 13 ppm. The current tolerance is expressed in
terms of glyphosate, including its metabolites and degradates; and
compliance with the tolerance level is determined by measuring
glyphosate and its N-acetyl-glyphosate metabolite. EPA is increasing
the tolerance level from 6 ppm to 13 ppm, as proposed, but is retaining
the current tolerance expression to clarify the chemical moieties that
are covered by the tolerance and specify how compliance with the
tolerance is to be measured.
V. Conclusion
Therefore, the previously established tolerance for residues of
glyphosate, including its metabolites and degradates, in or on corn,
field, forage is amended as set forth in the regulatory text.
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
[[Page 27271]]
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: May 2, 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 180.364 is amended by revising the following entry in the
table in paragraph (a)(2) to read as follows:
Sec. 180.364 Glyphosate; tolerances for residues.
(a) * * *
* * * * *
(2) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Corn, field, forage......................................... 13
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2011-11205 Filed 5-10-11; 8:45 am]
BILLING CODE 6560-50-P
