[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 http://www.regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the 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 http://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: http://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, http://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 http://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
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* * * * *
Corn, field, forage......................................... 13
* * * * *
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[FR Doc. 2011-11205 Filed 5-10-11; 8:45 am]
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