[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Rules and Regulations]
[Pages 27268-27271]
From the Federal Register Online via the Government Publishing 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-

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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: [email protected].

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: 
[email protected].

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

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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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