
[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Rules and Regulations]
[Pages 29963-29966]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14594]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0007; FRL-8417-5]


Glyphosate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation increases the tolerance for residues of 
glyphosate in or on cotton, gin byproducts. Cheminova, Inc requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective June 24, 2009. Objections and 
requests for hearings must be received on or before August 24, 2009, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0007. 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: Vickie Walters, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5704; e-mail address: walters.vickie@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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation

[[Page 29964]]

and may also request a hearing on those objections. You must file your 
objection or request a hearing on this regulation in accordance with 
the instructions provided in 40 CFR part 178. To ensure proper receipt 
by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0007 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk as 
required by 40 CFR part 178 on or before August 24, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2009-0007, 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. Petition for Tolerance

    In the Federal Register of March 25, 2009 (74 FR 12857) (FRL-8399-
4), 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 
8F7451) by Cheminova, One Park Drive, Research Triangle Park, NC 27707. 
The petition requested that 40 CFR 180.364 be amended by establishing 
tolerances for residues of the herbicide glyphosate, N-
(phosphonomethyl)glycine, resulting from the application of glyphosate, 
the isoproplyamine salt of glyphosate, the ethanolamine salt of 
glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of 
glyphosate, and the potassium salt of glyphosate in or on cotton, gin 
byproducts at 210 parts per million (ppm). That notice referenced a 
summary of the petition prepared by Cheminova. Inc, the registrant, 
which is available to the public 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.
    Cheminova, Inc has requested a Section 3 registration under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for 
application of glyphosate to glyphosate tolerant cotton including Bayer 
GHB614 cotton (GlyTol cotton), a genetically modified cotton being 
commercialized by Bayer Crop Science. As a result, the petitioner has 
requested that the current tolerance for cotton, gin byproducts be 
increased to 210 ppm. This petition was filed in conjunction with 
Cheminova's requested change to its FIFRA registration.
    Based upon review of the data supporting the petition, EPA has 
determined that the proposed tolerance in this petition should remain 
in 40CFR180.364 (a)(1) which reads: Tolerances are established for 
residues of the herbicide glyphosate, N-(phosphonomethyl)glycine, 
resulting from the application of glyphosate, the isoproplyamine salt 
of glyphosate, the ethanolamine salt of glyphosate, the dimethylamine 
salt of glyphosate, the ammonium salt of glyphosate, and the potassium 
salt of glyphosate on the following food commodities. The proposed 
numerical value for the proposed tolerance on cotton, gin byproducts 
remains 210 ppm.

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 the petitioned-for 
tolerances for residues of glyphosate on cotton, gin by products at 210 
ppm. EPA's assessment of exposures and risks associated with 
establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by glyphosate as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the rule 
making document referenced in this unit. A summary of the toxicological 
endpoints and current risk assessments for glyphosate can be found in 
the same rule making document.
    In amending the glyphosate cotton, gin byproducts tolerance, EPA 
relies on the risk assessment and safety finding made in the final rule 
published in the Federal Register of December 20, 2006 (71 FR 73586) 
(FRL-8385-7) which established tolerances for residues of glyphosate in 
or on noni at 0.20 ppm and various other commodities. For the reasons 
explained in this unit, increasing the cotton, gin byproducts tolerance 
to 210 ppm does not change the human exposure and risk to glyphosate as 
set forth in that 2006 rulemaking. Accordingly, EPA herein adopts the 
safety findings in that rulemaking.
    Increasing the current glyphosate tolerance for cotton, gin 
byproducts to 210 ppm does not result in changes in the exposure or 
risk estimates reported in the previous risk assessments for the 
reasons listed in this unit and discussed in the Agency review entitled 
Glyphosate Label Amendment to Permit Application of Glyphosate to 
Bayer's Glyphosate-Tolerant Cotton GHB614., available at 
www.regulations.gov in Docket ID number EPA-HQ-OPP-2009-0007 and 
identified as EPA-HQ-OPP-2009-0007-0002.

[[Page 29965]]

    1. Glyphosate is currently registered for application to cotton 
genetically modified to express the Agrobacterium EPSPS gene. Available 
information indicate that Bayer GHB614 cotton (GlyTol Cotton) has been 
genetically modified to produce the 2mEPSPS protein which is not 
inhibited by glyphosate. The 2mEPSPS gene was generated by introducing 
mutations into the wild maize gene. The 2mEPSPs protein differs from 
the wild maize EPSPS protein by two amino acids. Based on the current 
metabolism data and because tolerance to glyphosate in GHB614 cotton is 
conferred via modification of an endogenous plant EPSPS gene so that 
the plant is no longer sensitive (i.e. tolerance is not conveyed via 
metabolism of the herbicide), the Agency concludes that previous 
conclusions concerning the residues of concern for tolerance expression 
and risk assessment are applicable to GHB614 cotton (i.e. the residues 
of concern for tolerance expression and risk assessment are glyphosate 
per se).
    2. The numerical value of all but one feed tolerance will remain 
the same.
    3. The most recent dietary analysis assumed tolerance level 
residues and 100% crop treated.
    4. The estimate of glyphosate levels in drinking water is based on 
a glyphosate use involving direct application to water at 3.75 pounds 
active ingredient per acre. The proposed use pattern is the same as the 
currently registered use pattern on glyphosate tolerant cotton. Use of 
glyphosate on GlyTol Cotton will not result in higher levels in 
drinking water.
    5. Previously calculated dietary burden to beef and dairy cattle 
were based on alfalfa hay (400 ppm tolerance) being the significant 
contributor to the diet. Because cotton, gin byproducts constitute a 
minor feed commodity (5% of the beef cattle and not feed to dairy 
cattle), the Agency concludes that the increase in cotton, gin 
byproducts tolerance to 210 ppm will not significantly affect the 
magnitude of the residue in livestock. Therefore, no increase in 
currently established livestock tolerances is necessary.
    6. Previously calculated dietary burden to poultry were based on 
alfalfa meal (400 ppm). The previously calculated dietary burden to hog 
was based on alfalfa meal and barley grain (20 ppm). The numerical 
values for these commodities remain unchanged. Cotton, gin byproducts 
are not feed to poultry and hog. Therefore, the Agency concludes that 
the increase in the cotton, gin byproducts tolerance to 210 ppm will 
not significantly affect the magnitude of the residue in poultry or 
hog, and no increases in tolerance for these commodities are necessary.
    Therefore, based on the risk assessments discussed in the notices 
referenced above, EPA concludes 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) with fluorometric detection and gas 
chromatography with mass spectrometry (GC/MS)) are available to enforce 
the tolerance expression. The methods may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: residuemethods@epa.gov.

B. International Residue Limits

    There are no Codex MRLs for glyphosate on cotton, gin byproducts. 
MRLs are not set for cotton, gin byproduct, as it is not considered a 
major item in international trade. No Canadian or Mexican MRLs exist 
for glyphosate on cotton, gin byproducts.

C. Response to Comments

    One comment was received from a private citizen objecting to the 
establishment of tolerances. The Agency has received similar comments 
from this commenter on numerous previous occasions. Refer to the 
Federal Register of March 14, 2007 (72 FR 11784; FRL-8117-2) for the 
Agency response to these objections.

V. Conclusion

    Therefore, tolerances are established for residues of glyphosate, 
N-(phosphonomethyl)glycine, resulting from the application of 
glyphosate, the isoproplyamine salt of glyphosate, the ethanolamine 
salt of glyphosate, the dimethylamine salt of glyphosate, the ammonium 
salt of glyphosate, and the potassium salt of glyphosate on cotton, gin 
byproducts at 210 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) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

[[Page 29966]]

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: June 11, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.364 is amended by revising the following entry in the 
table in paragraph (a)(1) to read as follows:


Sec.  180.364  Glyphosate; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Cotton, gin byproducts...............................                210
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-14594 Filed 6-23-09; 8:45 am]
BILLING CODE 6560-50-S


