[Federal Register Volume 76, Number 68 (Friday, April 8, 2011)]
[Rules and Regulations]
[Pages 19701-19706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8428]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0988; FRL-8866-8]


Glyphosate (N-(phosphonomethyl) glycine); Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation replaces the established tolerance for 
residues of glyphosate in or on sweet corn, grain with corn, sweet, 
kernel plus cob with husk removed and reduces the established tolerance 
for residues of glyphosate and N-acetyl-glyphosate in or on poultry, 
meat. Monsanto Company requested these tolerances under the Federal 
Food, Drug and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 8, 2011. Objections and 
requests for hearings must be received on or before June 7, 2011, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0988. 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: Kable Bo Davis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0415; e-mail address: <a href="/cdn-cgi/l/email-protection#c1aaa0a3ada4efa5a0b7a8b281a4b1a0efa6aeb7"><span class="__cf_email__" data-cfemail="90fbf1f2fcf5bef4f1e6f9e3d0f5e0f1bef7ffe6">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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-2009-0988 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 
June 7, 2011. Addresses for mail

[[Page 19702]]

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-2009-0988, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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 March 24, 2010 (75 FR 14154-14157) (FRL-
8815-6), 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 
9F7644) by Monsanto Company, 1300 I St., NW., Suite 450 East, 
Washington, DC 20052. The petition requested that 40 CFR part 180 be 
amended by replacing the established tolerances for residues of the 
herbicide, glyphosate, in or on sweet corn, grain with the following: 
Corn, sweet, kernel plus cob with husk removed at a tolerance level of 
3.0 parts per million (ppm) and corn, sweet, forage at a tolerance 
level of 9.0 ppm. The petition also requested a reduction in the 
established tolerance for residues of glyphosate and its metabolite (N-
acetyl-glyphosate) in or poultry meat from 4.0 ppm to 0.1 ppm, as they 
believe the tolerance level was inadvertently increased when the 
poultry tolerances were moved from 40 CFR 180.364 (a)(1) to (a)(2). 
There were no comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA is 
revising the requested actions in several respects. EPA has concluded 
that a tolerance for residues of glyphosate in or on corn, sweet, 
kernel plus cob with husk removed should be set at 3.5 ppm, not 3.0 
ppm. Since the proposed forage tolerance is less than the currently 
established tolerance for this commodity, EPA has concluded that a 
revision to the currently established forage tolerance is unnecessary. 
EPA is also modifying the tolerance expression for 40 CFR 180.364(a)(1) 
and (a)(2) to clarify the coverage of the tolerance and the compounds 
to be measured in determining compliance with tolerance levels. The 
reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. * * 
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for glyphosate including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with glyphosate 
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.
    Glyphosate is of low acute toxicity following oral, dermal, and 
inhalation exposure. It is a mild eye irritant, slight skin irritant, 
and is not a dermal sensitizer in guinea pigs. Inhalation risk 
assessments are not required based on the low toxicity of the 
formulation products (toxicity category III or IV) and the physical 
characteristics of the technical product. An acute dose and endpoint 
for assessing acute risk have not been selected for any population 
subgroups because no effect that could be attributed to a single 
exposure (dose) was observed in oral toxicity studies including the 
developmental toxicity studies in rats and rabbits.
    A chronic feeding/carcinogenicity study in rats found no systemic 
effects in any of the parameters examined (body weight, food 
consumption, clinical signs, mortality, clinical pathology, organ 
weights, and histopathology). In a second chronic feeding/
carcinogenicity study in rats tested at higher dietary levels, a 
lowest-observed-adverse-effect level (LOAEL) was identified at 940-
milligrams/kilograms/day (mg/kg/day) & 1,183-mg/kg/day (male/female) 
based on decreased body-weight gains in females and increased incidence 
of cataracts and lens abnormalities, decreased urinary pH, increased 
absolute liver weight, and increased relative liver weight/brain weight 
in males. No evidence of carcinogenicity was found in rats or mice. In 
a chronic toxicity study in dogs, no systemic effects were found.
    Acceptable developmental toxicity studies in the rat and rabbit are 
available, as is an acceptable 2-generation reproduction study in the 
rat. No significant reproductive and developmental toxic effects were 
found. A focal tubular dilation of the kidneys was observed in a 3-
generation reproductive study on rats at the 30-mg/kg/day high dose 
treatment level (HDTL), however a 2-generational reproductive study on 
rats did not observe the same effect at the 1,500-mg/kg/day HDTL, nor 
were any adverse reproductive effects observed at any dose level. EPA 
concluded that the focal tubular dilation of the kidneys at the 30-mg/
kg/day level was a spurious rather than a glyphosate-related effect.
    In a prenatal developmental toxicity study in rats, maternal 
(systemic) effects observed included mortality, increased clinical 
signs, and reduced body-weight gain at the HDTL (3,500-mg/kg/day). 
Developmental (fetal) effects were observed only in the high-dose group

[[Page 19703]]

and included decreases in total implantations/dam and nonviable 
fetuses/dam, increased number of litters and fetuses with unossified 
sternebrae, and decreased mean fetal body weights. In a prenatal 
developmental toxicity study in rabbits, maternal (systemic) effects 
observed included mortality and clinical signs of toxicity at the HDTL 
(350-mg/kg/day). In the rabbits, developmental toxicity was not 
observed at any dose. On the basis of developmental studies in rats and 
rabbits and reproductive findings in rats, glyphosate exhibited no 
evidence of increased susceptibility of offspring.
    Neurotoxicity has not been observed in any of the acute, 
subchronic, chronic, developmental, or reproductive studies performed 
with glyphosate.
    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 can be found at http://www.regulations.gov in the document titled ``Glyphosate. Section 3 
Registration for Application of the Potassium Salt of Glyphosate to 
Glyphosate-Tolerant Sweet Corn. Human-Health Risk Assessment,'' pp. 26-
27 in docket ID number EPA-HQ-OPP-2009-0988.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern (LOC) to use in evaluating the risk posed by human exposure to 
the pesticide. For hazards that have a threshold below which there is 
no appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL the LOAEL. Uncertainty/safety 
factors are used in conjunction with the POD to calculate a safe 
exposure level--generally referred to as a population-adjusted dose 
(PAD) (a = acute c = chronic) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for glyphosate used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Glyphosate for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
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Acute dietary........................    An endpoint of concern (effect) attributable to a single dose was not
                                                               identified in the database.
                                      --------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL= 175.............  Chronic RfD = 1.75 mg/   Developmental Toxicity
                                       mg/kg/day UFA = 10x....   kg/day cPAD = 1.75 mg/   Study--Rabbit:
                                       UFH = 10x..............   kg/day.                  Maternal LOAEL = 350
                                       FQPA SF = 1x...........                            mg/kg/day based on
                                                                                          diarrhea, nasal
                                                                                          discharge and death in
                                                                                          maternal animals.
Incidental oral short-term (1 to 30    NOAEL= 175.............  LOC for MOE = < 100....  Developmental Toxicity
 days).                                mg/kg/day UFA = 10x....                            Study--Rabbit:
                                       UFH = 10x..............                            Maternal LOAEL = 350
                                       FQPA SF = 1x...........                            mg/kg/day based on
                                                                                          diarrhea, nasal
                                                                                          discharge and death in
                                                                                          maternal animals.
Incidental oral intermediate-term (1   NOAEL= 175.............  LOC for MOE = < 100....  Developmental Toxicity
 to 6 months).                         mg/kg/day UFA = 10x....                            Study--Rabbit:
                                       UFH = 10x..............                            Maternal LOAEL = 350
                                       FQPA SF = 1x...........                            mg/kg/day based on
                                                                                          diarrhea, nasal
                                                                                          discharge and death in
                                                                                          maternal animals.
Dermal short-term (1 to 30 days)       None...................  None...................  Based on the lack of
 Dermal intermediate-term (1 to 6                                                         toxicity up to the
 months).                                                                                 highest dose tested
                                                                                          (1,000 mg/kg/day) in
                                                                                          the 21 day dermal
                                                                                          toxicity study in
                                                                                          rabbits and the lack
                                                                                          of concern for
                                                                                          developmental and
                                                                                          reproductive effects,
                                                                                          the quantification of
                                                                                          dermal risks was not
                                                                                          conducted.
Inhalation short-term (1 to 30 days)   None...................  None...................  Based on the lack of
 Inhalation (1 to 6 months).                                                              toxicity up to the
                                                                                          highest concentration
                                                                                          tested (0.36 mg/L) in
                                                                                          the 28-day inhalation
                                                                                          toxicity study in
                                                                                          rats, and the physical
                                                                                          characteristics of the
                                                                                          technical, the
                                                                                          quantification of
                                                                                          inhalation risks was
                                                                                          not conducted.
Cancer (Oral, dermal, inhalation)....  None...................  None...................  No evidence of
                                                                                          carcinogenicity.
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UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to glyphosate, EPA considered exposure under the petitioned-
for tolerances as well as all existing glyphosate tolerances in 40 CFR 
180.364. EPA assessed dietary exposures from glyphosate in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.

[[Page 19704]]

    No such effects were identified in the toxicological studies for 
glyphosate; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture Continuing Survey of Food Intake by 
Individuals (USDA CSFII) (1994-1996 and 1998). The chronic analysis 
assumed tolerance-level residues, 100 percent crop treated (PCT), and 
Dietary Exposure Evaluation Model (DEEM (version 7.81)) default 
processing factors and incorporated glyphosate drinking water 
monitoring data.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that glyphosate does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The Agency used monitoring 
data from the United States Geological Survey (USGS) National Water-
Quality Assessment Program (NAWQA) to calculate drinking water 
exposure. For chronic dietary risk assessment, the water concentration 
of value 13.5 parts per million (ppb) was used to assess the 
contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    The sweet corn use is not anticipated to result in residential 
exposure. However, residential exposure is anticipated from the 
registered broadcast and spot treatment to residential lawns, gardens, 
and recreational areas including parks and golf courses. Based on the 
registered residential use patterns, there is a potential for short-
term and intermediate-term dermal and inhalation exposures to 
homeowners who mix and apply products containing glyphosate. Since 
short- and intermediate-term dermal and inhalation endpoints were not 
selected, no residential handler/applicator exposure assessment was 
conducted. Post-application dermal and inhalation exposure assessments 
were not conducted since short- and intermediate-term dermal and 
inhalation endpoints were not selected. Based on registered use 
patterns, toddlers may have short-term post-application incidental oral 
exposure from hand-to-mouth, object to mouth, and soil ingestion 
behavior on treated lawns and swimmers may have short-term post-
application incidental oral exposures from treated surface water. 
Exposures and risks from these scenarios were assessed because an 
applicable endpoint was identified. Further information regarding EPA 
standard assumptions and generic inputs for residential exposures may 
be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found glyphosate to share a common mechanism of 
toxicity with any other substances, and glyphosate does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
glyphosate does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA SF. In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is no quantitative or 
qualitative evidence of increased susceptibility of rats or rabbit 
fetuses to in utero exposure in developmental studies. A focal tubular 
dilation of the kidneys was observed in a 3-generation reproductive 
study on rats at the 30-mg/kg/day HDTL, however a 2-generational 
reproductive study on rats did not observe the same effect at the 
1,500-mg/kg/day HDTL, nor were any adverse reproductive effects 
observed at any dose level. A clear NOAEL was established and the 
chronic reference dose was set at a level well below (~17-fold) this 
effect. Therefore, the endpoints selected for risk assessment are 
protective of the effects seen in the 3-generation rat reproduction 
study. There are no residual uncertainties for pre- or postnatal 
toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database is complete with the exception of 
recently-required studies on acute and subchronic neuorotoxicity and 
immunotoxicity. There is no evidence of neurotoxicity in any of the 
toxicology studies. Accordingly, although an acute and subchronic 
neurotoxicity studies are now required as part of new data 
requirements, EPA does not believe that conducting these studies will 
result in a lower POD than that currently used for overall risk 
assessment, and therefore, a database uncertainty factor is not needed 
to account for lack of these studies.
    ii. The toxicology database for glyphosate does not show any 
evidence of treatment-related effects on the immune system. The overall 
weight of evidence suggests that this chemical does not directly target 
the immune system. Accordingly, although an immunotoxicity study is 
required as a part of the new data requirements in the 40 CFR part 158 
for conventional pesticide registration, EPA does not believe that 
conducting a functional immunotoxicity study will result in a lower POD 
than that currently use for overall risk assessment, and therefore, a 
data base uncertainty factor is not needed to account for lack of this 
study.
    iii. There is no quantitative or qualitative evidence of increased 
susceptibility of rats or rabbit fetuses to in utero exposure in 
developmental studies.
    iv. The dietary exposure analysis of exposure to glyphosate in food 
is conservative as it assumed tolerance level residues and 100 PCT. EPA 
made conservative (protective) assumptions in the water modeling used 
to assess exposure to glyphosate in drinking water. EPA used similarly 
conservative assumptions to assess postapplication exposure of children 
as well as incidental oral exposure of toddlers.

[[Page 19705]]

These assessments will not underestimate the exposure and risks posed 
by glyphosate.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-, intermediate-, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
glyphosate is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
glyphosate from food and water will utilize 12% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
glyphosate is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Glyphosate is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to glyphosate.
    Short-term incidental oral exposure may occur to young children 
(swimmer and turf non-dietary ingestion) and adults (swimmers). For 
young children, short-term aggregate exposure includes chronic dietary 
(food and water) and incidental oral ingestion exposure resulting from 
the turf use (highest exposure of all possible scenarios). For adults, 
short-term aggregate exposure includes chronic dietary exposure (food 
and water) and incidental oral ingestion exposure resulting from the 
aquatic use (highest exposure of all possible scenarios). See Table 
6.0.1 in the document titled ``Glyphosate. Section 3 Registration for 
Application of the Potassium Salt of Glyphosate to Glyphosate-Tolerant 
Sweet Corn. Human-Health Risk Assessment'' in docket ID number EPA-HQ-
OPP-2009-0988 for a summary of the short-term aggregate exposures and 
risk estimates (the populations included represent those with the 
highest dietary exposures). For glyphosate, the LOC is for MOEs below 
100. Since the aggregate MOEs are >=720, short-term aggregate exposure 
to glyphosate does not pose a risk of concern.
    4. Intermediate-term risk. Since the short-/intermediate-term 
incidental oral endpoints are identical, the short-term risk 
assessments are protective of intermediate-term exposure.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, glyphosate is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, 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.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established any MRLs for sweet corn commodities; 
however, it has established an MRL for residues of glyphosate, per se, 
in/on poultry, meat at 0.05 ppm. The U.S. tolerance of 0.10 ppm for 
poultry, meat is necessarily higher than the Codex MRL to account for 
residues of both gyphosate and its metabolite N-acetyl glyphosate. N-
acetyl glyphosate is found in genetically modified (GMO) glyphosate-
resistant commodities, including corn and soybeans; that are used as 
feed items for poultry in the U.S. Therefore, it is included in the 
U.S. tolerance expression for poultry but not the Codex expression, 
accounting for the difference in the established MRLs.

C. Revisions to Petitioned-For Tolerances

    EPA has concluded that a tolerance for residues of glyphosate in or 
on corn, sweet, kernel plus cob with husk removed at 3.5 ppm is needed 
because the highest residue from the field trials was 3.1 ppm. Since 
the proposed forage tolerance (9 ppm) is less than the currently 
established tolerance for this commodity (100 ppm), EPA has concluded 
that a revision to the currently established tolerance is unnecessary.
    Finally, EPA is revising the tolerance expressions in 40 CFR 
180.364(a)(1) and 40 CFR 180.364(a)(2) to clarify the chemical moieties 
that are covered by the tolerances and specify clearly how compliance 
with the tolerances is to be measured.

V. Conclusion

    Therefore this regulation changes the established tolerance for 
residues of glyphosate in or on corn, sweet, grain (at 0.1 ppm) to 3.5 
ppm for residues of glyphosate in or on corn, sweet, kernel plus cob 
with the husk removed. This regulation reduces the established 
tolerance for residues of glyphosate and N-acetyl-glyphosate in or on 
poultry, meat from 4.0 ppm to 0.10 ppm. This regulation also changes 
the tolerance expression for 40 CFR 180.364(a)(1) and (a)(2).

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

[[Page 19706]]

22, 2001) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal governments, on the relationship between the national government 
and the States or Tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 29, 2011.
G. Jeffery Herndon,
Acting 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:
    i. Revising the introductory text in paragraph (a)(1), and in the 
table, revise the entry for corn, sweet, grain 0.1 ppm; to corn, sweet, 
kernel plus cob with husk removed at 3.5 ppm; and
    ii. Revising the introductory text in paragraph (a)(2), and in the 
table, revise the entry for poultry, meat 4.0 ppm to 0.10 ppm. The 
revisions read as follows:


Sec.  180.364.  Glyphosate; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
glyphosate, including its metabolites and degradates, in or on the 
commodities listed below resulting from the application of glyphosate, 
the isopropylamine salt of glyphosate, the ethanolamine salt of 
glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of 
glyphosate, and the potassium salt of glyphosate. Compliance with the 
following tolerance levels is to be determined by measuring only 
glyphosate (N-(phosphonomethyl)glycine).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Corn, sweet, kernel plus cob with husk removed.............          3.5
 
                                * * * * *
------------------------------------------------------------------------

     (2) Tolerances are established for residues of glyphosate, 
including its metabolites and degradates, in or on the commodities 
listed below resulting from the application of glyphosate, the 
isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, 
the dimethylamine salt of glyphosate, the ammonium salt of glyphosate, 
and the potassium salt of glyphosate. Compliance with the following 
tolerance levels is to be determined by measuring only glyphosate (N-
(phosphonomethyl)glycine) and its metabolite N-acetyl-glyphosate (N-
acetyl-N-(phosphonomethyl)glycine; calculated as the stoichiometric 
equivalent of glyphosate).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Poultry, meat..............................................         0.10
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-8428 Filed 4-7-11; 8:45 am]
BILLING CODE 6560-50-P


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