[Federal Register Volume 76, Number 68 (Friday, April 8, 2011)]
[Rules and Regulations]
[Pages 19701-19706]
[FR Doc No: 2011-8428]

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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-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

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:
     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<PHONE_NUMBER>.

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

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
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.

    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.

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

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


[Federal Register: September 28, 2009 (Volume 74, Number 186)]
[Rules and Regulations]
[Page 49326]
[DOCID:fr28se09-9]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2009-0865]

Drawbridge Operation Regulation; Cape Fear River and Northeast
Cape Fear River, Wilmington, NC

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

-----------------------------------------------------------------------

SUMMARY: The Commander Fifth Coast Guard District has issued a
temporary deviation from the regulations governing the operation of the
Cape Fear River Memorial Bridge at mile 26.8 and the Isabel S. Holmes
Bridge at mile 1.0 across Northeast Cape Fear River at Wilmington NC.
The deviation is necessary to accommodate a road race. The deviation
allows the bridges to remain in the closed position.

DATES: This deviation is effective from 7 a.m. to 11 a.m. on November
1, 2009.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2009-0865 and are available online
by going to http://www.regulations.gov, inserting USCG-2009-0865 in the
``Keyword'' box and then clicking ``Search. They are also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Gary Heyer, Bridge Management Specialist, Fifth Coast
Guard District, telephone<PHONE_NUMBER>, e-mail Gary.S.Heyer @uscg.mil.
If you have questions on viewing the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Cape Fear River Memorial Bridge at mile
26.8, a vertical-lift type bridge, and the Isabel S. Holmes Bridge at
mile 1.0 across Northeast Cape Fear River, a bascule lift bridge, has
vertical clearances in the closed positions to vessels of 65 feet and
40 feet above mean high water, respectively.
    The North Carolina Department of Transportation has requested a
temporary deviation from the current operating regulations of the
aforementioned bridges set out in 33 CFR 117.823 and 33 CFR 117.829
(a), respectively, to accommodate the annual Battleship Half Marathon.
The deviation would allow the two drawbridges to remain in the closed
position to vessels from 7 a.m. to 11 a.m. on Sunday, November 1, 2009.
    The Coast Guard will inform the users of the waterways through our
Local and Broadcast Notices to Mariners of the closure periods for the
bridges so that vessels can arrange their transits to minimize any
impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: September 15, 2009.
Waverly W. Gregory, Jr.,
Chief, Bridge Administration Branch, By Direction of the Commander,
Fifth Coast Guard District.
[FR Doc. E9-23280 Filed 9-25-09; 8:45 am]

BILLING CODE 4910-15-P