[Federal Register: May 20, 2009 (Volume 74, Number 96)]
[Rules and Regulations]
[Page 23640-23645]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20my09-14]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0275; FRL-8412-6]
Iodosulfuron-methyl-sodium; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
iodosulfuron-methyl-sodium in or on wheat, forage; wheat, grain; wheat,
hay; and wheat, straw. Bayer Cropscience requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 20, 2009. Objections and
requests for hearings must be received on or before July 20, 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-2009-0275. 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: Hope Johnson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5410; e-mail address: johnson.hope@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 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-2009-0275 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 July 20, 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-2009-0275, 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 July 9, 2008 (73 FR 39289) (FRL-8371-2),
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 1F6299)
by Bayer Cropscience, 2 Alexander Drive, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.580 be amended by
establishing tolerances for residues of the herbicide iodosulfuron-
methyl-sodium, methyl 4-iodo-2-[3-(4-methoxy-6-methyl-1,3,5 triazin-2-
yl) ureidosulfonyl] benzoate, sodium salt, in or on wheat, grain at
0.02 parts per million (ppm); wheat, forage at 0.06 ppm; wheat, straw
at 0.05 ppm; and wheat, hay at 0.05 ppm. That notice referenced a
summary of the petition prepared by Bayer Cropscience, the registrant,
which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
concluded that 40 CFR 180.580 can be amended by establishing tolerances
for residues of the herbicide iodosulfuron-methyl sodium, methyl 4-
iodo-2-[3-(4-methoxy-6-methyl-1,3,5 triazin-2-yl) ureidosulfonyl]
benzoate, sodium salt, in or on wheat, grain at 0.02 ppm; wheat, straw
at 0.05 ppm; wheat, hay at 0.05ppm; and wheat, forage at 0.10 ppm
[[Page 23641]]
instead of the petitioned for 0.06 ppm for wheat, forage. The reason
for this change is 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 the petitioned-for
tolerances for residues of iodosulfuron-methyl-sodium on wheat, forage
at 0.06 ppm; wheat, grain at 0.02 ppm; wheat, hay at 0.05 ppm; and
wheat, straw at 0.05 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 iodosulfuron-methyl-sodium 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 document Iodosulfuron-Methyl-Sodium;
Human-Health Risk Assessment for Proposed Section 3 New Use on Wheat,
page 37 in docket ID number EPA-HQ-OPP-2009-0275.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
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
greater than that 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.
Iodosulfuron-methyl-sodium was assessed in a complete battery of
subchronic (mice and rats), chronic (mice, rats, and dogs),
carcinogenicity (mice and rats), developmental (rat and rabbit) and
reproductive (rat) toxicity studies. In general high doses typically in
the range of greater than 300 mg/kg/day were required to cause systemic
toxicity characterized as decreases in body weight, body weight gain,
hepatotoxicity in mice and/or dogs and gross and histopathological
changes in the hematopoietic system in dogs. Developmental toxicity was
seen only at the limit dose in the rats, no developmental toxicity was
seen in the rabbit, and no reproductive toxicity was seen in the rat.
Hematopoietic-related toxicity was only seen in female dogs in both
the subchronic and chronic toxicity studies. The hematopoietic system
involved in the production of blood includes primarily the bone marrow,
spleen, and lymph nodes. In both the subchronic and chronic studies,
microscopic pathology of the bone marrow and spleen were seen at
approximately (50 m/k/day; LOAEL). The NOAEL was 8 mg/kg/day.
The toxicity profile of iodosulfuron-methyl-sodium indicates that
the dog to be the most sensitive species with the effects on the
hematopoietic system being the most sensitive endpoint. The NOAEL
(approximately 8 mg/kg/day) based on the most sensitive endpoint is
used for assessing risk to intermediate (oral, dermal and inhalation
routes) and chronic (oral, dermal and inhalation routes) durations
resulting from exposure to iodosulfuron-methyl-sodium.
A summary of the toxicological endpoints for iodosulfuron-methyl-
sodium used for human risk assessment can be found at http://
www.regulations.gov in document Iodosulfuron-Methyl-Sodium; Human-
Health Risk Assessment for Proposed Section 3 New Use on Wheat, page 13
in docket ID number EPA-HQ-OPP-2009-0275.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to iodosulfuron-methyl-sodium, EPA considered exposure under
the petitioned-for tolerances as well as all existing iodosulfuron-
methyl-sodium tolerances in (40 CFR 180.580). EPA assessed dietary
exposures from iodosulfuron-methyl-sodium 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.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA),
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA used tolerance
level residues and 100% crop treated
[[Page 23642]]
information to complete the acute dietary exposure assessment. Drinking
water values were incorporated directly into the assessment.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA, 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance level
residues and 100% crop treated information to complete the chronic
dietary exposure assessment. Drinking water values were incorporated
directly into the assessment.
iii. Cancer. The Agency determined that iodosulfuron-methyl-sodium
was ``not likely to be a human carcinogen'' with regards to its
potential as a human carcinogen. This decision was based on the lack of
evidence for carcinogenicity in mice and rats. Iodosulfuron-methyl-
sodium was negative for mutagenicity in various assays. Furthermore,
registered sulfonyl urea compounds (structurally similar compounds)
have been found to be non-carcinogenic. Based on this weight-of-
evidence, an exposure assessment to evaluate cancer risk for
iodosulfuron-methyl-sodium was not necessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for iodosulfuron-methyl-sodium. Tolerance level residues and
100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for iodosulfuron-methyl-sodium in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of iodosulfuron-methyl-sodium. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at http://www.epa.gov/oppefed1/models/
water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST),
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models,
the estimated drinking water concentrations (EDWCs) of iodosulfuron-
methyl-sodium for acute exposures are estimated to be 0.60 parts per
billion (ppb) for surface water and 0.00004 ppb for ground water. For
chronic exposures for non-cancer assessments are estimated to be 0.067
ppb for surface water and 0.00004 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 0.60 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 0.067 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).
Iodosulfuron-methyl-sodium is currently registered for the
following uses that could result in residential exposures: Ornamental
turf. EPA assessed residential exposure using the following
assumptions: As the ornamental turf use is labeled ``intended for
professional use,'' and therefore is not available for direct
residential use, a residential handler assessment was not conducted.
All applications for the turf use are to be performed by professional
(commercial) applicators. The ornamental turf product is intended for
use on ornamental turfgrass on golf courses, sports fields, commercial
lawns, cemeteries, parks, campsites, recreational areas, home lawns,
roadsides, school grounds and sodfarms. Based on this use pattern,
short and intermediate term risk was assessed.
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 iodosulfuron-methyl-sodium to share a common
mechanism of toxicity with any other substances, and iodosulfuron-
methyl-sodium does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that iodosulfuron-methyl-sodium 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 website 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 safety
factor (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 qualitative
evidence of increased susceptibility based on the rat developmental
study where delayed ossification was observed in the fetuses of dams
that exhibited minimal maternal toxicity (salivation). Similarly, there
is qualitative and quantitative evidence of increased susceptibility
based on the multi-generation rat reproduction study where no parental
systemic effects were observed at the highest dose tested (HDT) and
offspring toxicity was observed at a lower dose. Susceptibility was not
observed in the developmental toxicity study in the rabbit.
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 for iodosulfuron-methyl-sodium is
complete, except for the requirements for an immunotoxicity, acute, and
subchronic neurotoxicity studies. The existing data are sufficient for
endpoint selection for exposure/risk assessment scenarios and for
evaluation of the requirements under FQPA. EPA has determined that an
additional uncertainty factor is not required to account for potential
neurotoxicity or immunotoxicity. The reasons for this determination are
described as follows:
a. The toxicity database for iodosulfuron-methyl-sodium is
complete, except for immunotoxicity testing. EPA began requiring
functional immunotoxicity testing of all food and non-food use
pesticides on December 26, 2007. Since this requirement went into
effect well after the tolerance petition was submitted, these studies
are not yet available for iodosulfuron-methyl-sodium.
[[Page 23643]]
In the absence of specific immunotoxicity studies, EPA has
evaluated the available iodosulfuron-methyl-sodium toxicity data to
determine whether an additional database uncertainty factor is needed
to account for potential immunotoxicity. In the case of iodosulfuron-
methyl-sodium, the available data do not indicate a concern for
potential immunotoxicity. No treatment-related changes were seen in
hematology parameters, organ weights (thymus, spleen), gross necropsy
(enlarged lymph nodes) or histopathology (spleen, thymus, lymph nodes)
when tested up to and including the limit dose (1000 mg/kg/day) in mice
or rats. Marginal effects, manifested as histopathological changes in
the bone marrow and spleen, were seen in female dogs. Minimal to
moderate hyperplasia of the hematopoietic cells was seen in the one
female. No treatment-related changes were seen in male dogs. The
subcapsular congestion in the spleen is a common finding and is
probably related to the means of euthanasia since barbiturates can
cause the splenic musculature to relax and often leads to blood filled
spleens. Therefore, the lesions of the spleen are not evidence of
immunotoxicity. In the absence of corroborative changes in any
hematology parameters, weights of thymus, spleen and lymph nodes, or
histopathological changes in the thymus and lymph nodes in the dogs,
the changes observed are considered hematopoietic, not immunotoxic.
Therefore an additional uncertainty factor is not needed to account for
potential immunotoxicity.
b. Acute and subchronic neurotoxicity testing is also required as a
result of changes made to pesticide data requirements in December 2007.
Although acute and subchronic neurotoxicity testing has not yet been
submitted, iodosulfuron-methyl-sodium does not belong to a class
chemical that would be expected to be neurotoxic. There is no evidence
of neurotoxicity in the data base in any species at any dose level. In
the 90-day dietary studies with mice and rats, there were no signs
indicative of neurotoxicity when tested at the limit dose (1000 mg/kg/
day). In both species, the LOAEL was based on decreases in body weight
and/or body weight gain. These findings indicate that the prospective
neurotoxicity studies will have to be tested at the Limit Dose and even
with the enhanced evaluation of neurotoxic parameters; these studies
will not yield a lower dose for risk assessment. Therefore, a database
uncertainty factor is not required.
ii. While there is qualitative evidence of increased
susceptibility based on the rat developmental study, the developmental
toxicity manifested as delayed ossification (which are variations not
malformations) were seen only at the limit dose in the presence of
maternal toxicity, and with a clear NOAEL for the effect of concern.
Susceptibility was not observed in the developmental toxicity study in
the rabbit. Additionally no parental systemic effects were observed at
the limit dose and offspring toxicity was observed at a lower dose
(34.2 mg/kg/day; manifested as decreased pup viability on post-natal
day (PND) 0 and 4) in the multi-generation rat reproduction study. In
spite of the lack of parental toxicity, there was a well characterized
NOAEL/LOAEL for offspring toxicity; the developmental NOAEL is used for
the acute dietary risk assessment; and the NOAEL (7.3 mg/kg/day) used
for the chronic dietary risk assessment is approximately 47-fold lower
than the offspring NOAEL (346 mg/kg/day). Therefore, there is low
concern for increased susceptibility for iodosulfuron-methyl-sodium and
no additional uncertainty factor is needed.
iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to iodosulfuron-methyl-sodium 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 iodosulfuron-methyl-sodium.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to iodosulfuron-methyl-sodium will occupy <1.0 % of the aPAD for (all
infants (<1 year old)) the population group receiving the greatest
exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
iodosulfuron-methyl-sodium from food and water will utilize 3.1% of the
cPAD for (children 3-5 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
iodosulfuron-methyl-sodium 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).
Iodosulfuron-methyl-sodium is currently registered for use 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 iodosulfuron-
methyl-sodium.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures aggregated result in aggregate MOEs of
110,000 for children 3-5 years old and 420,000 for adults 20-49 years
old.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Iodosulfuron-methyl-sodium is currently registered for use that
could result in intermediate-term residential exposure and the Agency
has determined that it is appropriate to aggregate chronic exposure to
iodosulfuron-methyl-sodium through food and water with intermediate-
term exposures for iodosulfuron-methyl-sodium.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures aggregated
result in aggregate MOEs of 21,000 for children 3-5 years old, and
84,000 for adults 20-49 years old.
[[Page 23644]]
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence for carcinogenicity in mice and rats, iodosulfuron-methyl-
sodium is not expected to pose a cancer risk.
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 iodosulfuron-methyl-sodium residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography using mass
spectrometric detection (LC/MS/MS) and by high performance liquid
chromatography with ultra violet detection (HPLC/UV)) is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex MRLs for residues of iodosulfuron-methyl-sodium,
and no Mexican MRLs have been established. Canadian MRLs have been
established for certain residues of iodosulfuron-methyl-sodium;
however, no MRLs have been established for wheat commodities at this
time.
C. Revisions to Petitioned-For Tolerances
Review of available field trial data indicate that the proposed
tolerance for wheat, forage (0.06 ppm) is too low; a tolerance of 0.10
ppm is appropriate based on the maximum residue limit (MRL) observed
in/on forage.
V. Conclusion
Therefore, tolerances are established for residues of iodosulfuron-
methyl-sodium, methyl 4-iodo-2-[3-(4-methoxy-6-methyl-1,3,5 triazin-2-
yl) ureidosulfonyl] benzoate, sodium salt, in or on wheat, forage at
0.10 ppm; wheat, grain at 0.02 parts per million (ppm); wheat, hay at
0.05 ppm; and wheat, straw at 0.05 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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 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 180.580 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:
Sec. 180.580 Iodosulfuron-methyl-sodium; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * * * *
Wheat, forage........................................ 0.10
Wheat, grain......................................... 0.02
Wheat, hay........................................... 0.05
[[Page 23645]]
Wheat, straw......................................... 0.05
------------------------------------------------------------------------
* * * * *
[FR Doc. E9-11633 Filed 5-19-09; 8:45 am]
BILLING CODE 6560-50-S