[Federal Register: September 26, 2007 (Volume 72, Number 186)]
[Rules and Regulations]
[Page 54569-54574]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se07-15]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0206; FRL-8147-4]
Sulfosulfuron; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
sulfosulfuron in or on grass, forage, fodder, and hay group 17, forage,
and grass, forage, fodder, and hay, group 17, hay. This regulation also
increases tolerances for fat, meat, and meat by byproducts of cattle,
goat, horse, and sheep, and milk. Monsanto Company requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 26, 2007. Objections and
requests for hearings must be received on or before November 26, 2007,
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-2006-0206. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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
[[Page 54570]]
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Vickie Walters, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5704; e-mail address: walters.vickie@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
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 an electronic copy of this Federal
Register document through the electronic docket 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 pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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-2006-0206 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 November 26, 2007.
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-2006-0206, 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'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 14, 2006 (71 FR 40106) (FRL-8057-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F7031) by Monsanto Company, 1300 I St., NW., Suite 450 East,
Washington, DC 20005. The petition requested that 40 CFR 180.552 be
amended by establishing a tolerance for residues of the herbicide
sulfosulfuron, 1-(4,6-dimethoxypyrimidin-2-yl)-3-[(2-ethane-sulfonyl-
imidazo[1,2-a]pyridine-3-yl)sulfonyl]urea, and its metabolites
converted to 2-(ethylsulfonyl)imidazol[1,2-a]pyridine and calculated at
sulfosulfuron, in or on grass, forage at 13.0 parts per million (ppm);
grass, hay at 14 ppm; milk at 0.02 ppm; fat of cattle, goat, horse, and
sheep at 0.03 ppm; meat of cattle, goat, horse, and sheep at 0.01 ppm;
and meat byproducts of cattle, goat, horse, and sheep at 0.4 ppm. .
That notice referenced a summary of the petition prepared by Monsanto
Company, 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 and Agency
procedures concerning commodity names, the Agency is correcting the
terminology and tolerance level for pending crops under 40 CFR 180.552
(a) as follows: Grass, forage, fodder and hay, group 17, forage at 14
ppm; grass, forage, fodder and hay, group 17, hay at 25 ppm; cattle,
fat at 0.02 ppm; cattle, meat at 0.01; cattle, meat byproducts at 0.30;
goat, fat at 0.02 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at
0.30; horse, fat at 0.02 ppm; horse, meat at 0.01 ppm; horse, meat
byproducts at 0.30; milk at 0.02; sheep, fat at 0.02 ppm; sheep, meat
at 0.01 ppm; and sheep; meat byproducts at 0.30 ppm. These entries will
replace current entries for cattle, fat; cattle, meat; cattle, meat
byproduct; goat, fat; goat, meat; goat, meat byproducts, horse, fat;
horse, meat; horse; meat byproduct; milk; sheep; fat; sheep, meat; and
sheep, meat byproducts listed in paragraphs 40 CFR 180. 552(a) and (b).
The current entries listed in 180.552 (b) for bahiagrass, forage at 11
ppm; bahiagrass, hay at 40 ppm; bermudagrass, forage at 11 ppm; and
bermudagrass, hay at 40 ppm are replaced by the entries for grass,
forage, fodder and hay, group 27, forage at 14 ppm; and grass, forage,
fodder and hay, group 17, hay at 25 ppm in 40 CFR 180.552 (a).
[[Page 54571]]
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. . .
.'' These provisions were added to FFDCA by the Food Quality Protection
Act (FQPA) of 1996.
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
tolerance for residues of sulfosulfuron on grass, forage, fodder and
hay, group 17, forage at 14 ppm; grass, forage, fodder and hay, group
17, hay at 25 ppm; cattle, fat 0.02 ppm; cattle, meat at 0.01; cattle,
meat byproducts at 0.3; goat, fat at 0.02 ppm; goat, meat at 0.01 ppm;
goat, meat byproducts at 0.3; horse, fat at 0.02 ppm; horse, meat at
0.01 ppm; horse, meat byproducts at 0.3; milk at 0.02; sheep, fat at
0.02 ppm; sheep, meat at 0.01 ppm; and sheep; meat byproducts at 0.3
ppm. EPA's assessment of exposures and risks associated with
establishing the tolerance 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 sulfosulfuron as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in the
final rule published in the Federal Register of May 19, 1999 (64 FR
27186 (FRL-6078-4).
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern is derived from
the highest dose at which no adverse effects are observed 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 is sometimes used for risk
assessment. Uncertainty/safety factors (UFs) are used in conjunction
with the LOC 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 risks by
comparing aggregate 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 LOC by all applicable UFs.
Short-term, intermediate-term, and long-term risks are evaluated by
comparing aggregate exposure to the LOC to ensure that the margin of
exposure (MOE) called for by the product of all applicable UFs is not
exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
A summary of the toxicological endpoints for sulfosulfuron used for
human risk assessment is discussed in Unit IV.A. of the final rule
published in the Federal Register of November 16, 2005 (70 FR 69457)
(FRL-7740-1)
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sulfosulfuron, EPA considered exposure under the
petitioned-for tolerances as well as all existing sulfosulfuron
tolerances in (40 CFR 180.552). EPA assessed dietary exposures from
sulfosulfuron 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
sulfosulfuron; 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 Unired States
Department of Agriculture (USDA) 1994-1996, or 1998 Continuing Survey
of Food Intake by Individuals (CSFII). As to residue levels in food,
EPA assumed all foods for which there are tolerances were treated and
contain tolerance-level residues and Dietary Exposure Evalutation Model
(DEEM) (version 7.76) default processing factors.
iii. Cancer. In accordance with the Agency's Proposed Guidelines
for Carcinogenic Risk Assessment (April 10, 1996), the CARC classified
sulfosulfuron as a likely human carcinogen. The weight-of-evidence for
this classification are as follows:
Occurrence of rare transitional cell papilloma and
cancinoma of urinary bladder in female rats.
Occurrence of rare benign mesenchymal tumors of the
urinary bladder in high dose male as well as renal adenomas in female
and possibly male mice.
The relevancy of the observed tumors to human exposure.
The Agency determined that a linear low-dose approach (Q 1*) for human
risk characterization and extrapolation of risk should be based on the
incidence of benign mesenchymal tumors in male mice. The rat
transitional tumors and mouse renal tumors were not used because of
their low incidence. This extrapolation, rather than an MOE approach is
supported by the lack of sufficient data to characterize the mechanism
of carcinogencity. The unit risk, Q 1* milligram/kilogram/day (mg/kg/
day)-1 of sulfosulfuron based upon male mouse
urinary bladder mescenchmal tumor rates is 1.03 X
10-3 (mg/kg/day)-1 in human
equivalents. The cancer dietary analysis assumed tolerance level
residues, 100% CT and DEEM (version 7.76) default processing factors.
2. Dietary exposure from drinking water.The Agency lacks sufficient
monitoring data to complete a comprehensive dietary exposure analysis
and risk assessment for
[[Page 54572]]
sulfosulfuron in drinking water. Because the Agency does not have
comprehensive monitoring data, drinking water concentration estimates
are made by reliance on simulation or modeling taking into account data
on the environmental fate characteristics of sulfosulfuron. 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) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of sulfosulfuron for
acute exposures are estimated to be 10.41 parts per billion (ppb) for
surface water and 2.6 ppb for ground water. The EWDCs for chronic
exposures are estimated to be 1.12 ppb for surface water and 2.6 ppb
for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 2.6 ppb was used to access
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).
Residential exposure is not expected for the new proposed uses.
However sulfosulfuron is registered for use on turf. Residential
homeowners are not expected to handle sulfosulfuron directly. However,
sulfosulfuron is applied by professional commercial operators to lawn
areas (such as apartment complexes, parks, schools, recreational areas
and public areas) where residents would come into contact with
sulfosulfuron residues. Therefore, as a part of a previous risk
assessment for this herbicide, post application exposure and risk to
residents (adults and children) were assessed. Post-application
inhalation exposure to children is considered to be negligible. Non-
dietary, incidental ingestion of residues from treated turfgrass and
ingestion of contaminated soil are possible. To address the short-term
residential risk to children from incidental oral exposure, the Agency
used the NOAEL of 24 mg/kg/day from the combined chronic toxicity/
carcinogenicity study in rats. This NOAEL is considered conservative
and health protective for this assessment because it represents the
lowest NOAEL in most sensitive species (the basis for the Chronic
Reference Dose (cRfD)). Agency SOPs for Residential Exposure
Assessments (Draft, December 18, 1997) were used as a guideline for
performing the residential post-application exposure (with amendments,
2001). Children's hand-to-mouth, object to mouth (turfgrass) and soil
ingestion were assessed. As discussed above, there are no residential
handler uses for sulfosulfuron. Therefore, the residential cancer
assessment for adults considered post-application only. Cancer risk for
residential adults was calculated based on high activity on treated
lawns. A transfer coefficient (TC) of 1,000 cm\2\/hr was used. Several
conservative assumptions are built into the assessment of residential
cancer risk. These include fifty years of exposure and an estimated 20%
of foliar residues being dislodgeable (DFRs) from turf, which is
derived from the maximum application rate. An average of 14 days of
DFRs were used for this cancer assessment, this would be considered a
10% decrease each day (from dilution by rain, and mowing or grass) of
the 20% residue for at least 14 days, and then taking the mean value of
this 14-day exposure. It should be noted that the current default DFR
is 5% from turf. At the time of the last risk assessment, the Agency
assumed 20% DFR as a default. As a result, the estimate of residential
adult risk is more conservative than it would be otherwise. The
Lifetime Average Daily Dose (LADD) = 6.0 X 10-5
mg/kg/day for a TC of 1,000 cm\2\/hr (high exposure activity for 1
hour).
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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to sulfosulfuron and any
other substances and sulfosulfuron does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that sulfosulofuron
has 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 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold 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. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. The developmental studies in
rat and rabbit and the reproductive study in rats did not indicate
increased susceptibility of rats or rabbits in utero and/or postnatal
exposure.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for sulfosulfuron is complete.
ii. There is no indication that sulfosulfuron is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that sulfosulfuron results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues Conservative ground water and
surface water modeling estimates were used. Similarly conservative
Residential SOPs were used to assess post-application exposure to
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
sulfosulfuron.
[[Page 54573]]
E. Aggregate Risks and Determination of Safety.
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the MOE called for by the product of all
applicable UFs is not exceeded.
1. Acute risk. An endpoint was not selected for acute dietary risk
assessment because there were no effects attributable to a single dose
(exposure) observed in oral toxicology studies (including developmental
toxicity studies in the rat and rabbit (at or up to 1,000 mg/kg/day))
and an acute neurotoxicity study in rat (at or up to 2, 000 mg/kg/day).
The acute oral toxicity of sulfosulfuron is also very low. Therefore,
sulfosulfuron 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 exposure to
sulfosulfuron from food and water will utilize < 1% of the cPAD for all
population subgroups including infants and children. Based the use
pattern, chronic residential exposure to residues of sulfosulfuron is
not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Sulfosulfuron is currently registered for use(s) that could result
in short-term residential exposure and the Agency has determined that
it is appropriate to aggregate chronic food and water and short-term
exposures for sulfosulfuron.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential
exposures aggregated result in an aggregate MOE of 1,300 for children
1-2 years old.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Though residential exposure could occur no toxicological effects
have been identified for intermediate-term toxicity. Therefore, the
aggregate risk is the sum of the risk from food and water.
5. Aggregate cancer risk for U.S. population. The cancer aggregate
risk assessment considered exposure from food, water, and residential
sources. EPA performs cancer assessments for the general U.S.
population only. The cancer dietary analyses assumed tolerance level
residues, 100% CT, and DEEM (version 7.76) default processing factors.
The dietary cancer risk from drinking water and food for the U.S.
population was 3 X 10-7. Residential cancer risk
was estimated for adults only based on dermal exposure to treated
areas. The estimated cancer risk for adults on day zero, based on high-
exposure activity for one hour (Tc=1,000 cm\2\/hr) is estimated to be
1.2 X 10-7. The aggregate cancer risk estimate
for adults is 3 X 10-7. If childhood incidental
oral exposure from residential sources is included in the aggregate
cancer risk assessment, the estimated cancer risk is 4 X
10-7. Since the cancer risk is less than the
negligible risk level of risks in the range of or below 1 X
10-6, EPA does not have a concern for aggregate
cancer risk from sulfosulfuron.
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 sulfosulfuron residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
In support of the use on wheat, the petitioner proposed two common-
moiety high-performance liquid chromatography (HPLC) methods with
fluorescence detection for enforcement of tolerances in wheat and
livestock commodities. For grasses the company used a common moiety
liquid chromatograph/mass spectrometry/mass spectrometry (LC/MS/MS)
method. The validated limit of quantitation (LOQ) was 0.005 and the
limit of detection (LOD) was 0.0026. The revision of the original HPLC
enforcement method to use LC/MC detection resolves the previous
deficiencies related to the specificity and confirmatory method. These
deficiencies are no longer outstanding.
Adequate enforcement methodology LC/MS/MS 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 established or proposed Codex or Mexican maximum
residue limits (MRLs) for residues of sulfosulfuron in grasses or
wheat. There are no established Canadian MRLs for residues of
sulfosulfuron in grasses. A Canadian MRL has been established for
residues of sulfosulfuron in wheat.
V. Conclusion
Therefore, tolerances are established for residues of
sulfosulfuron, 1-(4,6-dimethoxypyrimidin-2-yl)-3-[(2-ethane-sulfonyl-
imidazo[1,2-a]pyridine-3-yl)sulfonyl]urea, and its metabolites
converted to 2-(ethylsulfonyl)imidazol[1,2-a]pyridine and calculated at
sulfosulfuorn, as discussed in Unit II.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, 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
[[Page 54574]]
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 6, 2000) do not apply to this rule. In addition, This
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: September 13, 2007.
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 180.552 is amended by revising the table in paragraph (a),
and by removing the text and reserving paragraph (b) to read as
follows:
Sec. 180.552 Sulfosulfuron; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat......................... 0.02
Cattle, meat........................ 0.01
Cattle, meat byproducts............. 0.3
Goat, fat........................... 0.02
Goat, meat.......................... 0.01
Goat, meat byproducts............... 0.3
Grass, forage, fodder and hay, group 14
17, forage.........................
Grass, forage, fodder and hay, group 25
17, hay............................
Hog, fat............................ 0.005
Hog, meat........................... 0.005
Hog, meat byproducts................ 0.05
Horse, fat.......................... 0.02
Horse, meat......................... 0.01
Horse, meat byproducts.............. 0.3
Milk................................ 0.02
Sheep, fat.......................... 0.02
Sheep, meat......................... 0.01
Sheep, meat byproducts.............. 0.3
Wheat, forage....................... 4.0
Wheat, grain........................ 0.02
Wheat, hay.......................... 0.3
Wheat, straw 0.1
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. E7-18864 Filed 9-25-07; 8:45 am]
BILLING CODE 6560-50-S