Document ID: EPA-HQ-OPP-2006-0206-0003
Agency: epa
Document Type: Rule
Title: Sulfosulfuron; Pesticide Tolerance
Posted Date: 2007-09-26T04:00Z

[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]                         

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

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.

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

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