

[Federal Register: July 25, 2007 (Volume 72, Number 142)]
[Rules and Regulations]               
[Page 40759-40763]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy07-11]                         

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0076; FRL-8137-7]

 
Penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for combined residues 
or residues of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) in or on fish; fish, shellfish, 
mollusc; and fish, shellfish, crustacean. Dow AgroSciences LLC 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective July 25, 2007. Objections and 
requests for hearings must be received on or before September 24, 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-2006-0076. 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 web site 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 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: Philip V. Errico, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6663; e-mail address: 
errico.philip@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 the 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-2006-0076 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 September 24, 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-2006-0076, 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 April 14, 2006 (72 FR Page 19507) (FRL-
8063-4), 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 
5F7012) by Dow AgroSciences LLC, Dow AgroSciences

[[Page 40760]]

LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054. The petition 
requested that 40 CFR 180.605 be amended by establishing an exemption 
from tolerance for residues of the herbicide penoxsulam (2-(2,2-
difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-
6-(trifluoromethyl)benzenesulfonamide, in or on fish and shellfish 
resulting from its use as an aquatic herbicide. That notice referenced 
a summary of the petition prepared by Dow AgroSciences, LLC, the 
registrant, which is available to the public in the docket, http://www.regulations.gov.
 Comments were received on the notice of filing. 

EPA's response to these comments is discussed in Unit IV. below.
    The Registrant modified their submission and requested tolerances 
be established. The reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the 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 the 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 the 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 the FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D), of the FFDCA and the factors 
specified in section 408(b)(2)(D), 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 penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) on fish, shellfish, mollusc; fish; 
and shellfish, crustacean at 0.02, 0.01, and 0.01 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 penoxsulam (2-(2,2-difluoroethoxy)-N-
(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) 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 September 24, 2004 (EPA-HQ-OPP-
2004-0286), (FRL-7678-6).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from 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) is 
sometimes used for risk assessment. Uncertainty/safety factors (UF) 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 uncertainty/safety factors. Short-, intermediate, 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 uncertainty/safety factors 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 penoxsulam (2-(2,2-
difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-
6-(trifluoromethyl)benzenesulfonamide) used for human risk assessment 
can be found at http://www.regulations.gov in document ``Penoxsulam. Human 

Health Risk Assessment for Proposed Uses on Fish and Shellfish. PC 
Code: 119031, Petition No: 5F7012, DP Num: 325461.'' at page 42 in 
Docket ID EPA-HQ-OPP-2006-0076.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide, EPA considered exposure under the 
petitioned-for tolerances as well as all existing penoxsulam (2-(2,2-
difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-
6-(trifluoromethyl)benzenesulfonamide) tolerances in (40 CFR 180.605). 
EPA assessed dietary exposures from penoxsulam (2-(2,2-difluoroethoxy)-
N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) 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 
penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-
c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide; 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 USDA 1994-1996 
and 1998; Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to

[[Page 40761]]

residue levels in food, EPA assumed all foods for which there are 
tolerances were treated and contain tolerance-level residues.
    iii. Cancer. Penoxsulam was classified as ``Suggestive Evidence of 
Carcinogenic Potential.'' There is some cancer concern, but the data 
are judged not sufficient for a stronger conclusion or a quantitative 
cancer risk assessment (see Unit III.E.5).
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA assumed tolerance level residues and 100% of the crop is treated.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for penoxsulam (2-(2,2-difluoroethoxy)-N-
(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) 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 
penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-
c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide). 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 FQPA Index Reservoir Screening Tool and Screening 
Concentrations in Groundwater models, the estimated environmental 
concentrations (EECs) of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) for acute exposures are estimated 
to be 150 parts per billion (ppb) for surface water and 150 ppb for 
ground water. The EECs for chronic exposures are estimated to be 150 
ppb for surface water and 150 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 150 ppb was used to access 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 150 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).
    Penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) is currently registered for the 
following residential non-dietary sites: Turf/lawn. EPA assessed 
residential exposure using the following assumptions:
     1,000 ft2 per day by low pressure hand wand or 
back pack sprayer for spot treatment of lawns
     0.5 acres per day by push-type granular spreader for 
broadcast treatment of lawns
     0.06 lb active ingredient (ai) per acre for broadcast 
treatment
     0.0014 to 0.0016 lbs per 1,000 ft2 for spot 
treatment
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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 penoxsulam (2-(2,2-
difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-
6-(trifluoromethyl)benzenesulfonamide) and any other substances and 
penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-
c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) 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 penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) 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 data base 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 uncertainty/safety factors and/or special FQPA safety 
factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Based on the results of the 
submitted toxicology studies, EPA concluded that no FQPA safety factor 
is needed (i.e. 1X) since there are no residual uncertainties for 
prenatal and/or postnatal toxicity.
    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. There was no toxicologically significant evidence observed of 
neurotoxicity in either the acute or chronic neurotoxicity study.
    ii. No definitive quantitative or qualitative susceptibility was 
observed in either of the developmental rat or rabbit studies.
    iii. Significant dose-related effects in the 2-generation 
reproduction study were limited to the delay in preputial separation. 
No other endpoints of reproductive toxicity or offspring growth and 
survival were affected by treatment.
    iv. The chronic dietary food exposure assessment utilizes proposed 
tolerance level residues and 100% crop treated for all commodities. By 
using these conservative assessments, actual and chronic exposures/
risks will not be underestimated.
    v. The dietary drinking water assessment (Tier 1 estimates) 
utilizes values generated by model and associated modeling parameters 
which are designed to provide conservative, health protective, high-end 
estimates of water concentrations.

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 uncertainty/
safety factors.

[[Page 40762]]

For linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate, 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 
uncertainty/safety factors is not exceeded.
    1. Acute risk. There were no treatment-related effects observed in 
any of the available toxicity studies on penoxsulam that could be 
considered to have resulted from a single dose of penoxsulam. Therefore 
no acute exposure is expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-
c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) for the most 
highly exposed population subgroup from food and water, which utilizes 
7% of the cPAD is all infants (< 1 year old).
    3. Short-term risk and intermediate term risk. For this aquatic use 
pattern, short- and intermediate-term aggregate exposure takes into 
account residential exposure, exposure while swimming, plus chronic 
exposure to food and water (considered being a background exposure 
level). There is a potential for post application exposure from oral 
and dermal routes of exposure while swimming in aquatic sites and/or 
from turf (lawns, golf courses, sports fields, and sod farms) sites 
treated with penoxsulam.
    EPA used the SWIMODEL from the Residential Standard Operating 
Procedures (SOPs) to assess dermal and oral exposure to recreational 
swimmers. Parameters used in calculating exposure and risk are based on 
information for competitive swimmers both adult and children (6 years 
old) in swimming pools which includes an exposure duration of 5 hours. 
It is anticipated that recreational swimmers in weed infested areas 
would be less likely to swim with their heads immersed than 
recreational swimmers in weed-free swimming pools. Since there were no 
short-term dermal, systemic, neuro or developmental toxicity concerns, 
the short-term post application assessment addresses only the oral 
exposure, which results in the same estimated dose for intermediate-
term exposure. Thus a short-term aggregate exposure was not required, 
and the intermediate-term post application exposure assessment combined 
both oral and dermal exposures, and is also protective for short-term 
exposure. Short- and intermediate-term postapplication exposures 
resulted in MOEs> 100 and are therefore not a concern to the Agency. 
The Agency considers the swimmer dermal and oral MOEs to be over 
estimates of the actual risk, and therefore swimming exposure 
assessment was not used in assessing the short- and intermediate-term 
aggregate risk, and only the exposure resulting from the turf use was 
assessed.
    The short-term aggregate risk assessment estimates include both 
oral and inhalation exposures appropriate to the population of concern. 
Short-term dermal exposure was not aggregated because no toxicological 
endpoint was selected. For adults, short-term exposure to penoxsulam 
can occur as a result of the residential use on turf. Because oral 
exposure from the residential use as a handler is not expected in 
adults and no short-term dermal endpoint was selected, only the short-
term residential exposure by inhalation is expected in adults. The 
worst-case MOE residential exposure estimate was aggregated with the 
chronic dietary (food + water) to provide a worst-case estimate of 
short-term aggregate risk for U.S. population. As the aggregate MOE is 
greater than 100, the short-term aggregate risk to adults does exceed 
EPA's level of concern.
    For children/toddlers, short-term exposure to penoxsulam can occur 
as a result of the residential use on turf. Because post-application 
inhalation exposure is negligible and no short-term dermal endpoint was 
selected, only short-term residential exposure from oral exposure was 
included with food and drinking water in the short-term aggregate risk 
assessment for children/toddlers. The worst-case MOE residential 
exposure estimate for children was aggregated with the chronic dietary 
(food + water) to provide a worst-case estimate of short-term aggregate 
risk for all infants (< 1 year old), the child population subgroup with 
the highest estimated chronic dietary food exposure. As the aggregate 
MOE is greater than 100, the short-term aggregate risks to children do 
not exceed EPA's level of concern.
    Because the amount of residues on turf after 30 days will be 
negligible, both inhalation and dermal exposure is negligible, and 
therefore no intermediate-term aggregate exposure assessment from this 
turf use is required.
    4. Aggregate cancer risk for U.S. population. The cancer potential 
for penoxsulam is classified as ``Suggestive Evidence of Carcinogenic 
Potential.'' The classification is based on an increase in large 
granular lymphocyte leukemia (also called mononuclear cell leukemia 
(MNCL)) in male Fischer 344 rats. There were increased tumors at all 
dose levels which exceeded the laboratory historical control data. 
There is considerable controversy as to the significance and relevance 
of the tumors for humans, but they cannot be discounted in the overall 
weight of the evidence. While there is some cancer concern, the data 
are judged not sufficient for a stronger conclusion or a quantitative 
cancer risk assessment.
    5. 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 penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-
dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfonamide) residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, using high performance liquid 
chromatograph with tandem mass spectroscopy-mass spectroscopy detector 
(LC/MS/MS), and 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 maximum residue limits (MRLs) for fish; fish, 
shellfish, mollusc; and fish, shellfish, crustacean.

C. Response to Comments

    Comments were received from a private citizen objecting to this 
product being used in the world, and that the product is too dangerous 
to be allowed use. A print-out of what appears to be EPA's summary of 
the toxicological effects and tolerances for rice were included. No 
other information was provided. EPA has found that there is a 
reasonable certainty of no harm to humans after considering all 
pertinent toxicology studies and the exposure levels of humans to 
penoxsulam.

V. Conclusion

    Therefore, the tolerance is established for residues of penoxsulam 
(2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-
c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide,

[[Page 40763]]

in or on fish, shellfish, mollusc; fish; and shellfish, crustacean at 
0.02, 0.01, and 0.01 ppm. The registrant initially requested exemptions 
from tolerances for fish and shellfish. Based upon review of the data 
supporting the petition by EPA and subsequent to completion of this 
risk assessment, the registrant revised their submission and requested 
tolerances for finfish at 0.01 ppm; shellfish, crustacean at 0.01 ppm; 
and shellfish, mollusc at 0.02 ppm. For consistency the commodity terms 
are revised to fish at 0.01 ppm; fish, shellfish, crustacean at 0.01 
ppm; and fish, shellfish, mollusc at 0.02 ppm.

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 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: July 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 180.605 is amended by alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:


Sec.  180.605  Penoxsulam; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Fish.......................................................         0.01
Fish, shellfish, crustacean................................         0.01
Fish, shellfish, mollusc...................................         0.02
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-14335 Filed 7-24-07; 8:45 am]

BILLING CODE 6560-50-S
