
[Federal Register: April 24, 2009 (Volume 74, Number 78)]
[Rules and Regulations]               
[Page 18644-18648]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ap09-11]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0526; FRL-8411-9]

 
Penoxsulam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
penoxsulam in or on almond hulls; grape; nut, tree, group 14; and 
pistachio. Dow AgroSciences, LLC., requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 24, 2009. Objections and 
requests for hearings must be received on or before June 23, 2009, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0526. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: 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).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2008-0526 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 June 23, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0526, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through

[[Page 18645]]

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 August 13, 2008 (73 FR 47186) (FRL-8375-
8), 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 
8F7369) by Dow AgroSciences, LLC., 9330 Zionsville Rd., Indianapolis, 
IN 46268. The petition requested that 40 CFR 180.605 be amended by 
establishing tolerances 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 nut, tree, group14; 
grape; almond, hulls, and pistachio all at 0.1 parts per million (ppm). 
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. There were no comments received 
in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for residues of penoxsulam on almond hulls; grape; nut, 
tree, group 14, and pistachio all at 0.01 ppm. EPA's assessment of 
exposures and risks associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Penoxsulam exhibited minimal acute toxicity in the available 
studies. In subchronic and chronic feeding studies in rats and dogs, 
the most sensitive target organ was the urothelium of the urinary 
system. In subchronic and chronic feeding studies in mice, no effects 
of toxicological significance were observed. No developmental toxicity 
was observed in the developmental toxicity studies in rats and rabbits 
and there was no increased quantitative or qualitative susceptibility 
of fetuses, as compared to dams. In a two-generation reproduction study 
in rats, delays in preputial separation were noted; however, no other 
endpoints of reproductive toxicity or offspring growth and survival 
were affected by treatment. There was no increased quantitative or 
qualitative susceptibility of fetuses or offspring, as compared to 
adults. No treatment-related neurotoxicity was observed in acute or 
chronic neurotoxicity studies in rats, or in any of the other available 
studies on penoxsulam. No systemic or dermal toxicity was noted in a 
28-day dermal toxicity study in rats.
    With respect to carcinogenicity, penoxsulam was classified as 
having suggestive evidence of carcinogenicity. The classification was 
based on an increase in large granular lymphocyte leukemia (also called 
mononuclear cell leukemia (MNCL)). EPA concluded that the cancer risk 
to humans is negligible. The MNCL seen in the Fisher 344 rat study 
appears not to be treatment related because it was only seen in male 
rats, there was a lack of dose-response across the treatment groups 
(i.e., incidence did not increase with increasing dose), and Fisher 344 
rats are known to be susceptible to MNCL, especially as they age. MNCL 
in Fisher 344 rats has not been found in other mammals, and there is no 
comparable tumor seen in humans. Finally, there is no other evidence on 
penoxsulam to indicate a cancer concern, including the fact that no 
cancer concerns were identified in the mouse carcinogenicity study; 
there is no evidence that penoxsulam is genotoxic; and other chemicals 
in the class of compounds (triazolopyrimidines) have not shown evidence 
of MNCL in Fisher 344 rats. EPA determined that the chronic assessment 
is considered to be protective of potential cancer risks. Penoxsulam 
did not demonstrate any mutagenic potential in a battery of four 
mutagenicity studies. There is not a concern for mutagenicity resulting 
from exposure to penoxsulam.
    Specific information on the studies received and the nature of the 
adverse effects caused by penoxsulam as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in the document Penoxsulam Risk Assessment at 
Appendix A in docket ID number EPA-HQ-OPP-2008-0526 and 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, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).

[[Page 18646]]

    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for penoxsulam used for 
human risk assessment can be found at http://www.regulations.gov in 
document Penoxsulam Risk Assessment at Appendix A in docket ID number 
EPA-HQ-OPP-2008-0526 and in the final rule published in the Federal 
Register of September 24, 2004 (EPA-HQ-OPP-2004-0286), (FRL-7678-6).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to penoxsulam, EPA considered exposure under the petitioned-
for tolerances as well as all existing penoxsulam tolerances in 40 CFR 
180.605.
    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; 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 U.S. Department 
of Agriculture 1994-1996 and 1998 Continuiing Survey of Food Intake by 
Individuals. As to residue levels in food, EPA used tolerance level 
residues and 100% crop treated, and incorporated default processing 
factors for processed food forms.
    iii. Cancer. Penoxsulam has been classified as having ``suggestive 
evidence for carcinogenic potential'' based on some evidence of 
mononuclear cell leukemia (MNCL) in a penoxsulam cancer study in Fisher 
344 rats. However, the Agency concluded that the cancer risk to humans 
is negligible based on the following considerations. First, it is 
questionable that the MNCL seen in the Fisher 344 rat study was 
treatment related because it was only seen in male rats, there was a 
lack of dose-response across the treatment groups (i.e., incidence did 
not increase with increasing dose), and Fisher 344 rats are known to be 
susceptible to MNCL, especially as they age. Second, MNCL in Fisher 344 
rats is of questionable significance for humans because it has not been 
found in other mammals, and there is no comparable tumor seen in 
humans. Finally, there is no other evidence on penoxsulam to indicate a 
cancer concern, including the fact that no cancer concerns were 
identified in the mouse carcinogenicity study; there is no evidence 
that penoxsulam is genotoxic; and other chemicals in the class of 
compounds (triazolopyrimidines) have not shown evidence of MNCL in 
Fisher 344 rats.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for penoxsulam. Tolerance level residues and/or 100% 
crop treated were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency considered 
screening level water exposure models in the dietary exposure analysis 
and risk assessment for penoxsulam in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of penoxsulam. 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 model for surface water and the Screening 
Concentratin in Ground Water (SCI-GROW) model for ground water, the 
estimated drinking water concentrations (EDWCs) of penoxsulam for 
chronic exposures for non-cancer assessments are estimated to be 0.9 
parts per billion (ppb) for surface water and 23.3 ppb for ground 
water.
    In addition to uses that may result in the transport of penoxsulam 
residues to surface and/or ground water, penoxsulam may be applied 
directly to water, at a maximum rate of 150 ppb, for aquatic weed 
control. For chronic dietary risk assessment, the water concentration 
value of 150 ppb from the registered aquatic use was used to assess the 
contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Penoxsulam is currently registered for the following uses that 
could result in residential exposures following use on lawns and 
treatment of residential aquatic sites. EPA assessed residential 
exposure using the following assumptions: exposures can be of short- 
and intermediate-term durations and can be through dermal or oral 
routes.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found penoxsulam to share a common mechanism of 
toxicity with any other substances, and penoxsulam does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
penoxsulam does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. No developmental toxicity 
was observed in the developmental toxicity studies in rats and rabbits 
and there was no increased quantitative or qualitative susceptibility 
of fetuses, as compared to dams. In a two-generation reproduction study 
in rats, delays in preputial separation were noted; however, no other 
endpoints of reproductive toxicity or offspring growth and survival 
were affected by treatment. There was no increased quantitative or 
qualitative susceptibility of fetuses or offspring, as compared to 
adults. There are no residual uncertainties for pre- and/or post-natal 
toxicity resulting from exposure to penoxsulam and there is no

[[Page 18647]]

evidence of quantitative or qualitative susceptibility in the 
toxicological data.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for penoxsulam is complete, except for 
immunotoxicity testing. EPA began requiring functional immunotoxicity 
testing of all food and non-food use pesticides on December 26, 2007. 
Since this requirement went into effect well after the tolerance 
petition was submitted, these studies are not yet available for 
penoxsulam. In the absence of specific immunotoxicity studies, EPA has 
evaluated the available penoxsulam toxicity data to determine whether 
an additional database uncertainty factor is needed to account for 
potential immunotoxicity. There was no evidence of adverse effects on 
the organs of the immune system in any study with penoxsulam. Based on 
these considerations, EPA does not believe that conducting a special 
series 870.7800 immunotoxicity study will result in a point of 
departure less than the NOAEL of 14.7 milligrams/kilograms/day (mg/kg/
day) used in calculating the cPAD for penoxsulam; therefore, an 
additional database uncertainty factor is not needed to account for 
potential immunotoxicity.
    ii. There is no indication that penoxsulam 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 penoxsulam results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The chronic dietary food exposure assessment utilizes 
proposed tolerance level residues and 100% crop treated for all 
commodities. EPA made conservative (protective) assumptions in the 
residue estimates used to assess exposure to penoxsulam in drinking 
water. EPA used similarly conservative assumptions to assess 
postapplication exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by penoxsulam.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
penoxsulam is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
penoxsulam from food and water will utilize 7.1% of the cPAD for all 
infants, the population group receiving the greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Penoxsulam 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 exposure through food and water 
with short-term residential exposures to penoxsulam.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures aggregated result in aggregate MOEs of 1,500 
to children from oral post application exposure from turf treated with 
penoxsulam and 5,500 from adults applying penoxsulam to residential 
turf. As the aggregate MOE is greater than 100, the short-term 
aggregate risks to children and adults do not exceed EPA's level of 
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Penoxsulam is currently registered for use(s) that could result in 
intermediate-term residential exposure. However, the Agency has 
determined that it is not appropriate to aggregate these intermediate-
term exposures with chronic exposure to penoxsulam through food and 
water. Therefore, intermediate-term aggregate risk estimates are 
equivalent to the chronic aggregate risk estimates discussed above.
    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 residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography with tandem mass spectroscopy-mass spectroscopy detector 
(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 CODEX maximum residue limits (MRLs) for residues of 
penoxsulam in almond, hulls; grape; nut, tree, group 14, and pistachio.

V. Conclusion

    Therefore, tolerances are established for residues of penoxsulam on 
almond hulls; grape; nut, tree, group 14, and pistachio all at 0.01 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order

[[Page 18648]]

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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: April 17, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
 2. Section 180.605 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
------------------------------------------------------------------------
Almond, hulls................................................       0.01
                                * * * * *
Grape........................................................       0.01
Nut, tree, group 14..........................................       0.01
Pistachio....................................................       0.01
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-9441 Filed 4-23-09; 8:45 am]

BILLING CODE 6560-50-S
