Document ID: EPA-HQ-OPP-2009-0906-0011
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Isopyrazam
Posted Date: 2011-10-05T04:00Z

[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Rules and Regulations]
[Pages 61592-61597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25707]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0906; FRL-8874-6]

Isopyrazam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
isopyrazam in or on banana. Syngenta Crop Protection, Inc., requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 5, 2011. Objections and 
requests for hearings must be received on or before December 5, 2011, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0906. 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: Shaunta Hill, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 347-8961; e-mail address: hill.shaunta@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

[[Page 61593]]

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 get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0906 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
December 5, 2011. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0906, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 4, 2010 (75 FR 5790) (FRL-8807-
5), 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 
9E7606) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR part 180 be amended 
by establishing a tolerance for residues of the fungicide isopyrazam, 
in or on banana at 0.05 ppm parts per million (ppm). That notice 
referenced a summary of the petition prepared by Syngenta Crop 
Protection, Inc., the registrant, which is available 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 isopyrazam including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with isopyrazam 
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. Isopyrazam is of low acute toxicity by the oral, dermal and 
inhalation routes, and is not a skin or eye irritant. The primary 
target organ for isopyrazam toxicity is the liver based on subchronic 
and chronic oral studies in the rat, mouse rabbit and dog. The 
principal effects observed in these studies are increased organ weight 
and centrilobular hepatocyte hypertrophy. Liver toxicity is usually 
accompanied by reductions in body weight and food consumption. 
Isopyrazam does not cause reproductive toxicity. Developmental effects 
(eye abnormalities) were observed in the absence of maternal toxicity 
in two range finding developmental toxicity studies in rabbits 
providing some evidence of sensitivity/susceptibility following pre- 
and/or postnatal exposure. Developmental studies in rats produced 
developmental effects but only at doses that were also maternally 
toxic. Acute and subchronic oral neurotoxicity studies in rats show no 
evidence of neurotoxicity. Effects characteristic of neurotoxicity 
(side-to-side head wobble, ataxia, reduced stability) were observed on 
day 2 in one subchronic oral study in dogs and at week 4 in a second 
subchronic dog study. These effects were not observed in the chronic 
dog study. However, EPA concluded for the following reasons that it is 
unlikely that there was a neurotoxic basis for these effects. First, 
the effects were seen only in a study not specifically conducted to 
identify neurotoxic potential and where detailed clinical and 
histopathological analyses for neurotoxic effects were not performed 
whereas isopyrazam showed no evidence of neurotoxicity in the available 
acute and subchronic neurotoxicity studies. Second, isopyrazam is not 
structurally similar to known neurotoxicants or neurotoxic classes of 
chemicals. Finally, its pesticidal mode of action does not demonstrate 
potential for neurotoxicity. Based on these findings, a developmental 
neurotoxicity study for isopyrazam is not required.
    There is no evidence of immunotoxicity based on a 28-day dietary 
immunotoxicity study in rats. The lowest observed adverse effect level

[[Page 61594]]

(LOAEL) for immunotoxicity was not identified and the no observed 
adverse effect level (NOAEL) for immunotoxicity is 1,356 milligrams/
kilograms (mg/kg). The study NOAEL was 127 mg/kg/day, based on 
transient body weight loss and high liver weights at both 608 and 1,356 
mg/kg/day. The toxicology database for isopyrazam does not show any 
evidence of treatment-related effects on the immune system. The overall 
weight of evidence suggests that this chemical does not directly target 
the immune system.
    Isopyrazam is classified as ``Likely to be Carcinogenic to Humans'' 
based on tumors in male and female rats. Specific information on the 
studies received and the nature of the adverse effects caused by 
isopyrazam as well as the NOAEL and the LOAEL from the toxicity studies 
can be found at http://www.regulations.gov in document ``Isopyrazam 
Human Health Risk Assessment for the Establishment of a Tolerance for 
isopyrazam (SYN52043) Fungicide in/on Imported Banana,'' on pp. 8-12 in 
docket ID number EPA-HQ-OPP-2009-0906.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern (LOC) to use in evaluating the risk posed by human exposure to 
the pesticide. For hazards that have a threshold below which there is 
no appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed the NOAEL 
and the lowest dose at which adverse effects of concern are identified 
the LOAEL. Uncertainty/safety factors are used in conjunction with the 
POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). 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 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.
    PODs for incidental oral, dermal and inhalation exposure are not 
needed to assess risk for the requested tolerance on bananas because 
use of isopyrazam will only lead to dietary exposure, and have 
therefore not been selected for this risk assessment.
    The acute POD of 30 mg/kg/day (NOAEL) was selected based on the 
NOAEL from a subchronic toxicity study in dogs. In that study, clinical 
signs of toxicity (side-to-side head wobble) were observed beginning on 
day 2 and continuing throughout the study in 1 of 4 male dogs at the 
LOAEL of 100 mg/kg/day. Transient clinical signs (side-to-side head 
wobble, ataxia, reduced stability) were also observed at 300 mg/kg/day 
in 3 of 4 male dogs on days 2 and 3 only. An uncertainty factor of 100x 
(10x to account for interspecies extrapolation and 10x for intraspecies 
variation) was applied to the NOAEL to obtain an aRfD of 0.30 mg/kg/
day. This endpoint is considered to occur following a single dose and 
is applicable to the population of concern (general population, 
including infants and children). It is considered to be a very 
conservative endpoint since it is based on observations in 1/4 dogs and 
these acute clinical signs were not reproduced in a second 90-day study 
in dogs or in the chronic dog study. This endpoint is also protective 
of the effects seen at the limit dose (2,000 mg/kg/day) in the acute 
neurotoxicity study in rats (decreased rearing and locomotor activity) 
and the developmental effect (bilateral microphthalmia) in the 
developmental rabbit studies (at doses >=400 mg/kg/day). Therefore, a 
separate acute dietary endpoint for females of reproductive age is not 
necessary. As discussed in this unit, EPA has reduced the Food Quality 
Protection Act (FQPA) Safety Factor (SF) to 1x, and thus the acute 
Population Adjusted Dose (aPAD) is equivalent to the acute Reference 
Dose (aRfD).
    The chronic POD of 5.5 mg/kg/day was selected based on the NOAEL in 
a chronic toxicity/carcinogenicity feeding study in rats. The LOAEL in 
that study was 27.6 mg/kg/day based on decreased body weight and body 
weight gain in females; increased incidences of hepatocellular 
hypertrophy, pigment in centrilobular hepatocytes, eosinophilic foci of 
altered hepatocytes, vacuolation of centrilobular hepatocytes, bile 
duct hyperplasia, and bile duct fibrosis in both sexes; and brown 
pigment in the kidney in females. An uncertainty factor of 100x (10x to 
account for interspecies extrapolation and 10x for intraspecies 
variation) was applied to the dose to obtain the chronic reference dose 
(cRfD) of 0.055 mg/kg/day. As discussed in this unit, EPA has reduced 
the FQPA SF to 1x, and thus, the chronic population adjusted dose 
(cPAD) is equivalent to the cRfD.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to isopyrazam, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from isopyrazam 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.
    A conservative acute dietary (food only) exposure analysis was 
performed for the general U.S. population and various population 
subgroups. Tolerance level residues and 100 percent crop treated (PCT) 
assumptions were used. Dietary Exposure Evaluation Model (DEEM) default 
processing factors were used for processed commodities, since separate 
tolerances are not considered necessary for processed banana 
commodities.
    ii. Chronic exposure. Conservative chronic and cancer dietary (food 
only) exposure analyses were performed for the general U.S. population 
and various population subgroups. Tolerance level residues and 100 PCT 
assumptions were used. DEEM default and empirical processing factors 
were used for banana processed commodities, since separate tolerances 
for these commodities were not considered necessary.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
If quantitative cancer risk assessment is appropriate, cancer risk may 
be quantified using a linear or nonlinear approach. If sufficient 
information on the carcinogenic mode of action is available, a 
threshold or non-linear approach is used and a cancer RfD is calculated 
based on an earlier noncancer key event. If carcinogenic mode of action 
data are not available, or if the mode of action data determines a 
mutagenic mode of action, a default linear cancer slope factor approach 
is utilized. Based on the data summarized in Unit III.A., EPA has 
concluded that isopyrazam should be classified as ``Likely to be 
Carcinogenic to Humans''.
    A linear quantification of carcinogenic potential was required for 
isopyrazam based on rat tumors. A cancer slope factor or Q1* of 0.00629 
(mg/kg/day) -1 was calculated based on

[[Page 61595]]

an increase in liver adenomas and/or carcinomas in female rats. The 
resulting cancer aggregate (food) exposure estimate was less than the 
level of concern. Cancer risk was 1.3 x 10-7 for the general 
U.S. population. Cancer risk was quantified using the same estimates as 
discussed in Unit III.C.1.ii.
    2. Dietary exposure from drinking water. An assessment of residues 
in drinking water is not needed because there is no drinking water 
exposure associated with the establishment of a tolerance on imported 
crops.
    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). Isopyrazam is not 
registered for any specific use patterns that would result in 
residential exposure.
    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 isopyrazam to share a common mechanism of 
toxicity with any other substances, and isopyrazam does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
isopyrazam 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 Web site 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 SF. In 
applying this provision, EPA either retains the default value of 10x, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is some evidence for 
increased susceptibility following pre- and or postnatal exposures 
based on effects seen in range finding developmental toxicity studies 
in rabbits. Developmental effects (eye abnormalities) were observed in 
two preliminary developmental studies in Himalayan rabbits in the 
absence of maternal toxicity. These effects occurred at relatively high 
doses (200-400 mg/kg/day). There was no evidence of increased 
susceptibility in the main study in New Zealand white rabbits. In range 
finding and definitive developmental toxicity studies in rats, neither 
quantitative nor qualitative evidence of increased susceptibility of 
fetuses to in utero exposure to isopyrazam was observed. There was no 
evidence of increased susceptibility in a 2-generation reproduction 
study following pre- or postnatal exposure to isopyrazam. There is no 
evidence of neuropathology or abnormalities in the development of the 
fetal nervous system from the available toxicity studies conducted with 
isopyrazam. Clear NOAELs/LOAELs were established for the developmental 
effects seen in rats and rabbits as well as for the offspring effects 
seen in the 2-generation reproduction study and a dose-response 
relationship for the effects of concern is well characterized. The dose 
used for the acute dietary risk assessment (30 mg/kg/day), based on 
effects seen in the subchronic dog study, is protective of the 
developmental and offspring effects seen in rabbits at 200-400 mg/kg/
day. Based on these considerations, there are no residual uncertainties 
for pre-and/or postnatal susceptibility.
    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 isopyrazam is complete and adequate 
for assessing increased susceptibility under FQPA;
    ii. There is no indication of increased susceptibility of fetuses 
to in utero and/or postnatal exposure in the developmental and 
reproductive toxicity studies in rats;
    There is some evidence for increased susceptibility following pre- 
and or postnatal exposures based on effects seen in range finding 
developmental toxicity studies in rabbits. However, based on the 
discussion above, EPA has concluded that there are no residual 
uncertainties for pre-and/or postnatal susceptibility.
    iii. The dietary risk assessment is based on parent plus metabolite 
residues in/on banana, and will not underestimate dietary exposure to 
isopyrazam. For the acute, chronic and cancer dietary analyses, 
tolerance level residues of parent plus metabolite and 100 PCT 
assumptions were used for all treated commodities. There are no 
residual uncertainties identified in the exposure databases.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an 
adequate margin of exposure (MOE) exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
isopyrazam will occupy less than 1% of the aPAD for all populations.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
isopyrazam from food will utilize less than 1% of the cPAD for all 
populations receiving the greatest exposure. There are no residential 
uses for isopyrazam.
    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). Isopyrazam is 
not registered in the U.S. Short-term risk is assessed based on short-
term residential exposure plus chronic dietary exposure. Because there 
is no short-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess short-term risk), no 
further assessment of short-term risk is necessary, and EPA relies on 
the chronic dietary risk assessment for evaluating short-term risk for 
isopyrazam.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic

[[Page 61596]]

exposure to food and water (considered to be a background exposure 
level). Isopyrazam is not registered in the U.S. Intermediate-term risk 
is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure. Because there is no intermediate-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess intermediate-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for isopyrazam.
    5. Aggregate cancer risk for U.S. population. The Cancer Assessment 
Review Committee (CARC) classified isopyrazam as Likely to be 
Carcinogenic to Humans. This classification was based on the presence 
of thyroid follicular cell tumors in male rats, and liver and uterine 
tumors in female rats at doses that were adequate to evaluate the 
carcinogenic potential of isopyrazam. No treatment-related tumors were 
seen in mice. There is no mutagenic concern for isopyrazam.
    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 isopyrazam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method GRM006.01B) 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

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for isopyrazam on banana.

V. Conclusion

    Therefore, a tolerance is established for residues of isopyrazam, 
in or on banana at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal governments, on the relationship between the national government 
and the States or Tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 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 27, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.

    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 180.654 is added to read as follows:

Sec.  180.654  Isopyrazam; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide isopyrazam, including its metabolites and degradates, in or 
on the commodity

[[Page 61597]]

listed below. Compliance with the tolerance levels specified below is 
to be determined by measuring only isopyrazam, 3-difluoromethyl-1-
methyl-1H-pyrazole-4-carboxylic acid (9-isopropyl-1,2,3,4-tetrahydro-
1,4-methano-naphthalen-5-yl)-amide, in or on the following commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Banana\1\..................................................         0.05
------------------------------------------------------------------------
\1\ There is no U.S. registration for use of isopyrazam on banana.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2011-25707 Filed 10-4-11; 8:45 am]
BILLING CODE 6560-50-P