Prohydrojasmon, propyl-3-oxo-2-pentylcyclo-pentylacetate; Temporary Exemption From the Requirement of a Tolerance, 50922-50926 [2010-20177]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 159 (Wednesday, August 18, 2010)]
[Rules and Regulations]
[Pages 50922-50926]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20177]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0048; FRL-8839-4]


Prohydrojasmon, propyl-3-oxo-2-pentylcyclo-pentylacetate; 
Temporary Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a temporary exemption from the 
requirement of a tolerance for residues of the biochemical pesticide 
prohydrojasmon (PDJ), propyl-3-oxo-2-pentylcyclo-pentylacetate, on red 
apple varieties when applied/used as a plant growth-regulator in 
accordance with the terms of Experimental Use Permit (EUP) No. 62097-
EUP-R and when used in accordance with good agricultural practices. 
Fine Agrochemicals, Ltd., submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), requesting the temporary 
tolerance exemption. This regulation eliminates the need to establish a 
maximum permissible level for residues of prohydrojasmon (PDJ), propyl-
3-oxo-2-pentylcyclo-pentylacetate. The temporary tolerance exemption 
expires on August 1, 2012.

DATES: This regulation is effective August 18, 2010. Objections and 
requests for hearings must be received on or before October 18, 2010, 
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-2010-0048. All documents in the 
docket are listed in the docket index available at https://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 https://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: Gina Casciano, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 605-0513; e-mail 
address: casciano.gina@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:
     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 provides 
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

[[Page 50923]]

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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at https://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-2010-0048 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 
October 18, 2010. 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-2010-0048, by one of the following methods:
     Federal eRulemaking Portal: https://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. Background and Statutory Findings

    In the Federal Register of April 7, 2010 (75 FR 17715) (FRL-8810-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 9G7656) by Fine Agrochemicals, Ltd., c/o SciReg, Inc., 
12733 Director's Loop, Woodbridge, VA, 22192. The petition requested 
that 40 CFR part 180 be amended by establishing a temporary exemption 
from the requirement of a tolerance for residues of prohydrojasmon, 
propyl-3-oxo-2-pentylcyclo-pentylacetate, (PDJ), for its use in 
accordance with the terms of Experimental Use Permit (EUP) No. 62097-
EUP-R. This notice referenced a summary of the petition prepared by the 
petitioner Fine Agrochemicals, Ltd., c/o SciReg, Inc., which is 
available in the docket, https://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(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. Pursuant to section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C) of FFDCA, which require 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....'' Additionally, section 408(b)(2)(D) of FFDCA requires that 
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 performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information 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.
    PDJ is a synthetically made plant growth regulator which is both 
structurally similar and functionally identical to jasmonic acid (JA), 
a naturally occurring plant regulator present in all vascular (higher) 
plants. The jasomates, of which JA is a member, is a group of plant 
hormones involved in multiple stages of plant development and defense, 
including the ability to stimulate fruit ripening (Creelman and Mullet, 
et al., 1995). The highest levels of naturally occurring JA are found 
in actively growing plant tissues such as leaves, flowers, and 
developing fruit (Creelman and Mullet, et al., 1995; Mason et al., 
1992), thus JA has always been a natural component of diets containing 
plant materials. To date, there have been no reported toxic effects 
associated with the consumption of JA in fruits and vegetables.
    PDJ, a synthetic version of JA, is expected to behave in the same 
manner and have the same low toxicity profile as JA since it is 
structurally similar and functionally identical to naturally occurring 
JA. Studies submitted by the applicant and reviewed by EPA indicate 
that PDJ is not acutely toxic. No toxic endpoints were established, and 
no significant toxicological effects were observed in any of the acute 
toxicity studies. In addition, studies submitted indicate that PDJ is 
not genotoxic, has no subchronic toxic effects, and is not a 
developmental toxicant. Summaries of the toxicological data submitted 
in support of this temporary exemption from the requirement of a 
tolerance follow.

A. Acute Toxicity

     Acute toxicity studies on the technical grade active ingredient 
(TGAI) for PDJ, containing 97.98% PDJ, confirm

[[Page 50924]]

a low toxicity profile. The acute toxicity data show virtual 
nontoxicity for all routes of exposure and it can be concluded that any 
dietary risks associated with this plant regulator would be negligible.
    1. The acute oral median lethal dose (LD50) in rats was 
greater than 5,000 milligrams per kilogram (mg/kg) bodyweight. There 
were no observed toxicological effects on the test subjects in the 
acute oral study submitted (MRID No. 47927825). PDJ is classified as 
Toxicity Category IV for acute oral toxicity.
    2. The acute dermal LD50 in rats was greater than 2,000 
mg/kg bodyweight (MRID 47927826). PDJ is classified as Toxicity 
Category III for acute dermal toxicity.
    3. The acute inhalation median lethal concentration 
(LC50) was greater than 2.8 milligrams per liter (mg/L) in 
rats and showed no significant inhalation toxicity (MRID 47927827). PDJ 
is classified as Toxicity Category IV for acute inhalation toxicity.
    4. A primary eye irritation study on rabbits indicates that PDJ is 
minimally irritating to the eye (MRID 47927828). PDJ is classified as 
Toxicity Category IV for primary eye irritation.
    5. A skin irritation study on rabbits indicates that PDJ is not 
irritating to the skin (MRID 47927829). PDJ is classified as Toxicity 
Category IV for primary skin irritation.
    6. Data indicate that PDJ is not a dermal sensitizer (MRID 
47927830).

B. Mutagenicity

    Two mutagenicity studies, using the TGAI of PDJ (97.98% PDJ) as the 
test substance, were performed. These studies are sufficient to confirm 
that there are no expected dietary or non-occupational risks of 
mutagenicity with regard to new food uses.
    1. A Bacterial Reverse Gene Mutation Test (MRID No. 47927833) 
investigating doses of test substance up to those that were cytotoxic, 
both with and without metabolic S9 activation, found no incidences of a 
2-fold or greater increase in the number of revertants compared to the 
corresponding solvent control. Therefore, PDJ is considered to be non-
mutagenic under the conditions of this assay.
    2. An in vitro Mammalian Cell Chromosome Aberration Test (MRID No. 
47927834) tested PDJ genotoxicity on Chinese hamster lung cells (CHL/
IU) up to the cytotoxic dose level (80 micrograms per milliliter 
[[micro]g/mL], based on reduced mitotic activity) without S9 
activation, and up to the limit concentration of 5,000 [micro]g/mL with 
S9 activation. None of the test substance concentrations induced a 
significant increase in the incidence of cells with chromosomal 
abnormalities, either in the absence or presence of S9 activation. In 
both experiments, the fraction of cells with chromosomal aberrations 
was below 5%, indicating a negative response of the test substance. 
There was also no indication of a dose-response effect either with or 
without metabolic activation. All of the negative, solvent, and 
positive controls gave appropriate responses. Therefore, under the 
conditions of this assay, PDJ is considered to be non-mutagenic and 
does not cause chromosome aberrations.

C. Subchronic Toxicity

     In a subchronic toxicity study using the TGAI of PDJ (97.98% PDJ) 
as the test substance, no clinically or toxicologically significant 
effects were found in any treatment group (MRID 47927831). Therefore, 
the no observed adverse effect level (NOAEL) for PDJ has been 
established as the highest test substance dose, 10,000 parts per 
million (ppm) (equivalent to 566 mg/kg bw/day for male test animals and 
587 mg/kg bw/day for female test animals). A lowest observed adverse 
effect level (LOAEL) was not established, suggesting that the test 
animals could have tolerated a higher dose. In sum, the data submitted 
to the Agency indicate that PDJ has no subchronic toxicological effect.

D. Developmental Toxicity

     In a developmental toxicity study, using the TGAI of PDJ (97.98% 
PDJ) as the test substance (MRID 47927832), there were no treatment-
related effects found at necropsy in maternal animals nor were there 
effects on copra lutei, number of implantations, sex ratio, fetal body 
weight, or preimplantation embryonic mortality. The Agency does not 
consider the transient decrease in body weight or food intake as 
adverse and establishes the NOAEL for this study as 500 mg/kg bw/day. A 
LOAEL was not identified for maternal effects, suggesting that the test 
animals could have tolerated a higher dose. No treatment-related 
developmental effects were found on external examination of the 
fetuses. Visceral examination showed a slight increase in the incidence 
of thymic remnants; however, the increase was within the range of the 
performing laboratories historical control data. Therefore, the Agency 
does not consider this a treatment-related effect. There was also a 
slight increase in the incidence of a 14th rib, a common variation in 
this strain of rat and is therefore not considered an adverse effect. 
It was not accompanied by an increased incidence of abnormal embryos, 
either on external, skeletal, or visceral examination, and did not 
appear at a higher than normal rate. Based on the study results, the 
developmental effects NOAEL for the study is the highest dose tested 
500 mg/kg bw/day. A LOAEL was not identified for developmental effects, 
suggesting that the test animals could have tolerated a higher dose. In 
sum, the data submitted to the Agency indicate that PDJ is not a 
developmental toxicant.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA 
to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).

A. Dietary Exposure

    Dietary exposure to the residues of PDJ is expected to be 
insignificant, even in the event of exposure. Based on subchronic 
toxicity data submitted in support of this petition, the Agency has 
calculated the possibility of dietary exposure and concludes that in a 
worst case scenario, such as no degradation, PDJ residues consumed by a 
70 kg person are four orders of magnitude below the NOAEL that was 
calculated for this compound (EPA, 2010). Moreover, based on the fate 
and distribution data (absorption/desorption, hydrolysis, 
photodegredation in water, and aerobic soil metabolism) submitted by 
the applicant and reviewed by EPA, PDJ, when applied to plant material 
such as fruit and foliage, is expected to degrade rapidly, with 
calculated environmental concentrations ranging from 0.77 to 0.06 ppm 
on the day of application and declining to 0.0 by two days post 
application. In addition, these studies indicate that PDJ is relatively 
unstable in the environment with an aerobic soil half-life of 1.6 - 2.3 
hours, and upon consumption breaks down under gastric condition with a 
half-life of 0.8 days.
    1. Food. PDJ is structurally similar to the naturally occurring 
plant growth regulator JA. JA is naturally present in fruits and 
vegetables at various levels, generally not exceeding 10uM (2ppm), and 
has always been a component of any diet containing plant materials 
(Creelman and Mullet, 1995; Mason et al., 1992). Dietary exposure to 
residues of PDJ via exposure to treated fruit or foliage (e.g. apples) 
is not expected to exist above background levels of

[[Page 50925]]

naturally occurring JA. The maximum application rate of PDJ will be 
0.009 pounds of active ingredient per acre (lbs ai/A) or 200 parts per 
million active ingredient per acre (ppm ai/A). Using the Terrestrial 
Exposure Model (T-REX; USEPA), the Agency calculated that, in a 
theoretical application at the maximum rate, residue levels of PDJ on 
grasses, broadleaf foliage, fruits, pods, and seeds will range from 
0.77 to 0.06 ppm on the day of application and decline to 0.0 ppm by 2 
days post application (EPA, 2010). Given PDJ's expected short-lived 
presence on vegetation, no significant pesticidal residues are 
anticipated for harvested foods. Furthermore, PDJ is relatively 
unstable in the environment with an aerobic soil half-life of 1.6 - 2.3 
hours, and upon consumption breaks down under gastric condition with a 
half-life of 0.8 days.
    2. Drinking water exposure. Exposure of humans to PDJ in drinking 
water is unlikely since products are labeled for application directly 
to terrestrial plants and because data demonstrate a soil half-life for 
this chemical from 1.6-2.3 hours, as well as rapid degradation in water 
(EPA, 2010). Specifically, PDJ is not to be applied directly to water 
or to areas where surface water is present. In addition, the Agency 
estimated environmental concentrations to an aquatic site from PDJ 
runoff (spray to apple trees) using the GENeric Estimated Environmental 
Concentration model (GENEEC; EPA, 2001). The expected concentrations in 
surface water are well below (6 to 7 orders of magnitude) the maximum 
doses used in laboratory testing, where no toxic effects were seen 
(e.g. Acute Oral Toxicity LD50 > 5,000 mg/kg; Developmental 
Toxicity NOAEL > 500 mg/kg).

B. Other Non-Occupational Exposure

    Non-occupational exposure is not expected because PDJ is not 
approved for residential uses. The active ingredient is applied 
directly to commodities and degrades rapidly.
    1. Dermal exposure. Non-occupational dermal exposures to PDJ are 
expected to be negligible because of its directed agricultural use as a 
plant growth regulator applied to red apple varieties pre-harvest. Any 
dermal exposure associated with this experimental use permit is 
expected to be occupational in nature.
    2. Inhalation exposure. Non-occupational inhalation exposures are 
not expected to result from the agricultural uses of PDJ. Any 
inhalation exposure associated with this experimental use permit is 
expected to be occupational in nature.

V. 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 PDJ to share a common mechanism of toxicity with 
any other substances, and PDJ does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that PDJ 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 https://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the 
available information about consumption patterns among infants and 
children, special susceptibility of infants and children to pesticide 
chemical residues, and the cumulative effects on infants and children 
of the residues and other substances with a common mechanism of 
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA 
shall apply an additional tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database unless EPA 
determines that a different margin of safety will be safe for infants 
and children. Margins of exposure (safety), which are often referred to 
as uncertainty factors, are incorporated into EPA risk assessments 
either directly or through the use of a margin of exposure analysis, or 
by using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk.
    The acute, subchronic, and developmental toxicity data discussed in 
Unit III.B. indicate that PDJ has negligible toxicity. In addition, PDJ 
is structurally similar to jasmonic acid, which is ubiquitous in nature 
and present in all fruits and vegetables and for which there is no 
reported history of toxicological incident. Furthermore, based on 
subchronic toxicity data submitted in support of this petition, the 
Agency has calculated the possibility of dietary exposure and concludes 
that in a worst case scenario, such as no degradation, the PDJ residues 
consumed by a 70 kg person are four orders of magnitude below the NOAEL 
that was calculated for this compound (EPA, 2010). Therefore, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the United States population, including infants and children, from 
aggregate exposure to the residues of PDJ. This includes all 
anticipated dietary exposures and all other exposures for which there 
is reliable information. The Agency has arrived at this conclusion 
because the data and information available on PDJ do not demonstrate 
toxic potential to mammals. Thus, there are no threshold effects of 
concern and, as a result, an additional margin of safety is not 
necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

     Through this action, the Agency proposes a temporary exemption 
from the requirement of a tolerance of PDJ when used on red apple 
varieties without any numerical limitations for residues. The Agency 
has determined that residues resulting from PDJ use as a plant growth 
regulator are unlikely, and that there are no significant toxicity 
concerns even in the event that residues of this active ingredient are 
present. As a result, the Agency has concluded that an analytical 
method is not required for enforcement purposes for PDJ.

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 PDJ.

[[Page 50926]]

VIII. Conclusion

    Therefore, a temporary exemption is established for residues of PDJ 
when used on red apple varieties pre-harvest and in accordance with 
good agricultural practices.

IX. References

    1. Creelman, R.A. and J.E. Mullet (1995) Jasmonic acid distribution 
and action in plants: Regulation during development and response to 
biotic and abiotic stress. Proceedings of the National Academies of 
Science, 92: 4114-4119.
    2. EPA (2010) Environmental Protection Agency (EPA) Risk 
Assessment: Application for Experimental-Use Permit and Temporary 
Tolerance Exemption for FAL 1800 (Prohydrojasmon). May 18, 2010.
    3. Mason, H.S., DeWald, D.B., Creelman, R.A., Mullet J.E. (1992) 
Coregulation of Soybean and Vegetative Storage Protein Gene Expression 
by Methyl Jasmonate and Soluble Sugars. Plant Physiology, 98: 859-867.

X. 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 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) (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).

XI. 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: August 6, 2010.
Steven Bradbury,
Director, 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 180.1299 is added to subpart D to read as follows:


Sec.  180.1299  Prohydrojasmon; temporary exemption from the 
requirement of a tolerance.

    A temporary exemption from the requirement of a tolerance is 
established for residues of prohydrojasmon, propyl-3-oxo-2-pentylcyclo-
pentylacetate, when used on red apples varieties pre-harvest and when 
used in accordance with good agricultural practices and will expire on 
August 1, 2012.
[FR Doc. 2010-20177 Filed 8-17-10; 8:45 am]
BILLING CODE 6560-50-S