[Federal Register Volume 75, Number 159 (Wednesday, August 18, 2010)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20177]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Temporary Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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 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)
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
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
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 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-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: 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. 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, http://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
A. Acute Toxicity
Acute toxicity studies on the technical grade active ingredient
(TGAI) for PDJ, containing 97.98% PDJ, confirm
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
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
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
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
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 http://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
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.
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.
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: August 6, 2010.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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