[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12106]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Prohydrojasmon; Amendment of Temporary Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation revises the temporary exemption from the
requirement of a tolerance for residues of Prohydrojasmon (PDJ),
propyl-3-oxo-2-pentylcyclo-pentylacetate, by including grapes and
extending the date of expiration of the temporary tolerance exemption
from August 1, 2012, to August 1, 2014, when used as a plant growth
regulator pre-harvest and in accordance with good agricultural
practices and with the terms of Experimental Use Permit (EUP) No.
62097-EUP-1. Fine Agrochemicals, Ltd., submitted a petition to the U.S.
Environmental Protection Agency (EPA or the Agency) under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting the amendment to the
temporary tolerance exemption.
DATES: This regulation is effective May 18, 2012. Objections and
requests for hearings must be received on or before July 17, 2012, 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2010-0048; FRL-9347-9, is
available either electronically through http://www.regulations.gov or
in hard copy at the OPP Docket in the Environmental Protection Agency
Docket Center (EPA/DC), located in EPA West, Rm. 3334, 1301
Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is (202) 566-1744, and the telephone number for the OPP Docket is
(703) 305-5805. Please review the visitor instructions and additional
information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Gina Burnett, 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; email
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
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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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
July 17, 2012. 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 online 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 February 15, 2012, (77 FR 8755) (FRL-
9335-3), 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 1G7947) by Fine Agrochemicals, Ltd., c/o SciReg, Inc.,
12733 Director's Loop, Woodbridge, VA 22192. The petition requested
that 40 CFR 180.1299 be amended by including grapes in the temporary
exemption from the requirement of a tolerance for residues of
Prohydrojasmon (PDJ), propyl-3-oxo-2-pentylcyclo-pentylacetate, and
that the expiration date for the tolerance exemption be extended by 2
years in order to coincide with a 2-year extension of the petitioner's
Experimental Use Permit (EUP) for this biochemical. The petitioner
requests the tolerance exemption expiration date extension and EUP
extension in order to better assess the effects of application timing,
geography, and apple variety on efficacy (color enhancement). Fewer red
apple sites will be treated as compared to the two initial growing
seasons (2010 and 2011), but more acres will be treated per site,
increasing statistical power and confidence, and providing the
applicant with more useful data. Under the EUP extension, the
petitioner will also be approved to test PDJ on grapes. This notice
referenced a summary of the petition prepared by the petitioner, Fine
Agrochemicals, Ltd., which is available in the docket via 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.
The Agency established a temporary tolerance exemption for PDJ in a
Final Rule published in the Federal Register on August 18, 2010, (75 FR
50922-50926) (FRL-8839-4), to coincide with the approval of an
Experimental Use Permit (EUP) granted to Fine Agrochemicals, Ltd. The
temporary tolerance exemption supported uses on red apple varieties,
and will expire on August 1, 2012. This amendment proposes to expand
the crops covered by including grapes, and by extending the expiration
date of the tolerance exemption to August 1, 2014, to coincide with the
extension of the petitioner's EUP for the same time period. Since the
establishment of the temporary tolerance exemption, no new toxicology
data have been generated. As such, the toxicological profile as stated
in the August 18, 2010, issue of the Federal Register, and referenced
herein, has not changed. Copies of the August 18, 2010, document (75 FR
50922-50926), and the studies cited therein, are located under docket
identification (ID) number EPA-HQ-OPP-2010-0048.
As discussed in the August 18, 2010, Federal Register, (75 FR
50923), PDJ is a synthetic plant growth regulator that is structurally
similar and functionally identical to jasmonic acid (JA), a naturally
occurring plant regulator present in all vascular 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 (Ref. 1). The highest levels of
naturally occurring JA are found in actively growing plant tissues such
as leaves, flowers, and developing fruit (Refs. 1 and 3), 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 because it is
structurally similar and functionally identical to naturally occurring
JA. Studies submitted by the applicant in support of this temporary
exemption from the requirement of a tolerance, and reviewed by the
Agency, indicate that PDJ is not acutely toxic. These studies and the
Agency's conclusions are summarized at 75 FR 50922-50926, August 18,
2010. Specifically, no toxic endpoints were established, and no
significant toxicological effects were observed in any of the acute
toxicity studies (75 FR 50923-50924, August 18, 2010). In addition,
studies submitted indicate that PDJ is not genotoxic, has no subchronic
toxic effects, and is not a developmental toxicant (75 FR 50924, August
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 residues of PDJ is expected to be
insignificant, even in the event of exposure. In a worst case scenario,
such as no degradation of the applied compound, PDJ residues consumed
by a 70 kg person are four orders of magnitude below the No Observed
Adverse Effect Level (NOAEL) that was calculated for this compound (75
FR 50924, August 18, 2010).
1. Food. PDJ is structurally similar to the naturally occurring
plant growth regulator jasmonic acid (JA). JA is naturally present in
fruits and vegetables at various levels, generally not exceeding 2
parts per million (ppm), and has always been a component of any diet
containing plant materials (Refs. 1 and 2). Dietary exposure to
residues of PDJ via exposure to treated fruit or foliage is not
expected to exist above background levels of naturally occurring JA (75
FR 50924-50925, August 18, 2010).
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
(Ref. 3). In addition, 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 milligrams per kilogram (mg/kg);
developmental toxicity NOAEL > 500 mg/kg) (75 FR 50925, August 18,
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
not expected because the compound is intended only for agricultural use
as a plant growth regulator applied to apples and grapes 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 Web site 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.
Relevant data and information indicate that PDJ has negligible
acute, subchronic, and developmental toxicity (75 FR 50922-25, August
18, 2010). In addition, PDJ is structurally similar to jasmonic acid,
which is present in all fruits and vegetables and for which there is no
reported history of toxicological incident (EPA, 2010). Therefore, the
Agency concludes that there is a reasonable certainty that no harm will
result to the U.S. 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
An analytical method is not required for enforcement purposes for
the reasons stated above and because EPA is establishing an exemption
from the requirement of a tolerance without any numerical limitation.
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 Prohydrojasmon (PDJ),
The Agency acknowledges the need to extend the temporary tolerance
exemption to coincide with the approved extension of Fine Agrochemical,
Ltd.'s EUP for PDJ. In addition, the Agency concludes that there is a
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to the residues
of PDJ. Therefore, the temporary exemption is amended for residues of
PDJ on red apples to include grapes, when used pre-harvest as a plant
growth regulator, in accordance with good agricultural practices and
with the terms of EUP No. 62097-EUP-1, and will expire on August 1,
The references used in this document are in the OPP docket listed
under docket ID EPA-HQ-OPP-2010-0048, and may be seen by accessing the
regulatory.gov Web site.
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. 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,
3. EPA (2010) Environmental Protection Agency (EPA) Risk Assessment:
Application for Experimental-Use Permit and Temporary Tolerance
Exemption for FAL 1800 (Prohydrojasmon). May 18, 2010.
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) (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
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: May 3, 2012.
Director, Biopesticides and Pollution Prevention Division, Office of
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 revised 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 as a plant growth regulator on red apples
varieties and grapes pre-harvest, in accordance with good agricultural
practices and the terms of Experimental Use Permit No. 62097-EUP-1, and
will expire on August 1, 2014.
[FR Doc. 2012-12106 Filed 5-17-12; 8:45 am]
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