Document ID: EPA-HQ-OPP-2010-0048-0006
Agency: epa
Document Type: Rule
Title: Temporary Exemptions From Requirements of a Tolerance: Prohydrojasmon
Posted Date: 2012-05-18T04:00Z

[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Rules and Regulations]
[Pages 29548-29552]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12106]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0048; FRL-9347-9]

Prohydrojasmon; Amendment of Temporary Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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).

[[Page 29549]]

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 
address: burnett.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 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://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

[[Page 29550]]

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 
18, 2010).

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, 
2010).

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 
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 Web site at http://www.epa.gov/pesticides/cumulative.

[[Page 29551]]

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 
necessary.

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), 
propyl-3-oxo-2-pentylcyclo-pentylacetate.

VIII. Conclusion

    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, 
2014.

IX. References

    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, 
98: 859-867.
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

[[Page 29552]]

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).

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: May 3, 2012.
Keith Mathews,
Director, Biopesticides and Pollution Prevention Division, 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 180.1299 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]
BILLING CODE 6560-50-P