
[Federal Register Volume 78, Number 238 (Wednesday, December 11, 2013)]
[Rules and Regulations]
[Pages 75254-75257]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29561]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0832; FRL-9398-1]


Prohydrojasmon; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the biochemical pesticide prohydrojasmon 
(PDJ) when used as a plant growth regulator in or on apple and grape 
pre-harvest, in accordance with label directions and good agricultural 
practices. This regulation eliminates the need to establish a maximum 
permissible level for residues of PDJ.

DATES: This regulation is effective December 11, 2013. Objections and 
requests for hearings must be received

[[Page 75255]]

on or before February 10, 2014, 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-2012-0832, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., 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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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-
2012-0832 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 February 10, 2014. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0832, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at  http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of January 9, 2013, (78 FR 1798) (FRL-9374-
2), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 
2F8056) by Fine Agrochemicals Ltd. (the petitioner), on behalf of 
SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192. The petition 
requested that 40 CFR 180.1299 be amended by establishing an exemption 
from the requirement of a tolerance for residues of PDJ, propyl-3-oxo-
2-pentylcyclo-pentylacetate, in or on red apples and grapes. The notice 
referenced a summary of the petition prepared by the petitioner, which 
is available in the docket, http://www.regulations.gov. No substantive 
comments were 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 of 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 FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C), 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, FFDCA section 408(b)(2)(D) 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 FFDCA section 408(b)(2)(D), 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

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available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.

A. Overview of PDJ

    PDJ is a synthetically made 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 jasmonates, 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. The highest levels of 
naturally occurring JA are found in actively growing plant tissues such 
as leaves, flowers, and developing fruit, 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. See the document entitled, ``Federal Food, 
Drug, and Cosmetic Act (FFDCA) Considerations for Prohydrojasmon (PDJ), 
propyl-3-oxo-2-pentylcyclo-pentylacetate'' (July 16, 2013), available 
in the docket for this action.

B. Biochemical Pesticide Toxicology Data Requirements

    All applicable mammalian toxicology data requirements supporting 
the petition to exempt residues of PDJ from the requirement of a 
tolerance in or on apple and grape pre-harvest have been fulfilled. 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. There 
are no known effects on endocrine systems via oral, dermal, or 
inhalation routes of exposure. For a full discussion of the data upon 
which EPA relied, and its human health risk assessment based on that 
data, please refer to the document entitled, ``Federal Food, Drug, and 
Cosmetic Act (FFDCA) Considerations for Prohydrojasmon (PDJ), propyl-3-
oxo-2-pentylcyclo-pentylacetate'' (July 16, 2013). This document, as 
well as other relevant information, is available in the docket for this 
action as described under ADDRESSES.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 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

    The proposed use patterns may result in dietary exposure to PDJ; 
however, exposure to residues on treated fruit or foliage is not 
expected to exist above background levels of naturally occurring JA 
(see document entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) 
Considerations for Prohydrojasmon (PDJ), propyl-3-oxo-2-pentylcyclo-
pentylacetate'' (July 16, 2013)). No significant exposure via drinking 
water is expected; PDJ is applied at low rates, rapidly degrades, and 
is not directly applied to water. Should exposure occur, however, 
minimal to no risk is expected for the general population, including 
infants and children, due to the low toxicity of PDJ as demonstrated in 
the data submitted and evaluated by the Agency, as fully explained in 
the document entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) 
Considerations for Prohydrojasmon (PDJ), propyl-3-oxo-2-pentylcyclo-
pentylacetate'' (July 16, 2013).

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.

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 or exemption, 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 determined PDJ to have a non-toxic mode of action, and the 
compound does not appear to produce any toxic metabolites. For the 
purposes of this tolerance action, therefore, the EPA has assumed that 
PDJ does not have a common mechanism of toxicity with other substances. 
Following from this, the EPA concludes that there are no cumulative 
effects associated with PDJ that need to be considered. 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

    Section 408(b)(2)(C) of FFDCA provides that, in considering the 
establishment of a tolerance or tolerance exemption for a pesticide 
chemical residue, 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 ten-
fold (10x) margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the database on toxicity and exposure, unless EPA 
determines that a different margin of safety will be safe for infants 
and children. This additional margin of safety is commonly referred to 
as the Food Quality Protection Act Safety Factor. In applying this 
provision, EPA either retains the default value of 10x, or uses a 
different additional or no safety factor when reliable data are 
available to support a different additional or no safety factor.
    As part of its qualitative assessment, EPA evaluated the available 
toxicity and exposure data on PDJ and considered its validity, 
completeness, and reliability, as well as the relationship of this 
information to human risk. EPA considers the toxicity database to be 
complete and has identified no residual uncertainty with regard to 
prenatal and postnatal toxicity or exposure. No hazard was identified 
based on the available studies, as fully explained in the document 
entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations 
for Prohydrojasmon (PDJ), propyl-3-oxo-2-pentylcyclo-pentylacetate'' 
(July 16, 2013). Based upon its evaluation, EPA concludes that there 
are no threshold effects of concern to infants, children, or adults 
when PDJ is applied as a plant growth regulator to stimulate fruit 
ripening, and used in accordance with label directions and good 
agricultural practices. As a result, EPA concludes that no additional 
margin of exposure (safety) is necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes for 
the same reasons that EPA did not apply an extra 10x margin of safety, 
discussed in Unit VI., and because EPA is establishing an exemption 
from the requirement of a

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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 United Nations 
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.

VIII. Conclusion

    EPA 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 residues of PDJ. EPA is therefore 
establishing an exemption from the requirement of a tolerance for 
residues of PDJ when used as a plant growth regulator in or on apple 
and grape pre-harvest, in accordance with label directions and good 
agricultural practices.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d) 
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 FFDCA section 408(d), such as the tolerance 
exemption 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

X. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: October 25, 2013.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Revise Sec.  180.1299 to read as follows:


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

    An exemption from the requirement of a tolerance is established for 
residues of the biochemical pesticide prohydrojasmon (PDJ), propyl-3-
oxo-2-pentylcyclo-pentylacetate, when used as a plant growth regulator 
in or on apple and grape pre-harvest, in accordance with label 
directions and good agricultural practices.

[FR Doc. 2013-29561 Filed 12-10-13; 8:45 am]
BILLING CODE 6560-50-P


