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[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Rules and Regulations]
[Pages 22789-22794]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08829]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0134; FRL-9382-6]

Methyl Jasmonate; 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 methyl jasmonate in or 
on all food commodities when applied pre-harvest. Becker Underwood, 
Inc. submitted a petition to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA) requesting an exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of methyl jasmonate when applied pre-
harvest.

DATES: This regulation is effective April 17, 2013. Objections and 
requests for hearings must be received on or before June 17, 2013, 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-2012-0134, 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: Chris Pfeifer, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 308-0031; email 
address: pfeifer.chris@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. To access the OCSPP test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''

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

[[Page 22790]]

proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2012-0134 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 June 17, 2013. 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-2012-0134, 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.htm. 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 May 2, 2012 (77 FR 25957) (FRL-9346-1), 
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 
1F7941) by Becker Underwood, Inc.; 801 Dayton Avenue, Ames, IA 50010. 
The petition requested that 40 CFR part 180 be amended by establishing 
an exemption from the requirement of a tolerance for residues of methyl 
jasmonate. That document referenced a summary of the petition prepared 
by the petitioner Becker Underwood, 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 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 available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children.
    Methyl jasmonate is a biochemical pesticide active ingredient 
intended for use as a systemic acquired resistance (SAR) inducer on a 
variety of agricultural crops. It is applied pre-harvest as a seed 
treatment and an in-furrow soil treatment. Methyl jasmonate is a 
naturally occurring biochemical hormone found in most plants. It acts 
by eliciting plant defense responses in vulnerable seedlings. Methyl 
jasmonate is the principal compound of a class of plant hormones known 
as jasmonates, which are common to most plants but particularly 
concentrated in jasmine and honeysuckle. As a group, jasmonates are 
known to trigger plant responses to a variety of stresses. Methyl 
jasmonate, in particular, is known to bolster plant defenses against 
extreme temperature changes and attacks by insects, fungi and bacteria. 
It has a non-toxic mode of action and is present in most fruits, with 
especially high concentrations in apples and strawberries. As such, it 
is already a normal part of the human diet.
    With regard to dietary risks related to pesticidal use, EPA has 
determined that the information submitted by the applicant satisfies 
the required human health assessment data requirements and demonstrates 
that any potential residues of methyl jasmonate in or on foods do not 
pose a toxicological risk. First, methyl jasmonate is a ubiquitous and 
naturally occurring plant hormone that is already regarded as a safe 
and natural part of the human diet through such commonly consumed 
fruits as apples and strawberries (Memorandum from Miachel Rexrode, 
Ph.D., July 19, 2012). Data demonstrate that humans, including infants, 
regularly ingest methyl jasmonate in fruits and plants at much higher 
levels than what can be expected to be ingested from the pesticidal use 
of this active ingredient (Memorandum from Miachel Rexrode, Ph.D., July 
19, 2012). Second, the toxicity data demonstrate that methyl jasmonate 
is virtually non-toxic to humans and other non-target organisms, 
through all routes of exposure, including oral (Memorandum from Miachel 
Rexrode, Ph.D., July 19, 2012). Third, methyl jasmonate has been 
assessed and approved by Food and Agriculture Organization/World Health 
Organization (FAO/WHO) as a food additive (JECFA, 2005). Their robust 
assessment concluded that methyl jasmonate was non-toxic as a food 
additive, establishing a threshold of 540 microgram/day (ug/day), far 
above the maximum anticipated pesticidal residues of 373 ug ai/kg of 
seed (JECFA, 2005). Fourth, no toxicological endpoints have been 
identified for methyl jasmonate through any route of exposure 
(Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). Fifth, methyl 
jasmonate's non-toxic mode of action has been well established 
(Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). Further, 
methyl jasmonate biodegrades readily within four weeks (Memorandum from 
Miachel Rexrode, Ph.D., July 19, 2012). Because applications 
necessarily occur early in

[[Page 22791]]

the growing season due to its mode of action as a SAR inducer on seeds 
and seedlings, no significant pesticidal residues are anticipated for 
any harvested foods. Data show that any potential exposures are 
expected to be well within the range of exposures that would occur 
naturally, and are therefore not of concern (Memorandum from Miachel 
Rexrode, Ph.D., July 19, 2012). For all of the foregoing reasons, EPA 
finds that methyl jasmonate is virtually non-toxic and poses no dietary 
risks to humans.
    Summaries of the toxicological data submitted in support of this 
exemption from the requirement of a tolerance follow:

A. Acute Toxicity

    Acute toxicity studies, submitted to support the registration of 
the products containing methyl jasmonate, confirm a virtually non-toxic 
profile and support the finding that this active ingredient poses no 
significant human health risk with regard to new food uses. The acute 
toxicity data show virtual non-toxicity for all routes of exposure and 
suggest that any dietary risks associated with this naturally occurring 
plant hormone would be inconsequential.
    1. The acute oral median lethal doses (LD50s) in rats 
were greater than 3,129 milligrams per kilogram (mg/kg) and confirmed 
virtual non-toxicity through the oral route of exposure. There were no 
observed toxicological effects on the test subjects in the acute oral 
study submitted (Master Record Identification Number (MRID No.) 
48653901). Methyl jasmonate is Toxicity Category III for acute oral 
toxicity.
    2. The acute dermal median lethal dose (LD50) in rats 
was greater than 5,050 mg/kg. There were no clinical signs of toxicity 
or dermal irritation throughout the study. The data substantiate methyl 
jasmonate's virtual non-toxicity through the dermal route of exposure. 
(MRID No. 48653902). Methyl jasmonate is Toxicity Category IV for acute 
dermal toxicity.
    3. The acute inhalation median lethal concentration 
(LC50) was greater than 2.23 milligrams per liter (mg/L) in 
rats and showed no consequential inhalation toxicity (MRID No. 
48653903). Methyl jasmonate is Toxicity Category III for acute 
inhalation toxicity.
    4. A skin irritation study on rabbits indicated that methyl 
jasmonate was not irritating to the skin (MRID No. 48653905). Methyl 
jasmonate is Toxicity Category IV for dermal irritation.
    5. Data indicated methyl jasmonate is not a dermal sensitizer (MRID 
No. 48653906).
    Data indicate that methyl jasmonate is not acutely toxic. No toxic 
endpoints were established in any of the acute toxicity studies, and no 
significant toxicological effects were observed in any of the acute 
toxicity studies.

B. Subchronic Toxicity

    Based on its biodegradation properties, residues of methyl 
jasmonate are not expected to result in significant dietary exposure 
beyond the levels expected in background dietary exposures. Sufficient 
information (MRID No. 48653908) on methyl jasmonate was submitted to 
satisfy requirements for subchronic toxicity testing [i.e., 90-day Oral 
(OCSPP 870.3100), 90-day Inhalation (OCSPP 870.3465), and 90-day Dermal 
(OCSPP 870.3250)]. The information submitted was found acceptable based 
on the toxicological and exposure profile of methyl jasmonate, 
summarized below.
    Methyl jasmonate is a naturally occurring compound found in fruits 
and other plants and is already consumed in the human diet. This 
compound has a history of safe dietary exposure (Memorandum from 
Miachel Rexrode, Ph.D., July 19, 2012). The proposed use pattern of 
this active ingredient results in exposure levels that are lower than 
the current estimated dietary exposure (Memorandum from Miachel 
Rexrode, Ph.D., July 19, 2012). Oral exposure of children and adults to 
methyl jasmonate calculated from food consumption information from the 
U.S. EPA Exposure Factors Handbook (U.S. EPA, 2009) were found to be 
less than the residues resulting from a maximum application. Methyl 
jasmonate was reviewed by the Joint FAO/WHO Expert Committee on Food 
Additives (JECFA, 2005) and was identified as a non-toxic flavoring 
agent. Methyl jasmonate is not known or expected to be metabolized 
differently following exposure by the dermal route than the oral route, 
and a literature search yielded no reports of subchronic dermal 
toxicity effects in rodents or humans from methyl jasmonate exposure 
(Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). Prolonged 
dermal exposure is not expected because the product is not purposely 
applied to the skin and because handlers and applicators are required 
to wear appropriate personal protective equipment (PPE). There is a 
long history of safe inhalation exposure to methyl jasmonate because it 
is a naturally occurring volatile component of common plants. The 
potential inhalation exposure concentration from use of products 
containing methyl jasmonate will be less than or equal to naturally 
occurring concentrations from crops and other plants (Memorandum from 
Miachel Rexrode, Ph.D., July 19, 2012). Significant exposure to humans 
is not anticipated based on low application rates and, more 
importantly, rapid degradation in the environment (Memorandum from 
Miachel Rexrode, Ph.D., July 19, 2012).

C. Developmental Toxicity and Mutagenicity

    The applicant provided adequate information (MRID No. 48653908) to 
fulfill the developmental toxicity and mutagenicity data requirements 
[i.e., Prenatal Development (OCSPP 870.3700), Bacterial Reverse 
Mutation Test (OCSPP 870.5100), In vitro Mammalian Chromosome 
Aberration (OCSPP 870.5375), and In vitro Mammalian Cell Assay (OCSPP 
870.5300)]. The submitted information is sufficient to confirm that 
there are no expected dietary or non-occupational risks of mutagenicity 
with regard to new food uses. The information submitted was found 
acceptable based on the toxicological and exposure profile of methyl 
jasmonate, summarized below.
    There is a long history of safe dietary exposure to methyl 
jasmonate because it naturally occurs in apples, strawberries and 
mangos (Lalel et al., 2003), fruits that are part of the normal diet. 
The potential oral exposure to methyl jasmonate from the proposed uses 
of methyl jasmonate is well below the average exposure for women of 
child-bearing age from the consumption of fruits that naturally contain 
methyl jasmonate, and also well below the Joint FAO/WHO Expert 
Committee on Food Additives (JECFA) human exposure threshold (Munro, 
1999). Methyl jasmonate has been evaluated for safety by the FAO and 
determined to be metabolized to innocuous end products that are 
eliminated in the urine (Lalel et al., 2003). A literature search 
yields no reports of genotoxicity in laboratory studies on methyl 
jasmonate (Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). 
Significant exposure to child-bearing women is not anticipated based on 
low application rates, appropriate PPE requirements on the label, and 
rapid degradation in the environment.

D. Effects on Endocrine Systems

    There is no available evidence demonstrating that methyl jasmonate 
is an endocrine disruptor in humans. As a result, the Agency is not 
requiring information on the endocrine effects of methyl jasmonate at 
this time. However, the Endocrine Disruption Screening Program (EDSP) 
has established a protocol which guides the Agency in

[[Page 22792]]

selecting suspect ingredients for review, and the Agency reserves the 
right to require new information should the program require it. 
Presently, based on the lack of exposure and the virtually non-toxic 
profile of methyl jasmonate, no adverse effects to the endocrine are 
known or expected. Overall, the lack of evidence of endocrine 
disruption is consistent with methyl jasmonate's negligible toxicity 
profile and supports this exemption from the requirement of a 
tolerance.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in or on 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

    Because of methyl jasmonate's ability to biodegrade quickly 
relative to the time it is to be applied on seeds or to soil near 
planting, the Agency does not anticipate significant residues being 
present in or on food at the time of consumption. Moreover, any 
residues that are present in or on food at the time of consumption as a 
result of pesticide use are likely to be indistinguishable from 
naturally occurring methyl jasmonate due to its ubiquitous presence in 
plants. Finally, the Agency believes that it is unlikely that any 
exposure to the residues of methyl jasmonate will result in dietary 
risks because of the non-toxic mode of action as a SAR inducer and the 
pesticide's virtually non-toxic profile.
    1. Food. Exposure to residues of methyl jasmonate on foods is 
expected to be negligible. The application of methyl jasmonate is made 
directly to seeds through a contained seed-treatment or through in-
furrow or soil drench applications. This application scenario prevents 
drift and minimizes exposure to humans. Although applications will 
result in minimal exposure, the Agency has calculated that exposures 
associated with maximum application rates are still lower than the 
current estimated dietary exposure for regular fruit consumption 
(Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). Further, the 
data indicate that methyl jasmonate is readily biodegradable within 
four weeks (Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). 
Because applications necessarily occur early in the growing season due 
to its mode of action as a SAR inducer on seeds and seedlings, no 
significant pesticidal residues are anticipated for any harvested 
foods. However, in the event of exposure to residues of methyl 
jasmonate, no dietary risks are anticipated. As described in Unit III, 
acute, subchronic, mutagenic and developmental studies and information 
support its nontoxic profile. Furthermore, it is already present in the 
human fruit and vegetable diet without any known detrimental effects. 
There is no information in the public literature suggesting any health 
issues to either animals or plants relative to this compound. It is 
estimated that humans consume at least .348 ug/day on average, based on 
EPA models for apple and strawberry consumption (Memorandum from 
Miachel Rexrode, Ph.D., July 19, 2012). Finally, the dietary use of 
methyl jasmonate as a food additive was approved by the Joint FAO/WHO 
Expert Committee on Food Additives, which found methyl jasmonate to be 
non-toxic at a conservative threshold of 540 ug/day. (JECFA, 2005). By 
comparison, maximum residues have been calculated to be 373 ug ai/kg of 
seed (Memorandum from Miachel Rexrode, Ph.D., July 19, 2012). In sum, 
minimal dietary exposure is expected; however, any potential dietary 
exposures would not be expected to pose any consequential risk, mainly 
due to methyl jasmonate's virtually non-toxic profile.
    2. Drinking water exposure. Residues of methyl jasmonate are not 
expected to be present in drinking water because applications of methyl 
jasmonate are made directly to seeds, seedlings and soil. Methyl 
jasmonate residues are not expected to percolate through the soil 
because residues are not expected to persist beyond the time it would 
typically take for any residues to percolate into the groundwater. 
Nonetheless, given methyl jasmonate's virtually non-toxic profile as 
described in Unit III, risks from aquatic exposure would be negligible.

B. Other Non-Occupational Exposure

    Non-occupational exposure is not expected because methyl jasmonate 
is intended for commercial use. The active ingredient is applied 
directly to seeds or agricultural furrows, and it degrades rapidly. 
Further, health risks are not expected from any pesticidal exposure to 
this active ingredient, no matter the circumstances. A February, 2013 
Agency risk assessment of methyl jasmonate establishes that even a 
worst case exposure scenario involving prolonged and regular 
occupational exposures, which are not associated with this active 
ingredient, would pose negligible risks (Methyl Jasmonate BRAD, 
February 28, 2013). Methyl jasmonate is characterized by its 
biodegradability; low toxicity profile; nontoxic, SAR-inducing mode of 
action; and demonstrable lack of dietary effects.
    1. Dermal exposure. Non-occupational dermal exposures to methyl 
jasmonate are expected to be negligible because of its directed 
agricultural use. Even in the event of dermal exposure to residues, the 
nontoxic profile of methyl jasmonate (as described in Unit III) is not 
expected to result in any risks through this route of exposure.
    2. Inhalation exposure. Non-occupational inhalation exposures are 
not expected to result from the agricultural uses of methyl jasmonate. 
Any inhalation exposure associated with this new agricultural and 
commercial use pattern 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 methyl jasmonate to share a common mechanism of 
toxicity with any other substances, and methyl jasmonate does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
methyl jasmonate 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

    Health risks to humans, including infants and children, are 
considered negligible with regard to the pesticidal use of methyl 
jasmonate. As illustrated in Unit III, acute toxicity studies indicate 
that methyl jasmonate is virtually non-toxic. It is ubiquitous in 
nature and present in fruits and vegetables. There is no history of any 
toxicological incident involving its

[[Page 22793]]

consumption, and its use in food supplements is already allowed by the 
United States Food and Drug Administration. For all of these reasons, 
the Agency has determined that this food use of methyl jasmonate poses 
no foreseeable risks to human health or the environment. Thus, there is 
a reasonable certainty of no harm to the general U.S. population, 
including infants and children, from exposure to this active 
ingredient.

A. U.S. Population

    The Agency has determined that there is a reasonable certainty that 
no harm will result from aggregate exposure to residues of methyl 
jasmonate to the U.S. population. This includes all anticipated dietary 
exposures and other non-occupational exposures for which there is 
reliable information. The Agency arrived at this conclusion based on 
the low levels of mammalian dietary toxicity associated with methyl 
jasmonate, the natural ubiquity of methyl jasmonate in food, and 
information suggesting that the pesticidal use of methyl jasmonate will 
not result in significant exposure. For these reasons, the Agency has 
determined that methyl jasmonate residues in and on all food 
commodities will be safe, and that there is a reasonable certainty that 
no harm will result from aggregate exposure to residues of methyl 
jasmonate.

B. 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 exposure (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 the EPA determines that a different margin of exposure (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.
    Based on all the information evaluated for methyl jasmonate, the 
Agency concludes that 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 since 
the Agency 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 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 methyl jasmonate.

VIII. Conclusions

    Therefore, an exemption is established for residues of methyl 
jasmonate in or on all food commodities when applied preharvest.

IX. References

    Complete citations to the references used in this document are set 
forth in Appendix C to the document captioned ``Methyl Jasmonate BRAD 
(Biopesticides Registration Action Document) Methyl Jasmonate PC Code: 
028100'' (document ID number EPA-HQ-OPP-2012-0134-0006), found in the 
OPP docket listed under docket ID number EPA-HQ-OPP-2012-0134, and may 
be seen by accessing the www.regulations.gov Web site.

 X. 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 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).

[[Page 22794]]

XI. 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: March 22, 2013.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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 180.1320 is added to subpart D to read as follows:

Sec.  180.1320  Methyl jasmonate; exemption from the requirement of a 
tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of methyl jasmonate in or on all food commodities when methyl 
jasmonate is applied pre-harvest.

[FR Doc. 2013-08829 Filed 4-16-13; 8:45 am]
BILLING CODE 6560-50-P
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