Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Rules and Regulations 22789 

The corrections do not involve 

changes to the technical standards 

related to test methods or monitoring 

methods; thus, the requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272) do not 

apply. 

The corrections also do not involve 

special consideration of environmental 

justice-related issues as required by EO 

12898, Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (SBREFA), 

generally provides that before a rule 

may take effect, the agency 

promulgating the rule must submit a 

rule report, which includes a copy of 

the rule, to each House of the Congress 

and to the Comptroller General of the 

United States. A major rule cannot take 

effect until 60 days after it is published 

in the Federal Register. 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 

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 80 

Environmental protection, 

Administrative practice and procedure, 

Agriculture, Air pollution control, 

Confidential business information, 

Diesel fuel, Energy, Forest and forest 

products, Fuel additives, Gasoline, 

Imports, Labeling, Motor vehicle 

pollution, Penalties, Petroleum, 

Reporting and recordkeeping 

requirements. 

Dated: April 8, 2013. 

Gina McCarthy, 

Assistant Administrator, Office of Air and 

Radiation. 

40 CFR part 80 is amended as follows: 

PART 80—[AMENDED] 

■ 1. The authority citation for part 80 

continues to read as follows: 

Authority: 42 U.S.C. 7414, 7521(1) and 

7601(a). 

■ 2. Section 80.1454 (k)(1) introductory 

text and (k)(2) introductory text are 

revised to read as follows: 

§ 80.1454 What are the recordkeeping 

requirements under the RFS program? 

* * * * * 

(k)(1) Biogas and electricity in 

pathways involving feedstocks other 

than grain sorghum. A renewable fuel 

producer that generates RINs for biogas 

or electricity produced from renewable 

biomass (renewable electricity) for fuels 

that are used for transportation pursuant 

to § 80.1426(f)(10) and (11), or that uses 

process heat from biogas to generate 

RINs for renewable fuel pursuant to 

§ 80.1426(f)(12) shall keep all of the 

following additional records: 

* * * * * 

(2) Biogas and electricity in pathways 

involving grain sorghum as feedstock. A 

renewable fuel producer that produces 

fuel pursuant to a pathway that uses 

grain sorghum as a feedstock shall keep 

all of the following additional records, 

as appropriate: 

* * * * * 

[FR Doc. 2013–09068 Filed 4–16–13; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 


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22790 Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Rules and Regulations 

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 preharvest as a seed treatment and an infurrow 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 


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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 childbearing 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 


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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 nonoccupational 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 seedtreatment 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. Nonoccupational 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. Nonoccupational 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 


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Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Rules and Regulations 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). 


erowe on DSK2VPTVN1PROD with RULES
22794 Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Rules and Regulations 

1See 42 CFR 88.17(a)(2)(i). 

2STAC [World Trade Center Health Program 

Scientific/Technical Advisory Committee) [2012]. 

Letter from Elizabeth Ward, Chair to John Howard, 

MD, Administrator. This letter is included in 

NIOSH Docket 257, http://www.cdc.gov/niosh/ 

docket/archive/docket257.html. 

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 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.1320 is added to 

subpart D to read as follows: 

§ 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 88 

World Trade Center Health Program; 

Certification of Breast Cancer in WTC 

Responders and Survivors Exposed to 

PCBs 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Change in certification 

requirements. 

SUMMARY: On September 12, 2012, HHS 

published a final rule in the Federal 

Register adding certain types of cancer 

to the List of World Trade Center 

(WTC)-Related Health Conditions (List) 

established in the WTC Health Program 

regulation. Breast cancer was included 

on the List, although only individuals 

experiencing nighttime sleep disruption 

as a result of response and cleanup 

activities involving shiftwork are 

currently considered to have 

experienced exposure relevant for 

certification. A recent publication in 

The Lancet Oncology by the 

International Agency for Research on 

Cancer (IARC) concludes that there is 

limited evidence that polychlorinated 

biphenyls (PCBs) cause breast cancer in 

humans. As described below, the WTC 

Program Administrator (Administrator) 

has found that PCBs were present in 

WTC dust in the New York City disaster 

area and, accordingly, the Program will 

now certify breast cancer in eligible 

WTC responders and survivors who 

were exposed to either shiftwork/ 

nighttime sleep disruption or PCBs as a 

result of the 9/11 attacks. 

DATES: This change in certification 

requirements is effective April 17, 2013. 

FOR FURTHER INFORMATION CONTACT: Paul 

Middendorf, Senior Health Scientist, 

1600 Clifton Rd. NE., MS: E–20, Atlanta, 

GA 30329; telephone (404)498–2500 

(this is not a toll-free number); email 

pmiddendorf@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

A. Background 

On September 7, 2011, the 

Administrator received a written 

petition to add cancers to the List of 

WTC-Related Health Conditions in 42 

CFR 88.1 (Petition 001). On October 5, 

2011, the Administrator formally 

exercised his option to request a 

recommendation from the WTC Health 

Program Scientific/Technical Advisory 

Committee (STAC) regarding the 

petition.1 The Administrator requested 

that the STAC ‘‘review the available 

information on cancer outcomes 

associated with the exposures resulting 

from the September 11, 2001, terrorist 

attacks, and provide advice on whether 

to add cancer, or a certain type of 

cancer, to the List specified in the 

Zadroga Act.’’ Following three public 

meetings where the Committee 

deliberated on the issues, the STAC 

submitted its recommendation on 

Petition 001 to the Administrator on 

April 2, 2012. After considering the 

STAC’s recommendation, the 

Administrator issued a notice of 

proposed rulemaking on June 13, 2012 

[77 FR 35574]. On September 12, 2012, 

HHS published a final rule in the 

Federal Register adding certain types of 

cancer to the List of WTC-Related 

Health Conditions in 42 CFR 88.1 [77 

FR 56138]. On October 12, 2012, HHS 

published a Federal Register notice to 

correct errors in Table 1 of the final rule 

(the list of cancers covered by the 

Program) [77 FR 62167]. 

B. Administrator’s Determination on 

the Inclusion of Female Breast Cancer 

In the final rule, the Administrator 

established a four-pronged Methodology 

for evaluating whether to add certain 

types of cancer to the List: 

Epidemiologic Studies of September 11, 

2001 Exposed Populations (Method 1); 

Established Causal Associations 

(Method 2); Review of Evaluations of 

Carcinogenicity in Humans, requiring 

both Published Exposure Assessment 

Information, and Evaluation of 

Carcinogenicity in Humans from 

Scientific Studies (Method 3, including 

criteria 3A and 3B); and Review of 

Information Provided by the WTC 

Health Program Scientific/Technical 

Advisory Committee (Method 4). A full 

narrative description and graphic of the 

Methodology were published in the 

final rule [77 FR 56138, 56142–56143 

(September 12, 2012)]. 

At the time of the Administrator’s 

deliberation, breast cancer was 

determined to meet Method 4 (the STAC 

had provided a reasonable basis for its 

inclusion on the List). In its April 2, 

2012 recommendation, the STAC had 

reported that: 

There is evidence of PCB [polychlorinated 

biphenyl] exposures to WTC responders and 

survivors based on air samples, window film 

samples and one biomonitoring study. 

Studies have linked total and congenerspecific PCB levels in serum and adipose 

tissue with breast cancer, although evidence 

has been conflicting. PCBs and some other 

substances at the WTC site are endocrine 

disruptors. Breast cancer risks are highly 

related to hormonal factors, including 

endogenous and exogenous estrogens, and 

could plausibly be affected by endocrine 

disruptors. A recent study found that PCBs 

enhanced the metastatic properties of breast 

cancer cells by activating rho-associated 

kinase. Shiftwork involving circadian rhythm 

disruption has been classified by IARC as 

probably carcinogenic to humans, based in 

part on epidemiologic studies associating 

shiftwork with increased risks of breast 

cancer. Both shiftwork and long shifts were 

common for workers involved in rescue, 

recovery, clean up, restoration and other 

activities at the WTC site.2 [references 

omitted] 

Although the STAC specified that 

PCBs might be causally associated with 

breast cancer, the Committee provided 

stronger evidence (IARC classification 

as a carcinogen) that shiftwork 


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