50922 Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 

Commodity Parts per million 

Oats, forage 0.15 ppm 

Oats, hay 0.04 ppm 

Oats, straw 0.07 ppm 

Rye, forage 0.15 ppm 

Rye, straw 0.07 ppm 

Sorghum, grain, forage 0.03 ppm 

Sorghum, grain, stover 0.06 ppm 

Teosinte, forage 0.15 ppm 

Teosinte, hay 0.04 ppm 

Teosinte, straw 0.07 ppm 

Triticale, forage 0.15 ppm 

Triticale, hay 0.04 ppm 

Triticale, straw 0.07 ppm 

Wheat, forage 0.15 ppm 

Wheat, hay 0.03 ppm 

Wheat, straw 0.03 ppm 

[FR Doc. 2010–20443 Filed 8–17–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0048; FRL–8839–4] 

Prohydrojasmon, propyl-3-oxo-2- 

pentylcyclo-pentylacetate; Temporary 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

temporary exemption from the 

requirement of a tolerance for residues 

of the biochemical pesticide 

prohydrojasmon (PDJ), propyl-3-oxo-2- 

pentylcyclo-pentylacetate, on red apple 

varieties when applied/used as a plant 

growth-regulator in accordance with the 

terms of Experimental Use Permit (EUP) 

No. 62097-EUP-R and when used in 

accordance with good agricultural 

practices. Fine Agrochemicals, Ltd., 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting the temporary 

tolerance exemption. This regulation 

eliminates the need to establish a 

maximum permissible level for residues 

of prohydrojasmon (PDJ), propyl-3-oxo2-pentylcyclo-pentylacetate. The 

temporary tolerance exemption expires 

on August 1, 2012. 

DATES: This regulation is effective 

August 18, 2010. Objections and 

requests for hearings must be received 

on or before October 18, 2010, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0048. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: Gina 

Casciano, 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; e-mail address: 

casciano.gina@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 


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Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 50923 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. How Can I File an Objection or 

Hearing Request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections.You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0048 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before October 18, 2010. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket . Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0048, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of April 7, 

2010 (75 FR 17715) (FRL–8810–7), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 9G7656) 

by Fine Agrochemicals, Ltd., c/o SciReg, 

Inc., 12733 Director’s Loop, 

Woodbridge, VA, 22192. The petition 

requested that 40 CFR part 180 be 

amended by establishing a temporary 

exemption from the requirement of a 

tolerance for residues of 

prohydrojasmon, propyl-3-oxo-2- 

pentylcyclo-pentylacetate, (PDJ), for its 

use in accordance with the terms of 

Experimental Use Permit (EUP) No. 

62097-EUP-R. This notice referenced a 

summary of the petition prepared by the 

petitioner Fine Agrochemicals, Ltd., c/o 

SciReg, 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 

section 408(c)(2)(B) of FFDCA, in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which require 

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue....’’ 

Additionally, section 408(b)(2)(D) of 

FFDCA requires that the Agency 

consider ‘‘available information 

concerning the cumulative effects of a 

particular pesticide’s residues’’ and 

‘‘other substances that have a common 

mechanism of toxicity.’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

PDJ is a synthetically made plant 

growth regulator which is both 

structurally similar and functionally 

identical to jasmonic acid (JA), a 

naturally occurring plant regulator 

present in all vascular (higher) plants. 

The jasomates, of which JA is a member, 

is a group of plant hormones involved 

in multiple stages of plant development 

and defense, including the ability to 

stimulate fruit ripening (Creelman and 

Mullet, et al., 1995). The highest levels 

of naturally occurring JA are found in 

actively growing plant tissues such as 

leaves, flowers, and developing fruit 

(Creelman and Mullet, et al., 1995; 

Mason et al., 1992), thus JA has always 

been a natural component of diets 

containing plant materials. To date, 

there have been no reported toxic effects 

associated with the consumption of JA 

in fruits and vegetables. 

PDJ, a synthetic version of JA, is 

expected to behave in the same manner 

and have the same low toxicity profile 

as JA since it is structurally similar and 

functionally identical to naturally 

occurring JA. Studies submitted by the 

applicant and reviewed by EPA indicate 

that PDJ is not acutely toxic. 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. Summaries of 

the toxicological data submitted in 

support of this temporary exemption 

from the requirement of a tolerance 

follow. 

A. Acute Toxicity 

Acute toxicity studies on the 

technical grade active ingredient (TGAI) 

for PDJ, containing 97.98% PDJ, confirm 


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a low toxicity profile. The acute toxicity 

data show virtual nontoxicity for all 

routes of exposure and it can be 

concluded that any dietary risks 

associated with this plant regulator 

would be negligible. 

1. The acute oral median lethal dose 

(LD50) in rats was greater than 5,000 

milligrams per kilogram (mg/kg) 

bodyweight. There were no observed 

toxicological effects on the test subjects 

in the acute oral study submitted (MRID 

No. 47927825). PDJ is classified as 

Toxicity Category IV for acute oral 

toxicity. 

2. The acute dermal LD50 in rats was 

greater than 2,000 mg/kg bodyweight 

(MRID 47927826). PDJ is classified as 

Toxicity Category III for acute dermal 

toxicity. 

3. The acute inhalation median lethal 

concentration (LC50) was greater than 

2.8 milligrams per liter (mg/L) in rats 

and showed no significant inhalation 

toxicity (MRID 47927827). PDJ is 

classified as Toxicity Category IV for 

acute inhalation toxicity. 

4. A primary eye irritation study on 

rabbits indicates that PDJ is minimally 

irritating to the eye (MRID 47927828). 

PDJ is classified as Toxicity Category IV 

for primary eye irritation. 

5. A skin irritation study on rabbits 

indicates that PDJ is not irritating to the 

skin (MRID 47927829). PDJ is classified 

as Toxicity Category IV for primary skin 

irritation. 

6. Data indicate that PDJ is not a 

dermal sensitizer (MRID 47927830). 

B. Mutagenicity 

Two mutagenicity studies, using the 

TGAI of PDJ (97.98% PDJ) as the test 

substance, were performed. These 

studies are sufficient to confirm that 

there are no expected dietary or nonoccupational risks of mutagenicity with 

regard to new food uses. 

1. A Bacterial Reverse Gene Mutation 

Test (MRID No. 47927833) investigating 

doses of test substance up to those that 

were cytotoxic, both with and without 

metabolic S9 activation, found no 

incidences of a 2-fold or greater increase 

in the number of revertants compared to 

the corresponding solvent control. 

Therefore, PDJ is considered to be nonmutagenic under the conditions of this 

assay. 

2. An in vitro Mammalian Cell 

Chromosome Aberration Test (MRID No. 

47927834) tested PDJ genotoxicity on 

Chinese hamster lung cells (CHL/IU) up 

to the cytotoxic dose level (80 

micrograms per milliliter [μg/mL], based 

on reduced mitotic activity) without S9 

activation, and up to the limit 

concentration of 5,000 μg/mL with S9 

activation. None of the test substance 

concentrations induced a significant 

increase in the incidence of cells with 

chromosomal abnormalities, either in 

the absence or presence of S9 activation. 

In both experiments, the fraction of cells 

with chromosomal aberrations was 

below 5%, indicating a negative 

response of the test substance. There 

was also no indication of a doseresponse effect either with or without 

metabolic activation. All of the negative, 

solvent, and positive controls gave 

appropriate responses. Therefore, under 

the conditions of this assay, PDJ is 

considered to be non-mutagenic and 

does not cause chromosome aberrations. 

C. Subchronic Toxicity 

In a subchronic toxicity study using 

the TGAI of PDJ (97.98% PDJ) as the test 

substance, no clinically or 

toxicologically significant effects were 

found in any treatment group (MRID 

47927831). Therefore, the no observed 

adverse effect level (NOAEL) for PDJ has 

been established as the highest test 

substance dose, 10,000 parts per million 

(ppm) (equivalent to 566 mg/kg bw/day 

for male test animals and 587 mg/kg bw/ 

day for female test animals). A lowest 

observed adverse effect level (LOAEL) 

was not established, suggesting that the 

test animals could have tolerated a 

higher dose. In sum, the data submitted 

to the Agency indicate that PDJ has no 

subchronic toxicological effect. 

D. Developmental Toxicity 

In a developmental toxicity study, 

using the TGAI of PDJ (97.98% PDJ) as 

the test substance (MRID 47927832), 

there were no treatment-related effects 

found at necropsy in maternal animals 

nor were there effects on copra lutei, 

number of implantations, sex ratio, fetal 

body weight, or preimplantation 

embryonic mortality. The Agency does 

not consider the transient decrease in 

body weight or food intake as adverse 

and establishes the NOAEL for this 

study as 500 mg/kg bw/day. A LOAEL 

was not identified for maternal effects, 

suggesting that the test animals could 

have tolerated a higher dose. No 

treatment-related developmental effects 

were found on external examination of 

the fetuses. Visceral examination 

showed a slight increase in the 

incidence of thymic remnants; however, 

the increase was within the range of the 

performing laboratories historical 

control data. Therefore, the Agency does 

not consider this a treatment-related 

effect. There was also a slight increase 

in the incidence of a 14th rib, a common 

variation in this strain of rat and is 

therefore not considered an adverse 

effect. It was not accompanied by an 

increased incidence of abnormal 

embryos, either on external, skeletal, or 

visceral examination, and did not 

appear at a higher than normal rate. 

Based on the study results, the 

developmental effects NOAEL for the 

study is the highest dose tested 500 mg/ 

kg bw/day. A LOAEL was not identified 

for developmental effects, suggesting 

that the test animals could have 

tolerated a higher dose. In sum, the data 

submitted to the Agency indicate that 

PDJ is not a developmental toxicant. 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other 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 

Dietary exposure to the residues of 

PDJ is expected to be insignificant, even 

in the event of exposure. Based on 

subchronic toxicity data submitted in 

support of this petition, the Agency has 

calculated the possibility of dietary 

exposure and concludes that in a worst 

case scenario, such as no degradation, 

PDJ residues consumed by a 70 kg 

person are four orders of magnitude 

below the NOAEL that was calculated 

for this compound (EPA, 2010). 

Moreover, based on the fate and 

distribution data (absorption/ 

desorption, hydrolysis, 

photodegredation in water, and aerobic 

soil metabolism) submitted by the 

applicant and reviewed by EPA, PDJ, 

when applied to plant material such as 

fruit and foliage, is expected to degrade 

rapidly, with calculated environmental 

concentrations ranging from 0.77 to 0.06 

ppm on the day of application and 

declining to 0.0 by two days post 

application. In addition, these studies 

indicate that PDJ is relatively unstable 

in the environment with an aerobic soil 

half-life of 1.6 – 2.3 hours, and upon 

consumption breaks down under gastric 

condition with a half-life of 0.8 days. 

1. Food. PDJ is structurally similar to 

the naturally occurring plant growth 

regulator JA. JA is naturally present in 

fruits and vegetables at various levels, 

generally not exceeding 10uM (2ppm), 

and has always been a component of 

any diet containing plant materials 

(Creelman and Mullet, 1995; Mason et 

al., 1992). Dietary exposure to residues 

of PDJ via exposure to treated fruit or 

foliage (e.g. apples) is not expected to 

exist above background levels of 


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naturally occurring JA. The maximum 

application rate of PDJ will be 0.009 

pounds of active ingredient per acre (lbs 

ai/A) or 200 parts per million active 

ingredient per acre (ppm ai/A). Using 

the Terrestrial Exposure Model (T-REX; 

USEPA), the Agency calculated that, in 

a theoretical application at the 

maximum rate, residue levels of PDJ on 

grasses, broadleaf foliage, fruits, pods, 

and seeds will range from 0.77 to 0.06 

ppm on the day of application and 

decline to 0.0 ppm by 2 days post 

application (EPA, 2010). Given PDJ’s 

expected short-lived presence on 

vegetation, no significant pesticidal 

residues are anticipated for harvested 

foods. Furthermore, PDJ is relatively 

unstable in the environment with an 

aerobic soil half-life of 1.6 - 2.3 hours, 

and upon consumption breaks down 

under gastric condition with a half-life 

of 0.8 days. 

2. Drinking water exposure. Exposure 

of humans to PDJ in drinking water is 

unlikely since products are labeled for 

application directly to terrestrial plants 

and because data demonstrate a soil 

half-life for this chemical from 1.6-2.3 

hours, as well as rapid degradation in 

water (EPA, 2010). Specifically, PDJ is 

not to be applied directly to water or to 

areas where surface water is present. In 

addition, the Agency estimated 

environmental concentrations to an 

aquatic site from PDJ runoff (spray to 

apple trees) using the GENeric 

Estimated Environmental Concentration 

model (GENEEC; EPA, 2001). The 

expected concentrations in surface 

water are well below (6 to 7 orders of 

magnitude) the maximum doses used in 

laboratory testing, where no toxic effects 

were seen (e.g. Acute Oral Toxicity LD50

> 5,000 mg/kg; Developmental Toxicity 

NOAEL > 500 mg/kg). 

B. Other Non-Occupational Exposure 

Non-occupational exposure is not 

expected because PDJ is not approved 

for residential uses. The active 

ingredient is applied directly to 

commodities and degrades rapidly. 

1. Dermal exposure. Nonoccupational dermal exposures to PDJ 

are expected to be negligible because of 

its directed agricultural use as a plant 

growth regulator applied to red apple 

varieties pre-harvest. Any dermal 

exposure associated with this 

experimental use permit is expected to 

be occupational in nature. 

2. Inhalation exposure. Nonoccupational inhalation exposures are 

not expected to result from the 

agricultural uses of PDJ. Any inhalation 

exposure associated with this 

experimental use permit is expected to 

be occupational in nature. 

V. Cumulative Effects from Substances 

with a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found PDJ to share a 

common mechanism of toxicity with 

any other substances, and PDJ does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that PDJ 

does not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

FFDCA section 408(b)(2)(C) provides 

that EPA shall assess the available 

information about consumption patterns 

among infants and children, special 

susceptibility of infants and children to 

pesticide chemical residues, and the 

cumulative effects on infants and 

children of the residues and other 

substances with a common mechanism 

of toxicity. In addition, FFDCA section 

408(b)(2)(C) provides that EPA shall 

apply an additional tenfold margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database unless 

EPA determines that a different margin 

of safety will be safe for infants and 

children. Margins of exposure (safety), 

which are often referred to as 

uncertainty factors, are incorporated 

into EPA risk assessments either 

directly or through the use of a margin 

of exposure analysis, or by using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk. 

The acute, subchronic, and 

developmental toxicity data discussed 

in Unit III.B. indicate that PDJ has 

negligible toxicity. In addition, PDJ is 

structurally similar to jasmonic acid, 

which is ubiquitous in nature and 

present in all fruits and vegetables and 

for which there is no reported history of 

toxicological incident. Furthermore, 

based on subchronic toxicity data 

submitted in support of this petition, 

the Agency has calculated the 

possibility of dietary exposure and 

concludes that in a worst case scenario, 

such as no degradation, the PDJ residues 

consumed by a 70 kg person are four 

orders of magnitude below the NOAEL 

that was calculated for this compound 

(EPA, 2010). Therefore, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the United States 

population, including infants and 

children, from aggregate exposure to the 

residues of PDJ. This includes all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information. The Agency has 

arrived at this conclusion because the 

data and information available on PDJ 

do not demonstrate toxic potential to 

mammals. Thus, there are no threshold 

effects of concern and, as a result, an 

additional margin of safety is not 

necessary. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

Through this action, the Agency 

proposes a temporary exemption from 

the requirement of a tolerance of PDJ 

when used on red apple varieties 

without any numerical limitations for 

residues. The Agency has determined 

that residues resulting from PDJ use as 

a plant growth regulator are unlikely, 

and that there are no significant toxicity 

concerns even in the event that residues 

of this active ingredient are present. As 

a result, the Agency has concluded that 

an analytical method is not required for 

enforcement purposes for PDJ. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for PDJ. 


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50926 Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 

VIII. Conclusion 

Therefore, a temporary exemption is 

established for residues of PDJ when 

used on red apple varieties pre-harvest 

and in accordance with good 

agricultural practices. 

IX. References 

1. Creelman, R.A. and J.E. Mullet 

(1995) Jasmonic acid distribution and 

action in plants: Regulation during 

development and response to biotic and 

abiotic stress. Proceedings of the 

National Academies of Science, 92: 

4114-4119. 

2. EPA (2010) Environmental 

Protection Agency (EPA) Risk 

Assessment: Application for 

Experimental-Use Permit and 

Temporary Tolerance Exemption for 

FAL 1800 (Prohydrojasmon). May 18, 

2010. 

3. Mason, H.S., DeWald, D.B., 

Creelman, R.A., Mullet J.E. (1992) 

Coregulation of Soybean and Vegetative 

Storage Protein Gene Expression by 

Methyl Jasmonate and Soluble Sugars. 

Plant Physiology, 98: 859-867. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 6, 2010. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.1299 is added to 

subpart D to read as follows: 

§ 180.1299 Prohydrojasmon; temporary 

exemption from the requirement of a 

tolerance. 

A temporary exemption from the 

requirement of a tolerance is established 

for residues of prohydrojasmon, propyl3-oxo-2-pentylcyclo-pentylacetate, 

when used on red apples varieties preharvest and when used in accordance 

with good agricultural practices and 

will expire on August 1, 2012. 

[FR Doc. 2010–20177 Filed 8–17–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0272; FRL–8837–5] 

2-propenoic acid, 2-methyl-, C12-16- 

alkyl esters, telomers with 1- 

dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated; Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 2-propenoic 

acid, 2-methyl-, C12-16-alkyl esters, 

telomers with 1-dodecanethiol, 

polyethylene-polypropylene glycol 

ether with propylene glycol 

monomethacrylate (1:1), and styrene 

2,2’-(1,2-diazenediyl)bis[2- 

methylbutanenitrile]-initiated, number 

average molecular weight (in AMU) 

4000; when used as an inert ingredient 

in a pesticide chemical formulation 40 

CFR 180.960. Clariant Corporation 

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 2-propenoic acid, 2- 

methyl-, C12-16-alkyl esters, telomers 

with 1-dodecanethiol, polyethylenepolypropylene glycol ether with 

propylene glycol monomethacrylate 

(1:1), and styrene 2,2’-(1,2- 

diazenediyl)bis[2-methylbutanenitrile]- 

initiated on food or feed commodities. 


erowe on DSK5CLS3C1PROD with RULES