29548 Federal Register / Vol. 77, No. 97 / Friday, May 18, 2012 / Rules and Regulations 

Target Organism Waiver Requests, and 

Metabolism/Residue Studies. 

Memorandum from R. S. Jones to C. 

Greene, dated 04/04/2011. 

15. Joint FAO/WHO Expert Committee on 

Food Additives (JECFA). 2006. Summary 

and Conclusions. Sixty-Seventh Meeting. 

Rome, 20–29 June 2006. ftp://ftp.fao.org/ 

ag/agn/jecfa/jecfa67_final.pdf (Accessed 

04/04/2011). 

16. Koontz, J. L., J. E. Marcy, W. E. Barbeau, 

and S. E. Duncan. 2003. Stability of 

Natamycin and Its Cyclodextrin 

Inclusion Complexes in Aqueous 

Solution. Journal of Agricultural Food 

Chemistry. 51 (24): 7111–7114. 

17. USEPA. 2011. Science Review in Support 

of the Registration of Natamycin TGAI, a 

Technical Grade Active Ingredient 

(TGAI) Product; and Natamycin L, an 

End-Use Product (EP), Respectively 

Containing 91.02% and 10.34% 

Natamycin, a New Active Ingredient. 

Hazard Assessment for Tier I Toxicity 

Studies and Waiver Requests, Tier I NonTarget Organism Waiver Requests, and 

Metabolism/Residue Studies. 

Memorandum from R. S. Jones to C. 

Greene, dated 04/04/2011. 

18. Subchronic (rat) feeding studies 

demonstrate that the No Observable 

Adverse Effect Level NOAEL was 500 

ppm in the diet (42 mg/kg bw/day for 

males and 48 mg/kg bw/day for females) 

(MRID 48105511). 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

exemption 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 exemption in this final 

rule, do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of 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) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

XI. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 8, 2012. 

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 180.1315 is added to 

subpart D to read as follows: 

§ 180.1315 Natamycin; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of natamycin in or on mushrooms when 

applied as a fungistat to prevent the 

germination of fungal spores on 

mushrooms produced in enclosed 

mushroom production facilities. 

[FR Doc. 2012–12105 Filed 5–17–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0048; FRL–9347–9] 

Prohydrojasmon; Amendment of 

Temporary Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation revises the 

temporary exemption from the 

requirement of a tolerance for residues 

of Prohydrojasmon (PDJ), propyl-3-oxo2-pentylcyclo-pentylacetate, by 

including grapes and extending the date 

of expiration of the temporary tolerance 

exemption from August 1, 2012, to 

August 1, 2014, when used as a plant 

growth regulator pre-harvest and in 

accordance with good agricultural 

practices and with the terms of 

Experimental Use Permit (EUP) No. 

62097–EUP–1. Fine Agrochemicals, 

Ltd., submitted a petition to the U.S. 

Environmental Protection Agency (EPA 

or the Agency) under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting the amendment to the 

temporary tolerance exemption. 

DATES: This regulation is effective May 

18, 2012. Objections and requests for 

hearings must be received on or before 

July 17, 2012, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 


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Federal Register / Vol. 77, No. 97 / Friday, May 18, 2012 / Rules and Regulations 29549 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0048; 

FRL–9347–9, is available either 

electronically through http:// 

www.regulations.gov or in hard copy at 

the OPP Docket in the Environmental 

Protection Agency Docket Center (EPA/ 

DC), located in EPA West, Rm. 3334, 

1301 Constitution Ave. NW., 

Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Gina 

Burnett, Biopesticides and Pollution 

Prevention Division (7511P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 605–0513; 

email address: burnett.gina@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections.You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0048 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before July 17, 2012. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket . Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0048, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of February 

15, 2012, (77 FR 8755) (FRL–9335–3), 

EPA issued a notice pursuant to section 

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

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

pesticide tolerance petition (PP 1G7947) 

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

Inc., 12733 Director’s Loop, 

Woodbridge, VA 22192. The petition 

requested that 40 CFR 180.1299 be 

amended by including grapes in the 

temporary exemption from the 

requirement of a tolerance for residues 

of Prohydrojasmon (PDJ), propyl-3-oxo2-pentylcyclo-pentylacetate, and that 

the expiration date for the tolerance 

exemption be extended by 2 years in 

order to coincide with a 2-year 

extension of the petitioner’s 

Experimental Use Permit (EUP) for this 

biochemical. The petitioner requests the 

tolerance exemption expiration date 

extension and EUP extension in order to 

better assess the effects of application 

timing, geography, and apple variety on 

efficacy (color enhancement). Fewer red 

apple sites will be treated as compared 

to the two initial growing seasons (2010 

and 2011), but more acres will be 

treated per site, increasing statistical 

power and confidence, and providing 

the applicant with more useful data. 

Under the EUP extension, the petitioner 

will also be approved to test PDJ on 

grapes. This notice referenced a 

summary of the petition prepared by the 

petitioner, Fine Agrochemicals, Ltd., 

which is available in the docket via 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe ’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Pursuant to 

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

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

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

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue * * *.’’ 

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

FFDCA requires that the Agency 

consider ‘‘available information 

concerning the cumulative effects of [a 


srobinson on DSK4SPTVN1PROD with RULES
29550 Federal Register / Vol. 77, No. 97 / Friday, May 18, 2012 / Rules and Regulations 

particular pesticide’s] * * * residues 

and other substances that have a 

common mechanism of toxicity.’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

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

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness, and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

The Agency established a temporary 

tolerance exemption for PDJ in a Final 

Rule published in the Federal Register 

on August 18, 2010, (75 FR 50922– 

50926) (FRL–8839–4), to coincide with 

the approval of an Experimental Use 

Permit (EUP) granted to Fine 

Agrochemicals, Ltd. The temporary 

tolerance exemption supported uses on 

red apple varieties, and will expire on 

August 1, 2012. This amendment 

proposes to expand the crops covered 

by including grapes, and by extending 

the expiration date of the tolerance 

exemption to August 1, 2014, to 

coincide with the extension of the 

petitioner’s EUP for the same time 

period. Since the establishment of the 

temporary tolerance exemption, no new 

toxicology data have been generated. As 

such, the toxicological profile as stated 

in the August 18, 2010, issue of the 

Federal Register, and referenced herein, 

has not changed. Copies of the August 

18, 2010, document (75 FR 50922– 

50926), and the studies cited therein, 

are located under docket identification 

(ID) number EPA–HQ–OPP–2010–0048. 

As discussed in the August 18, 2010, 

Federal Register, (75 FR 50923), PDJ is 

a synthetic plant growth regulator that 

is structurally similar and functionally 

identical to jasmonic acid (JA), a 

naturally occurring plant regulator 

present in all vascular plants. The 

jasomates, of which JA is a member, is 

a group of plant hormones involved in 

multiple stages of plant development 

and defense, including the ability to 

stimulate fruit ripening (Ref. 1). The 

highest levels of naturally occurring JA 

are found in actively growing plant 

tissues such as leaves, flowers, and 

developing fruit (Refs. 1 and 3), thus JA 

has always been a natural component of 

diets containing plant materials. To 

date, there have been no reported toxic 

effects associated with the consumption 

of JA in fruits and vegetables. 

PDJ, a synthetic version of JA, is 

expected to behave in the same manner 

and have the same low toxicity profile 

as JA because it is structurally similar 

and functionally identical to naturally 

occurring JA. Studies submitted by the 

applicant in support of this temporary 

exemption from the requirement of a 

tolerance, and reviewed by the Agency, 

indicate that PDJ is not acutely toxic. 

These studies and the Agency’s 

conclusions are summarized at 75 FR 

50922–50926, August 18, 2010. 

Specifically, no toxic endpoints were 

established, and no significant 

toxicological effects were observed in 

any of the acute toxicity studies (75 FR 

50923–50924, August 18, 2010). In 

addition, studies submitted indicate that 

PDJ is not genotoxic, has no subchronic 

toxic effects, and is not a developmental 

toxicant (75 FR 50924, August 18, 2010). 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other 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 residues of PDJ is 

expected to be insignificant, even in the 

event of exposure. In a worst case 

scenario, such as no degradation of the 

applied compound, PDJ residues 

consumed by a 70 kg person are four 

orders of magnitude below the No 

Observed Adverse Effect Level (NOAEL) 

that was calculated for this compound 

(75 FR 50924, August 18, 2010). 

1. Food. PDJ is structurally similar to 

the naturally occurring plant growth 

regulator jasmonic acid (JA). JA is 

naturally present in fruits and 

vegetables at various levels, generally 

not exceeding 2 parts per million (ppm), 

and has always been a component of 

any diet containing plant materials 

(Refs. 1 and 2). Dietary exposure to 

residues of PDJ via exposure to treated 

fruit or foliage is not expected to exist 

above background levels of naturally 

occurring JA (75 FR 50924–50925, 

August 18, 2010). 

2. Drinking water exposure. Exposure 

of humans to PDJ in drinking water is 

unlikely since products are labeled for 

application directly to terrestrial plants 

and because data demonstrate a soil 

half-life for this chemical from 1.6–2.3 

hours, as well as rapid degradation in 

water (Ref. 3). In addition, the expected 

concentrations in surface water are well 

below (6 to 7 orders of magnitude) the 

maximum doses used in laboratory 

testing, where no toxic effects were seen 

(e.g., acute oral toxicity LD50 > 5,000 

milligrams per kilogram (mg/kg); 

developmental toxicity NOAEL > 500 

mg/kg) (75 FR 50925, August 18, 2010). 

B. Other Non-Occupational Exposure 

Non-occupational exposure is not 

expected because PDJ is not approved 

for residential uses. The active 

ingredient is applied directly to 

commodities and degrades rapidly. 

1. Dermal exposure. Nonoccupational dermal exposures to PDJ 

are not expected because the compound 

is intended only for agricultural use as 

a plant growth regulator applied to 

apples and grapes pre-harvest. Any 

dermal exposure associated with this 

experimental use permit is expected to 

be occupational in nature. 

2. Inhalation exposure. 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 Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 


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Federal Register / Vol. 77, No. 97 / Friday, May 18, 2012 / Rules and Regulations 29551 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

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

that EPA shall assess the available 

information about consumption patterns 

among infants and children, special 

susceptibility of infants and children to 

pesticide chemical residues, and the 

cumulative effects on infants and 

children of the residues and other 

substances with a common mechanism 

of toxicity. In addition, FFDCA section 

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

apply an additional tenfold margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database unless 

EPA determines that a different margin 

of safety will be safe for infants and 

children. Margins of exposure (safety), 

which are often referred to as 

uncertainty factors, are incorporated 

into EPA risk assessments either 

directly or through the use of a margin 

of exposure analysis, or by using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk. 

Relevant data and information 

indicate that PDJ has negligible acute, 

subchronic, and developmental toxicity 

(75 FR 50922–25, August 18, 2010). In 

addition, PDJ is structurally similar to 

jasmonic acid, which is present in all 

fruits and vegetables and for which 

there is no reported history of 

toxicological incident (EPA, 2010). 

Therefore, the Agency concludes that 

there is a reasonable certainty that no 

harm will result to the U.S. population, 

including infants and children, from 

aggregate exposure to the residues of 

PDJ. This includes all anticipated 

dietary exposures and all other 

exposures for which there is reliable 

information. The Agency has arrived at 

this conclusion because the data and 

information available on PDJ do not 

demonstrate toxic potential to 

mammals. Thus, there are no threshold 

effects of concern and, as a result, an 

additional margin of safety is not 

necessary. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes for the 

reasons stated above and because EPA is 

establishing an exemption from the 

requirement of a tolerance without any 

numerical limitation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for Prohydrojasmon (PDJ), propyl-3-oxo2-pentylcyclo-pentylacetate. 

VIII. Conclusion 

The Agency acknowledges the need to 

extend the temporary tolerance 

exemption to coincide with the 

approved extension of Fine 

Agrochemical, Ltd.’s EUP for PDJ. In 

addition, the Agency concludes that 

there is a reasonable certainty that no 

harm will result to the U.S. population, 

including infants and children, from 

aggregate exposure to the residues of 

PDJ. Therefore, the temporary 

exemption is amended for residues of 

PDJ on red apples to include grapes, 

when used pre-harvest as a plant growth 

regulator, in accordance with good 

agricultural practices and with the terms 

of EUP No. 62097–EUP–1, and will 

expire on August 1, 2014. 

IX. References 

The references used in this document 

are in the OPP docket listed under 

docket ID EPA–HQ–OPP–2010–0048, 

and may be seen by accessing the 

regulatory.gov Web site. 

1. Creelman, R.A. and J.E. Mullet (1995) 

Jasmonic acid distribution and action in 

plants: Regulation during development 

and response to biotic and abiotic stress. 

Proceedings of the National Academies 

of Science, 92: 4114–4119. 

2. Mason, H.S., DeWald, D.B., Creelman, 

R.A., Mullet J.E. (1992) Coregulation of 

Soybean and Vegetative Storage Protein 

Gene Expression by Methyl Jasmonate 

and Soluble Sugars. Plant Physiology, 98: 

859–867. 

3. EPA (2010) Environmental Protection 

Agency (EPA) Risk Assessment: 

Application for Experimental-Use Permit 

and Temporary Tolerance Exemption for 

FAL 1800 (Prohydrojasmon). May 18, 

2010. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 


srobinson on DSK4SPTVN1PROD with RULES
29552 Federal Register / Vol. 77, No. 97 / Friday, May 18, 2012 / Rules and Regulations 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

XI. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 3, 2012. 

Keith Mathews, 

Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 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 revised 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 as a plant growth regulator 

on red apples varieties and grapes preharvest, in accordance with good 

agricultural practices and the terms of 

Experimental Use Permit No. 62097– 

EUP–1, and will expire on August 1, 

2014. 

[FR Doc. 2012–12106 Filed 5–17–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2012–0003; Internal 

Agency Docket No. FEMA–8231] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP) that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. 

DATES: The effective date of each 

community’s scheduled suspension is 

the third date (‘‘Susp.’’) listed in the 

third column of the following tables. 

FOR FURTHER INFORMATION CONTACT: If 

you want to determine whether a 

particular community was suspended 

on the suspension date or for further 

information, contact David Stearrett, 

Federal Insurance and Mitigation 

Administration, Federal Emergency 

Management Agency, 500 C Street SW., 

Washington, DC 20472, (202) 646–2953. 

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

Federal flood insurance that is not 

otherwise generally available from 

private insurers. In return, communities 

agree to adopt and administer local 

floodplain management measures aimed 

at protecting lives and new construction 

from future flooding. Section 1315 of 

the National Flood Insurance Act of 

1968, as amended, 42 U.S.C. 4022, 

prohibits the sale of NFIP flood 

insurance unless an appropriate public 

body adopts adequate floodplain 

management measures with effective 

enforcement measures. The 

communities listed in this document no 

longer meet that statutory requirement 

for compliance with program 

regulations, 44 CFR part 59. 

Accordingly, the communities will be 

suspended on the effective date in the 

third column. As of that date, flood 

insurance will no longer be available in 

the community. We recognize that some 

of these communities may adopt and 

submit the required documentation of 

legally enforceable floodplain 

management measures after this rule is 

published but prior to the actual 

suspension date. These communities 

will not be suspended and will continue 

to be eligible for the sale of NFIP flood 

insurance. A notice withdrawing the 

suspension of such communities will be 

published in the Federal Register. 

In addition, FEMA publishes a Flood 

Insurance Rate Map (FIRM) that 

identifies the Special Flood Hazard 

Areas (SFHAs) in these communities. 

The date of the FIRM, if one has been 

published, is indicated in the fourth 

column of the table. No direct Federal 

financial assistance (except assistance 

pursuant to the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act not in connection with a 

flood) may be provided for construction 

or acquisition of buildings in identified 

SFHAs for communities not 

participating in the NFIP and identified 

for more than a year on FEMA’s initial 

FIRM for the community as having 

flood-prone areas (section 202(a) of the 

Flood Disaster Protection Act of 1973, 

42 U.S.C. 4106(a), as amended). This 

prohibition against certain types of 

Federal assistance becomes effective for 

the communities listed on the date 

shown in the last column. The 

Administrator finds that notice and 

public comment procedures under 5 

U.S.C. 553(b), are impracticable and 

unnecessary because communities listed 

in this final rule have been adequately 

notified. 

Each community receives 6-month, 

90-day, and 30-day notification letters 

addressed to the Chief Executive Officer 

stating that the community will be 

suspended unless the required 

floodplain management measures are 

met prior to the effective suspension 

date. Since these notifications were 

made, this final rule may take effect 

within less than 30 days. 

National Environmental Policy Act. 

This rule is categorically excluded from 

the requirements of 44 CFR part 10, 

Environmental Considerations. No 

environmental impact assessment has 

been prepared. 

Regulatory Flexibility Act. The 

Administrator has determined that this 

rule is exempt from the requirements of 

the Regulatory Flexibility Act because 

the National Flood Insurance Act of 

1968, as amended, Section 1315, 42 

U.S.C. 4022, prohibits flood insurance 


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