Federal Register / Vol. 78, No. 44 / Wednesday, March 6, 2013 / Rules and Regulations 14461 

part 136),’’ EPA/821–R–00–003, 

February 2000 

Dated: February 27, 2013. 

Nancy K. Stoner, 

Acting Assistant Administrator. 

[FR Doc. 2013–05248 Filed 3–5–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0357; FRL–9373–9] 

Fenpyrazamine; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fenpyrazamine 

in or on multiple commodities which 

are identified and discussed later in this 

document. Valent U.S.A. Corporation 

and Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 6, 2013. Objections and requests 

for hearings must be received on or 

before May 6, 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–2011–0357, 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: 

Gene Benbow, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–0235; email address: 

benbow.gene@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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&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–2011–0357 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 May 6, 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– 

2011–0357, 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 

Confidential Business Information (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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 6, 2011 

(76 FR 39358) (FRL–8875–6) and of July 

20, 2011 (76 FR 43233) (FRL–8880–1), 

EPA issued documents pursuant to 

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

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

pesticide petitions (PP 1F7841) by 

Valent U.S.A. Corporation, 1600 Riviera 

Ave., Suite 200, Walnut Creek, CA 

94596 and PP 1E7850 by IR–4, 500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petitions 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide 

fenpyrazamine, S-allyl 5-amino-2- 

isopropyl-4-(2-methylphenyl)-3-oxo-2,3- 

dihydropyrazole-1-carbothioate, in or 

on: Almond at 0.02 parts per million 

(ppm); almond, hulls at 1.5 ppm; 

lettuce, head at 2.5 ppm; lettuce, leaf at 

2.5 ppm; small fruit vine climbing 

subgroup, except fuzzy kiwi fruit, crop 

subgroup 13–07F at 3.5 ppm; grape, 

juice at 7.0 ppm; grape, raisins at 4.5 

ppm; low growing berry subgroup 13– 

07G at 3.0 ppm (PP 1F7841); pistachio 

at 0.02 ppm; Caneberry subgroup 13– 

07A at 7.0 ppm; Bushberry subgroup 

13–07B at 7.0 ppm; and ginseng at 0.80 

ppm (PP 1E7850). Those documents 

referenced a summary of the petitions 

prepared by Valent U.S.A. Corporation, 

the registrant, which are available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notices of filing. 

Based upon review of the data 

supporting the petition, EPA has 

determined that the tolerances should 

be based upon parent fenpyrazamine 

only, has revised the tolerance levels for 

several commodities, and determined a 

tolerance is not needed for raisins. The 

reason for these changes is explained in 

Unit IV.D. 


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III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(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. Section 

408(b)(2)(C) of FFDCA requires 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 * * * .’’ Consistent 

with FFDCA section 408(b)(2)(D), and 

the factors specified in FFDCA section 

408(b)(2)(D), EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure for 

fenpyrazamine including exposure 

resulting from the tolerances established 

by this action. EPA’s assessment of 

exposures and risks associated with 

fenpyrazamine follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies 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 principal toxicological findings 

for fenpyrazamine in repeated dose 

studies in rodents, rabbits, and dogs 

were reduced bodyweights/bodyweight 

weight gains. In addition, thyroid 

follicular cell hypertrophy was observed 

in rats in the subchronic, chronic/ 

carcinogenicity and reproduction 

toxicity (parental animals only) studies. 

Although increased liver weights, 

hepatocellular hypertrophy, and 

alterations in hematology and clinical 

chemistry parameters were observed in 

several studies, they were not 

considered to be toxicologically relevant 

since the magnitude of the changes was 

within normal variability. The liver 

alterations were therefore considered 

adaptive rather than adverse effects. 

There was no evidence of increased 

susceptibility of developing organisms 

after in utero or post-natal exposure to 

fenpyrazamine in the developmental 

toxicity studies (rats and rabbits) or the 

multi-generation reproduction toxicity 

study. In both the rat and rabbit 

developmental studies, maternal effects 

(decreased body weight) occurred at 

doses lower than or equal to those 

eliciting developmental effects 

(decreased fetal weight, skeletal 

variations in rats and late abortions and 

premature deliveries in rabbits). Since 

the late abortions and premature 

deliveries occurred at doses higher than 

the maternal LOAEL, this finding is not 

considered to be indicative of 

susceptibility. In the multi-generation 

reproduction toxicity study, thyroid 

toxicity was observed in parental 

animals at the same dose eliciting 

decreased body weights in the offspring. 

Reproductive effects manifested as 

decreases in implantations and 

increases in postimplantation loss 

occurred at a dose level approximately 

4x higher than the parental and 

offspring LOAELs. 

The only potential sign of 

neurotoxicity was a decrease in total 

motor activity and total number of 

rearings observed in the acute 

neurotoxicity study in rats. However, 

given that the liver is the target tissue, 

these effects may be nonspecific effects 

secondary to general toxicity. These 

effects were not observed in the 

subchronic neurotoxicity or any other 

studies in the database. 

In a 28-day dermal toxicity study, no 

hazard was identified at the limit dose 

1,000 milligrams/kilogram/day (mg/kg/ 

day). Similarly, an immunotoxicity 

study in rats did not indicate that the 

immune system is a target for 

fenpyrazamine toxicity. 

Although an increase in the incidence 

of hepatocellular and thyroid follicular 

carcinomas was noted in the chronic/ 

carcinogenicity study in rats, the 

concern for these findings is low based 

on the following weight of evidence 

considerations: 

1. The marginal increases occurred 

only at the high dose; 

2. There was no reduction in the 

latency period (i.e., tumors were seen 

only at the terminal sacrifice); and 

3. The incidences were only slightly 

outside the historical control range of 

the testing laboratories. 

In addition, no neoplastic lesions 

attributable to treatment were observed 

in the carcinogenicity study in mice and 

no indication of mutagenicity was noted 

in the mutagenicity battery. Based on 

this evidence, in accordance with the 

Agency’s 2005 Guidelines for Cancer 

Risk Assessment, EPA classified 

fenpyrazamine as ‘‘Not Likely to be 

Carcinogenic to Humans’’. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fenpyrazamine as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in section 4.5.4 in 

the document ‘‘Human Health Risk 

Assessment for the Section 3 

Registration and Establishment of 

Tolerances on Almond, Small Fruit 

Climbing Subgroup 13–07F, Head and 

Leaf Lettuce, and Low Growing Berry 

Subgroup 13–07G, Bushberry Subgroup 

13–07B, Caneberry Subgroup 13–07A, 

Ginseng, and Pistachio’’ in docket ID 

number EPA–HQ–OPP–2011–0357. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for fenpyrazamine used for 

human risk assessment is shown in the 

following Table. 


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TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FENPYRAZAMINE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/Scenario Point of departure and uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (General population including infants and children and females 13–49 years of age).

NOAEL = 80 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.8 mg/kg/day 

aPAD = 0.8 mg/kg/day 

Acute Neurotoxicity Screening Battery—Rats. 

LOAEL = based on a statistically significant decrease in 

total motor activity (total distance) in males at 400 and 

2,000 mg/kg/day on day 1. Number of rearings was statistically decreased in males at 400 and 2,000 mg/kg/ 

day, and in females at 2,000 mg/kg/day on day 1. 

Chronic dietary (All populations) ............ NOAEL = 30 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.3 mg/kg/day 

cPAD = 0.3 mg/kg/day 

Developmental Toxicity Study in Rabbits. 

Maternal LOAEL = 50 mg/kg/day [based on decreased 

body weight and food consumption]. 

Cancer (Oral, dermal, inhalation) .......... Fenpyrazamine is classified as ‘‘Not Likely to be Carcinogenic to Humans‘‘. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to 

determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human 

population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. LOC = level of concern. 

N/A = not applicable. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fenpyrazamine, EPA 

considered exposure under the 

petitioned-for tolerances in 40 CFR 180. 

EPA assessed dietary exposures from 

fenpyrazamine in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

for fenpyrazamine. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 2003 

to 2008 United States Department of 

Agriculture (USDA) National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA). For 

residue levels in food, EPA assumed 100 

percent crop treated (PCT) and tolerance 

level residues of parent fenpyrazamine 

plus the maximum residue of S–2188– 

DC (expressed as parent fenpyrazamine) 

observed in the crop field trials for the 

proposed uses. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the 2003 to 2008 United States 

Department of Agriculture (USDA) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). For 

residue levels in food, EPA assumed 100 

PCT and tolerance level residues of 

parent fenpyrazamine plus the 

maximum residue of S–2188–DC 

(expressed as parent fenpyrazamine) 

observed in the crop field trials for the 

proposed uses. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fenpyrazamine does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

fenpyrazamine. Tolerance level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fenpyrazamine in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fenpyrazamine. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the Tier 1 FQPA Index 

Reservoir Screening Tool (FIRST v. 

1.1.1, released March 26, 2008) for 

surface water and the Screening 

Concentration in Ground Water (SCI– 

GROW) model for ground water, the 

estimated drinking water concentrations 

(EDWCs) of fenpyrazamine for acute 

exposures are estimated to be 213.5 

parts per billion (ppb) for surface water 

and 1.31 ppb for ground water. The 

chronic exposures are estimated to be 

72.5 ppb for surface water and 1.31 ppb 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 213.5 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 72.5 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Fenpyrazamine is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. 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 fenpyrazamine to share a 

common mechanism of toxicity with 

any other substances, and 

fenpyrazamine does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that fenpyrazamine 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. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 


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and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence of increased preand/or postnatal susceptibility based on 

the results of the rat and rabbit prenatal 

developmental toxicity studies, and the 

rat 2-generation reproductive toxicity 

study. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1x. That decision is 

based on the following findings: 

i. The toxicity database for 

fenpyrazamine is complete. 

ii. There is no evidence of increased 

pre- and/or postnatal susceptibility for 

fenpyrazamine. 

iii. There is no residual uncertainty in 

the exposure database for 

fenpyrazamine with respect to dietary 

(food and water) exposure. The dietary 

food exposure assessments were 

performed based on 100 PCT and 

tolerance-level residues of parent 

fenpyrazamine plus the maximum 

reside of the metabolite S–2188–DC, 

empirical concentration factors and 

default processing factors. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

fenpyrazamine in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by 

fenpyrazamine. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the aPAD and chronic 

population-adjusted dose (cPAD). For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-term, intermediate-term, and 

chronic-term risks are evaluated by 

comparing the estimated aggregate food, 

water, and residential exposure to the 

appropriate PODs to ensure that an 

adequate MOE exists. Since there are no 

residential uses proposed for 

fenpyrazamine, the aggregate risks are 

equal to the dietary and drinking water 

assessments. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fenpyrazamine will occupy 9.2% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fenpyrazamine 

from food and water will utilize 7.3% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term or intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Fenpyrazamine is not registered for any 

use patterns that would result in shortterm or intermediate-term residential 

exposure. Short-term and intermediateterm risk is assessed based on shortterm or intermediate-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-term or 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short-term risk), no further 

assessment of short-term or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short-term 

and intermediate-term risk for 

fenpyrazamine. 

4. Aggregate cancer risk for U.S. 

population. Based on the results of two 

adequate rodent carcinogenicity studies, 

fenpyrazamine is not expected to pose 

a cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

fenpyrazamine residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Parent fenpyrazamine only is the 

residue of concern for tolerance 

enforcement purposes. Valent U.S.A. 

Corporation has submitted the results of 

an independent laboratory validation 

(ILV) by liquid chromatography and 

mass spectrometry (LC/MS/MS), 

Method RM–45C–1, titled 

‘‘Determination of S–2188 and S–2188– 

DC in crops’’. The method is considered 

adequate for enforcement of tolerances 

in plant commodities. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

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. 

Fenpyrazamine is a new active 

ingredient and MRLs have not been 

established by Codex, Canada, or 

Mexico for the commodities proposed 

for registration in the US. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency established parent 

fenpyrazamine only as the residue of 

concern for tolerance enforcement in 

plants and tolerances were 

recommended accordingly. These differ 

from the tolerances proposed by the 

registrant, which are based on residues 

of parent fenpyrazamine and the 

metabolite S–2188–DC expressed as 

fenpyrazamine. In addition, the 

Organization for the Economical 

Cooperation and Development (OECD) 

calculation procedures were used to 

estimate the tolerances and based on 

these procedures, the Agency has 

determined that the lettuce, head 

tolerance should be lowered from 2.0 to 

1.5 ppm; lettuce, leaf from 2.5 ppm to 

2 ppm; Caneberry subgroup 13–07A 

from 7.0 ppm to 5 ppm; Bushberry 

subgroup 13–07B from 7.0 ppm to 5 

ppm; small fruit vine climbing subgroup 

except fuzzy kiwi fruit, subgroup 13– 

07F from 3.5 ppm to 3 ppm; and grape, 

juice from 7.0 ppm to 4 ppm. Finally, 

the submitted grape processing data 

indicate that residues of parent 

fenpyrazamine only concentrate in 

raisins at 1.1x. Therefore, the 

concentration factor for raisin is not 


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Federal Register / Vol. 78, No. 44 / Wednesday, March 6, 2013 / Rules and Regulations 14465 

high enough to justify the need of a 

separate tolerance for raisins. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fenpyrazamine, S-allyl 5- 

amino-2-isopropyl-4-(2-methylphenyl)- 

3-oxo-2,3-dihydropyrazole-1- 

carbothioate, in or on Almond at 0.02 

ppm; almond, hulls at 1.5 ppm; 

pistachio at 0.02 ppm; lettuce, head at 

1.5 ppm; lettuce, leaf at 2 ppm; 

Caneberry subgroup 13–07A at 5 ppm; 

Bushberry subgroup 13–07B at 5 ppm; 

small fruit vine climbing subgroup 

except fuzzy kiwi fruit, subgroup 13– 

07F at 3 ppm; grape, juice at 4 ppm; low 

growing berry subgroup 13–07G at 3 

ppm; and ginseng at 0.7 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

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). 

VII. 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: February 21, 2013. 

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. In subpart C, add § 180.671 to read 

as follows: 

§ 180.671 Fenpyrazamine; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

fenpyrazamine, in or on the following 

commodities. Compliance with the 

tolerance levels specified in the 

following table is to be determined by 

measuring only fenpyrazamine S-allyl 5- 

amino-2-isopropyl-4-(2-methylphenyl)- 

3-oxo-2,3-dihydropyrazole-1- 

carbothioate, in or on the following 

commodities: 

Commodity Parts per 

million 

Almond ........................................ 0.02 

Almond, hulls .............................. 1.5 

Berry, low growing, subgroup 

13–07G ................................... 3 

Bushberry subgroup 13–07B ...... 5 

Caneberry subgroup 13–07A ..... 5 

Fruit, small vine climbing, except 

fuzzy kiwifruit, subgroup 13– 

07F .......................................... 3 

Ginseng ...................................... 0.7 

Grape, juice ................................ 4 

Lettuce, head .............................. 1.5 

Lettuce, leaf ................................ 2 

Pistachio ..................................... 0.02 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2013–04813 Filed 3–5–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 120918468–3111–02] 

RIN 0648–XC536 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Pollock in the West 

Yakutat District of the Gulf of Alaska 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS is prohibiting directed 

fishing for pollock in the West Yakutat 

District of the Gulf of Alaska (GOA). 

This action is necessary to prevent 

exceeding the 2013 total allowable catch 

of pollock in the West Yakutat District 

of the GOA. 

DATES: Effective 1200 hours, Alaska 

local time (A.l.t.), March 3, 2013, 

through 2400 hours, A.l.t., December 31, 

2013. 

FOR FURTHER INFORMATION CONTACT: 

Obren Davis, 907–586–7228. 

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 


pmangrum on DSK3VPTVN1PROD with RULES