Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 73945 

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: December 6, 2012. 

Lois Rossi, 

Director, Registration 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 180.639 is amended as 

follows: 

■ a. In paragraph (a)(1) revise the 

introductory text and the entries for 

‘‘apple, wet pomace,’’ and ‘‘fruit, pome, 

group 11.’’ 

■ b. Revise the introductory text to 

paragraph (d). 

The revised text reads as follows: 

§ 180.639 Flubendiamide; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of 

flubendiamide, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only 

flubendiamide N2-[1, 1-dimethyl-2- 

(methylsulfonyl)ethyl]-3-iodo-N1-[2- 

methyl-4- [1,2,2,2-tetrafluoro-1- 

(trifluoromethyl)ethyl]phenyl]-1,2- 

benzenedicarboxamide, in or on the 

following commodities: 

Commodity Parts per 

million 

* * * * * 

Apple, wet pomace ................... 5.0 

* * * * * 

Fruit, pome, group 11 ............... 1.5 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for residues 

of flubendiamide, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only 

flubendiamide N2-[1, 1-dimethyl-2- 

(methylsulfonyl)ethyl]-3-iodo-N1-[2- 

methyl-4- [1,2,2,2-tetrafluoro-1- 

(trifluoromethyl)ethyl]phenyl]-1, 2- 

benzenedicarboxamide, in or on the 

following commodities: 

* * * * * 

[FR Doc. 2012–29979 Filed 12–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0541; FRL–9360–3] 

Fenpyroximate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of the insecticide 

fenpyroximate in or on multiple 

commodities identified and discussed 

later in this document. In addition, this 

regulation removes established 

tolerances for certain commodities/ 

groups superseded by this action. The 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

December 12, 2012. Objections and 

requests for hearings must be received 

on or before February 11, 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–2011–0541, 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: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; email address: 

jackson.sidney@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 those engaged in the 

following activities: 

• 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/ 


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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–2011–0541 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 February 11, 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 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–2011–0541, 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), Mail Code: 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 Wednesday, 

September 7, 2011 (76 FR 55329) (FRL– 

8886–7), EPA issued a notice pursuant 

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

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

pesticide petition (PP 1E7881) by IR–4, 

Project Headquarters, 500 College Road 

East, Suite 201 W, Princeton, NJ 08540; 

and on Wednesday, May 2, 2012 (77 FR 

25954) (FRL–9346–1) for PP 1F7902 by 

Nichino America, Inc., 4550 New 

Linden Hill Road, Suite 501, 

Wilmington, DE 19808. The petitions 

requested that 40 CFR 180.566 be 

amended by establishing tolerances for 

residues of the insecticide 

fenpyroximate, (E)-1,1-dimethylethyl 4- 

[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol4-yl) 

methyene]amino]oxy]methyl]benzoate 

and its Z-isomer, (Z)-1,1-dimethylethyl 

4-[[[[(1,3-dimethyl-5-phenoxy-1Hpyrazol-4-yl)methylene]amino]oxy]

methyl]benzoate, in or on avocado at 0.2 

parts per million (ppm); bean, snap at 

0.4 ppm; canistel at 0.2 ppm; cucumber 

at 0.25 ppm; fruit, citrus, group 10–10 

at 0.6 ppm; fruit, pome, group 11–10 at 

0.4 ppm; mango at 0.2 ppm; papaya 0.2 

ppm; sapodilla at 0.2 ppm; sapote, black 

at 0.2 ppm; sapote, mamey at 0.2 ppm; 

star apple at 0.2 ppm; tea, plucked 

leaves at 15 ppm; and vegetable, 

fruiting, group 8–10 at 0.2 ppm; corn, 

field, grain at 0.02 ppm; corn, field, 

forage/silage at 2.0 ppm; corn, field, 

stover at 7.0 ppm; corn, field, aspirated 

fractions at 2.0 ppm; corn, pop, grain at 

0.02 ppm; corn, pop, forage/silage at 2.0 

ppm; corn, pop, stover at 7.0 ppm; and 

corn, pop, aspirated fractions at 2.0 

ppm. In addition, petition 1E7881 

proposed to remove established 

tolerances in or on the raw agricultural 

commodities/groups: Fruit, citrus, group 

10 at 0.60 ppm; fruit, pome, group 11 at 

0.40 ppm; and vegetable, fruiting, group 

8 at 0.20 ppm. The notices referenced a 

summary of the respective petition 

prepared by Nichino America, Inc., the 

registrant, available in the docket, 

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

no comments received in response to 

these notices of filing. Based upon 

review of the data supporting the 

petitions, EPA is establishing tolerance 

levels for certain commodities other 

than the proposed level. The reasons for 

these changes are explained in Unit 

IV.C. 

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 fenpyroximate 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fenpyroximate follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. 

Fenpyroximate induced moderate 

acute oral and inhalation toxicity in 

rats. It exhibited low dermal acute 

toxicity and was neither a skin nor eye 

irritant. Fenpyroximate was a slight to 

moderate sensitizer by the maximization 

test method. Subchronic and chronic 

oral exposures to fenpyroximate 

resulted in overall systemic toxicity (no 

specific target organ/tissue identified). 

The most sensitive species tested was 

the dog. The effects reported in the dog 

included slight bradycardia, deficits in 

food consumption, body weight, bodyweight gain, and an increased incidence 

of emesis and diarrhea. Emaciation and 

torpor (sluggish inactivity) were 

reported in female dogs at lower dose 

levels than males. The highest dose 

tested in the dog (50 milligrams/ 

kilogram/day (mg/kg bw/day)) resulted 

in first- and second-degree heart block, 

increased urea concentration, decreased 

glucose, and altered plasma electrolyte 

levels among other signs of toxicity. In 

subchronic and chronic studies with 

rats, the primary effect was decreased 

body-weight gain in both sexes with 

hematological changes (e.g., higher 

counts of red blood cells) at higher 

doses. 


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In a rat prenatal developmental 

toxicity study, a fenpyroximate dose 

level that marginally affected maternal 

body weight and food consumption also 

resulted in an increased litter incidence 

of increased thoracic ribs, indicating 

increased prenatal (qualitative) 

susceptibility. In the rabbits, there no 

developmental effects reported at the 

levels tested. In the rat two-generation 

reproductive toxicity study, there was 

no indication of increased pre- or postnatal susceptibility; maternal toxicity 

(decreased body-weight) and offspring 

toxicity (decreased lactational weight 

gain in both generations) occurred at the 

same dose. Reproductive parameters 

were not affected. 

Acute and subchronic neurotoxicity 

studies in the rat show no evidence that 

fenpyroximate specifically targets the 

nervous system. In the acute 

neurotoxicity study, neurotoxicity signs 

such as decreases in motor activity 

occurred in the presence of other effects 

including decreases in body weight and 

food consumption, and in the absence of 

neuropathology. Similar results were 

noted in a delayed acute neurotoxicity 

study in the hen where no effects 

(neurotoxic or otherwise) were reported. 

The results of the rat subchronic 

neurotoxicity study did not indicate any 

neurotoxicity-specific effects; deficits in 

body weight and food consumption 

were the main effects reported. Effects 

reported in a rat immunotoxicity study 

were limited to decreased body-weight 

gain, indicating the fenpyroximate does 

not directly target the immune 

system.There is no evidence of 

carcinogenic potential for 

fenpyroximate based on the results of 

carcinogenicity studies via the oral 

route in either the rats or mice resulting 

in the carcinogenicity classification of 

‘‘not likely’’ to be carcinogenic to 

humans. Genotoxicity studies including 

mutagenicity did not demonstrate any 

genotoxic potential resulting from 

fenpyroximate exposure. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fenpyroximate 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 document: 

‘‘Fenpyroximate. Human-Health Risk 

Assessment for (1) Proposed Section 3 

Uses on Cucumber, Snap Bean, 

Avocado, Black Sapote, Canistel, 

Mamey Sapote, Mango, Papaya, 

Sapodilla, Star Apple, Corn (Field, Pop, 

Silage, and Grown for Seed); (2) 

Updated Tolerances for Citrus FruitGroup 10–10, Pome Fruit Group 11–10, 

and Fruiting Vegetable Group 8–10; (4) 

the Establishment of a Tolerance on 

Imported Tea; (3) Increase in Maximum 

Seasonal Application Rate on Mint; and 

(4) Proposed Label Amendment to 

Include Aerial Applications to Existing 

Uses on Citrus in Texas, Melons, 

Fruiting Vegetables, and Snap Beans,’’ 

dated April 16, 2012 at p. 32 in docket 

ID number EPA–HQ–OPP–2011–0541– 

0005. 

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 

fenpyroximate used for human risk 

assessment is shown in the following 

Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FENPYROXIMATE 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 (Females 13–50 

years of age).

NOAEL = 5.0 mg/kg 

bw.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

aRfD = .....................

aPAD = 0.05 mg/kg 

bw 

Prenatal Developmental Toxicity Study—Rat. LOAEL = 25 mg/ 

kg/day based on increase in the fetal incidence of additional 

thoracic ribs. 

Acute dietary (General population including infants and 

children).

NOAEL = 37.5 mg/ 

kg bw.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

aRfD = .....................

aPAD = 0.375 mg/kg 

bw 

Acute Neurotoxicity Study—Rat. 

LOAEL = 150 mg/kg bw based on decreased motor activity 

(total activity counts and total time spent in movement) in 

both sexes, and a reduction in auditory startle response in 

females at 24 hours post dose, and mild dehydration in 

males. 

Chronic dietary (All populations) NOAEL = 5.0 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

cRfD = .....................

cPAD = 0.05 mg/kg/ 

day 

Chronic toxicity—Dogs. 

LOAEL = 15 mg/kg/day based on an increased incidence of 

bradycardia, diarrhea, and decreases in cholesterol, bodyweight gain, and food consumption (M); vomiting, diarrhea, 

excess salivation and decrease cholesterol in females. 


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

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not likely to be carcinogen.’’ 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. mg/kg bw = milligram/kilogram of body weight. NOAEL = no-observed-adverse-effect-level. PAD = population-adjusted 

dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fenpyroximate, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fenpyroximate tolerances in 40 

CFR 180.566. EPA assessed dietary 

exposures from fenpyroximate 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 fenpyroximate. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA assumed 100 

percent crop treated (PCT), tolerancelevel residues for all commodities, 

DEEMTM (ver. 7.81) default processing 

factors for all commodities except for 

apple, pear, and grape juice; raisin; 

orange, grapefruit, tangerine, lemon and 

lime juice; tomato paste and puree; and 

peppermint and spearmint oil. 

Chemical-specific data were used to 

calculate empirical processing factors 

for these commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed 100 PCT, tolerance-level 

residues for all commodities, and 

DEEMTM (ver. 7.81) default processing 

factors for most commodities except for 

apple, pear, and grape juice; raisin; 

orange, grapefruit, tangerine, lemon and 

lime juice; tomato paste and puree; and 

peppermint and spearmint oil. 

Chemical-specific data were used to 

calculate empirical processing factors 

for these commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fenpyroximate 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 percent 

crop treated (PCT) information. EPA did 

not use anticipated residue or PCT 

information in the dietary assessment 

for fenpyroximate. 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 fenpyroximate in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fenpyroximate. 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 First Index Reservoir 

Screening Tool (FIRST), a Provisional 

Cranberry Model and Screening 

Concentration in Ground Water (SCI– 

GROW) model, the Agency calculated 

conservative estimated drinking water 

concentrations (EDWCs) of 

fenpyroximate. Tier 1 EDWCs reflect 

exposure in drinking water to the 

residues of fenpyroximate and its 

isomer/degradate, its cis isomer M–1, 

and its carboxylic acid M–3, all of 

which are assumed to have similar 

toxicity. 

For acute exposures, EDWCs are 

estimated to be 43 parts per billion 

(ppb) for surface water and 0.27 ppb for 

ground water. 

For chronic exposures, EDWCs are 

estimated to be 8.6 ppb for surface water 

and 0.27 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 43 ppb was 

used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 8.6 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). 

Fenpyroximate 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 fenpyroximate to 

share a common mechanism of toxicity 

with any other substances, and 

fenpyroximate does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that fenpyroximate 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 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 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 


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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 evidence of increased prenatal 

(qualitative) susceptibility in a rat 

prenatal developmental toxicity study. 

A dose level that marginally affected 

maternal body weight and food 

consumption also resulted in an 

increased litter incidence of increased 

thoracic ribs. However, concern for prenatal and post-natal toxicity to 

fenpyroximate is low because (1) there 

was a clear NOAEL in the rat prenatal 

developmental toxicity study; (2) the 

NOAEL for this developmental study is 

being used as POD for the acute dietary 

risk assessment for the population of 

concern—females 13–49 years old; (3) in 

the rabbit, there were no developmental 

effects reported at the levels tested, and 

(4) in the rat two-generation 

reproductive toxicity study, there was 

no indication of increased pre- or postnatal susceptibility. 

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 for all exposure 

scenarios. That decision is based on the 

following findings: 

i. The toxicity database for 

fenpyroximate is complete. 

ii. There is no indication that 

fenpyroximate is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is evidence that 

fenpyroximate results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. Increased 

(qualitative) prenatal susceptibility was 

seen following oral exposures in the rat 

developmental toxicity study. However, 

for the reasons noted in Unit III.D.2., the 

concern is low. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessment 

utilizes tolerance-level residues 

(established or recommended) and 100 

PCT for all proposed/established 

commodities. By using these 

assumptions, the acute and chronic 

exposures/risks will not be 

underestimated. The dietary drinking 

water assessment utilizes water 

concentration values generated by 

models and associated modeling 

parameters, which are designed to 

provide conservative, health-protective, 

high-end estimates of water 

concentrations that will not likely be 

exceeded. There are no registered or 

proposed uses that will result in 

residential exposure. These assessments 

will not underestimate the exposure and 

risks posed by fenpyroximate. 

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 acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, 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. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fenpyroximate will occupy 3.6% of the 

aPAD for children 1 to 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 fenpyroximate 

from food and water will utilize 9.0% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. There are no 

residential uses for fenpyroximate. 

3. Short- and intermediate-term risks. 

Short-term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Short- and intermediate-term adverse 

effects were identified; however, 

fenpyroximate is not registered for any 

use patterns that would result in shortand intermediate-term residential 

exposure. Short- and intermediate-term 

risks are assessed based on short- and 

intermediate term residential exposures 

plus chronic dietary exposure. Because 

there are no short- and intermediateterm 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- and intermediate-term risks), no 

further assessments of short- and 

intermediate-term risks are necessary. 

EPA relies on the chronic dietary risk 

assessment for evaluating short- and 

intermediate-term risks for 

fenpyroximate. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fenpyroximate 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 

fenpyroximate residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography with nitrogen/ 

phosphorus detection (GC/NPD), 

Method S19, has passed an Agency 

validation) and is available to enforce 

the tolerance expression. 

These methods 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. 

Codex MRLs are established for 

residues of fenpyroximate per se in/on 

several crop commodities. 

Harmonization with the Codex MRLs is 

not possible because the U.S. tolerance 

expressions include both the parent 

fenpyroximate and additional 

metabolites/isomers. However, the 

Agency is lowering the pome fruit 

tolerance from 0.40 ppm to 0.30 ppm in 

order to harmonize with the Codex MRL 

level. Similarly, based on recently 


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73950 Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 

submitted residue data on citrus, EPA is 

lowering the existing citrus fruit 

tolerance from 0.60 ppm to 0.50 ppm in 

order to harmonize with the Codex MRL 

level. 

C. Revisions to Petitioned-For 

Tolerances 

EPA modified/revised certain IR–4 

proposed tolerances based on results 

from the Organization for Economic Cooperation and Development (OECD) 

tolerance calculation procedures in 

order to determine appropriate tolerance 

levels from available U.S. residue data. 

The proposed tolerance at 0.20 ppm for 

avocado, black sapote, mamey sapote, 

canistel, mango, papaya, sapodilla, and 

star apple was lowered to 0.15 ppm. 

Similarly, proposed tolerances for 

cucumber and tea, dried were increased 

from 0.25 ppm to 0.40 ppm, and from 

15 ppm to 20 ppm, respectively. The 

submitted residue data for corn grain 

were not entered into the tolerance 

spreadsheet for OECD calculations 

because all treated samples showed 

combined fenpyroximate residues below 

the level of quantitation (LOQ) of 0.02 

ppm. However, based on available 

residue data, EPA established a 

tolerance for grain, aspirated fractions at 

0.40 ppm to replace proposed tolerances 

for corn, field aspirated fractions at 2.0 

ppm and corn, pop aspirated fractions at 

2.0 ppm. In addition, EPA established a 

tolerance for corn, refined oil at 0.05 

ppm. Also, tolerances for fruit, citrus 

crop group 10–10 and fruit, pome, group 

11–10 were reduced to 0.50 ppm and 

0.30 ppm, respectively, in order to 

harmonize with Codex MRL. 

The Agency is deleting the existing 

tolerance for okra at 0.20 ppm since it 

is included in vegetable, fruiting group 

8–10 established by this action. In 

addition, EPA corrected commodity 

definitions to comply with current EPA 

policy as follows: ‘‘corn, field, forage/ 

silage’’ and ‘‘corn, pop, forage/silage’’ 

were corrected to ‘‘corn, field, forage’’ 

and ‘‘corn, pop, forage,’’ respectively, 

and ‘‘tea, plucked leaves’’ was corrected 

to ‘‘tea, dried.’’ 

Finally, EPA has revised the tolerance 

expression to clarify (1) that, as 

provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of fenpyroximate not 

specifically mentioned; and (2) that 

compliance with the specified tolerance 

levels is to be determined by measuring 

only the specific compounds mentioned 

in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the insecticide 

fenpyroximate, (E)-1,1-dimethylethyl 4- 

[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol4-yl)methyene]amino]oxy]methyl]

benzoate and its Z-isomer, (Z)-1,1- 

dimethylethyl 4-[[[[(1,3-dimethyl-5- 

phenoxy-1H-pyrazol-4-yl)methylene]

amino]oxy]methyl]benzoate, including 

its metabolites and degradates in or on 

avocado at 0.15 ppm, bean, snap, 

succulent at 0.40 ppm, canistel at 0.15 

ppm, corn, field, grain at 0.02 ppm, 

corn, field, forage at 2.0 ppm, corn, 

field, stover at 7.0 ppm, corn, pop, grain 

at 0.02 ppm, corn, pop, forage at 2.0 

ppm, corn, pop, stover at 7.0 ppm, corn, 

field, refined oil at 0.05 ppm, grain, 

aspirated fractions at 0.40 ppm, 

cucumber at 0.4 ppm, fruit, citrus, group 

10–10 at 0.50 ppm, fruit, pome, group 

11–10 at 0.30 ppm, mango at 0.15 ppm, 

papaya 0.15 ppm, sapodilla at 0.15 ppm, 

sapote, black at 0.15 ppm, sapote, 

mamey at 0.15 ppm, star apple at 0.15 

ppm, tea, dried at 20 ppm, and 

vegetable, fruiting, group 8–10 at 0.20 

ppm. 

Lastly, EPA is removing the entries for 

‘‘fruit, citrus, group 10,’’ ‘‘fruit, pome, 

group 11,’’ ‘‘okra’’ and ‘‘vegetable, 

fruiting, group 8’’ from the table at 40 

CFR 180.566(a)(1) since ‘‘new 

tolerances’’ established by this action 

will supersede the existing tolerances. 

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) (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). 

VII. 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. 


emcdonald on DSK67QTVN1PROD with 
Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 73951 

Dated: December 4, 2012. 

Lois Rossi, 

Director, Registration 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. In § 180.566 revise paragraph (a)(1), 

and the introductory texts of paragraphs 

(a)(2), (a)(3) and (b) to read as follows: 

§ 180.566 Fenpyroximate; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the 

insecticide fenpyroximate, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only the sum 

of fenpyroximate, (E)-1,1-dimethylethyl 

4-[[[[(1,3-dimethyl-5-phenoxy-1Hpyrazol-4-yl)methylene]amino]oxy]

methyl]benzoate and its Z-isomer, (Z)- 

1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5- 

phenoxy-1H-pyrazol-4-yl)methylene]

amino]oxy]methyl]benzoate, calculated 

as the stoichiometric equivalent of 

fenpyroximate. 

Commodity Parts per 

million 

Almond, hulls ............................ 3 .0 

Avocado .................................... 0 .15 

Bean, snap, succulent .............. 0 .40 

Berry, low growing, subgroup 

13–07G ................................. 1 .0 

Canistel ..................................... 0 .15 

Citrus, dried pulp ...................... 2 .5 

Citrus, oil ................................... 10 

Corn, field, forage ..................... 2 .0 

Corn, field, grain ....................... 0 .02 

Corn, field, refined oil ............... 0 .05 

Corn, field, stover ..................... 7 .0 

Corn, pop, forage ..................... 2 .0 

Corn, pop, grain ........................ 0 .02 

Corn, pop, stover ...................... 7 .0 

Cotton, gin byproducts ............. 10 

Cotton, undelinted seed ........... 0 .10 

Cucumber ................................. 0 .40 

Fruit, citrus, group 10–10 ......... 0 .50 

Fruit, pome, group 11–10 ......... 0 .30 

Grain, aspirated fractions ......... 0 .40 

Grape ........................................ 1 .0 

Hop, dried cones ...................... 10 

Mango ....................................... 0 .15 

Melon subgroup 9A .................. 0 .10 

Nut, tree, group 14 ................... 0 .10 

Papaya ...................................... 0 .15 

Peppermint, tops ...................... 7 .0 

Pistachio ................................... 0 .10 

Sapodilla ................................... 0 .15 

Sapote, black ............................ 0 .15 

Sapote, mamey ........................ 0 .15 

Spearmint, tops ........................ 7 .0 

Star, apple ................................ 0 .15 

Commodity Parts per 

million 

Tea, dried 1 ............................... 20 

Vegetable, fruiting, group 8–10 0 .20 

1There are no U.S. Registrations. 

(2) Tolerances are established for 

residues of the insecticide 

fenpyroximate, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only the sum 

of fenpyroximate, (E)-1,1-dimethylethyl 

4-[[[[(1,3-dimethyl-5-phenoxy-1Hpyrazol-4-yl)methylene]amino]oxy]

methyl]benzoate and its metabolites (E)- 

4-[(1,3-dimethyl-5-phenoxypyrazol-4- 

yl)-methyleneaminooxymethyl]benzoic 

acid and (E)-1,1-dimethylethyl-2- 

hydroxyethyl 4-[[[[(1,3-dimethyl-5- 

phenoxy-1H-pyrazol-4-yl)methylene]

amino]oxy]methyl]benzoate, calculated 

as the stoichiometric equivalent of 

fenpyroximate. 

* * * * * 

(3) Tolerances are established for 

residues of the insecticide 

fenpyroximate, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only the sum 

of fenpyroximate, (E)-1,1-dimethylethyl 

4-[[[[(1,3-dimethyl-5-phenoxy-1Hpyrazol-4-yl)methylene]amino]oxy]

methyl]benzoate and its metabolite (E)- 

4-[(1,3-dimethyl-5-phenoxypyrazol-4- 

yl)-methyleneaminooxymethyl]benzoic 

acid, calculated as the stoichiometric 

equivalent of fenpyroximate. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of the insecticide 

fenpyroximate, including its metabolites 

and degradates in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only the sum 

of fenpyroximate, (E)-1,1-dimethylethyl 

4-[[[[(1,3-dimethyl-5-phenoxy-1Hpyrazol-4-yl) methylene]amino]

oxy]methyl]benzoate and its Z-isomer, 

(Z)-1,1-dimethylethyl 4-[[[[(1,3- 

dimethyl-5-phenoxy-1H-pyrazol-4-yl)

methylene]amino]oxy]methyl]benzoate, 

calculated as the stoichiometric 

equivalent of fenpyroximate. 

* * * * * 

[FR Doc. 2012–29900 Filed 12–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–1012; FRL–9365–6] 

Pyriproxyfen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyriproxyfen 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 12, 2012. Objections and 

requests for hearings must be received 

on or before February 11, 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–2011–1012, 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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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 


emcdonald on DSK67QTVN1PROD with