64322 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations 

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: October 16, 2014. 

Daniel J. Rosenblatt, 

Acting 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 § 180.205: 

■ a. In the table for paragraph (a), 

remove the entries for ‘‘Ginger’’ and 

‘‘Potato’’ and add alphabetically the 

entry ‘‘Vegetable, tuberous and corm, 

subgroup 1C’’; 

■ b. In the table for paragraph (c), 

remove the entries for and ‘‘Cassava,’’ 

‘‘Tanier,’’ and ‘‘Yam, true, tuber’’. 

The addition reads as follows: 

§ 180.205 Paraquat; tolerances for 

residues. 

(a) * * * 

Commodity Parts 

per million 

* * * * * 

Vegetable, tuberous and 

corn, subgroup 1C ............ 0.50 

* * * * * 

* * * * * 

[FR Doc. 2014–25592 Filed 10–28–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0659; FRL–9917–30] 

Prallethrin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of the insecticide 

prallethrin, including its metabolites 

and degradates, in or on all food 

commodities from use of prallethrin in 

food handling establishments where 

food and food products are held, 

processed, prepared and/or served, or as 

a wide-area mosquito adulticide at 1.0 

part per million (ppm). McLaughlin 

Gormley King Company requested these 

tolerances under the Federal Food, Drug 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 29, 2014. Objections and 

requests for hearings must be received 

on or before December 29, 2014, 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–2013–0659, 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), West William 

Jefferson Clinton 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: 

Daniel J. Rosenblatt, Registration 

Division (RD) (7505P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 305–7090; 

email address: RDFRNotices@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://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 


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C. How can I file an objection or hearing 

request? 

Under section 408(g) of FFDCA, 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–2013–0659 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 December 29, 2014. 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– 

2013–0659, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of October 25, 

2013 (78 FR 63938) (FRL–9901–96), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 2F8090) by 

McLaughlin Gormley King Company, 

8810 Tenth Avenue, Minneapolis, MN 

55427. The petition requested that 40 

CFR 180.545 be amended by 

establishing a tolerance of 1.0 ppm for 

residues of the insecticide prallethrin, 

including its metabolites and 

degradates, in or on all raw agricultural 

commodities and processed food, and 

food products in food handling 

establishments where food and food 

products are held, processed, prepared 

and/or served, or as a wide-area 

mosquito adulticide. That document 

referenced a summary of the petition 

prepared by McLaughlin Gormley King 

Company, the registrant, which is 

available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 prallethrin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with prallethrin 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. 

Prallethrin is a member of the 

pyrethroid class of insecticides. 

Pyrethroids have historically been 

classified into two groups, Type I and 

Type II, based upon chemical structure 

and neurotoxicological effect. Type I 

pyrethroids lack an alpha-cyano moiety 

and induce a syndrome consisting of 

aggressive sparring, altered sensitivity to 

external stimuli, and fine tremor 

progressing to whole-body tremor and 

prostration in rats. These Type I 

pyrethroid-specific behaviors are 

collectively described as the Tsyndrome. Type II pyrethroids contain 

an alpha-cyano moiety and produce a 

syndrome that includes pawing, 

burrowing, salivation, and coarse 

tremors leading to choreoathetosis in 

rats. These Type II pyrethroid-specific 

behaviors are collectively described as 

the CS-syndrome (Verschoyle and 

Aldridge 1980; Lawrence and Casida 

1982). Prallethrin is structurally similar 

to Type I pyrethroids. The adverse 

outcome pathway (AOP) shared by 

pyrethroids involves the ability to 

interact with voltage-gated sodium 

channels (VGSCs) in the central and 

peripheral nervous system, leading to 

changes in neuron firing, and ultimately 

neurotoxicity. 

Prallethrin has been evaluated for a 

variety of toxic effects in experimental 

toxicity studies. Neurotoxicity was 

observed throughout the database and is 

the most sensitive endpoint. Effects 

were seen across species, sexes, and 

routes of administration. In the acute rat 

neurotoxicity study, decreased 

exploratory behavior was seen at the 

time of peak effect. Reduced motor 

activity and transient tremors were also 

observed in the study. In the subchronic 

rat neurotoxicity study, a higher arousal 

rate was observed in animals at the 

highest dose tested. Clinical signs of 

neurotoxicity were also observed in 

other toxicity studies (subchronic and 

chronic oral studies in dogs, 

developmental toxicity studies in the rat 

and rabbit, 21-day dermal and 28-day 

inhalation studies in rats). No 

neurotoxic effects were observed in rats 

in the chronic toxicity study. 

Effects were also observed in the liver 

(rats, mice, and dogs), heart (dogs), and 

thyroid gland (rats). Some effects were 

also seen in the kidney (mice and rats). 

However, neurotoxicity was the most 

sensitive endpoint in the toxicology 

database, and other effects were 

generally seen in the presence of 

neurotoxicity and/or at higher doses. 

Liver effects observed included 

increased weight, elevated serum 

cholesterol and alkaline phosphatase 


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activity, centrilobular hepatocyte 

vacuolation, histiocytic infiltration, 

enlarged liver, and perilobular 

hepatocellular hypertrophy. In dogs, 

myocardial fiber degeneration was seen 

in females in the subchronic study at 

the highest dose tested. Heart effects 

were also seen in one mid-dose female 

in the chronic study (hemorrhage and 

red discoloration). However, there was 

no dose response for the observed heart 

lesions in the study. Thyroid effects 

were observed in rats and consisted of 

increases in the number of small 

follicles and follicular cell hypertrophy 

and hyperplasia. The thyroid effects 

were seen in short-term studies in the 

presence of liver effects. Kidney effects 

observed were increased weights and 

histopathology. 

Developmental and reproduction 

studies are available for prallethrin. 

There was no evidence of increased 

quantitative or qualitative susceptibility 

in any of the studies. In the 

developmental studies, no toxic effects 

were noted in fetuses up to the highest 

doses tested. Maternal effects in the 

studies included tremors, salivation, 

exaggerated reflexes, and 

chromorhinorrhea. In the reproduction 

study, decreased pup body weights were 

seen during the lactation period. Effects 

seen in parental animals were decreased 

body weights and body weight gains, 

increased liver weights and microscopic 

findings in the liver, kidney, thyroid, 

and pituitary. 

Prallethrin is classified as ‘‘Not Likely 

to be Carcinogenic to Humans.’’ No 

tumors were observed in rat and mouse 

carcinogenicity studies up to the highest 

doses tested. In both the rat and mouse 

studies, the animals could have 

tolerated higher dose levels; however, 

EPA determined that dose levels were 

adequate to assess potential 

carcinogenicity. 

Prallethrin tested negative in the 

majority of the genotoxicity studies. It 

also tested negative in an in vitro 

chromosomal aberration study in 

Chinese Hamster Ovary (CHO K1) cells 

without metabolic activation, but tested 

positive at all doses with metabolic 

activation. However, clastogenicity was 

not clearly dose-related, was seen at 

nontoxic and slightly toxic doses, and 

was not expressed in in vivo studies and 

structure-activity comparisons with the 

other pyrethroids revealed no 

correlations with clastogenicity. Other 

gene mutation, chromosomal aberration, 

and unscheduled DNA synthesis (UDS) 

studies were negative; therefore, there is 

no concern for genotoxicity. 

Acute lethality studies conducted 

with prallethrin indicate moderate acute 

toxicity via the oral and inhalation 

routes of administration (Category II) 

and low acute toxicity via the dermal 

route (Categories IV). It is not irritating 

to the skin (Category IV) but is 

minimally irritating to the eye (Category 

IV). It is not a dermal sensitizer. The 

weight of evidence from the available 

guideline, non-guideline, mechanism of 

action, and pharmacokinetics studies 

supports characterizing the toxicological 

profile of pyrethroids, including 

prallethrin, as being rapid in onset and 

associated with acute, peak exposures. 

Also, there is no apparent increase in 

hazard from repeated/chronic exposures 

to prallethrin. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by prallethrin as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found in the 

document titled ‘‘Prallethrin: Human 

Health Risk Assessment for the 

Tolerance Petition to Amend the Section 

3 Mosquito Adulticide Registration to 

Include Use of the Insecticide Over All 

Crops,’’ dated September 15, 2014, by 

going to http://www.regulations.gov. 

The referenced document is available in 

the docket established by this action, 

which is described under ADDRESSES. 

Locate and click on the hyperlink for 

docket ID number EPA–HQ–OPP– 

2013–0659. Double-click on the 

document to view the referenced 

information. 

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 (LOC) 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 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 prallethrin used for 

human risk assessment are shown in 

Tables 1 and 2 of this unit. Based on the 

proposed use patterns for prallethrin, 

endpoints and points of departure were 

selected for dietary (acute only), dermal, 

inhalation, and incidental oral 

exposures. 

For oral exposures (acute dietary and 

incidental oral), the endpoint and POD 

were selected from a chronic dog study 

in which neurotoxicity was observed 

within 4 weeks of dosing and was 

considered to have potentially resulted 

from a single dose, based on a weightof-the-evidence. For dermal assessment, 

the endpoint was selected from the 

route-specific 21-day dermal study in 

the rat, in which clinical signs were 

observed within 1 to 3 days of dosing. 

The endpoints being used to assess oral 

and dermal exposures are the same 

(neurotoxicity); therefore, risks from 

those routes of exposure were 

combined. Although the LOAEL for 

inhalation is also based on 

neurotoxicity, derivation of the human 

equivalent concentrations (HECs) used 

for inhalation risk assessment shows 

that assessing inhalation exposure based 

on the portal-of-entry effects is 

protective of the systemic endpoints, 

including neurotoxicity. As a result, 

inhalation exposure was not combined 

with either the dermal or the oral routes 

of exposure. 

A chronic dietary risk assessment was 

not conducted for prallethrin. Given 

what is known about pyrethroid 

toxicokinetics/dynamics, in general, and 

as there is no apparent increase in 

hazard from repeated/chronic exposures 

to prallethrin, the acute dietary 

exposure assessment is protective of 

chronic dietary exposures. Based on the 

toxicity profile, intermediate- or longterm exposure assessments were not 

conducted for adults or children. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PRALLETHRIN FOR USE IN DIETARY AND NONOCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS

Exposure/scenario 

Point of departure 

and uncertainty/

FQPA safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute Dietary (Children ≥6 

years old and Adults).

NOAEL = 2.5 mg/kg/

day.

UFA = 10× 

UFH = 10× 

FQPA SF = 1× 

Acute RfD = 0.025 

mg/kg/day.

aPAD= 0.025 mg/kg/

day. 

Chronic dog study (capsule). LOAEL = 5 mg/kg/day based on 

clinical signs of neurotoxicity. 

Acute Dietary (Children <6 

years old).

NOAEL = 2.5 mg/kg/

day.

UFA = 10× 

UFH = 10× 

FQPA SF = 3× 

Acute RfD = 0.025 

mg/kg/day.

aPAD= 0.008 mg/kg/

day 

Incidental Oral Short-Term (1 to 

30 days).

NOAEL = 2.5 mg/kg/

day.

UFA = 10× 

UFH = 10× 

FQPA SF = 3× 

Residential LOC for 

MOE = 300.

Dermal Short-term (1 to 30 

days) (Children <6 years old).

Dermal NOAEL = 30 

mg/kg/day.

UFA = 10× 

UFH = 10× 

FQPA SF = 3× 

Residential LOC for 

MOE = 300.

21-day Dermal Rat. LOAEL = 150 mg/kg/day based on observed clinical signs of toxicity (fixation, abnormal gait, tremors, sensitivity to external stimuli, vocalization, twitching and 

writhing spasms), all beginning between days 1 and 3 of a 

21-day dermal study in rats. 

Dermal Short-term (1 to 30 

days) (Children ≥6 years old 

and Adults).

Dermal NOAEL = 30 

mg/kg/day.

UFA = 10× 

UFH = 10× 

FQPA SF = 1× 

Residential LOC for 

MOE = 100.

Inhalation Short-term (1 to 30 

days) (Children <6 years old).

Inhalation NOAEL = 

0.001 mg/L.

UFA = 3× 

UFH = 10× 

FQPA SF = 3× 

HEC/HED calculations used for risk 

assessment (see 

below) 

Residential LOC for 

MOE = 100.

28-Day Inhalation Rat. LOAEL = 0.0044 mg/L based on irregular respiration, decreased spontaneous activity, salivation, 

incontinence, and nasal discharge. 

Inhalation Short-term (1 to 30 

days) (Children ≥6 years old 

and Adults).

Inhalation NOAEL = 

0.001 mg/L.

UFA = 3× 

UFH = 10× 

FQPA SF = 1× 

HEC/HED calculations used for risk 

assessment 

Residential LOC for 

MOE = 30.

aPAD = acute population adjusted dose. FQPA SF = FQPA Safety Factor. HEC = human equivalent concentration. HED = human equivalent 

dose. LOAEL = lowest observed adverse effect level. LOC = level of concern. MOE = margin of exposure. NOAEL = no observed adverse effect 

level. 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. 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). 

TABLE 2—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PRALLETHRIN FOR USE IN DIETARY AND NONOCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS

Residential HECs HEDs 

Residential HECs and HEDs .... Handler/Outdoor 

Post-application.

0.00020 mg/L .......... 0.006 mg/kg/day. 

Residential LOC for MOE = 100 

(Children <6 years old).

Indoor Post-application without air 

ventilation.

0.00014 mg/L .......... N/A. 

Residential LOC for MOE = 30 

(Children ≥6 years old and 

Adults).

Indoor Post-application with air ventilation.Adults: 0.00004 mg/L 

Children: 0.00003 

mg/L. 

N/A. 

Bystander ................ 0.00002 mg/L .......... N/A. 


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TABLE 2—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PRALLETHRIN FOR USE IN DIETARY AND NONOCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS—Continued 

Residential HECs HEDs 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not Likely to be Carcinogenic to Humans.’’ 

HEC = human equivalent concentration. HED = human equivalent dose. Kg = kilogram. LOC = level of concern. L = Liter. Mg = milligram. 

MOE = margin of exposure. N/A = Not applicable. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to prallethrin, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

prallethrin tolerances in 40 CFR 

180.545. Acute and chronic aggregate 

dietary (food and drinking water) 

exposure assessments were conducted 

using the Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEM– 

FCID) Version 3.16. This software uses 

2003–2008 food consumption data from 

the U.S. Department of Agriculture’s 

(USDA’s) National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). 

i. Acute exposure. The acute dietary 

risk assessment is partially refined, and 

is based on the assumption that as a 

result of potential use in food handling 

establishments (FHEs), most 

commodities will have residues at onehalf the limit of quantification (LOQ) of 

the analytical method used in the FHE 

residue trials (0.05 ppm). It was also 

based on the assumptions that all flour 

food forms will contain residues at the 

highest level found in the FHE residue 

trials on flour, and that tree nuts and 

peanuts will contain residues at the 

highest level found in the FHE residue 

trials on peanuts. Based on residue data, 

the highest residue value (0.0045 ppm) 

was used for all crops as a result of 

treatment from the mosquito adulticide 

use. 

The percent FHE value of 4.65% was 

applied to the FHE residue values, and 

the adulticide residues were 

incorporated at a level of 100% (i.e., all 

foods could potentially have residues 

resulting from the mosquito adulticide 

use). Residues from food handling 

(modified by the % FHE estimate) and 

mosquito adulticide treatments were 

combined. 

ii. Chronic exposure. A chronic 

dietary risk assessment was not 

conducted. However, a chronic 

exposure assessment was conducted to 

determine background levels of dietary 

exposure for estimating aggregate risk. 

The exposure estimates are based on the 

highest residue value from the FHE 

residue trials for tree nuts, peanuts, and 

all flour food forms; and on the LOQ of 

the method used in the FHE trials (0.10 

ppm). The data were treated in the same 

manner as the data in the acute dietary 

risk assessment, with the exception that 

the average residue value from the 

adulticide trials (0.0007 ppm) was used 

instead of the highest residue value 

(0.0045 ppm). 

For the chronic exposure assessment, 

EPA applied a percent FHE value of 

4.65% to the FHE residue values and 

assumed 100 percent crop treated (PCT) 

for the proposed mosquito adulticide 

use, just as we have done for the acute 

exposure assessment. This value is 

considered to be an overestimate of the 

potential for the mosquito adulticide to 

drift onto growing crops. Residues from 

the FHE and adulticide uses were then 

combined. Processing factors were not 

used because the assumption was made 

that foods in an FHE could be treated 

after processing. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that prallethrin 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. Section 

408(b)(2)(F) of FFDCA states that EPA to 

states that the Agency may use data on 

the actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. In addition, the 

Agency must provide for periodic 

evaluation of any estimates used. To 

provide for the periodic evaluation of 

the estimate of PCT as required by 

section 408(b)(2)(F) of FFDCA, EPA may 

require registrants to submit data on 

PCT. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency estimates a maximum 

4.65% probability that a food a person 

consumes contains residues as a result 

of treatment in an FHE at some point 

with any pesticide (i.e., it is not specific 

to prallethrin). This value was derived 

by taking into account the daily 

probability of treatment and the percent 

of expenditures resulting in potential 

residues in restaurants, commercial 

kitchens, food warehouses, and food 

processors. For both the acute and 

chronic assessments, this value was 

used for the FHE component of the 

residue for all commodities with the 

exception of drinking water. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 


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several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which prallethrin may be applied in a 

particular area. 

Specific information on the 

methodology to estimate PCT can be 

found in the document entitled 

‘‘Prallethrin: Upper Bound Estimate of 

the Likelihood of Insecticide Residues 

on Food Resulting from Treatment in 

Food Handling Establishments,’’ dated 

September 7, 2014, by going to http://

www.regulations.gov. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for prallethrin. These simulation models 

take into account data on the physical, 

chemical, and fate/transport 

characteristics of prallethrin. 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), Tier II Pesticide 

Root Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS), and 

the Pesticide Flooded Application 

Model (PFAM), the surface water 

estimated drinking water concentration 

(EDWC) value of 0.591 parts per billion 

(ppb) was used in the acute assessment 

and that the annual average surface 

water EDWC value of 0.0375 ppb was 

used in the chronic assessment. 

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). 

Prallethrin is currently registered for 

the following uses that could result in 

residential exposures: A variety of 

residential pet, indoor and outdoor uses 

for pests found on turf, and in homes 

and commercial settings, including food 

handling establishments. However, for 

purposes of this assessment, only 

registered residential products and use 

sites with the highest application rates 

or percent active ingredient (a.i.) were 

assessed because they are representative 

of the worst case exposure scenarios for 

the exposed populations. 

EPA assessed potential residential 

handler exposure scenarios resulting 

from mixing/loading/applying sprays to 

lawns using hose-end and backpack 

sprayers because exposure from treating 

lawns were higher than from other 

application methods and sites. A 

quantitative assessment was not 

required for handling of total release 

fogger products since the labels state 

that the room/house must be vacated 

immediately by the user once initiated. 

EPA assessed post-application dermal 

exposure for adults and children as well 

as incidental oral (i.e., hand-to-mouth) 

exposure for children resulting from 

contact with residues deposited on turf 

and indoor surfaces following 

application with aerial and truckmounted fogger mosquito vector control 

applications, hand-held spray 

applications on turf and lawn, and 

indoor aerosol foggers, respectively. 

Adult and child post-application 

inhalation exposure resulting from both 

aerial and truck-mounted mosquito 

vector control applications were also 

assessed. A quantitative postapplication inhalation exposure 

assessment was not performed for turf 

or indoor aerosol foggers because 

inhalation exposure from these 

application methods is anticipated to be 

negligible. Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http://

www.epa.gov/pesticides/trac/science/

trac6a05.pdf. 

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.’’ 

The Agency has determined that the 

pyrethroids and pyrethrins share a 

common mechanism of toxicity (go to 

http://www.regulations.gov and search 

under document ID number EPA–HQ– 

OPP–2008–0489–0006). The members of 

this group share the ability to interact 

with voltage-gated sodium channels 

ultimately leading to neurotoxicity. The 

cumulative risk assessment for the 

pyrethroids/pyrethrins was published 

on November 9, 2011, and is available 

at http://www.regulations.gov under 

EPA–HQ–OPP–2011–0746. No 

cumulative risks of concern were 

identified, allowing the Agency to 

consider new uses for pyrethroids. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity, and to 

evaluate the cumulative effects of this 

class of chemicals, see EPA’s Web site 

at http://www.epa.gov/oppsrrd1/

reevaluation/pyrethroidspyrethrins.html. 

Prallethrin is included in the 

pyrethroids/pyrethrins cumulative risk 

assessment. No dietary, residential or 

aggregate risk estimates of concern have 

been identified in the single chemical 

assessment. In the cumulative 

assessment, residential exposure was 

the greatest contributor to the total 

exposure. An existing residential turf 

use for prallethrin was evaluated to 

determine the potential contribution it 

would have on the cumulative risk 

assessment. Although the turf use was 

considered the main contributor for 

residential exposure, the turf assessment 

indicated that exposure from turf would 

not impact the residential component of 

the cumulative risk estimates for the 

pyrethroids. 

Therefore, since the proposed 

mosquito adulticide contributes far less 

exposure than the registered turf uses, 

there will be no impact on the 

residential component of the cumulative 

risk estimates. 

Dietary exposures make a minor 

contribution to the total pyrethroid 

exposure. The dietary exposure 

assessment performed in support of the 

pyrethroid cumulative was much more 

highly refined than that performed for 

prallethrin. In addition, for the 

prallethrin risk assessment, the most 

sensitive apical endpoint in the 

prallethrin database was selected to 

derive the POD. Further, the POD 

selected for prallethrin is specific to 

prallethrin, whereas the POD selected 

for the cumulative assessment was 

based on common mechanism of action 

data that are appropriate for all 20 

pyrethroids included in the cumulative 

assessment. Dietary exposure to 

prallethrin residues resulting from the 

proposed mosquito adulticide use over 

all crops will contribute very little to the 

dietary exposure to prallethrin alone; 

therefore, the proposed use will make 

an insignificant contribution to dietary 

risk to the pyrethroids as a whole. 

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, 


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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 

Food Quality Protection Act Safety 

Factor (FQPA 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. 

The prallethrin toxicity database 

includes developmental toxicity studies 

in the rat and rabbit, and a reproduction 

study in the rat. No evidence of 

increased qualitative or quantitative 

susceptibility was noted in any of these 

studies. This lack of susceptibility is 

consistent with the results of guideline 

developmental and reproduction studies 

with other pyrethroid pesticides. 

High-dose studies assessing what dose 

results in lethality to 50% of the tested 

population (LD50) in the scientific 

literature indicate that pyrethroid 

exposure can result in increased 

quantitative sensitivity in the young, 

specifically in the form of neurotoxicity. 

Examination of pharmacokinetic and 

pharmacodynamic data indicates that 

the sensitivity observed at high doses is 

related to pyrethroid age-dependent 

pharmacokinetics, which is the activity 

of enzymes associated with the 

metabolism of pyrethroids. With 

otherwise equivalent administered 

doses for adults and juveniles, 

predictive pharmacokinetic models 

indicate that the differential adultjuvenile pharmacokinetics will result in 

a 3x greater dose at the target organ in 

juveniles compared to adults. No 

evidence of increased quantitative or 

qualitative susceptibility was seen in 

the pyrethroid scientific literature 

related to pharmacodynamics (the effect 

of pyrethroids at the target tissue) both 

with regard to interspecies differences 

between rats and humans and to 

differences between juveniles and 

adults. Specifically, there are in vitro 

pharmacodynamic data and in vivo data 

indicating similar responses between 

adult and juvenile rats at low doses and 

data indicating that the rat is a 

conservative model compared to the 

human based on species-specific 

pharmacodynamics of homologous 

sodium channel isoforms in rats and 

humans. 

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 3x for infants and 

children less than 6 years of age. For the 

general population, including children 

greater than 6 years of age, EPA is 

reducing the FQPA SF to 1x. These 

decisions are based on the following 

findings: 

i. The toxicology database for 

prallethrin is considered complete with 

respect to guideline toxicity studies for 

prallethrin; however, the Agency lacks 

additional information to fully 

characterize the potential for juvenile 

sensitivity to the neurotoxic effects of 

pyrethroids. In light of the literature 

studies indicating a possibility of 

increased sensitivity in juvenile rats at 

high doses, EPA identified a need, and 

requested proposals for, additional nonguideline studies to evaluate the 

potential for sensitivity in juvenile rats. 

A group of pyrethroid registrants is 

currently conducting those studies. 

Pending the results of those studies, 

however, the available toxicity studies 

for prallethrin can be used to 

characterize toxic effects including 

potential developmental and 

reproductive toxicity, as well as 

neurotoxicity. Acceptable 

developmental toxicity studies in rats 

and rabbits, reproduction studies in rats, 

neurotoxicity studies (acute, 

subchronic, and developmental) in rats 

are available. In addition, route-specific 

dermal and inhalation toxicity studies 

are available. The Immunotoxicity study 

has been waived. As discussed in Unit 

IV.D.2., EPA concludes that the 3x 

FQPA SF will be adequate for protecting 

infants and children less than 6 years 

old. 

ii. After reviewing the extensive body 

of data and peer-reviewed literature on 

pyrethroids, the Agency has reached a 

number of conclusions regarding fetal 

and juvenile sensitivity for pyrethroids, 

including the following: 

• Based on an evaluation of over 70 

guideline toxicity studies for 24 

pyrethroids submitted to the Agency, 

including prenatal developmental 

toxicity studies in rats and rabbits, and 

pre- and postnatal multi-generation 

reproduction toxicity studies and DNTs 

in rats in support of pyrethroid 

registrations, there is no evidence that 

pyrethroids directly impact developing 

fetuses. None of the studies show any 

indications of fetal toxicity at doses that 

do not cause maternal toxicity. 

• Increased susceptibility was seen in 

offspring animals in the DNT study with 

the pyrethroid zeta-cypermethrin 

(decreased pup body weights) and DNT 

and reproduction studies with another 

pyrethroid beta-cyfluthrin (decreased 

body weights and tremors). However, 

the reductions in body weight and the 

other non-specific effects occur at 

higher doses than neurotoxicity, the 

effect of concern for pyrethroids. The 

available developmental and 

reproduction guideline studies in rats 

with zeta-cypermethrin did not show 

increased sensitivity in the young to 

neurotoxic effects. Overall, findings of 

increased sensitivity in juvenile animals 

in pyrethroid studies are rare. Therefore, 

the residual concern for the postnatal 

effects is reduced. 

• High-dose LD50 studies (studies 

assessing what dose results in lethality 

to 50% of the tested population) in the 

scientific literature indicate that 

pyrethroids can result in increased 

quantitative sensitivity to juvenile 

animals. Examination of 

pharmacokinetic and pharmacodynamic 

data indicates that the sensitivity 

observed at high doses is related to 

pyrethroid age-dependent 

pharmacokinetics—the activity of 

enzymes associated with the 

metabolism of pyrethroids. 

Furthermore, a rat physiologically-based 

pharmacokinetic (PBPK) model predicts 

a 3-fold increase of pyrethroid 

concentration in juvenile brain 

compared to adults at high doses. 

• In vitro pharmacodynamic data and 

in vivo data indicate that adult and 

juvenile rats have similar responses to 

pyrethroids at low doses and therefore 

juvenile sensitivity is not expected at 

relevant environmental exposures. 

Further, data also show that the rat is a 

conservative model compared to the 

human based on species-specific 

pharmacodynamics of homologous 

sodium channel isoforms. 

iii. There are no residual uncertainties 

with regard to dietary exposure. The 

dietary exposure assessments are based 

on highly conservative residue levels for 

the mosquito adulticide use and for the 

FHE uses. Furthermore, conservative, 

upper-bound assumptions were used to 

determine exposure through drinking 

water and residential sources, such that 

these exposures have not been 

underestimated. 

Taking all of this information into 

account, EPA has reduced the FQPA SF 

for women of child-bearing age because 

there is no evidence in the over 70 

guideline toxicity studies submitted to 

the Agency that pyrethroids directly 

impact developing fetuses. In addition, 

none of the studies show any 

indications of fetal toxicity at doses that 

do not cause maternal toxicity. Because 

there remains some uncertainty as to 

juvenile sensitivity due to the findings 

in the high-dose LD50 studies, EPA is 

retaining a 3x FQPA SF for infants and 

children less than 6 years of age. By age 

6, the metabolic system is expected to 

be at or near adult levels thus reducing 

concerns for potential age-dependent 

sensitivity related to pharmacokinetics; 

therefore for children over 6, a 1x factor 


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is appropriate. Although EPA is seeking 

additional data to further characterize 

the potential neurotoxicity for 

pyrethroids, EPA has reliable data that 

show that reducing the FQPA SF to 3x 

will protect the safety of infants and 

children less than 6 years old. These 

data include: 

a. Data from developmental and 

reproductive toxicity guideline studies 

with prallethrin that show no 

sensitivity. 

b. Data showing that the potential 

sensitivity at high doses is likely due to 

pharmacokinetics. 

c. A rat PBPK model predicting a 3- 

fold increase of pyrethroid 

concentration in the juvenile brain 

compared to adults at high doses due to 

age-dependent pharmacokinetics. 

d. Data indicating that the rat is a 

conservative model compared to the 

human based on species-specific 

pharmacodynamics of homologous 

sodium channel isoforms. 

iv. Although EPA has required 

additional data on transferable residues 

from treated turf for prallethrin, EPA is 

confident that it has not underestimated 

turf exposure due to the 

conservativeness of the default turf 

transfer value and conservative 

assumptions in the short-term turf 

assessment procedures (e.g., assuming 

residues do not degrade over the thirty 

day assessment period and assuming 

high-end activities on turf for every day 

of the assessment period). The 

additional data on turf transferable 

residues have been required in case 

requirement of exposure assessments is 

needed on the future, and to further 

EPA’s general understanding of the 

availability of pesticide residues on turf. 

For several reasons, EPA has 

determined that reliable data show that 

a 3x factor is protective of the safety of 

infants and children less than 6 years of 

age. First, it is likely that the extensive 

guideline studies with pyrethroids, 

which indicate that increased sensitivity 

in juvenile animals in pyrethroid 

studies is rare, better characterize the 

potential sensitivity of juvenile animals 

than the LD50 studies. The high doses 

that produced juvenile sensitivity in the 

literature studies are well above normal 

dietary or residential exposure levels of 

pyrethroids to juveniles and lower 

levels of exposure anticipated from 

dietary and residential uses are not 

expected to overwhelm the juvenile’s 

ability to metabolize pyrethroids, as 

occurred with the high doses used in 

the literature studies. The fact that a 

greater sensitivity to the neurotoxicity of 

pyrethroids is not found in guideline 

studies following in utero exposures 

(based on more than 70 studies for 24 

pyrethroids) supports this conclusion, 

despite the relatively high doses used in 

the studies. Second, in vitro data 

indicate similar pharmacodynamic 

response to pyrethroids between 

juvenile and adult rats. Finally, as 

indicated, pharmacokinetic modeling 

only predicts a 3x difference between 

juveniles and adults. Therefore, the 

FQPA SF of 3x is protective of potential 

juvenile sensitivity. 

Specific information about the 

reevaluation of the FQPA SF for 

pyrethroids may be found in document 

ID number EPA–HQ–OPP–2011–0746– 

0011. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. Acute aggregate risk from 

exposure to prallethrin results from 

exposure to residues in food and 

drinking water alone. The acute dietary 

exposure analysis included both food 

and drinking water; therefore, acute 

aggregate risk estimates are equivalent 

to the acute dietary risk estimates. The 

acute risk estimate for the general U.S. 

population is 10% of the aPAD. The 

population subgroup with the highest 

acute dietary risk estimate is children 1– 

2, which uses 76% of the aPAD. Acute 

aggregate risk is not of concern for the 

general U.S. population or any other 

population subgroup. 

2. Chronic risk. Using the exposure 

assumptions described in this unit, 

there is no increase in hazard with 

increasing dose duration; therefore, the 

acute aggregate assessment is protective 

of potential chronic aggregate 

exposures. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). The short-term 

aggregate risk assessments resulted in 

MOEs of 620 for children, and 1,600 for 

adult females and the general U.S. 

population. The adult and children’s 

MOEs are greater than their respective 

LOCs of 100 and 300. As a result, the 

short-term aggregate risk estimates are 

not of concern for the general U.S. 

population or any population subgroup. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because no intermediate-term adverse 

effect was identified, prallethrin is not 

expected to pose an intermediate-term 

risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the data 

summarized in Units III.A. and 

III.C.1.iii., EPA has concluded that 

prallethrin is not expected to pose a 

cancer risk to humans. 

6. 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 prallethrin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

A method based on gas 

chromatography with electron capture 

detection (GC/ECD), ID #262, is 

adequate for the enforcement of 

tolerances for residues of prallethrin in 

or on crop commodities. The reported 

limits of quantitation (LOQs) are 0.01 to 

0.10 ppm, depending on the 

commodity. The limits of detection 

(LODs) were reported to be 0.004 to 0.06 

ppm, depending on the commodity. 

Multiresidue methods testing for 

prallethrin have not been conducted, 

and is not required, based on previous 

Agency discussions with the petitioner 

on November 3, 2010. 

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 section 408(b)(4) of FFDCA. 

The Codex Alimentarius is a joint 


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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, 

section 408(b)(4) of FFDCA requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established a MRL for prallethrin. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the insecticide 

prallethrin, including its metabolites 

and degradates, in or on all raw 

agricultural commodities and processed 

food from use of prallethrin in food 

handling establishments where food and 

food products are held, processed, 

prepared and/or served, or as a widearea mosquito adulticide at 1.0 part per 

million (ppm). Compliance with the 

tolerance level specified is to be 

determined by measuring only 

prallethrin, 2-methyl-4-oxo-3-(2-propyn1-yl)-2-cyclopenten-1-yl-2,2-dimethyl-3- 

(2-methyl-1-propen-1- 

yl)cyclopropanecarboxylate. 

EPA is revising 40 CFR 180.545 to 

clarify the tolerance. EPA is merging 

paragraphs (a)(1) and (2) together into a 

new paragraph (a). EPA is removing 

paragraphs (a)(3) and (4) as they contain 

language that is more appropriately 

regulated under the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

as use directions on the label. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

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 action 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) (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: October 17, 2014. 

Daniel J. Rosenblatt, 

Acting 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. Revise § 180.545 to read as follows: 

§ 180.545 Prallethrin; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide prallethrin, including its 

metabolites and degradates, in or on all 

raw agricultural commodities and 

processed food from use of prallethrin 

in food handling establishments where 

food and food products are held, 

processed, prepared and/or served, or as 

a wide-area mosquito adulticide at 1.0 

part per million (ppm). Compliance 

with the tolerance level specified is to 

be determined by measuring only 

prallethrin, 2-methyl-4-oxo-3-(2-propyn1-yl)-2-cyclopenten-1-yl-2,2-dimethyl-3- 

(2-methyl-1-propen-1- 

yl)cyclopropanecarboxylate. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2014–25732 Filed 10–28–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 140822715–4882–02] 

RIN 0648–BE37 

Magnuson-Stevens Fishery 

Conservation and Management Act 

Provisions; Fisheries of the 

Northeastern United States; Tilefish 

Fishery; 2015–2017 Specifications 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: NMFS issues final 

specifications for the commercial 


rmajette on DSK2TPTVN1PROD with RULES