7266 Federal Register / Vol. 78, No. 22 / Friday, February 1, 2013 / Rules and Regulations 

2004, the Coast Guard established 

regulations for the security of 

Department of Defense assets and 

military cargo in the navigable waters of 

Puget Sound to and adjacent waters. 

(See 69 FR 52600, Aug. 27, 2004). When 

subject to enforcement, this regulation 

prohibits persons and vessels from the 

immediate vicinity of these facilities 

during military cargo loading and 

unloading operations. The security zone 

will also provide for the regulation of 

vessel traffic in the vicinity of military 

cargo loading facilities in the navigable 

waters of the United States. In addition, 

the regulation establishes requirements 

for all vessels to obtain permission of 

the COTP or Designated Representative, 

including the Vessel Traffic Service 

(VTS), to enter, move within, or exit 

these security zones when they are 

enforced. Entry into this zone is 

prohibited unless otherwise exempted 

or excluded under 33 CFR 165.1321 or 

unless authorized by the Captain of the 

Port or Designated Representative. 

This notice is issued under authority 

of 33 CFR 165.1321 and 5 U.S.C. 552 (a). 

In addition to this notice in the Federal 

Register, the Coast Guard will provide 

the maritime community with 

notification of this enforcement period 

via marine information broadcasts and 

on-scene assets. If the COTP determines 

that the regulated area need not be 

enforced for the full duration stated in 

this notice, a Broadcast Notice to 

Mariners may be used to grant general 

permission to enter the regulated area. 

Dated: January 23, 2013. 

S.J. Ferguson, 

Captain, U.S. Coast Guard, Captain of the 

Port, Puget Sound. 

[FR Doc. 2013–02133 Filed 1–31–13; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0234; FRL–9376–1] 

Alpha-Cypermethrin; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of alphacypermethrin, in or on multiple 

commodities which are identified and 

discussed later in this document. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 1, 2013. Objections and 

requests for hearings must be received 

on or before April 2, 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–2010–0234, 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: 

BeWanda Alexander, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–7460; email address: 

alexander.bewanda@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0234 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 April 2, 2013. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2010–0234, 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 Petition-For Tolerance 

In the Federal Register of May 19, 

2010 (75 FR 28009) (FRL–8823–2), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 0F7690) by BASF 

Corporation, 26 Davis Drive, P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. The petition requested that 

40 CFR 180.418 be amended by 


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establishing tolerances for residues of 

the insecticide alpha-cypermethrin in or 

on tree nuts, Group 14; dried shelled 

pea and bean, except soybean, subgroup 

6C; corn, grain; pop corn; sweet corn; 

soybeans; and sugar beet, roots at 0.05 

parts per million (ppm); succulent 

shelled pea and bean, subgroup 6B; and 

root and tuber vegetables, Group 1 at 0.1 

ppm; cucurbit vegetables, Group 9; 

fruiting vegetables, Group 8; sugar beet, 

tops; and wheat, grain at 0.2 ppm; citrus 

fruit, Group 10 at 0.35 ppm; cottonseed; 

edible podded legume vegetable, 

subgroup 6A; and sorghum, grain at 0.5 

ppm; and rice, grain at 1.5 ppm; citrus, 

dried pulp at 1.8 ppm; head and stem 

Brassica, subgroup 5A at 2.0 ppm; 

citrus, oil at 4.0 ppm; leafy vegetable, 

except Brassica, Group 4 at 10 ppm; and 

alfalfa, hay at 15 ppm. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

established tolerances for alphacypermethrin ((R)-cyano(3- 

phenoxyphenyl)methyl (1S,3S)-rel-3- 

(2,2-dichloroethenyl)-2,2- 

dimethylcyclopropane carboxylate) as 

explained in Unit IV.D. 

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 alphacypermethrin including exposure 

resulting from the tolerances established 

by this action. EPA’s assessment of 

exposures and risks associated with 

alpha-cypermethrin 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. 

Alpha-cypermethrin, cypermethrin, 

and zeta-cypermethrin are all pyrethroid 

insecticides and are isomer mixtures of 

the same chemical. The cypermethrins 

have been evaluated for a variety of 

toxic effects in experimental toxicity 

studies. Behavioral changes commonly 

seen with type II pyrethroids were 

consistently noted in the toxicology 

database for the cypermethrins. These 

behavioral changes included tremors, 

gait abnormalities, limb conditions, 

ataxia and hypersensitivity. 

Additionally, body weight changes were 

routinely observed and mortality was 

seen in a few studies in rats and dogs. 

Clinical signs were also noted in all 

acute neurotoxicity studies. Decreased 

activity, gait abnormalities, tremors, 

limb conditions, and hypersensitivity 

were observed at the mid and high 

doses. Additionally, slight nerve 

degeneration was seen in the acute 

neurotoxicity study with alphacypermethrin at the high dose. In the 

subchronic neurotoxicity studies with 

cypermethrin and zeta-cypermethrin, 

similar behavioral effects were seen 

along with decreased food consumption, 

body weight, and body weight gain. 

Acute toxicology studies conducted 

with cypermethrins indicate moderate 

acute toxicity via the oral route and low 

toxicity via the acute dermal or 

inhalation routes. Additionally, mild 

irritation was seen in primary eye and 

skin irritation studies but no dermal 

sensitization was observed. 

Dermal toxicity studies are available 

for zeta-cypermethrin (rat) and 

cypermethrin (rabbit), in which local 

irritation was observed in rats and 

rabbits at the highest doses tested. No 

systemic effects were observed in the 

21-day dermal study in the rat 

conducted with zeta-cypermethrin at 

dose levels up to 1,000 milligrams/ 

kilogram/day (mg/kg/day). In the dermal 

toxicity study in rabbits with 

cypermethrin, systemic effects were 

observed (focal necrosis of the liver, 

decreased testicular weights, and 

decreased body weight in females). 

However, these observations in the 

rabbit were not used for risk assessment 

because the testing method (i.e., abraded 

skin) does not simulate actual exposure 

and results in compromised test 

conditions. Additionally, there would 

be physiological differences between 

abraded and non-abraded animals, 

further undermining the relevance of 

these results for risk assessment. 

Developmental toxicity and 

reproduction studies are available for 

the cypermethrins. In the 

developmental toxicity studies in rats 

with cypermethrin and zetacypermethrin, there was no evidence of 

developmental toxicity up to the highest 

doses tested. Maternal toxicity included 

decreased body weight gain and food 

consumption in both chemicals. 

Splayed limbs, spasms and 

hypersensitivity to noise and 

convulsions were seen with 

cypermethrin, and ataxia, urine-stained 

abdominal fur, and fecal-stained fur 

were seen with zeta-cypermethrin. In 

the developmental toxicity study in rats 

with alpha-cypermethrin, offspring 

effects were limited to decreased fetal 

body weight. Maternal effects 

observations in the study were unsteady 

gait, piloerection, limb splay, and 

hypersensitivity to sound and touch at 

the same dose. In the developmental 

toxicity studies in rabbits with the 

cypermethrins, there was no evidence of 

developmental toxicity up to the highest 

dose tested. Maternal effects seen with 

cypermethrin included decreased body 

weight gain, anorexia, abdomino-genital 

staining, decreased feces, and red or 

pink material in the pan. With alphacypermethrin, maternal effects were 

body weight loss and decreased food 

consumption. Multi-generation 

reproduction studies in rats are 

available for cypermethrin and zetacypermethrin. In the reproduction study 

with cypermethrin, decreased body 

weight gain was observed in adult 

animals and decreased body weight gain 

was seen in offspring animals at the 

highest dose tested. In the reproduction 

study using zeta-cypermethrin, 

decreased body weight gain and 

mortality were observed in offspring 

animals in the presence of mortality, 

increased brain weights, decreased body 

weights, and neurotoxicity in maternal 

animals. 

No effects were observed in an 

immunotoxicity study in rats with 

alpha-cypermethrin up to the limit dose. 

Alpha-cypermethrin is classified as a 

Group C ‘‘Possible human carcinogen,’’ 

based on an increased incidence of lung 

adenomas and adenomas plus 

carcinomas combined in females in a 

mouse carcinogenicity study. The 


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presence of common benign tumors 

(lung adenomas), in one species (mice) 

and one sex (female), with no increase 

in the proportion of malignant tumors or 

decrease in the time-to-tumor 

occurrence, together with the lack of 

mutagenic activity, was not considered 

strong enough to warrant a quantitative 

estimation of human risk. 

Quantification of risk using a non-linear 

approach (i.e., acute populationadjusted dose (aPAD), acute reference 

dose (aRfD)) adequately accounts for all 

chronic toxicity, including 

carcinogenicity that could result from 

exposure to alpha-cypermethrin. While 

the Agency would typically use a 

chronic population-adjusted dose 

(cPAD) to protect for cancer concerns, 

use of the aPAD is protective because 

increasing toxicity with increasing 

duration of exposure is not 

demonstrated for the cypermethrins. 

The no-observed-adverse-effect-level 

(NOAEL) observed in the mouse cancer 

study in which tumors were observed is 

14 mg/kg/day, 2-fold higher than the 

point of departure (POD) used for acute 

risk assessment. The lowest-observedadverse-effect-level (LOAEL) in the 

mouse cancer study is 57 mg/kg/day 

based on liver effects, not tumor 

formation. The tumors were seen at 229 

mg/kg/day. The acute POD of 7.16 mg/ 

kg/day selected for risk assessment is 

32-fold lower than the dose that 

induced lung tumors in mice. Only the 

mouse study with cypermethrin 

resulted in tumor formation, no 

evidence of carcinogenicity was 

observed in cancer studies in rats with 

cypermethrin or mice with alphacypermethrin. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by chemical name as well 

as the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

Human Health Risk Assessment for New 

Active Ingredient—Alpha-cypermethrin 

at pg. 23 in docket ID number EPA–HQ– 

OPP–2012–0185–0005. 

B. Toxicological Points of Departure and 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological 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 and the lowest dose at which 

adverse effects of concern are identified. 

Uncertainty/safety factors are used in 

conjunction with the POD to calculate a 

safe exposure level—generally referred 

to as a PAD or a reference dose (RfD)— 

and a safe margin of exposure (MOE). 

For non-threshold risks, EPA 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 alpha-cypermethrin used 

for human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ALPHA-CYPERMETHRIN FOR USE IN HUMAN HEALTH

RISK ASSESSMENT

Exposure/Scenario POD and uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (children ≥6 years 

old and adults).

Wolansky MDL1SD = 

7.16 mg/kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

aRfD = 0.07 mg/kg/ 

day.

aPAD = 0.07 mg/kg/ 

day.

Wolansky BMD = 11.20 mg/kg/day based on motor activity. 

Acute dietary (children <6 years 

old).

Wolansky BMDL1SD

= 7.16 mg/kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

aRfD = 0.07 mg/kg/ 

day.

aPAD = 0.023 mg/ 

kg/day.

Wolansky BMD = 11.20 mg/kg/day based on motor activity. 

Chronic dietary (All populations) Because of the rapid reversibility of the most sensitive neurotoxicity endpoint used for quantifying risks, there 

is no increase in hazard with increasing dosing duration, and therefore the acute dietary endpoint is protective for chronic exposure. 

Incidental oral short-term (1 to 

30 days).

Wolansky BMDL1SD

= 7.16 mg/kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

LOC for MOE = 300 Wolansky BMD = 11.20 mg/kg/day based on motor activity. 

Inhalation short-term (1 to 30 

days) (children <6 years old).

Inhalation study .......

NOAEL = 0.01 mg/L 

HEC = 0.008 mg/L 

HED = 1.15 mg/kg/ 

day 

UFA = 3x 

UFH = 10x 

FQPA SF = 3x 

Residential LOC for 

MOE = 100.

21-day inhalation study in the rat—LOAEL = .05 mg/L based 

on increased salivation. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ALPHA-CYPERMETHRIN FOR USE IN HUMAN HEALTH

RISK ASSESSMENT—Continued 

Exposure/Scenario POD and uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Inhalation short-term (1 to 30 

days) (children ≥6 years old 

and adults) (1 to 6 months).

Inhalation study 

NOAEL = 0.01 

mg/L.

HEC = 0.008 mg/L 

HED = 1.15 mg//kg/ 

day 

UFA = 3x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 30 .. 21-day inhalation study in the rat—LOAEL = 0.05 mg/L based 

on increased salvation. 

Cancer (Oral, dermal, inhalation).Alpha cypermethrin has been classified as a Group C ‘‘Possible human carcinogen based on lung adenomas 

in female mice. Because of the rapid reversibility of the most sensitive neurotoxicity endpoint used for 

quantifying risks, there is no increase in hazard with increasing dosing duration. Therefore, the acute dietary endpoint is protective of the endpoints from repeat dosing studies, including cancer dietary exposures. 

Point of Departure (POD) = A data 

point or an estimated point that is 

derived from observed dose-response 

data and used to mark the beginning of 

extrapolation to determine risk 

associated with lower environmentally 

relevant human exposures. NOAEL = no 

observed adverse effect level. LOAEL = 

lowest observed adverse effect level. 

BMD = benchmark dose. BMDL = 

benchmark dose (lower confidence 

limit). UF = uncertainty factor. UFA = 

extrapolation from animal to human 

(interspecies). UFH = potential variation 

in sensitivity among members of the 

human population (intraspecies). FQPA 

SF = FQPA Safety Factor. PAD = 

population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. MOE = 

margin of exposure. LOC = level of 

concern. N/A = not applicable. HEC = 

human equivalent concentration. HED = 

human equivalent dose. Mg/kg/day = 

milligrams/kilogram/day. Mg/L = 

milligrams/liter. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to alpha-cypermethrin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing cypermethrin and zetacypermethrin tolerances in 40 CFR 

180.418. EPA assessed dietary 

exposures from alpha-cypermethrin 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 alpha-cypermethrin. 

In assessing aggregate risk to alphacypermethrin, EPA considered not only 

the exposure associated with the 

proposed food uses for alphacypermethrin, but also the potential 

dietary and drinking water contribution 

and residential exposure from existing 

uses of cypermethrin and zetacypermethrin. In estimating acute 

dietary exposure, EPA used food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA used a partially refined 

(probabilistic) dietary exposure 

assessment to determine the exposure 

and risk estimates which result from the 

use of cypermethrins on the crops listed 

under 40 CFR 180.418 and the proposed 

new uses. Anticipated residues from 

USDA Pesticide Data Program (PDP) 

monitoring data, field trial data, and 

empirical processing factors, and 

percent crop treated (PCT) estimates for 

some commodities were used where 

appropriate. 

ii. Chronic exposure. Based on the 

data summarized in Unit III.A., there is 

no increase in hazard from repeated 

exposures to alpha-cypermethrin; the 

acute dietary exposure assessment is 

higher than for chronic dietary 

exposures because the acute exposure 

levels are greater than the chronic 

exposure levels, therefore, a chronic 

dietary risk assessment was not 

conducted. 

iii. Cancer. As noted in Unit III.A., the 

Agency has determined that 

quantification of risk using a non-linear 

approach (i.e., aPAD) will adequately 

account for all chronic toxicity, 

including carcinogenicity, that could 

result from exposure to alphacypermethrin. Additionally, because an 

assessment of cancer risk would 

estimate exposure based on average 

residue levels and the acute assessment 

used high-end residue levels, the acute 

dietary assessment will be protective of 

any cancer effects resulting from 

consumption of alpha-cypermethrin 

residues in foods. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

section 408(f)(1) that data be provided 5 

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such Data CallIns as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances demonstrating that the 

levels in food are not above the levels 

anticipated. 

Section 408(b)(2)(F) of FFDCA 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. 


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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 FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. The following maximum 

PCT estimates were used in the acute 

dietary risk assessment, which was 

relied on in assessing chronic risk, for 

the following crops that are currently 

registered for the cypermethrins: 

Almonds, 2.5%; apples, 2.5%; broccoli, 

30%; cabbage, 30%; carrot, 10%; 

cauliflower, 25%; celery, 60%; cherries, 

5%; grapefruit, 50%; green beans, 20%; 

green peas, 15%; lemon, 2.5%; lettuce, 

65%; orange, 45%; peach, 5%; peppers, 

30%; potato, 5%; sweet corn, 20%; 

spinach, 45%; tomato, 10%; and 

watermelon, 10%. 

The following average PCT estimates 

were used to calculate average dietary 

exposures in order to assess short-term 

aggregate risk to the cypermethrins: 

Almonds, 1%; apples, 1%; broccoli, 

20%; cabbage, 15%; carrot, 2.5%; 

cauliflower, 15%; celery, 35%; cherries, 

5%; grapefruit, 35%; green beans, 15%; 

green peas, 10%; lemon, 1%; lettuce, 

55%; orange, 35%; peach, 2.5%; 

peppers, 15%; potato, 1%; sweet corn, 

15%; spinach, 30%; tomato, 5%; and 

watermelon, 2.5%. The zetacypermethrin PCT data was used as a 

surrogate for future PCT of alphacypermethrin. 

In most cases, EPA uses available data 

from the U.S. 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 1. 

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 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 

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 alpha-cypermethrin may be 

applied in a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for alpha-cypermethrin in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of alpha-cypermethrin. 

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) and Screening 

Concentration in Ground Water (SCI– 

GROW) models the estimated drinking 

water concentrations (EDWCs) of alphacypermethrin were 3.77 parts per billion 

(ppb) for surface water and 0.0036 ppb 

for ground water. In the dietary risk 

assessment conducted to support the 

proposed uses, EPA incorporated the 

surface water EDWCs directly into the 

dietary model, since surface water 

estimates were higher than those 

provided for ground 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). Alphacypermethrin is not registered for any 

specific use patterns that would result 

in residential exposure. There are no 

proposed residential uses associated 

with alpha-cypermethrin; however, 

there are registered residential uses for 

cypermethrin and zeta-cypermethrin 

that have been reassessed to reflect 

updates to the Agency’s 2012 

Residential standard operating 

procedures (SOPs) along with policy 

changes for body weight assumptions 

and inhalation rates. These revised 

residential exposures have been 

incorporated into the human health 

aggregate risk assessment for alphacypermethrin, which must consider all 

potential exposures to the 

cypermethrins. The Agency has 

determined that short-term exposures 

are likely to occur in a residential 

setting for the cypermethrins; however, 

they do not increase in potency with 

repeated dosing. EPA assessed 

residential exposure using the following 

assumptions. The quantitative 

exposure/risk assessment developed for 

residential handlers is based on the 

following scenarios: 

• Mixer/loader/applicator using hoseend sprayer on turf; 

• Mixer/loader/applicator using 

backpack on turf and gardens; 

• Mixer/loader/applicator using 

manually pressurized handwand for 

indoor surfaces; 

• Application via aerosol can for 

indoor surfaces and space. 

Since a dermal endpoint was not 

identified, only a quantitative inhalation 

handler exposure assessment was 

performed. Residential handler 

inhalation exposure estimates were 

calculated based on a human equivalent 

concentration and human equivalent 

dose which reflect 24 hours of exposure. 

Since handler exposure is expected to 

be significantly less than 24 hours, the 

inhalation exposure estimates are 

sufficiently protective of all scenarios 

(turf, gardens, and indoor surface 

space). Although there is potential 

inhalation exposure resulting from the 

application of dog tags and spot-on 

products for pets, inhalation exposure is 

considered negligible for these scenarios 

and therefore a quantitative assessment 

was not performed for these uses. 

There is the potential for postapplication exposure for individuals as 

a result of being in an environment that 

has been previously treated with 

cypermethrin or zeta-cypermethrin. 

However, the combination of low vapor 

pressure for chemicals typically used as 

active ingredients in outdoor residential 

pesticide products and dilution in 

outdoor air is likely to result in minimal 

inhalation exposure. Therefore, a 

quantitative post-application inhalation 

exposure assessment for cypermethrin 

turf uses was not conducted. Since a 

dermal endpoint was not identified, and 

indoor post-application inhalation 

exposure resulting from aerosol space 

sprays, foggers, and pet (i.e., dog tag, 

spot-on) uses is negligible, the only 


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potential post-application exposure 

pathways of concern are incidental oral 

for children, and post-application 

inhalation exposure for adults and 

children resulting from indoor crack 

and crevice applications made with a 

manually pressurized handwand. The 

quantitative exposure/risk assessment 

for residential post-application 

exposures is based on the following 

scenarios: 

• Incidental oral (hand-to-mouth, 

object-to-mouth, and soil ingestion) 

exposure from turf for children. 

• Incidental oral (hand-to-mouth and 

object-to-mouth) exposure from indoor 

foggers for children. 

• Incidental oral (hand-to-mouth and 

object-to-mouth) exposure from pets for 

children. 

• Inhalation exposure for adults and 

children resulting from crack and 

crevice application to an indoor surface. 

• Incidental oral (hand-to-mouth and 

object-to-mouth) exposure for children 

from indoor surface applications. 

Risk estimates resulting from different 

exposure routes may be combined when 

it is likely that they can occur 

simultaneously based on the use pattern 

and when the toxicological effects 

across different routes of exposure are 

the same. Although, in the case of 

children, inhalation and incidental oral 

exposure routes share a common 

toxicological endpoint, risk estimates 

were not combined for those routes for 

turf, indoor fogger, and pet since postapplication inhalation exposure is 

considered negligible. However, 

inhalation and incidental oral exposures 

were combined for post-application risk 

assessment associated with the indoor 

crack and crevice use. Inhalation and 

incidental oral routes have different 

LOCs. Therefore, in order to combine 

exposure from the various routes, the 

aggregate risk index (ARI) approach is 

used to estimate exposure and risk. 

When this approach is used, aggregate 

risks are not of concern provided the 

calculated ARI is greater than 1. 

The incidental oral scenarios from 

indoor exposure following crack and 

crevice applications and outdoor 

exposure from turf were not combined, 

not only because they are not likely to 

co-occur, but also because combining 

these scenarios would be overlyconservative due to the conservative 

nature of each of the individual 

assessments. 

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 is required to consider 

the cumulative risks of chemicals 

sharing a common mechanism of 

toxicity. The Agency has determined 

that the pyrethroids and pyrethrins, 

including the cypermethrins, share a 

common mechanism of toxicity. 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 and 

pyrethrins was published in the Federal 

Register on November 9, 2011 (76 FR 

69726) (FRL–8888–9), and is available at 

http://www.regulations.gov in the public 

docket, EPA–HQ–OPP–2011–0746. 

Further information about the 

determination that pyrethroids and 

pyrethrins share a common mechanism 

of toxicity may be found in document 

ID: EPA–HQ–OPP–2008–0489–0006. 

The cypermethrins were included in 

a recent cumulative risk assessment for 

pyrethrins and pyrethroids. The 

proposed new uses of alphacypermethrin will not significantly 

impact the cumulative assessment 

because, in the cumulative assessment, 

residential exposure was the greatest 

contributor to the total exposure. There 

are no new residential uses for the 

cypermethrins, and the proposed new 

uses will have no impact on the 

residential component of the cumulative 

risk estimates. 

Dietary exposures make a minor 

contribution to total pyrethroid 

exposure. The dietary exposure 

assessment performed in support of the 

pyrethroid cumulative was much more 

highly refined than that performed for 

the single chemical. The dietary 

exposure assessment for the single 

chemical included conservative 

assumptions, using field trial data for 

many commodities, including the 

proposed new uses, with the 

assumption of 100 PCT, and the most 

sensitive apical endpoint in the 

cypermethrins hazard database was 

selected to derive the POD. 

Additionally, the POD selected for 

alpha-cypermethrin is specific to the 

cypermethrins, whereas the POD 

selected for the cumulative assessment 

was based on-common-mechanism-ofaction data that are appropriate for all 

20 pyrethroids included in the 

cumulative assessment. 

For information regarding EPA’s 

efforts to evaluate the risk of exposure 

to pyrethroids, refer to http:// 

www.epa.gov/oppsrrd1/reevaluation/ 

pyrethroids-pyrethrins.html. 

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 

Food Quality Protection Act (FQPA) 

Safety Factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

In guideline developmental and 

reproduction studies with the 

cypermethrins, there was no evidence of 

increased qualitative or quantitative 

susceptibility in rats or rabbits. 

In a guideline developmental 

neurotoxicity (DNT) study with zetacypermethrin, there was increased 

sensitivity in the offspring based on 

body weight changes in pups (5%–10%) 

in the absence of treatment-related 

effects in maternal animals. Although, 

there was a 5%–8% decrease in 

maternal body weight in this study, a 

body weight decrease of <10% is 

generally not considered adverse in 

adults, as this is considered to be within 

the range of variability because the 

magnitude of body weight per se is 

typically small (as an example, a 3 gram 

(g) decrease in body weight from a 338 

g rat), and adults are no longer in the 

growth/development phase. In contrast, 

the offspring are at a stage of growth and 

development and are therefore expected 

to be gaining rather than losing weight. 

Thus, a smaller percent decrease in 

body weight is considered adverse in 

the young relative to adults. In the case 

of zeta-cypermethrin, the decrease in 

body weight of the young is comparable 

to adults; however, it was considered 

adverse in the young but not in the 

adults. This disparity in interpretation 

leads to an apparent increase in 

sensitivity in the young; however, 

concern is reduced since the magnitude 

of body weight decrements was similar 

in adult and young animals. The results 

from the DNT study are very similar to 

results observed in the reproduction 


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studies where body weight (bwt) 

changes (decreased body weight gain) 

were seen in maternal and offspring 

animals at doses similar to those in the 

DNT study, with no indication of 

increased susceptibility. Therefore, 

there is no residual concern for effects 

observed in the study. Additionally, 

there are well-characterized dose 

responses, with clear NOAELs and 

LOAELs for effects seen in the DNT and 

reproduction studies, and the endpoints 

and PODs selected for risk assessment 

are protective. 

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 in the young, 

typically 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—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 inter-species 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. The FQPA SF was 

reduced to 1X for the general 

population, women of child bearing age 

and children > 6 years. For exposures 

from birth to <6 years of age, a 3X FQPA 

SF was retained based on the following 

considerations: 

i. The toxicology database for the 

cypermethrins is not complete. While 

the database is considered to be 

complete with respect to the guideline 

toxicity studies for alpha-cypermethrin, 

EPA lacks additional data to fully 

characterize the potential for juvenile 

sensitivity to neurotoxic effects of 

pyrethroids. In light of the literature 

studies indicating a possibility of 

increased sensitivity to cypermethrins 

in juvenile rats at high doses, EPA has 

requested proposals for study protocols 

which could identify and quantify 

potential juvenile sensitivity. However, 

when evaluated together, the toxicity 

studies for the cypermethrins can be 

used to characterize toxic effects 

including potential developmental and 

reproductive toxicity, immunotoxicity, 

and neurotoxicity. Acceptable 

developmental toxicity studies in rats 

and rabbits, reproduction studies in rats, 

neurotoxicity studies (acute 

neurotoxicity (ACN), subchronic 

neurotoxicity (SCN), and DNT) in rats, 

and immunotoxicity studies in rats are 

available. In addition, route-specific 

dermal and inhalation studies are 

available. 

ii. After reviewing the extensive body 

of data and peer-reviewed literature on 

pyrethroids, the Agency has reached a 

number of conclusions regarding fetal 

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 

prenatal 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 

zeta-cypermethrin (decreased pup body 

weights) and DNT and reproduction 

studies with 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 PBPK model predicts 

a three-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 and residential 

exposure. The dietary exposure 

assessments are based on high-end 

health protective residue levels (that 

account for parent and metabolites of 

concern), processing factors, and PCT 

assumptions. 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 and 

children over 6 years to 1X since after 

evaluation of over 70 guideline toxicity 

studies submitted to the Agency, 

including prenatal developmental 

toxicity studies in rats and rabbits, and 

multi-generation reproduction toxicity 

studies and DNTs in rats, there is no 

evidence that pyrethroids directly 

impact developing fetuses. 

Additionally, none of the studies show 

any indications of fetal/offspring 

toxicity at doses that do not cause 

maternal toxicity. However, since there 

remains some uncertainty as to juvenile 

sensitivity due to the findings in the 

high-dose LD50 studies, EPA is retaining 

a FQPA SF for infants and children less 

than 6 years of age. This age group is a 

close approximation to the most 

sensitive human population, children 

from birth to <6 years old. EPA is 

seeking additional data to further 

characterize the potential neurotoxic 

risk pyrethroid toxicity. However, EPA 

has reliable data that show that reducing 

the FQPA SF to 3X will protect the 

safety of infants and children. These 

data include: 

(a) data from guideline studies with 

zeta-cypermethrin at relatively high 

doses that show no sensitivity with 

regard to neurotoxic effects (the most 

sensitive effect for the pyrethroids) and 

no residual concern regarding overall 


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juvenile sensitivity (i.e., sensitivity seen 

in body weight changes occurred at 

doses above the level chosen for the 

POD); 

(b) data showing that the potential 

sensitivity at high doses is due to 

pharmacokinetics alone; 

(c) a rat PBPK model predicting a 

three-fold increase of pyrethroid 

concentration in juvenile brain 

compared to adults at high doses due to 

age-dependent pharmacokinetics; and 

(d) data indicating that the rat is a 

conservative model compared to the 

human based on species-specific 

pharmacodynamics of homologous 

sodium channel isoforms. 

For several reasons, EPA concludes 

these data show that a 3X factor is 

protective of the safety of infants and 

children. First, it is likely that the 

extensive guideline studies with zetacypermethrin showing no neurotoxicity 

sensitivity between adults and juveniles 

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 lack of 

increased neurotoxic sensitivity of the 

young in the overwhelming majority (69 

of 70) of the prenatal and postnatal 

guideline studies for pyrethroids 

supports this conclusion, despite the 

relatively high doses used in those 

studies. Second, limited in vitro and in 

vivo data indicate similar 

pharmacodynamic response to 

pyrethroids between juvenile and adult 

rats. The portion of the uncertainty 

factor that accounts for potential 

pharmacodynamic differences between 

animals and humans (i.e., the interspecies extrapolation factor) is likely to 

overstate the risk of the cypermethrins 

given the data showing similarities in 

pharmacodynamics between animals 

and humans. For the inter-species 

factor, the pharmacodynamic portion of 

the factor is generally considered to be 

3X. However, for pyrethroids the actual 

difference is likely to be lower than 3X. 

In addition, there are data that show 

that there are no lifestage 

pharmacodynamic differences between 

young and adult rats. Standard 

uncertainty factors, such as those used 

in the cypermethrin risk assessment, 

assume that there will be such 

differences. Finally, as indicated, 

pharmacokinetic modeling only predicts 

a 3X difference between juveniles and 

adults. Thus, even if there is increased 

juvenile neurotoxic sensitivity and even 

if the existing interspecies and 

intraspecies factors do not provide extra 

protection due to the conservative 

nature of their pharmacodynamic 

components for pyrethroids, the 3X 

additional factor will protect the young. 

Therefore, the FQPA factor of 3X is 

protective of potential juvenile 

sensitivity. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the aPAD and 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 alphacypermethrin will occupy 87% of the 

aPAD for all infants (<1 year old) and 

children 1–2 years old, the population 

groups receiving the greatest exposure. 

This assessment is considered to be 

conservative, because tolerance level 

residues and distributions of field trial 

data (as opposed to monitoring data) 

were used for many commodities. 

Additionally, although upper-bound 

estimates were used for drinking water, 

drinking water is not considered to be 

a major source of dietary exposure for 

the cypermethrins. 

2. Chronic risk. Separate chronic and 

cancer dietary risk assessments were not 

conducted for the cypermethrins. 

Because of the rapid reversibility of the 

most sensitive neurotoxicity endpoint 

used for quantifying risks, there is no 

increase in hazard with increasing 

dosing duration, and therefore the acute 

dietary endpoint is protective for 

chronic and cancer dietary 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). 

Cypermethrin and zeta-cypermethrin 

are currently registered for uses that 

could result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to the cypermethrins 

including alpha-cypermethrin. 

For assessing short-term aggregate 

risk, the average dietary exposure 

estimate was used since it represents a 

background exposure level from food 

and drinking water that may co-occur 

with residential exposures. Dietary and 

oral (hand to mouth) risks for children, 

and dietary and inhalation risks for 

adults were combined in this 

assessment, since the toxicological 

endpoints were the same. However, the 

level of concern (LOC) values were 

different (oral adults and children ≥6 

years old = 100; children <6 years old 

= 300), while inhalation LOC = 30. 

Therefore, the respective risk estimates 

are combined using the aggregate risk 

index (ARI) approach. When this 

approach is used, aggregate risks are not 

of concern provided the calculated ARI 

is greater than 1. The ARI for adults was 

calculated to be 56 and the ARI for 

children was 2.3. Because these ARIs 

are greater than 1, the risk estimates are 

not of concern. 

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). An 

intermediate-term aggregate risk 

assessment was not conducted because 

the cypermethrins are acutely toxic and 

do not increase in potency with 

repeated dosing. Because the 

neurotoxicity POD used for acute risk 

assessment is lower (more protective) 

than PODs for longer durations of 

exposure and acute and short-term 

exposure levels are higher than longer 

term exposure levels, the acute and 

short-term aggregate assessments are 

protective for intermediate-term 

aggregate risks anticipated from the 

cypermethrins. 

5. Aggregate cancer risk for U.S. 

population. For the reasons discussed in 

Unit III.A. (cancer effects are non-linear 

and appear at higher doses than acute 

effects) and Unit III.E.2. (chronic 

exposures are lower than acute 

exposures), the acute aggregate 

assessment is protective of potential 

cancer risk. 

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 the 

cypermethrin residues. 


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IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate tolerance-enforcement 

methods are available in PAM Volume 

II for determining residues of 

cypermethrin, zeta-cypermethrin and 

alpha-cypermethrin in plant (Method I) 

and livestock (Method II) commodities. 

Both methods are gas chromatographic 

methods with electron-capture detection 

(GC/ECD), and have undergone 

successful Agency petition method 

validations (PMVs). Method I has a limit 

of detection (LOD) of 0.01 ppm, and 

Method II has LODs of 0.005 ppm in 

milk, and 0.01 ppm in livestock tissues. 

These methods are not stereospecific; 

thus no distinction is made between 

residues of cypermethrin (all eight 

stereoisomers), zeta-cypermethrin 

(enriched in four isomers) and alphacypermethrin (two isomers). 

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. 

There are multiple Codex MRLs for 

alpha-cypermethrin, but all are in 

conjunction with MRLs for total 

cypermethrin isomers (no MRLs have 

been established solely for alphacypermethrin). However, although the 

definitions of the isomers covered differ 

formally between U.S. tolerances and 

Codex MRLs, the definitions of coverage 

are effectively harmonized since the 

tolerance enforcement methods are not 

stereospecific, and thus do not 

distinguish between residues of 

cypermethrin, zeta-cypermethrin and 

alpha-cypermethrin. For enforcement 

purposes, the same moiety is being 

regulated. As to harmonization of 

tolerance levels, U.S. tolerances and 

Codex MRLs are identical for tree nuts, 

tomatoes, and cattle meat byproducts. 

However, the proposed U.S. use 

patterns for all of the other crops for 

which U.S. tolerances are being 

established differ from the use patterns 

underlying the Codex MRLs associated 

with these crops. Therefore, these U.S. 

tolerances cannot be established at the 

same level as the Codex MRLs. 

C. Response to Comments 

There were no comments received on 

this petition. 

D. Revisions to Petitioned-For 

Tolerances 

No revisions to the tolerance levels in 

the petition, as proposed by BASF, were 

necessary. However, all the proposed 

commodity definitions (except for 

soybean, seed) were revised to reflect 

the correct commodity definitions, per 

the Agency’s current commodity 

vocabulary. Additionally, appropriate 

tolerances for alpha-cypermethrin in 

livestock commodities (which were not 

proposed by BASF) were added 

(reflecting those established for zetacypermethrin), based on the potential 

for residues in livestock feed items 

associated with the proposed uses. 

V. Conclusion 

Therefore, tolerances are established 

for residues of alpha-cypermethrin ((R)- 

cyano(3-phenoxyphenyl)methyl (1S,3S)- 

rel-3-(2,2-dichloroethenyl)-2,2- 

dimethylcyclopropane carboxylate, in or 

on cotton, undelinted seed, vegetable, 

legume, edible podded, subgroup 6A, 

and sorghum, grain, grain at 0.50 ppm; 

vegetable, root and tuber, group 1, 

except sugar beet, pea and bean, 

succulent shelled, subgroup 6B, and 

hog, fat at 0.10 ppm; nut, tree, group 14– 

12, pea and bean, dried shelled, except 

soybean, subgroup 6C, corn, field, grain, 

corn, pop, grain, corn, sweet, kernel 

plus cob with husks removed, soybean, 

seed, beet, sugar, roots, cattle, meat 

byproducts, egg, goat, meat byproducts, 

hog, meat, horse, meat byproducts, 

poultry, fat, poultry, meat, and sheep, 

meat byproducts at 0.05 ppm; vegetable, 

leafy, group 4 at 10 ppm; Brassica, head 

and stem, subgroup 5A at 2.0 ppm; rice, 

grain at 1.5 ppm; vegetable, cucurbit, 

group 9, vegetable, fruiting, group 8–10, 

beet, sugar, tops, wheat, grain, cattle, 

meat, goat, meat, horse, meat, and 

sheep, meat at 0.20 ppm; fruit, citrus, 

group 10–10 at 0.35 ppm; citrus, oil at 

4.0 ppm; citrus, dried pulp at 1.8 ppm; 

alfalfa, hay at 15 ppm; cattle, fat, goat, 

fat, horse, fat, sheep, fat at 1.0 ppm; and 

milk, fat, reflecting at 0.10 ppm in 

whole milk at 2.5 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 22 / Friday, February 1, 2013 / Rules and Regulations 7275 

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: January 23, 2013. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.418 add paragraph (a)(3) to 

read as follows: 

§ 180.418 Cypermethrin and an isomer 

alpha-cypermethrin; tolerances for 

residues. 

(a) * * * 

(3) Tolerances are established for 

residues of the insecticide, alphacypermethrin, (R)-cyano(3- 

phenoxyphenyl)methyl (1S,3S)-rel-3- 

(2,2-dichloroethenyl)-2,2- 

dimethylcyclopropane carboxylate, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only total 

cypermethrin, cyano(3- 

phenoxyphenyl)methyl 3-(2,2- 

dichloroethenyl)-2,2- 

dimethylcyclopropane carboxylate, in or 

on the commodity. 

Commodity Parts per 

million 

Alfalfa, hay .................................. 15 

Beet, sugar, roots ....................... 0 .05 

Commodity Parts per 

million 

Beet, sugar, tops ........................ 0 .20 

Brassica, head and stem, subgroup 5A ................................. 2 .0 

Cattle, fat .................................... 1 .0 

Cattle, meat ................................ 0 .20 

Cattle, meat byproducts ............. 0 .05 

Citrus, dried pulp ........................ 1 .8 

Citrus, oil ..................................... 4 .0 

Corn, field, grain ......................... 0 .05 

Corn, pop, grain .......................... 0 .05 

Corn, sweet, kernel plus cob 

with husks removed ................ 0 .05 

Cotton, undelinted seed ............. 0 .50 

Egg ............................................. 0 .05 

Fruit, citrus, group 10–10 ........... 10 

Goat, fat ...................................... 1 .0 

Goat, meat .................................. 0 .20 

Goat, meat byproducts ............... 0 .05 

Hog, fat ....................................... 1 .0 

Hog, meat ................................... 0 .05 

Horse, fat .................................... 1 .0 

Horse, meat ................................ 0 .20 

Horse, meat byproducts ............. 0 .05 

Milk, fat, reflecting 0.10 ppm in 

whole milk ............................... 2 .5 

Nut, tree, group 14–12 ............... 0 .05 

Pea and bean, dried shelled, except soybean, subgroup 6C .... 0 .05 

Pea and bean, succulent 

shelled, subgroup 6B .............. 0 .10 

Poultry, fat .................................. 0 .05 

Poultry, meat .............................. 0 .05 

Rice, grain .................................. 1 .5 

Sheep, fat ................................... 1 .0 

Sheep, meat ............................... 0 .20 

Sheep, meat byproducts ............ 0 .05 

Sorghum, grain, grain ................. 0 .50 

Soybean, seed ............................ 0 .05 

Vegetable, cucurbit, group 9 ...... 0 .20 

Vegetable, fruiting, group 8–10 .. 0 .20 

Vegetable, leafy, group 4 ........... 10 

Vegetable, legume, edible podded, subgroup 6A ................... 0 .50 

Vegetable, root and tuber, group 

1, except sugar beet ............... 0 .10 

Wheat, grain ............................... 0 .20 

* * * * * 

[FR Doc. 2013–02206 Filed 1–31–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0789; FRL–9376–1] 

2-Pyrrolidone, 1-Ethenyl-, Polymer 

With Ethenol; Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 2-pyrrolidone, 

1-ethenyl-, polymer with ethenol; when 

used as an inert ingredient in a pesticide 

formulation. Sekisui Specialty 

Chemicals America, LLC submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of 2-pyrrolidone, 

1-ethenyl-, polymer with ethenol on 

food or feed commodities. 

DATES: This regulation is effective 

February 1, 2013. Objections and 

requests for hearings must be received 

on or before April 2, 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–2012–0789, 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: 

David Lieu, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–0079; email address: 

Lieu.David@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). 


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