Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Rules and Regulations 72975 

(not included are all other types of 

silviculture facilities); 

* * * * * 

[FR Doc. 2012–29688 Filed 12–6–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0472; FRL–9371–7] 

Zeta Cypermethrin; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of zetacypermethrin in or on multiple 

commodities which are identified and 

discussed later in this document. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

December 7, 2012. Objections and 

requests for hearings must be received 

on or before February 5, 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–2010–0472, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

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. 

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–2010–0472 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before February 5, 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– 

2010–0472, 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 issue of 

August 4, 2010 (75 FR 46924) (FRL– 

8834–9), 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 0E7717) by 

the IR–4 Project, Rutgers, The State 

University of New Jersey, 500 College 

Rd. East, Suite 201 W, Princeton, NJ 

08540. The petition requested that 40 

CFR 180.418 be amended by 

establishing tolerances for residues of 

the insecticide zeta-cypermethrin, in or 

on pistachio at 0.05 parts per million 

(ppm), artichoke, globe at 0.80 ppm; 

barley, grain at 1.7 ppm; barley, hay at 

5.0 ppm; barley, straw at 19.0 ppm; 

buckwheat, grain at 1.7 ppm; 

buckwheat, hay at 5.0 ppm; buckwheat, 

straw at 19.0 ppm; oat, grain at 1.7 ppm; 

oat, hay at 5.0 ppm; oat, straw at 19.0 

ppm; rye, grain at 1.7 ppm; rye, hay at 

5.0 ppm; and rye, straw at 19.0 ppm. 

That document referenced a summary of 

the petition prepared by FMC, the 

registrant, which is available in the 

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

comment was received on the notice of 

filing. EPA’s response to this comment 

is discussed in Unit IV.C. 

In the Federal Register issue of 

February 25, 2011 (76 FR 10584) (FRL– 

8863–3), 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 0E7804) by 

the IR–4 Project, Rutgers, The State 

University of New Jersey, 500 College 

Rd. East, Suite 201 W, Princeton, NJ 

08540. The petition requested that 40 

CFR 180.418 be amended by 

establishing tolerances for residues of 

the insecticide zeta-cypermethrin, (Scyano(3-phenoxyphenyl) methyl 

(±))(cis-trans 3-(2,2-dichloroethenyl)-2,2 

dimethylcyclopropanecarboxylate and 


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72976 Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Rules and Regulations 

its inactive R-isomers, in or on avocado, 

black sapote, canistel, mamey sapote, 

mango, papaya, sapodilla, and star 

apple at 0.45 ppm. That document 

referenced a summary of the petition 

prepared by FMC, the registrant, which 

is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petitions, EPA has 

modified the levels for which tolerances 

are being established for some 

commodities. The reason for these 

changes is 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 zetacypermethrin including exposure 

resulting from the tolerances established 

by this action. EPA’s assessment of 

exposures and risks associated with 

zeta-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. 

The petitions for registration of these 

new uses of zeta-cypermethrin rely on 

zeta-cypermethrin data, as well as 

previously submitted data for the 

related registered insecticide 

cypermethrin, and the pending new 

active ingredient alpha-cypermethrin. 

Alpha-cypermethrin, cypermethrin, and 

zeta-cypermethrin are all pyrethroid 

insecticides and are isomer mixtures of 

the same chemical. Cypermethrin 

consists of a mixture of eight isomers 

(four diastereoisomeric pairs). Zetacypermethrin is composed of four of the 

eight isomers of cypermethrin, and also 

contains one of the isomers in alphacypermethrin. Alpha-cypermethrin 

consists of two of the four cis-isomers of 

cypermethrin. 

Alpha-cypermethrin, cypermethrin, 

and zeta-cypermethrin 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. These 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. 

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 milligram/ 

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 observed 

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 alphacypermethrin, cypermethrin, and zetacypermethrin, 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 was 

seen in offspring animals at the highest 

dose tested. In the reproduction study 

with 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. 

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 

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 


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mutagenic activity, was not considered 

strong enough to warrant a linear or nothreshold approach to quantitation of 

human cancer risk. Quantification of 

risk using a non-linear approach (i.e., 

acute population adjusted dose (aPAD), 

acute reference dose (aRfD)) will 

adequately account for all chronic 

toxicity, including carcinogenicity that 

could result from exposure to 

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. 

Acute lethality studies conducted 

with alpha-cypermethrin, cypermethrin, 

and zeta-cypermethrin 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. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by zeta-cypermethrin as 

well as the NOAEL and the LOAEL from 

the toxicity studies can be found at 

http://www.regulations.gov on pp. 60– 

67 of the document entitled ‘‘ZetaCypermethrin—Human Health Risk 

Assessment for New Poultry House Use 

and Agricultural Uses on Tropical Fruit, 

Artichoke, Barley, Oat, Rye, Buckwheat, 

and Pistachio’’ in docket ID number 

EPA–HQ–OPP–2010–0472. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological PODs and levels of 

concern (LOCs) 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. 

The PODs are developed based on a 

careful analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for zeta-cypermethrin used 

for human risk assessment is shown in 

Table 1 of this unit. 

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

RISK ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (children ≥ 6 years old and 

adults).

Wolansky BMDL1SD = 7.16 

mg/kg.

UFA = 10x 

UFH =10x 

FQPA SF = 1x 

Acute RfD = 0.07 mg/kg/ 

day.

aPAD = 0.07 mg/kg/day 

Wolansky BMD = 11.20 mg/kg based on 

motor activity. 

Acute dietary (children <6 years old) ........ Wolansky BMDL1SD = 7.16 

mg/kg.

UFA = 10x 

UFH =10x 

FQPA SF = 3x 

Acute RfD = 0.07 mg/kg/ 

day.

aPAD = 0.023 mg/kg/day 

Wolansky BMD = 11.20 mg/kg 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.

UFA = 10x 

UFH =10x 

FQPA SF = 3x 

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

motor activity. 

Inhalation short-term (1 to 30 days) (children <6 years old).NOAEL = 0.01 mg/L ..........

HEC = 0.008 mg/L 

HED = 1.15 mg/kg/day 

UFA = 3x 

UFH = 10x 

FQPA SF = 3x 

LOC for MOE = 100 .......... 21-Day inhalation study in the rat. 

LOAEL = 0.05 mg/L based on increased salivation. 


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

RISK ASSESSMENT—Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Inhalation short-term (1 to 30 days) (children ≥ 6 years old and adults).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 salivation. 

Cancer (oral, dermal, inhalation) ............... Zeta-cypermethrin has been classified as a possible human carcinogen. 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. 

1SD = 1 standard deviation. BMD = benchmark dose. BMDL = benchmark dose (lower limit of a 95% confidence interval). FQPA SF = Food 

Quality Protection Act Safety Factor. HEC = human equivalent concentration. HED = human equivalent dose. L = Liter. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal 

to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to zeta-cypermethrin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing zeta-cypermethrin tolerances in 

40 CFR 180.418. EPA assessed dietary 

exposures from zeta-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 zetacypermethrin. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA conducted a 

partially refined (probabilistic) dietary 

exposure assessment to determine the 

exposure and risk estimates which 

result from all the existing uses of 

cypermethrin and zeta-cypermethrin, as 

well as proposed new uses of alphacypermethrin and zeta-cypermethrin. 

Anticipated residues from USDA 

Pesticide Data Program (PDP) 

monitoring data, field trial data, and 

empirical processing factors were used 

where appropriate. Percent crop treated 

(PCT) estimates were used for some 

commodities. 

ii. Chronic exposure. Based on the 

data summarized in Unit III.A., there is 

no increase in hazard from repeated 

exposures to zeta-cypermethrin; the 

acute dietary exposure assessment is 

protective for chronic dietary exposures 

because acute exposure levels are higher 

than chronic exposure levels. 

Accordingly, a dietary exposure 

assessment for the purpose of assessing 

chronic dietary risk was not conducted. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or non-linear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or non-linear approach is 

used and a cancer RfD is calculated 

based on an earlier non-cancer key 

event. If carcinogenic mode of action 

data are not available, or if the mode of 

action data determines a mutagenic 

mode of action, a default linear cancer 

slope factor approach is utilized. 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 zetacypermethrin. 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 zeta-cypermethrin 

residues in foods. 

iv. Anticipated residue and percent 

crop treated (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 call-ins 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. 

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. 

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 for the following crops 

that are currently registered for zetacypermethrin/cypermethrin: 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, 


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30%; potato, 5%; spinach, 45%; sweet 

corn, 20%; 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 for 

the following crops that are currently 

registered for cypermethrin/zetacypermethrin: 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%; 

spinach, 30%; sweet corn, 15%; tomato, 

5%; and watermelon, 2.5%. 

In most cases, EPA uses available data 

from the 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 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 zeta-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 zeta-cypermethrin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

zeta-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 zetacypermethrin for acute exposures are 

estimated to be 3.77 parts per billion 

(ppb) for surface water and 0.0036 ppb 

for ground water. The annual average 

typically used for chronic exposures are 

estimated to be 0.066 ppb for surface 

water and 0.0036 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 3.77 ppb was 

used to assess the contribution to 

drinking water. For the purpose of 

assessing short-term aggregate risk (i.e., 

food, drinking water, and residential 

exposures) the chronic water 

concentration value of 0.066 ppb was 

used to assess the contribution to 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

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

indoor pest control, termiticides, and 

flea and tick control on pets). 

Cypermethrin and zeta-cypermethrin 

are registered for use on a variety of 

indoor and outdoor residential 

environments including: Lawns, 

gardens, pets, and indoor surfaces and 

spaces. 

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. 

Post-application inhalation exposure 

resulting from activities on or around 

previously treated turf is generally not 

assessed; 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 

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. 


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• 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 one. 

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 overly 

conservative 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 zeta-cypermethrin, 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/ 

pyrethrins was published in the Federal 

Register issue of November 9, 2011 (76 

FR 69726) (FRL–8888–9), and is 

available at http://www.regulations.gov 

in the 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 

number 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 zeta-cypermethrin 

will not significantly impact the 

cumulative assessment because, in the 

cumulative assessment, residential 

exposure was the greatest contributor to 

the total exposure. As there are no new 

residential uses for the cypermethrins, 

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 zeta-cypermethrin is specific to the 

cypermethrins, 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. 

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 10-fold (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 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. 

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 

studies where body weight 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, 

specifically in the form of neurotoxicity. 

Examination of pharmacokinetic and 


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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. EPA is reducing the 

FQPA SF 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. The decisions regarding 

the FQPA SFs being used are 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 zeta-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 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 alpha-cypermethrin, cypermethrin, 

and zeta-cypermethrin 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 

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 

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 physiologically-based 

pharmacokinetic (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 to 1X because there is 

no evidence in the 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, that pyrethroids directly impact 

developing fetuses. Additionally, 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 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-dependant sensitivity 

related to pharmacokinetics. EPA is 

seeking additional data to further 

characterize the potential neurotoxicity 

for pyrethroids. 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: 

• 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 

juvenile sensitivity (i.e., sensitivity seen 

in body weight changes occurred at 

doses above the level chosen for the 

POD). 

• Data showing that the potential 

sensitivity at high doses is likely due to 

pharmacokinetics. 

• 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. 

• Data indicating that the rat is a 

conservative model compared to the 

human based on species-specific 

pharmacodynamics of homologous 

sodium channel isoforms. 


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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 fact that a 

greater sensitivity to the neurotoxicity of 

pyrethroids is not found in guideline 

studies following in utero exposures 

(based on 76 studies for 24 pyrethroids) 

supports this conclusion, despite the 

relatively high doses used in the 

studies. Second, in vitro and in vivo 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. 

The portion of the uncertainty factor 

that accounts for potential 

pharmacodynamic differences between 

animals and rats (i.e., the inter-species 

extrapolation factor) are likely to 

overstate the risk of zeta-cypermethrin 

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 zeta-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 inter-species factor does 

not provide extra protection due to the 

conservative nature of their 

pharmacodynamic components for 

pyrethroids, the 3X additional factor 

will protect the young. 

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, cypermethrin, and zetacypermethrin will occupy 87% of the 

aPAD for all infants less than 1 year old 

and children 1–2 years old, the 

population groups receiving the greatest 

exposure. 

2. Chronic risk. Based on the data 

summarized in Unit III.A., there is no 

increase in hazard with increasing 

dosing duration. Furthermore, chronic 

dietary exposures will be lower than 

acute exposures. 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). 

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 cypermethrin and zetacypermethrin. 

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, 

inhalation, and incidental 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 LOC values for children 

younger than 6 years old were different 

for oral and inhalation exposure, with 

an incidental oral LOC of 300, and an 

inhalation LOC of 100. Likewise, the 

inhalation and dietary LOCs for adults 

were different, with an inhalation LOC 

of 30 and a dietary LOC of 100. 

Therefore, the respective risk estimates 

are combined using the 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 

zeta-cypermethrin is acutely toxic and 

does 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 

cypermethrin and zeta-cypermethrin 

exposure. 

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 alphacypermethrin, cypermethrin, and zetacypermethrin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate tolerance-enforcement 

methods are available in ‘‘PAM Volume 

II’’ for determining residues of alphacypermethrin, cypermethrin, and zetacypermethrin 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 8 

stereoisomers), zeta-cypermethrin 


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(enriched in 4 isomers) and alphacypermethrin (2 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 

zeta-cypermethrin, but all are in 

conjunction with MRLs for total 

cypermethrin isomers (no MRLs have 

been established solely for zetacypermethrin). However, although the 

definitions of the covered isomers in the 

Codex MRLs and U.S. tolerances differ 

formally, they are effectively 

harmonized since the tolerance 

enforcement methods are not stereospecific, and thus do not distinguish 

between residues of alphacypermethrin, cypermethrin, and zetacypermethrin. For enforcement 

purposes, the same moiety is being 

regulated. These tolerances will result 

in harmonized MRLs between EPA and 

Codex for mango (at 0.7 ppm) and 

papaya (at 0.5 ppm). The tolerances for 

artichoke, barley, buckwheat, oats, and 

rye will not be harmonized with Codex 

for the following reasons. In the case of 

artichoke, Codex has set a lower MRL of 

0.1 ppm based on field trials conducted 

with alpha-cypermethrin with a 

different use pattern, including a lower 

use rate and longer pre-harvest interval 

(PHI). The Agency’s tolerance for 

artichoke of 0.6 ppm is supported by the 

submitted residue data, with a higher 

use rate and shorter PHI. In addition, for 

grains (barley, oats, buckwheat, and 

rye), the Codex MRLs assume a postharvest treatment whereas the proposed 

use pattern in the United States is for 

pre-harvest treatment. 

C. Response to Comments 

A comment was received that 

objected to the proposed tolerances 

primarily because of the amounts of 

pesticides already consumed and 

carried by the American population. 

The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned 

completely. However, under the existing 

legal framework provided by FFDCA 

section 408, EPA is authorized to 

establish pesticide tolerances or 

exemptions where persons seeking such 

tolerances or exemptions have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. This citizen’s comment appears 

to be directed at the underlying statute 

and not EPA’s implementation of it; the 

citizen has made no contention that 

EPA has acted in violation of the 

statutory framework. 

D. Revisions to Petitioned-for 

Tolerances 

The Agency has modified the levels 

for which tolerances are being 

established for artichoke, globe (0.80 to 

0.60 ppm); barley, grain (1.7 to 3.0 

ppm); barley, hay (5.0 to 6.0 ppm); 

barley, straw (19.0 to 20 ppm); 

buckwheat, grain (1.7 to 3.0 ppm); 

buckwheat, hay (5.0 to 6.0 ppm); 

buckwheat, straw (19.0 to 20.0 ppm); 

oat, grain (1.7 to 3.0 ppm); oat, hay (5.0 

to 6.0 ppm); oat, straw (19.0 to 20.0 

ppm); rye, grain (1.7 to 3.0 ppm); rye, 

hay (5.0 to 6.0 ppm); rye, straw (19.0 to 

20.0 ppm); mango (0.45 to 0.70 ppm); 

and avocado; canistel; papaya; 

sapodilla; sapote, black; sapote, mamey; 

and star apple (0.45 to 0.50 ppm). These 

revisions are due to either EPA’s use of 

the Organization for Economic 

Cooperation and Development (OECD) 

tolerance calculation procedures or to 

harmonize with Codex MRLs. 

Also, EPA has revised the tolerance 

expression to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of zetacypermethrin not specifically 

mentioned. 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the insecticide, zetacypermethrin, (S-cyano(3- 

phenoxyphenyl) methyl (±))(cis-trans 3- 

(2,2-dichloroethenyl)-2,2 

dimethylcyclopropanecarboxylate), 

including its metabolites and degradates 

in or on pistachio at 0.05 ppm; 

artichoke, globe at 0.60 ppm; barley, 

grain at 3.0 ppm; barley, hay at 6.0 ppm; 

barley, straw at 20 ppm; buckwheat, 

grain at 3.0 ppm; buckwheat, hay at 6.0 

ppm; buckwheat, straw at 20.0 ppm; oat, 

grain at 3.0 ppm; oat, hay at 6.0 ppm; 

oat, straw at 20.0 ppm; rye, grain at 3.0 

ppm; rye, hay at 6.0 ppm; rye, straw at 

20.0 ppm; mango at 0.70 ppm; and 

avocado; canistel; papaya; sapodilla; 

sapote, black; sapote, mamey; and star 

apple at 0.50 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 


srobinson on DSK4SPTVN1PROD with 
72984 Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Rules and Regulations 

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: November 30, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.418, revise the introductory 

text of paragraph (a)(2) and 

alphabetically add the following 

commodities to the table in paragraph 

(a)(2) to read as follows: 

§ 180.418 Cypermethrin and an isomer 

zeta-cypermethrin; tolerances for residues. 

(a) * * * 

(2) Tolerances are established for 

residues of zeta-cypermethrin, (Scyano(3-phenoxyphenyl) methyl 

(±))(cis-trans 3-(2,2-dichloroethenyl)-2,2 

dimethylcyclopropanecarboxylate), 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table 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 

* * * * * 

Artichoke, globe ...................... 0 .60 

Avocado .................................. 0 .50 

Barley, grain ........................... 3 .0 

Barley, hay .............................. 6 .0 

Barley, straw ........................... 20 .0 

* * * * * 

Buckwheat, grain .................... 3 .0 

Buckwheat, hay ...................... 6 .0 

Buckwheat, straw ................... 20 .0 

* * * * * 

Canistel ................................... 0 .50 

* * * * * 

Mango ..................................... 0 .70 

* * * * * 

Oat, grain ................................ 3 .0 

Oat, hay .................................. 6 .0 

Oat, straw ............................... 20 .0 

* * * * * 

Papaya .................................... 0 .50 

* * * * * 

Pistachio ................................. 0 .05 

* * * * * 

Rye, grain ............................... 3 .0 

Rye, hay ................................. 6 .0 

Rye, straw ............................... 20 .0 

* * * * * 

Sapodilla ................................. 0 .50 

Sapote, black .......................... 0 .50 

Sapote, mamey ...................... 0 .50 

* * * * * 

Star apple ............................... 0 .50 

* * * * * 

* * * * * 

[FR Doc. 2012–29683 Filed 12–6–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0759; FRL–9371–3] 

Buprofezin Pesticide Tolerances; 

Technical Correction 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; technical correction. 

SUMMARY: EPA issued a final rule in the 

Federal Register of Wednesday, October 

17, 2012, concerning buprofezin 

pesticide tolerances. This document 

corrects a typographical error. 

DATES: This final rule correction is 

effective December 7, 2012. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0759, 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: 

Amaris Johnson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–9542; email address: 

johnson.amaris@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

The Agency included in the final rule 

a list of those who may be potentially 

affected by this action. 

II. What does this technical correction 

do? 

The preamble for FR Doc. 2012–25548 

published in the Federal Register issue 

of Wednesday, October 17, 2012 (77 FR 

63745) (FRL–9364–9) is corrected as 

follows: On page 63750, third column, 

under Unit IV. D., Revisions to 

Petitoned-for Tolerances, in the second 

paragraph, correct the last word in the 

paragraph, which now reads ‘‘Logan’’ to 

read ‘‘Longan.’’ 

III. Why is this correction issued as a 

final rule? 

Section 553 of the Administrative 

Procedure Act (APA) (5 U.S.C. 

553(b)(3)(B)) provides that, when an 

agency for good cause finds that notice 

and public procedure are impracticable, 

unnecessary, or contrary to the public 

interest, the agency may issue a final 

rule without providing notice and an 

opportunity for public comment. EPA 

has determined that there is good cause 

for making this technical correction 

final without prior proposal and 

opportunity for comment, because it is 


srobinson on DSK4SPTVN1PROD with