53944 Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations 

Subpart HH—New York 

■ 2. Section 52.1683 is amended by 

removing and reserving paragraphs 

(h)(3) and (i)(4), removing paragraphs 

(i)(6)(v) and (i)(6)(vi) and adding 

paragraph (j) to read as follows: 

§ 52.1683 Control strategy: Ozone. 

* * * * * 

(j)(1) The 1990 and 2007 conformity 

emission budgets for the New York 

portion of the New York-Northern New 

Jersey-Long Island nonattainment area 

contained in New York’s January 29, 

2003 SIP revision, amended by New 

York’s June 29, 2003 submittal and 

January 18, 2005 comment letter. 

(2) The revised commitment to 

perform a mid-course review and 

submit the results by December 31, 2004 

included in the January 29, 2003 SIP 

revision is approved. 

[FR Doc. 05–18094 Filed 9–12–05; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0205; FRL–7725–7] 

Cyfluthrin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of cyfluthrin in 

or on almond hulls, cucurbit vegetable 

crop group 9, fruiting vegetable group 8; 

grass forage; grass hay; grape; grape, 

raisin; leafy Brassica greens, subgroup 

5B; leafy vegetable group, except 

Brassica, group 4; pistachio; pome fruit 

group 11; stone fruit group 12; tuberous 

and corm vegetable subgroup 1C; 

peanut; peanut, hay; pea and bean, 

dried shelled, except soybean, subgroup 

6C; tree nuts, Crop Group 14; turnip 

greens; wheat forage; wheat hay; and 

wheat straw. Bayer CropScience and the 

Interregional Research Project Number 4 

(IR–4) requested the tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 13, 2005. Objections and 

requests for hearings must be received 

on or before November 14, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2005–

0205.All documents in the docket are 

listed in the EDOCKET index at http:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: Olga 

Odiott, Registration Division (7505C), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9369; e-mail address: 

odiott.olga@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings 

In the Federal Register of January 28, 

2004 (69 FR 4143) (FRL–7339–6), EPA 

issued a notice pursuant to section 

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

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

pesticide petitions (PP 1F6290, 2F6445, 

and 2F6479) by Bayer CropScience, 2 

T.W. Alexander Drive, Research 

Triangle Park, NC 27709; and (PP 

1E6318, 3E6776, and 3E6583) by the 

Interregional Research Project Number 4 

(IR-4), Technology Centre and Rutgers 

State University of New Jersey, 681 U.S. 

Highway #1 South, North Brunswick, NJ 

08902–390. The petitions requested that 

40 CFR 180.436 be amended by 

establishing tolerances for residues of 

the insecticide cyfluthrin, cyano (4- 

fluoro-3-phenoxyphenyl)methyl-3-(2,2- 

dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate, in or on 

almond hulls at 1.0 parts per million 

(ppm); pistachio at 0.01 ppm; and tree 

nuts, crop group 14 at 0.01 ppm (PP 

1F6290); cucurbit vegetable crop group 

at 0.10 ppm; fruiting vegetable group at 

0.5 ppm; leafy Brassica greens subgroup 

at 7.0 ppm; leafy vegetable group at 6.0 

ppm; pome fruit group at 0.10 ppm; 

pome fruit wet pomace at 0.30 ppm; 

stone fruit group at 0.30 ppm; wheat 

forage, wheat hay and wheat straw at 5.0 

ppm; and wheat shorts at 3.5 ppm (PP 

2F6445); grape at 0.8 ppm; grape, raisin 

at 3.5 ppm; peanut at 0.01 ppm; and 

peanut, hay at 6.0 ppm (PP 2F6479); 

tuberous and corm vegetable subgroup 

at 0.01 ppm (PP 1E6318); turnip greens 

at 7 ppm (PP 3E6583); and grass forage 

at 6 ppm; grass hay at 8 ppm; and pea 

and bean, dried shelled, except soybean, 

subgroup 6C at 0.15 ppm (PP 3E6776). 

That notice included a summary of the 

petition prepared by Bayer Crop 

Science, the registrant. The registrant 

has submitted a request to voluntarily 

Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations 53945 

cancel uses of cyfluthrin on stored 

grains effective December 31, 2004. 

Based on EPA’s review, the petitions 

were revised by the petitioners as 

follows: i. by increasing proposed 

tolerances for grapes to 1.0 ppm and the 

proposed tolerances for wheat hay and 

straw to 6.0 ppm; ii. by increasing the 

proposed pome fruit crop group 

tolerance to 0.5 ppm to harmonize with 

the Codex apple MRL and deleting the 

proposed tolerance on pome fruit wet 

pomace since expected residues are 

below the pome fruit tolerance of 0.5 

ppm; iii. by decreasing proposed 

tolerances for almond hulls to 0.5 ppm; 

iv. by removing tolerances for peanut oil 

since residues will be lower than 

residues in peanuts; v. by removing 

tolerances in prume since maximum 

expected residues are below the 

proposed tolerance for the stone fruit 

crop group; and vi. by withdrawing the 

proposed tolerance for wheat shorts 

since it is already covered under wheat 

milled by products. 

Although EPA requested a number of 

changes to the initial petitions, the 

nature of the changes (changes in 

tolerance levels) are not considered 

significant. Therefore, EPA is issuing 

this as a final action. EPA is also 

removing the existing tolerance for 

potato, since a tolerance is being 

established on the entire tuberous and 

corm vegetable subgroup; removing 

time-limited tolerances established for 

grape and grape, raisin at 1.0 and 1.5 

ppm, respectively, in connection with 

Section 18 emergency exemptions since 

they are no longer needed; and 

establishing tolerances with regional 

registrations for grass forage and hay. 

One comment was received in 

response to the notice of filing. The 

comment is described and discussed in 

Unit V. Comments. 

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. . . .’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of FFDCA 

and a complete description of the risk 

assessment process, see the final rule on 

Bifenthrin Pesticide Tolerances in the 

Federal Register November 26, 1997 (62 

FR 62961) (FRL–5754–7). 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for the cyfluthrin tolerances 

described in Unit II. EPA’s assessment 

of exposures and risks associated with 

establishing the tolerances 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 nature of the 

toxic effects caused by cyfluthrin and its 

enriched isomer, beta-cyfluthrin] as well 

as the no-observed-adverse-effect-level 

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

toxicity studies reviewed are discussed 

in the Federal Register of September 27, 

2002 (67 FR 60976) (FRL–7199–8). 

Cyfluthrin is a type II pyrethroid (i.e., 

it has a cyano group at the carbon 

position of the alcohol moiety and it is 

more effective when the ambient 

temperature is raised). Beta-cyfluthrin is 

an enriched isomer of cyfluthrin. 

Bridging data on beta-cyfluthrin were 

submitted so that the toxicity of betacyfluthrin could be compared with that 

of cyfluthrin and the databases could be 

combined to form one complete 

database for both chemicals. The 

scientific quality of the data is relatively 

high, and the toxicity profiles of both 

cyfluthrin and beta-cyfluthrin can be 

characterized for all effects, including 

potential developmental, reproductive 

and neurotoxic effects. A beta-cyfluthrin 

developmental neurotoxicity study has 

been submitted and a preliminary 

review indicates that effects are seen 

only at doses higher than those chosen 

for risk assessment purposes. 

B. Toxicological Endpoints 

The dose at which no adverse effects 

are observed (the NOAEL) from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intraspecies differences. 

Three other types of safety or 

uncertainty factors may be used: 

‘‘Traditional UFs’’ the ‘‘special FQPA 

safety factor;’’ and the ‘‘default FQPA 

safety factor.’’ By the term ‘‘traditional 

UF,’’ EPA is referring to those additional 

UFs used prior to FQPA passage to 

account for database deficiencies. These 

traditional UFs have been incorporated 

by the FQPA into the additional safety 

factor for the protection of infants and 

children. The term ‘‘special FQPA safety 

factor’’ refers to those safety factors that 

are deemed necessary for the protection 

of infants and children primarily as a 

result of the FQPA. The ‘‘default FQPA 

safety factor’’ is the additional 10X 

safety factor that is mandated by the 

statute unless it is decided that there are 

reliable data to choose a different 

additional factor (potentially a 

traditional UF or a special FQPA safety 

factor). 

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (aRfD or cRfD) where the RfD is 

equal to the NOAEL divided by an UF 

of 100 to account for interspecies and 

intraspecies differences and any 

traditional UFs deemed appropriate 

(RfD = NOAEL/UF). Where a special 

FQPA safety factor or the default FQPA 

safety factor is used, this additional 

factor is applied to the RfD by dividing 

the RfD by such additional factor. The 

acute or chronic Population Adjusted 

Dose (aPAD or cPAD) is a modification 

of the RfD to accommodate this type of 

safety factor. 

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the LOC. For example, when 

100 is the appropriate UF (10X to 

account for interspecies differences and 

53946 Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations 

10X for intraspecies differences) the 

LOC is 100. To estimate risk, a ratio of 

the NOAEL to exposures (margin of 

exposure (MOE) = NOAEL/exposure) is 

calculated and compared to the LOC. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk). An example of how such a 

probability risk is expressed would be to 

describe the risk as one in one hundred 

thousand (1 x 10-5), one in a million (1 

x 10- 6), or one in ten million (1 x 10-7). 

Under certain specific circumstances, 

MOE calculations will be used for the 

carcinogenic risk assessment. In this 

non-linear approach, a ‘‘point of 

departure’’ is identified below which 

carcinogenic effects are not expected. 

The point of departure is typically a 

NOAEL based on an endpoint related to 

cancer effects though it may be a 

different value derived from the dose 

response curve. To estimate risk, a ratio 

of the point of departure to exposure 

(MOEcancer = point of departure/ 

exposures) is calculated. 

A summary of the toxicological 

endpoints for cyfluthrin used for human 

risk assessment is shown in following 

Table 1: 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CYFLUTHRIN FOR USE IN HUMAN RISK ASSESSMENT

Exposure Scenario 

Dose Used in Risk Assessment, Interspecies and 

Intraspecies and any Traditional UF 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute dietary (general population including infants and 

children) 

NOAEL = 2.0 mg/kg/day 

UF = 100 

Acute RfD = 0.02 mg/kg/day 

Special FQPA SF = 1 

aPAD = acute RfD = 0.02 

mg/kg/day 

Acute mammalian neurotoxicity (betacyfluthrin) 

LOAEL = 10 mg/kg/day based on clinical 

signs, changes in FOB parameters and decreases in motor activity. 

Chronic dietary (all populations) NOAEL = 2.4 mg/kg/day 

UF = 100 

Chronic RfD = 0.024 mg/kg/ 

day 

Special FQPA SF = 1 

cPAD = chronic RfD = 

0.024 mg/kg/day 

53–week chronic toxicity feeding - dog 

(cyfluthrin) 

LOAEL = 10.64 mg/kg/day based on clinical 

signs, gait abnormalities, and abnormal postural reactions. 

Incidental oral short term, and 

intermediate-term (1 to 30 

days and 1 to 6 

months)(residential) 

NOAEL = 2.36/2.5 mg/kg/day Special FQPA SF = 1 

LOC for MOE = 100 

90–day dog feeding study (beta-cyfluthrin) 

LOAEL = 13.9/15.4 mg/kg/day for males/females, respectively based on gait abnormalities, increased incidence of vomiting, and 

suggestive decreased body weight gain. 

Short-term and intermediateterm dermal (1 to 30 days 

and 1 to 6 months) (residential) 

oral study NOAEL = 2.36/2.5 

mg/kg/day (dermal 

absortion rate = 5% 

LOC for MOE = 100 90–day dog feeding study (beta- cyfluthrin) 

LOAEL = 13.9/15.4 mg/kg/day for males/females, respectively, based on gait abnormalities, increased incidence of vomiting, 

and suggestive decreased body weight gain. 

Long-term dermal (several 

months to lifetime) (residential) 

Oral study NOAEL = 2.4 mg/ 

kg/day (dermal absorption 

rate = 5% when appropriate) 

LOC for MOE = 100 53–week chronic toxicity feeding - dog 

(cyfluthrin) 

LOAEL = 10.64 mg/kg/day based on clinical 

signs, gait abnormalities, and abnormal postural reactions. 

Short-term inhalation (1 to 30 

days) (residential) 

inhalation study NOAEL = 

0.00026 mg/L (0.07 mg/kg/ 

day) (inhalation absorption 

rate = 100%) 

LOC for MOE= 100 28–day inhalation study - rat (beta-cyfluthrin) 

LOAEL = 0.0027 mg/L (0.73 mg/kg/day) based 

on decreases in body weight in both sexes 

and decreased urinary pH in males. 

Intermediate and long-term inhalation (1 to 6 months and 

<6 months) (residential) 

inhalation study NOAEL = 

0.00009 mg/L (0.02 mg/kg/ 

day) (inhalation absorption 

rate = 100%) 

LOC for MOE = 100 13–week inhalation study - rat (cyfluthrin) 

LOAEL = 0.00071 mg/L (0.16 mg/kg/day) 

based on decreases in body weight and 

body weight gain in males and clinical signs 

in females. 

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

C. Exposure Assessment 

The residue included in the risk 

assessment and tolerance expression for 

plants and animals is cyfluthrin per se. 

Parent cyfluthrin is also the residue of 

concern in the drinking water 

assessment. 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.436) for the 

residues of cyfluthrin, in or on a variety 

of raw agricultural commodities. 

Tolerances have been established on 

plant commodities ranging from 0.01 

ppm for corn grain and potatoes to 300 

ppm for aspirated grain fractions and on 

animal commodities ranging from 0.01 

ppm for poultry commodities to 15 ppm 

for milk fat. In addition, a tolerance of 

0.05 ppm is established for cyfluthrin in 

animal feeds and processed foods as a 

Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations 53947 

result of its use in food, and feedhandling establishments. 

Although the uses on stored grain 

have been voluntarily cancelled by the 

registrant established tolerances 

reflecting these uses are to remain in 40 

CFR § 180.436(a)(1) to allow for 

clearance of the remaining product and 

treated stored grain from the channels of 

trade. Although the Agency did not 

specifically include potential cyfluthrin 

residues in stored grains in the dietary 

exposure assessments, the Agency 

concludes that these assessments do not 

underestimate dietary exposure and risk 

because: 

• About 90% of the stored grain usage 

was for treatment of stored wheat grain, 

so potential exposure from cyfluthrin 

use on stored grains would come from 

wheat; 

• Residue monitoring data in wheat 

flour indicate very low or nondetectable residues from cyfluthrin use 

on stored grain; 

• The current dietary exposure 

estimates from the remaining existing 

and the newly proposed uses includes 

a new foliar use on wheat. The wheat 

field trial data used to estimate dietary 

exposure reflect maximum rates and 

minimum pre-harvest intervals (PHI’s), 

and these residues were significantly 

higher than monitoring data residues for 

wheat. Monitoring data residues in 

wheat flour from cyfluthrin use on 

stored grain were so low that they 

would not increase dietary exposure 

estimates if they had been included in 

the assessment; 

• Exposure from residues in wheat 

(based on the high end foliar use 

residues) was not significant for any of 

the population subgroups, including 

infants and children; and 

• Residues in stored grains were not 

a major component of secondary residue 

estimates in livestock commodities, and 

concomitant dietary exposure from 

consumption of animal commodities 

such as meat and milk. 

Risk assessments were conducted by 

EPA to assess dietary exposures from 

cyfluthrin in food as follows: 

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse 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. 

In conducting the acute dietary risk 

assessment EPA used the Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEMTM/FCID), which 

incorporates food consumption data as 

reported by respondents in the United 

States Department of Agriculture 

(USDA) 1994–1996, and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII), and 

accumulated exposure to the chemical 

for each commodity. The following 

assumptions were made for the acute 

exposure assessments: Percent crop 

treated (PCT) values for crops with 

established tolerances, for crops with 

proposed tolerances, anticipated 

residues in animal commodities, and 

processing factors (including washing 

and peeling factors). Crop field trial data 

were used for proposed commodities 

and Pesticide Data Program (PDP) 

monitoring data were used for registered 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the DEEMTM software with the 

FCID, which incorporates food 

consumption data as reported by 

respondents in the USDA 1994–1996, 

and 1998 Nationwide CSFII, and 

accumulated exposure to the chemical 

for each commodity. The following 

assumptions were made for the chronic 

exposure assessments: Average PCT 

values for crops with established 

tolerances, projected PCT estimates for 

crops with proposed tolerances, 

anticipated residues in animal 

commodities, and processing factors 

(including washing and peeling factors). 

Crop field trial data were used for 

proposed commodities, and PDP 

monitoring data were used for registered 

commodities. 

iii. Anticipated residue and PCT 

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

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 

chemicals that have been measured in 

food. If EPA relies on such information, 

EPA must pursuant to section 408(f)(1) 

require 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. Following the initial 

data submission, EPA is authorized to 

require similar data on a time frame it 

deems appropriate. For the present 

action, EPA will issue such Data CallIns for information relating to 

anticipated residues as are required by 

FFDCA section 408(b)(2)(E) and 

authorized under FFDCA section 

408(f)(1). Such Data Call-Ins will be 

required to be submitted no later than 

5–years from the date of issuance of this 

tolerance. 

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 the 

Agency can make the following 

findings: Condition 1, that 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 such pesticide residue; 

condition 2, that the exposure estimate 

does not underestimate exposure for any 

significant subpopulation group; and 

condition 3, if data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. In addition, the 

Agency must provide for periodic 

evaluation of any estimates used. To 

provide for the periodic evaluation of 

the estimate of PCT as required by 

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

require registrants to submit data on 

PCT. 

The Agency used PCT information as 

follows. Average and maximum values 

for PCT data were used in the chronic 

and acute analyses, respectively, for the 

following commodities with established 

tolerances: Alfalfa (1 chronic, 2.5 acute), 

broccoli (3 chronic, 5 acute) cabbage (8 

chronic, 12 acute), cantaloupes (2 

chronic, 5 acute), carrots (1 chronic, 5 

acute), cauliflower (1 chronic, 2.5 

acute), corn (5 chronic, 10 acute), cotton 

(10 chronic, 15 acute), garlic (1 chronic, 

2.5 acute), grapefruit (1 chronic, 2.5 

acute), green beans (1 chronic, 2.5 

acute), lemons (5 chronic, 10 acute), 

lettuce (5 chronic, 10 acute), mustard 

greens (1 chronic, 2.5 acute), onions (1 

chronic, 2.5 acute), oranges (15 chronic, 

20 acute), peas (1 chronic, 2.5 acute), 

peppers (10 chronic, 15 acute), potatoes 

(25 chronic, 35 acute), pumpkins (1 

chronic, 5 acute), sorghum (1 chronic, 

2.5 acute), soybeans (1 chronic, 2.5 

acute), squash (1 chronic, 2.5 acute), 

sugarcane (5 chronic, 8 acute), 

sunflowers (3 chronic, 5 acute), sweet 

corn (5 chronic, 8 acute), tangerines (5 

chronic, 8 acute), tomatoes (5 chronic, 8 

acute), and watermelons (5 chronic, 8 

acute). 

Projected PCT estimates were used for 

commodities with proposed tolerances 

as follows: Apples 73%, grapes 23%, 

peaches 39%, pears 59%, plums 28%, 

spinach 15%, winter wheat 4%, and 

collards greens 15%. 

The Agency believes that the three 

conditions listed in Unit III.C.1.iii have 

been met. With respect to Condition 1, 

PCT estimates are derived from 

available federal, state, and private 

market survey data. For existing crop 

sites on pesticide registrations (‘‘existing 

use’’), EPA uses an average PCT for 

chronic dietary exposure estimates. The 

average PCT figure is derived by 

combining available federal, state, and 

private market survey data on the 

existing use, averaging by year, 

averaging across all years, and rounding 

53948 Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations 

up to the nearest multiple of five except 

for those situations in which the average 

PCT is less than one. In those cases < 

1% is used as the average and < 2.5% 

is used as the maximum. EPA uses a 

maximum PCT for acute dietary 

exposure estimates. The maximum PCT 

figure is the single maximum value 

reported overall from available federal, 

state, and private market survey data on 

the existing use, across all years, and 

rounded up to the nearest multiple of 

five. However, in cases where the 

rounded average PCT and the maximum 

PCT were initially identical at 5%, the 

maximum was further adjusted upward 

to 8%. In most cases, EPA uses available 

data from United States Department of 

Agriculture /National Agricultural 

Statistics Service (USDA/NASS), 

Proprietary Market Surveys, and the 

National Center for Food and 

Agriculture Policy (NCFAP) for the most 

recent 6 years. The Agency is reasonably 

certain that the percentage of the food 

treated is not likely to be an 

underestimation 

The Agency projects PCT for a new 

pesticide use by assuming that the PCT 

for the pesticide’s initial five years will 

not exceed the average PCT of the 

dominant pesticide (the one with the 

largest PCT) within its chemical type 

over three latest available years. For 

apples, grapes, peaches, pears, plums, 

and winter wheat the chemical type 

within which cyfluthrin was compared 

consisted of all other insecticides. For 

spinach and collards the corresponding 

chemical type consisted of all other 

synthetic pyrethroids with which 

cyfluthrin was price competitive (which 

excluded permethrin for spinach). The 

PCTs included in the average may be 

each for the same pesticide or for 

different pesticides since the same or 

different pesticides may dominate for 

each year selected. Typically, EPA uses 

USDA/NASS as the source for raw PCT 

data because it is non-proprietary and 

directly available without computation. 

The assumption was made that 

cyfluthrin would entirely replace the 

current market leader among all 

insecticides for each crop. This 

assumption is a conservative one 

because it is not likely that cyfluthrin 

will entirely replace the market leader 

for each commodity. For spinach and 

collard greens, the Agency looked at all 

the competing pyrethroids only (as 

opposed to all insecticides) and 

assumed that cyfluthrin would compete 

with pyrethroids that are priced 

competitively with cyfluthrin. The 

assumption was made that cyfluthrin 

would entirely replace the current 

market leader among all competitive 

pyrethroids for spinach and collards. 

The value of 15% used for spinach and 

collard greens is very consistent with 

the PCT values determined for the 

registered commodities. These are 

considered to be conservative estimates 

of the percent crop treated that 

cyfluthrin will obtain. 

This method of projecting PCT for a 

new pesticide, with or without regard to 

specific pest(s), produces an upper-end 

projection that is unlikely, in most 

cases, to be exceeded in actuality 

because the dominant pesticide is wellestablished and accepted by farmers. 

Factors that bear on whether a 

projection based on the dominant 

pesticide could be exceeded are whether 

the new pesticide is more efficacious or 

controls a broader spectrum of pests 

than the dominant pesticide within its 

similar type, whether it is more costeffective than the dominant pesticide, 

and whether it is likely to be readily 

accepted by growers and experts. These 

factors have been considered for 

cyfluthrin, and they indicate that it is 

unlikely that actual PCT for cyfluthrin 

will exceed the PCT for the dominant 

pesticide in the next five years. 

As to Conditions 2 and 3, 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 information on the 

regional consumption of food to which 

cyfluthrin may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

cyfluthrin in drinking water. Because 

the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

cyfluthrin. 

The Agency uses the FQPA Index 

Reservoir Screening Tool (FIRST) or the 

Pesticide Root Zone Model/Exposure 

Analysis Modeling System (PRZM/ 

EXAMS), to produce estimates of 

pesticide concentrations in an index 

reservoir. The SCI-GROW model is used 

to predict pesticide concentrations in 

shallow ground water. For a screeninglevel assessment for surface water EPA 

will use FIRST (a Tier 1 model) before 

using PRZM/EXAMS (a Tier 2 model). 

The FIRST model is a subset of the 

PRZM/EXAMS model that uses a 

specific high-end runoff scenario for 

pesticides. Both FIRST and PRZM/ 

EXAMS incorporate an index reservoir 

environment, and both models include 

a percent crop (PC) area factor as an 

adjustment to account for the maximum 

PC coverage within a watershed or 

drainage basin. 

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. The 

primary use of these models by the 

Agency at this stage is to provide a 

screen for sorting out pesticides for 

which it is unlikely that drinking water 

concentrations would exceed human 

health levels of concern. 

Since the models used are considered 

to be screening tools in the risk 

assessment process, the Agency does 

not use estimated environmental 

concentrations (EECs), which are the 

model estimates of a pesticide’s 

concentration in water. EECs derived 

from these models are used to quantify 

drinking water exposure and risk as a 

%RfD or %PAD. Instead drinking water 

levels of comparison (DWLOCs) are 

calculated and used as a point of 

comparison against the model estimates 

of a pesticide’s concentration in water. 

DWLOCs are theoretical upper limits on 

a pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food, and from 

residential uses. Since DWLOCs address 

total aggregate exposure to cyfluthrin 

they are further discussed in the 

aggregate risk sections in Unit III.E. 

Based on the FIRST and SCI-GROW 

models, the EECs of cyfluthrin for acute 

exposures are estimated to be 3.4 ppb 

for surface water and 0.0016 ppb for 

ground water. The EECs for chronic 

exposures are estimated to be 0.082 ppb 

for surface water and 0.0016 ppb 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). 

Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations 53949 

Cyfluthrin is currently registered for 

use on a variety of indoor (e.g. total 

release fogger and crack and crevice 

spray) and outdoor (e.g. spray fogger) 

applications. Residential exposure for 

adults was assessed via the inhalation 

and dermal routes, while exposure for 

infants and children was assessed via 

inhalation, dermal, and oral (hand-tomouth) routes. Outdoor handler 

inhalation and dermal exposure were 

assessed. Residential applicator for 

indoor total release fogger was not 

assessed quantitatively, because indoor 

inhalation exposure to a homeowner 

would likely be less than inhalation 

exposure to a homeowner that would 

result from outdoor lawn treatments. 

Residential post-application 

inhalation exposure following 

treatments to lawns was estimated using 

time weight averages from an 

imidacloprid study (Eberhart and 

Ellisor, 1994). In the study, air 

concentration measurements were taken 

in the vicinity of the volunteer subjects 

performing the Jazzercize routines. 

These data served as appropriate 

surrogate data for cyfluthrin since the 

vapor pressure of cyfluthrin (3.3 x 10-8

torr) is similar to that of imidacloprid 

(6.9 x 10-9 torr). 

Residential MOEs were assessed for 

indoor and outdoor uses for application 

and post-application exposure. This is 

considered a conservative assessment 

assuming the lawn and carpet uses 

happen on the same day. All residential 

cyfluthrin MOEs calculated were well 

above the target MOEs (100 for 

inhalation, oral, and dermal exposures) 

and therefore, do not exceed the 

Agency’s level of concern. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the 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.’’

Cyfluthrin is a member of the 

pyrethroid class of pesticides. EPA is 

not currently following a cumulative 

risk approach based on a common 

mechanism of toxicity for the 

pyrethroids. Although all pyrethroids 

alter nerve function by modifying the 

normal biochemistry and physiology of 

nerve membrane sodium channels, 

available data show that there are 

multiple types of sodium channels and 

it is currently unknown whether the 

pyrethroids as a class have similar 

effects on all channels or whether 

modifications of different types of 

sodium channels would have a 

cumulative effect. Nor do we have a 

clear understanding of effects on key 

downstream neuronal function, e.g., 

nerve excitability, or how these key 

events interact to produce their 

compound specific patterns of 

neurotoxicity. Without such 

understanding, there is no basis to make 

a common mechanism of toxicity 

finding. There is ongoing research by 

the EPA’s Office of Research and 

Development and pyrethroid registrants 

to evaluate the differential biochemical 

and physiological actions of pyrethroids 

in mammals. This research is expected 

to be completed by 2007. When 

available, the Agency will consider this 

research and make a determination of 

common mechanism as a basis for 

assessing cumulative risk. For 

information regarding EPA’s procedures 

for cumulating effects from substances 

found to have a common mechanism on 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative/. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold 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 data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a margin of exposure (MOE) analysis 

or through using uncertainty (safety) 

factors in calculating a dose level that 

poses no appreciable risk to humans. In 

applying this provision, EPA either 

retains the default value of 10X when 

reliable data do not support the choice 

of a different factor, or, if reliable data 

are available, EPA uses a different 

additional safety factor value based on 

the use of traditional uncertainty factors 

and/or FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

susceptibility of rats or rabbits to in 

utero exposure in developmental oral 

studies; however, there was some 

indication of increased susceptibility in 

developmental inhalation studies. A 

clear NOAEL was established for the 

fetal effects in every case. No residual 

uncertainties were identified. 

The data also demonstrated increased 

susceptibility of rats and mice to 

postnatal exposure to cyfluthrin. A clear 

NOAEL was established for the 

offspring effects in every case. No 

residual uncertainties were identified. 

3. Conclusion. EPA determined that 

the FQPA SF to protect infants and 

children should be removed. The 

recommendation is based on the 

following: 

• The toxicology databases for 

cyfluthrin and beta-cyfluthrin together 

are considered adequate for selecting 

toxicity endpoints for risk assessment. 

The toxicity profiles of both cyfluthrin 

and beta-cyfluthrin can be characterized 

for all effects, including potential 

developmental, reproductive and 

neurotoxic effects. Exposure data are 

complete or are estimated based on data 

that reasonably accounts for potential 

exposures. 

• There is no evidence of increased 

susceptibility of rats or rabbits to in 

utero exposure in developmental oral 

studies, and the degree of concern for 

the effects observed in the inhalation 

developmental studies is considered 

low since a clear NOAEL was 

established for the fetal effects in every 

case. 

• The NOAEL used for short-term 

inhalation exposure scenarios is 

protective of the effects seen in the 

developmental studies via the 

inhalation route. 

• The degree of concern for the effects 

observed in the reproductive studies 

was considered low since a clear 

NOAEL was established for the 

offspring effects in every case. 

• The NOAEL used to establish the 

cRfD for all populations is protective of 

the effects seen in the young in the 

reproduction studies. 

• A beta-cyfluthrin developmental 

neurotoxicity study has been submitted 

and a preliminary review indicates that 

effects are seen only at doses higher 

than those chosen for risk assessment 

purposes. 

E. Aggregate Risks and Determination of 

Safety 

To estimate total aggregate exposure 

to a pesticide from food, drinking water, 

and residential uses, the Agency 

calculates DWLOCs which are used as a 

point of comparison against EECs. 

DWLOC values are not regulatory 

standards for drinking water. DWLOCs 

are theoretical upper limits on a 

pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food and residential 

uses. In calculating a DWLOC, the 

Agency determines how much of the 

acceptable exposure (i.e., the PAD) is 

available for exposure through drinking 

water e.g., allowable chronic water 

exposure (mg/kg/day) = cPAD - (average 

53950 Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations 

food + residential exposure). This 

allowable exposure through drinking 

water is used to calculate a DWLOC. 

A DWLOC will vary depending on the 

toxic endpoint, drinking water 

consumption, and body weights. Default 

body weights and consumption values 

as used by the EPA’s Office of Water are 

used to calculate DWLOCs: 2 liter (L)/ 

70 kg (adult male), 2L/60 kg (adult 

female), and 1L/10 kg (child). Default 

body weights and drinking water 

consumption values vary on an 

individual basis. This variation will be 

taken into account in more refined 

screening-level and quantitative 

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer. 

When EECs for surface water and 

ground water are less than the 

calculated DWLOCs, EPA concludes 

with reasonable certainty that exposures 

to the pesticide in drinking water (when 

considered along with other sources of 

exposure for which EPA has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

this time. Because EPA considers the 

aggregate risk resulting from multiple 

exposure pathways associated with a 

pesticide’s uses, levels of comparison in 

drinking water may vary as those uses 

change. If new uses are added in the 

future, EPA will reassess the potential 

impacts of residues of the pesticide in 

drinking water as a part of the aggregate 

risk assessment process. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food to cyfluthrin will 

occupy 42% of the aPAD for the U.S. 

population, 34% of the aPAD for 

females 13–years and older, 85% of the 

aPAD for all infants < 1 year old, and 

81% of the aPAD for children 3-5 years 

old, the children population at greatest 

exposure. In addition, there is potential 

for acute dietary exposure to cyfluthrin 

in drinking water. After calculating 

DWLOCs and comparing them to the 

EECs for surface water and ground 

water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the aPAD, as shown in the following 

Table 2: 

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO CYFLUTHRIN

Population Subgroup aPAD (mg/kg/ day) % aPAD (Food) Surface Water 

EEC (ppb) 

Ground Water 

EEC (ppb) 

Acute DWLOC 

(ppb) 

U.S. population 0.02 42 3.4 0.0 016 400 

All infants (<1 year old) 0.02 85 3.4 0.0016 30 

Children (1–2 years old) 0.02 81 3.4 0.0 016 40 

Females (13–49 years old) 0.02 34 3.4 0.0 016 400 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to cyfluthrin from food 

will utilize 1.5% of the cPAD for the 

U.S. population, 2.4% of the cPAD for 

all infants <1 year old, the infant 

subpopulations at greatest exposure, 

and 5.7% of the cPAD for children 1–

2 years old, the children subpopulation 

at greatest exposure. The registered 

residential termiticide uses do 

constitute a chronic inhalation exposure 

scenario, however, the vapor pressure of 

cyfluthrin is so low (3.3 x 10-8 torr) that 

such exposures are anticipated to be 

negligible. In addition, there is potential 

for chronic dietary exposure to 

cyfluthrin in drinking water. After 

calculating DWLOCs and comparing 

them to the EECs for surface water and 

ground water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD, as shown in the following 

Table 3: 

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON- CANCER) EXPOSURE TO CYFLUTHRIN

Population Subgroup cPAD mg/kg/day %cPAD (Food) Surface Water 

EEC (ppb) 

Ground Water 

EEC (ppb) 

Chronic DWLOC 

(ppb) 

U.S. population 0.024 1.5 0.082 0.0016 840 

All infants (<1 year old) 0.024 2.4 0.082 0.0016 230 

Children (1–2 years old) 0.024 5.7 0.082 0.0016 230 

Females (13–49 years old) 0.024 1.0 0.082 0.0016 720 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Cyfluthrin is currently registered for 

use that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic food and water and 

short-term exposures for cyfluthrin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that food 

and residential exposures aggregated 

result in aggregate MOEs =/>500. These 

aggregate MOEs do not exceed the 

Agency’s level of concern for aggregate 

exposure to food and residential uses. In 

addition, short-term DWLOCs were 

calculated and compared to the EECs for 

chronic exposure of cyfluthrin in 

ground water and surface water. After 

calculating DWLOCs and comparing 

them to-the EECs for surface water and 

ground water, EPA does not expect 

short-term aggregate exposure to exceed 

the Agency’s level of concern, as shown 

in the following Table 4: 

Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations 53951 

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO CYFLUTHRIN

Population Subgroup 

Aggregate MOE 

(Food + Residential) 

Aggregate Level 

of Concern (LOC) 

Surface Water 

EEC (ppb) 

Ground Water 

EEC (ppb) 

Short-Term 

DWLOC (ppb) 

Adult male 500 100 0.082 0.0016 630 

Adult female 500 100 0.082 0.0016 540 

Child 500 100 0.082 0.0016 180 

Infant 550 100 0.082 0.0016 200 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

food and residential exposures 

aggregated result in aggregate MOEs =/ 

> 250. These aggregate MOEs do not 

exceed the Agency’s level of concern for 

aggregate exposure to food and 

residential uses. In addition, 

intermediate-term DWLOCs were 

calculated and compared to the EECs for 

chronic exposure of cyfluthrin in 

ground and surface water. After 

calculating DWLOCs and comparing 

them to the EECs for surface water and 

ground water, EPA does not expect 

intermediate-term aggregate exposure to 

exceed the Agency’s level of concern, as 

shown in following Table 5: 

TABLE 5.—AGGREGATE RISK ASSESSMENT FOR INTERMEDIATE-TERM EXPOSURE TO CYFLUTHRIN

Population Subgroup 

Aggregate MOE 

(Food + Residential) 

Aggregate Level 

of Concern (LOC) 

Surface Water 

EEC (ppb) 

Ground Water 

EEC (ppb) 

Intermediate-Term 

DWLOC (ppb) 

Adult male 250 100 0.082 0.0016 490 

Adult female 250 100 0.082 0.0016 420 

Child 300 100 0.082 0.0016 160 

Infant 290 100 0.082 0.0016 160 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to cyfluthrin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(GC/electron capture detection (ECD) 

methods) is available in PAM Vol. II to 

enforce the tolerances. GC/ECD 

enforcement method 85823, and Bayer’s 

GC/MS method 108139–1, with 

modifications, were used to analyze 

samples in the current crop field trials 

and processing studies. Each method 

was adequately validated using fortified 

control samples analyzed in conjunction 

with the field trial or processing study 

samples. 

B. International Residue Limits 

A tolerance of 0.5 ppm is 

recommended for the pome fruit crop 

group to harmonize with the Codex 

apple MRL. 

V. Comments 

In response to the notice of filing one 

communication was received from a 

private citizen objecting to the 

establishment of the proposed 

tolerances. The comment contained 

general and unsubstantiated objections 

to the use of pesticides on food , the use 

of animal testing to determine the safety 

of pesticides, and EPA’s risk assessment 

and safety finding methodologies. The 

Agency understands the commentor’s 

concerns and recognizes that some 

individuals believe that pesticides 

should be banned completely. However, 

under the existing legal framework 

provided by section 408 of the Federal 

Food, Drug and Cosmetic Act (FFDCA) 

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. 

The Agency disagrees with the 

commenter’s objections to animal 

testing. Since humans and animals have 

complex organ systems and mechanisms 

for the distribution of chemicals in the 

body, as well as processes for 

eliminating toxic substances from their 

systems, EPA relies on laboratory 

animals such as rats and mice to mimic 

the complexity of human and higherorder animal physiological responses 

when exposed to a pesticide. EPA is 

committed, however, to reducing the 

use of animals whenever possible. EPArequired studies include animals only 

when the requirements of sound 

toxicological science make the use of an 

animal absolutely necessary. The 

Agency’s goal is to be able to predict the 

potential of pesticides to cause harmful 

effects to humans and wildlife by using 

fewer laboratory animals as models and 

have been accepting data from 

alternative (to animals) test methods for 

several years. As progress is made on 

finding or developing non-animal test 

models that reliably predict the 

potential for harm to humans or the 

environment, EPA expects that it will 

need fewer animal studies to make 

safety determinations. 

VI. Conclusion 

Therefore, tolerances are established 

for residues of cyfluthrin as requested in 

the revised petitions. 

53952 Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations 

VII. Objections and Hearing Requests 

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of FFDCA provides 

essentially the same process for persons 

to ‘‘object’’ to a regulation for an 

exemption from the requirement of a 

tolerance issued by EPA under new 

section 408(d) of FFDCA, as was 

provided in the old sections 408 and 

409 of FFDCA. However, the period for 

filing objections is now 60 days, rather 

than 30 days. 

A. What Do I Need to Do to File an 

Objection or Request a Hearing? 

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2005–0205 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 14, 2005. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255. 

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VI.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2005–0205, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

VIII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitledFederal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’‘‘Policies 

that have federalism implications’’ is 

defined in the Executive Order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations 53953 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

IX. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 22, 2005. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.436 is amended by 

removing the commodity potato from 

the table in paragraph (a); by 

alphabetically adding new commodities 

to the table in paragraph (a); and by 

adding paragraph (c) to read as follows: 

§ 180.436 Cyfluthrin; tolerances for 

residues. 

(a) *** 

Commodity Parts per million 

Almond, hulls ....................................................................................... 0.5 

Brassica, leafy greens, subgroup 5B .................................................. 7.0 

Fruit, pome, group 11 .......................................................................... 0.5 

Fruit, stone, group 12 .......................................................................... 0.3 

Grape ................................................................................................... 1.0 

Grape, raisin ........................................................................................ 3.5 

Nut, tree, group 14 .............................................................................. 0.01 

Pea and bean, dried shelled, except soybean, subgroup 6C ............. 0.15 

Peanut .................................................................................................. 0.01 

Peanut, hay .......................................................................................... 6.0 

Pistachio .............................................................................................. 0.01 

Turnips, greens .................................................................................... 7.0 

Vegetable, cucurbit, group 9 ............................................................... 0.1 

Vegetable, fruiting, group 8 ................................................................. 0.5 

Vegetable, leafy greens, except Brassica, group 4 ............................ 6.0 

Vegetable, tuberous and corm, subgroup 1C ..................................... 0.01 

Wheat, forage ...................................................................................... 5.0 

Wheat, hay ........................................................................................... 6.0 

Wheat, straw ........................................................................................ 6.0 

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registration, as defined in § 180.1(n), are 

established for residues of cyfluthrin in 

or on the following raw agricultural 

commodities: 

Commodity Parts per million 

Grass, forage .................. 6.0 

Grass, hay ...................... 8.0 

* * * * * 

[FR Doc. 05–17823 Filed 9–12–05; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Office of Inspector General 

45 CFR Part 61 

RIN 0906–AA46 

Health Care Fraud and Abuse Data 

Collection Program: Reporting of Final 

Adverse Actions; Correction 

AGENCY: Office of Inspector General 

(OIG), HHS. 

ACTION: Correction amendment. 

SUMMARY: This document corrects the 

final regulations establishing the 

Healthcare Integrity and Protection Data 

Bank (HIPDB), the national health care 

fraud and abuse data collection program 

for the reporting and disclosing of 

certain adverse actions taken against 

health care providers, suppliers and 

practitioners and for maintaining a data 

base of final adverse actions taken 

against health care providers, suppliers 

and practitioners. In the implementing 

HIPDB regulations published in the 

Federal Register on October 26, 1999 

(64 FR 57740), an inadvertent error 

appeared in the regulations text 

concerning the definition of the term