Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58437

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks April 23, 1997 (62 FR

19885). 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 FFDCA section 408(d), such as

the exemption 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. 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 August 10, 1999 (64 FR

43255). 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

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

X. Submission to Congress and the

Comptroller General

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: September 21, 2000.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

371.

2. In § 180.1001, the table in

paragraph (d) is amended by adding

alphabetically the following inert

ingredient to read as follows:

§ 180.1001 Exemptions from the

requirement of a tolerance.

* * * * *

(d)* * *

Inert ingredients Limits Uses

*****

Yucca extract from

Yucca schidigera.

............. Wetting

agent

*****

* * * * *

[FR Doc. 00–24946 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301061; FRL–6746–5]

RIN 2070–AB78

Hexythiazox; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for residues of the ovicide/

miticide hexythiazox (trans-5-(4-

chlorophenyl)-N-cyclohexyl-4-methyl-2-

oxothiazolidine-3-carboxamide) and its

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety (expressed as

parent) in or on wet apple pomace,

almonds, strawberries, stone fruit

(excluding plums), milk, fat and meat

byproducts in cattle, goats, horses,

swine, and sheep. It also increases the

tolerance in apples and establishes a

tolerance with regional registration in

cotton. Gowan Company requested this

tolerance under the Federal Food, Drug,

and Cosmetic Act, as amended by the

Food Quality Protection Act of 1996.

DATES: This regulation is effective

September 29, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301061,

must be received by EPA on or before

November 28, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301061 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT By

mail: William G. Sproat, Jr., Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave.,

NW.,Washington, DC 20460; telephone

number: (703) 308–8587; and e-mail

address: sproat.william@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

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 the table could also

58438 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. To access the

OPPTS Harmonized Guidelines

referenced in this document, go directly

to the guidelines at http://

www.gpo.gov/opptsfrs/home/

guidelin.htm.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301061. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

Hexythiazox is the active ingredient

in Savey Ovicide/Miticide 50 WP (EPA

Reg. No. 10163–208). Permanent

tolerances are established under 40 CFR

180.448(a) for residues of hexythiazox

and its metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety (expressed as

parent) in/on apples at 0.02 parts per

million (ppm), hops at 2.0 ppm, and

pears at 0.3 ppm. Time-limited

tolerances established under 40 CFR

180.448(b) for residues in/on undelinted

cotton seed and cotton gin byproducts at

0.1 and 2.0 ppm expired on October 10,

1999. Additional time-limited

tolerances for residues in/on dates (0.1

ppm), hops (2.0 ppm), and strawberries

(3.0 ppm) established under 40 CFR

180.448(b) are set to expire on

September 15, 2000.

In the Federal Register of July 31,

1996, 61 FR 39971, (FRL–5384–6); April

30, 1997, 62 FR 23455, (FRL–5600–8);

January 28, 1998, 63 FR 4252, (FRL–

5763–6); and August 26, 1998, 63 FR

45487, (FRL–6023–5), EPA issued a

notice pursuant to section 408 of the

Federal Food, Drug, and Cosmetic Act

(FFDCA), 21 U.S.C. 346a as amended by

the Food Quality Protection Act of 1996

(FQPA) (Public Law 104–170)

announcing the filing of a pesticide

petition (PP 6F4738, 8F4985) for

tolerance by Gowan Company, P.O. Box

5569, Yuma AZ 85366-5569. This notice

included a summary of the petition

prepared by Gowan Company, the

registrant. There were no comments

received in response to the notice of

filing.

The petition(s) requested that 40 CFR

180.448 be amended by establishing a

tolerance for residues of the insecticide

hexythiazox, in or on various food

commodities as follows: (1) On July 31,

1996 PP 6F4738 proposed the

establishment of tolerances for stone

fruits (except plums) at 1 ppm; almond

nutmeat at 0.2 ppm and almond hulls at

10 ppm; milk, cattle meat, and cattle fat

at 0.05 ppm, and cattle meat by

products at 0.1 ppm. On April 30, 1997,

the petitioner refiled the petition

pursuant to the Food Quality Protection

Act (FQPA). On January 28, 1998, the

petitioner amended the tolerance

petition by proposing to establish a

tolerance for stone fruits including

plums at 1 ppm; prunes at 5 ppm; and

all tree nuts at 0.2 ppm. Based upon

EPA’s review of the field residue data,

the tolerance for almonds was changed

from 0.2 ppm to 0.3 ppm. Also, the

commodity terms almonds, nutmeat and

almond hulls was changed to almond

and almond, hulls. EPA was unable to

complete its review of the field residue

data for tree nuts and plums (prunes)

and therefore is limiting tolerances to

stone fruits (except plums) and almond

at this time. Also, the commodity term

Stone Fruits (except plums) was

corrected to read Fruit, stone group

(except plums). Based upon data from a

ruminant feeding study, the tolerances

proposed in milk, cattle fat and meat

byproducts are too high and are reduced

to 0.02 ppm. Tolerances for meat are not

required. The petition was amended to

specify tolerances in cattle, goats,

horses, swine, and sheep fat and meat

byproducts and milk at 0.02 ppm. (2)

On August 26, 1998, PP 8F4985

proposed the establishment of

tolerances for strawberries at 3.0 ppm;

the increase of tolerances in apples from

0.02 ppm to 0.40 ppm; wet apple

pomace at 0.70 ppm; cotton, undelinted

seed at 0.20 ppm; and cotton gin

byproducts at 3.0 ppm, geographically

limited to California only. Based upon

apple processing studies, the pomace

tolerance of 0.70 ppm is too low and is

revised to 0.80 ppm. The use on cotton

is limited to California based on the

geographical representation of the

residue data submitted. Additional

residue data would be required to

expand the area of usage.

Hexythiazox is currently proposed for

use on stone fruits (except plums) to

control European red mites, Twospotted

spider mites, McDaniel spider mite,

Strawberry spider mites, Pacific spider

mites, Pecan leaf scorch mites, and

Willamette mites; almonds to control

European red mites, Twospotted spider

mites, McDaniel spider mites,

Strawberry spider mites, Pacific spider

mites, Pecan leaf scorch mites, and

Willamette mites; strawberries to

control Twospotted spider mites; apples

to control European red mites,

Twospotted spider mites, McDaniel

spider mite, Pacific spider mites, and

Willamette mites; and in cotton to

control Twospotted spider mites,

Strawberry spider mites, Pacific spider

mites, and Carmine spider mites.

Section 408(b)(2)(A)(i) of the 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) 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) 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

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58439

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 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7).

III. Aggregate Risk Assessment and

Determination of Safety

Consistent with 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, consistent with

section 408(b)(2), for a tolerance for

residues of hexythiazox on stone fruits

(except plums) at 1 ppm; almonds at 0.3

ppm and almond hulls at 10 ppm; milk

at 0.02 ppm; fat of cattle, goats, horses,

swine and sheep at 0.02 ppm; meat byproducts of cattle, goats, horses, swine

and sheep at 0.02 ppm; strawberries at

3.0 ppm; wet apple pomace at 0.80 ppm;

cotton, undelinted seed (CA only), at

0.20 ppm; and cotton gin byproducts

(CA only) at 3.0 ppm. This regulation

also increases the tolerance on apples

from 0.02 ppm to 0.50 ppm. EPA’s

assessment of exposures and risks

associated with establishing the

tolerance 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 hexythiazox are

discussed in the following Table 1 as

well as the no observed adverse effect

level (NOAEL) and the lowest observed

adverse effect level (LOAEL) from the

toxicity studies reviewed.

TABLE 1.—SUBCHRONIC, CHRONIC AND OTHER TOXICITY

Guideline No. Study Type Results

870.3100 90–Day oral toxicity rodents NOAEL = 8.1/5.4 mg/kg/day males, females

LOAEL = 58.6/38.1 mg/kg/day, males, females based on increased absolute and relative liver weights in both sexes, increased relative ovarian

and kidney weights, and fatty degeneration of the adrenal zona

fasciculata.

870.3700a Prenatal developmental in rodents Maternal NOAEL = 240 mg/kg/day

LOAEL = 720 mg/kg/day based on decreased maternal body weight gain

and decreased food consumption.

Developmental NOAEL = ≥ 2,160 mg/kg/day

LOAEL > 2,160 mg/kg/day.

870.3700b Prenatal developmental in nonrodents Maternal NOAEL = ≥ 1080 mg/kg/day

LOAEL = > 1,080 mg/kg/day.

Developmental NOAEL = ≥ 1,080 mg/kg/day

LOAEL = > 1,080 mg/kg/day.

870.3800 Reproduction and fertility effects Parental/Systemic NOAEL = 29.73/34.77 mg/kg/day, males/females

LOAEL = 180.67/207.67 mg/kg/day, males/females based on decreased

body weight gain and increased absolute and relative liver, kidney, and

adrenal weights.

Reproductive NOAEL = > 180.67/207.67mg/kg/day, males/females

LOAEL >180.67/207.67 mg/kg/day, males/females.

Offspring NOAEL = 29.73/34.77 mg/kg/day, males/females

LOAEL = 180.67/207.67 mg/kg/day, males/females based on decreased

pup body weight during lactation, and delayed hair growth and/or eye

opening.

870.4100b Chronic toxicity dogs NOAEL = 2.5 mg/kg/day

LOAEL = 12.5 mg/kg/day based on increased absolute and relative adrenal weights and associated adrenal histopathology.

870.4300 Chronic Toxicity/Carcinogenicity rats NOAEL = 23/29 mg/kg/day, males/females

LOAEL = 163/207 mg/kg/day, males/females based on decreased body

weight and body weight gain and increased absolute and relative liver

weights. No evidence of carcinogenicity

870.4300 Carcinogenicity mice NOAEL = 41.6/51.2 mg/kg/day, males/females

LOAEL = 267/318 mg/kg/day, males/females based on decreased male

body weight and body weight gain and increased absolute and relative

liver weights in both sexes. Evidence of carcinogenicity (causes liver tumors in females)

870.5100 Gene Mutation (Salmonella typhimurium and

Escherichia coli reverse gene mutation

assay)

The test was negative up to the highest dose tested (6400 micrograms/

plate +/- S9)

58440 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

TABLE 1.—SUBCHRONIC, CHRONIC AND OTHER TOXICITY—Continued

Guideline No. Study Type Results

870.5300 Gene Mutation (In vitro mammalian cell forward

gene mutation assay in CHO cells)

Independently performed trials were negative up to precipitating doses (≥

micrograms/mL) and severely cytotoxic concentrations (200 micrograms/

mL -S9; 400 micrograms/mL + S9)

870.5375 Cytogenetics (In vitro mammalian cell cytogenetic assay in CHO cells)The test was negative up to precipitating doses accompanied by severe

cytotoxicity (≥ 167 micrograms/mL +/-S9)

870.5395 Cytogenetics (In vivo mouse micronucleus

assay)

The results were inconclusive because a positive response, which was

within the wide range of historical background data, was recorded for female mice at the mid-and high- doses (500 and 10,000 mg/kg). The

assay should be repeated to confirm or refute the equivocal results.

870.5550 Other Effects (In vitro UDS assay in primary rat

hepatocytes

The test was negative up to a lethal dose (250 micrograms/mL).

870.7485 Metabolism and pharmacokinetics Absorption and distribution of dosed radioactivity were rapid. The radioactive material was rapidly eliminated in the urine and feces; the majority of the radioactivity was eliminated within 24 hours. There were no observable differences in the total elimination of NA-73 between male and

female rats. The major route of elimination in both the male and female

rats was by fecal excretion. The major metabolite found, PT-1-8 (cis),

accounted for 8-12% of the administered radioactivity in the low dose

groups. Approximately 11-20% and 65-69% of the dosed radioactivity

was identified as unchanged NA-73 in the low-dose and high-dose

groups, respectively. All other metabolites were present at low concentrations (<2%). There was no apparent sex difference in metabolite

formation. Significant levels of NA-73 equivalent 14C- residues were detected in the fat, liver, and adrenals. A sex-related difference in the residue levels of all tissues was observed, with residues in female tissues

being two-fold higher than those found in male tissues.

870.7485 Metabolism and pharmacokinetics Total recovery of radioactivity 72 hours after treatment accounted for

101.9-103% of the dose. The distribution of radioactivity 72 hours after

dosing was as follows: (1) 30% (male and female) was excreted in the

urine, (2) 60% (female) to 67% (male) was excreted in the feces, and

(3) about 4% (male) to 10% (female) of the administered radioactivity remained in the tissues, with the highest concentration in the fat (2.3 ppm,

males; 5.4 ppm, females). Significant sex differences existed for the

pharmacokinetics of NA-73 in these rats, with females exhibiting slower

elimination rats and higher tissue residues (about double) than males.

NA-73 was metabolized to a large number of metabolites that were excreted both in the urine and feces. Seven metabolites were structurally

identified in addition to the parent compound in both excreta of both

sexes, with the major fecal metabolite, PT-1-8 (cis) accounting for 10%

of the dosed radioactivity. The others were all minor metabolites accounting for less than 1.4%. About 20% of the dose was excreted as unchanged NA-73 (97% of which was in the feces). No significant sex difference was apparent with respect to metabolite formation.

870.7600 Dermal penetration The total percent of dose absorbed averaged 2%, 1%, and 1.1% for

cannulated rats (10-hour sacrifice) and 0.8%, 0.2%, and 0.2% for noncannulated rats (1-hour sacrifice) at the low, medium, and high dose levels, respectively. The amount of radioactivity in the blood, carcass, urine

and other organs totaled <2% of the applied dose. The results of this

study (2% dermal absorption) can be used 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.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, 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 FQPA Safety

Factor.

For non-dietary risk assessments

(other than cancer) the UF is used to

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58441

determine the LOC. For example, when

100 is the appropriate UF (10X to

account for interspecies differences and

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 is expressed as 1 × 10-6 or one

in a million). 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 hexythiazox used for human risk

assessment is shown in the following

Table 2:

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR HEXYTHIAZOX FOR USE IN HUMAN RISK

ASSESSMENT

Exposure scenario Dose used in risk assessment, UF FQPA SF and LOC for risk assessment Study and toxicological effects

Acute Dietary (females 13–50

years of age)

Developmental NOAEL = 240 mg/

kg/day UF = 100 Acute RfD =

2.4 mg/kg/day

FQPA SF = 1X aPAD = acute

RfD/FQPA SF = 2.4 mg/kg/day

Developmental Toxicity Study—

Rat

Developmental LOAEL = 720 mg/

kg/day based on delayed ossification

Acute Dietary (general population

including infants and children)2

Chronic Dietary (all populations) NOAEL = 2.5 mg/kg/day UF =

100 Chronic RfD = 0.025 mg/

kg/day

FQPA SF = 1X cPAD = chronic

RfD/FQPA SF = 0.025 mg/kg/

day

1–Year Toxicity Feeding Study—

Dog

LOAEL = 12.5 mg/kg/day based

on increased absolute and relative adrenal weights and associated adrenal histopathology

Short-Term Dermal (1–7 days)

(Occupational/Residential)

Oral maternal NOAEL = 240 mg/

kg/day (dermal absorption rate

= 2%)

LOC for MOE = 100 (Occupational)Developmental Toxicity Study—

Rat

LOC for MOE = 100 (Residential,

includes the FQPA SF)

LOAEL = 720 mg/kg/day based

on decreased maternal body

weight gain during gestation

days 7–17 and decreased food

consumption on gestation days

9–12

Intermediate-Term Dermal (1

week–several months) (Occupational/Residential)

Oral NOAEL = 5.4 mg/kg/day

(dermal absorption rate = 2%)

LOC for MOE = 100 (Occupational)13–Week Feeding Study—Rat

LOC for MOE = 100 (Residential,

includes the FQPA SF)

LOAEL = 38.1 mg/kg/day based

on increased absolute and relative liver weights in both

sexes, increased relative ovarian and kidney weights, and

fatty degeneration of the adrenal zone fasciculata

Long-Term Dermal (several

months—lifetime) (Occupational/

Residential)

Oral NOAEL = 2.5 mg/kg/day

(dermal absorption rate = 2%)

LOC for MOE = 100 (Occupational)1–Year Feeding Study—Dog

LOC for MOE = 100 (Residential,

includes the FQPA SF)

LOAEL = 12.5 mg/kg/day based

on increased absolute and relative adrenal weights and associated adrenal histopathology

Short-Term Inhalation (1–7 days)

(Occupational/Residential)

Oral NOAEL = 240 mg/kg/day (inhalation absorption rate =

100%)

LOC for MOE = 100 (Occupational)Developmental Toxicity Study—

Rat

58442 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR HEXYTHIAZOX FOR USE IN HUMAN RISK

ASSESSMENT—Continued

Exposure scenario Dose used in risk assessment, UF FQPA SF and LOC for risk assessment Study and toxicological effects

LOC for MOE = 100 (Residential,

includes the FQPA SF)

LOAEL = 720 mg/kg/day based

on decreased maternal body

weight gain during gestation

days 7–17 and decreased food

consumption on gestation days

9–12

Intermediate-Term Inhalation (1

week–several months) (Occupational/Residential)

Oral NOAEL = 5.4 mg/kg/day (inhalation absorption rate =

100%)

LOC for MOE = 100 (Occupational)13–Week Feeding Study—Rat

LOC for MOE = 100 (Residential,

includes the FQPA SF)

LOAEL = 38.1 mg/kg/day based

on increased absolute and relative liver weights in both

sexes, increased relative ovarian and kidney weights, and

fatty degeneration of the adrenal zone fasciculata

Long-Term Inhalation (several

months—lifetime) (Occupational/

Residential)

Oral NOAEL = 2.5 mg/kg/day (inhalation absorption rate =

100%)

LOC for MOE = 100 (Occupational)1–Year Feeding Study—Dog

LOC for MOE = 100 (Residential,

includes the FQPA SF)

LOAEL = 12.5 mg/kg/day based

on increased absolute and relative adrenal weights and associated adrenal histopathology

Cancer (oral, dermal, inhalation) Category C (possible human carcinogen)Q1* = 2.22 x 10-2 Increases in incidence of malignant and combined benign/malignant liver tumors in mice

1 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern 2 A dose and endpoint attributable to a single exposure were not identified from the available oral toxicity studies, including maternal toxicity in

the developmental toxicity studies. * The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.448) for the

residues of hexythiazox, in or on a

variety of raw agricultural commodities.

Tolerances are established on plant

commodities ranging from 0.02 ppm on

apples to 2.0 ppm on hops. Hexythiazox

is the common name for the active

ingredient in Savey Ovicide/Miticide.

When formulated as the product Savey

50 WP, the product is registered for

agricultural use on outdoor terrestrial

food crops. When sold under an

alternate brand name, Hexygon, the

product is also registered for

commercial non-food use on outdoor

ornamental and nursery stock. Savey 50

WP contains 50% hexythiazox by

weight. For these petitions, Savey will

be applied to hops, stone fruit, pome

fruit, strawberry, and cotton crops at a

maximum of 0.1875 pounds of active

ingredient per acre (ai/Acre) (1.6 lbs ai/

Acre for cotton). Savey is formulated

as a wettable powder (packaged in open

bags or water soluble paks) and is

applied once per season or crop. Savey

provides control against tetranychid

mite species by direct or indirect

contact with treated plant surfaces.

According to label specifications the use

of this product may include alternation

of active classes of insecticides on

succeeding generations and targeting the

most susceptible life stage. Risk

assessments were conducted by EPA to

assess dietary exposures from

hexythiazox 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 one

day or single exposure. The Dietary

Exposure Evaluation Model (DEEM)

analysis evaluated the individual food

consumption as reported by

respondents in the USDA 1989–1992

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: For acute dietary

risk assessments, the entire distribution

of single day food consumption events

is combined with a single residue level

(deterministic analysis) to obtain a

distribution of exposure in mg/kg. A

conservative analysis was performed

using existing and recommended

tolerance level residues and 100% crop

treated (CT) information for all

commodities. For acute dietary risk,

EPA’s level of concern is >100% aPAD.

The acute dietary exposure estimate for

the females 13-50 years old subgroup is

presented in Table 3 at the 95th

percentile. The results of the acute

analysis indicate that the estimated

acute dietary risk associated with the

existing and recommended uses of

hexythiazox is below EPA’s current

level of concern for the females 13-50

years old subgroup, as shown in the

following Table 3:

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58443

TABLE 3.—ACUTE RESULT AT 95TH PERCENTILE FROM DEEM ANALYSIS

Subgroup Exposure (mg/kg/

day) % aPAD

Females 13-50 years old 0.002617 <1

For the acute dietary analysis, existing

and recommended tolerance level

residues and 100% CT information were

used for all commodities (conservative,

Tier 1 analysis). DEEM default

processing factors were used.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

DEEM analysis evaluated the

individual food consumption as

reported by respondents in the USDA

1989–1992 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 chronic exposure assessments: For

chronic dietary risk assessments, the 3–

day average of consumption for each

sub-population was combined with

residues in commodities to determine

average exposure in mg/kg/day. A

refined, deterministic analysis was

performed using AR levels for most

crops and % CT or anticipated market

share information for all crops. For

chronic dietary risk, EPA’s level of

concern is >100% cPAD. Dietary

exposure estimates for the U.S.

population and other representative

subgroups are presented in Table 4. The

results of the chronic analysis indicate

that the estimated chronic dietary risk

associated with the existing and

recommended uses of hexythiazox is

below EPA’s current level of concern for

the U.S. population and all population

subgroups, as shown in the following

Table 4:

TABLE 4.—SUMMARY OF RESULTS FROM CHRONIC DEEM ANALYSIS

Subgroups Exposure (mg/kg/day) % cPAD

U.S. Population 0.000011 <1

All infants (<1 year old) 0.000027 <1

Children (1-6 years old) 0.000028 <1

Children (7-12 years old) 0.000015 <1

Females (13-50 years old) 0.000008 <1

Males (13-19 years old) 0.000004 <1

Males (20 + years old) 0.000008 <1

Seniors (55 + years old) 0.000010 <1

For the chronic and cancer analyses,

ARs from field trial data, the weighted

average of %CT Quantitative Usage

Analyses (QUA), and processing factors

(where applicable) were used (see Table

5). DEEM default processing factors

were used unless otherwise noted in the

following Table 5:

TABLE 5.—SUMMARY OF HEXYTHIAZOX ARS FOR CHRONIC AND CANCER DIETARY RISK ASSESSMENT BASED ON FIELDTRIAL DATA

Commodity Recommended Tolerance (ppm) Processing Factor AR (ppm)

CT/Anticipated Market Share

(%)

Almond nutmeat 0.30 NA 0.046 2

Almond hulls 10 NA 2.7 2

Cherries 1.0 NA 0.20 <1

Peaches 1.0 NA 0.14 1

Nectarines 1.0 NA 0.054 2

Undelinted cottonseed 0.20 NA 0.059 1

Cottonseed meal 0.20 0.01 x 0.059 1

Refined cottonseed oil 0.20 0.13 x 0.059 1

Apples 0.50 NA 0.12 2

58444 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

TABLE 5.—SUMMARY OF HEXYTHIAZOX ARS FOR CHRONIC AND CANCER DIETARY RISK ASSESSMENT BASED ON FIELDTRIAL DATA—Continued

Commodity Recommended Tolerance (ppm) Processing Factor AR (ppm)

CT/Anticipated Market Share

(%)

Apple juice 0.50 0.5 xc 0.12 2

Wet apple pomace 0.80 2.4 x 0.12 2

Pearsb 0.30 NA 0.30* 3

Hopsb 2.0 NA 2.0* 45

Datesb 0.10 NA 0.10* 45

Strawberries 3.0 NA 0.75 14

Milk 0.02 NA 0.00019

Livera 0.02 NA 0.0016

Meat by-products (except liver)a 0.02 NA 0.00066

Fata 0.02 NA 0.00021

Hog Meat 0.02 NA 1.0 x 10-9d

Hog Liver 0.02 NA 4.8 x 10-8d

Hog Meat by-products (except liver) 0.02 NA 2.0 x 10-8d

Hog Fat 0.02 NA 6.3 x 10-9d

*Ars were not calculated for these crops

aThese ARs were used for meat, fat and meat by-products of cattle, horses, goats and sheep in the chronic and cancer analyses.

bARs were not calculated for commodities not included in the subject petitions.

cDEEM default ratio kept constant for ‘‘apple-juice/cider’’ and ‘‘apple-juice-concentrate’’. dThese ARs were rounded up to 0.000001 ppm because DEEM can not accomidate more than 6 place holders.

iii. Cancer. A refined, deterministic

carcinogenic risk estimate analysis was

performed using AR levels for most

crops and % CT or anticipated market

share information for all crops. The

dietary exposure estimate for the U.S.

population is presented in Table 6. The

result of the carcinogenicity analysis

indicates that the estimated dietary risk

associated with the existing and

recommended uses is below the level

the Agency generally considers

negligible for excess lifetime cancer risk

(1 × 10-6), as shown in the following

Table 6:

TABLE 6.—SUMMARY OF RESULTS

FROM CARCINOGENIC DEEM ANALYSIS

Subgroup Exposure

(mg/kg/day) Lifetime Risk

U.S. Population 0.000011 2.4 x 10-7

For the cancer analyses, ARs from

field trial data, the weighted average of

%CT (QUA) and processing factors

(where applicable) were used (see Table

5 above). DEEM default processing

factors were used unless otherwise

noted in Table 5.

iv. Anticipated residue and percent

crop treated information. Section

408(b)(2)(E) 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 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. As required by section

408(b)(2)(E), EPA will issue a data callin for information relating to anticipated

residues to be submitted no later than 5

years from the date of issuance of this

tolerance.

Section 408(b)(2)(F) 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 percent crop treated

(PCT) as required by section

408(b)(2)(F), EPA may require

registrants to submit data on PCT.

The Agency used percent crop treated

(PCT) information specified above. The

Agency believes that the three

conditions listed above have been met.

With respect to Condition 1, PCT

estimates are derived from Federal and

private market survey data, which are

reliable and have a valid basis. EPA uses

a weighted average PCT for chronic

dietary exposure estimates. This

weighted average PCT figure is derived

by averaging State-level data for a

period of up to 10 years, and weighting

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58445

for the more robust and recent data. A

weighted average of the PCT reasonably

represents a person’s dietary exposure

over a lifetime, and is unlikely to

underestimate exposure to an individual

because of the fact that pesticide use

patterns (both regionally and nationally)

tend to change continuously over time,

such that an individual is unlikely to be

exposed to more than the average PCT

over a lifetime. For acute dietary

exposure estimates, EPA uses an

estimated maximum PCT. The exposure

estimates resulting from this approach

reasonably represent the highest levels

to which an individual could be

exposed, and are unlikely to

underestimate an individual’s acute

dietary exposure. The Agency is

reasonably certain that the percentage of

the food treated is not likely to be an

underestimation. 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

hexythiazox 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

hexythiazox 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

hexythiazox.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and SCIGROW, which predicts pesticide

concentrations in groundwater. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening-level

assessment for surface water. The

GENEEC model is a subset of the PRZM/

EXAMS model that uses a specific highend runoff scenario for pesticides.

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop 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

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever 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) from these

models 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 hexythiazox

they are further discussed in the

aggregate risk sections below.

Based on the GENEEC and SCI-GROW

models the estimated environmental

concentrations (EECs) of hexythiazox in

surface water and ground water for

acute exposures are estimated to be

910.32 ng/L for surface water and 1.47

ng/L for ground water. The EECs for

chronic exposures are estimated to be

280.88 ng/L for surface water and 1.47

ng/L 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).

Hexythiazox is not registered for use on

any sites that would result in residential

exposure.

4. Cumulative exposure to substances

with a common mechanism of toxicity.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

EPA does not have, at this time,

available data to determine whether

hexythiazox has a common mechanism

of toxicity with other substances or how

to include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

hexythiazox does not appear to produce

a toxic metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not

assumed that hexythiazox has a

common mechanism of toxicity with

other substances. For information

regarding EPA’s efforts to determine

which chemicals have a common

mechanism of toxicity and to evaluate

the cumulative effects of such

chemicals, see the final rule for

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997).

D. Safety Factor for Infants and

Children

1. Safety factor for infants and

children—i. In general. FFDCA section

408 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 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.

ii. Prenatal and postnatal sensitivity.

EPA has evaluated the toxicology data

base of hexythiazox and re-assessed the

cRfD, as well as the toxicological

endpoints recommended for acute

dietary and occupational/residential

exposure risk assessments. The Agency

also addressed the potential enhanced

sensitivity of infants and children from

exposure to hexythiazox as required by

FQPA and concluded that the pre- and

post-natal toxicology data base for

hexythiazox is complete with respect to

FQPA considerations. The results of

these studies indicated no increased

susceptibility of rats or rabbits to in

utero and/or postnatal exposure to

hexythiazox. In the developmental

toxicity study in rabbits, no

58446 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

developmental effects were seen at

doses up to the limit dose. In the

developmental toxicity study in rats, the

developmental effects (delayed

ossification) occurred at the same dose

level (720 mg/kg/day) as the maternal

effects (decreased maternal body weight

gain and decreased food consumption).

In the two generation reproduction

study, the effects in the offspring

(decreased pup body weight during

lactation and delayed hair growth and/

or eye opening) were observed only at

treatment levels which resulted in

evidence of parental toxicity (decreased

body weight gain and increased absolute

and relative liver, kidney, and adrenal

weights).

A developmental neurotoxicity (DNT)

study is not required at this time.

However, EPA has requested an

evaluation to determine the relationship

between the adrenal effects (increased

adrenal weights and/or adrenal

pathology) seen in four studies (90-day

feeding study in rats, chronic/

carcinogenicity rat, chronic dog, and 2-

generation reproduction study in rats)

and the need for a DNT. It appears that

the effects are more endocrine-related

(not developmental) and will be

addressed once the endocrine policy is

in place. The possibility of the effects

being endocrine related is also

supported by reports of ovarian weight

increases in several studies in rats. In

addition, the results of the

developmental toxicity studies in rats

and rabbits and the 2-generation

reproduction study do not support a

DNT. No neuropathology or CNS

malformations were seen in the

developmental toxicity studies. In the 2-

generation reproduction study in rats,

there were no findings in pups that were

suggestive of changes in neurological

development, although no functional

assessment was performed.

Additionally, there was no evidence of

neurotoxicity in other studies.

iii. Conclusion. There is a complete

toxicity data base for hexythiazox and

exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. EPA

determined that the 10X safety factor to

protect infants and children should be

removed and reduced to 1x. The FQPA

factor is removed because an additional

safety factor is not needed to protect the

safety of infants and children.

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 the model

estimates of a pesticide’s concentration

in water (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

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 USEPA Office of Water

are used to calculate DWLOCs: 2L/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

groundwater are less than the calculated

DWLOCs, OPP concludes with

reasonable certainty that exposures to

the pesticide in drinking water (when

considered along with other sources of

exposure for which OPP has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because OPP 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, OPP 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. Acute aggregate risk

estimates are below EPA’s level of

concern. A Tier 1 acute dietary exposure

analysis for hexythiazox was performed

using tolerance level residues and

assuming 100% crop treated for all

commodities. The acute analysis

applied to the population subgroup

Females 13-50 yrs old. The acute dietary

exposure estimates (food only) for this

population subgroup was <1% of the

aPAD. Thus, the acute dietary risk

associated with the proposed uses of

hexythiazox does not exceed EPA’s

level of concern (>100% aPAD). The

surface and ground water EECs were

used to compare against back-calculated

DWLOCs for aggregate risk assessments.

For the acute scenario, the DWLOCs are

72,000 ppb for females 13-50 years old.

For ground and surface water, the EECs

for hexythiazox are less than EPA’s

DWLOCs for hexythiazox in drinking

water as a contribution to acute

aggregate exposure as shown in Table 7

below. Therefore, EPA concludes with

reasonable certainty that residues of

hexythiazox in drinking water do not

contribute significantly to the acute

aggregate human health risk at the

present time, as shown in the following

Table 7:

TABLE 7.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO HEXYTHIAZOX

Scenario/Population Subgroup aPAD, mg/

kg/day

Dietary Exposure, mg/

kg/day

Allowable

Drinking

Water Exposure1, mg/

kg/day

DWLOC,

ppb

Surface

Water, ppb

Ground

Water, ppb

Females 13-50 yrs old 2.4 0.002617 2.4 72,000 0.910 0.0015

1Allowable Drinking Water Exposure (mg/kg/day) = aPAD (mg/kg/day) - Dietary Exposure from DEEM (mg/kg/day)

2. Chronic risk. Chronic (non-cancer)

aggregate risk estimates are below EPA’s

level of concern. A refined analysis was

performed using AR levels for most

crops and % CT or anticipated market

share information for all crops. The

chronic analysis applied to the U.S.

population and all population

subgroups. The chronic (non-cancer)

dietary exposure estimates (food only)

for the general U.S. population and all

population subgroups were <1% of the

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58447

cPAD. Thus, the chronic (non-cancer)

dietary risk associated with the

proposed uses of hexythiazox does not

exceed EPA’s level of concern (>100%

cPAD). The surface and ground water

EECs were used to compare against

back-calculated DWLOCs for aggregate

risk assessments. For the chronic (noncancer) scenario, the DWLOCs are 870

ppb for the U.S. population, 870 ppb for

females 13-50 years old, and 250 ppb for

all infants (<1 year old). For ground and

surface water, the EECs for hexythiazox

are less than EPA’s DWLOCs for

hexythiazox in drinking water as a

contribution to chronic (non-cancer)

aggregate exposure (Table 8). Therefore,

EPA concludes with reasonable

certainty that residues of hexythiazox in

drinking water do not contribute

significantly to the chronic (non-cancer)

aggregate human health risk at the

present time, as shown in the following

Table 8:

TABLE 8.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO HEXYTHIAZOX

Scenario/Population Subgroup cPAD, mg/

kg/day

Dietary Exposure,

mg/kg/day

Allowable Drinking

Water Exposure1,

mg/kg/day

DWLOC,

ppb

Surface Water

EEC, ppb

Ground Water

EEC, ppb

U.S. Population 0.025 0.000011 0.025 870 0.094 0.0015

All infants (<1 year old) 0.025 0.000027 0.025 250 0.094 0.0015

Children (1-6 years old) 0.025 0.000028 0.025 250 0.094 0.0015

Children (7-12 years old) 0.025 0.000015 0.025 250 0.094 0.0015

Females (13-50 years old) 0.025 0.000008 0.025 870 0.094 0.0015

Males (13-19 years old) 0.025 0.000004 0.025 870 0.094 0.0015

Males (20+ years old) 0.025 0.000008 0.025 870 0.094 0.0015

Seniors (55+ years old) 0.025 0.000010 0.025 870 0.094 0.0015

1 Allowable Drinking Water Exposure (mg/kg/day) = cPAD (mg/kg/day) - Chronic Dietary Exposure from DEEM (mg/kg/day)

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).

Hexythiazox is not registered for use on

any sites that would result in residential

exposure. Therefore, the aggregate risk

is the sum of the risk from food and

water, which do not exceed the

Agency’s level of concern.

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). Hexythiazox is not

registered for use on any sites that

would result in residential exposure.

Therefore, the aggregate risk is the sum

of the risk from food and water, which

do not exceed the Agency’s level of

concern.

5. Aggregate cancer risk for U.S.

population. Chronic (cancer) aggregate

risk estimates are below EPA’s level of

concern. A refined analysis was

performed using AR levels for most

crops and % CT or anticipated market

share information for all crops. The

chronic analysis applied to the U.S.

population and all population

subgroups. The carcinogenic risk

estimate (food only) for the general U.S.

was <1 × 10-6. Thus, the carcinogenic

dietary risk associated with the

proposed uses of hexythiazox does not

exceed the level of concern that the

Agency generally considers negligible

for excess lifetime cancer risk (1 x 10-6).

The surface and ground water EECs

were used to compare against backcalculated DWLOCs for aggregate risk

assessments. For the carcinogenic risk

scenario, the DWLOCs are 1.2 ppb for

the U.S. population. For ground and

surface water, the EECs for hexythiazox

are less than EPA’s DWLOCs for

hexythiazox in drinking water as a

contribution to carcinogenic aggregate

exposure (Table 9). Therefore, EPA

concludes with reasonable certainty that

residues of hexythiazox in drinking

water do not contribute significantly to

the carcinogenic aggregate human

health risk at the present time, as shown

in the following Table 9:

TABLE 9.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (CANCER) EXPOSURE TO HEXYTHIAZOX

Scenario/Population

Subgroup Q1* Dietary Exposure,mg/kg/day

Allowable Drinking

Water Exposure1,

mg/kg/day

DWLOC, ppb2 Surface Water

EEC, ppb

Ground Water

EEC, ppb

U.S. Population 2.22 × 10-2 0.000011 0.000034 1.2 0.094 0.0015

1 Allowable Drinking Water Exposure (mg/kg/day) = negligible risk(1 × 10-6/Q1* - (average food + residential exposure (ADD) (mg/kg/day) 2 DWLOCcancer = chronic water exposure (mg/kg/day) × body weight (kg)/water consumption (L) × 10-3(mg/μg)

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, and to infants and children

from aggregate exposure to hexythiazox

residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

Plants. Metabolism studies have been

submitted and reviewed in conjunction

with petitions for hexythiazox

tolerances in/on apples, pears, grapes

and citrus. The residues of concern in

these crops are hexythiazox and its

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety.

No further plant metabolism data are

necessary to support the proposed uses

on apples, almonds, stone fruits and

strawberries. However, as metabolism

58448 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

data are only available for fruit, the

nature of the residue is not understood

in cotton. Given the limited metabolism

of hexythiazox observed in apple, pear,

grape and citrus leaves and that the use

on cotton will be limited to California,

EPA concludes that the nature of the

residue is understood in cotton for the

purposes of this petition only. For a

national registration on cotton,

additional plant metabolism data will be

required.

Livestock. The Agency has previously

concluded that the nature of the

residues of hexythiazox in cattle and

goats is adequately understood. The

residues of concern in ruminants are

hexythiazox and its metabolites

containing the (4-chlorophenyl)-4-

methyl-2-oxo-3-thiazolidine moiety.

A poultry metabolism study was

reviewed in conjunction with the

original tolerance petition for apples

and was deemed inadequate due to

incomplete characterization of 14Cresidues in liver, fat and eggs. However,

as the available data indicate that the

metabolism of hexythiazox in poultry is

similar to that in plants and ruminants,

EPA can recommend in favor of

permanent tolerances for cotton RACs

provided that the registration is

conditional upon submission of an

adequate poultry metabolism study.

B. Analytical Enforcement Methodology

The HPLC/UV analytical methods

(EN-CAS Method Nos. ENC–4/96, –5/96,

and –4/97, respectively) used for

determining the combined residues of

hexythiazox and its metabolites in

apples, cotton, and rotational crops are

adequate for data collection purposes.

The submitted HPLC/UV analytical

method (EN-CAS Method No. ENC-8/96)

used for determining the combined

residues of hexythiazox and its

metabolites in/on almond and stone

fruit commodities is also adequate for

data collection purposes. Adequate

method validation data were submitted.

These methods are based on Method

AMR–985–87, which has been deemed

acceptable as a tolerance enforcement

method in conjunction with a petition

for use on apples. The method has been

validated for use on various crop

commodities, and has been forwarded to

FDA for inclusion in PAM II. This

earlier method is considered sufficient

to enforce the proposed permanent

tolerances for residues in/on apples,

cotton, stone fruit, almonds, and

strawberries. The PAM-II analytical

enforcement method for residues of

hexythiazox and its metabolites (AMR–

985–87) is available to measure residues

in meat, milk and eggs.

The petitioner has submitted data

describing the testing of hexythiazox

through FDA Multiresidue protocols C

through E. This information has been

forwarded to the FDA. In addition,

hexythiazox and its metabolites have

been tested according to the FDA

Multiresidue protocols C through E by

BASF Corporation in conjunction with

a petition for use on hops. The

information pertaining to the testing of

hexythiazox per se, which indicated

that hexythiazox was not recovered

from hops, has been forwarded to the

FDA. Multiresidue method testing data

for the major metabolites of hexythiazox

have been submitted to EPA and will be

forwarded to FDA.

C. Magnitude of Residues

An adequate number of residue field

trials reflecting the proposed use rules

were submitted to EPA to demonstrate

that tolerances for apples at 0.5 ppm;

wet apple pomace at 0.80 ppm; stone

fruits (except plums) at 1 ppm; almond

at 0.3 ppm and almond hulls at 10 ppm;

milk at 0.02 ppm; fat of cattle, goats,

horses, swine and sheep at 0.02 ppm;

meat by-products of cattle, goats, horses,

swine and sheep at 0.02 ppm; cotton,

undelinted seed (CA only), at 0.20 ppm;

and cotton gin byproducts (CA only) at

3.0 ppm will not be exceeded when

hexythiazox products labeled for these

uses are used as directed. For

strawberries, EPA is requiring

submission of additional crop field

studies from three other strawberry

growing areas of the United States as

confirmatory data in support of the

proposed tolerances.

D. Rotational Crop Restrictions

A limited confined rotational crop

study was submitted and needs to be

repeated as a condition of registration.

Although the study was limited in

nature, the data indicated that residues

of hexythiazox and its metabolites

would not be present in crops planted

4 months after application of

hexythiazox. The proposed label

specifies a 120-day rotational crop

restriction. Therefore, tolerances for

residues in rotational crops will not be

required.

E. International Residue Limits

The Codex Alimentarius Commission

has established maximum residue limits

(MRLs) for residues of hexythiazox per

se in/on cherries and peaches at 1 mg/

kg, plums (including prunes) at 0.2 mg/

kg, apples at 0.5 mg/kg and strawberries

at 0.5 mg/kg; no codex MRLs are

established for residues in/on cotton

commodities. The Codex MRLs and U.S.

tolerances are not compatible because

the U.S. tolerance expression currently

includes parent hexythiazox and its

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety. Neither Canadian

nor Mexican MRLs have been

established for residues of hexythiazox

in the subject crops.

F. Endocrine Disruption

The Food Quality Protection Act

(FQPA; 1996) requires that EPA develop

a screening program to determine

whether certain substances (including

all pesticides and inerts) may have an

effect in humans that is similar to an

effect produced by a naturally occurring

estrogen, or such other endocrine

effect.... EPA has been working with

interested stakeholders, including other

government agencies, public interest

groups, industry and research scientists

to develop a screening and testing

program as well as a priority setting

scheme to implement this program. The

Agency’s proposed Endocrine Disrupter

Screening Program was published in the

Federal Register of December 28, 1998,

63 FR 71541 (FRL–XXXX–X). The

Program uses a tiered approach and

anticipates issuing a Priority List of

chemicals and mixtures for Tier 1

screening in the year 2000. As the

Agency proceeds with implementation

of this program, further testing of

hexythiazox and its end-use products

for endocrine effects may be required.

V. Conclusion

Therefore, the tolerances are

established for residues of the ovicide/

miticide hexythiazox (trans-5-(4-

chlorophenyl)-N-cyclohexyl-4-methyl-2-

oxothiazolidine-3-carboxamide) and its

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety (expressed as

parent), in or on almond at 0.3 ppm and

almond hulls at 10 ppm; apple at 0.50

ppm; apple, wet pomace at 0.80 ppm;

cotton, undelinted seed (CA only), at

0.20 ppm; and cotton gin byproducts

(CA only) at 3.0 ppm; milk at 0.02 ppm;

fruit, stone (except plums) at 1.0 ppm;

strawberry at 3.0 ppm; fat of cattle,

goats, horses, swine, and sheep at 0.02

ppm; and meat byproducts of cattle,

goats, horses, swine, and sheep at 0.02

ppm.

Conditional registration for use of

hexythiazox on these crops are being

proposed to allow development and

review of a 21-day dermal toxicity study

(data gap); an acceptable in vivo mouse

micronucleus assay; an acceptable

poultry metabolism study; and three

additional strawberry residue trials.

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58449

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the 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 the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) 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), as was provided in the

old FFDCA sections 408 and 409.

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 control

number OPP–301061 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 28, 2000.

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 (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. 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) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(I) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. 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 Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301061, 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. In

person or by courier, bring a copy to the

location of the PIRIB described in Unit

I.B.2. You may also send an electronic

copy of your request via e-mail to: oppdocket@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 file

format 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).

VII. Regulatory Assessment

Requirements

This final rule establishes a tolerance

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). 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

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or require 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 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

58450 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

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

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

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

VIII. Submission to Congress and the

Comptroller General

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: September 21, 2000.

James Jones,

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 180.448 is amended by

revising the table in paragraph (a), by

removing from the table in paragraph (b)

the entries for ‘‘cotton seed,

undelinted’’; ‘‘cotton gin byproducts’’;

‘‘hops’’; and ‘‘strawberries’’, and by

adding text to paragraph (c) to read as

follows:

§ 180.448 Hexythiazox; tolerances for

residues.

(a) * * *

Commodity Parts per million

Almond ............................ 0.30

Almond, hulls .................. 10

Apple ............................... 0.50

Apple, wet pomace ......... 0.80

Cattle, fat ........................ 0.02

Cattle, mbyp ................... 0.02

Fruit, stone, group (except plums) ................. 1.0

Goat, fat .......................... 0.02

Goat, mbyp ..................... 0.02

Hops ............................... 2.0

Horse, fat ........................ 0.02

Horse, mbyp ................... 0.02

Milk ................................. 0.02

Pears .............................. 0.30

Sheep, fat ....................... 0.02

Sheep, mbyp .................. 0.02

Strawberry ...................... 3.0

Swine, fat ........................ 0.02

Swine, mbyp ................... 0.02

* * * * *

(c) Tolerances with regional

registrations.Tolerances with regional

registrations as defined 40 CFR 180.1(n),

are established for the combined

residues of the ovicide/miticide

hexythiazox (trans-5-(4-chlorophenyl)-

N-cyclohexyl-4-methyl-2-

oxothiazolidine-3-carboxamide) and its

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety (expressed as

parent) in or on the following

commodities:

Commodity Parts per million

Cotton, gin byproducts (CA only) ... 3.0

Cotton, undelinted

seed (CA only) .. 0.20

* * * * *

[FR Doc. 00–24945 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301059; FRL–6745–2]

RIN 2070–AB78

Methacrylic Acid-Methyl MethacrylatePolyethylene Glycol Methyl Ether

Methacrylate Copolymer; and Maleic

Anhydride-α-Methylstyrene Copolymer

Sodium Salt; Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

exemption from the requirement of a

tolerance for residues of two polymers

methacrylic acid-methyl methacrylatepolyethylene glycol methyl ether

methacrylate copolymer; and maleic

anhydride-α-methylstyrene copolymer

sodium salt when used as an inert

ingredient surfactant in or on growing

crops or when applied to raw

agricultural commodities after harvest.

Huntsman Petrochemical Corporation

submitted a petition to EPA under the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996 requesting an

exemption from the requirement of a

tolerance. This regulation eliminates the

need to establish a maximum

permissible level for residues of

methacrylic acid-methyl methacrylatepolyethylene glycol methyl ether

methacrylate copolymer; and maleic

anhydride-α-methylstyrene copolymer

sodium salt.

DATES: This regulation is effective

September 29, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301059,

must be received by EPA on or before

November 28, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit XI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301059 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Treva Alston, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308-8373 and e-mail

address: alston.treva@epa.gov.