Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58375

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

FR Doc. 00–24947 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301063; FRL–6744–8]

RIN 2070–AB78

Triallate,(S-2,3,3-trichloroallyl

diisopropylthiocarbamate); Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for the combined residues of

the herbicide triallate (S-2,3,3,

trichloroallyl diisopropylthiocarbamate)

and its metabolite, TCPSA (2,3,3-

trichloroprop-2-ene sulfonic acid) in or

on sugar beet, root; sugar beet, top; and

sugar beet, pulp. Monsanto 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–301063,

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–301063 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: James A. Tompkins (PM 25),

Registration Division (7505C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460;

telephone number: 703 305–5697; and

e-mail address: Tompkins.Jim

@epamail.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

codes

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

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 Registerlistings at http://

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

OPPTS Harmonized Guidelines

referenced in this document, go directly

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

opptsfrs/home/guidelin.htm.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301063. 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

In the Federal Register of May 16,

1997 (62 FR 27027) (FRL–5717–6), 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 8F2128) for tolerance by

Monsanto, 600 13th St., NW., Suite 660,

Washington, DC 20005. This notice

included a summary of the petition

prepared by Monsanto, the registrant.

There were no comments received in

response to the notice of filing.

The petition requested that 40 CFR

180.314 be amended by establishing a

tolerance for residues of the herbicide

triallate, and its metabolite, TCPSA in or

on sugar beet root at 0.01 part per

million (ppm), sugar beet top at 0.5

ppm, and sugar beet pulp at 0.2 ppm

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

exposure to the pesticide chemical

residue.... ’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. For

58376 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

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 the herbicide triallate and its

metabolite, TCPSA in or on sugar beet

root at 0.01 ppm, sugar beet top at 0.5

ppm, and sugar beet pulp at 0.2 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 triallate (S-2,3,3,

trichloroallyl diisopropylthiocarbamate)

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 in rodents Rat NOAEL = 5 mg/kg/day

LOAEL = 25 mg/kg/day based on decreased body weight in males

and females, slight anemia in females (decreased red blood

cells, hematocrit and hemoglobin) and histopathology of the kidney in males (tubular epithelial regeneration and nephropathy).

870.3200 21-Day dermal toxicity in rodents Rat NOAEL = 500 mg/kg/day

LOAEL = 3,000 mg/kg/day based on body weight gain decreases,

relative kidney and liver weight increases, increased presence of

basophillic tubules of the renal cortex, and alpha 2 -globulin inclusions in the proximal convoluted renal tubules in rats.

870.3465 Subchronic inhalation toxicity Rat NOAEL = less than 2.62 mg/kg/day, not established

LOAEL = 2.62 mg/kg/day based on histological changes in kidney

(nephropathy and tubular epithelial regeneration).

870.3700 Prenatal developmental toxicity in rodents Rat Maternal NOAEL = 10 mg/kg/day

LOAEL = 30 mg/kg/day based on decreases in body weight gain

and food consumption. Developmental NOAEL = 30 mg/kg/day

LOAEL = 90 mg/kg/day based on decreased fetal body weight, external malformations (protruding tongue) and skeletal variations.

870.3700 Prenatal developmental toxicity in nonrodents

Rabbit

Maternal NOAEL = 15 mg/kg/day

LOAEL = 45 mg/kg/day based on clinical signs and decreases in

body weight gain.

Developmental NOAEL = 5 mg/kg/day

LOAEL = 15 mg/kg/day based on decreased fetal body weight and

increased skeletal variations.

870.3800 Reproduction and fertility effects Rat Parental/Systemic NOAEL = 7.5 mg/kg/day

LOAEL = 30 mg/kg/day based on maternal mortality, increased

incidences of chronic nephritis, head bobbing, circling movements and reduced body weight.

Reproductive NOAEL = 7.5 mg/kg/day

LOAEL = 30 mg/kg/day based on based on increased neonatal

mortality during the F2b litter interval, reduced pup weights at

birth during the F2b litter interval, reduced pup weights in late

lactation for all litters, reduced pregnancy rate and shortened

gestation length.

870.4100 Chronic toxicity Dog NOAEL = 2.5 mg/kg/day

LOAEL = 15.0 mg/kg/day based on increased alkaline phosphatase

levels at all time intervals in male and female dogs.

870.4100 Chronic toxicity Dog NOAEL = 1.5 mg/kg/day

LOAEL = 5.0 mg/kg/day based on increased hemosiderin deposition in the spleen, increased serum alkaline phosphatase and increased liver weight in females.

870.4200 Combined chronic toxicity/carcinogenicity Rat NOAEL = 2.5 mg/kg/day

LOAEL = 12.5 mg/kg/day based on decreased survival (males and

females), decreased body weight (males) and increased adrenal

weight (males).

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58377

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

Guideline No. Study Type Results

Evidence of carcinogenicity: Renal tubular adenomas in male rats.

870.4200 Combined chronic toxicity/carcinogenicity Mouse NOAEL = (males) 3 mg/kg/day

LOAEL = (males) 9 mg/kg/day based on increased absolute liver

weight, increased incidence of altered foci of the liver and hematopoiesis in the spleen.

NOAEL (females) = 37.5 mg/kg/day

LOAEL (females) >37.5 mg/kg/day, not established

Evidence of carcinogenicity: Increased incidence of hepatocellular

carcinomas and hepatocellular adenomas (males).

870.4200 Combined chronic toxicity/carcinogenicity Hamster NOAEL = (males) 50 ppm

LOAEL = (males) 300 ppm based on decreased triglyceride levels

(males and females)

870.5100 Gene Mutation in Salmonella typhimurium. Positive. Triallate induced a mutagenic response in Salmonella

typhimuriumstrains TA1535 and TA100 at noncytotoxic doses of

0.1 μg/plate and above -S9 activation and TA1535, TA98 and

TA100 at 0.001 μg/plate and above +S9. In tester strains TA1537

and TA1538, there were no appreciable increases in revertant

colonies of evidence of cytotoxicity at any dose. Mutagenesis

was confirmed in a repeat test with Salmonella typhimurium

strainTA1535 at dose levels of 1, 5, and 10 μg/plate +/- S9 activation.

870.5300 Gene Mutation/In vitro mammalian cell assay in

mouse lymphoma cells Negative.

Negative. Triallate did not induce forward gene mutations at the

thymidine kinase (TK+-) locus in L51784 mouse lymphoma cells

at concentration of 0.005 to 0.04 μl/ml in the absence or presence of metabolic activation.

870.5300 Gene Mutation/In vitro mammalian cell assay in

mouse lymphoma cells

Positive. Triallate induced forward gene mutations at the thymidine

kinase (TK+/-) locus in L51784 mouse lymphoma cells. The frequency of gene mutations was greater than or equal to a two-fold

increase and occurred at noncytotoxic concentrations of 60 μg/ml

-S9 activation and 21 and 24 7mu;g/ml +S9 activation.

870.5385 Cytogenetics/In vivo hamster micronucleus assay Negative. There was no evidence of either a clastogenic or

aneugenic effect in male and female hamsters fed dietary concentrations of 0, 600, 2,000 or 6,000 ppm Triallate at any sacrifice time.

870.5395 Cytogenetics/In vivo mouse micronucleus assay Negative. There was no evidence of either a clastogenic or

aneugenic effect in male and female mice administered 70, 350,

or 700 mg/kg Triallate at any sacrifice time.

870.5550 Other Mutagenic Mechanisms/In vitro unscheduled

DNA synthesis in primary rat hepatocytes

Negative. Triallate did not induce a genotoxic effect in primary rat

hepatocytes at concentrations of 5, 10, 50, 100, 500 and 1,000

μg/mL.

870.5550 Other Mutagenic Mechanisms/In vivo In vitro unscheduled DNA synthesis in primary rat

hepatocytes

Negative. There was no evidence that Triallate induce either a

cytotoxic or genotoxic response a any dose (50, 250 or 500 mg/

kg) or sacrifice time (92 or 16 hours).

870.5900 Other Mutagenic Mechanisms/In vitro sister chromatid exchange in Chinese hamster ovary cellsPositive. Triallate induced significant increases in the number of

sister chromatid exchanges per cell at concentrations of 1.6 x

10-5M to 8.1 x 10-5M -S9 activation and 0.8 x 10-5M to 4.0 x

10-5M +S9 activation after either a two or four hour exposure period, respectively. Repeat assays conducted for 30 hours at concentrations up to 40.4 x 10-5M -S9 activation and for 2 hours at

concentrations up to 12.1 x 10-5M +S9 activation confirmed these

findings.

870.6100 Acute delayed neurotoxicity Hen Systemic NOAEL less than 312.5 mg/kg, not established

LOAEL = 312.5 mg/kg based on acute, reversible clinical signs

(muscle weakness/paralysis, salivation and involuntary neck

movement). Triallate did not induce delayed peripheral neuropathy.

870.6200 Acute neurotoxicity screening battery Rat NOAEL = 60 mg/kg

58378 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

LOAEL = 300 mg/kg based on decreased body weight gain and alterations in motor activity.

870.6200 Subchronic neurotoxicity screening battery Rat NOAEL = 6.38/8.14 mg/kg/day for male/female rats

LOAEL = 32.9/38.9 mg/kg/day for male/female rats based on decreased body weights, body weight gains, food consumption and

lesions (nerve fiber degeneration) in the central and peripheral

nervous systems.

870.6200 Subchronic neurotoxicity screening battery Rat Neurotoxic NOAEL = 134.32 mg/kg/day

LOAEL = 223.79 mg/kg/day based on behavioral effects

(histopathology for axonal degeneration was not conducted at

this dose level). At 295 mg/kg/day, nuerohistopathological lesions

occurred in both the central and peripheral nerves. Systemic

NOAEL = 34.64 mg/kg/day

LOAEL = 134.32 mg/kg/day based on decreased body weight and

food consumption and food efficiency.

870.6300 Developmental neurotoxicity Rat Maternal NOAEL = 30 mg/kg/day

LOAEL = 60 mg/kg/day based on reductions in body weight gains

and food consumption.

Developmental Neurotoxicity NOAEL = 30 mg/kg/day

LOAEL = 60 mg/kg/day based [on increased motor activity.

870.7485 Metabolism and pharmacokinetics Rat General metabolism

Analysis of whole body elimination in male and female rats indicated that 85% of the radiolabeled triallate was excreted within

24 hours of dosing. Most radioactivity was excreted in approximately equal amounts (42%) in the urine and feces of male rats

after 10 days. Females excreted 51% in urine and 32% in feces

after 10 days. Males and females retained about 0.4% of the

dose in organs and tissues and approximately 2% in the remaining carcass. The distribution of radioactivity in both sexes indicated that the greatest amount of activity was found in the red

blood cells followed by whole blood, spleen, kidney, liver and

lung.

870.7485 Metabolism and pharmacokinetics Rat General metabolism

Seven metabolites, in concentrations of greater than one percent,

were identified in rat urine; 2,3,3-trichloro-2-propenesulfinic acid

(20-27%), N-acetyl-S-(2,2-dichloro-1-[methyl-sufonyl) methyl]ethenyl)-L-cysteine (6–11%), (E)-S-(2carboxy-2-chloroethenyl)-

L-cysteine (4–5%), carbon dioxide (4%), 2,3,3-trichloro-propene

sulfonic acid (3–5%), (E)-3-((carboxymethyl)thio)-2-chloro-2-propenoic acid (1–3%), and 1-((3,3,2-trichloro-2-propenyl)thio)-betaD-glucuronic acid. The remaining metabolites were found at less

than 1% of the administered dose.

Special studies Assessment of the kidney for alpha 2μ globulins in

the rat subchronic and chronic feeding studies

Data from this study is considered a preliminary indication that

triallate may be classified as an alpha 2μ globulin type

nephrotoxin. Additional data and analysis considered necessary

for a more conclusive decision.

Several acute toxicology studies place

technical triallate in acute toxicity

category III for acute oral toxicity and

primary eye irritation and in toxicity

category IV for acute dermal toxicity,

acute inhalation toxicity, and primary

dermal irritation. Triallate is a skin

sensitizer.

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

intra species 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.

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58379

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

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 x 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 (MOE cancer =

point of departure/exposures) is

calculated. A summary of the

toxicological endpoints for triallate (S2,3,3-trichloroallyl

diisopropylthiocarbamate) used for

human risk assessment is shown in the

following Table 2:

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR TRIALLATE (S-2,3,3-TRICHLOROALLYL

DIISOPROPYLTHIOCARBAMATE) FOR USE IN HUMAN RISK ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF

FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects

Acute Dietary females 13–50

years of age

NOAEL = 5 mg/kg/day, UF =

100, Acute RfD = 0.05 mg/

kg/day

FQPA SF = 3, aPAD = acute

RfD÷FQPA SF = 0.017 mg/

kg/day

Developmental toxicity study -Rabbits

Developmental LOAEL = 15 mg/kg/day based

on decreased fetal body weight and increased skeletal variations.

Acute Dietary general population including infants and

children

NOAEL = 60 mg/kg/day, UF =

100, Acute RfD = 0.60 mg/

kg/day

FQPA SF = 1 aPAD = acute

RfD÷ FQPA SF = 0.60 mg/

kg/day

Acute Neurotoxicity-Rat

LOAEL = 300 mg/kg/day based on decreased

body weight and alterations in motor activity

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

= 100, Chronic RfD = 0.025

mg/kg/day

FQPA SF = 1, cPAD = chronic RfD÷ FQPA SF = 0.025

mg/kg/day

Chronic Toxicity/Carcinogenicity-Rat

LOAEL = 12.5 mg/kg/day based on decreased survival in males and females, decreased body weight in males, increased

adrenal weight in males

Short- Term Dermal (1 to 7

days) (Residential)

oral study NOAEL= 5 mg/kg/

day (dermal absorption rate

= 1%)

LOC for MOE = 100 (Residential)Developmental Toxicity - Rabbit LOAEL = 15

mg/kg/day based on Increased skeletal

malformations/variations

Intermediate-Term Dermal (1

week to several months)

(Residential)

(oral) study NOAEL = 5 mg/

kg/day (dermal absorption

rate = 1%

LOC for MOE = 100 (Residential)Developmental Toxicity-Rabbit LOAEL = 15

mg/kg/day based on Increased skeletal

malformations/variations

Long-Term Dermal (several

months to lifetime) (Residential)

Dermal (or oral) study

NOAEL= none mg/kg/day

(dermal absorption rate =

none% when appropriate)

LOC for MOE = none (Residential)none

LOAEL = none mg/kg/day based on none Not

identified, continuous exposure greater

than 180 days not expected

Short-Term Inhalation (1 to 7

days) (Residential)

inhalation (or oral) study

NOAEL= 5 mg/kg/day (inhalation absorption rate =

100%

LOC for MOE = 100 (Residential)Developmental toxicity-Rabbit

LOAEL = 15 mg/kg/day based on Increased

skeletal malformations/variations

Intermediate-Term Inhalation

(1 week to several months)

(Residential)

inhalation (or oral) study

NOAEL = 5 mg/kg/day (inhalation absorption rate =

100%

LOC for MOE = 100 (Residential)Developmental toxicity-Rabbit

LOAEL = 15 mg/kg/day based on Increased

skeletal malformations/variations

58380 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR TRIALLATE (S-2,3,3-TRICHLOROALLYL

DIISOPROPYLTHIOCARBAMATE) FOR USE IN HUMAN RISK ASSESSMENT—Continued

Exposure Scenario Dose Used in Risk Assessment, UF

FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects

Long-Term Inhalation (several

months to lifetime)(Residential)

inhalation (or oral) study

NOAEL= none mg/kg/day

(inhalation absorption rate =

100%

LOC for MOE = none (Residential)none LOAEL = none mg/kg/day based on

none

Not identified, continuous exposure greater

than 180 days not expected

Cancer (oral, dermal, inhalation)............................................ ............................................ Q*7.17 x 10-2(mg/kg/day)-1

............................................ ............................................ Group C chemical-likely to be a human carcinogen

*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 180.314(a)) for

residues of the herbicide triallate (S2,3,3, trichloroallyl

diisopropylthiocarbamate), per se

(parent only) in or on a variety of raw

agricultural commodities; Barley, grain;

Barley, straw; Lentils; Lentils, forage;

Lentils, hay; Peas, forage; Peas, hay;

Wheat, grain; and Wheat, straw. Under

reregistration, the triallate tolerance

expression will be revised in order to

reflect the Agency’s determination that

triallate and its TCPSA metabolite

should be regulated and assessed for

dietary exposure in plant commodities.

The Agency decided to regulate on the

TCPSA metabolite because it is present

at more than 10% of the total

radioactive residue (TRR) in the plant

metabolism studies. Tolerances are to be

expressed as triallate for the combined

residues of the herbicide triallate (S2,3,3-S-2,3,3-trichloroallyl

diisopropylthiocarbamate) and its

metabolite TCPSA (2,3,3-trichloroprop2-ene sulfonic acid) in or on the

following commodities: Sugar Beet,

root; Sugar Beet, top; and Sugar Beet,

pulp. No tolerances have been

established for processed food/feed or

animal commodities. Risk assessments

were conducted by EPA to assess

dietary exposures from triallate (S-2,3,3-

trichloroallyl diisopropylthiocarbamate)

and its metabolite TCPSA 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. A probalistic

(Monte Carlo) acute dietary analysis was

conducted for triallate residues in food.

This analysis is highly refined (Tier 3),

and represents a realistic estimate of

acute dietary exposure in food possible

with current data, based on all uses

supported through reregistration and the

proposed used of triallate on sugar

beets. The percent acute population

adjusted doses (PADs) are significantly

below the Agency’s level of concern at

the 99.9th percentile of exposure for the

females 13+ subgroup (<2% aPAD) and

for the general population (<1% aPAD).

For acute dietary analyses, anticipated

residues and percent of crop treated

data were used. For the purposes of this

assessment, residue field trial data were

used for the acute anticipated residues

calculations.

ii. Chronic exposure . In conducting

the 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

chronic (non-cancer) dietary risk from

exposure through food is <1% of the

Agency’s level of concern (<100% of the

chronic PAD) for the general U.S.

population and all subgroups. For

chronic dietary analyses, anticipated

residues and percent of crop treated

data were used. For the purposes of this

assessment, residue field trial data were

used for the chronic anticipated residue

calculations.

iii. Cancer. Triallate is classified as a

Group C chemical (possible human

carcinogen), based on hepatocellular

carcinomas in male mice, with a

positive trend and borderline

significance in female mice, and

increased incidence of renal tubular cell

adenomas in rats. A linear low-dose

(Q1

*) approach was used to characterize

human health risk. The unit risk,

Q1

*based on the hepatocellular

carcinomas in male mice, is 7.17 x

10-2(mg/kg/day)-1in human equivalents.

The Agency generally considers risks in

the range of 1 x 10-6(1 in 1 million) or

less as negligible risk for cancer dietary

exposure. The results of this analysis

indicate that the cancer dietary risk of

7.1 x 10-8from exposure through food,

associated with the uses supported

through reregistration and the proposed

use of triallate on sugar beets, is below

the Agency’s level of concern for food

alone.

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;

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58381

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.

A routine chronic dietary exposure

analysis for triallate and its metabolite

(TCPSA) was based on percent crop

treated (PCT) information as follows:

Acute Estimated MaximumChronic Weighted

Average

Barley 13% .................. Barley 9%

Barley bran 13% ......... Barley bran 9%

Barley flour 13% .......... Barley flour 9%

Dry pea 30% ............... Dry pea 13%

Sugar beet dried pulp

21%.

Sugar beet dried

pulp 21%

Sugar beet molasses

21%.

Sugar beet molasses 21%

Sugar beet root 21% ... Sugar beet root 21%

Sugar beet tops 21% .. Sugar beet tops

21%

Sugar beet sugar 21% Sugar beet sugar

21%

Wheat bran 8% ........... Wheat bran 6%

Wheat flour 8% ........... Wheat flour 6%

Wheat grain 8% .......... Wheat grain 6%

Wheat mill by-products

8%.

Wheat mill by-products 6%

Wheat shorts 8% ......... Wheat shorts 6%

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

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

triallate S-2,3,3-trichloroallyl

diisopropylthiocarbamate may be

applied in a particular area.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for triallate

and its metabolite TCPSA 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 environmental fate and transport

and physical characteristics of triallate

and TCPSA.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) and the Pesticide Root Zone/

EXposure Analysis Modeling System

(PRZM/EXAMS) to produce estimates of

pesticides in surface source drinking

water. The Screening-concentration in

ground water (SCI-GROW) model was

used to estimate concentrations in

shallow groundwater. The primary use

of the models by the Agency is to screen

out pesticides with low potential of

reaching concentrations in drinking

water exceeding human health levels of

concern. EPA will use GENEEC (a tier

1 model) before using PRZM/EXAMS (a

tier 2 model). The GENEEC model was

designed to simulate runoff from a 10

hectare (ha) field into a static 1 ha small

water body. It was originally designed to

assess pesticide concentrations in

aquatic environments for ecological risk

assessments. The PRZM/EXAMS model

scenario is designed as a refined

screening model which incorporates a

watershed scale assessment with a flowthrough index reservoir. Additionally,

the PRZM/EXAMS modeling

incorporates a percent cropped area

(PCA) to account for the extent of

cropping area within a watershed. None

of the models consider the impact of

water treatment (mixing, dilution, or

treatment) on pesticide concentrations

in raw water. In cases where the

screening model predictions exceed

human health levels of concern, the

Agency will require targeted monitoring

studies to assess the actual pesticide

concentrations in drinking water.

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 Percent of

Reference Dose (%RfD) or Percent of

Population Adjusted Dose (%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 triallate and

its metabolite TCPSA, they are further

discussed in the aggregate risk sections

below.

Based on the PRZM-EXAMS and SCIGROW models the estimated

environmental concentrations (EECs) of

triallate and its metabolite TCPSA in

surface water and ground water for

acute exposures are estimated to be

9.452 parts per billion (ppb) for surface

water and 0.21 ppb for ground water.

The EECs for chronic (non-cancer)

exposures are estimated to be 1.26 ppb

for surface water and 0.21 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).

Triallate 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

58382 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

EPA does not have, at this time,

available data to determine whether

triallate 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, triallate

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 triallate 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.

Quantitatively, there is evidence of

increased susceptibility in the prenatal

developmental toxicity study in rabbits;

developmental effects (decreased fetal

body weight and increased incidence of

malaligned sternebrae) were observed in

the absence of maternal toxicity.

iii. Conclusion. There is a complete

toxicity data base for triallate and

exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures—EPA

determined that some additional safety

factor was needed to protect infants and

children because the toxicity data

indicated increased sensitivity to the

young. The FQPA factor was reduced to

3x because the toxicology data base is

complete; increased sensitivity was

observed in only one species (rabbits);

there is no quantitative or qualitative

indication of increased susceptibility in

the prenatal developmental toxicity

study in rats, the 2-generation

reproduction study in rats, or the

developmental neurotoxicity in rats;

adequate data are available or

conservative modeling assumptions are

used to assess dietary food and drinking

water exposure; and there are currently

no registered residential uses for

triallate.

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. Using the exposure

assumptions discussed in this unit for

acute exposure, the acute dietary

exposure from food to triallate, and its

metabolite, TCPSA will occupy <1% of

the aPAD for the U.S. population, 1.8%

of the aPAD for females 13 years and

older, <1% of the aPAD for all infants

(<1 year) and <1% of the aPAD for

children (1-6 years). In addition, there is

potential for acute dietary exposure to

triallate and its metabolite TCPSA in

drinking water.After calculating

DWLOCs and comparing them to the

EECs for surface and ground water, EPA

does not expect the aggregate exposure

to exceed 100% of the aPAD, as shown

in the following Table 3:

TABLE 3.—AGGREGATE ACUTE RISK ASSESSMENT FOR TRIALLATE AND ITS METABOLITE TCPSA

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

EEC (ppb)

Ground

Water EEC

(ppb)

Acute

DWLOC

(ppb)

U.S.Population 0.60 <1 9.4 0.21 21,000

Children (1-6 years) 0.60 <1 9.4 0.21 6,000

Females (13+ nursing) 0.017 1.8 9.4 0.21 500

2. Chronic risk . Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to triallate and its

metabolite, TCPSA from food will

utilize <1% of the cPAD for the U.S.

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58383

population, <1% of the cPAD for Nonnursing infants (<1 year old) and <1% of

the cPAD for children (1-6 years old).

There are no residential uses for triallate

and its metabolite TCPSA that result in

chronic residential exposure to triallate

and its metabolite TCPSA, as shown in

the following Table 4:

TABLE 4.—AGGREGATE CHRONIC RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO TRIALLATE AND ITS

METABOLITE, TCPSA

Population Subgroup cPAD mg/kg/day %cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. Population 0.025 <1 1.26 0.21 875

Females (13+, nursing) 0.025 <1 1.26 0.21 250

Children (1-6 years) 0.025 <1 1.26 0.21 750

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).

Triallate 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).

Triallate 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. The Agency generally

considers risks in the range of 1 x 10-6(1

in 1 million) or less as negligible risk for

cancer. The results of this analysis

indicate that the cancer dietary (food)

risk estimate of 7.1 x 10-8associated with

the uses supported through

reregistration and the proposed use on

sugar beets is not of concern. The cancer

DWLOC is 0.45 ppb. The Tier II (PRZMEXAMS) estimated average

concentration of triallate + TCPSA in

surface water is 0.566 ppb (mean annual

with 2 incorporation) and 1.26 ppb

(mean annual with no incorporation).

Concentrations in ground water are not

expected to be higher than 0.21 ppb.

The 36-year annual mean estimated

concentrations in surface water exceed

the DWLOCs for triallate + TCPSA in

drinking water as a contribution to

cancer aggregate exposure. However, the

drinking water component is based on

model predictions, which are generally

conservative in estimating chemical

concentrations in drinking water. To

address this concern, the registrant

initiated a 3-year surface drinking water

monitoring study in June 1999 to

measure raw and finished triallate +

TCPSA concentrations at five surface

drinking water collection locations.

Interim results of the surface water

monitoring study indicated that peak

and mean exposure to total parent

triallate and TCPSA at all five sites are

below the cancer DWLOC (0.45 ppb).

Additional monitoring data will be

provided on a quarterly basis, with a

final report of the study expected in late

2002. Based on the interim results of the

surface water monitoring study, which

indicated that peak and mean exposure

to total parent triallate and TCPSA are

below the cancer DWLOC (0.45 ppb),

the aggregate cancer risk for the U.S.

Population is expected to be less than 1

x 10-6.

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 triallate and

its metabolite (TCPSA) combined

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

In conjunction with the regional

registration of triallate on sugar beets,

the registrant has proposed a GC/ECD

method (designated as Method RES-099-

96, Version No. 2) for tolerance

enforcement purposes. The method

determines residues of triallate and its

TCPSA metabolite. This method has

been subjected to a successful

independent laboratory validation. The

method has also been validated in an

Agency study at Beltsville, MD. The

laboratory (Analytical Chemistry

Branch, BEAD) verified the limits of

quantitation (LOQs) to be 0.025 ppm

triallate and 0.025 ppm TCPSA in/on

sugar beet roots, and 0.05 ppm triallate

and 0.20 ppm TCPSA in/on sugar beet

foliage. The Beltsville report (7/28/98)

also estimated the limits of detection

(LODs) to be 0.001 ppm triallate and

0.004 ppm TCPSA in sugar beet root,

and 0.005 ppm triallate and 0.04 ppm

TCPSA in sugar beet top. The expected

dietary burdens of triallate to beef/dairy

cattle and poultry animals were

recalculated following tolerance

reassessment of livestock feed items.

There is no reasonable expectation of

finite residues (Category 3 of 40 CFR

section 180.6); therefore, tolerances are

not required for milk, eggs, and animal

tissues.

Adequate enforcement methodology

is available to enforce the tolerance

expression. The method may be

requested from: Calvin Furlow, PIRIB,

IRSD (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW,

Washington, DC 20460; telephone

number: (703) 305–5229; e-mail address:

furlow.calvin@epa.gov.

B. International Residue Limits

There are no Codex MRLs for triallate;

therefore, no questions of compatibility

with U.S. tolerances exists.

C. Conditions

Completion of the 3-year surface

drinking water study will be a condition

of registration. Monitoring data will be

provided on a quarterly basis, with a

final report of the study expected in late

2002.

V. Conclusion

Therefore, the tolerance is established

for the combined residues of the

herbicide triallate (S-2,3,3, trichloroallyl

diisopropylthiocarbamate) and its

metabolite, TCPSA (2,3,3-

Trichloroprop-2-ene sulfonic acid) in or

on sugar beet, root, sugar beet, top, and

sugar beet pulp.

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

58384 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

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–301063 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–301063, 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

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

seq.) do not apply. In addition, the

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58385

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 180.314 is revised to read

as follows:

§ 180.314 Triallate; tolerances for

residues.

(a) General. Tolerances are

established for residues of the herbicide

(S-2,3,3-trichloroallyl

diisopropylthiocarbamate) in or on the

following raw agricultural commodities:

Commodity Parts per million

Barley, grain ......... 0.05

Barley, straw ......... 0.05

Lentils ................... 0.05

Lentils, hay ........... 0.05

Peas ...................... 0.05

Peas, forage ......... 0.05

Peas, hay .............. 0.05

Wheat, grain ......... 0.05

Wheat, straw ......... 0.05

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. Tolerances are established

for residues of the herbicide triallate (S2,3,3-trichloroallyl

diisopropylthiocarbamate) and its

metabolite 2,3,3-trichloroprop-2-

enesulfonic acid in or on the following

food commodities:

Commodity Parts per million

Sugar beet, pulp ... 0.2

Sugar beet, root .... 0.1

Sugar beet, top ..... 0.5

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 00–24942 Filed 9–28–00; 8:45 a.m.]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301062; FRL–6747–9]

RIN 2070–AB78

Dimethomorph, (E,Z) 4-[3-(4-

chlorophenyl)-3-(3,4-

dimethoxyphenyl)-1-oxo-2-

propenyl]morpholine; Pesticide

Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

permanent tolerances for residues of

dimethomorph, (E,Z) 4-[3-(4-

chlorophenyl)-3-(3,4-dimethoxyphenyl)-

1-oxo-2- propenyl]morpholine in or on

dried hops cones, grapes, raisins, tomato

fruit, and tomato paste. American

Cyanamid Company requested these

tolerances 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–301062,

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–301062 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT By

mail: Mary Waller, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW.,Washington,

DC 20460; telephone number: (703)

308–9354; and e-mail address:

waller.mary@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: