Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations 30065

proposal would expand the permissible

attachments and enclosures beyond

those contemplated in the Domestic

Mail Classification Schedule (DMCS),

and would be beyond the authority of

the Postal Service to adopt. The Postal

Service respectfully disagrees. Under

DMCS 544.2, Bound Printed Matter may

contain attachments and enclosures ‘‘as

specified by the Postal Service.’’ The

comment appears to suggest that this

discretion is limited by the additional

phrase ‘‘and as described in subsections

a and e of section 523.1,’’ which

concerns order forms with books and

sound recordings. Under the reading

apparently favored by the commenter,

the permissible attachments and

enclosures under DMCS 544.2 would be

limited to these order forms in

accordance with standards prescribed

by the Postal Service. In contrast, the

Postal Service believes that the two

parts of section 544.2 should be read

independently. That is, the permissible

attachments and enclosures include the

order forms described in 523.1, and, in

addition to that, any other attachment

and enclosure specified by the Postal

Service. Nevertheless, the Postal Service

agrees with the commenter that the

permissible attachments and enclosures

should not be without limits. Indeed, as

explained above, the Postal Service

believes that the amount of nonprint

attachments and enclosures should be

relatively small in comparison to the

qualifying Bound Printed Matter, and

rejected requests that the ratio be

increased beyond the standard

proposed.

After full consideration of the

comments received and for the reasons

discussed above, the Postal Service

adopts, without revisions, the proposed

changes in the Domestic Mail Manual,

which is incorporated by reference in

the Code of Federal Regulations (see 39

CFR part 111).

List of Subjects in 39 CFR Part 111

Administrative practice and

procedure, Postal Service.

PART 111—[AMENDED]

1. The authority citation for 39 CFR

part 111 continues to read as follows:

Authority: 5 U.S.C. 552(a); 39 U.S.C. 101,

401, 403, 404, 3001–3011, 3201–3219, 3403–

3406, 3621, 3626, 5001.

2. Revise Domestic Mail Manual

E712.1.2, as follows:

Domestic Mail Manual

* * * * *

E ELIGIBILITY

* * * * *

E712 Bound Printed Matter

* * * * *

1.0 BASIC STANDARDS

* * * * *

1.2 Enclosures and Attachments

(Revise 1.2 to add new standards for

attachments and enclosures as follows:)

In addition to the basic standards in

E710, BPM may have the following

attachments and enclosures:

a. Any printed matter mailable as

Standard Mail.

b. Nonprint attachments and

enclosures. The combined weight of all

nonprint attachments and enclosures in

the mailpiece must be less than or equal

to 25 percent of the weight of the Bound

Printed Matter in the mailpiece. The

individual cost of each nonprint

attachment or enclosure must be less

than or equal to the cost of a ‘‘low cost’’

item as defined in E670.5.11. In

addition, the combined cost of all

nonprint attachments and enclosures

must not exceed two times the cost of

a ‘‘low cost’’ item as defined in

E670.5.11.

* * * * *

This change will be published in a

future issue of the Domestic Mail

Manual. An appropriate amendment to

39 CFR 111.3 to reflect these changes

will be published.

Stanley F. Mires,

Chief Counsel, Legislative.

[FR Doc. 01–13973 Filed 6–4–01; 8:45 am]

BILLING CODE 7710–12–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301131; FRL–6782–5]

RIN 2070–AB78

Pyriproxyfen; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for residues of pyriproxyfen in

or on pistachio. The Interregional

Research Project Number 4 (IR-4)

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 June

5, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301131, must be received

by EPA on or before August 6, 2001.

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–301131 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt Jamerson, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave.,

NW.,Washington, DC 20460; telephone

number: (703) 308–9368; and e-mail

address: jamerson.hoyt@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

30066 Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

theFederal Register listings at http://

www.epa.gov/fedrgstr/. A frequently

updated electronic version of 40 CFR

part 180 is available at http://

www.access.gpo.gov/nara/cfr/

cfrhtml_00/Title_40/40cfr180_00.html, a

beta site currently under development.

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–301131. 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 April 4,

2001 (66 FR 17883) (FRL–6772–4), 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 0E6081) for tolerance by IR4, Technology Center of New Jersey,

Rutgers, The State University of New

Jersey, 681 U.S. Highway #1 South,

North Brunswick, NJ 08902–3390. This

notice included a summary of the

petition prepared by Valent U.S.A.

Corporation, 1333 North California

Blvd., P.O. Box 8025, Walnut Creek, CA

94596–8025, the registrant. There were

no comments received in response to

the notice of filing.

The petition requested that 40 CFR

180.510 be amended by establishing a

tolerance for residues of the insecticide

pyriproxyfen, 2-[1-methyl-2-(4-

phenoxyphenoxy)ethoxypyridine, in or

on pistachio at 0.02 part per million

(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

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 pyriproxyfen on pistachio 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 pyriproxyfen 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 Subchronic feeding in rats (13

weeks)

NOAEL = 23.49 mg/kg/day in males 27.68 mg/kg/day in females

LOAEL = 117.79 milligram/kilogram/day (mg/kg/day) in males and 141.28 mg/

kg/day in females based on higher mean total cholesterol and phospholipids;

decreased mean red blood cells, hematocrit and hemoglobin counts and increased liver weight.

870.3150 Subchronic oral toxicity in dogs

(13 weeks)

NOAEL = 100 mg/kg/day

LOAEL = 300 mg/kg/day based on increased absolute and relative liver weight

in males and hepatocellular hypertrophy in females. These findings were

also observed at 1,000 mg/kg/day and may represent adaptive changes at

both 300 mg/kg/day and the limit dose of 1,000 mg/kg/day.

870.3200 21-Day dermal toxicity (rat) NOAEL = >1,000 mg/kg/day

There was no dermal or systemic toxicity at the 1,000 mg/kg/day dose, highest

dose tested (HDT).

Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations 30067

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

Guideline No. Study Type Results

870.3700a Prenatal developmental (rat) Maternal NOAEL = 100 mg/kg/day

LOAEL = 300 mg/kg/day based on increased incidences in mortality and clinical signs at 1,000 mg/kg/day with decreases in food consumption, body

weight, and body weight gain together with increases in water consumption

at 300 and 1,000 mg/kg/day.

Developmental NOAEL = 300 mg/kg/day

LOAEL = 1,000 mg/kg/day based on increased incidences of skeletal variations

and unspecified visceral variations at 1,000 mg/kg/day.

870.3700b Prenatal developmental (rabbit) Maternal NOAEL = 100 mg/kg/day

LOAEL = 300 mg/kg/day based on based on premature delivery/abortions, soft

stools, emaciation, decreased activity and bradypnea.

Developmental NOAEL = 300 mg/kg/day

LOAEL = 1,000 mg/kg/day. There were no effects observed in the 4 litters examined.

870.3800 Reproduction and fertility effects

(rat)

Parental/systemic NOAEL = 76 mg/kg/day in males and 87 mg/kg/day in females

LOAEL = 386 mg/kg/day and males 442mg/kg/day in females based on decreased body weight, weight gain and food consumption in both sexes and

both generations. Increased liver weight in both sexes of the F1 generation

and liver and kidney histopathology in F1 males.

Reproductive NOAEL = 386 mg/kg/day in males and 442 mg/kg/day in females

(highest dose tested).

Offspring NOAEL = 97 mg/kg/day in males and 105 mg/kg/day in females

LOAEL = 519 mg/kg/day in males and 554 mg/kg/day in females based on decreased pup body weight on lactation.

870.3800 Perinatal and postnatal study of

pyriproxyfen orally administered

to rats

Maternal NOAEL: 100 mg/kg/day

Maternal LOAEL: 300 mg/kg/day based on increased clinical signs, decreased

body weight gains, and decreased food consumption

Pup NOAEL: 100 mg/kg/day

Pup LOAEL: 300 mg/kg/day based on decreased body weight and increased

incidence of dilation of the renal pelvis. At 500 mg/kg/day, there was an increase in pup mortality during lactation

Pup Reproductive, Developmental, and Learning

NOAEL: 500 mg/kg/day

LOAEL: ≥500 mg/kg/day

870.3800 Non-guideline study of rats orally

exposed prior to and in the

early stages of pregnancy

Parental NOAEL = 100 mg/kg/day

Parental LOAEL = 300 mg/kg/day based on increased clinical signs, decreased

body weight gains, and increased water consumption in both sexes, and increased food consumption, changes in organ weights, and gross pathological

findings in the males only.

Developmental NOAEL = 1,000 mg/kg/day

Developmental LOAEL = 1,000 mg/kg/day

870.4300 Chronic toxicity/oncogenicity (rat) NOAEL = 35.1 mg/kg/day (females)

LOAEL = 182.7 mg/kg/day (females) based on decrease in body weight gain in

females at 182.70 mg/kg/day. There was no evidence of carcinogenic response.

870.4100 1-Year chronic feeding (dog) NOAEL = 100 mg/kg/day

LOAEL = 300 mg/kg/day based on decreased weight gain, increased absolute

and relative liver weight, mild anemia, increased cholesterol and triglycerides

in both sexes and slight anemia in males.

870.4200 Carcinogenicity mice NOAEL = 84 mg/kg/day in males and 109 mg/kg/day in females

LOAEL = 320 mg/kg/day in males and 547 mg/kg/day in females based on

renal lesions in both sexes. No statistically significant increase in tumor incidence relative to controls were observed in either sex at any dose up to the

highest dose tested.

870.5100 Gene Mutation Assay (Ames Test)

Reverse Mutation

Negative for induction of gene mutation measured as the reversion to histidine

protrophy of 5 S. typhimurium strains and E. coli WP2 uvra at doses from 10

to 5,000 μg/plated with and withour S-9 activation.

870.5300 Gene Mutation Negative for induction of gene mutation in Chinese hamster V79 cells with and

without metabolic activation up to cytotoxic doses.

30068 Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations

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

Guideline No. Study Type Results

870.5380 Structural

ChromosomalAbberation In vivo

Nonclastogenic in Chinese hamster ovary cells both with and without S-9 activation up to cytotoxic doses.

870.5550 Unscheduled DNA Synthesis Did not induce an increase in unscheduled DNA synthesis both with and without activation in HeLa cells exposed up to insoluble doses ranging to 6.4 μg/

mL without activation and 51.2 μg/mL with activation.

870.7485 Metabolism Rats were orally dosed with 14C-labeled pyriproxyfen at 2 or 1,000 mg/kg and

at repeated oral doses 14 daily doses of unlabeled pyriproxyfen at 2 mg/kg

followed by administration of a single oral dose of labeled pyriproxyfen at 2

mg/kg. Most radioactivity was excreted in the feces 81-92% and urine 5-12%

over a 7 day collection period. Expired air was not detected. Tissue radioactivity levels were very low less than 0.3% except for fat. Examination of

urine, feces, liver, kidney, bile and blood metabolites yielded numerous > 20

identified metabolites when compared to synthetic standards. The major biotransformation reactions of pyriproxyfen include: 1. Oxidation of the 4’ - position of the terminal phenyl group; 2. Oxidation at the 5’ - position of pyridine;

3. Cleavage of the ether linkage and conjugation of the resultant phenols

with sulfuric acid.

870.7600 Dermal penetration

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

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 pyriproxyfen

used for human risk assessment is

shown in the following Table 2:

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

ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF

FQPA SF* and Level of

Concern for Risk AssessmentStudy and Toxicological Effects

Acute dietary all populations Not applicable Not applicable No effects that could be attributed to a single

exposure were observed in oral toxicity studies.

Chronic dietary all populations NOAEL= 35.1 mg/kg/day

UF = 100

Chronic RfD = 0.35 mg/kg/

day

FQPA SF = 1X

cPAD = chronic RfD

÷FQPA SF

=0.35 mg/kg/day

2-Year chronic feeding study in rats

LOAEL = 182.7 mg/kg/day based on a decrease in body weight gains in females.

Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations 30069

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

ASSESSMENT—Continued

Exposure Scenario Dose Used in Risk Assessment, UF

FQPA SF* and Level of

Concern for Risk AssessmentStudy and Toxicological Effects

Short-term dermal and inhalation (1 to 7 days) (residential)Not applicable

Absorption rate = not more

than 10%

Not applicable 21-Day dermal toxicity study lack of dermal or

systemic toxicity at the limit-dose of 1,000

mg/kg/day.

Intermediate-term dermal and

inhalation (1 week to several

months) (residential)

Not applicable

Absorption rate = not more

than 10%

Not applicable 21-Day dermal toxicity study

Lack of dermal or systemic toxicity at the limitdose of 1,000 mg/kg/day.

Long-term dermal and inhalation

(several months to lifetime)

(residential)

35.1 mg/kg/day LOC for MOE = 100

(residential)

Chronic toxicity/carcinogenicity in rats

LOAEL = 182.7 mg/kg/day based on decreased weight gain in female rats.

Cancer (oral, dermal, inhalation) ‘‘Group E’’ human carcinogenNot applicable There is no evidence of carcinogenic potential.

*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 180.510) for the

combined residues of pyriproxyfen, in

or on a variety of raw agricultural

commodities. Permanent tolerances are

established under 40 CFR 180.510(a) for

residues of pyriproxyfen in/on the

following commodities: pome fruits

(crop group 11) (0.2 ppm), citrus fruits

(crop group 10) (0.3 ppm), fruiting

vegetables (except cucurbits) (crop

group 8) (0.2 ppm), tree nuts (crop

group 14) (0.02 ppm), cotton seed (0.05

ppm), cotton gin byproducts (2.0 ppm),

almond hulls (2.0 ppm), citrus oil (20

ppm), and citrus pulp, dried (2.0 ppm).

Tolerances are also proposed by

McLaughlin Gormley King Company for

residues of pyriproxyfen in/on all food

commodities at 0.10 ppm from use of

the pesticide in food handling

establishments. Risk assessments were

conducted by EPA to assess dietary

exposures from pyriproxyfen in food as

follows:

i. Acute exposure. Acute dietary risk

assessments are performed for a fooduse pesticide if a toxicological study has

indicated the possibility of an effect of

concern occurring as a result of a 1 day

or single exposure. An acute dose and

endpoint were not selected for any

population subgroup because no effects

that could be attributed to a single

exposure were observed in oral toxicity

studies. Therefore, an acute exposure

assessment was not conducted.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment 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 chronic exposure assessments: The

chronic dietary exposure analysis for

pyriproxyfen assumed tolerance level

residues and 100% crop treated for all

commodities with established or

proposed tolerances.

iii. Cancer. A cancer dietary exposure

assessment was not performed since

there was no evidence of

carcinogenicity in studies conducted

with rats and mice.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

pyriproxyfen 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

pyriproxyfen.

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

Screening Concentrations in Ground

Water (SCI-GROW), which predicts

pesticide concentrations in ground

water. In general, EPA will use GENEEC

(a tier 1 model) before using PRZM/

EXAMS (a tier 2 model) for a screeninglevel 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 pyriproxyfen

they are further discussed in the

aggregate risk sections below.

Based on the PRZM/EXAMS and SCIGROW models, the EECs of

pyriproxyfen for acute exposures are

estimated to be 0.46 parts per billion

(ppb) for surface water and 0.006 ppb

for ground water. The EECs for chronic

30070 Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations

exposures are estimated to be 0.11 ppb

for surface water and 0.006 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).

Pyriproxyfen is currently registered

for use on residential non-dietary sites.

Pyriproxyfen is the active ingredient in

many registered residential (indoor,

nonfood) products for flea and tick

control. Formulations include foggers,

aerosol sprays, emulsifiable

concentrates and impregnated materials

(pet collars). Pyriproxyfen residues from

residential exposure to pet collars was

estimated using the following

assumptions: an application rate of 0.58

mg ai/day (product label), average body

weight for a 1 to 6–year old child of 10

kg, the active ingredient dissipates

uniformly through 365 days (the label

instructs to change the collar once a

year), and 1% of the active ingredient is

available for dermal and inhalation

exposure per day (assumption from

Draft HED Standard Operating

Procedures (SOPs) for Residential

Exposure Assessments, December 18,

1997). The assessment also assumes an

absorption rate of 100%. This is a

conservative assumption since the

dermal absorption was estimated to be

10%.

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

pyriproxyfen 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,

pyriproxyfen 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 pyriproxyfen 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.

There is no indication of increased

susceptibility of rats or rabbit fetuses to

in utero and/or postnatal exposure in

the developmental and reproductive

toxicity studies.

iii. Conclusion. There is a complete

toxicity data base for pyriproxyfen 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 (reduced to 1X). The FQPA

factor is removed because: (1) The

toxicology data base is complete; (2)

there is no indication of increased

susceptibility of rats or rabbit fetuses to

in utero and/or postnatal exposure in

the developmental and reproductive

toxicity studies; (3) a developmental

neurotoxicity study is not required; (4)

dietary (food) exposure estimates are

unrefined (assuming tolerance level

residues and 100% crop treated) and

likely result in an overestimate of the

actual dietary exposure; (5) the models

are used for ground and surface source

drinking water exposure assessments

result in estimates that are upper-bound

concentrations; and (6) the Draft

Standard Operating Procedures for

Residential Exposure Assessments have

been used as the basis for all

calculations which normally rely on one

or more upper-percentile assumptions

and are considered to be protective.

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

ground water 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. An acute dietary dose

and endpoint was not identified. Thus

the risk from acute aggregate exposure is

considered to be negligible.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to pyriproxyfen from food

will utilize 0.9% of the cPAD for the

U.S. population, 1.6 % of the cPAD for

all infants (< year) and 2.6% of the

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

exception of the pet collar uses,

residential uses of pyriproxyfen result

in short-term, intermittent exposures.

Chronic residential postapplication risk

Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations 30071

assessments were conducted to estimate

the potential risk from the pet collar

uses. The estimated chronic term MOE

is 61,000 for children and 430,000 for

adults. The risk estimates indicate that

potential risks from pet collar use do not

exceed EPA level of concern (MOEs>

100). In addition, there is potential for

chronic dietary exposure to

pyriproxyfen 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 cPAD, as shown in the following

Table 3:

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

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

EEC (ppb)

Ground Water

EEC (ppb)

Chronic DWLOC

(ppb)

U.S. Population 0.35 0.9% 0.11 0.006 12,000

All Infants (<1 year) 0.35 1.6% 0.11 0.006 3,400

Children (1-6 years) 0.35 2.6% 0.11 0.006 3,400

Females (13-50 years) 0.35 0.7% 0.11 0.006 10,000

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).

Though residential exposure could

occur with the use of pyriproxyfen, no

toxicological effects have been

identified for short-term toxicity.

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. Aggregate cancer risk for U.S.

population. Pyriproxyfen is classified as

Group E for human carcinogenicity; not

carcinogenic in animal studies in two

species.

5. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, and to infants and children

from aggregate exposure to pyriproxyfen

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The gas-chromotography/nitrogenphosphorous specific flame ionization

detector (NPD) and high-pressure liquid

chromotography/fluorescence (FLD)

method RM-33N-2 is adequate for

collecting data on residues of

pyriproxyfen in/on nutmeat. Adequate

method validation data have been

submitted for this method and EPA has

successfully validated the analytical

method for analysis of nutmeat. The

limit of quantitation (LOQ) is 0.02 ppm

for residues of pyriproxyfen in/on

nutmeat.

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, Canadian, or

Mexican tolerances for pyriproxyfen

residues in/on pistachios. Therefore,

international harmonization is not an

issue at this time.

V. Conclusion

Therefore, the tolerance is established

for residues of pyriproxyfen in or on

pistachio at 0.02 ppm.

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–301131 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 August 6, 2001.

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

30072 Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations

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–301131, 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 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 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

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).

For these same reasons, the Agency has

determined that this rule does not have

any ‘‘tribal implications’’ as described

in Executive Order 13175, entitled

Consultation and Coordination with

Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

‘‘meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications.’’ ‘‘Policies that have tribal

implications’’ is defined in the

Executive Order to include regulations

that have ‘‘substantial direct effects on

one or more Indian tribes, on the

relationship between the Federal

government and the Indian tribes, or on

the distribution of power and

responsibilities between the Federal

government and Indian tribes.’’ This

rule will not have substantial direct

effects on tribal governments, on the

relationship between the Federal

government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.

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).

Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations 30073

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 17, 2001.

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), 346(a) and

371.

2. Section 180.510 is amended by

revising the introductory text in

paragraph (a)(1) and alphabetically

adding the commodity ‘‘pistachio’’ to

the table to read as follows:

§ 180.510 Pyriproxyfen; tolerances for

residues.

(a) General. (1) Tolerances are

established for residues of the

insecticide pyriproxyfen 2-[1-methyl-2-

(4-phenoxyphenoxy)ethoxypyridine in

or on the following food commodities:

Commodity Parts per million

*****

Pistachio ...................................................................................................................................... 0.02

** ***

* * * * *

[FR Doc. 01–14085 Filed 6–4–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301133; FRL–6783–5]

RIN 2070–AB78

Clethodim; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for combined residues of

clethodim in or on the root vegetable

(except sugar beet) subgroup. The

Interregional Research Project Number 4

(IR-4) requested this tolerance under the

Federal Food, Drug, and Cosmetic Act

(FFDCA), as amended by the Food

Quality Protection Act (FQPA) of 1996.

This final rule establishes permanent

tolerances for clethodim and as part of

that process the Agency has reassessed

existing tolerances. By law, EPA is

required to reassess 66% of the

tolerances in existence on August 2,

1996, by August 2002, or about 6,400

tolerances. All permanent tolerances for

clethodim that existed on August 2,

1996, were previously reassessed by

April 1998. Consequently, regarding the

actions in this final rule, no tolerance

reassessments are counted toward the

August 2002 review deadline of FFDCA

section 408(q).

DATES: This regulation is effective June

5, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301133, must be received

by EPA on or before August 6, 2001.

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–301133 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Shaja R. Brothers, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–3194; and e-mail

address: brothers.shaja@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

theFederal Register listings at http://

www.epa.gov/fedrgstr/. A frequently

updated electronic version of 40 CFR

part 180 is available at http://

www.access.gpo.gov/nara/cfr/

cfrhtml_00/Title_40/40cfr180_00.html, a

beta site currently under development.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301133. 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.