Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations 66773

[FR Doc. 01–31802 Filed 12–26–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301205; FRL–6817–9]

RIN 2070–AB78

Imazamox; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for residues of imazamox in or

on the raw agricultural commodities:

alfalfa forage, seed and hay, canola seed,

vegetable, legume, group wheat forage,

grain, bran, germ, shorts, hay and straw.

BASF Corporation, formerly American

Cyanamid Company, requested this

tolerance under the Federal Food, Drug,

and Cosmetic Act, as amended by the

Food Quality Protection Act of 1996.

DATES: This regulation is effective

December 27, 2001. Objections and

requests for hearings, identified by

docket control number OPP–301205,

must be received by EPA on or before

February 25, 2002.

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–301205 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Jim Tompkins, 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@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

Categories NAICS Examples of Potentially Affected Entities

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 Register listings at http://

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

OPPTS Harmonized Guidelines

referenced in this document, go directly

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

opptsfrs/home/guidelin.htm. A

frequently updated electronic version of

40 CFR part 180 is available at http://

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

cfrhtml_180/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–301205. 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 March 29,

2000 (65 FR 16594) (FRL–6498–5), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

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

amended by the Food Quality Protection

Act of 1996 (FQPA) (Public Law 104–

170) announcing the filing of a pesticide

petition (PP) for tolerance by American

Cyanamid Company, P.O. Box 400,

Princeton, NJ 08543–0400. This notice

included a summary of the petition

prepared by American Cyanamid

Company, the registrant. There were no

comments received in response to the

notice of filing. The petition was

subsequently transferred to BASF

Corporation, P.O. Box 400, Princeton, NJ

08543–0400.

The petition requested that 40 CFR

180.508 be amended by establishing a

tolerance for residues of the herbicide

imazamox, (±)-2-[4,5-dihydro-4-methyl4-(1-methylethyl)-5-oxo-1H-imidazol-2-

yl]-5-(methoxymethyl)-3-

pyridinecarboxylic acid, in or on the

raw agricultural commodities: vegetable,

legume, group at 0.05 ppm; canola, seed

at 0.05 ppm. Tolerances are established

for the combined residues of the

herbicide imazamox, and its metabolite,

AC263284 (±)-2-[4,5-dihydro-4-methyl4-(1-methylethyl)-5-oxo-1H-imidazol-2-

yl]-5-(hydroxymethyl)-3-

pyridinecarboxylic acid in or on the

following raw agricultural commodities

wheat, grain, forage and hay at 0.3 ppm,

wheat, straw at 0.2 ppm, wheat, bran at

1.0 ppm, wheat, shorts at 0.8 ppm, and

wheat, germ at 0.6 ppm. Tolerances are

established for the combined residues of

the herbicide imazamox, and its

metabolite, AC263284 (free and

conjugated), and AC312622, (±)-2-[4,5-

dihydro-4-methyl-4-(1-methylethyl)-5-

oxo-1H-imidazol-2-yl]-3,5-

pyridinecarboxylic acid in or on the

following raw agricultural commodities:

alfalfa, seed at 0.4 ppm, alfalfa, forage at

2.0 ppm and alfalfa, hay at 4.0 ppm

respectively.

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

66774 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

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 tolerances for

residues of the herbicide imazamox, (±)-

2-[4,5-dihydro-4-methyl-4-(1-

methylethyl)-5-oxo-1H-imidazol-2-yl]-5-

(methoxymethyl)-3-pyridinecarboxylic

acid, in or on the raw agricultural

commodities: vegetable, legume, group

at 0.05 ppm; canola, seed at 0.05 ppm.

Tolerances are established for the

combined residues of the herbicide

imazamox, and its metabolite,

AC263284 (±)-2-[4,5-dihydro-4-methyl4-(1-methylethyl)-5-oxo-1H-imidazol-2-

yl]-5-(hydroxymethyl)-3-

pyridinecarboxylic acid in or on the

following raw agricultural commodities

wheat, grain, forage and hay at 0.3 ppm,

wheat, straw at 0.2 ppm, wheat, bran at

1.0 ppm, wheat, shorts at 0.8 ppm, and

wheat, germ at 0.6 ppm. Tolerances are

established for the combined residues of

the herbicide imazamox, and its

metabolite, AC263284 (free and

conjugated), and AC312622, (±)-2-[4,5-

dihydro-4-methyl-4-(1-methylethyl)-5-

oxo-1H-imidazol-2-yl]-3,5-

pyridinecarboxylic acid in or on the

following raw agricultural commodities:

alfalfa, seed at 0.4 ppm, alfalfa, forage at

2.0 ppm and alfalfa, hay at 4.0 ppm

respectively. 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 imazamox are

discussed in the following Table 1 as

well as the no observed adverse effect

level (NOAEL). There was no lowest

observed adverse effect level (LOAEL)

in any of the subchronic or chronic

toxicity studies reviewed.

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results

870.1100 ............. Acute Oral ............................................... LD50 > 5,000 mg/kg (limit dose), toxicity category IV

870.1200 ............. Acute Dermal .......................................... LD50 > 4,000 mg/kg (twice the limit dose), toxicity category III

870.1300 ............. Acute Inhalation ...................................... LC50 > 6.3 mg/L, toxicity category IV

870.2400 ............. Primary Eye Irritation .............................. moderately irritating, toxicity category III

870.2500 ............. Primary Skin Irritation ............................. Non-irritating, toxicity category IV

870.2600 ............. Dermal Sensitization ............................... Non sensitizer

870.3100 ............. 90–Day oral toxicity rodents ................... NOAEL = 1,661 mg/kg/day, Highest Dose Tested (HDT)

870.3150 ............. 90–Day oral toxicity in nonrodents ......... NOAEL = 1,333 mg/kg/day, HDT

870.3200 ............. 21/28–Day dermal toxicity ...................... NOAEL = 1,000 mg/kg/day, HDT

870.3700 ............. Prenatal developmental in rodents ......... Maternal and Developmental NOAEL = 1,000 mg/kg/day, HDT

870.3700 ............. Prenatal developmental in nonrodents ... Maternal and Developmental NOAEL = 900 mg/kg/day, HDT

870.3800 ............. Reproduction and fertility effects ............ Parental/Systemic, Reproductive and Offspring NOAEL = 1469 mg/kg/day, HDT

870.4100 .............

870.4200 .............

Chronic toxicity and Carcinogenicity rodents.NOAEL = 1,068 mg/kg/day, HDT; no evidence of carcinogenicity

870.4100 ............. Chronic toxicity dogs ............................... NOAEL = 1,165 mg/kg/day, HDT

870.4300 ............. Carcinogenicity mice ............................... NOAEL = 1,053 mg/kg/day, HDT; no evidence of carcinogenicity

870.5100 ............. Gene Mutation ........................................ Negative

870.5375 ............. Cytogenetics ........................................... Negative

870.5385 ............. Other Effects ........................................... Negative

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations 66775

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

Guideline No. Study Type Results

870.7485 ............. Metabolism and pharmacokinetics ......... Rapidly excreted primarily in the urine following intravenous administration, and

in the urine and feces following oral administration, mainly as unchanged parent.

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.508) for the

residues of imazamox, in or on the raw

agricultural commodity soybeans. Due

to low toxicity, it was determined that

a dietary risk assessment of imazamox

in food is not needed and, therefore,

none was conducted.

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. No appropriate

endpoint attributable to a single

exposure (dose) was identified in the

imazamox toxicity database including

oral developmental toxicity studies in

rats and rabbits.

ii. Chronic exposure. There were no

observed adverse effects at the highest

dose tested (1,000 mg/kg/day or higher)

in any of the subchronic or chronic

toxicity tests conducted and the August

1998 OPPTS Series 870 Harmonized

Test Guidelines for health effects

recommend for subchronic and chronic

testing the highest dose tested should

not exceed 1,000 mg/kg/day using the

procedures described for these studies,

unless potential human exposure data

indicate the need for higher doses.

When imazamox was tested up to or

above the limit dose, no significant

adverse effects were observed.

Therefore, it was determined that a

chronic dietary risk assessment of

imazamox in food is not needed and,

therefore, none was conducted.

2. Dietary exposure from drinking

water. The Agency uses the First Index

Reservoir Screening Tool (FIRST) or the

Pesticide Root Zone/Exposure Analysis

Modeling System (PRZM/EXAMS), to

produce estimates of pesticide

concentrations in an index reservoir.

The screening concentration in ground

water (SCI-GROW) model is used to

predict pesticide concentrations in

shallow groundwater. For a screeninglevel assessment for surface water EPA

will use FIRST (a tier 1 model) before

using PRZM/EXAMS (a tier 2 model).

The FIRST model is a subset of the

PRZM/EXAMS model that uses a

specific high-end runoff scenario for

pesticides. While both FIRST and

PRZM/EXAMS incorporate an index

reservoir environment, 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.

Based on the FIRST and SCI-GROW

models the estimated environmental

concentrations (EECs) of imazamox for

acute exposures are estimated to be 32

parts per billion (ppb) for surface water

and 0.62 ppb for ground water. The

EECs for chronic exposures are

estimated to be 3.4 ppb for surface water

and 0.62 ppb for ground water. These

concentrations were compared to the

lowest high dose tested in the toxicity

studies (900 mg/kg) divided by an

uncertainty factor of 100, i.e., 9 mg/kg.

For chronic exposure in surface water,

the EEC of 3.4 ppb is 5/10,000% of 9

mg/kg. For acute exposure in surface

water, the EEC of 32 ppb is 4/1,000% of

9 mg/kg. For chronic and acute

exposure in ground water, the EEC of

0.62 ppb is 7/10,000% of 9 mg/kg.

Because the concentration of imazamox

in drinking water are much smaller than

9 mg/kg, the contribution of

consumption of imazamox via drinking

water to total dietary consumption of

imazamox (food plus water) is not

significant.

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). Imazamox

is not registered for use on any sites that

would result in residential exposure.

4. Cumulative exposure to substances

with a common mechanism of toxicity.

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

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

EPA does not have, at this time,

available data to determine whether

imazamox 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,

imazamox 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 imazamox 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. 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 database on toxicity

and exposure unless EPA determines

that a different margin of safety will be

safe for infants and children.

2. Prenatal and postnatal sensitivity.

No significant toxicity or pre- or postnatal toxicity was seen in any of the

studies conducted with imazamox.

3. Conclusion. Due to its low toxicity

a risk assessment using a safety factor

approach was not conducted for

imazamox. For similar reasons, it would

not be appropriate to use an additional

10x safety factor to protect infants and

children.

E. Aggregate Risks and Determination of

Safety

1. Acute risk. Since the acute toxicity

is low (toxicity categories III and IV) for

all tests conducted, the occurrence of an

effect of concern as a result of a one day

or single exposure is highly unlikely. It

66776 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

was determined that contribution of

additional dietary risk due to drinking

water consumption is insignificant as

described in section C. 2. above.

2. Chronic risk. There were no

observed adverse effects at the highest

dose tested (1,000 mg/kg/day or higher)

in any of the subchronic or chronic

toxicity tests conducted and the August

1998 OPPTS Series 870 Harmonized

Test Guidelines for health effects

recommend for subchronic and chronic

testing the highest dose tested should

not exceed 1000 mg/kg/day using the

procedures described for these studies,

unless potential human exposure data

indicate the need for higher doses.

When imazamox was tested up to or

above the limit dose, no significant

adverse effects were observed.

Therefore, it was determined that a

chronic dietary risk assessment of

imazamox in food is not needed and,

therefore, none was conducted.

3. Determination of safety. Based on

the low toxicity of imazamox and the

rationales described above, 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

imazamox residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The method may be requested from

Francis Griffith, Analytical Chemistry

Branch, Environmental Science Center,

701 Mapes Road, Fort George G. Mead,

Maryland, 20755–5350; telephone

number: (410) 305–2905; e-mail address:

griffith.francis@epa.gov.

B. International Residue Limits

There are no established or proposed

Codex Maximum Residue Limits (MRLs)

for imazamox.

V. Conclusion

Therefore, tolerances are established

for residues of the herbicide imazamox,

(±)-2-[4,5-dihydro-4-methyl-4-(1-

methylethyl)-5-oxo-1H-imidazol-2-yl]-5-

(methoxymethyl)-3-pyridinecarboxylic

acid, in or on the raw agricultural

commodities: vegetable, legume, group

at 0.05 ppm; canola, seed at 0.05 ppm.

Tolerances are established for the

combined residues of the herbicide

imazamox, and its metabolite,

AC263284 (±)-2-[4,5-dihydro-4-methyl4-(1-methylethyl)-5-oxo-1H-imidazol-2-

yl]-5-(hydroxymethyl)-3-

pyridinecarboxylic acid in or on the

following raw agricultural commodities

wheat, grain, forage and hay at 0.3 ppm,

wheat, straw at 0.2 ppm, wheat, bran at

1.0 ppm, wheat, shorts at 0.8 ppm, and

wheat, germ at 0.6 ppm. Tolerances are

established for the combined residues of

the herbicide imazamox, and its

metabolite, AC263284 (free and

conjugated), and AC312622, (±)-2-[4,5-

dihydro-4-methyl-4-(1-methylethyl)-5-

oxo-1H-imidazol-2-yl]-3,5-

pyridinecarboxylic acid in or on the

following raw agricultural commodities:

alfalfa, seed at 0.4 ppm, alfalfa, forage at

2.0 ppm and alfalfa, hay at 4.0 ppm

respectively

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–301205 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 February 25, 2002.

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–301205, 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

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations 66777

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). Because this rule has

been exempted from review under

Executive Order 12866 due to its lack of

significance, this rule is not subject to

Executive Order 13211, Actions

Concerning Regulations That

Significantly Affect Energy Supply,

Distribution, or Use (66 FR 28355, May

22, 2001). This final rule does not

contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). Nor does it require any

special considerations under Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or OMB review or any Agency

action under Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

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

tolerances and exemptions that are

established on the basis of a petition

under 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).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: December 18, 2001.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

371.

2. Section 180.508 is amended by

revising paragraph (a) to read as follows:

§ 180.508 Imazamox; tolerances for

residues.

(a) General. (1) Tolerances are

established for residues of the herbicide

imazamox, (±)2-[4,5-dihydro-4-methyl4-(1-methylethyl)-5-oxo-1H-imidazol-2-

yl]-5-(methoxymethyl)-3-

pyridinecarboxylic acid in or on the raw

agricultural commodities:

66778 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Rules and Regulations

Commodity Parts per million

Canola, seed ........................ 0.05

Vegetable, legume, group .... 0.05

(2) Tolerances are established for the

combined residues of the herbicide

imazamox, and its metabolite AC263284

[(±)2-[4,5-dihydro-4-methyl-4-(1-

methylethyl)-5-oxo-1H-imidazol-2-yl]-5-

(hydroxymethyl)-3-pyridinecarboxylic

acid in or on the raw agricultural

commodities:

Commodity Parts per million

Wheat, grain ......................... 0.30

Wheat, forage ....................... 0.30

Wheat, hay ........................... 0.30

Wheat, straw ......................... 0.20

Wheat, bran .......................... 1.0

Wheat, shorts ....................... 0.80

Wheat, germ ......................... 0.60

(3) Tolerances are established for the

combined residues of the herbicide

imazamox, and its metabolite AC263284

(free and conjugated), and AC312622,

[(±)-2-[4,5-dihydro-4-methyl-4-(1-

methylethyl)-5-oxo-1H-imidazol-2-yl]-

3,5-pyridinecarboxylic acid in or on the

raw agricultural commodities:

Commodity Parts per million

Alfalfa, seed .......................... 0.40

Alfalfa, forage ....................... 2.0

Alfalfa, hay ............................ 4.0

* * * * *

[FR Doc. 01–31799 Filed 12–26–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301197; FRL–6816–1]

RIN 2070–AB78

Halosulfuron-methyl; Pesticide

Tolerances for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

Halosulfuron-methyl in or on asparagus.

This action is in response to EPA’s

granting of an emergency exemption

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) authorizing use of the

pesticide on asparagus. This regulation

establishes a maximum permissible

level for residues of halosulfuronmethyl in this food commodity. The

tolerance will expire and is revoked on

December 31, 2003.

DATES: This regulation is effective

December 27, 2001. Objections and

requests for hearings, identified by

docket control number OPP–301197,

must be received by EPA on or before

February 25, 2002.

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 VII. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301197 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Meredith Laws, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–9366; and e-mail

address: laws.meredith@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by

this action if you are an agricultural

producer, food manufacturer, or

pesticide manufacturer. Potentially

affected 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 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_180/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–301197. 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, 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

EPA, on its own initiative, in

accordance with sections 408(e) and

408(l)(6) of the Federal Food, Drug, and

Cosmetic Act (FFDCA), 21 U.S.C. 346a,

is establishing a tolerance for residues of

the herbicide halosulfuron-methyl,

methyl 5-[(4,6-dimethoxy-2-

pyrimidinyl)

amino]carbonylaminosulfonyl-3-chloro1-methyl-1H-pyrazole-4-carboxylate, in

or on asparagus at 2.0 parts per million

(ppm). This tolerance will expire and is

revoked on 12/31/03. EPA will publish

a document in the Federal Register to

remove the revoked tolerance from the

Code of Federal Regulations (CFR).