Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Rules and Regulations 67489

scene Coast Guard patrol personnel

include commissioned, warrant and

petty officers of the Coast Guard on

board Coast Guard, Coast Guard

Auxiliary, local, state, and federal law

enforcement vessels.

(3) No person may enter the waters

within the boundaries of the security

zone unless previously authorized by

the Captain of the Port, Portland, Maine

or his authorized patrol representative.

Dated: December 7, 2001.

M. P. O’Malley,

Commander, U.S. Coast Guard Captain of

the Port, Portland, Maine.

[FR Doc. 01–32119 Filed 12–28–01; 8:45 am]

BILLING CODE 4910–15–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301202; FRL–6817–1]

RIN 2070–AB78

Clethodim; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for combined

residues of clethodim and its

metabolites and their sulphoxides and

sulphones in or on tall fescue forage and

tall fescue hay. This action is in

response to EPA’s granting of an

emergency exemption under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on tall fescue. This

regulation establishes a maximum

permissible level for residues of

clethodim in these food commodities.

The tolerances will expire and are

revoked on June 30, 2004.

DATES: This regulation is effective

December 31, 2001. Objections and

requests for hearings, identified by

docket control number OPP–301202,

must be received by EPA on or before

March 1, 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–301202 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Barbara Madden, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–6463]; and e-mail

address: Madden.Barbara@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

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–301202. 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 combined

residues of the herbicide clethodim,

[(E)-(±)-2-[1-[[(3-chloro-2-

propenyl)oxy]imino]propyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one] and its metabolites

containing the 5-(2-

ethylthiopropyl)cyclohexene-3-one and

5-(2-ethylthiopropyl)-5-

hydroxycyclohexene-3-one moieties and

their sulphoxides and sulphones,

expressed as clethodim, in or on tall

fescue forage at 10 parts per million

(ppm) and tall fescue hay at 20 ppm.

These tolerances will expire and are

revoked on June 30, 2004. EPA will

publish a document in the Federal

Register to remove the revoked

tolerance from the Code of Federal

Regulations.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment. EPA does not intend for its

actions on section 18 related tolerances

to set binding precedents for the

application of section 408 and the new

safety standard to other tolerances and

exemptions. Section 408(e) of the

67490 Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Rules and Regulations

FFDCA allows EPA to establish a

tolerance or an exemption from the

requirement of a tolerance on its own

initiative, i.e., without having received

any petition from an outside party.

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. . . .Section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) authorizes EPA to exempt

any Federal or State agency from any

provision of FIFRA, if EPA determines

that ‘‘emergency conditions exist which

require such exemption.’’ This

provision was not amended by the Food

Quality Protection Act (FQPA). EPA has

established regulations governing such

emergency exemptions in 40 CFR part

166.

III. Emergency Exemption for

Clethodim on Tall Fescue and FFDCA

Tolerances

Missouri is the second leading State

in beef cows and grass hay production.

These cows are predominantly raised on

tall fescue (Festuca arundinacea) forage

and hay because of its adaptation to the

environmental conditions in Missouri.

Tall fescue is susceptible to an

endopyte-fungus Acremonium

coenophialum which produces peptide

ergot alkaloids that are toxic to cattle.

Over the last decade a great deal of

information has been developed about

the causal relationship of the fungal

endophyte-fescue relationship and the

true nature of the toxic interactions.

This increased awareness was aided by

the identification of the primary toxic

compound of A. coenophialum called

ergovaline which is found in the highest

concentration in the seedhead and seed

of tall fescue. Therefore control of these

reproductive structures will help reduce

the overall concentration of ergovaline.

The toxic effects of ergovaline

include: reproductive problems,

summer syndrome (weight loss),

staggers, reduced milk production, and

fescue foot (poor circulation leading to

loss of hind feet). The reproductive

problems include reduction in

pregnancy rates from 86 to 91% in

endophyte-free pastures down to 67 to

72% in endophyte-infected pastures (a

22% reduction). Decreased milk

production has been demonstrated with

beef cattle showing a 25% reduction in

milk production and Polled Hereford

cows showing a 40% reduction in milk

production. This reduced milk

production will directly reduce calf

survival. Another related syndrome is a

hyperthermia response. This is believed

to be a peripheral vasoconstriction

associated with the endophyte. This

leads to a reduced temperature in the

legs and tail, an increase temperature in

the core body, increased respiration,

open mouthed breathing, and reduced

average daily weight gain.

Currently, there are no pesticides

registered for control of tall fescue

seedheads in pasture or hay fields. Tests

of vaccines and use of anthelmintics

(anti-parasitoids) have provided only

short-term relief (days) to cattle from the

problem. Non-chemical control methods

include pasture renovation and

reseeding to non-endophytic fescue,

rotation to non-fescue pastures, dilution

with legumes, supplementing the feed

with grain to reduce the amount of toxin

ingested, controlled grazing (heavy

foraging reduces seedhead formation),

ammoniate hay to neutralize the toxic

effects of ergovaline, and mechanically

removing the seedheads with mowing.

Taken singly or together these cultural

methods do not provide an effective,

economic long-term relief from the

problem. Pasture renovation or dilution

with legumes does not stop the

reintroduction of endophyte-fescue.

Rotation to non-fescue pastures is

difficult because other pasture grasses

do not grow as well therefore, there are

very few non-fescue pastures.

Supplementing grazing with other

grains is expensive due to the cost of the

grain, and the equipment to feed it.

Controlled heavy grazing to remove

seedheads is difficult because of the

heavy flush of vegetative growth

coincides with seedhead formation in

the spring. Ammoniating hay is not

effective in a pasture situation.

Mechanical mowing to remove

seedheads requires mowing the fields

two to four times during the season and

is costly in terms of time and money.

EPA has authorized under FIFRA

section 18 the use of clethodim on tall

fescue to suppress stem and seedhead

formation in tall fescue pasture or hay

to reduce toxin producing endophytefungus in Missouri. After having

reviewed the submission, EPA concurs

that emergency conditions exist for this

State.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

clethodim in or on tall fescue forage and

tall fescue hay. In doing so, EPA

considered the safety standard in

FFDCA section 408(b)(2), and EPA

decided that the necessary tolerance

under FFDCA section 408(l)(6) would be

consistent with the safety standard and

with FIFRA section 18. Consistent with

the need to move quickly on the

emergency exemption in order to

address an urgent non-routine situation

and to ensure that the resulting food is

safe and lawful, EPA is issuing this

tolerance without notice and

opportunity for public comment as

provided in section 408(l)(6). Although

these tolerances will expire and are

revoked on June 30, 2004, under FFDCA

section 408(l)(5), residues of the

pesticide not in excess of the amounts

specified in the tolerance remaining in

or on tall fescue forage and tall fescue

hay after that date will not be unlawful,

provided the pesticide is applied in a

manner that was lawful under FIFRA,

and the residues do not exceed a level

that was authorized by this tolerance at

the time of that application. EPA will

take action to revoke these tolerances

earlier if any experience with, scientific

data on, or other relevant information

on this pesticide indicate that the

residues are not safe.

Because these tolerances are being

approved under emergency conditions,

EPA has not made any decisions about

whether clethodim meets EPA’s

registration requirements for use on tall

fescue or whether a permanent tolerance

for this use would be appropriate.

Under these circumstances, EPA does

not believe that these tolerances serve as

a basis for registration of clethodim by

a State for special local needs under

FIFRA section 24(c). Nor do these

tolerances serve as the basis for any

State other than Missouri to use this

pesticide on this crop under section 18

of FIFRA without following all

provisions of EPA’s regulations

implementing section 18 as identified in

40 CFR part 166. For additional

information regarding the emergency

exemption for clethodim, contact the

Agency’s Registration Division at the

address provided underFOR FURTHER

INFORMATION CONTACT.

Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Rules and Regulations 67491

IV. Aggregate Risk Assessment and

Determination of Safety

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).

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 clethodim and to make a

determination on aggregate exposure,

consistent with section 408(b)(2), for

time-limited tolerances for combined

residues of clethodim in or on tall

fescue forage at 10 ppm and tall fescue

hay at 20 ppm.

No fescue residue data were

submitted for this specific emergency

exemption request. The proposed use

rate of clethodim for tall fescue is

approximately one-eighth of the rate

registered for use on alfalfa and clover.

Therefore, the use of alfalfa and clover

was translated to tall fescue for this

section 18 use. The established

tolerances for meat and milk are

adequate to cover this section 18 use.

According to Table 1 of OPPTS

860.1000 and the recommended and

established tolerances for clethodim, the

maximum theoretical dietary burdens

were determined for beef and dairy

cattle. Based on previous feeding

studies, the secondary residues in meat

and milk will not exceed the established

tolerances as a result of this section 18

use.

Residues of clethodim in or on tall

fescue are not expected to increase

dietary exposure. Since tall fescue is not

consumed by humans, any exposure to

residues of clethodim from this

emergency exeption will result from the

consumption of meat or milk. The use

of clethodim on tall fescue is not

expected to result in exceedances of the

tolerances that already exist for meat

and milk. Therefore, establishing the tall

fescue tolerance will not increase the

most recent estimated aggregate risks

resulting from use of clethodim, as

discussed in the September 17, 2001

Federal Register (66 FR 47971, FRL–

6800–9) final rule establishing

tolerances for combined residues of

clethodim in or on green onion, leaf

lettuce, the Brassica head and stem

subgroup, flax seed, flax meal, mustard

seed, canola seed and canola meal,

because in that prior action, risk was

estimated assuming all meat and milk

products contained tolerance level

residues. Refer to the September 17,

2001 Federal Register document for a

detailed discussion of the aggregate risk

assessments and determination of

safety. EPA relies upon that risk

assessment and the findings made in the

Federal Register document in support

of this action. Below is a brief summary

of the aggregate risk assessment.

An endpoint for acute dietary

exposure was not identified since no

effects were observed in oral toxicity

studies that could be attributable to a

single dose. Short-term and

intermediate-term aggregate exposure

takes into account residential exposure

plus chronic exposure to food and water

(considered to be a background

exposure level). Clethodim is not

registered for use on any sites that

would result in residential exposure.

Therefore, short-term and intermediateterm aggregate risks were not assessed.

Clethodim has been classified as a group

E carcinogen. Therefore, clethodim is

not expected to pose a cancer risk to

humans. Therefore, the only exposure

scenario the Agency assessed is for

chronic (non-cancer) exposures to

clethodim.

Using the Dietary Exposure

Evaluation Model (DEEMTM), an

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 clethodim for

each commodity. The following

assumptions were made for the chronic

exposure assessments: The 3–day

average of consumption for each subpopulation is combined with residues to

determine average exposure as

milligram/kilogram/day (mg/kg/day).

The chronic analysis was performed

using tolerance level residues for all

crops and livestock commodities. The

projected percent crop treated (PCT)

data (2% for lettuce, broccoli and

cauliflower, 15% for cabbage, 25% for

onion, and 1% for brussels sprouts),

weighted average PCT treated data for

existing registrations, and 100% crop

treated (CT) data for all other uses.

Using the exposure assumptions

described above, EPA has concluded

that exposure to clethodim from food

will utilize less than 1% of the chronic

population adjusted dose (cPAD) for the

U.S. population, less than 1% of the

cPAD for females (13-50 years) and less

than 1% of the cPAD for children 1-6

years old. There are no residential uses

for clethodim that result in chronic

residential exposure to clethodim. In

addition, there is potential for chronic

dietary exposure to clethodim in

drinking water. After calculating

drinking water levels of comparision

(DWLOCs) and comparing them to the

estimated environmental concentration

(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 1:

TABLE 1.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO CLETHODIM

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

EEC (ppb)

Ground Water

EEC (ppb)

Chronic DWLOC

(ppb)

U.S. population (total) 0.01 0.0030 6.1 0.08 250

Children 1-6 years 0.01 0.0061 6.1 0.08 40

Females 13-50 years 0.01 0.0023 6.1 0.08 230

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

clethodim residues.

V. Other Considerations

A. Analytical Enforcement Methodology

As discuseed in the September 17,

2001 Federal Register document (66 FR

47971), an adequate enforcement

methodology is available to enforce the

tolerance expression. The methods may

be requested from: Francis Griffith,

Analytical Chemistry Branch,

Environmental Science Center, 701

Mapes Road, Fort George G. Mead,

Maryland, 20755–5350; telephone

67492 Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Rules and Regulations

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

griffith.francis@epa.gov.

B. International Residue Limits

There are no established Codex

maximum residue limits for residues of

clethodim in or on tall fescue forage or

hay. Therefore, there are no questions

with respect to Codex/U.S. tolerance

compatibility.

C. Conditions

One application may be made. A

maximum of 0.031 pound active

ingredient may be applied per acre.

Clethodim is not to be applied within 15

days of grazing, feeding, or harvesting

(cutting) forage or hay.

VI. Conclusion

Therefore, the tolerance is established

for combined residues of clethodim,

[(E)-(±)-2-[1-[[(3-chloro-2-

propenyl)oxy]imino]propyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one] and its metabolites

containing the 5-(2-

ethylthiopropyl)cyclohexene-3-one and

5-(2-ethylthiopropyl)-5-

hydroxycyclohexene-3-one moieties and

their sulphoxides and sulphones,

expressed as clethodim, in or on tall

fescue forage at 10 ppm and tall fescue

hay at 20 ppm.

VII. 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–301202 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 March 1, 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 VII.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 the docket control

number OPP–301202, 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).

VIII. Regulatory Assessment

Requirements

This final rule establishes timelimited tolerances under FFDCA section

408. 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

Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Rules and Regulations 67493

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 FIFRA

section 18 exemption under FFDCA

section 408, such as the tolerances 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.

IX. 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 19, 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 180.458 is amended by

adding paragraph (b) to read as follows:

§ 180.458 Clethodim; tolerances for

residues.

* * * * *

(b)Section 18 emergency exemptions.

Time-limited tolerances are established

for the combined residues of clethodim,

[(E)-(±)-2-[1-[[(3-chloro-2-

propenyl)oxy]imino]propyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one] and its metabolites

containing the 5-(2-

ethylthiopropyl)cyclohexene-3-one and

5-(2-ethylthiopropyl)-5-

hydroxycyclohexene-3-one moieties and

their sulphoxides and sulphones,

expressed as clethodim in connection

with use of the pesticide under section

18 emergency exemptions granted by

EPA. These tolerances will expire and

are revoked on the date specified in the

following table:

Commodity Parts per million Expiration/revocation

date

Fescue, tall, forage ............................................................................................................................ 10 6/30/04

Fescue, tall, hay ................................................................................................................................ 20 6/30/04

67494 Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Rules and Regulations

* * * * *

[FR Doc. 01–32105 Filed 12–28–01; 8:45 am]

BILLING CODE 6560–50–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Medicare & Medicaid

Services

42 CFR Parts 413, 419, and 489

[CMS–1159–F3]

RIN 0938–AL35

Medicare Program; Prospective

Payment System for Hospital

Outpatient Services; Delay in Effective

Date of Calendar Year 2002 Payment

Rates and the Pro Rata Reduction on

Transitional Pass-Through Payments

AGENCY: Centers for Medicare &

Medicaid Services (CMS), HHS.

ACTION: Final rule; delay of effective

date.

SUMMARY: This document delays the

effective date of the payment rates

announced for Medicare hospital

outpatient services paid under the

prospective payment system for

calendar year 2002. These rates were

announced in a November 30, 2001 final

rule (66 FR 59856). In addition, this

document delays the effective date of

the uniform reduction to be applied to

each of the transitional pass-through

payments for CY 2002. Certain

provisions of the November 30, 2001

rule, as discussed in the SUPPLEMENTARY

INFORMATION section, are not delayed.

DATES: The effective date of the

amendments to 42 CFR published at 66

FR 59856 (November 30, 2001) remains

January 1, 2002, except that the effective

date for § 419.32(b)(1)(iii) is delayed

indefinitely. Also, the effective date for

§ 419.62(d), added at 66 FR 55865,

published on November 2, 2001, is

delayed indefinitely. The effective date

of the payment rates announced for

Medicare hospital outpatient services

paid under the prospective payment

system for calendar year 2002,

published in the preamble and addenda

of the November 30, 2001 final rule, and

the uniform reduction to be applied to

each of the transitional pass-through

payments for CY 2002, published in the

preamble and addenda of the November

30, 2001 final rule, is delayed until no

later than April 1, 2002. These rates

were announced in a November 30,

2001 final rule (66 FR 59856). We will

publish a document in the Federal

Register announcing the new effective

date for the rates and for

§ 419.32(b)(1)(iii) and § 419.62(d).

FOR FURTHER INFORMATION CONTACT:

James L. Hart, (410) 786–0378.

SUPPLEMENTARY INFORMATION:

Availability of Copies and Electronic

Access

Copies: To order copies of the Federal

Register containing this document, send

your request to: New Orders,

Superintendent of Documents, P.O. Box

371954, Pittsburgh, PA 15250–7954.

Specify the date of the issue requested

and enclose a check or money order

payable to the Superintendent of

Documents, or enclose your Visa or

Master Card number and expiration

date. Credit card orders can also be

placed by calling the order desk at (202)

512–1800 or by faxing to (202) 512–

2250. The cost for each copy is $9. As

an alternative, you can view and

photocopy the Federal Register

document at most libraries designated

as Federal Depository Libraries and at

many other public and academic

libraries throughout the country that

receive the Federal Register.

This Federal Register document is

also available from the Federal Register

online database through GPO Access, a

service of the U.S. Government Printing

Office. The Website address is: http://

www.access.gpo.gov/nara/index.html.

I. Background

On November 30, 2001, we published

a final rule announcing the final

ambulatory payment classification

(APC) groups, relative weights, and

payment rates under the hospital

outpatient prospective payment system

(OPPS) for calendar year 2002 (66 FR

59856). As discussed in detail in that

document, in setting the APC relative

weights, we incorporated 75 percent of

the estimated costs for devices eligible

for transitional pass-through payments

in 2002 into the costs of the APC groups

associated with the use of the devices

(66 FR 59906).

After the publication of the November

30 final rule, we discovered that the

final rule reflects several inadvertent

technical errors in which we incorrectly

associated specific devices approved for

transitional pass-through payments with

particular procedures. The effects of the

errors we have identified are of a

magnitude significant enough to affect

not only the estimate of total

transitional pass-through payments and

the uniform reduction percentage to be

applied to transitional pass-through

payments in 2002, but also the payment

rates for all APCs. Using rates that

reflect these errors would result in

inappropriate, uneven effects on

payments to hospitals. Thus, we believe

it would be inappropriate to proceed to

make the payment rates published on

November 30 effective without further

changes.

In order to thoroughly assess the

accuracy of the data files containing

these errors and to assure that they do

not contain further errors that might

also have significant implications, an

intensive review of the data will be

necessary. Because of the time needed

for this review, we cannot complete this

review and recalculate the rates before

the previously published effective date

of January 1, 2002. We will, therefore,

continue to pay for services covered

under the OPPS after January 1 and

until no later than April 1, 2002 under

the rates in effect on December 31, 2001.

We will also continue until no later than

April 1, 2002 to make transitional passthrough payments for drugs and devices

without applying the uniform reduction

announced on November 30, 2001.

Once our review has been completed

and the rates corrected, we will publish

a final rule with revised rates and a

revised calculation of the uniform

reduction in transitional pass-through

payments. We will announce the

effective date of these changes in that

rule.

II. List of OPPS Provisions That Are Not

Delayed

This document does not delay the

following provisions:

• Medicare, Medicaid, and SCHIP

Benefits Improvement and Protection

Act of 2000 coinsurance limit.

• Limitation of coinsurance amount

to inpatient hospital deductible amount.

• Changes in services covered within

the scope of OPPS.

• Categories of hospitals subject to,

and excluded from, the OPPS.

• Criteria for new technology APCs.

• Provider-based issues.

• Change to the definition of ‘‘singleuse devices’’ for transitional passthrough payments.

III. Waiver of Notice of Proposed

Rulemaking and the 30-Day Delay in

the Effective Date

We ordinarily publish a notice of

proposed rulemaking in the Federal

Register and invite public comment on

the proposed rule. The notice of

proposed rulemaking includes a

reference to the legal authority under

which the rule is proposed, and the

terms and substances of the proposed

rule or a description of the subjects and

issues involved. This procedure can be

waived, however, if an agency finds

good cause that a notice-and-comment