17096 Federal Register / Vol. 62, No. 68 / Wednesday, April 9, 1997 / Rules and Regulations

public inspection during normal

business hours at the following location:

U.S. Environmental Protection Agency,

Region 5, Air Programs Branch, 77 West

Jackson Boulevard, Chicago, Illinois

60604.

FOR FURTHER INFORMATION CONTACT:

Alvin Choi, Permits and Grants Section,

Air Programs Branch (AR–18J), U.S.

Environmental Protection Agency,

Region 5, 77 West Jackson Boulevard,

Chicago, Illinois 60604. Telephone:

(312) 886–3507.

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Carbon monoxide,

Hydrocarbons, Nitrogen dioxide, Ozone,

Sulfur dioxide, Volatile organic

compounds.

Dated: March 28, 1997.

Valdas V. Adamkus,

Regional Administrator.

Therefore the amendment to 40 CFR

part 52 which added § 52.770(c)(109) is

withdrawn.

[FR Doc. 97–9146 Filed 4–8–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300471; FRL–5599–8]

RIN 2070–AB78

Imazapyr; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Rule.

SUMMARY: This document establishes

tolerances for the residues of the

herbicide imazapyr, [2-[4,5-dihydro-4-

methyl-4-(1-methylethyl)-5-oxo-1Himidazol-2-yl]-3-pyridinecarboxylic

acid], applied as the acid, in or on field

corn. American Cyanamid submitted a

petition to EPA under the Federal Food,

Drug and Cosmetic Act as amended by

the Food Quality Protection Act of 1996

requesting the tolerances.

DATES: This rule becomes effective April

9, 1997. Written objections must be

submitted by June 9, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300471],

may be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. A copy of any

objections and hearing requests filed

with the Hearing Clerk should be

identified by the docket control number

and submitted to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M. St., SW.,

Washington, DC 20460. In person, bring

copy of objections and hearing requests

to: Rm. 1132, CM #2, 1921 Jefferson

Davis Highway, Arlington, VA 22202.

Fees accompanying objections and

hearing requests shall be labeled

‘‘Tolerance Petition Fees’’ and

forwarded to: EPA Headquarters

Accounting Operations Branch, OPP

(Tolerance Fees), P.O. Box 360277M,

Pittsburgh, PA 15251.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to :

opp-docket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket number [OPP–300471]. No

Confidential Business Information (CBI)

should be submitted through e-mail.

Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found in

Unit IX of this document.

FOR FURTHER INFORMATION CONTACT: By

Mail: Philip V. Errico, Product Manager

(PM) 25, Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number and

e-mail address: Rm. 241, CM #2, 1921

Jefferson Davis Highway, Arlington, VA

22202. (703) 305–6027; e-mail:

errico.philip@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 12, 1996

(61 FR 66658)(FRL–5576–9) EPA issued

a notice announcing that American

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

08543 had submitted pesticide petition

6F4641 which requested that the

Administrator, pursuant to section 408

of the Federal Food, Drug and Cosmetic

Act (FFDCA), and in conformity with

the Food Quality Protection Act (FQPA)

of 1996, amend 40 CFR part 180 to

establish tolerances for residues of

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

methylethyl)-5-oxo-1H-imidazol-2-yl]-3-

pyridinecarboxylic acid], applied as the

acid in or on field corn grain, fodder,

and forage at 0.05 ppm. The notice

contained a summary of the petition

prepared by the petitioner, American

Cyanamid, including information and

arguments to support their conclusion

that the petition complied with FQPA.

It was stated in the notice that the

conclusions and arguments were not

EPA’s.

There were no comments received in

response to the notices of filing.

The data submitted in the petition

and other relevant material have been

evaluated. The toxicological data listed

below were considered in support of

these tolerances.

I. Toxicology Profile

1. A battery of acute toxicity studies

placing technical imazapyr in toxicity

category I for eye irritation, category IV

for oral LD50 and primary dermal

irritation, category III for dermal and

inhalation LD50.

2. A 90–day rat feeding study at doses

of 0, 15,000, or 20,000 ppm (males= 0,

1,248, or 1,695 milligrams per kilogram

per day (mg/kg/day); females 0, 1,423,

or 1,784 mg/kg/day) with a no-observedeffect level (NOEL) of 1,695 mg/kg/day

the highest dose tested (HDT).

3. A 21-day rabbit dermal toxicity

study at doses of 0, 100, 200, or 400 mg/

kg/day which showed occasional

statistically significant findings but

these had no consistent pattern of

toxicity. The NOEL was determined to

be 400 mg/kg/day HDT.

4. A 1-year dog chronic toxicity study

at doses of 0, 25, 125, or 250 mg/kg/day.

The NOEL was 250 mg/kg/day HDT.

5. A 2–year rat chronic/

carcinogenicity study at doses of 0,

1,000, 5,000, or 10,000 ppm (males= 0,

49.9, 252.6, or 503 mg/kg/day; females=

0, 64.2, 317.6, or 638.6 mg/kg/day) with

a NOEL of 503 mg/kg/day HDT.

6. An 18–month mouse

carcinogenicity study at doses of 0,

1,000, 5,000, or 10,000 ppm (males= 0,

126, 674, or 1,301 mg/kg/day; females=

0, 151, 776, or 1,639 mg/kg/day) with a

NOEL of 1,301 mg/kg/day HDT.

7. A rat developmental toxicity study

at doses of 0, 100, 300, or 1,000 mg/kg/

day. At 1,000 mg/kg/day, the only

clinical sign of toxicity in gravid dams

was salivation. The NOEL for maternal

toxicity is 300 mg/kg/day. There were

no developmental findings in this study

up to the limit dose of 1,000 mg/kg/day

HDT.

8. A rabbit developmental toxicity

study at doses of 0, 25, 100, or 400 mg/

kg/day with a maternal and

developmental NOEL of 400 mg/kg/day

HDT.

9. A rat two-–generation reproduction

study at dietary concentrations of 0,
Federal Register / Vol. 62, No. 68 / Wednesday, April 9, 1997 / Rules and Regulations 17097

1,000, 5,000, or 10,000 ppm (males= 0,

74.2, 380.5, or 738 mg/kg/day; females=

0, 94.3, 471.2, or 933.3 mg/kg/day) with

a NOEL of 10,000 ppm HDT.

10. A metabolism study in rats

indicated that imazapyr was rapidly

absorbed and excreted by 7 days postdosing, with the majority of the

administered 14C-label (90%) eliminated

in the urine within 48 hours. Metabolite

characterization studies showed that

essentially all the test material was

excreted unchanged. Two minor

metabolites, CL 252,974 and CL 60,032,

were detected in the urine or feces of

treated rats; however, their contribution

combined was less than or equal to

0.5% of the administered dose. An

additional 12 unidentified metabolites

were isolated, but they contributed less

than 3% of the total dose.

11. Acceptable studies on gene

mutation and other genotoxic effects:

Ames Salmonella Assay; CHO/HGPRT

Point Mutation Assay; In vitro CHO cell

chromosome aberration assay; Dominant

lethal assay; and Unscheduled DNA

synthesis (UDS) yielded negative

results.

II. Dose Response Assessment

1. Reference dose. The Reference Dose

(RfD) represents the level at or below

which daily aggregate dietary exposure

over a lifetime will not pose appreciable

risks to human health. The RfD is

determined by using the toxicological

end-point or the NOEL for the most

sensitive mammalian toxicological

study. To assure the adequacy of the

RfD, the Agency uses an uncertainty

factor in deriving it. The factor is

usually 100 to account for both

interspecies extrapolation and

intraspecies variability represented by

the toxicological data. The EPA has

established an RfD of 2.5 mg/kg/day

based on a NOEL of 250 mg/kg/day from

a 1–year chronic dog feeding study.

2. Carcinogenicity classification.

Using the Guidelines for Carcinogenic

Risk Assessment published September

24, 1986 (51 FR 33992), the EPA has

classified imazapyr as Group ‘‘E’’, not a

likely human carcinogen.

3. Developmental toxicant

determination. The acceptable

developmental studies (two-generation

reproduction study in rats and prenatal

developmental toxicity studies in rats

and rabbits) provided no indication of

increased sensitivity of rats or rabbits to

in utero and/or postnatal exposure to

imazapyr.

III. Non-dietary (Residential and

Occupational) Exposure Assessment

Imazapyr products marketed for

residential use include total vegetation

control products that are used for plot

treatments or bare ground applications.

These products are to be applied only

where no plant growth is desired and

are not to be used on lawns. Therefore,

for these limited residential uses, the

potential for exposure is minimal, and

is expected to be non-chronic. These

products are in Toxicity Categories II for

eye irritation. Under the protective

clothing requirements of the Worker

Protection Standards (WPS), handlers of

these products are expected to be

adequately protected.

Imazapyr is also registered for use on

non-food sites including railroad,

utility, pipeline, and highway rights-ofway, utility plant sites, petroleum tank

farms, pumping installations, fence

rows, storage areas, non-irrigation

ditchbanks, under asphalt, under pond

liners, wildlife management areas,

forestry site preparation, and other noncrop areas. These low rate uses entail

minimal exposure potential for the

general population. Use of protective

clothing also reduces exposure.

Since imazapyr is a group E chemical

(evidence of non-carcinogenicity for

humans); the 21 day dermal study

lacked any significant observable effects

at the limit dose, and no adverse effects

were observed in developmental

toxicity studies in rats up to 1,000 mg/

kg/day and rabbits up to 400 mg/kg/day,

no toxicological endpoints for nonchronic residential exposures were

identified. Therefore, non-chronic risk

assessments are not required for

occupational or non-occupational

residential uses.

IV. Dietary Exposure Assessment

Use of a agricultural pesticide may

result, directly or indirectly, in pesticide

residues in food. Primary residues or

indirect/inadvertent residues in

agricultural commodities are

determined by chemical analysis. To

account for the diversity of growing

conditions, cultural practices, soil types,

climates, crop varieties and methods of

application of the pesticide, data from

studies that represent the commodities

are collected and evaluated to determine

an appropriate level of residue that

would not be exceeded if the pesticide

is used as represented in the studies.

1. Plant/animal metabolism and

magnitude of the residue. The nature

(metabolism) of imazapyr in plants and

animals is adequately understood for

the purposes of these tolerances. There

are no Codex maximum residue levels

established for residues of imazapyr on

corn or the rotational crops. In all the

plant and animal (poultry and

ruminants) metabolism studies

submitted, the residue of concern was

the parent per se, imazapyr.

2. Residue analytical methods. The

analytical method proposed as an

enforcement method for field corn

commodities is GS/MS Method M

2468.02. The method is suitable for

detecting residues of the parent

compound, imazapyr, in field corn

forage, silage, grain, fodder, meal and

oil. Tolerances for meat, milk, poultry,

and eggs, are not required for this

petition, therefore, an analytical method

for the enforcement of animal tolerances

is not needed.

V. Aggregate Exposure Assessment

In examining aggregate exposure,

FQPA directs EPA to consider available

information concerning exposures from

pesticide residue in food, including

water, and all other non-occupational

exposures. The aggregate sources of

exposure the Agency looks at includes

food, drinking water or groundwater,

and exposure from pesticide use in

gardens, lawns, or buildings (residential

and other indoor uses).

1. Acute dietary. As part of the hazard

assessment process, the Agency reviews

the available toxicology database to

determine the endpoints of concern. For

imazapyr, the Agency does not have a

concern for an acute dietary assessment

since the available data do not indicate

any evidence of significant toxicity from

a 1 day or single event exposure by the

oral route. Therefore, an acute dietary

risk assessment was not required.

2. Chronic dietary. Using the Dietary

Risk Evaluation System (DRES), a

chronic exposure analysis was

performed using tolerance level residues

and 100 percent crop treated to estimate

the Theoretical Maximum Residue

Contribution (TMRC) for the general

population and 22 subgroups. This

exposure analysis showed that exposure

from residues in/on corn for the U.S.

population and all subgroups would be

less than 1% of the RfD.

3. Drinking water. To determine the

exposure from drinking water, the

Agency applied modeling procedures.

Using the estimated chronic drinking

water values of 1 μg/L for surface water

and 3 μg/L for ground water, the

exposure to imazapyr from drinking

water was calculated to be 3 × 10-5

milligrams per kilogram of body weight

per day (mg/kg bw/day) for the U.S

population (surface water), 1 × 10-4 mg/

kg bw/day for children (surface water),

7 × 10-5 mg/kg bw/day for U.S.

population (ground water), and 3 × 10-4

mg/kg bw/day for children (ground

water). The calculations are included in

the docket for this rulemaking.
17098 Federal Register / Vol. 62, No. 68 / Wednesday, April 9, 1997 / Rules and Regulations

4. Non-dietary (residential and nonoccupational) exposure. Imazapyr is

registered for residential and nonoccupational uses. As part of the hazard

assessment process, the Agency reviews

the available toxicological database to

determine the endpoints of concern. For

imazapyr, the Agency does not have a

concern for acute, short-term, or

intermediate-term occupational or

residential risk assessment since the

available data do not indicate any

evidence of significant toxicity by the

dermal or inhalation routes, or from a 1

day or single event exposure by the oral

route. Therefore, acute, short-term or

intermediate-term non-occupational or

residential risk assessment was not

required.

As part of the hazard assessment

process it was determined that a chronic

residential assessment was not

necessary. The exposures which would

result from the use of imazapyr were

determined to be of an intermittent

nature. The frequency and duration of

these exposures do not exhibit a chronic

exposure pattern. The exposures do not

occur often enough to be considered a

chronic exposure i.e., a continuous

exposure that occurs for at least several

months. Therefore, chronic residential

exposures were not aggregated with

dietary exposures in estimating chronic

risk.

5. Cumulative exposure to substances

with 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.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may be

helpful in determining whether a

pesticide shares a common mechanism

of toxicity with any other substances,

EPA does not at this time have the

methodology to resolve the scientific

issues concerning common mechanism

of toxicity in a meaningful way. EPA

has begun a pilot process to study this

issue further through examination of

particular classes of pesticides. The

Agency hopes that the results of this

pilot process will increase the Agency‘s

scientific understanding of this question

such that EPA will be able to develop

and apply scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although, at present, the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

imazapyr 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, imazapyr

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 imazapyr has a common

mechanism of toxicity with other

substances. After EPA develops

methodologies for more fully applying

common mechanism of toxicity issues

to risk assessments, the Agency will

develop a process (either as part of the

periodic review of pesticides or

otherwise) to reexamine those tolerance

decisions made earlier.

The registrant must submit, upon

EPA’s request and according to a

schedule determined by the Agency,

such information as the Agency directs

to be submitted in order to evaluate

issues related to whether imazapyr

shares a common mechanism of toxicity

with any other substance and, if so,

whether any tolerance for imazapyr

needs to be modified or revoked.

VI. Determination of Safety for the U.S.

Population and Non-Nursing Infants

A. U.S. Population and Non-Nursing

Infants

Using the Dietary Risks Evaluation

System (DRES) a chronic analysis was

performed based on 100% of the crop

treated and all residues at tolerance

levels. Based on the dietary/water risk

assessment, the proposed uses utilize

less than 1% of the RfD for the U.S.

population; less than 1% of the RfD for

nonnursing infants under 1 year old;

less than 1% for nursing infants under

1 year old; less than 1% for children 1

to 6 years old; and less than 1% for

children 7 to 12 years old. The Agency

concluded that no harm will occur to

non-nursing infants, or any other

members of the U.S. population from

aggregate exposure to imazapyr.

B. Infants and Children

Risk to infants and children was

determined by the use of two

developmental toxicity studies in rats

and rabbits and the two-generation

reproduction study in rats discussed

below. The developmental toxicity

studies evaluates the potential for

adverse effects on the developing

organism resulting from exposure

during prenatal development. The

reproduction study provides

information relating to effects from

exposure to the chemical on the

reproductive capability of both (mating)

parents and on systemic toxicity.

The toxicological database for

evaluating pre- and post-natal toxicity

for imazapyr is considered to be

complete at this time. In the rabbits, no

evidence of maternal or developmental

toxicity was observed at doses up to 400

mg/kg/day, highest dose tested HDT. In

the rat developmental toxicity study,

maternal (systemic) toxicity was noted

(indicated by salivation) at 1,000 mg/kg/

day HDT.

In the rat two-generation reproduction

study, no evidence of toxicity was noted

in either the adults or the offspring at

dietary levels at or close to the limit

dose.

FFDCA section 408 provides that the

EPA shall apply an additional safety

factor of 10 in the case of threshold

effects for infants and children to

account for pre- and post-natal toxicity

and the completeness of the database

unless EPA determines, based on

reliable data, that a different safety

factor would be appropriate. The

Agency believes that an additional

safety factor for infants and children is

not warranted. A complete set of

developmental and reproductive studies

have been submitted and EPA has found

them to be acceptable. The NOEL used

to calculate the RfD for the general U.S.

population is 250 mg/kg bw/day derived

from the 1–year chronic toxicity study

in dogs. That NOEL is lower than the

developmental NOELs for the teratology

studies in rabbits and rats (1.6 and 4x,

respectively), as well as lower than the
Federal Register / Vol. 62, No. 68 / Wednesday, April 9, 1997 / Rules and Regulations 17099

NOEL for the two-generation

reproduction study in male and female

rats (3.2 to 3.9x). The Agency does not

believe the effects seen in the above

studies are of such concern to require an

additional safety factor. Accordingly,

the Agency believes the RfD has an

adequate margin of protection for

infants and children. The percent RfD

utilized by imazapyr is less than 1% for

nursing infants (less than 1 year old),

and for non-nursing infants and

children 1 to 6 years old. EPA

concluded that there is reasonable

certainty that no harm will occur to

infants and children from aggregate

exposure to imazapyr.

VII. Other Considerations

1. Endocrine effects. No specific tests

have been conducted with imazapyr to

determine whether the chemical may

have an effect in humans that is similar

to an effect produced by a naturally

occuring estrogen or other endocrine

effects. However, there were no

significant findings in other relative

toxicity studies, i.e., teratology and

multi-generation reproductive studies,

which would suggest that imazapyr

produces endocrine related effects.

2. Data Gap. Additional storage

stability data are required to support the

18 and 27 month storage stability

tabulated data, including storage

temperature, analysis, raw data,

representative chromatograms, and

quality assurance (good laboratory

practices).

VIII. Objections and Hearing Requests

The new FFDCA section 408 (g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under the new

section 408 (e) and (l)(6) as was

provided in the old section 408 and

section 409. However, the period for

filing objections is 60 days rather than

30 days. EPA currently has procedural

regulations which governs the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by June 9, 1997 file

written objections to any aspect of this

regulation and may also request a

hearing with the Hearing Clerk, at the

address given below (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issue(s) on

which a hearing is requested, the

requestor‘s contentions on each such

issue, and a summary of any evidence

relied upon by the objector, (40 CFR

178.27). 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

issue(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

‘‘Confidential Business Information’’

(CBI), Information marked as CBI 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.

IX. Public Docket

A record has been established for this

rulemaking under the docket number

[OPP–300471] (including any comments

and data submitted electronically). A

public version of this record, including

printed, paper versions of electronic

comments, which does not include any

information claimed as CBI, is available

for inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA 22202.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rule-making record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

X. Regulatory Assessment

Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a ‘‘significant regulatory action’’ and

since this action does not impose any

information collection requirements

subject to approval under the Paperwork

Reduction Act, 44 U.S.C. 3501 et seq.,

it is not subject to review by the Office

of Management and Budget. In addition,

this action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 Pub.L. 104–4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28. 1993), or special

considerations as required by Executive

Order 12898 (59 FR 7629), February 16,

1994).

Because tolerances established on the

basis of a petition under section 408(d)

of FFDCA do not require issuance of a

proposed rule, the regulatory flexibility

analysis requirements of the Regulatory

Flexibility Act (RFA), 5 U.S.C. 604(a),

do not apply. Prior to the recent

amendment of the FFDCA, EPA had

treated such rulemakings as subject to

the RFA; however, the amendments to

the FFDCA clarify that no proposal is

required for such rulemakings and

hence that the RFA is inapplicable.

Nonetheless, the Agency has previously

assessed whether establishing tolerances

or exemptions from tolerance, raising

tolerance levels, or expanding

exemptions adversely impact small

entities and concluded, as a generic

matter, that there is no adverse impact.

(46 FR 24950, May 4, 1981).

Under 5 U.S.C. 801(a)(1)(A) of the

Administrative Procedure Act (APA) as

amended by the Small Business

Regulatory Enforcement Fairness Act of

1996 (Title II of Pub. L. 104–121, 110

Stat. 847), EPA submitted 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 General
17100 Federal Register / Vol. 62, No. 68 / Wednesday, April 9, 1997 / Rules and Regulations

Accounting Office prior to publication

of the rule in today’s Federal Register.

This rule is not a ‘‘major rule’’ as

defined by 5 U.S.C. 804(2) of the APA,

as amended.

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agriculatural commodities, Pesticides

and pest, Reporting and recordkeeping

requirements.

Dated: March 31, 1997.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a. and 371.

2. By adding § 180.500 to read as

follows:

§ 180.500 Imazapyr; tolerances for

residues.

Tolerances are being established for

residues of the herbicide imazapyr, [2-

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

methylethyl)-5-oxo-1H-imidazol-2-yl]-3-

pyridinecarboxylic acid], applied as the

acid or ammonium salt, in or on the

following raw agricultural commodities:

Commodity Parts per

million

Corn, field, forage (silage) ........ 0.05

Corn, field, grain ....................... 0.05

Corn, field, stover ..................... 0.05

[FR Doc. 97–9091 Filed 4–8–97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 1

[OST Docket No. 1; Amdt. 1–286]

Organization and Delegation of Powers

and Duties Delegated to the

Commandant, United States Coast

Guard

AGENCY: Office of the Secretary, DOT.

ACTION: Final rule.

SUMMARY: The Secretary of

Transportation is delegated to the

Commandant, United States Coast

Guard, the authority contained in the

Antarctic Science, Tourism, and

Conservation Act of 1996, to issue such

regulations as are necessary and

appropriate to implement the Protocol

on Environmental Protection to the

Antarctic Treaty relating to the

prevention of marine pollution and

emergency response action for vessels.

In order that the Code of Federal

Regulations reflect this delegation, a

change is necessary.

EFFECTIVE DATE: April 9, 1997.

FOR FURTHER INFORMATION CONTACT:

LCDR Ray Perry, Environmental

Standards Division (G–MSO–4), (202)

267–2714, U.S. Coast Guard, 2100

Second Street, SW., Washington, DC

20593; or Ms. Gwyneth Radloff, Office

of the General Counsel, C–50, (202)

366–9305, Department of

Transportation, 400 Seventh Street,

SW., Washington, DC 20590.

SUPPLEMENTARY INFORMATION: Public

Law 104–227 is the Antarctic Science,

Tourism, and Conservation Act of 1996

(hereafter referred to as the Act). Section

106 of this Act amends section 6 of the

Antarctic Conservation Act of 1978 (16

U.S.C. 2405) by requiring the Secretary

to issue such regulations as are

necessary and appropriate, in addition

to regulations issued under the Act to

Prevent Pollution from Ships (33 U.S.C.

1901 et seq.), to implement Annex IV of

the Protocol on Environmental

Protection to the Antarctic Treaty. It

also requires the Secretary to issue such

regulations as are necessary and

appropriate, with the concurrence of the

Director of the National Science

Foundation, to implement Article 15 of

the Protocol with respect to vessels. The

Secretary of Transportation is delegating

his authority under the Act to the

Commandant of the Coast Guard.

This rule adds a specific delegation of

authority to 49 CFR 1.46, thus amending

the codification to reflect the Secretarial

delegation of authority to the

Commandant of the Coast Guard.

Since this amendment relates to

departmental management,

organization, procedure, and practice,

notice and comment on it are

unnecessary under 5 U.S.C. 553(b).

Further, since the amendment expedites

the Coast Guard’s ability to implement

international treaty obligations, the

Secretary finds good cause under 5

U.S.C. 553(d)(3) for the final rule to be

effective on the date of publication in

the Federal Register.

List of Subjects in 49 CFR Part 1

Authority delegations (Government

agencies), Organization and functions

(Government agencies).

In consideration of the foregoing, Part

1 of Title 49, Code of Federal

Regulations, is amended to read as

follows:

PART 1—[AMENDED]

1. The authority citation for Part 1

continues to read as follows:

Authority: 49 U.S.C. 322; Pub. L. 101–552,

28 U.S.C. 2672, 31 U.S.C. 3711(a)(2).

1.46 [Amended]

2. Section 1.46 is amended by adding

a new paragraph (hhh) to read as

follows:

1.46 Delegations to Commandant of the

Coast Guard.

* * * * *

(hhh) Carry out the functions and

exercise the authority vested in the

Secretary by 16 U.S.C. 2405 to issue

such regulations as are necessary and

appropriate to implement the Antarctic

Science, Tourism, and Conservation Act

of 1996, Pub. L. No. 104–227, 110 Stat.

3034.

* * * * *

Issued at Washington, DC this 28th day of

March, 1997.

Rodney E. Slater,

Secretary of Transportation.

[FR Doc. 97–9155 Filed 4–8–97; 8:45 am]

BILLING CODE 4910–62–P

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety

Administration

49 CFR Part 531

[Docket No. 96–085; Notice 2]

Passenger Automobile Average Fuel

Economy Standards; Final Decision To

Grant Exemption

AGENCY: National Highway Traffic

Safety Administration (NHTSA), DOT.

ACTION: Final decision.

SUMMARY: This final decision responds

to a petition filed by Rolls-Royce

Motors, Ltd. (Rolls-Royce) requesting

that it be exempted from the generally

applicable average fuel economy

standard of 27.5 miles per gallon (mpg)

for model years (MYs) 1998 and 1999

and that a lower alternative standard be

established. In this document, NHTSA

establishes an alternative standard for

Rolls Royce of 16.3 mpg for MYs 1998

and 1999.

DATES: Effective date: May 27, 1997.

This exemption and the alternative

standards apply to Rolls Royce for MYs

1998 and 1999.

Petitions for reconsideration: Petitions

for reconsideration must be received no

later than May 27, 1997.

ADDRESSES: Petitions for reconsideration

of this rule should refer to the docket