18528 Federal Register / Vol. 62, No. 73 / Wednesday, April 16, 1997 / Rules and Regulations

MAINE—OZONE—Continued

Designated area

Designation Classification

Date1 Type Date1 Type

York County ............................................................................................ .................... Nonattainment ............. .................... Moderate.2

* * * * * * *

1 This date is November 15, 1990, unless otherwise noted. 2 Attainment date extended to November 15, 1997.

* * * * *

[FR Doc. 97–9862 Filed 4–15–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185, and 186

[OPP–300473; FRL–5600–2]

RIN 2070–AB78

Clopyralid; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes

tolerances for residues of the herbicide

clopyralid (3,6-dichloro-2-pyridinecarboxylic acid) in or on the raw

agricultural commodities corn, field,

fodder; corn, field, forage; corn, field,

grain; and corn, field, milling fractions.

It also removes time-limited tolerances

for residues of clopyralid on the same

commodities that expired on December

31, 1996. DowElanco requested these

tolerances under the Federal Food, Drug

and Cosmetic Act (FFDCA) as amended

by the Food Quality Protection Act of

l996 (Pub. L. 104–170).

DATES: This regulation becomes

effective April 16, 1997. Written

objections must be received on or before

June 16, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300473;

PP 8F3622, 0H 5597], may be submitted

to: Hearing Clerk (1900), Environmental

Protection Agency, Rm. M3708, 401 M

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

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically to

the OPP by sending electronic mail (email) 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–300473; PP

8F3622, 0H5597]. 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 below in this

document.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne I. Miller, Product Manager

(PM) 23, Registration Division (7505C),

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 237, CM #2, 1921 Jefferson Davis

Hwy., Arlington, VA 22202, (703)–305–

6224; e-mail:

miller.joanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On April

25, l994 EPA established time-limited

tolerances under sections 408 and 409

of the Federal Food Drug, and Cosmetic

Act (FFDCA), 2l U.S.C. 346a(d) and 348,

for residues of clopyralid on corn, field,

fodder; corn, field, forage; corn, field,

grain; and corn, field, milling fractions

(59 FR 19639)(FRL–4775–4). These

tolerances expired on December 31,

l996. DowElanco, on September 27,

l996, requested that the time-limited

tolerances for residues of the herbicide

clopyralid in the field corn commodities

under the regulations mentioned above

be made permanent tolerances based on

residue data that they had submitted as

required to change the tolerances from

time-limited to permanent tolerances.

DowElanco also submitted a summary

of its petition as required under the

Federal Food, Drug and Cosmetic Act

(FFDCA) as amended by the Food

Quality Protection Act of l996 (Pub. L.

104–170).

A notice announcing the filing of

DowElanco’s petition was published in

the Federal Register, (61 FR 65221–

65223, December 11, l996)(FRL–5574–

4). The proposed analytical method for

determining residues is gas

chromatography with electrolytic

conductivity detection. The method for

enforcement is available from the FDA;

it is pending publication in the

Pesticide Analytical Manual II.

The basis for the conditional timelimited tolerances that expired

December 31, l996 was given in the

Federal Register notice of Final Rule (59

FR 19339). The required residue

chemistry data have been received,

reviewed and found adequate by EPA to

support the proposed tolerances. Based

on the review of the residue chemistry

data, EPA finds the tolerances

established by this Final Rule

adequately supported.

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 toxicology data listed

below were found acceptable by EPA in

support of these tolerances.

I. Toxicological Profile

1. A rat oral lethal dose (LD50) of

4,300 milligrams/kilogram (mg/kg) of

body weight.

2. A 13–week mouse feeding study

with a no-observed-effect level (NOEL)

of 750 mg/kg/day.

3. Two 180–day dog feeding studies

with NOEL > 50 mg/kg/day.

4. A rabbit teratology study with a

developmental and a maternal NOEL >

250 mg/kg/day, highest dose tested

(HDT).

5. A rat teratology study with a

developmental NOEL of > 250 mg/kg/
Federal Register / Vol. 62, No. 73 / Wednesday, April 16, 1997 / Rules and Regulations 18529

day (HDT) and a maternal toxicity

NOEL of 75 mg/kg/day.

6. A two-generation rat reproduction

study with a reproductive NOEL of >

1,500 mg/kg/day and a systemic NOEL

of 500 mg/kg/day.

7. A 1–year dog feeding study with a

NOEL of 100 mg/kg/day.

8. A 2–year rat chronic feeding/

oncogenicity study with a NOEL of 50

mg/kg/day with no oncogenic potential

observed under the conditions of the

study at doses up to and including 150

mg/kg/day (HDT). A significant decrease

in mean body weights of females

occurred at 150 mg/kg/day.

9. A repeat 2–year rat chronic feeding/

oncogenicity study with a systemic

NOEL of 15 mg/kg/day and with no

oncogenic potential observed under

conditions of the study up to 1,500 mg/

kg/day (HDT). Hyperplasia and

thickening of the limiting ridge of the

stomach occurred at 150 mg/kg/day.

10. Three 2–year mouse oncogenicity

studies with no oncogenic potential

observed under the conditions of the

study up to and including 2,000 mg/kg/

day (HDT) and a systemic NOEL of 500

mg/kg/day.

11. A dominant lethal assay, negative.

12. In vivo rat cytogenic study,

negative.

13. In vitro Salmonella and

Saccharomyces assay, negative.

14. An in vivo mouse host-mediated

assay, negative.

15. An unscheduled DNA synthesis

assay in rats, negative.

16. In an animal metabolism study At

doses of 5 mg/kg (oral), radiolabeled

clopyralid was excreted within 24 hours

in all dosed rats. Fecal elimination was

minor. Detectable levels of residual

radio-activity were observed in the

carcass and stomach at 72 hours postdose. Analysis of urine and fecal

extracts showed no apparent

metabolism of clopyralid.

II. Aggregate Exposures

1. From food and feed uses. The

primary source for human exposure to

clopyralid will be from ingestion of both

raw and processed agricultural

commodities as proposed in the

December 11, 1996 Notice for Filing

cited above. Based on exposure from

existing permanent tolerances listed in

40 CFR 180.431(a) of the Code of

Federal Regulations and the subject

proposed tolerances in field corn raw

agricultural commodities, the

Theoretical Maximum Residue

Contributions (TMRC) for the U.S. (48

States) adult population is 0.008214 mg/

kg body weight/day; for non-nursing

infants, 0.015400; for children 1 to 6

years old, 0.018454. These estimates are

based on the assumption that 100% of

the field corn commodities are derived

from field corn cultured with the aid of

the herbicide clopyralid.

2. From potable water. In examining

aggregate exposure, FQPA directs EPA

to consider available information

concerning exposures from the pesticide

residue in food and all other nonoccupational exposures. The primary

non-food sources of exposure the

Agency looks at include drinking water

(whether from groundwater or surface

water), and exposure through pesticide

use in gardens, lawns, or buildings

(residential and other indoor uses).

There is presently no EPA Lifetime

Health Advisory level for clopyralid and

its degradates as drinking water

contaminates. EPA does not have

drinking water monitoring data

available to perform a quantitative

drinking water risk assessment.

Available environmental fate data,

conservative screening tools, GENEEC

and Leaching Index have been used to

estimate environmental concentrations

of clopyralid in surface water and the

leaching potential of clopyralid. The

results of these screens indicate that

clopyralid is moderately persistent,

highly mobile in a soil and water

environment, and may impact ground

water and surface water.

Because the Agency lacks sufficient

water-related exposure data to complete

a comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

consumption of contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause clopyralid to exceed the

RfD if the tolerance being considered in

this document were granted. The

Agency has therefore concluded that the

potential exposures associated with

clopyralid in water, even at the higher

levels the Agency is considering as a

conservative upper bound, would not

prevent the Agency from determining

that there is a reasonable certainty of no

harm if the tolerance is granted.

3. From non-dietary uses. There is

only one non-dietary use registered

under the Federal Insecticide, Fungicide

and Rodenticide Act, as amended. The

use is for residential weed control in

turf.

i. Short-term or intermediate-term. A

part of the hazard assessment process,

the Agency reviews the available

toxicological database to determine the

endpoints of concern. For clopyralid,

the Agency does not have a concern for

a short-term or intermediate-term

residential risk assessment because the

available data does not indicate any

evidence of significant toxicity by the

dermal and inhalation routes. Therefore,

a short-term or intermediate-term

residential risk assessment was not

required.

ii. Chronic. As part of the hazard

assessment process an endpoint of

concern was determined for the chronic

occupational or residential assessment.

However, during the exposure

assessment process, the exposures that

would result from the use of clopyralid

were determined to be of an intermittent

nature. The frequency and duration of

these exposures do not exhibit a chronic

exposure pattern. The exposure does not

occur often enough to be considered a

chronic exposure; i.e, a continuous

exposure that occurs for at least several

months. Therefore, it was not deemed

appropriate to aggregate exposure from

the residential use with exposure from

food and drinking water.

iii. Acute. As part of the hazard

assessment process, the Agency reviews

the available toxicological database to

determine the endpoints of concern. For

clopyralid, the Agency does not have a

concern for an acute dietary assessment

because 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.

4. 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
18530 Federal Register / Vol. 62, No. 73 / Wednesday, April 16, 1997 / Rules and Regulations

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the 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 case 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

clopralid 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,

clopyralid 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 clopyralid has a common

mechanism of toxicity with other

substances.

III. Determination of Safety for U.S.

Population and Non-nursing Infants

A. The U.S. Population

Based on a NOEL of 50.80 mg/kg bwt/

day from a 2–year, rat feeding study

with a decreased mean body weight gain

effect, and using an uncertainty factor of

100 to account for the interspecies

extrapolation and intraspecies

variability, the Agency has determined

a Reference Dose (RfD) of 0.5 mg/kg

bwt/day for this assessment of chronic

risk. As indicated above, there is no

endpoint of concern identified with

acute and short- or intermediate-term

exposures. Based on the available

toxicity data and the available exposure

data identified above, the proposed and

existing tolerances will utilize 2% of the

RfD for the U.S. population. As

indicated above, whatever bounding

figure EPA chooses for drinking water

exposure, the exposure estimate for

clopyralid would not exceed the RfD.

B. Infants and Children

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of exposure (safety) for infants and

children in the case of threshold effects

to account for pre- and post-natal

toxicity and the completeness of the

database unless EPA determines that a

different margin of exposure (safety)

will be safe for infants and children.

Margins of exposure (safety) are often

referred to as uncertainty (safety)

factors. EPA believes that reliable data

support using the standard margin of

exposure (usually 100x for combined

inter- and intra-species variability)) and

not the additional tenfold margin of

exposure when EPA has a complete

database under existing guidelines and

when the severity of the effect in infants

or children or the potency or unusual

toxic properties of a compound do not

raise concerns regarding the adequacy of

the standard margin of exposure.

Based on current data requirements,

the data base relative to pre- and postnatal toxicity is complete. Risk to

infants and children was determined by

use of two developmental toxicity

studies and a two-generation

reproduction study. Both developmental

studies had developmental NOELs of >

250 mg/kg/day, the highest dose tested.

These studies also demonstrated that

there was no developmental (prenatal)

toxicity, at dosages at or below dosages

that resulted in maternal toxicity. The

maternal NOEL was > 250 mg/kg/day in

the rabbit study and 75 mg/kg/day in

the rat study. The developmental

NOELs are fivefold higher in both the

rat and rabbit than the NOEL used for

establishing the RfD. Based on current

data requirements, the data base relative

to pre- and post-natal toxicity is

complete. There were no treatmentrelated effects on any reproductive

parameter in the adults or their

offspring. The NOEL for reproductive

effects was 1,500 mg/kg bwt/day, and

there was no effect on reproductive

parameters at > 1,500 mg/kg/day nor

was there an adverse effect on the

morphology, growth or viability of the

offspring. The NOEL of the study was 30

times greater than the NOEL of 50.0 mg/

kg/day used for establishing the RfD.

These data taken together suggest

minimal concern for developmental or

reproductive toxicity and do not

indicate any increased pre- or post-natal

sensitivity. Therefore, EPA concludes

that an additional uncertainty factor is

not necessary to protect the safety of

infants and children and that the RfD at

0.5 mg/kg/day is appropriate for

assessing aggregate risk to infants and

children.

The percent of the RfD that will be

utilized by the aggregate exposure from

all tolerances to clopyralid will range

from 3% for non-nursing infants, up to

3.6% for children (1 to 6 years of age).

Therefore, EPA concludes that there is

a reasonable certainty that no harm will

result to infants and children from

aggregate exposure. As indicated above,

whatever bounding figure EPA chooses

for drinking water exposure, the

exposure estimate for clopyralid would

not exceed the RfD. Non-dietary

exposures were discussed above under

‘‘Non-Dietary Exposure.’’

IV. Other Considerations

1. Endocrine effects. There was no

reported endocrine effect in any of the

toxicological studies reviewed in the

toxicological profile of this final rule.

2. Metabolism in plants and animals.

The metabolism of clopyralid in plants

and animals is adequately understood

for the purposes of these tolerances.

There are no metabolites of toxicological

significance in plants. The residue of

concern in plants and animals is the

parent compound, clopyralid. In animal

metabolism studies with C14 labeled

clopyralid, the residues found were

clopyralid and its glycine conjugate.

3. Analytical method. There is a

practical analytical method for detecting

and measuring levels of clopyralid in or

on food with a limit of detection that

allows monitoring of food with residues

at or above the levels set in these

tolerances. The analytical method for

determining residues is gas

chromatography with electrolytic

conductivity detection, described in a

method submitted by DowElanco.

The quantitative limit of the method

is 0.05 micrograms/gram in field corn

fodder and forage and grain. EPA has

provided information on this method to

FDA. Because of the long lead time from

establishing these tolerances to

publication, the enforcement
Federal Register / Vol. 62, No. 73 / Wednesday, April 16, 1997 / Rules and Regulations 18531

methodology is being made available in

the interim to anyone interested in

pesticide enforcement when requested

by mail from: Calvin Furlow, Public

Response Branch, Field Operations

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location and telephone

number; Rm. 1130A, CM #2, l921

Jefferson Davis Highway, Arlington, VA

22202, (703)–305–5937.

4. International tolerances. There are

no Codex Alimentarius Commission

(Codex) Maximum Residue Levels

(MRLs) for clopyralid.

V. Summary of Findings

The analysis for clopyralid using

tolerance level residues shows that the

proposed use in the culture of field corn

will not cause exposure to exceed the

levels at which the Agency believes

there is an appreciable risk. All

population subgroups examined by EPA

are exposed to clopyralid residues at

levels below 100 percent of the RfD for

chronic effects.

Based on the information cited above,

the Agency has determined that the

establishment of these tolerances will be

safe therefore, the tolerances are

established as set forth below.

In addition to the tolerances being

amended, since for purposes of

establishing tolerances FQPA has

eliminated all distinctions between raw

and processed food, EPA is combining

the tolerances that now appear in

§§ 185.1100 and 186.1100 with the

tolerances in § 180.431 and is

eliminating §§ 185.1100 and 186.1100.

VI. 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 new

section 408(e) and (1)(6) as was

provided in the old section 408 and in

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 16, 1997,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (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 such issues,

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 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.

VII. Public Docket

EPA has established a record for this

rulemaking under docket number [OPP–

300473] (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.

Electronic comments may 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 rulemaking 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.

VIII. Regulatory Assessment

Requirements

Under Executive Order 12866 (58 FR

51735, Oct. 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, l993, special considerations

as required by Executive Order 12898

(59 FR 7629, February 16, l994).

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, l981).

Pursuant to 5 U.S.C. 801(a)(1)(A), 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 Accounting

Office prior to publication of the rule in

today’s Federal Register. This rule is
18532 Federal Register / Vol. 62, No. 73 / Wednesday, April 16, 1997 / Rules and Regulations

not a major rule as defined by 5 U.S.C.

804(2).

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Environmental protection, Food

additives, Pesticides and pests.

40 CFR Part 186

Environmental protection, Animal

feeds, Pesticides and pests.

Dated: April 4, 1997.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

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

b. Section 180.431 is amended as

follows:

i. In paragraph (a) by revising the

introductory text, and adding new

entries to the table.

ii. In paragraph (b) by removing the

text, and adding a paragraph heading.

iii. In paragraph (c) by the

redesignating the text as paragraph (b),

by adding a new paragraph heading, and

by reserving it.

iv. By adding paragraph (d) with a

paragraph heading only and reserving it.

§ 180.431 Clopyralid; tolerances for

residues.

(a) General. Tolerances are

established for combined residues of the

herbicide clopyralid (3,6-dichloro-2-

pyridinecarboxylic acid) in or on the

following commodities:

Commodity Parts per

million

* * * * *

Corn, field, fodder ..................... 10.0

Corn, field, forage ..................... 3.0

Corn, field, grain ....................... 1.0

Corn, field, milling fractions ...... 1.5

* * * * *

(b) Section 18 emergency exemptions.

* * *

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 346a and 348.

§ 185.1100 [Removed]

b. By removing § 185.1100 Clopyralid.

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority: 21 U.S.C. 342, 348 and 701.

§ 186.1100 [Removed]

b. By removing § 186.1100 Clopyralid.

[FR Doc. 97–9372 Filed 4–15–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL MARITIME COMMISSION

46 CFR Part 586

[Docket No. 96–20]

Port Restrictions and Requirements in

the United States/Japan Trade

AGENCY: Federal Maritime Commission.

ACTION: Amendment to final rule.

SUMMARY: The Federal Maritime

Commission is amending the final rule

in this proceeding to provide that fees

shall not be assessed on vessels for

which fees have been assessed within

the preceding seven days, or in the case

of vessels calling at ports in Hawaii,

within the preceding forty days.

DATES: Effective Date: April 14, 1997.

ADDRESSES: Requests for publicly

available information or additional

filings should be addressed to: Joseph C.

Polking, Secretary, Federal Maritime

Commission, 800 North Capitol Street,

N.W., Washington, D.C. 20573, (202)

523–5725.

FOR FURTHER INFORMATION CONTACT:

Thomas Panebianco, General Counsel,

Federal Maritime Commission, 800

North Capitol Street, N.W., Washington,

D.C. 20573, (202) 523–5740.

SUPPLEMENTARY INFORMATION: On March

4, 1997, the Commission published a

final rule in this proceeding assessing

per-voyage fees, effective April 14, on

Japanese liner carriers in response to

restrictive and unfavorable requirements

for the use of Japanese ports (62 FR

9696). On April 4, 1997, Nippon Yusen

Kaisha (NYK), one of the three Japanese

carriers subject to the imposition of fees,

submitted a ‘‘Request for Clarification’’

of the final rule to the Commission’s

General Counsel. In its request, NYK

urges that the Commission make certain

modifications to the final rule with

regard to the assessment of fees. The

request will therefore be treated as a

petition for amendment of the Final

Rule.

NYK’s request centers on the

application of the final rule as written

to two particular NYK trans-Pacific

service strings. The final rule, 46 CFR

586.2, states:

(c) Assessment of fees. A fee of one

hundred thousand dollars is assessed each

time a designated vessel is entered in any

port of the United States from any foreign

port or place.

NYK operates a weekly service with the

rotation: Japan/Taiwan/Hong Kong/Los

Angeles/Portland/Vancouver/Seattle/

Japan. Under the final rule, vessels in

this string would be subject to a

$100,000 fee first when they enter Los

Angeles from Hong Kong, then another

fee when they arrive at Seattle from

Vancouver. NYK suggests that this sort

of ‘‘double assessment’’ was not

envisaged by the Commission when it

promulgated the rule. It also states that

such double assessments could lead

NYK to drop a U.S. port from its

rotation.

NYK also offers bi-monthly sailings to

Honolulu in the following pattern: Far

East/Honolulu/Central America/

Honolulu/Far East. Under the rule, NYK

would be subject to fees on both the

eastbound and the westbound legs of

this voyage. NYK indicates that this

could cause it to drop one Hawaiian

port call from its rotation. NYK points

out that the Commission, in levying the

fee, adopted an approach designed to

‘‘eliminate the concern that the fee

could lead to lines dropping or

consolidating port calls in the U.S.’’

NYK suggests an amendment to the rule

that would be in keeping with this

intent, addressing the issues raised by

the two above-described service strings.

NYK proposed adding the following to

paragraph (c):

provided that no fee is assessed against a

designated vessel (1) if that vessel has

previously been assessed a fee under this rule

within the past ten days, or (2) for a vessel

calling in the state of Hawaii, has previously

been assessed a fee under this rule within the

past forty-five days.

The proposed amendment is in

keeping with the Commission’s

sensitivity to avoiding unnecessary

adverse effects to U.S. ports and

shippers. The proposed amendment

would prevent NYK from being

subjected to two fee assessments for one

set of west coast port calls based on its

unique service structure, heading off the