Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations 61635

longer necessary. The Baton Rouge

serious ozone nonattainment area is

required to have an enhanced I/M

program under section 182 of the Clean

Air Act (the Act) as amended in 1990.

This disapproval initiates the sanction

process of section 179(a) of the Act.

[FR Doc. 97–30376 Filed 11–18–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300557; FRL–5746–1]

Methyl Salicylate; Establishment of an

Exemption from Requirement of a

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes an

exemption from the requirement of a

tolerance for residues of the insecticide

methyl salicylate in or on food, when

used as an insect repellent in food

packaging and animal feed packaging at

an application rate that does not exceed

0.2 mg of methyl salicylate per square

inch of packaging materials.

EFFECTIVE DATE: NOVEMBER 19, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number [OPP–300557/PP

7F4818], 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

[OPP–300557] and submitted to: Public

Information and Records Integrity

Branch, Information Resources and

Services 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 Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

electronic objections and hearing

requests must be submitted as an ASCII

file avoiding 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 5.1 file format

or ASCII file format. All copies of

electronic objections and hearing

requests must be identified by the

docket control number [OPP–300557].

No Confidential Business Information

(CBI) should be submitted through email. Copies of electronic objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Sheryl K. Reilly, Biopesticides and

Pollution Prevention Division (7501W),

Office of Pesticide Programs, U.S.

Environmental Protection Agency, 401

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

Office location and telephone number:

Room CS15-W31, 2800 Jefferson Davis

Hwy., Arlington, VA, (703/308-8265); email: reilly.sheryl@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Tenneco

Packaging, 1603 Orrington Ave.,

Evanston, IL, 60201, requested in

pesticide petition PP 7F4818 the

establishment of an exemption from the

requirement of a tolerance for residues

of the insecticide methyl salicylate on

food, when used as a insect repellent in

food packaging and animal feed

packaging materials alone or in

conjunction with inert components

which conform to the requirements of

regulations issued by the Food and Drug

Administration under section 409 of the

Federal Food, Drug, and Cosmetic Act

(FFDCA). A notice of filing (FRL–5721–

6) was published in the Federal Register

(62 FR 32331) on June 13, 1997, and the

notice announced that the comment

period would end on July 13, 1997; no

comments were received.

The data submitted in the petition

and all other relevant material have

been evaluated. Following is a summary

of EPA’s findings regarding this petition

as required by section 408(d) of the

FFDCA, as recently amended by the

Food Quality Protection Act.

I. Risk Assessment and Statutory

Findings

New section 408(c)(2)(A)(i) of the

FFDCA allows EPA to establish an

exemption from the requirement of 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(c)(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 an in

residential settings, but does not include

occupational exposure. Section

408(c)(2)(B) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue... .’’ EPA performs a number of

analyses to determine the risks from

aggregate exposure to pesticide residues.

First, EPA determines the toxicity of

pesticides. Second, EPA examines

exposure to the pesticide through food,

drinking water, and through other

exposures that occur as a result of

pesticide use in residential settings.

II. Toxicological Profile

Consistent with section 408(b)(2)(D)

of FFDCA, EPA has reviewed the

available scientific data and other

relevant information in support of this

action and considered its validity,

completeness and reliability and the

relationship of this information to

human risk. EPA has also considered

available information concerning the

variability of the sensitivities of major

identifiable subgroups of consumers,

including infants and children.

Additionally, 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.’’ Methyl

salicylate (CAS Registry Number 119–

36–8) is the primary chemical

component of a naturally occurring

fragrant oil, oil of wintergreen. If present

at all, residues of methyl salicylate that

may be found in foods in contact with

treated packaging materials is expected

to be minimal and considerably below

the levels expected in existing GRAS

uses of the active ingredient as a direct

food flavoring ingredient.

The toxicity of methyl salicylate has

been extensively studied in animal

bioassays of acute, subchronic, and

chronic duration. Studies include

assessments of the mutagenicity,

developmental toxicity, and

reproductive effects of methyl salicylate.

The petitioner submitted data from the

scientific literature to support all

toxicology studies typically required for

registration of biochemical pesticides.

1. Acute toxicity . The acute oral LD50

for methyl salicylate in the rat ranges
61636 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations

from 887-1,250 mg/kg. Acute dermal

toxicity (LD50) has been reported to be

> 5 g/kg in the rabbit.

2. Skin and eye irritation. Methyl

salicylate has been reported to be a

severe eye irritant. Methyl salicylate has

been reported to produce mild dermal

irritation in rabbits at a concentration of

1%. Moderate to severe irritation is

produced in rabbits and guinea pigs at

concentrations above 1%. Applied full

strength to intact or abraded rabbit skin

for 24 hours under occlusion, methyl

salicylate was moderately irritating.

However, tested at 8% in petrolatum, it

produced no irritation after a 48 hour

closed-patch test on human subjects.

3. Mutagenicity. No evidence for

genotoxicity was observed in two

studies with prokaryotic test systems;

no data on genotoxicity in mammalian

test systems are available.

4. Subchronic toxicity. Studies of

subchronic duration with

administration by the oral route have

been conducted in both rats and dogs.

In rats, no adverse effects were seen at

a dose of 50 mg/kg/day in the diet. In

dogs, doses ≤250 mg/kg/day did not

result in any adverse effects, however,

the liver appeared to be the target organ

of toxicity at doses above this level. No

toxicity was observed when rats were

exposed to methyl salicylate via

inhalation of saturated air (approx. 700

mg/m3) after twenty 7-hour exposures.

5. Developmental toxicity. Methyl

salicylate has been tested for

developmental effects in hamsters, rats

and mice by the oral and dermal routes.

In hamsters, oral or dermal doses of

methyl salicylate at doses of 1,750 mg/

kg/day induced maternal toxicity and

increased the incidence of neural tube

defects. In rats given methyl salicylate at

up to 6,000 mg/kg/day in petroleum

based grease by the dermal route, no

developmental effects were observed.

However, undiluted methyl salicylate

applied to the skin of pregnant rats

caused total litter resorptions at 1,000

mg/kg/day (a dose that was reduced

from 2,000 mg/kg/day because of

excessive maternal toxicity). The results

of a continuous breeding study in mice

were consistent with findings in the

developmental studies because of the

decreased numbers of litters per pair,

reduced average number of pups per

litter, decreased proportion of pups born

alive in each litter, and reduced mean

pup weights in mice given 500 mg/kg/

day. The no-observed-adverse-effect

level (NOAEL) for these effects was 250

mg/kg/day.

6. Chronic toxicity. Toxicity resulting

from chronic exposure has been

evaluated in studies of two-years’

duration as well as studies initially

intended to evaluate multi-generational

reproductive and developmental effects.

In mice, the NOAEL for reproductive

parameters and the other toxic

endpoints examined has been reported

as 250 mg/kg/day. When rats were

exposed to methyl salicylate in the diet

for two years, no adverse effects were

noted at levels of 0.1% (approx. 50 mg/

kg/day); pituitary lesions were increased

in animals exposed to 0.5% (approx.

250 mg/kg/day). In dogs orally exposed

to methyl salicylate for two years, no

adverse effects were observed at 50 mg/

kg/day; the LOAEL (liver effects) was

reported as 150 mg/kg/day.

7. Carcinogenicity. No studies have

been performed with the primary

purpose of determining the oncogenicity

of methyl salicylate; however, chronic

exposure studies with two-year

exposure durations that included

extensive pathology did not indicate

any increases in incidences of benign or

malignant tumors.

8. Toxicology data waivers. Waivers

for acute inhalation toxicity, dermal

sensitization, and immune response

studies were accepted by the Agency,

based on the long history of use of

methyl salicylate by humans without

any indication of deleterious effects.

Besides its use as a flavoring agent in

foods (see GRAS Assessment, below),

methyl salicylate has been used in

mouthwash, suntan lotions, and in U.S.

Pharmocopeia (U.S.P.) preparations as a

counterirritant and analgesic for painful

muscles or joints, in liniments,

ointments, and other preparations. In

addition, the manufacturing use product

is a liquid, which is not expected to

result in the release of appreciable

quantities of inhalable methyl salicylate

during the manufacturing process, and

worker exposure via the dermal route

will be minimized through the use of

rubber gloves and splash proof goggles

and/or face shields. In the end-use

formulation, methyl salicylate will be

incorporated into a solid matrix in the

packaging materials, and the release of

vapors at a very low rate over extended

periods of time will not result in

significant worker or consumer dermal

and inhalation exposure.

9. GRAS assessment. The Flavoring

Extract Manufacturer’s Association

(FEMA) has determined GRAS levels of

methyl salicylate and oil of wintergreen

in foods and beverages as indicated in

the table below.

TABLE 1- FEMA GRAS LEVELS IN

FOOD (PPM)

Food Methyl Salicylate

Oil of Wintergreen

Beverages ......... 59 56

Ice cream .......... 27 44

Candy ................ 840 260

Baked goods ..... 54 1,500

Chewing gum .... 8,400 3,900

Syrups ............... 200 ---

GRAS food levels in Table 1 are above

both the maximum food residue

concentration (approx. 16 ppm) and the

maximum dietary exposure

concentration (approx. 4.7 ppm)

estimated by the Petitioner for the

proposed use pattern for methyl

salicylate. These estimates used highly

conservative assumptions for migration

of methyl salicylate from packaging and

food consumption. Petitioner has shown

that even under worst-case exposure

conditions (i.e., assuming 30% of all

food consumed is in contact with

packaging containing methyl salicylate,

and 100% of the methyl salicylate

migrates to food) exposure to methyl

salicylate from use in packaging

materials would be less than that

received by chewing one stick of

chewing gum at the GRAS-approved

level. Residue data requirements were

thus waived by the Agency.

III. Aggregate Exposures

In examining aggregate exposure,

FFDCA section 408 directs EPA to

consider available information

concerning exposures from the pesticide

residue in food and all other nonoccupational exposures, including

drinking water from groundwater or

surface water and exposure through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses).

There is no established Maximum

Contaminant Level (MCL) for residues

of methyl salicylate in drinking water

under the Safe Drinking Water Act.

There are five currently registered

pesticide products that contain methyl

salicylate as an active ingredient. These

products include impregnated materials

and pellets to be used as vertebrate

repellents, and disinfectants/germicides

registered for use in household,

institutional, hospital, and eating

establishment premises. In addition,

methyl salicylate has many nonpesticidal uses, such as liniments,

lotions, and other products listed above.

With regard to dietary exposure, as

noted above in Table 1, methyl

salicylate is used as a flavoring in many

food products.
Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations 61637

Aggregate exposure to methyl

salicylate from all these sources is

difficult to determine, largely because of

its use in a wide variety of food

products. While it is difficult to develop

a precise estimate of total human

exposure to methyl salicylate, EPA

believes that its history of safe use as a

flavoring additive and its low toxicity at

relatively high doses indicate that

current exposures are likely to be

significantly below levels that may

result in adverse health effects. The

likely dietary exposures from the

pesticidal use in food packaging would

be indirect (i.e., resulting from food

contact with a treated surface) and

therefore unlikely to add significantly to

existing exposures. However, because

studies evaluated by the Agency

indicate that methyl salicylate is toxic to

humans at certain high levels, EPA

believes it is appropriate to place some

limitation on the amount of methyl

salicylate that may be applied to

packaging material for the purposes of

repelling insects to ensure that large

quantities of the substance are not used

in food packaging. The limitation of 0.2

mg per square inch of packaging

materials established by this regulation

is based on the lowest GRAS level (27

ppm for ice cream) and a worst-case

scenario, which assumes 100% transfer

of the active ingredient from the

packaging material to food contained

within, without consideration of the

physical and chemical barriers between

the chemical and the food. Using the

lowest GRAS level is a conservative step

that ties the potential exposure to what

is already likely to be in the food

supply. The limit, therefore, ensures

that any increased human exposure

resulting from the pesticidal use of

methyl salicylate in packaging material

would add very little to the existing

exposures -- exposures which EPA

believes to be safe. Therefore, EPA

concludes that there is a reasonable

certainty of no harm from aggregate

dietary exposure under this exemption.

A. Dietary Exposure

Dietary exposure of methyl salicylate

via food or water is difficult to estimate

due to the use of methyl salicylate as a

flavoring in many food products.

However, based upon its long history of

safe use as an additive in food and

beverages and its low toxicity at

relatively high doses, the Agency

believes that current dietary exposure is

likely to be significantly below levels

that may cause adverse health effects.

The likely dietary exposures from the

registered products would be indirect

(i.e., resulting from food contact with a

treated surface) and therefore add very

little to existing exposures. Therefore,

EPA concludes that there is a reasonable

certainty of no harm from aggregate

dietary exposure under this exemption.

B. Non-dietary, Non-occupational

Exposure

There are five currently registered

pesticide products that contain methyl

salicylate as an active ingredient. These

products include impregnated materials

and pellets to be used as vertebrate

repellents, and disinfectants/germicides

registered for use in household,

institutional, hospital, and eating

establishment premises. In addition,

methyl salicylate is already widely used

in liniments, lotions, and other products

listed above. The Agency considers the

toxicology data base available to support

non-pesticidal uses and exposures

adequate to support a conclusion of

insignificant increase in non-dietary,

non-occupational exposure and toxicity

from the pesticidal use in food and feed

packaging materials.

IV. Cumulative Exposure

The Agency has considered the

potential for cumulative toxicity effects

of pesticidal uses of methyl salicylate

and other substances that may have a

common mechanism of toxicity. The

Agency concluded that consideration of

a common mechanism of toxicity is not

appropriate because there is no

information in the publicly available

literature that indicates there are other

substances that share a common

mechanism of toxicity with methyl

salicylate. Thus, only the potential risks

of methyl salicylate were considered in

this exemption from the requirement of

a tolerance.

V. Safety Factors

A. U.S. Population

Methyl salicylate is the major

component of a naturally occurring

fragrant oil. FEMA has listed methyl

salicylate on its GRAS list for use as a

flavoring ingredient in foods and

beverages. An FDA Advisory Review

Panel has concluded that methyl

salicylate is safe for use up to a

concentration of 0.4% in the form of a

rinse or mouthwash. The compound is

extensively used in foods, beverages,

pharmaceuticals, lotions and perfumes

and has wide distribution in commerce

with no reports of adverse outcomes

associated with intended uses. The

toxicity of methyl salicylate has been

adequately and reliably characterized; it

is summarized in this submission.

Based on this information, EPA

concludes that there is reasonable

certainty of no harm from aggregate

exposures to pesticidal uses of methyl

salicylate over a lifetime, and that no

significant human health risks will

result from such exposures.

B. Infants and Children

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre- and postnatal toxicity and the

completeness of the data base unless

EPA concludes that a different margin of

safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through the use of a

margin of exposure analysis or through

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans.

Due to the low expected toxicity of

this compound, EPA has not used a

safety factor analysis in assessing the

risk of these compounds. For the same

reasons the additional safety factor is

unnecessary.

VI. Determination of Safety for U.S.

Population, Infants and Children

Based on its long history of use by

humans without any indication of

deleterious effects, there is reasonable

certainty that no harm will result from

aggregate exposure to the United States

population, including infants and

children, to residues of methyl

salicylate. This includes all anticipated

dietary exposures and all other

exposures for which there is reliable

information. As a result, EPA

establishes an exemption from the

requirement of a tolerance pursuant to

FFDCA section 408(j)(3) for methyl

salicylate, on the condition that Methyl

salicylate be used in accordance with

the following provisions:

Tenneco Packaging must immediately

notify the EPA of any findings that have

a bearing on safety. The company must

also keep records of production,

distribution, and performance and on

request make the records available to

any authorized officer or employee of

the EPA or the Food and Drug

Administration.

This exemption from the requirement

of a tolerance may be revoked if any

experience with or scientific data on

this pesticide indicate that the tolerance

is not safe.

VII. Other Considerations

A. Endocrine Disrupters

Methyl salicylate has been studied in

several tests of reproductive and

developmental effects, including

multigenerational studies. In addition,
61638 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations

the pathology of endocrine-sensitive

tissues and organs has been evaluated

following repeated (i.e., subchronic) and

long-term (i.e., chronic) exposures. No

such effects were reported in any of

these studies. The Agency has no

information to suggest that methyl

salicylate will have an effect on the

immune and endocrine systems. The

Agency is not requiring information on

the endocrine effects of this biochemical

pesticide at this time; Congress has

allowed 3 years after August 3, 1996, for

the Agency to implement a screening

program with respect to endocrine

effects.

B. Analytical Method

The Agency proposes to establish an

exemption from the requirement of a

tolerance with a numerical limitation.

Therefore, for enforcement purposes,

quantitative analysis of the active

ingredient methyl salicylate may be

performed by a gas chromatographic

method using flame ionization detection

as described by the Association of

Official Analytical Chemists (Method

969.13, AOAC Official Methods of

Analysis, 1990, pages 754–755).

VIII. Codex Maximum Residue Level

No known maximum residue limits

(MRLs) have been established for

methyl salicylate by the Codex

Alimentarius Commission.

IX. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

exemption regulation issued by EPA

under new section 408(e) as was

provided in the old section 408.

However, the period for filing objections

is 60 days, rather than 30 days. EPA

currently has procedural regulations

which govern 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 adversely affected by this

regulation may, January 20, 1998, file

written objections to the 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 genuine and

substantial issue of fact; there is

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

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.

X. Public Docket

A record has been established for this

rulemaking under the docket number

[OPP–300557]. A public version of this

record, 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, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA

22202.

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.

XI. Regulatory Assessment

Requirements

The Office of Management and Budget

has exempted this notice from the

requirement of section 3 of Executive

Order 12866.

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), entitled Enhancing

the Intergovernmental Partnership, or

special consideration 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).

XII. Submission to Congress and the

General Accounting Office

Under 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 in today’s

Federal Register. This rule is not a

major rule as defined by 5 U.S.C. 804(a).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, pesticides

and pests, Reporting and record keeping

requirements.

Dated: November 5, 1997.

Stephen L. Johnson,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:
Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations 61639

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

2. Section 180.1189 is added to read

as follows:

§ 180.1189 Methyl salicylate; exemption

from the requirement of a tolerance.

The biochemical pesticide methyl

salicylate is exempt from the

requirement of a tolerance for residues

in or on food or feed when used as an

insect repellent in food packaging and

animal feed packaging at an application

rate that does not exceed 0.2 mg of

methyl salicylate per square inch of

packaging materials.

[FR Doc. 97–30251 Filed 11–18–97; 8:45am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300571; FRL–5752–8]

RIN 2070–AB78

Fomesafen; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

fomesafen in or on dry beans. This

action is in response to EPA’s granting

of emergency exemptions under section

18 of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on dry beans. This

regulation establishes a maximum

permissible level for residues of

fomesafen in this food commodity

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and is revoked on October

31, 1998.

DATES: This regulation is effective

November 19, 1997. Objections and

requests for hearings must be received

by EPA on or before January 20, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300571],

must 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 identified

by the docket control number, [OPP–

300571], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@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 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300571]. 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.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrea Beard, 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: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308–9356, e-mail:

beard.andrea@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e) and (l)(6), is establishing

a tolerance for residues of the herbicide

fomesafen, in or on dry beans at 0.05

part per million (ppm). This tolerance

will expire and is revoked on October

31, 1998. EPA will publish a document

in the Federal Register to remove the

revoked tolerance from the Code of

Federal Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq. The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996) (FRL–5572–9).

New 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 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

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

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.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.