Federal Register / Vol. 60, No. 26 / Wednesday, February 8, 1995 / Proposed Rules 7509

A public hearing will be held at the

Ramada Inn, 10 Thomas Circle NW,

Washington DC.

Materials relevant to this proposal

have been placed in Air and Radiation

Docket A–95–02 by EPA. The docket is

located at the above address in room M–

1500 Waterside Mall (ground floor) and

may be inspected from 8 a.m. to 4 p.m.,

Monday through Friday, including all

non-government holidays.

FOR FURTHER INFORMATION CONTACT:

Kathryn Sargeant, Emission Control

Strategies Branch, Emission Planning

and Strategies Division, U.S.

Environmental Protection Agency, 2565

Plymouth Road, Ann Arbor, MI 48105.

(313) 668–4441.

SUPPLEMENTARY INFORMATION: The terms

and substance of the rule changes

proposed in this document, and a

description of the subjects and issues

involved, are included in the document

announcing the interim final rule

published in the Final Rules Section of

this Federal Register. This proposal is

identical in substance to the interim

final rule, except that the proposal

would not limit the application of the

proposed rule changes to a six-month

period.

Dated: January 31, 1995.

Carol M. Browner,

Administrator.

[FR Doc. 95–3002 Filed 2–7–95; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[PP 5F4427/P606; FRL–4936–6]

RIN 2070–AC18

Pesticide Tolerance for Chlorpyrifos

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish a

time-limited tolerance for residues of

the insecticide chlorpyrifos [O,O-diethyl

O-(3,5,6-trichloro-2-pyridyl)

phosphorothioate] in or on the raw

agricultural commodities oats and

barley when blended together in a

mixture containing 97% oats and 3%

barley. The proposal to establish

maximum permissible levels for

residues of the insecticide was

requested in a petition submitted by

General Mills.

DATES: Comments, identified by the

document control number, [PP 5F4427/

P606], must be received on or before

March 10, 1995.

ADDRESSES: By mail, submit written

comments 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

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

Jefferson Davis Hwy., Arlington, VA

22202.

Information submitted as a comment

concerning this notice 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 comment 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. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Dennis H. Edwards, Jr., Product

Manager (PM) 19, Registration Division

(7505C), Environmental Protection

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

DC 20460. Office location and telephone

number: Rm. 207, CM #2, 1921 Jefferson

Davis Hwy., Arlington, VA 22202, (703)-

305-6386.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of November 21, 1994

(59 FR 60013), which announced that

General Mills had submitted pesticide

petition (PP) 5F4427 to EPA requesting

that the Administrator, pursuant to

section 408(e) of the Federal Food, Drug,

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

346a, amend 40 CFR 180.342 by

establishing a tolerance for residues of

the insecticide chlorpyrifos in or on the

raw agricultural commodity oats at 15

ppm, provided that such tolerance

applies only to oats that were treated

post-harvest with chlorpyrifos on or

before June 15, 1994; that such tolerance

applies only to oats to be used as animal

feed or as a constituent of animal feed;

that, notwithstanding any other

provision of law or regulation, this

tolerance does not authorize the

presence of residues of chlorpyrifos in

any human food item made from such

treated oats, other than residues

resulting from the use of the oats for

animal feed purposes; and that such

tolerance expires on December 31, 1996.

Chlorpyrifos is registered under the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA) for application

to many growing crops; associated

tolerance regulations have been

established under the FFDCA. It is not,

however, registered for use on oats or

for treatment of stored grain. A pest

control operator under contract to

General Mills improperly treated stored

oats and fraudulently claimed to have

used a different pesticide, chlorpyrifosmethyl, that is registered for use on

stored grains such as oats. The illegal

residues were discovered by a routine

FDA inspection. Processed food

products manufactured from improperly

treated oats were determined by the

Agency not to be a human health hazard

and those that had entered commerce

were not recalled. Processed products

that had not yet entered commerce were

retained by General Mills and

subsequently destroyed. Approximately

18 million bushels of stored unmilled

oats treated with chlorpyrifos are at

present controlled by General Mills or

its customers. Although the Agency has

determined that the use of the stored

oats for the production of food does not

constitute a human health hazard, no

approval has been sought by General

Mills to use the treated oats for human

food purposes.

Chlorpyrifos is registered for use on

other crops that are used for livestock or

poultry feed purposes. General Mills has

submitted data to demonstrate that the

use of treated oats for livestock or

poultry feed will not yield residues in

meat, milk, or eggs that exceed existing

tolerances for chlorpyrifos in these

commodities. To ensure that the oats

will be unacceptable for human food

production, General Mills has stated

that they will be blended to include not

less than 3% barley and 97% oats.

Accordingly, the definition of the raw

agricultural commodity in the petition

has been amended to ‘‘oats and barley

when blended together in a mixture

containing 97% oats and 3% barley.’’

There were no comments or requests

for a referral to an advisory committee

received in response to the notice of

filing.

The data submitted in the petition

and other relevant material have been

evaluated. Toxicological data

considered in support of the proposed

tolerance include:

1. A 2-year dog feeding study with a

no-observed-effect-level (NOEL) for

systemic effects of 1.0 milligram (mg)/

kilogram (kg)/day and lowest-effectlevel (LEL) (increased liver weight) of

3.0 mg/kg/day. The NOELs for

cholinesterase (ChE) inhibition were as

follows: 0.01 mg/kg/day for plasma, 0.1

mg/kg/day for red blood cells, and 1.0

mg/kg/day for brain cells. Levels tested

were 0, 0.01, 0.03, 0.1, 1.0, and 3 mg/

kg/day.
7510 Federal Register / Vol. 60, No. 26 / Wednesday, February 8, 1995 / Proposed Rules

2. A voluntary human study with

chronic ChE NOEL of 0.03 mg/kg/day

(based on 20 days of exposure at this

level).

3. A 2-year mouse chronic toxicity/

carcinogenicity study with a NOEL of 15

ppm for systemic effects (equivalent to

2.25 mg/kg/day) and no carcinogenic

effects observed under the conditions of

the study at all levels tested (0, 0.5, 5,

and 15 ppm, equivalent to 0.075, 0.75,

and 2.25 mg/kg/day).

4. A voluntary human study with

acute ChE NOEL of 0.10 mg/kg/day

(based on daily single-dose exposures of

0, 0.014, 0.03, or 0.10 mg/kg/day)

determined at 1, 3, 6, and 9 days of

treatment.

5. A 2-year rat feeding/carcinogenicity

study with ChE NOEL of 0.1 and LEL of

1.0 mg/kg/day (based on decreased

plasma and brain ChE activity), and a

systemic NOEL of 1.0 mg/kg/day and

LEL of 10 mg/kg/day (based on

decreased erythrocyte and hemoglobin

values and increased platelet count

during the first year). There were no

observed carcinogenic effects at the

levels tested (0.05, 0.1, 1.0, and 10 mg/

kg/day) under the conditions of the

study. Chlorpyrifos is classified as a

Group E chemical (no evidence of

carcinogenicity).

6. A three-generation reproduction

study in rats with no reproductive

effects observed at the dietary levels

tested (0, 0.1, 0.3, and 1.0 mg/kg/day).

7. Two rat developmental toxicity

studies: one negative for developmental

toxicity at all dose levels (levels tested

were 0.1, 3.0, and 15.0 mg/kg/day); and

one with maternal NOEL of 15 mg/kg/

day and developmental NOEL of 2.5

mg/kg/day (levels tested, by gavage,

were 0, 0.5, 2.5, and 15 mg/kg/day).

8. A mouse developmental toxicity

study with a teratogenic NOEL greater

than 25 mg/kg/day (highest dose tested)

and a developmental fetotoxic NOEL of

10 mg/kg/day and LEL of 25 mg/kg/day

(decreased fetal length and increased

skeletal variants).

9. A developmental toxicity study in

rabbits with maternal and

developmental NOELs of 81 mg/kg/day,

and maternal and developmental LELs

of 140 mg/kg/day (based on maternal

decreased food consumption on

gestation day 15 to 19, and body weight

loss during the dosing period followed

by a compensatory weight gain; and

based on a slight reduction in fetal

weights and crown-rump lengths, and

fetal increased incidence of unossified

fifth sternebrae and/or xiphisternum).

Levels tested were 0, 1, 9, 81, and 140

mg/kg/day.

10. An acute delayed neurotoxicity

study in the hen that was negative at 50

and 100 mg/kg/day.

11. Several mutagenicity studies

which were all negative. These include

an Ames assay, two Chinese hamster

ovary cell mutation assays, a

micronucleus assay for chromosomal

aberration, an in vitro chromosomal

aberration assay with and without

enzymatic activation, and an

unscheduled DNA synthesis assay.

12. A general metabolism study in rats

shows that the major metabolite of

chlorpyrifos is 3,5,6-trichloro-2-

pyridinol (TCP). The studies listed

below were conducted to demonstrate

that TCP is less toxic than chlorpyrifos

and is not a ChE inhibitor.

a. A 90-day rat feeding study with a

systemic NOEL of 30 mg/kg/day. Levels

tested were 0, 10, 30, and 100 mg/kg/

day.

b. A rat developmental toxicity study

with no developmental toxicity

observed at the dosages tested (0, 50,

100, and 150 mg/kg/day).

c. Mutagenicity studies (including an

Ames assay and an unscheduled DNA

synthesis assay) were negative for

mutagenic effects.

Based on the above studies, the

Agency has concluded that the TCP

metabolite is not of toxicological

concern.

For the assessment of chronic dietary

risk, the reference dose (RfD) based on

the human voluntary ChE study (ChE

NOEL of 0.03 mg/kg/day) and using a

10-fold uncertainty factor is calculated

to be 0.003 mg/kg of body weight/day.

Tolerances for food uses appear in 40

CFR 180.342 and 40 CFR 185.1000. The

Dietary Risk Exposure Section (DRES)

used, when justified and appropriate,

anticipated residues rather than

published tolerance values, and data

regarding percent crop treated (when

less than 100%). The anticipated

residue contribution (ARC) from

published uses of chlorpyrifos is

0.000860 mg/kg of body weight/day for

the overall U.S. population. This

represents 28.7% of the RfD. None of

the DRES subgroups has an exposure

that exceeds the RfD. The population

subgroup most highly exposed is

nonnursing infants, less than 1 year old,

with an ARC from published uses of

0.002147 mg/kg of body weight/day,

71.6% of the RfD. The next most highly

exposed population subgroup is

children, 1 to 6 years old, with an ARC

from published uses of 0.001914 mg/kg

of body weight/day, 63.8% of the RfD.

The proposed tolerance on oats does not

raise the ARC as a percentage of the RfD

because the oats are not to be used for

human food and any secondary residues

occurring in milk, eggs, or meat of

livestock and poultry will fall within

existing tolerances for these

commodities. The ARC was calculated

assuming tolerance level residues of

chlorpyrifos on these commodities.

The DRES detailed acute analysis

estimates the distribution of single-day

exposures for the overall U.S.

population and certain subgroups. The

analysis evaluates individual food

consumption as reported by

respondents in the USDA 1977-1978

Nationwide Food Consumption Survey

(NFCS) and accumulates exposure to the

chemical for each commodity. Each

analysis assumes uniform distribution

of chlorpyrifos in the commodity (oats).

Since the toxicological endpoint to

which exposure is being compared in

this analysis is neurotoxicity, four

human population subgroups (infants,

less than 1 year old; children, 1 to 12

years old; females, 13 years old and

older; males, 13 years old and older), as

well as the overall population, are of

interest.

The Margin of Exposure (MOE) is a

measure of how close the high-end

exposure comes to the NOEL and is

calculated as the ratio of the NOEL to

the exposure. (NOEL/exposure = MOE.)

For neurotoxicity, the Agency is

generally not concerned unless the MOE

is below 10 when the NOEL is based on

human data. For the overall population

the calculated MOE at high end (topmost eaters—defined as the top 0.5% of

the population in terms of consumption)

as a result of all commodities, other

than oats, treated with chlorpyrifos is

less than 10. In the overall population

6% of consumers have an MOE less

than 10.

The DRES analysis to estimate the

potential increased risk of neurotoxicity

resulting from residues of chlorpyrifos

in meat, poultry, eggs, and milk

obtained from animals fed treated oats

indicates that the MOE is greater than

10 for the overall U.S. population and

for each of the 4 population subgroups.

The calculated MOE at high end (topmost eaters—in this case defined as the

top 0.5% of the population/

subpopulation in terms of consumption)

for the overall population is 33; for

infants, less than 1 year old it is 20; for

children, 1 to 12 years old it is 25; for

females, 13 years old and older it is 83;

and for males, 13 years old and older it

is 71.

The Margin of Exposure estimates are

considered conservative because a major

assumption is that the high-end eater

consumed only meat, poultry, eggs, and/

or milk from animals fed only oats

containing chlorpyrifos residues. The

increase in calculated estimates of acute
Federal Register / Vol. 60, No. 26 / Wednesday, February 8, 1995 / Proposed Rules 7511

risk from chlorpyrifos residues as a

result of the proposed temporary

tolerance would be negligible.

The petition for a tolerance has

resulted from a misuse of chlorpyrifos,

and the Agency does not generally grant

a tolerance to cover misuse. The

following points, however, were

considered. The petitioner was not

directly responsible for the misuse.

Although human food produced from

the treated chlorpyrifos was not

determined by the Agency to be a

human health hazard, the petitioner has

not sought approval for use of the

treated oats as human food and

destroyed all human food made from

the treated oats that had not entered

commerce. The tolerance is time

limited. Finally, if this tolerance is not

approved, 18 million bushels of oats, or

approximately 15% of the privately held

U.S. stocks, will have to be destroyed

despite EPA’s conclusion that use of the

oats as an animal feed protects the

public health.

To ensure that the oats are used as an

animal feed, EPA has amended the

commodity definition from ‘‘the raw

agricultural commodity oats’’ to ‘‘the

raw agricultural commodities oats and

barley when blended together in a

mixture containing 97% oats and 3%

barley.’’ Blending barley with oats will

make the oats unsuitable for milling to

produce human food. The petitioner has

agreed to blend barley into the treated

oats prior to sale or distribution.

The nature of the residue in plants

and animals is adequately understood.

Adequate methodology is available for

enforcement purposes and for analysis

of chlorpyrifos in oat grain. The FDA

Pestrack data base (PAM Vol. I, January,

1994) indicates that complete recovery

has been obtained for chlorpyrifos

under FDA multiresidue methods 302

and 303, and partial recovery has been

obtained with method 304.

The pesticide is considered useful for

the purpose for which the tolerance is

sought.

There are currently no actions

pending against continued registration

of this chemical.

Based on the information and data

considered, the Agency has determined

that the tolerance established by

amending 40 CFR 180 would protect the

public health. Therefore, it is proposed

that the tolerance be established as set

forth below.

Any person who has registered or

submitted an application for registration

of a pesticide, under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) as amended, which

contains any of the ingredients listed

herein, may request within 30 days after

publication of this document in the

Federal Register that this rulemaking

proposal be referred to an Advisory

Committee in accordance with section

408(e) of the FFDCA.

Interested persons are invited to

submit written comments on the

proposed regulation. Comments must

bear a notation indicating the document

control number, [PP 5F4427/P606]. All

written comments filed in response to

this petition will be available in the

Public Response and Program Resources

Branch, at the address given above, from

8 a.m. to 4 p.m., Monday through

Friday, except legal holidays.

Under Executive Order 12866 (58 FR

51735, Oct. 4, 1993), the Agency must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

all the requirements of the Executive

Order (i.e., Regulatory Impact Analysis,

review by the Office of Management and

Budget (OMB)). Under section 3(f), the

order defines ‘‘significant’’ as those

actions likely to lead to a rule (1) having

an annual effect on the economy of $100

million or more, or adversely and

materially affecting a sector of the

economy, productivity, competition,

jobs, the environment, public health or

safety, or State, local or tribal

governments or communities (also

known as ‘‘economically significant’’);

(2) creating serious inconsistency or

otherwise interfering with an action

taken or planned by another agency; (3)

materially altering the budgetary

impacts of entitlement, grants, user fees,

or loan programs; or (4) raising novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in this Executive

Order.

Pursuant to the terms of this

Executive Order, EPA has determined

that this rule is not ‘‘significant’’ and is

therefore not subject to OMB review.

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96-

54, 94 Stat. 1164, 5 U.S.C. 601-612), the

Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: February 1, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, it is proposed that 40 CFR

part 180 be amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.342, by adding new

paragraph (f), to read as follows:

§ 180.342 Chlorpyrifos; tolerances for

residues.

* * * * *

(f) A tolerance of 15 ppm is

established for residues of the pesticide

chlorpyrifos [O,O-diethyl O-(3,5,6-

trichloro-2-pyridyl) phosphorothioate]

in or on the raw agricultural

commodities oats and barley when

blended together as a mixture

containing 97% oats and 3% barley.

(1) Such tolerance applies only to oats

that were treated post-harvest with

chlorpyrifos on or before June 15, 1994.

(2) Such tolerance applies only to oats

to be used as animal feed or as a

constituent of animal feed.

(3) Notwithstanding any other

provision of law or regulation, this

tolerance does not authorize the

presence of residues of chlorpyrifos in

any human food item made from such

treated oats, other than residues

resulting from the use of the oats for

animal feed purposes.

(4) Such tolerance expires on

December 31, 1996.

[FR Doc. 95–3206 Filed 2–3–95; 5:06 pm]

BILLING CODE 6560–50–F

40 CFR Parts 185 and 186

[FAP 3H5673, 4H5695, 4H5696/P591; FRL–

4915–1]

RIN 2070–AC18

Food and Feed Additive Regulations

for d-Limonene, Dihydro-5-Pentyl2(3H)-Furanone, and Dihydro-5-Heptyl2(3H)-Furanone

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish

food/feed additive regulations for

residues of the insecticides d-limonene,

dihydro-5-pentyl-2(3H)-furanone, and

dihydro-5-heptyl-2(3H)-furanone when

used as active ingredients in insectrepellent tablecloths and in insect-