Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Rules and Regulations 5333

List of Subjects

32 CFR Part 255

Armed forces, Health care, Health

records, Privacy.

32 CFR Part 340

Organization and functions.

PARTS 255 AND 340—[REMOVED]

Accordingly, by the authority of 10

U.S.C. 301, 32 CFR parts 255 and 340

are removed.

Dated: January 24, 1997.

L.M. Bynum,

Alternate OSD Federal Register Liaison

Officer, Department of Defense.

[FR Doc. 97–2753 Filed 2–4–97; 8:45 am]

BILLING CODE 5000–04–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[PP–5F4578/R–2277; FRL–5585–8]

RIN 2070–AB78

Glufosinate Ammonium; Tolerances

for Residues

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes

time-limited tolerances for residues of

the herbicide glufosinate ammonium

(butanoic acid, 2-amino-4-

(hydroxymethylphosphinyl)-,

monoammonium salt) and its

metabolites: 2-acetamino-4-

methylphosphinico-butanoic acid and

3-methylphosphinico-propionic acid, in

or on various raw agricultural

commodities (RACs), derived from

transgenic field corn and transgenic

soybeans. AgrEvo USA Co. submitted a

petition to EPA under the Federal Food,

Drug and Cosmetic Act (FFDCA) as

amended by the Food Quality Protection

Act of l996 (FQPA) requesting the

tolerances.

EFFECTIVE DATE: This regulation

becomes effective February 5, 1997. The

tolerances expire and are revoked

automatically without further action by

EPA on July 13, l999.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [PP–5F4578/R–

2277], 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 Hwy., Arlington, VA.

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 control number [PP–5F4578/

R–2277]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries. Additional

information on electronic submissions

can be found in Unit IX. of this

preamble.

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, telephone number, and

e-mail address: Rm. 237, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA,

(703)-305-6224; e-mail:

miller.joanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of October 25, 1995 (60

FR 54689)(FRL–4982–4), EPA issued a

notice pursuant to section 408(d) of

FFDCA, 21 U.S.C. 346a(d), announcing

the filing of a pesticide tolerance

petition by AgrEvo USA Co., Little Falls

One, 2711 Centerville Rd., Wilmington,

DE 19808. The petition requested that

40 CFR 180.473 be amended by adding

tolerances for residues of glufosinate

ammonium and its metabolites 2-

acetamido-4-methylphosphinicobutanoic acid and 3-

methylphosphinico-propionic acid, in

or on the following RACs: corn, field,

grain at 0.2 part per million (ppm); corn,

field, forage at 4.0 ppm; corn, field,

silage at 3.5 ppm; corn, field, fodder at

5.5 ppm; soybean seed at 2.0 ppm; and

soybean hulls at 6.0 ppm. In the Federal

Register of July 31, l996 (61 FR

39964)(FRL–5384–7), EPA issued a

notice of an amendment to the petition.

The tolerances requested were changed

to residues of glufosinate-ammonium

and its metabolites, 2-acetamido-4-

methylphosphinico-butanoic acid and

3-methylphosphico-propionic acid

expressed as glufosinate free acid

equivalents, in or on the following

RACs: corn, field, grain, at 0.2 ppm;

corn, field, forage, at 4.0 ppm; corn,

field, fodder, at 6.0 ppm; soybeans, at

2.0 ppm; aspirated grain fractions, at

25.0 ppm; eggs, at 0.05 ppm; poultry,

meat at 0.05 ppm; poultry, fat at 0.05

ppm; and poultry, meat by-products

(mbyp) at 0.10 ppm. The revised

petition also requested that a maximum

residue level be established for the same

residues in or on the processed

commodity under section 701 of

FFDCA: soybean hulls at 5.0 ppm.

In the Federal Register of November

18, l996 (61 FR 58684) (FRL–5572–7),

EPA issued a third Notice of Filing to

amend the petition to bring the petition

in conformity with FQPA (Pub. L. 104-

170). The notice contained a summary

of the petition prepared by the

petitioner and this summary contained

conclusions and arguments to support

its conclusion that the petition

complied with FQPA. In this instance

the petitioner proposed to amend 40

CFR 180.473 by establishing tolerances

for residues of glufosinate ammonium in

or on the following RACs: corn, field,

grain, at 0.2 ppm; corn, field, forage, at

4.0 ppm; corn, field, fodder, at 6.0 ppm;

soybeans, at 2.0 ppm; soybean hulls, at

5.0 ppm; aspirated grain fractions, at

25.0 ppm; eggs, at 0.05 ppm; poultry,

meat at 0.05 ppm; poultry, fat at 0.05

ppm; and poultry, mbyp at 0.10 ppm.

The residues of glufosinate-ammonium

were defined as butanoic acid, 2-amino4-(hydroxymethylphosphinyl)-,

monoammonium salt and its

metabolites: 2-acetamido-4-

methylphosphinico-butanoic acid and

3-methylphosphinico-propionic acid

expressed as glufosinate free acid

equivalents.

There were no comments or requests

for referral to an advisory committee

received in response to the notices of

filing. The Notice of Filings were

incorrectly stated for eggs and the

poultry commodities because the

residue chemistry data showed only the

parent chemical and one metabolite, 3-

methylphosphinico-propionic acid. The

subject regulation is therefore amended

accordingly. The data submitted in the
5334 Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Rules and Regulations

petition and other relevant material

have been evaluated. The toxicology

data listed below were considered in

support of these tolerances.

I. Toxicological Profile

1. A battery of acute toxicity studies

placing technical glufosinateammonium in Toxicity Categories II and

III.

2. A 90-day feeding study in rats at

dietary intakes of 0, 0.52, 4.1, 32, or 263

mg/kg/day with a no-observed-effect

level (NOEL) of 4.1 mg/kg/day. The

lowest-observed-effect level (LOEL) was

established at 32 mg/kg/day based on

increased absolute and relative kidney

weights.

3. A 90-day feeding study in mice at

dietary intakes of 0, 16.6, 67.1, or 278

mg/kg/day with a NOEL of 16.6 mg/kg/

day and an LOEL of 67.1 mg/kg/day

based on increased absolute and relative

liver weights (both sexes) and an

increase in serum potassium levels

(males).

4. Three teratology studies in rats at

doses from 0.5 to 250 mg/kg/day with

no teratogenic effects occurring up to

and including 250 mg/kg/day. A NOEL

for developmental toxicity was 50 mg/

kg/day, based upon an increase in the

incidence of dilated renal pelvis and

hydroureter in fetuses at 250 mg/kg/day.

The maternal NOEL was 10 mg/kg/day,

based on the finding of hyperactivity

and vaginal bleeding of dams at 50 mg/

kg/day.

5. A teratology study in rabbits at

doses of 0, 2, 6.3, or 20 mg/kg/day with

no teratogenic effects occurring up to

and including 20 mg/kg/day, and a

maternal NOEL of 6.3 mg/kg/day and a

developmental NOEL of 20 mg/kg/day,

the highest dose tested.

6. A two-generation reproduction

study in rats at dietary concentrations of

0, 40, 120, or 360 ppm with an NOEL

for reproductive effects at 120 ppm

(equivalent to 12 mg/kg/day) based

upon reduced number of pups in the

high-dose group. The NOEL for parental

toxicity was 40 ppm (4 mg/kg/day)

based upon increased kidney weights in

the high-dose group.

7. A 12-month feeding study in dogs

at doses of 0, 2, 5, or 8.5 mg/kg/day. The

NOEL was 5.0 mg/kg/day based upon

the death of one male and one female

dog at 8.5 mg/kg/day with no other

treatment-related toxicity.

8. A mouse carcinogenicity study at

doses of 0, 2.8, 10.8, or 22.7 mg/kg/day

in males and 0, 4.2, 16.2, or 64.0 mg/kg/

day in females for 104 weeks with no

carcinogenic effects observed under the

conditions of the study up to and

including 64 mg/kg/day and a systemic

NOEL of 10.8 and 16.2 for males and

females, respectively, based on the doserelated increase in mortality.

9. A chronic feeding/carcinogenicity

study in rats at dietary doses of 0, 2.5,

8.8, or 31.5 mg/kg/day (males) and 0,

2.4, 8.2, or 28.7 mg/kg/day (females)

with an NOEL of 2.1 mg/kg/day for

systemic effects based on an increase in

kidney weights in females at the two

higher doses. There were no treatmentrelated carcinogenic effects at any dose

level. The study was determined to be

unacceptable because a high enough

dose was not tested.

10. Acceptable studies on gene

mutation (Salmonella, E coli., and

mouse lymphoma assays), structural

chromosomal aberration (in vivo

micronucleus assay in mice), and other

genotoxic effects (unscheduled DNA

synthesis assay with rat hepatocytes)

yielded negative results.

11. Pharmacokinetic and metabolism

studies in rats indicated that

approximately 80 to 90 percent of the

orally administered dose of glufosinate

ammonium remained unabsorbed and

was eliminated in the feces.

Approximately 10 to 15 percent was

eliminated in the urine. The major

metabolic pathway is oxidative

deamination yielding the metabolite, 3-

methyl-phospinico propionic acid.

II. Method of Determining Risks

1. Human dietary exposure. Residues

in the agricultural commodities

harvested from the crop cultured with

the aid of the pesticide are determined

by chemical analysis. To account for the

diversity of growing conditions, culture

practices, soil types, climatic

conditions, crop varieties and methods

of use of the pesticide, data from studies

that represent the resulting commodities

are collected and evaluated to determine

an appropriate level of residue that

would not be exceeded if the pesticide

is used as represented in the studies.

The conduct of the field trial and

guidelines for determining the residues

are given in EPA ‘‘OPPTS Test

Guidelines, Series 860, Residue

Chemistry, August l996’’(see 61 FR

44308, August 28, 1996, for availability

of document)(FRL–5390–7).

The method of chemical analysis

proposed for determining the residues

in the various commodities is evaluated

by a method ‘‘try-out’’ in EPA

laboratories. If the method is found to be

acceptable the Agency accepts the claim

that a method of analysis is available for

determining residues. The method must

be appropriate for enforcement

purposes. The presence of the pesticide

or degradates of the pesticide in potable

water may also be a source of dietary

exposure that must be considered in

establishing a tolerance level for a

agricultural commodity.

The Reference Dose (RfD) is assumed

to be the exposure at or below which

daily aggregate exposure over a lifetime

will not pose an appreciable risk to

human health. To assure the adequacy

of the RfD, the Agency uses an

uncertainty factor in deriving it. The

factor is usually 100, based on the

assumption that certain segments of the

human population could be as much as

100 times more sensitive than the

species represented by the toxicology

data.

If the pesticide is determined to be a

human carcinogen, the toxicological

end-point must be determined based on

the nature of the carcinogenic response

and a knowledge of its mode of action.

The Agency uses a weight of evidence

in classifying the potential of the

pesticide as a human carcinogen.

Glufosinate-ammonium has not been

determined to be a human carcinogen,

therefore a derived RfD was used as the

toxicological end-point in the dietary

risk assessments and the subject action.

Available data show no indication that

it is carcinogenic, however this Agency

is requiring a repeat rat carcinogenicity

study.

2. Non-dietary exposure. Margins of

Exposures (MOEs) are determined for

non-dietary exposures based on

toxicological end-points and measured

or estimated exposures. Dermal

absorption studies are required for

pesticidal chemicals that have serious

toxic effects as identified by oral or

inhalation studies, for which a

significant route of human exposure is

dermal and for which the assumption of

100% absorption does not produce an

adequate margin of safety. Glufosinate

ammonium has not been identified as

having a serious toxic effects by either

oral or inhalation routes of exposure. A

rat glufosinate ammonium dermal

absorption study at doses of 0.1, 1.0 and

10 mg/rat on 6 square centimeters of

skin showed maximum levels of

absorption between 4 to 10 hours. The

absorption at 0.1 was 42.5 to 50.8% of

the applied radioactivity, whereas at

10.0, 26% of the dose was absorbed.

The petitioner has informed EPA that

a dermal absorption study was

submitted to the State of California for

the formulated product, that is to be

registered for use in the culture of

transgenic corn and soybeans. The

petitioner stated that the data indicated

that the dermal absorption by rats

following 0.5- to 24-hour dermal

exposures at dose levels of 12 to 1,218

micrograms per square centimeter

averaged approximately 6%, with an

upper limit of 19%. The only values
Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Rules and Regulations 5335

greater than 10% were following 24-

hour exposures at dose level of 1,218

micrograms per square centimeter. The

petitioner also stated that in vitro data

with the same formulation suggest that

the rate of penetration in rats is about

3 to 29 times higher than in humans,

depending on the dose level.

An acceptable rat oncogenicity study

is required and is one of the reasons for

designating these tolerances ‘‘timelimited’’ with an expiration date.

Without an acceptable rat oncogenicity

study the risk from the many nondietary uses can not be determined

precisely. Also, without appropriate

dermal absorption data EPA cannot

determine the risks from the non-dietary

use exposures. As an interim policy in

safety decisions, EPA is using a default

assumption based on the information

available from similar pesticides. A

maximum of 20% of the RfD is being

assigned for all non-dietary uses of

glufosinate ammonium in the risk

analysis associated with this final rule.

III. Aggregate Exposures

1. Food and feed uses. The primary

source for human exposure to

glufosinate ammonium will be from

ingestion of both raw and processed

agricultural commodities as proposed in

the November 18, 1996 Notice for Filing

cited above and as established already

by 40 CFR 180.473.

2. Potable water. There is presently no

EPA Lifetime Health Advisory level for

glufosinate ammonium and its

degradates as drinking water

contaminates. At the dosage of proposed

uses and existing uses, the level of

contamination of drinking water is not

expected to be significant in the analysis

of risk from the proposed and existing

uses of this pesticide. At the maximum

application rate of 0.75 lb per acre, the

Agency does not expect residues to

reach ground water.

3. Non-dietary uses. Glufosinate

ammonium is registered for use as a

post-emergent herbicide for non-food

use-sites, such as areas around

ornamentals, shade trees, Christmas

trees, shrubs, walks, driveways, flower

beds, farmstead buildings, in shelter

belts, and along fences. It is also

registered for use as a post-emergent

herbicide on farmsteads, areas

associated with airports, commercial

plants, storage and lumber yards,

highways, educational facilities, fence

lines, ditch banks, dry ditches, schools,

parking lots, tank farms, pumping

stations, parks, utility rights-of-way,

roadsides, railroads, and other public

areas and similar industrial and

nonfood crop areas. The exposure from

these uses are expected to be dermal in

nature. Results of an acute dermal

toxicity study indicate that there is

dermal absorption of glufosinate

ammonium. This Agency has no

quantitative data on dermal absorption

for the formulation of this chemical.

Without these data the Agency cannot

determine the risk from exposure to

children and adults, nor determine the

aggregate risk to the public exposed by

these non-food uses of this pesticide.

For this reason, the Agency is using a

maximum default assumption of 20% of

the RfD (0.004 mg/kg bwt/day) as the

exposure from these uses.

The petitioner has argued in their

Notice of Filing that these non-food use

exposures are not expected to pose any

acute toxicity concerns and that the

average homeowner would not expect to

use pesticide products containing

glufosinate ammonium more than four

times per year, therefore such exposure

would not ‘‘normally be factored into a

chronic exposure assessment.’’ They did

not address the matter of aggregate risk

from the chronic effects of all such

exposures, nor the need for such

exposure data for determining the

aggregate exposure.

4. Cumulative exposure to substances

with common mechanism of toxicity.

The mechanism of toxicity is believed to

be caused by an interference with

neurotransmitter function of glutamate,

to which it is a close structural analog.

No other substance with this

mechanism of toxicity has been

identified; for this reason, only

exposures to glufosinate ammonium and

its metabolites and degradates have

been identified for quantitation in the

risk assessment for the proposed

tolerances.

IV. Determination of Safety for U.S.

Population and Non-Nursing Infants

A. The U.S. Population

Based on a NOEL of 2.1 mg/kg bwt/

day from a 2-year rat chronic toxicity

study that demonstrated increased

absolute and relative kidney weights in

males as an endpoint effect, and using

an uncertainty factor of 100 the Agency

has determined a RfD of 0.02 mg/kg

bwt/day for this assessment of risk.

Based on the available toxicity data and

the available exposure data identified

above, the proposed tolerances will

utilize 3.7% of the RfD. Existing

tolerances utilize 2.07% of the RfD;

therefore, the subject proposed

tolerances for use of glufosinate

ammonium in the culture of transgenic

corn and soybeans will result in a

cumulative total use of 25.77% of the

RfD, when the 20% default assumption

for the non-food use exposures is

included.

B. Non-Nursing Infants

Exposure to non-nursing infants as a

result of the use of glufosinate

ammonium in the culture of transgenic

corn and soybeans will result in the use

of 17.2% of the RfD. Existing exposures

from established tolerances utilize

10.6% of the RfD. The cumulative

exposure will be 47.8% of the RfD,

when the 20% default assumption for

the non-food uses are included.

C. Nonfood Uses

Exposure from nonfood uses of

glufosinate ammonium and from

contaminated potable water sources

have not been precisely addressed in

this assessment. However, EPA does not

foresee that these exposures will result

in a cumulative level that exceeds the

RfD. EPA concludes that there is

reasonable certainty that no harm will

result from the aggregate exposures to

residues and degradates of glufosinate

ammonium.

V. Determination of Safety for Infants

and Children

Risk to infants and children was

determined by use of three teratology

studies in rats that had a NOEL for

developmental toxicity of 2.24 mg/kg/

day, based on an increase in the

incidence of dilated renal pelvis with

dyroureter in the fetuses at 10 mg/kg/

day and a maternal NOEL also 2.24 mg/

kg/day and a teratology study in rabbits

that had a NOEL of 20 mg/kg/day for

developmental effects and a maternal

NOEL of 6.3 mg/kg/day, and a twogeneration reproduction study in rats

that had a NOEL of 12 mg/kg/day for

reproductive effects. The effect was

reduced number of pups in the highdose group. The NOEL for parental

toxicity was also 12 mg/kg/day based

upon increased kidney weights in the

high-dose group.

FFDCA section 408 provides that EPA

shall apply an additional safety factor

for infants and children in the case of

threshold effects to account for pre- and

post-natal toxicity and the completeness

of the data base unless EPA determines

that such additional factor is not

necessary to protect the safety of infants

and children. Based on current data

requirements, the data base relative to

pre- and post-natal toxicity is complete.

The NOEL of 2.1 mg/kg bwt/day from a

2-year rat chronic toxicity study is lower

than the NOELs from the developmental

studies in rats and rabbits. In the

reproduction study, the NOEL was

about 6 times greater than the NOEL

used for establishing the RfD. Effect of
5336 Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Rules and Regulations

pups in the reproduction study did not

indicate a greater sensitivity for infants

and children. Therefore, EPA concludes

that an additional uncertainty factor is

not necessary to protect the safety of

infants and children and that the RfD at

0.02 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 to glufosinate ammonium will

range from 29.098 for children 7-12

years old, up to 48.303 for non-nursing

infants. Therefore, EPA concludes that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure.

VI. Other Considerations

A. Endocrine Effects

An evaluation of the potential effects

on the endocrine systems of mammals

has not been determined; however, no

evidence of such effects were reported

in the chronic toxicology studies

described in Unit I. in this document.

There were no observed pathology of

the endocrine organs in these studies.

There is no evidence at this time that

glufosinate ammonium causes

endocrine effects.

B. Metabolism in Plants and Animals

The metabolism of glufosinate

ammonium in plants and animals is

adequately understood for the purposes

of these tolerances. The only crop

residue found after the preemergence

use is the metabolite 3-

methylphosphinico-propionic acid,

which is found in only trace quantities.

With the exception of corn grain, the

principal residue identified in the

metabolism studies after post-emergence

use of glufosinate ammonium was 2-

acetamido-4-methylphosphinicobutanoic acid, with lesser quantities of

glufosinate and 3-methylphosphinicopropionic acid. In corn grain, which

exhibits much lower total radio-labeled

residues than the other commodities,

the principal residue identified was 3-

methylphospinico-propionic acid, with

lesser amounts of 2-acetamido-4-

methylphosphinico-butanoic acid.

C. Analytical Method

There is a practical analytical method

for detecting and measuring levels of

glufosinate ammonium and its

metabolites 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 proposed

analytical method for determining

residues is high-pressure liquid

chromatography. EPA has provided

information on this method to the Food

and Drug Administration. Because of

the long lead time from establishing

these tolerances to publication, the

enforcement 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 umber: Rm. 1130A, CM

#2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703)-305-5937.

D. International Tolerances

The following Codex Alimentarius

Commission (Codex) Maximum Residue

Levels (MRLs) for glufosinate

ammonium have been established:

maize, at 0.1 ppm, maize forage, at 0.2

ppm, and soya bean (dry) at 0.1 ppm.

These tolerances are for use-patterns for

no-till systems of culture of nontransgenic corn and soybeans. AgrEvo

USA Co. states that a petition for the

same tolerances as proposed in the

November 18, l996 EPA Notice of Filing

is pending with the Joint Meeting of the

Food and Agriculture Organization

Panel of Experts on Pesticide Residues

in Food and the Environment and the

World Health Organization Expert

Group on Pesticide Residues to establish

Codex MRLs for use of glufosinate

ammonium in the culture of transgenic

corn and soybeans. The proposed

tolerances for corn and soybean

commodities are greater than the MRLs

established by the Codex Alimentarius

Commission because glufosinate

ammonium is applied as a postemergence herbicide in the culture of

transgenic corn and soybeans; whereas

the Codex MRLs are for preemergence

applications of this herbicide in the

culture of these crops. Studies showed

the level of residues from the postemergence use was greater.

E. Data Gaps

A data gap currently exists for a rat

carcinogenicity study. All tolerances are

time-limited because of this data gap.

The time limitation allows for

development and review of the data. A

repeat rat carcinogenicity study has

been required and is expected to be

submitted and reviewed prior to the

expiration date of these tolerances. A

mouse carcinogenicity and a rat

carcinogenicity study have been

reviewed and showed no evidence of

carcinogenicity. However, the EPA Peer

Review Committee determined that the

rat study was flawed in that the study

was not conducted at the maximum

tolerated dose. Based on the

toxicological data and the levels of

exposure, EPA has determined that the

existing tolerances and the proposed

tolerances will be safe.

VII. Summary of Findings

The analysis for glufosinate

ammonium using tolerance level

residues shows that the existing uses on

apples, grapes, and tree nut group and

the proposed uses on transgenic corn

and soybeans 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 glufosinate ammonium

residues at levels below 100% of the

RfD for chronic effects. Based on the

information cited above, the Agency has

determined that the establishment of the

time-limited tolerances by amending 40

CFR 180.473 will be safe; therefore, the

time-limited tolerances are established

as set forth below.

VIII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under 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 April 7, 1997, file

written objections to any aspect of this

regulation (including the automatic

revocation provision) and may also

request a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given under the ADDRESSES

section (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
Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Rules and Regulations 5337

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

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.

IX. Public Docket

A record has been established for this

rulemaking under docket control

number [PP–5F4578/R–2277]. 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 Operation Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

The official record for this

rulemaking, as well as the public

version, as described above, is kept in

paper form. Accordingly, in the event

there are objections and hearing

requests, 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. The official rulemaking record is

the paper record maintained at the

address in ADDRESSES at the beginning

of this document.

X. Regulatory Assessment

Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a ‘‘significant regulatory action’’ and

since this action does not impose any

information collection requirements

subject to approval under the Paperwork

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

it is not subject to review by the Office

of Management and Budget. In addition,

this action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104-4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, l993), or 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.

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

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

804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: January 17, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR Chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.473, by adding

alphabetically the following

commodities and tolerances to

paragraph (a) and adding paragraph (c)

to read as follows:

§ 180.473 Glufosinate ammonium;

tolerances for residues.

(a) * * *

Commodity Parts per

million Expiration date

* * * * *

Eggs ............................................................................................................................................................. 0.05 July 13, 1999.

* * * * *

Poultry, fat .................................................................................................................................................... 0.05 July 13, 1999.

Poultry, mbyp ............................................................................................................................................... 0.10 July 13, 1999.

Poultry, meat ................................................................................................................................................ 0.05 July 13, 1999.

* * * * *

* * * * *

(c) Time-limited tolerances are

established for residues of the herbicide

glufosinate ammonium (butanoic acid,

2-amino-4-(hydroxymethylphosphinyl)-

,monoammonium salt), and its

metabolites 2-acetamido-4-

methylphosphinico-butanoic acid and

3-methylphosphinico-propionic acid in

or on the following raw agricultural

commodities derived from transgenic

corn and soybeans that are tolerant to

the herbicide glufosinate ammonium, as

provided below. These tolerances shall

expire and be automatically revoked on

July 13, l999.
5338 Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Rules and Regulations

Commodity Parts per

million Expiration date

Aspirated Grain Fractions ............................................................................................................................ 25.0 July 13, 1999.

Corn, field, forage ........................................................................................................................................ 0.4 July 13, 1999.

Corn, field, grain ........................................................................................................................................... 0.2 July 13, 1999.

Corn, field, stover ......................................................................................................................................... 6.0 July 13, 1999.

Soybean, hulls .............................................................................................................................................. 5.0 July 13, 1999.

Soybeans ..................................................................................................................................................... 2.0 July 13, 1999.

[FR Doc. 97–2838 Filed 2–4–97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

43 CFR Part 4700

[NV–960–1060–00–24 1A]

RIN 1004–AC61

Adoption Fee for Wild Free-Roaming

Horses and Burros

AGENCY: Bureau of Land Management,

Interior.

ACTION: Final rule.

SUMMARY: In this final rule, the Bureau

of Land Management (BLM) revises its

procedures used to set adoption fees for

Wild Horses and Burros. The purpose of

the amendment is to allow BLM more

flexibility in establishing adoption fees,

to recover a higher proportion of the

associated cost, and encourage

adoptions consistent with the basic

goals of the Wild Horse and Burro

adoption program. The rule also allows

BLM to use competitive methods.

EFFECTIVE DATE: March 7, 1997.

FOR FURTHER INFORMATION CONTACT: Lili

Thomas, (702) 785–6457 or Bob

Barbour, (202) 452–7785.

SUPPLEMENTARY INFORMATION:

I. Background

II. Discussion of Final Rule and Response to

Comments

III. Procedural Matters

I. Background

In the 1950’s a group concerned with

the welfare of America’s diminishing

wild horse herds formed under the

leadership of Velma Bronn Johnson.

Better known as ‘‘Wild Horse Annie,’’

this woman from Nevada, along with

many others, worked to ensure a place

for wild horses and burros on Federal

rangelands.

In 1971, Congress passed The Wild

Free-Roaming Horse and Burro Act. To

keep the ecological balance and

maintain healthy rangelands, wild

horses and burros are periodically

removed and placed in the Adopt-AHorse or Burro Program. This successful

program, begun in 1973, has offered

animals for ‘‘adoption’’ to qualified

private individuals who agree to

provide them humane treatment.

Through the Adopt-a-Horse or Burro

Program BLM placed over 150,000

animals in private care since 1976.

The current adoption fee of $125 for

wild horses and $75 for wild burros was

set in 1982. This fee is supposed to

recapture some adoption cost, and

assure a prompt adoption of animals

after their removal from public lands.

The adoption fee was originally set

using the market price of horses in 1982.

In the early 1980’s the value of horses

and burros was low because of an

overabundance of these animals in the

market. Currently the market value of

the lowest quality domestic horse is

about $300, well above the fee BLM

charges. Additionally, since 1982,

BLM’s costs to feed, provide veterinary

care and transport wild horses and

burros have increased significantly. A

flexible adoption fee system will shift

some of the cost of the adoption from

the general taxpayer to the individuals

who benefit directly from this program.

Future adoption fees will reflect market

value of the animals and strike a balance

between supply and demand. The

increased cost per animal will help

insure that the adopters are adopting the

animal for itself rather than future

financial gain before or after title is

received.

Under this system BLM may offer

horses and burros to the public at

competitive adoptions. Animals not

selected by the public through a

competitive adoption would be

available at the established adoption fee.

The BLM Director may reduce or waive

the adoption fee for animals that are

unadoptable at the base fee. BLM is not

changing the qualification requirements

for adoption of a wild horse or burro.

Adopters must meet the requirements of

43 CFR part 4750 before BLM allows

them to participate in an adoption

event.

Before each adoption event BLM will

provide information on how the

adoption will be conducted and the

method to be used in establishing

adoption fees.

II. Discussion of Final Rule and

Response to Comments

The BLM received 25 comments in

response to the proposed rule which

was published in the Federal Register

on July 10, 1996 (61 FR 36333). Five of

the comments did not relate specifically

to the adoption fee issue or involved

other aspects of the Wild Horse and

Burro program. Fourteen comments

favored the changes BLM is making to

increase the flexibility of the adoption

fee system. Those in favor of the

proposal expressed the view that cost to

the American taxpayer should be

reduced and the beneficiaries of the

program should pay a reasonable price

for the benefits they receive. Several

believed that a competitive bidding

system is a reasonable means to

determine the price to adopt an

individual animal. Seven of those who

expressed favorable comments about an

increased fee also voiced opposition to

what they perceived as a requirement

for use of competitive adoptions. Most

of those who expressed concern about

the competitive bidding aspect of the

proposed rule favored an across-theboard increase in fees for all animals.

BLM is making the regulatory change

to provide flexibility in the

establishment of adoption fees and to

allow the public to decide what they

will pay to adopt an individual animal.

One element of this increased flexibility

involves appropriate use of competitive

adoptions. Because of the comments

received, BLM revised the regulation at

43 CFR 4750.4–2(b) to clarify that

competitive adoptions are one way of

establishing adoption fees, but not the

only way.

Six comments expressed opposition

to the proposed change. The primary

reason for this opposition was a concern

that under a competitive system only

people who are well off could own a

more desirable horse. BLM believes it is

appropriate to allow individual adopters

to decide through a competitive