Federal Register / Vol. 63, No. 72 /Wednesday, April 15, 1998 /Rules and Regulations 18329

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 119 of the Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

XIII. Regulatory Assessment

Requirements

This final rule establishes an

exemption from the tolerance

requirement under FFDCA section

408(d) in response to a petition

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104–4). Nor does it require any

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or special considerations as

required by Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629), February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since tolerance

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the exemption in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply.

Nevertheless, the Agency previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950) was provided to the

Chief Counsel for Advocacy of the Small

Business.

XIV. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

Agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and the Comptroller General of

the United States. EPA will submit 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 United

States prior to publication of the rule in

the 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: April 3, 1998.

Marcia E. Mulkey,

Director, Office of Pesticide Programs.

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.1194 is added to read

as follows:

§ 180.1194 Canola oil; exemption from the

requirement of a tolerance.

An exemption from the requirement

of a tolerance is established for residues

of the biochemical pesticide, canola oil,

conforming to the following definition

when used as an insecticide, in or on all

food commodities: Canola oil, also

known as low erucic rapeseed oil, is the

fully refined, bleached, and deodorized

edible oil obtained from certain varieties

of Brassica Napus or B. Campestris of

the family Cruciferae. Canola oil

contains no more than 2 percent erucic

acid.

[FR Doc. 98–10013 Filed 4–14–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300644; FRL–5785–7]

RIN 2070–AB78

Spinosad; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

permanent tolerances for residues of

spinosad in or on almonds at 0.02 parts

per million (ppm); almond hulls at 2.0

ppm; apples at 0.2 ppm; apple pomace,

wet at 0.5 ppm; citrus fruits group at 0.3

ppm; citrus pulp, dried at 0.5 ppm;

citrus oil at 3.0 ppm; cottonseed at 0.02

ppm; cotton gin byproducts at 1.5 ppm;

fruiting vegetables (except cucurbits)

group at 0.4 ppm; Brassica (cole), leafy

vegetables, head and stem subgroup at

2.0 ppm; Brassica (cole), leafy

vegetables, greens subgroup at 10.0

ppm; leafy vegetables (except Brassica

vegetables) group at 8.0 ppm; fat of

cattle, goats, hogs, horses, and sheep at

0.6 ppm; meat of cattle, goats, hogs,

horses, and sheep at 0.04; meat

byproducts of cattle, goats, hogs, horses,

and sheep at 0.2 ppm; milk fat at 0.5

ppm; and whole milk at 0.04 ppm. This

regulation also removes the time

limitation for the tolerance for residues

of spinosad on cottonseed which

expires on November 15, 1999.

DowElanco requested these tolerances

under the Federal Food, Drug, and

Cosmetic Act (FFDCA), as amended by

the Food Quality Protection Act of 1996

(FQPA) (Pub. L. 104-170). In addition,

this regulation removes time-limited

tolerances set under section 408(1)(6) of

the FFDCA, as amended by the FQPA

for residues of spinosad on fruiting

vegetables (except cucurbits) group,

tomato paste, leafy vegetables (except

Brassica vegetables) group, and Brassica

(cole), leafy vegetables, group at 0.25,

0.50, 10.0, and 10.0 ppm, respectively.

These tolerances were set under the
18330 Federal Register / Vol. 63, No. 72 /Wednesday, April 15, 1998 /Rules and Regulations

section 18 emergency exemption

provision of the FQPA and they expire

on September 30, 1998. With this

regulation, permanent tolerances are

now being established to replace these

time-limited tolerances with the

exception of tomato paste. A tolerance

will not be established for tomato paste

because EPA has determined that the

maximum amount of spinosad residues

expected in tomato paste is less than the

proposed tolerance for tomatoes.

Therefore, no tolerance is required for

tomato paste.

DATES: This regulation is effective April

15, 1998. Objections and requests for

hearings must be received by EPA on or

before June 15, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300644],

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–

300644], 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. 119, 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 5.1/6.1 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–

300644]. 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: Beth Edwards, 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) 305-5400, e-mail:

edwards.beth@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On

February 26, 1997, EPA established a

time-limited tolerance under section

408 and 409 of the FFDCA, 21 U.S.C.

346a(d) and 348 for residues of spinosad

on cottonseed (62 FR 8626) (FRL–5590–

8). This tolerance expires on November

15, 1999. DowElanco, on December 11,

1997, requested that the time limitation

be removed based on a cotton gin trash

residue study that they had submitted as

a condition of the registration and the

time-limited tolerance. DowElanco also

submitted a summary of its petition as

required under the FFDCA as amended

by the Food Quality Protection Act

(FQPA) of 1996 (Pub. L. 104-170).

On October 22, 1997, EPA established

time-limited tolerances under section

408(1)(6) of the FFDCA, as amended by

the FQPA of 1996 for residues of

spinosad on fruiting vegetables (except

cucurbits) group, tomato paste, leafy

vegetables (except Brassica vegetables)

group, and Brassica (cole), leafy

vegetables group at 0.25, 0.50, 10.0, and

10.0 ppm, respectively (62 FR 54771)

(FRL–5746–6). These tolerances were

set under the Section 18 emergency

exemption provision of the FQPA and

they expire on September 30, 1998.

These emergency exemption tolerances

for spinosad were granted to control

Western Flower Thrips on fruiting

vegetables (excluding cucurbits) in the

states of Florida, Georgia and Arkansas,

and to control beet armyworm on leafy

vegetables (except Brassica) and

Brassica leafy vegetables in Arizona.

In the Federal Register issues of

December 24, 1996 (61 FR 67801) (FRL–

5578–2), October 8, 1997 (62 FR 52558)

(FRL–5748–6), and March 4, 1998 (63

FR 10609) (FRL–5774–1), EPA issued

notices pursuant to section 408 of the

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

the filing of pesticide petitions (PP)

7F4797, 7F4871, and 8F4942 for

tolerances by DowElanco, 9330

Zionsville Road, Indianapolis IN 46268-

1054. These notices included a

summary of the petitions prepared by

DowElanco, the registrant. There were

no comments received in response to

the notices of filing.

The petitions requested that 40 CFR

180.495 be amended by removing the

time limitation for the tolerance for

residues of the insecticide spinosad in

or on cottonseed at 0.02 ppm and by

establishing tolerances in or on almonds

at 0.02 ppm; almond hulls at 2.0 ppm;

apples at 0.2 ppm; apple pomace, wet at

0.5 ppm; citrus fruits group at 0.3 ppm;

citrus pulp, dried at 0.5 ppm; citrus oil

at 3.0 ppm; cotton gin byproducts at 1.5

ppm; fruiting vegetables (except

cucurbits) group at 0.4 ppm; leafy

vegetables (except Brassica vegetables)

group at 8.0 ppm; Brassica (cole), leafy

vegetables, head and stem subgroup at

2.0 ppm; Brassica (cole), leafy

vegetables, greens subgroup at 15.0

ppm; fat of cattle, goats, hogs, horses,

and sheep at 0.7 ppm; meat of cattle,

goats, hogs, horses, and sheep at 0.04

ppm; meat byproducts of cattle, goats,

hogs, horses, and sheep at 0.2 ppm; milk

fat at 0.5 ppm; and whole milk at 0.04

ppm. EPA determined that the

requested tolerances for fat of cattle,

goats, hogs, horses, and sheep at 0.7

ppm and Brassica (cole), leafy

vegetables, greens subgroup at 15.0 ppm

were too high based on magnitude of the

residue studies. EPA recommended that

the tolerances be set at 0.6 ppm and 10.0

ppm, respectively.

I. Risk Assessment and Statutory

Findings

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. . . .’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures
Federal Register / Vol. 63, No. 72 /Wednesday, April 15, 1998 /Rules and Regulations 18331

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

or less of the RfD) is generally

considered acceptable by EPA. EPA

generally uses the RfD to evaluate the

chronic risks posed by pesticide

exposure. For shorter term risks, EPA

calculates a margin of exposure (MOE)

by dividing the estimated human

exposure into the NOEL from the

appropriate animal study. Commonly,

EPA finds MOEs lower than 100 to be

unacceptable. This 100-fold MOE is

based on the same rationale as the 100-

fold uncertainty factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

‘‘acute,’’ ‘‘short-term,’’ ‘‘intermediate

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

to the pesticide for a period of 1-7 days,

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children. The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

II. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action.
18332 Federal Register / Vol. 63, No. 72 /Wednesday, April 15, 1998 /Rules and Regulations

EPA has sufficient data to assess the

hazards of spinosad and to make a

determination on aggregate exposure,

consistent with section 408(b)(2), for

tolerances for residues of spinosad on

almonds at 0.02 ppm; almond hulls at

2.0 ppm; apples at 0.2 ppm; apple

pomace, wet at 0.5 ppm; citrus fruits

group at 0.3 ppm; citrus pulp, dried at

0.5 ppm; citrus oil at 3.0 ppm;

cottonseed at 0.02 ppm; cotton gin

byproducts at 1.5 ppm; fruiting

vegetables (except cucurbits) group at

0.4 ppm; leafy vegetables (except

Brassica vegetables) group at 8.0 ppm;

Brassica (cole), leafy vegetables, head

and stem subgroup at 2.0 ppm; Brassica

(cole), leafy vegetables, greens subgroup

at 10.0 ppm; fat of cattle, goats, hogs,

horses, and sheep at 0.6 ppm; meat and

meat byproducts of cattle, goats, hogs,

horses, and sheep at 0.04 ppm; milk fat

at 0.5 ppm; and whole milk at 0.04 ppm.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies 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. The nature of the

toxic effects caused by spinosad are

discussed below.

1. Acute toxicity studies with

technical spinosad (88% - 90.4%): Oral

LD50 in the rat is > 5,000 milligram/

kilogram (mg/kg) for males and females

- Toxicity Category IV; dermal LD50 in

the rat is >2,800 mg/kg for males and

females - Toxicity Category III;

inhalation LC50 in the rat is >5.18 mg/

L - Toxicity Category IV; primary eye

irritation in the rabbit (slight

conjunctival irritation) - Toxicity

Category IV; primary dermal irritation in

the rabbit (no erythema and edema) -

Toxicity Category IV. Spinosad is not a

sensitizer.

2. Acute toxicity studies with the enduse (44% formulation) product for

spinosad: Oral LD50 in the rat is >5,000

mg/kg for males and females - Toxicity

Category IV; dermal LD50 in the rat is

>2,800 mg/kg for males and females -

Toxicity Category III; inhalation LC50 in

the rat is >5 mg/L - Toxicity Category IV;

primary eye irritation in the rabbit

(slight conjunctival irritation) - Toxicity

Category IV; primary dermal irritation in

the rabbit (slight transient erythema and

edema) - Toxicity Category IV; not a

sensitizer.

3. In a subchronic feeding study in

rats, the no-observed adverse effect level

(NOAEL) was 33.9 and 38.8 mg/kg/day

for males and females, respectively. The

lowest observed effect level (LOEL) was

68.5 and 78.1 mg/kg/day for males and

females, respectively based on

decreased body weight gain, anemia,

and vacuolation in multiple organs

(kidney, liver, heart, spleen, adrenals,

and thyroid).

4. In a subchronic feeding study in

mice, the NOEL was 7.5 mg/kg/day and

the LOEL was 22.5 mg/kg/day based on

cytoplasmic vacuolation in multiple

organs (kidney, liver, heart, stomach,

lymphoid organs, and ovary).

5. In a subchronic feeding study in

dogs, the NOEL was 4.89 and 5.38 mg/

kg/day for males and females,

respectively. The LOEL was 9.73 mg/kg/

day and 10.5 mg/kg/day based on

decreased mean body weights and food

consumption, and anemia.

6. In a 21-day dermal study in rats,

the NOEL for systemic effects was >

1,000 mg/kg/day (limit dose). No

systemic toxicity was observed at any

dose tested.

7. In a chronic feeding study in dogs,

the NOEL was 2.68 mg/kg/day. The

LOEL was 8.22 mg/kg/day based on

increased liver enzymes (ALT, AST),

triglycerides; vacuolated cells

(parathyroid), and arteritis.

8. In a carcinogenicity study in mice,

the NOEL was 11.4 mg/kg/day. The

LOEL was 50.9 mg/kg/day based on

decreased body weight gains, increased

mortality, hematologic effects, increased

thickening of the gastric mucosa, and

histologic changes in the stomach of

males.

9. In a chronic feeding/

carcinogenicity/neurotoxicity study in

rats, the NOEL (systemic) was 9.5 and

12.0 mg/kg/day for males and females,

respectively. The LOEL (systemic) was

24.1 and 30.3 mg/kg/day for males and

females, respectively based on

vacuolation of epithelial follicular cells

of the thyroid. The neurological NOEL

was 46 and 57 mg/kg/day for males and

females, respectively. The neurological

LOEL was not determined.

10. In a developmental study in

rabbits, the maternal NOEL was ≥50 mg/

kg/day. The maternal LOEL was not

established. The developmental NOEL

was ≥50 mg/kg/day. The developmental

LOEL was not established.

11. In a developmental study in rats,

the maternal NOEL was >200 mg/kg/

day. The maternal LOEL was not

established. The developmental NOEL

was >200 mg/kg/day. The

developmental LOEL was not

established.

12. In a two-generation reproduction

toxicity study in rats, the systemic

NOEL was 10 mg/kg/day. The systemic

LOEL was 100 mg/kg/day based on

increased organ weights (heart, liver,

kidney, spleen, thyroid), histopath

lesions in the lungs and mesenteric

lymph nodes, stomach (F), and prostate.

The reproductive NOEL was 10 mg/kg/

day. The reproductive LOEL was 100

mg/kg/day based on decreased litter

size, decreased pup survival, decreased

body weight, increased incidence of

dystocia and/or vaginal bleeding postpartum with associated increased

mortality of dams.

13. Studies on gene mutation and

other genotoxic effects: In a Gene

Mutation Assay (mouse forward

mutation) there was no forward

mutation induction in mouse lymphoma

L5178Y Tk +/- cells at concentrations of

0, 1, 5, 10, 15, 20, or 25 μg/ml without

metabolic activation or at

concentrations of 15 through 50 μg/ml

with metabolic activation. In a

Structural Chromosomal Aberration

Assay in vitro there was no increase in

the number of CHO (chinese hamster

ovary) cells with chromosomal

aberrations at concentratioins from 20 to

35 μg/ml (without activation) or

concentrations from 100 to 500 μg/ml

(with activation). In a Micronucleus

Test in mice, there was no increase in

the frequencey of micronuclei in bone

marrow cells from mice treated at

concentratioins from 500 to 2,000 μg/ml

for two days. In Other Genotoxicity

Assays, unscheduled DNA synthesis

was not induced in adult rat

hepatocytes in vitro at concentrations of

0.01 to 5 μg/ml tested.

14. The results of three metabolism

studies are as follows: (i) Approximately

95% of technical spinosad was

eliminated by 24 hours mainly in the

urine (34%), bile (36%), and tissues and

carcass (21%). Metabolites include the

glutathione conjugates of the unchanged

form as well as N- and O-demethylated

forms of XDE-105 (Factor D). (ii) At 100

mg/kg/dose, the radiolabeled XDE-105

(Factor D) was primarily excreted in the

feces (68%) after 24-hours. The

absorption, distribution, and

elimination of 14C-XDE-105 (Factor A)

demonstrated no appreciable differences

based on dose or repeated dosing. (iii)

At high (100 mg/kg) doses, there are no

major differences in the bioavailability,

routes or rates of excretion or

metabolism of 14C-XDE-105 (Factor A)

following oral administration.

15. In an acute neurotoxicity study,

groups of Fischer 334 rats (10/sex/dose)

received a single oral (gavage)

administration of spinosad (87.9%) at

dose levels of 0, 200, 630, or 2,000 mg/
Federal Register / Vol. 63, No. 72 /Wednesday, April 15, 1998 /Rules and Regulations 18333

kg. There were no effects on

neurobehavioral endpoints or

histopathology of the nervous system.

For neurotoxicity, the NOEL was ≥

2,000 mg/kg/day, highest dose tested

(HDT). A LOEL was not established.

16. In a subchronic neurotoxicity

study, groups of Fischer 344 rats (10/

sex/dose) were administered diets

containing spinosad at levels of 0, 0.003,

0.006, 0.012, or 0.06% (0, 2.2, 4.3, 8.6,

or 42.7 mg/kg/day for males and 2.6,

5.2, 10.4, or 52.1 mg/kg/day for females,

respectively). There were no effects on

neurobehavior endpoints or

histopathology of the nervous system.

For neurotoxicity, the NOEL was ≥ 42.7

and ≥52.1 mg/kg/day in males and

females, respectively (HDT).

17. In the 2-year chronic neurotoxicity

study, groups of Fischer 344 rats (65/

sex/dose) received diets containing

spinosad at dose levels of 0, 0.005, 0.02,

0.05, or 0.1% (0, 2.4, 9.5, 24.1, or 49.4

mg/kg/day for males and 0, 3.0, 12.0,

30.3, or 62.2 mg/kg/day for females,

respectively). Neurobehavioral testing

performed at 3, 6, 9, and 12 months of

study was negative, and

histopathological evaluation of perfused

tissues at study termination did not

identify pathology of the central or

peripheral nervous system. There was

no evidence of neurotoxicity. For

neuropathology, the NOEL was 0.1% (≥

46 mg/kg/day for males and 57 mg/kg/

day for females (HDT).

B. Toxicological Endpoints

1. Acute toxicity. EPA did not select

a dose and endpoint for an acute dietary

risk assessment due to the lack of

toxicological effects attributable to a

single exposure (dose) in studies

available in the data base including oral

developmental toxicity studies in rats

and rabbits. In the acute neurotoxicity

study the NOEL was ≥2,000 mg/kg/day.

2. Short - (1 day to 7 days),

intermediate- (1 week to several

months), and chronic - term

occupational and residential dermal

and inhalation toxicity. EPA did not

select a dose or endpoint for short-,

intermediate and long-term dermal risk

assessments because (i) lack of

appropriate endpoints; (ii) the

combination of molecular structure and

size as well as the lack of dermal or

systemic toxicity at 2,000 mg/kg/day in

a 21-day dermal toxicity study in rats

which indicates the lack of dermal

absorption; and (iii) the lack of longterm exposure based on the current use

pattern. Therefore, a dermal risk

assessment is not required. EPA also

determined that based on the current

use pattern and exposure scenario, an

inhalation risk assessment is not

required.

3. Chronic toxicity. EPA has

established the RfD for spinosad at

0.027 mg/kg/day. This RfD is based on

a chronic toxicity study in dogs using a

NOEL of 2.68 mg/kg/day. The LOEL was

8.46 mg/kg/day based on vacuolation in

glandular cells (parathyroid) and

lymphatic tissues, arteritis and increases

in serum enzymes such as alanine

aminotransferase, and aspartate

aminotransferase, and triglyceride levels

in dogs fed spinosad in the diet at dose

levels of 1.44, 2.68, or 8.46 mg/kg/day

for 52 weeks. A 100-fold uncertainty

factor (UF) was applied to the NOEL of

2.68 mg/kg/day to account for inter- and

intra-species variation.

EPA determined that the 10X factor to

account for enhanced sensitivity of

infants and children (as required by

FQPA) should be removed. Thus, an

uncertainty factor of 100 is adequate

and the RfD remains at 0.027 mg/kg/

day.

The FQPA factor is removed because:

(i) The data provided no indication of

increased susceptibility of rats or rabbits

to in utero and/or post-natal exposure to

spinosad. In the prenatal developmental

toxicity studies in rats and rabbits and

the two-generation reproduction study

in rats, effects in the offspring were

observed only at or below treatment

levels which resulted in evidence of

parental toxicity. (ii) No neurotoxic

signs have been observed in any of the

standard required studies conducted.

(iii) The toxicology data base is

complete and there are no data gaps.

4. Carcinogenicity. There is no

evidence of carcinogenicity in studies in

either the mouse or rat.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.495) for the residues of

spinosad in or on cottonseed at 0.02

ppm (to expire on 11/15/99). Timelimited tolerances for Section 18

emergency exemptions are established

under 40 CFR 180.495 for residues of

spinosad in or on Brassica (cole) leafy

vegetables at 10 ppm, fruiting vegetables

(except cucurbit vegetables) at 0.25

ppm, leafy vegetables (except Brassica

vegetables) at 10 ppm, and tomato paste

at 0.5 ppm. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from spinosad as

follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a one day or single exposure. No acute

toxicological endpoints were identified

for spinosad due to the lack of

toxicological effects attributable to a

single exposure (dose). Therefore, the

Agency concludes that there is a

reasonable certainty of no harm from

acute dietary exposure.

ii. Chronic exposure and risk. The RfD

used for the chronic dietary analysis is

0.027 mg/kg/day. In conducting this

chronic dietary risk assessment, EPA

made very conservative assumptions:

100% of citrus, almonds, apples,

fruiting (except cucurbit) vegetables,

Brassica leafy vegetables, leafy

vegetables, cottonseed, and ruminant

commodities having spinosad tolerances

will contain spinosad residues and

those residues will be at the level of the

established tolerance. This results in an

overestimate of human dietary

exposure. This chronic dietary risk

assessment used 10 ppm tolerances for

the leafy vegetables (except Brassica

vegetables) crop group and for the

Brassica leafy vegetables head and stem

subgroup from section 18 tolerances that

were established last year. For the

section 3 registrations on these groups,

EPA has recommended tolerances of 8

ppm (leafy vegetables) and 2 ppm

(Brassica head and stem leafy

vegetables). The use pattern for these

section 18 registrations is identical to

the section 3 registrations proposed in

this risk assessment, but due to an

incomplete data base at the time the

Section 18s were reviewed, the

tolerances were set high which resulted

in a conservative risk assessment. With

this action, these section 18 tolerances

are replaced by the new section 3

tolerances. Thus, in making a safety

determination for this tolerance, EPA is

taking into account this conservative

exposure assessment.

The existing spinosad tolerances

(published, pending, and including the

Section 18 tolerances) result in a

Theoretical Maximum Residue

Contribution (TMRC) that is equivalent

to the following percentages of the RfD:

U.S. Population (24% of RfD); Nursing

Infants (<1 year old)( 8% of RfD); NonNursing Infants (<1 year old) (24% of

RfD); Children (1-6 years old) (34% of

RfD); Children (7-12 years old) (29% of

RfD); Northeast Region (25% of RfD);

Western Region (27% of RfD); NonHispanic Blacks (27% of RfD); NonHispanic Others (37% of RfD); Females

13+ years, Nursing (27% of RfD).

2. From drinking water. The Agency

has determined that spinosyns Factor A

and Factor D are immobile in soil and

will not leach into ground water. Based

on structure/activity relationships, the

Agency concluded that the spinosad

metabolites/fermentation impurities
18334 Federal Register / Vol. 63, No. 72 /Wednesday, April 15, 1998 /Rules and Regulations

(spinosyns Factor B, Factor B of D,

Factor K, and other related factors) were

of no more toxicological concern than

the two parent compounds (spinosyns

Factor A and Factor D) and therefore,

only these were considered in the

drinking water assessment. EPA used

the ‘‘Interim Approach for Addressing

Drinking Water Exposure in Tolerance

Decision Making’’ issued on November

17, 1997. Thus, the PRZM/EXAMS

Models were run to produce estimates

of spinosad in surface water. The

primary use of these models is to

provide a screen for sorting out

pesticides for which OPP has a high

degree of confidence that the true levels

of the pesticide in drinking water will

be less than the human health drinking

water levels of concern (DWLOCs). A

human health DWLOC is the

concentration of a pesticide in drinking

water which would result in acceptable

aggregate risk, after having already

factored in all food exposures and other

non-occupational exposures for which

OPP has reliable data. PRZM/EXAMS

was used to conduct a Tier 2 surface

water analysis. The Tier 2 estimated

drinking water concentration (EEC) of

spinosad from surface water sources is

not likely to exceed 0.059 μg/L from use

on apples, 0.092 μg/L from use on

Brassica vegetables, 0.065 μg/L from use

on cotton, and 0.075 μg/L from use on

citrus.

i. Acute exposure and risk. Because

no acute dietary endpoint was

determined, the Agency concludes that

there is a reasonable certainty of no

harm from acute exposure from drinking

water.

ii. Chronic exposure and risk. Based

on the chronic dietary (food) exposure

and using default body weights and

water consumption figures, chronic

drinking water levels of concern

(DWLOC) for drinking water were

calculated. The chronic drinking water

exposure and risk estimates are

0.019890 mg/kg/day (690 μg/L DWLOC)

for the overall U.S. population; 0.01896

mg/kg/day (570 μg/L DWLOC) for

females 13+ years, nursing; and

0.016865 mg/kg/day (170 μg/L DWLOC)

for children age 1-6 years.

3. From non-dietary exposure. There

are no current residential uses for

spinosad. However, the proposed use of

a 0.5% spinosad product on structural

lumber may have residential uses. This

product is injected into drilled holes

and then sealed after treatment. Due to

the lack of toxicity endpoints (hazard)

and minimal contact with the active

ingredient during and after application,

exposure to residential occupants is not

expected.

4. Cumulative exposure to substances

with common mechanism of toxicity.

Spinosad has not yet been grouped with

any other insecticides into a class.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

spinosad has a common mechanism of

toxicity with other substances or how to

include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

spinosad does not appear to produce a

toxic metabolite produced by other

substances. For the purposes of these

tolerance actions, therefore, EPA has not

assumed that spinosad has a common

mechanism of toxicity with other

substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

Chronic risk. Using the TMRC

exposure assumptions described in Unit

I.B. of this Preamble, EPA has

concluded that aggregate exposure to

spinosad from food will utilize 24% of

the RfD for the U.S. population. For the

most highly exposed populations

subgroup, children (1-6 years old) and

non-Hispanic others, chronic dietary

(food only) exposure occupies 34% and

37% of the RfD, respectively. This is a

conservative risk estimate for reasons

described above. EPA generally has no

concern for exposures below 100% of

the RfD because the RfD represents the

level at or below which daily aggregate

dietary exposure over a lifetime will not

pose appreciable risks to human health.

The chronic DWLOC for the infants and

children subgroup is 170 ppb. The

chronic modeling estimates (EECs) for

spinosad residues in surface water are

as high as 0.092 ppb from use on

Brassica leafy vegetables. The maximum

estimated concentrations of spinosad in

surface water are less than EPA’s levels

of concern for spinosad in drinking

water as a contribution to chronic

aggregate exposure. Taking into account

present uses and uses proposed in this

risk assessment, EPA concludes with

reasonable certainty that residues of

spinosad in drinking water (when

considered along with other sources of

exposure for which EPA has reliable

data ) would not result in unacceptable

levels of aggregate human health risk at

this time. Therefore, the Agency

concludes that there is a reasonable

certainty that no harm will result from

chronic aggregate exposure to spinosad

residues from food and water.

No dermal or inhalation endpoints

were identified. Due to the nature of the

non-dietary use, EPA believes that the

use of spinosad in treating structural

lumber will not result in any exposure

through the oral route. Therefore, the

chronic aggregate risk is the sum of food

and water.
Federal Register / Vol. 63, No. 72 /Wednesday, April 15, 1998 /Rules and Regulations 18335

E. Aggregate Cancer Risk for U.S.

Population

The RfD Committee determined that

there is no evidence of carcinogenicity

in studies in either the mouse or rat.

Therefore, a carcinogenic risk

assessment is not required.

F. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

spinosad, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a two-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

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 post-natal toxicity and the

completeness of the database unless

EPA determines 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 use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard MOE and

uncertainty factor (usually 100 for

combined inter- and intra-species

variability) and not the additional

tenfold MOE/uncertainty factor when

EPA has a complete data base under

existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard MOE/safety factor.

ii. Developmental toxicity studies. a.

In a prenatal developmental toxicity

study, groups of pregnant SpragueDawley rats (30/group) received oral

(gavage) administration of spinosad

(88.6%) in aqueous 0.5%

methycellulose at dose levels of 0,10,

50, 200 mg/kg/day during gestation days

6 through 17. For maternal toxicity, the

NOEL was ≥200 mg/kg/day (HDT); a

LOEL was not established. Marginal

maternal toxicity was reported at this

dose level (decreased body weight gain).

Based upon the results of a rangefinding study, which showed maternal

toxicity (body weight and food

consumption decreases at 100 and 300

mg/kg/day), the dose level of 200 mg/

kg/day in the main study was

considered adequate. For developmental

toxicity, the NOEL was >200 mg/kg/day;

a LOEL was not established. In the

range-finding study, fetal body weight

decrements occurred at 300 mg/kg/day.

b. In a prenatal developmental

toxicity study, groups of pregnant New

Zealand White rabbits (20/group)

received oral (gavage) administration of

spinosad (88.6%) in 0.5% aqueous

methyl cellulose at doses of 0, 2.5, 10,

or 50 mg/kg/day during gestation days

7 through 19. For maternal toxicity, the

NOEL was ≥50 mg/kg/day (HDT); a

LOEL was not established. At this dose,

slight body weight loss was observed in

the first few days of dosing, but this

finding was not supported by other

signs. In the range-finding study,

inanition was observed at doses of 100,

200, and 400 mg/kg/day, with

significant decreases in body weight

gain during dosing. All does at these

dose levels were sacrificed prior to

scheduled termination; no fetal data

were available. No evidence of

developmental toxicity was noted. For

developmental toxicity, the NOEL was

≥50 mg/kg/day; a LOEL was not

established. (No fetal effects were noted

for fetuses of the range-finding study at

doses up to 50 mg/kg/day).

iii. Reproductive toxicity study. In a

two-generation reproduction study,

groups of Sprague-Dawley rats (30/sex/

group) received diets containing

spinosad (88%) at dose levels of 0,

0.005, 0.02, or 0.2% (3, 10, or 10 mg/

kg/day, respectively) for two successive

generations. For parental systemic

toxicity, the NOEL was 0.02% (10 mg/

kg/day) and the LOEL was 0.2% (100

mg/kg/day), based on increased heart,

kidney, liver, spleen, and thyroid

weights (both sexes), histopathology in

the spleen and thyroid (both sexes),

heart and kidney (males), and

histopathologic lesions in the lungs and

mesenteric lymph nodes (both sexes),

stomach (females), and prostate. For

offspring toxicity, the NOEL was 0.02%

(10 mg/kg/day) and the LOEL was 0.2%

(100 mg/kg/day) based on decreased

litter size, survival (F2), and body

weights. Reproductive effects at that

dose level included increased incidence

of dystocia and/or vaginal bleeding after

parturition with associated increase in

mortality of dams.

iv. Neurotoxicity. a. In an acute

neurotoxicity study, groups of Fischer

344 rats (10/sex/dose) received a single

oral (gavage) administration of spinosad

(87.9%) at dose levels of 0, 200, 630, or

2,000 mg/kg. There were no effects on

neurobehavioral endpoints or

histopathology of the nervous system.

For neurotoxicity, the NOEL was >2,000

mg/kg (HDT); a LOEL was not

established.

b. In a subchronic neurotoxicity

study, groups of Fisher 344 rats (10/sex/

dose) were administered diets

containing spinosad at levels of 0, 0.003,

0.006, 0.012, or 0.06% (0, 2.2, 4.3, 8.6,

or 42.7 mg/kg/day for males and 2.6,

5.2, 10.4, or 52.1 mg/kg/day for females,

respectively). There were no effects on

neurobehavioral endpoints or

histopathology of the nervous system.

For neurotoxicity, the NOEL was ≥42.7

for males and ≥52.1 mg/kg/day for

females (HDT).

c. In the 2-year chronic toxicity study,

groups of Fischer 344 rats (65/sex/dose)

received diets containing spinosad at

dose levels of 0, 0.005, 0.02, 0.05, or

0.1% (0, 2.4, 9.5, 24.1, or 49.4 mg/kg/

day for males and 0, 3.0, 12.0, 30.3, or

62.2 mg/kg/day for females,

respectively). Neurobehavioral testing

performed at 3, 6, 9, and 12 months of

study was negative, and

histopathological evaluation of perfused

tissues at study termination did not

identify pathology of the central or

peripheral nervous system. There was

no evidence of neurotoxicity. For

neuropathology, the NOEL was 0.1%

(>49.4 mg/kg/day for males and 62.8

mg/kg/day for females).

v. Pre- and post-natal sensitivity.

There was no increased susceptibility to

rats or rabbits following in utero and/or

postnatal exposure to spinosad.

vi. Conclusion. The data provided no

indication of increased susceptibility of

rats or rabbits to in utero and/or

postnatal exposure to spinosad. In the

prenatal developmental toxicity studies

in rats and rabbits and the twogeneration reproduction study in rats,

effects in the offspring were observed

only at or below treatment levels which

resulted in evidence of parental toxicity.

In addition, all neurotoxicity studies

were negative for effects on the central

or peripheral nervous system.

EPA determined that the 10X factor to

account for enhanced sensitivity of

infants and children (as required by

FQPA) should be removed. The FQPA

factor is removed because:

(i) The data provided no indication of

increased susceptibility of rats or rabbits

to in utero and/or post natal exposure to

spinosad. In the prenatal developmental

toxicity studies in rats and rabbits and

the two-generation reproduction study

in rats, effects in the offspring were

observed only at or below treatment
18336 Federal Register / Vol. 63, No. 72 /Wednesday, April 15, 1998 /Rules and Regulations

levels which resulted in evidence of

parental toxicity.

(ii) No neurotoxic signs have been

observed in any of the standard required

studies conducted.

(iii) The toxicology data base is

complete and there are no data gaps.

2. Acute risk. An acute risk

assessment is not required because no

acute toxicological endpoints were

identified for spinosad.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to spinosad

from food will utilize 34% of the RfD for

children age 1-6 years old. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. EPA concludes that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to spinosad

residues.

G. Endocrine Disruption

EPA is required to develop a

screening program to determine whether

certain substances (including all

pesticides and inerts) ‘‘may have an

effect in humans that is similar to an

effect produced by a naturally occurring

estrogen, or such other endocrine

effect...’’ The Agency is currently

working with interested stakeholders,

including other government agencies,

public interest groups, industry and

research scientists in developing a

screening and testing program and a

priority setting scheme to implement

this program. Congress has allowed 3

years from the passage of FQPA (August

3, 1999) to implement this program. At

that time, EPA may require further

testing of this active ingredient and end

use products for endocrine disrupter

effects.

III. Other Considerations

A. Metabolism In Plants and Animals

EPA has reviewed the results of plant

metabolism studies (apples, cabbage,

cotton, tomatoes, turnips) and livestock

metabolism studies (goat and hen). The

metabolism of spinosad in plants and

animals is adequately understood for

the purposes of these tolerances. Based

on structure/activity relationships, EPA

concluded that the spinosad

metabolites/fermentation impurities

(spinosyns Factor B, Factor B or D,

Factor K, and other related Factors)

were of no more toxicological concern

than the two parent compounds

(spinosyns Factor A and Factor D).

EPA focused on the following data/

information: the overall low toxicity of

spinosad; the low levels of metabolites/

fermentation impurities present; and

that spinosad appears to photodegrade

rapidly and become incorporated into

the general carbon pool. EPA concluded

that only 2 parent compounds

(spinosyns Factor A and Factor D) need

to be included in the tolerance

expression and used for dietary risk

assessment purposes.

B. Analytical Enforcement Methodology

Method GRM 94.02 (method for

determination of spinosad residues in

cottonseed and related commodities

using HPLC/UV) underwent successful

independent lab validation and EPA lab

validation and has been submitted to

FDA for inclusion in PAM II as Method

I. Additional methods have been

submitted for other crop matrices (leafy

vegetables - GRM 95.17; citrus - GRM

96.09; tree nuts - GRM 96.14; fruiting

vegetables - GRM 95.04; and cotton gin

byproducts - GRM 94.02.S1). All of

these methods are essentially similar to

GRM 94.02 and have been submitted to

FDA for inclusion in PAM II as letter

methods. These methods are adequate

for regulation of the tolerance

expression.

Method RES 94094 (method for

determination of spinosad residues in

ruminant commodities using HPLC/UV)

underwent successful independent lab

validation and EPA lab validation. This

method is adequate for regulation of the

tolerance expression.

Method RES 95114 (method for

determination of spinosad residues in

ruminant commodities using

immunoassay) underwent successful

independent lab validation and EPA lab

validation.This method is adequate for

regulation of the tolerance expression.

C. Magnitude of Residues

Adequate residue data were provided

to support tolerances of 0.02 ppm for

almonds; 2.0 ppm for almond hulls; 0.2

for apples; 2.0 ppm for the head and

stem subgroup of the Brassica leafy

vegetables crop group; 10.0 ppm for the

greens subgroup of the Brassica leafy

vegetables crop group; 0.3 ppm for the

citrus fruits crop group; 0.02 ppm on

cottonseed; 1.5 ppm on cotton gin

byproducts; 0.4 ppm for the fruiting

vegetables (except cucurbit vegetables)

crop group; and, 8.0 ppm for the leafy

vegetables (except Brassica vegetables )

crop group.

Processing data provided for apples

indicated concentration of residues in

wet apple pomace. Based on the

concentration factor of 5.6X and the

highest average field trial (HAFT)

residue level of 0.089 ppm for apples,

the data support a tolerance of 0.5 ppm

for wet apple pomace.

Processing data provided for citrus

indicated concentration of residues in

dried citrus pulp and citrus oil. Based

on the concentration factor of 2.4X in

dried pulp and 12.7X in oil and the

highest average field trial (HAFT)

residue level of 0.200 ppm for oranges,

the data support tolerances of 0.5 ppm

for dried citrus pulp and 3.0 ppm for

citrus oil.

Processing data provided for

cottonseed did not indicate any

concentration of residues in meal or

hulls. No tolerances are required for

processed cotton commodities.

There are no livestock feedstuffs

associated with Brassica leafy

vegetables, fruiting vegetables, and leafy

vegetables.

A ruminant feeding study was

submitted. Based on the results of this

study, the data support the following

tolerances: fat (or cattle, goats, hogs,

horses, and sheep) at 0.6 ppm; meat (of

cattle, goats, hogs, horses, and sheep) at

0.04 ppm; meat byproducts (of cattle,

goats, hogs, horses, and sheep) at 0.2

ppm; milk fat at 0.5 ppm; and whole

milk at 0.04 ppm. These levels are

adequate for the feed items associated

with all existing and proposed uses

covered in this risk assessment.

Requirements for a poultry feeding

study have been waived based on the

minimal impact of spinosad residues in

a typical poultry diet.

D. International Residue Limits

No CODEX, Canadian, or Mexican

MRLs have been established for residues

of spinosad on any crops.

IV. Conclusion

Therefore, the tolerances are

established for residues of spinosad in

almonds at 0.02 ppm; almond hulls at

2.0 ppm; apples at 0.2 ppm; apple

pomace, wet at 0.5 ppm; citrus fruits

group at 0.3 ppm; citrus pulp, dried at

0.5 ppm; citrus oil at 3.0 ppm;

cottonseed at 0.02 ppm; cotton gin

byproducts at 1.5 ppm; fruiting

vegetables (except cucurbits) group at

0.4 ppm; Brassica (cole), leafy

vegetables, head and stem subgroup at

2.0 ppm; Brassica (cole), leafy

vegetables, greens subgroup at 10.0

ppm; leafy vegetables (except Brassica

vegetables) group at 8.0 ppm; fat of

cattle, goats, hogs, horses, and sheep at

0.6 ppm; meat of cattle goats, hogs,

horses, and sheep at 0.04; meat

byproducts of cattle, goats, hogs, horses,

and sheep at 0.2 ppm; milk fat at 0.5

ppm; and whole milk at 0.04 ppm.
Federal Register / Vol. 63, No. 72 /Wednesday, April 15, 1998 /Rules and Regulations 18337

In addition, EPA is removing the time

limitation for the tolerance for residues

of spinosad on cottonseed. Also, EPA is

removing the time limited tolerances

established under section 408(1)(6) of

the FFDCA, as amended by FQPA, in 40

CFR 180.495 (b) Section 18 emergency

exemptions.

V. 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 (l)(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 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 may, by June 15, 1998,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (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 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

issues 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.

VI. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300644] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 119 of the Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

VII. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Pub. L.

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the tolerances in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply.

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Envorcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit 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 United

States prior to publication of the rule in

the 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.
18338 Federal Register / Vol. 63, No. 72 /Wednesday, April 15, 1998 /Rules and Regulations

Dated: April 9, 1998.

James Jones,

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 § 180.495, paragraphs (a) and (b)

are revised to read as follows:

§ 180.495 Spinosad; tolerances for

residues.

(a) General. Tolerances are

established for residues of the

insecticide Spinosad. Factor A is 2-[(6-

deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]-13-[[5-(dimethylamino)-

tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-

9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,6btetradecahydro-14-methyl-1H-asIndaceno[3,2-d]oxacyclododecin-7,15-

dione. Factor D is 2-[(6-deoxy-2,3,4-triO-methyl-α-L-manno-pyranosyl)oxy]-

13-[[5-(dimethylamino)-tetrahydri-6-

methyl-2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-4,14-dimethyl-1H-asIndaceno[3,2-d]oxacyclododecin-7,15-

dione.

Commodity Parts per

million

Almonds .................................... 0.02

Almond hulls ............................. 2.0

Apples ....................................... 0.2

Apple pomace, wet ................... 0.5

Brassica (cole), leafy vegetables, greens subgroup .......... 10.0

Brassica (cole), leafy vegetables, head and stem subgroup ..................................... 2.0

Cattle, fat .................................. 0.6

Cattle, mbyp .............................. 0.2

Cattle, meat .............................. 0.04

Citrus fruits group ..................... 0.3

Citrus oil .................................... 3.0

Citrus pulp, dried ...................... 0.5

Cotton gin byproducts ............... 1.5

Cottonseed ................................ 0.02

Fruiting vegetables (except

cucurbits) group .................... 0.4

Goat, fat .................................... 0.6

Goat, mbyp ............................... 0.2

Goat, meat ................................ 0.04

Hogs, fat ................................... 0.6

Hogs, mbyp ............................... 0.2

Hogs, meat ............................... 0.04

Horses, fat ................................ 0.6

Horses, mbyp ............................ 0.2

Horses, meat ............................ 0.04

Leafy vegetables (except Brassica vegetables) group .......... 8.0

Commodity Parts per

million

Milk, fat ..................................... 0.5

Milk, whole ................................ 0.04

Sheep, fat ................................. 0.6

Sheep, mbyp ............................. 0.2

Sheep, meat ............................. 0.04

(b) Section 18 emergency exemptions.

[Reserved]

* * * * *

[FR Doc. 98–10023 Filed 4–14–98; 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–AD28

Wild Horse and Burro Adoptions;

Power of Attorney

AGENCY: Bureau of Land Management,

Interior.

ACTION: Final rule.

SUMMARY: The Bureau of Land

Management is amending its regulations

to prohibit anyone from adopting wild

horses and burros on behalf of another

person using a written authorization to

act as that person’s agent or attorney

(power of attorney). This action is

necessary to implement a portion of a

court-approved settlement agreement

between BLM and the Animal

Protection Institute of America, Inc. The

effect of this action is to eliminate the

potential for adopters to misuse the

power of attorney to obtain large

numbers of wild horses and burros for

commercial sale.

DATES: This rule is effective May 15,

1998.

FOR FURTHER INFORMATION CONTACT: Bud

Cribley, (202) 452–5073; or Lili Thomas,

(702) 785–6457.

SUPPLEMENTARY INFORMATION:

I. Background

II. Discussion of the Final Rule and Response

to Comments

III. Procedural Matters

I. Background

In 1971, Congress passed legislation

to protect, manage, and control wild

horses and burros on the public lands.

The Wild Free-Roaming Horses and

Burros Act (WHA) declared these

animals to be ‘‘living symbols of the

historic and pioneer spirit of the West.’’

Pub. L. 92–195, section 1, 85 Stat. 649

(1971) (current version at 16 U.S.C. 1331

(1994)). Congress further declared that

all wild free-roaming horses and burros

are under the jurisdiction of the

Secretary of the Interior for the purpose

of management and protection, and that

the Secretary shall manage them in a

manner that is designed to achieve and

maintain a thriving natural ecological

balance on the public lands. 16 U.S.C.

1333(a). Section 3(b) of the WHA

authorized the Secretary, where an area

is found to be overpopulated, to cause

additional excess wild free-roaming

horses and burros to be captured and

removed for private maintenance under

humane conditions and care. Congress

also authorized the Secretary to issue

such regulations as the Secretary deems

necessary to further the purposes of the

law. 16 U.S.C. 1336.

The WHA protected wild horses and

burros so well that within a few years

their numbers exceeded the carrying

capacity of the Western rangelands and

posed a threat to wildlife, livestock, and

the improvement of range conditions.

To correct this problem, in 1978,

Congress passed amendments to the

WHA as part of the Public Rangelands

Improvement Act. Pub. L. 95–514,

section 14, 92 Stat. 1803, 1808 (1978)

(current version at 16 U.S.C. 1333(b)–

(d)). The amendments sought to

facilitate humane adoption of excess

animals by allowing adopters to take

title to up to 4 animals per year after

having successfully cared for them for

one year. 16 U.S.C. 1333(c). Under the

amendments, individuals can adopt (but

not take title to) more than 4 animals

per year if the Secretary finds they can

humanely care for more than four. 16

U.S.C. 1333(b)(2)(B).

To carry out this mandate, the

Secretary, acting through BLM, issued

regulations governing, among other

things, the adoption process and who is

eligible to adopt animals removed from

the public lands. These regulations were

proposed in 1984 (49 FR 49252,

December 18, 1984) and adopted in

1986 (51 FR 7410, March 3, 1986). See

43 CFR part 4700 (1997). The 1986

regulations limited adoptions to four

animals per year per person, but also

allowed a person to adopt animals on

behalf of another person through the use

of a power of attorney. A power of

attorney is a written document that

authorizes one person to act as an agent

or attorney for another. Under the

existing regulations, one agent could get

powers of attorney from several people

and adopt more animals than any one

person is allowed to adopt.

As discussed in the proposed rule,

several investigations of adopters of