8626 Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Rules and Regulations

establishing a precedent for any future

request for revision to any state

implementation plan. Each request for

revision to the state implementation

plan shall be considered separately in

light of specific technical, economic,

and environmental factors and in

relation to relevant statutory and

regulatory requirements.

IV. Administrative Review

A. Executive Order 12866

This action has been classified as a

Table 3 action for signature by the

Regional Administrator under the

procedures published in the Federal

Register on January 19, 1989 (54 FR

2214–2225), as revised by a July 10,

1995 memorandum from Mary Nichols,

Assistant Administrator for Air and

Radiation. The Office of Management

and Budget (OMB) has exempted this

regulatory action from E.O. 12866

review.

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act,

5 U.S.C. 600 et seq., EPA must prepare

a regulatory flexibility analysis

assessing the impact of any proposed or

final rule on small entities. 5 U.S.C. 603

and 604. Alternatively, EPA may certify

that the rule will not have a significant

impact on a substantial number of small

entities. Small entities include small

businesses, small not-for-profit

enterprises, and government entities

with jurisdiction over populations of

less than 50,000.

SIP approvals under sections 110 and

301, and subchapter I, part D of the CAA

do not create any new requirements but

simply approve requirements that the

State is already imposing. Therefore,

because the Federal SIP approval does

not impose any new requirements, I

certify that it does not have a significant

impact on any small entities affected.

Moreover, due to the nature of the

Federal-State relationship under the

CAA, preparation of a flexibility

analysis would constitute Federal

inquiry into the economic

reasonableness of State action. The CAA

forbids EPA to base its actions

concerning SIPs on such grounds.

Union Electric Co. v. U.S. EPA, 427 U.S.

246, 255–66 (1976); 42 U.S.C.

7410(a)(2).

C. Unfunded Mandates

Under section 202 of the Unfunded

Mandates Reform Act of 1995

(‘‘Unfunded Mandates Act’’), signed

into law on March 22, 1995, EPA must

prepare a budgetary impact statement to

accompany any proposed or final rule

that includes a Federal mandate that

may result in estimated costs to State,

local, or tribal governments in the

aggregate; or to the private sector, of

$100 million or more. Under section

205, EPA must select the most costeffective and least burdensome

alternative that achieves the objectives

of the rule and is consistent with

statutory requirements. Section 203

requires EPA to establish a plan for

informing and advising any small

governments that may be significantly

or uniquely impacted by the rule.

EPA has determined that the approval

action proposed does not include a

Federal mandate that may result in

estimated costs of $100 million or more

to either State, local, or tribal

governments in the aggregate, or to the

private sector. This Federal action

approves pre-existing requirements

under State or local law, and imposes

no new requirements. Accordingly, no

additional costs to State, local, or tribal

governments, or to the private sector,

result from this action.

D. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. section 801(a)(1)(A) as

added by the Small Business Regulatory

Enforcement Fairness Act of 1996, 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. section 804(2).

E. Petitions for Judicial Review

Under section 307(b)(1) of the CAA,

petitions for judicial review of this

action must be filed in the United States

Court of Appeals for the appropriate

circuit by April 28, 1997. Filing a

petition for reconsideration by the

Administrator of this final rule does not

affect the finality of this rule for the

purposes of judicial review nor does it

extend the time within which a petition

for judicial review may be filed and

shall not postpone the effectiveness of

such rule or action. This action may not

be challenged later in proceedings to

enforce its requirements. (See section

307(b)(2), 42 U.S.C. 7607(b)(2).

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Carbon monoxide,

Hydrocarbons, Incorporation by

reference, Intergovernmental relations,

Lead, Nitrogen dioxide, Ozone,

Particulate matter, Reporting and

recordkeeping requirements, Sulfur

oxides, Volatile organic compounds.

Dated: February 14, 1997.

Charles Findley,

Acting Regional Administrator.

Part 52, chapter I, title 40 of the Code

of Federal Regulations is amended as

follows:

PART 52—[AMENDED]

1. The authority citation for Part 52

continues to read as follows:

Authority: 42 U.S.C. 7401–7671q.

Subpart WW—Washington

2. Section 52.2470 is amended by

adding paragraph (c)(70) to read as

follows:

§ 52.2470 Identification of plan.

* * * * *

(c) * * *

(70) On January 24, 1996 the Director

of WDOE submitted to the Regional

Administrator of EPA regulations of the

SWAPCA for the control of air pollution

in Clark, Cowlitz, Lewis, Skamania and

Wahkiakum Counties, Washington

(SWAPCA 400—General Regulation for

Air Pollution Sources).

(i) Incorporation by reference.

(A) The January 24, 1996, letter from

WDOE to EPA submitting requests for

revisions to the Washington SIP to

include regulations of the SWAPCA for

the control air of pollution in Clark,

Cowlitz, Lewis, Skamania and

Wahkiakum Counties, Washington, as

revisions to the Washington SIP, Stateeffective September 21, 1995. EPA is

approving the following sections of

SWAPCA 400—General Regulation for

Air Pollution Sources: 010; 020; 030

except the second sentence of (14), (45)

and (80); 040 except (1)(c), (1)(d), (2), (4)

and (6)(a); 050 except the exception

provision of (3); 052; 060; 070 except

(5); 074; 081; 091; 100 except the first

sentence of (3)(a)(iv) and (4); 101; 105;

107; 109 except for (3)(b), (3)(c), (3)(g),

(3)(h), and (3)(i), 110; 112; 113; 114; 151;

161; 171; 190; 200; 205; 210; 220; 230;

240; 250; 260; 270; and 280.

[FR Doc. 97–4659 Filed 2–25–97; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[OPP–300454; FRL–5590–8]

RIN 2070–AC78

Spinosad; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Rule.

SUMMARY: This regulation establishes a

time-limited tolerance with an
Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Rules and Regulations 8627

expiration date of November 15, 1999

for residues of the insecticide Spinosad

in or on the raw agricultural commodity

cottonseed. DowElanco submitted a

petition to EPA under the Federal Food

Drug and Cosmetic Act (FFDCA) as

amended by the Food Quality Protection

Act of 1996 (Pub. L. 104–170) requesting

the tolerance.

EFFECTIVE DATE: This regulation

becomes effective February 26, 1997.

The tolerance expires on November 15,

1999.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300454],

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–

300454], should be 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 a copy of objections and

hearing requests to Rm. 1132, CM#2,

1921 Jefferson Davis Highway,

Arlington, VA 22202. A copy of

objections and hearing requests filed

with the Hearing Clerk may also be

submitted electronically by sending

electronic mail (e-mail) to: OPPdocket@epamail.epa.gov.

Copies of objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Copies of objections and hearing

requests will also be accepted on disks

in WordPerfect 5.1 file format or ASCII

file format. All copies of objections and

hearing requests in electronic form must

be identified by the docket number

[OPP–300454]. 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: George T. LaRocca, Product

Manager (PM) 13, 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: Rm. 204, CM #2, 1921

Jefferson Davis Highway, Arlington, VA

22202, (703) 305-6100, e-mail:

larocca.george@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA,

issued a notice, published in the

Federal Register of July 10, 1996, (61 FR

36373)(FRL–5380–7), which announced

that DowElanco, 9330 Zionsville Road,

Indianapolis, IN 46268–1054, had

submitted a pesticide petition (PP

6F4735) to EPA requesting that the

Administrator, pursuant to section 408

of the Federal Food, Drug, and Cosmetic

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

establish a tolerance for residues of the

insecticide Spinosad in or on the raw

agricultural commodity cottonseed at

0.02 parts per million (ppm). Spinosad

is a fermentation derived tetracyclic

macrolide product produced by the

actinomycete, saccharopolyspora

spinosa and consists of two structurally

related compounds, namely, Spinosyn

A (CAS No. 131928–60–7) and Spinosyn

D (CAS No. 131929–63–) whose

chemical structures differ by a single

methyl group. Spinosyn 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,16btetradecahydro-14-methyl-1H-asIndaceno[3,2-d]oxacyclododecin-7,15-

dione. Spinosyn D is 2-[(6-deoxy-2,3,4-

tri-O-methyl-α-L-manno-pyranosyl)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,16btetradecahydro-4,14-dimethyl-1H-asIndaceno[3,2-d]oxacyclododecin-7,15-

dione.

In the Federal Register of November

22, 1996 (61 FR 59437) EPA issued a

second notice of filing to amend the

petition to bring it into conformity with

the Food Quality Protection Act (FQPA)

of 1996. The notice contained a

summary of the petition prepared by the

petitioner and this summary contained

conclusions and assessments to support

its conclusion that the petition

complied with FQPA.

In March 1995 Spinosad was accepted

by EPA as a reduced risk pesticide.

Reduce risk status was granted

primarily due to Spinosad’s low acute

mammalian toxicity, low non-target

organism toxicity and compatibility

with integrated pest management. The

criteria initiating EPA’s reduced risk

pesticide process are set forth in

Pesticide Regulation Notice 93–9 dated

July 21, 1993 and the January 22, 1993

Federal Register (58 FR 5854).

There were no comments or requests

for referral to an advisory committee

received in response to the notice.

I. Background and Statutory Authority

The FQPA of 1996 (Pub. L. 104–170)

was signed into law August 3, 1996.

FQPA amends both the FFDCA, 21

U.S.C. 301 et seq., and the Federal

Insecticide, Fungicide, and Rodenticide

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

FQPA amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

New section 408(b)(2)(A)(i) 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, but does not

include occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’ Section 408(b)(2)(D)

specifies factors EPA is to consider in

establishing a tolerance. Section

408(b)(3) requires EPA to determine that

there is a practical method for detecting

and measuring levels of the pesticide

chemical residue in or on food and that

the tolerance be set at a level at or above

the limit of detection of the designated

method. Section 408(b)(4)requires EPA

to determine whether a maximum

residue level has been established for

the pesticide chemical by the Codex

Alimentarius Commission. If so, and

EPA does not propose to adopt that

level, EPA must publish for public

comment a notice explaining the

reasons for departing from the Codex

level. Section 408(b)(2)(A) governs

EPA’s establishment of tolerances and

incorporating the provisions of section

408(b)(2)(C) and (D).

II. Risk Assessment and Statutory

Findings

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
8628 Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Rules and Regulations

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

For many of these studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(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 significant 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.

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 margin of exposure

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.

In examining aggregate exposure,

FQPA 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, and other

non-occupational exposures, such as

where residues leach into groundwater

or surface water that is consumed as

drinking water. 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. 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 percent 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.

Consistent with sections 408(b)(2)(C)

and (D), EPA has reviewed the available

scientific data and other relevant

information in support of this action.

EPA has also assessed the toxicology

data base for spinosad in its evaluation

of applications for registration on

cotton. 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 the

time-limited tolerances for residues of

Spinosad on cottonseed at 0.02 ppm.

EPA’s assessment of the database,

dietary exposures and risks associated

with establishing these tolerances

follows:

A. Toxicology Data Base

The data submitted in the petition

and other relevant material have been

evaluated. The toxicological data

considered in support of the tolerance

include the following:

1. A battery of acute toxicity studies

placing the technical Spinosad in

Toxicity Category III and IV.

2. In a 21–day dermal study in rabbits

the NOEL for dermal and systemic

toxicity was 1,000 milligrams per

kilogram per day (mg/kg/day) (limit

dose). New Zealand White strain rabbits

were given 15 dermal applications at 0,

100, 500, or 1,000 mg/kg/day for 21 days

. Under the conditions of the test, there

was no evidence of treatment-related

toxicity from dermal application at

doses up to 1,000 mg/kg/day.

3. In a 13–week feeding neurotoxicity

study, Fischer 344 strain rats were given

daily levels of 0, 2.2, 4.3, 8.6, or 42.7

mg/kg body weight for males and 0, 2.6,

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

There were no effects observed on the

functional observational battery (FOB),

motor activity, or histological

observations of the nervous system.

Therefore, the NOEL for acute

mammalian neurotoxicity in rats is

≥42.7 or 52.1 mg/kg/day for male and

female rats, respectively.

4. A chronic 2–year feeding study in

dogs at dietary doses of 1.44, 2.68, or

8.46 mg/kg/day in males, and 1.33, 2.72

or 8.22 mg/kg/day respectively in

females with a NOEL of 2.68 mg/kg/day

(100/120 ppm).

5. Two mouse carcinogenicity studies

have been submitted and fulfill the

requirement for mouse carcinogenicity

testing. In the first study mice were

dosed at 0, 3.4, 11.4 and 50.9 mg/kg/day

in males and 4.2, 13.8, and 67.0 mg/kg/

day respectively in females with

systemic NOEL of 11.4 mg/kg/day for

males and 13.8 mg/kg/day in females. In

the second study, involving only

females, dosing was at 0, 1.3 and 41.5

mg/kg/day highest dose tested (HDT).

These studies, along with additional

information from the petitioner do not

indicate a potential for carcinogenicity.

6. A 24–month chronic feeding/

carcinogenicity study in rats. The

chronic feeding study using rats

indicates that the rat is a less sensitive

species than the dog with respect to

Spinosad. The rat feeding study data

support the NOEL selected from the dog

feeding study as the basis of the RfD.

The rat feeding study is currently

determined to be supplemental since

additional histopathology data on the

animals that died during the study are

required to upgrade the study from

supplementary status. NOELs and

lowest observed effect levels (LOELs)

will be established for this study once

the additional data are reviewed. There

were no treatment related carcinogenic

effects observed at any dose level.

7. Mutagenicity studies including an

in vitro forward mutation assay (mouse

lymphoma cells), in vitro chromosome

aberration assay (Chinese hamster ovary

cells), an in vivo micronucleus assay

(mice), and an in vitro unscheduled

DNA synthesis assay (primary rat

hepatocytes) showed no mutagenic

activity associated with Spinosad.

8. A metabolism study in rats

demonstrates that there were no major

differences between the bioavailability,

routes of excretion, or metabolism of

14C-Spinosad (Factor A) and 14CSpinosad (Factor D). Urine and fecal

excretions were almost completed at 48

hours post-dosing.
Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Rules and Regulations 8629

9. An oral developmental toxicity

study in rats with a developmental

NOEL of ≥200 mg/kg/day highest dose

tested (HDT). The NOEL for maternal

toxicity is ≥200 mg/kg/day HDT. An oral

developmental toxicity study in rabbits

with a developmental NOEL of ≥50 mg/

kg/day HDT. The NOEL for maternal

toxicity is ≥50 mg/kg/day HDT. With

respect to both studies there were no

developmental effects that could be

attributed to administration of Spinosad

up to the HDT.

10. A two generation reproduction

study in rats at dietary doses of 0, 3, 10,

and 100 mg/kg/day with a NOEL for

parental effects at 10 mg/kg/day based

upon increases in heart, kidney, liver,

spleen, and thyroid weights (both

sexes), corroborative histopathology in

the spleen and thyroid (both sexes),

heart and kidney (males only), and

histopathologic lesions in the lungs and

mesenteric lymph nodes (both sexes),

stomach (females only), and prostate in

the high dose group (100 mg/kg/day).

The NOEL for reproductive effects

was also 10 mg/kg/day based upon both

maternal and reproductive effects

including decreases in litter size,

survival (F2 litters only), and body

weights in the offspring, and increased

incidence of dystocia and/or vaginal

bleeding after parturition with

associated increases in mortality in the

dams in the high dose group (100 mg/

kg/day).

B. Toxicological Profile

1. Chronic effects. Based on the

available chronic toxicity data, EPA has

established the Reference Dose (RfD) for

spinosad at 0.0268 mg/kg/day based on

a NOEL of 2.68 mg/kg/day and an

uncertainty factor of 100. The NOEL is

based on a 2–year dog chronic feeding

study.

2. Acute toxicity. Based on the

available acute toxicity data, EPA has

determined that Spinosad does not pose

any acute dietary risk.

3. Carcinogenicity. Based on the

available carcinogenicity studies in two

rodent species Spinosad has not been

determined to be a human carcinogen.

A final cancer classification using the

Guidelines for Carcinogen Risk

Assessment published September 24,

1986 (51 FR 33992) is pending;

however, the current data does not

indicate that a cancer risk assessment

will be necessary.

III. Aggregate Exposure

1. Food and fee uses. For purposes of

assessing the potential dietary exposure

from use of Spinosad on cotton EPA has

estimated aggregate exposure based on

the TMRC from the tolerance for

spinosad on cottonseed at 0.02 ppm.

The TMRC is obtained by multiplying

the tolerance level residue for

cottonseed (0.02 ppm) by the food

consumption factors for foods derived

from cottonseed. Cottonseed is fed to

animals thus exposure to residues in

cottonseed might result if such residues

are transferred to meat, milk, poultry or

eggs. However, based upon the results of

animal metabolism studies, EPA

concludes there is no reasonable

expectation of finite residues of

spinosad in poultry tissues and eggs

from cotton uses. With respect to meat

and milk extrapolation from existing

ruminant metabolism, studies indicates

that secondary residues of spinosad in

ruminant commodities are expected to

be negligible. The analysis also included

two commodities processed from

cottonseed; cottonseed oil and

cottonseed meal. Tolerance level

residues on the oil and meal were

assumed however EPA notes that

Spinosad residues do not concentrate in

processed commodities, and therefore

this risk estimate is very conservative.

The dietary risk assessment will be

reevaluated with respect to secondary

residues in ruminant tissues and milk

upon submission and review of the field

trial data for cotton gin by-products.

There are no other established U.S.

tolerances for Spinosad, and there are

no registered uses for Spinosad on food

or feed crops in the United States.

As indicated above, in conducting

this exposure assessment, EPA has

made very conservative assumptions—

100 percent of cottonseed will contain

spinosad residues including cottonseed

oil and meal, and those residues would

be at the level of the tolerance —which

results in an overestimate of human

exposure. Thus, in making a safety

determination for these tolerances, EPA

is taking into account this conservative

exposure assessment.

2. Potable water. There is no

established Maximum Concentration

Level (MCL) for residues of Spinosad in

drinking water. Because the Agency

lacks specific water-related exposure

data for most pesticides, EPA has begun

and nerly completed a process to

identify a reasonable yet conservative

bounding figure for the potential

contribution of water-related exposure

to the aggregate risk posed by a

pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. EPA then

applied the estimated residue levels, in

conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOELs) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

This analysis can be found in the

Special Record for the FQPA. While

EPA has not yet pinpointed the

appropriate bounding figure for

consumption of contaminated water, the

ranges EPA is continuing to examine are

all well below the level that would

cause spinosad to exceed the RfD, if the

tolerance being considered in this

document are granted. EPA has

therefore concluded that the potential

exposure associated with spinosad in

water, even at the higher levels EPA is

considering as a conservative upper

bound, would not prevent EPA from

determining that there is a reasonable

certainty of no harm if the proposed

tolerance on cottonseed is granted.

3. Non-dietary uses. EPA has not

estimated non-occupational exposure

for Spinosad since there are no chronic

or acute residential risks expected from

the use of Spinosad on cotton. The

potential for non-occupational exposure

to the general population is, thus, not

expected to be significant.

4. Cumulative exposure to substances

with common mechanism of toxicity.

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

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

While 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 in a meaningful

way. EPA is commencing 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 enable

the Agency to apply common

mechanism issues to its pesticide risk

assessments. At present, however, the

Agency does not know how to apply the

information in its files concerning

common mechanism issues to risk

assessments, and therefore believes that

in most cases there is no available

information concerning common

mechanism that can be scientifically

applied to tolerance decisions. Where it

is clear that a particular pesticide may

share a significant common mechanism

with other chemicals, a tolerance

decision may be affected by common

mechanism issues. The Agency expects

that most tolerance decisions will fall

into the area in between, where EPA can

not reasonably determine whether a

pesticide does or does not share a
8630 Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Rules and Regulations

common mechanism of toxicity with

other chemicals (and, if so, how that

common mechanism should be factored

into a risk assessment). In such

circumstances, the Agency will reach a

tolerance decision based on the best,

currently available and useable

information, without regard to common

mechanism issues. However, the

Agency will also revisit such decisions

when the Agency learns how to apply

common mechanism information to

pesticide risk assessments.

In the case of Spinosad, it is unlikely

that this pesticide shares a common

mechanism of toxicity with other

pesticides since Spinosad is a unique

insecticide structurally unrelated to

other registered pesticides. However

since EPA has determined that it does

not now have the capability to apply the

information in its files to a resolution of

common mechanism issues in a manner

that would be useful in a risk

assessment, this tolerance determination

does not take into account common

mechanism issues. The Agency will

reexamine the tolerance for Spinosad, if

reexamination is appropriate, after the

Agency has determined how to apply

common mechanism issues to its

pesticide risk assessments.

IV. Determination of Safety for Infants

and Children

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 2–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.

Available data indicate that no

developmental toxicity was observed in

the rabbit study at the HDT (50 mg/kg/

day). Slight maternal toxicity was

observed in the rabbit at the HDT and

consisted of marginal reductions in

body weight gain, defecation, and food

consumption. In the rat developmental

study, a slight 1–day reduction in

maternal body weight gain and body

weight was observed at the HDT, but

otherwise no developmental or maternal

toxicity was observed at a high dose

level (200 mg/kg/day). Developmental

toxicity studies established the NOELs

for maternal and developmental toxicity

at ≥50 mg/kg/day in rabbits (HDT) and

≥200 mg/kg/day in rats HDT.

Reproductive toxicity appears to be

related to systemic maternal toxicity,

and was characterized by decreases in

mean litter size and body weight

throughout lactation. The NOEL for

reproductive toxicity is 10 mg/kg/day.

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 database unless EPA determines

that such additional factor is not

necessary to protect the safety of infants

and children. EPA believes that reliable

data support using a different safety

factor (usually 100x) and not the

additional safety factor when EPA has a

complete data base 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

traditional safety factors.

Based on current data requirements,

the database relative to pre- and postnatal toxicity is complete. These data

taken together suggest minimal concern

for developmental or reproductive

toxicity and do not indicate any

increased pre- or postnatal sensitivity.

Therefore, EPA concludes that

reliable data support use of a 100-fold

safety factor and an additional 10-fold

safety factor is not needed to protect the

safety of infants and children.

V. Determination of Safety for U.S.

Population Including Infants and

Children

1. Reference dose (RfD). A chronic

dietary exposure/risk assessment was

performed for Spinosad using an RfD of

0.02 mg/kg/day based on a NOEL of 2.68

mg/kg/day from a 2–year dog feeding

study with an uncertainty factor of 100.

Using the conservative exposure

assumptions described above and based

on the completeness and reliability of

the toxicity data base, EPA has

concluded that aggregate exposure to

Spinosad from it use on cotton will

utilize less than 1 percent of the RfD for

the U.S. population and for all of the 22

population subgroups including

children and infants. EPA generally has

no concern for exposures below 100

percent of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose significant risks to

human health.

2. Aggregate risks. Based upon the

available toxicity and exposure data and

worst case assumptions for dietary

exposure aggregate chronic risks are

expected to be less than 1% of the RfD

for the general U.S. population,

including all population subgroups. As

indicated above although EPA has not

yet identified a water exposure figure

based on available environmental data,

Spinosad is not expected to be mobile

in soil or water environments and poses

relatively little threat to ground and

drinking water. EPA therefore concludes

that there is reasonable certainty that no

harm will result to consumers,

including infants and children, from

aggregate exposure to spinosad residues.

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 toxicology studies described

above. There is no evidence at this time

that Spinosad causes endocrine effects.

B. Metabolism in Plants and Animals

The metabolism of spinosad in plants

and animals is adequately understood

for the purpose of this tolerance. There

are no Codex maximum residue levels

established for residues of Spinosad on

cottonseed. There is a practical

analytical method for detecting and

measuring levels of spinosad in or on

food with a limit of detection that

allows monitoring of food with residues

at or above the levels set in the

tolerance. EPA has provided

information on this method to FDA. The

method is available to anyone who is

interested in pesticide residue

enforcement from: By mail, Calvin

Furlow, Public Response and Program

Resources Branch, Field Operations

Division (7506C), Office of Pesticide

Programs, Environmental Protection

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

20460. Office location and telephone

number: Crystal Mall #2, Rm 1128, 1921

Jefferson Davis Hwy., Arlington, VA

22202, 703–305–5805.

C. Summary of Findings

Tolerances are time limited to allow

for development and review of residue

field trials on cotton gin by products.

The analysis for Spinosad using

tolerance level residues shows that the

proposed use on cotton will not cause

exposure to exceed the levels at which

EPA believes there is an appreciable

risk. All population subgroups

examined by EPA are exposed to

Spinosad residues at levels well below

100 percent of the RfD for chronic

effects. Based on the information and

data considered, EPA concludes that the

proposed time-limited tolerance will be

safe. Therefore, the tolerance is

established as set forth below.
Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Rules and Regulations 8631

VII. 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 the new

section 408(d) 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 its

current procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by April 28, 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 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

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Docket

A record has been established for this

rulemaking under docket number [OPP–

300454]. A public version of this record,

which does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 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

Virginia address in ‘‘ADDRESSES’’ at

the beginning of this document.

IX. 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

as defined by 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 mandate as described in the

Unfunded Mandates Reform Act of 1995

(Pub. L. 104–4), or require prior

consultation with State officials as

specified by Executive Order 12875 (58

FR 58093, October 28, 1993), or special

considerations as required by Executive

Order 12898 (59 FR 7629, February 16,

1994).

Pursuant to the requirements of the

Regulatory Flexibility Act (5 U.S.C.

601–612), the Administrator has

determined that regulations establishing

new tolerances or raising tolerance

levels or establishing exemptions from

tolerance requirements do not have a

significant economic impact on a

substantial number of small entities. A

certification statement to this effect was

published in the Federal Register of

May 4, 1981 (46 FR 24950).

Under 5 U.S.C. 801(a)(1)(A) of the

Administrative Procedure Act (APA) as

amended by the Small Business

Regulatory Enforcement Fairness Act of

1996 (Title II of Pub. L. 104–121, 110

Stat. 847), 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) of the APA

as amended.

List of Subjects In 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and Recordkeeping

requirements.

Dated: February 13, 1997.

Daniel M.Barolo,

Director, Office of Pesticide Programs.

Therefore, 40 CFR Chapter I is

amended as follows:

PART 180—[AMENDED]

1. The statutory authority for part 180

continues to read as follows:

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

b. By adding a new § 180.495 to read

as follows:

§ 180.495 Spinosad; tolerances for

residues.

(a) [Reserved]

(b) A time-limited tolerance is

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)-tetrahydro-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.
8632 Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Rules and Regulations

Commodity Parts per

million Expiration Date

Cottonseed ................................................................................................................................................... 0.02 November 15, 1999

[FR Doc. 97–4625 Filed 2–25–97; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 261

[FRL–5694–6]

Hazardous Waste Management

System; Identification and Listing of

Hazardous Waste; Final Exclusion;

Correction

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule; correction.

SUMMARY: On July 18, 1996, the

Environmental Protection Agency (EPA

or Agency) published a final rule

granting a petition submitted by United

Technologies Automotive, Inc. (UTA),

Dearborn, Michigan, to exclude (or

‘‘delist’’), conditionally, on a one-time,

upfront basis, a certain solid waste

generated by UTA’s chemical

stabilization treatment of lagoon sludge

at the Highway 61 Industrial Site in

Memphis, Tennessee, from the lists of

hazardous wastes in §§ 261.31 and

261.32. Based on careful analyses of the

waste-specific information provided by

the petitioner, the Agency concluded

that UTA’s petitioned waste will not

adversely affect human health and the

environment. Delisting levels for

cadmium, chromium, lead, nickel, and

cyanide which would be protective of

human health and the environment

were calculated and promulgated. This

action addresses the fact that the actual

volume of waste to be disposed is

39,400 cubic yards, instead of the

20,500 cubic yards estimated by the

petitioner prior to publication of the

final rule. Therefore, today’s document

corrects the delisting levels for the

constituents of concern by using the

dilution attenuation factor (DAF) of 79

for 40,000 cubic yards, instead of the

DAF of 96 for 20,500 cubic yards.

EFFECTIVE DATE: July 18, 1996.

ADDRESSES: The RCRA regulatory

docket for the final rule and today’s

document is located at the EPA Library,

U.S. Environmental Protection Agency,

Region 4, 100 Alabama Street, S.W.,

Atlanta, Georgia 30303, and is available

for viewing from 9:00 a.m. to 4:00 p.m.,

Monday through Friday, excluding

Federal holidays.

The reference number for this docket

is R4–96–UTEF. The public may copy

material from any regulatory docket at

no cost for the first 100 pages, and at a

cost of $0.15 per page for additional

copies. For copying at the Tennessee

Department of Environment and

Conservation, please see below.

FOR FURTHER INFORMATION CONTACT: For

general information, contact the RCRA

Hotline, toll free at (800) 424–9346, or

at (703) 412–9810. For technical

information concerning this notice,

contact Judy Sophianopoulos,

Enforcement and Compliance Branch,

(Mail Code 4WD–RCRA), U.S.

Environmental Protection Agency,

Region 4, 100 Alabama Street, S.W.,

Atlanta, Georgia 30303–3104, (404) 562–

8604, or call, toll free, (800) 241–1754,

and leave a message, with your name

and phone number, for Ms.

Sophianopoulos to return your call. You

may also contact Wayne Gregory,

Tennessee Department of Environment

and Conservation (TDEC), 5th Floor, L

& C Tower, 401 Church Street,

Nashville, Tennessee 37243–1535, (615)

532–0847. If you wish to copy

documents at TDEC, please contact Mr.

Gregory for copying procedures and

costs.

SUPPLEMENTARY INFORMATION:

I. Reasons and Basis for Today’s

Document

Each delisting level in the final rule

was calculated by multiplying the

health-based level for each constituent

of concern by the dilution attenuation

factor (DAF) of 96 for a one-time

disposal of an estimated volume of

20,500 cubic yards of petitioned waste.

See 61 FR 37399, July 18, 1996. The

petitioner reported that the actual

volume to be disposed is 39,400 cubic

yards. The DAF for this volume is 79.

See the proposed rule for this petitioned

waste at 61 FR 14703, April 3, 1996.

Therefore, today’s document corrects

the delisting level for each constituent

of concern by multiplying each healthbased level by 79.

II. Corrections to the Preamble of Final

Rule

On page 37399, of the Federal

Register of July 18, 1996, Table 1 of the

Preamble:

The delisting level for chromium is

corrected to read: ‘‘7.9; delisting level is

set at less than 5.0, the toxicity

characteristic level.’’

The delisting level for cyanide is

corrected to read: ‘‘15.8; (cyanide

extraction must be conducted using

deionized water.)’’

The delisting levels for cadmium,

lead, and nickel are corrected to read:

‘‘0.40,’’ ‘‘1.18,’’ and ‘‘ 7.9,’’ respectively.

List of Subjects in 40 CFR Part 261

Environmental protection, Hazardous

waste, Recycling, Reporting and

recordkeeping requirements.

Dated: January 31, 1997.

Jewell A. Harper,

Deputy Director, Waste Management Division.

Correction to Final Rule

PART 261—[CORRECTED]

Appendix IX [Corrected]

On page 37402, of the Federal

Register of July 18, 1996, in appendix IX

to part 261, in the third column of table

1, condition (3) is corrected to read as

follows:

Appendix IX to Part 261—Wastes

Excluded Under §§ 260.20 and 260.22

TABLE 1.—WASTES EXCLUDED FROM

NON-SPECIFIC SOURCES

Facility Address Waste description

* * * * *

(3) Delisting Levels: All

leachable concentrations for these constituents must not exceed the following levels (ppm): Cadmium—

0.40; cyanide—15.8;

lead—1.18; and nickel—7.9. The leachable

concentration of chromium must be less

than 5.0 ppm. Metal

concentrations in the

waste leachate must

be measured by the

method specified in 40

CFR 261.24. The cyanide extraction must

be conducted using

deionized water. Total

cyanide concentration

in the leachate must

be measured by Method 9010 or Method

9012 of SW–846.

* * * * *

[FR Doc. 97–4755 Filed 2–25–97; 8:45 am]

BILLING CODE 6560–50–P