1592 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

[FR Doc. 01–110 Filed 1–8–01; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301097; FRL–6760–2]

RIN 2070–6760–2

Spinosad; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

spinosad in or on alfalfa forage, alfalfa

hay, sugar beets, sugar beet tops, sugar

beet molasses, grass forage, grass hay,

peanuts, and peanut hay and, modifies

tolerances for livestock commodities on

a time-limited basis. This action is in

response to EPA’s granting of an

emergency exemption under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on alfalfa, sugar beets,

pastureland and rangeland, and

peanuts. This regulation establishes

maximum permissible levels for

residues of spinosad on these food

commodities. These tolerances will

expire and are revoked on December 31,

2002.

DATES: This regulation is effective

January 9, 2001. Objections and requests

for hearings, identified by docket

control number OPP–301097, must be

received by EPA on or before March 12,

2001.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VII. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301097 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrew Ertman, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number:(703)308-9367; and e-mail

address: ertman.andrew@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by

this action if you are an agricultural

producer, food manufacturer, or

pesticide manufacturer. Potentially

affected categories and entities may

include, but are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of This

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. To access the

OPPTS Harmonized Guidelines

referenced in this document, go directly

to the guidelines at http://www.epa.gov/

opptsfrs/home/guidelin.htm.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301097. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Mall #2, 1921 Jefferson Davis

Hwy., Arlington, VA, from 8:30 a.m. to

4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

EPA, on its own initiative, in

accordance with sections 408(e) and

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

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

is establishing tolerances for residues of

the insecticide spinosad, in or on the

following commodities: alfalfa, forage at

4.0 parts per million (ppm); alfalfa, hay

at 4.0 ppm; beet, sugar at 0.020 ppm;

beet, sugar, tops at 10.0 ppm; beet,

sugar, molasses at 0.250 ppm; grass,

forage at 7.0 ppm; grass, hay at 7.0 ppm;

peanut at 0.020 ppm; and peanut, hay

at 10.0 ppm.

Furthermore, tolerances for livestock

commodities are being modified, on a

time-limited basis, as follows: meat of

cattle, horses, goats, hogs, and sheep

from 0.15 to 0.60 ppm; fat of cattle,

horses, goats, hogs, and sheep from 3.5

to 15.0 ppm; meat byproducts (mbyp) of

cattle, horses, goats, hogs, and sheep

from 1.0 ppm to 3.50 ppm; milk, whole

from 0.5 to 2.0 ppm; milk, fat from 5.0

ppm to 20.0 ppm; eggs from 0.02 to

0.030 ppm; and poultry, fat from 0.2

ppm to 0.30 ppm. These tolerances will

expire and are revoked on December 31,

2002. EPA will publish a document in

the Federal Register to remove the

revoked tolerances from the Code of

Federal Regulations.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of Federal

Insecticide, Fungicide, and Rodenticide

Act FIFRA. Such tolerances can be

established without providing notice or

period for public comment. EPA does

not intend for its actions on section 18

related tolerances to set binding

precedents for the application of section

408 and the new safety standard to other

tolerances and exemptions. Section

408(e) of the FFDCA allows EPA to

establish a tolerance or an exemption

from the requirement of a tolerance on

its own initiative, i.e., without having

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1593

received any petition from an outside

party.

Section 408(b)(2)(A)(i) of the FFDCA

allows EPA to establish a tolerance (the

legal limit for a pesticide chemical

residue in or on a food) only if EPA

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) defines ‘‘safe’’ to

mean that ‘‘there is a reasonable

certainty that no harm will result from

aggregate exposure to the pesticide

chemical residue, including all

anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by the

Food Quality Protection Act (FQPA).

EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

III. Emergency Exemption for Spinosad

on Alfalfa, Pastureland and Rangeland,

Peanuts, and Sugarbeets and FFDCA

Tolerances

The states of Texas, New Mexico,

Kansas and Oklahoma all requested the

use of spinosad to control an emergency

situation with the beet armyworm on

alfalfa. The states of Texas and New

Mexico requested the use of spinosad to

control an emergency situation with the

beet armyworm in peanuts. The state of

California requested the use of spinosad

on sugar beets to control armyworms,

and the state of Arkansas requested the

use of spinosad to control armyworms

in pastureland and rangeland. EPA has

authorized under FIFRA section 18 the

use of spinosad on alfalfa in Texas, New

Mexico, Kansas, and Oklahoma to

control the beet armyworm; on peanuts

in Texas and in New Mexico to control

the beet armyworm; on sugar beets in

California to control armyworms; and

on pastureland and rangeland in

Arkansas for control of armyworms.

After having reviewed the submissions,

EPA concurs that emergency conditions

exist for these states.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

spinosad in or on alfalfa, peanuts, sugar

beets and pastureland and rangeland. In

doing so, EPA considered the safety

standard in FFDCA section 408(b)(2),

and EPA decided that the necessary

tolerances under FFDCA section

408(l)(6) would be consistent with the

safety standard and with FIFRA section

18. Consistent with the need to move

quickly on the emergency exemptions in

order to address urgent non-routine

situations and to ensure that the

resulting food is safe and lawful, EPA is

issuing these tolerances without notice

and opportunity for public comment as

provided in section 408(l)(6). Although

these tolerances will expire and are

revoked on December 31, 2002, under

FFDCA section 408(l)(5), residues of the

pesticide not in excess of the amounts

specified in the tolerances remaining in

or on alfalfa forage, alfalfa hay, sugar

beets, sugar beet tops, sugar beet

molasses, grass forage, grass hay,

peanuts, peanut hay and the modified

livestock commodity tolerances after

that date will not be unlawful, provided

the pesticide is applied in a manner that

was lawful under FIFRA, and the

residues do not exceed a level that was

authorized by these tolerances at the

time of that application. EPA will take

action to revoke these tolerances earlier

if any experience with, scientific data

on, or other relevant information on this

pesticide indicate that the residues are

not safe.

Because these tolerances are being

approved under emergency conditions,

EPA has not made any decisions about

whether spinosad meets EPA’s

registration requirements for use on

many or whether permanent tolerances

for these uses would be appropriate.

Under these circumstances, EPA does

not believe that these tolerances serve as

a basis for registration of spinosad by a

State for special local needs under

FIFRA section 24(c). Nor do these

tolerances serve as the basis for any

States other than Texas, New Mexico,

Kansas and Oklahoma for alfalfa; Texas

and New Mexico for peanuts; California

for sugarbeets; or Arkansas for

pastureland and rangeland to use this

pesticide on these crops under section

18 of FIFRA without following all

provisions of EPA’s regulations

implementing section 18 as identified in

40 CFR part 166. For additional

information regarding the emergency

exemption for spinosad, contact the

Agency’s Registration Division at the

address provided under FOR FURTHER

INFORMATION CONTACT.

IV. Aggregate Risk Assessment and

Determination of Safety

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7).

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

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

time-limited tolerances for residues of

spinosad in or on alfalfa, forage at 4.0

ppm; alfalfa, hay at 4.0 ppm; beet, sugar

at 0.020 ppm; beet, sugar, tops at 10.0

ppm; beet, sugar, molasses at 0.250

ppm; grass, forage at 7.0 ppm; grass, hay

at 7.0 ppm; peanut at 0.020 ppm; and

peanut, hay at 10.0 ppm, as well as the

modified tolerances for livestock

commodities as follows: meat of cattle,

horses, goats, hogs, and sheep from 0.15

to 0.60 ppm; fat of cattle, horses, goats,

hogs, and sheep from 3.5 to 15.0 ppm;

meat byproducts of cattle, horses, goats,

hogs, and sheep from 1.0 ppm to 3.50

ppm; milk, whole from 0.5 to 2.0 ppm;

milk, fat from 5.0 ppm to 20.0 ppm; eggs

from 0.02 to 0.03 ppm; and poultry, fat

from 0.2 ppm to 0.30 ppm. EPA’s

assessment of the dietary exposures and

risks associated with establishing the

tolerances follows.

A. Toxicological Endpoints

The dose at which no adverse effects

are observed (the NOAEL) from the

toxicology study identified as

appropriate for use in risk assessment is

used to estimate the toxicological

endpoint. However, the lowest dose at

which adverse effects of concern are

identified (the LOAEL) is sometimes

used for risk assessment if no NOAEL

was achieved in the toxicology study

selected. An uncertainty factor (UF) is

applied to reflect uncertainties inherent

in the extrapolation from laboratory

animal data to humans and in the

variations in sensitivity among members

of the human population as well as

other unknowns. An UF of 100 is

routinely used, 10X to account for

interspecies differences and 10X for

intra species differences.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

1594 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor.

For non-dietary risk assessments

(other than cancer) the UF is used to

determine the level of concern (LOC).

For example, when 100 is the

appropriate UF (10X to account for

interspecies differences and 10X for

intraspecies differences) the LOC is 100.

To estimate risk, a ratio of the NOAEL

to exposures (margin of exposure (MOE)

= NOAEL/exposure) is calculated and

compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

(e.g., risk is expressed as 1 x 10-6 or one

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non-linear approach,

a ‘‘point of departure’’ is identified

below which carcinogenic effects are

not expected. The point of departure is

typically a NOAEL based on an

endpoint related to cancer effects

though it may be a different value

derived from the dose response curve.

To estimate risk, a ratio of the point of

departure to exposure (MOEcancer = point

of departure/exposures) is calculated. A

summary of the toxicological endpoints

for spinosad used for human risk

assessment is shown in the following

Table 1:

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR SPINOSAD FOR USE IN HUMAN RISK ASSESSMENT

Exposure Scenario Dose Used in Risk

Assessment, UF

FQPA SF* and Level of

Concern for Risk

Assessment

Study and Toxicological Effects

Acute Dietary females 13–50 years of

age

N/A N/A No appropriate endpoint available; risk assessment not required

Acute Dietary general population including infants and childrenN/A N/A No appropriate endpoint available; risk assessment not required

Chronic Dietary all populations NOAEL = 2.68 mg/kg/

day UF = 100 Chronic

RfD = 0.027 mg/kg/day

FQPA SF = 1x cPAD =

chronic RfD FQPA SF =

0.027 mg/kg/day

Chronic Toxicity - Dog LOAEL = 8.22 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

Short-Term Dermal (1 to 7 days)

(Residential)

N/A N/A No appropriate endpoint available. No dermal absorption expected based on lack of toxicity at

1000 mg/kg/day in a 21–day dermal toxicity

study in rats as well as molecular structure and

size.

Intermediate-Term Dermal (1 week to

several months) (Residential)

N/A N/A No appropriate endpoint available. No dermal absorption expected based on lack of toxicity at

1000 mg/kg/day in a 21–day dermal toxicity

study in rats as well as molecular structure and

size.

Long-Term Dermal (several months

to lifetime) (Residential)

N/A N/A No appropriate endpoint available; use pattern

does not indicate a need for this risk assessment

Short-Term Inhalation (1 to 7 days)

(Residential)

N/A N/A The low toxicity, use pattern and application rate

does not indicate a need for risk assessment

via this route.

Intermediate-Term Inhalation (1 week

to several months) (Residential)

N/A N/A The low toxicity, use pattern and application rate

does not indicate a need for risk assessment

via this route.

Long-Term Inhalation (several months

to lifetime) (Residential)

N/A N/A The low toxicity, use pattern and application rate

does not indicate a need for risk assessment

via this route.

Cancer (oral, dermal, inhalation) N/A N/A No cancer endpoints were identified, and thus a

cancer risk assessment is not required.

*

The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

B. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.495) for the

residues of spinosad, in or on a variety

of raw agricultural commodities.

Tolerances range from 0.02 ppm (many

commodities; limit of quantitation) to 20

ppm (aspirated grain fractions). Risk

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1595

assessments were conducted by EPA to

assess dietary exposures from spinosad

in food as follows:

i. Acute exposure. Acute dietary risk

assessments are performed for a fooduse 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. An acute dietary

exposure risk assessment is not required

because the Agency did not identify an

acute dietary endpoint that was

applicable to females (13+ years) or to

the general population, including

infants and children.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

Dietary Exposure Evaluation Model

(DEEM) analysis evaluated the

individual food consumption as

reported by respondents in the USDA

1989–1992 nationwide Continuing

Surveys of Food Intake by Individuals

(CSFII) and accumulated exposure to

the chemical for each commodity.

Tolerance level residues were used for

all commodities with the exception of

the following: anticipated residues were

used for the livestock feed commodities

from alfalfa, peanuts, pastures and

rangeland, and sugar beets. This Tier 2

DEEM analysis shows that dietary (food

only) exposure estimates are below the

Agency’s level of concern for all

population subgroups. The highest

chronic dietary exposure was for

children 1-6 years old at 0.015291 mg/

kg/day, representing 57% of the chronic

PAD (cPAD). Exposure for the U.S.

population was 0.007679 mg/kg/day,

representing 28% of the cPAD.

iii. Cancer. No cancer endpoints were

identified, and thus a cancer risk

assessment is not required.

iv. Anticipated residue and percent

crop treated information. Section

408(b)(2)(E) authorizes EPA to use

available data and information on the

anticipated residue levels of pesticide

residues in food and the actual levels of

pesticide chemicals that have been

measured in food. If EPA relies on such

information, EPA must require that data

be provided 5 years after the tolerance

is established, modified, or left in effect,

demonstrating that the levels in food are

not above the levels anticipated.

Following the initial data submission,

EPA is authorized to require similar

data on a time frame it deems

appropriate. As required by section

408(b)(2)(E), EPA will issue a data callin for information relating to anticipated

residues to be submitted no later than 5

years from the date of issuance of this

tolerance.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

spinosad in drinking water. Because the

Agency does not have comprehensive

monitoring data, drinking water

concentration estimates are made by

reliance on simulation or modeling

taking into account data on the physical

characteristics of spinosad.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and SCIGROW, which predicts pesticide

concentrations in groundwater. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening-level

assessment for surface water. The

GENEEC model is a subset of the PRZM/

EXAMS model that uses a specific highend runoff scenario for pesticides.

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a %RfD or %PAD.

Instead, drinking water levels of

comparison (DWLOCs) are calculated

and used as a point of comparison

against the model estimates of a

pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to spinosad

they are further discussed in the

aggregate risk sections below.

Based on the PRZM/EXAMS and SCIGROW models the estimated

environmental concentrations (EECs) of

spinosad for chronic exposures are

estimated to be 0.057 parts per billion

(ppb) for surface water and 0.006 ppb

for ground water.

3. From non-dietary exposure. The

term ‘‘residential exposure’’ is used in

this document to refer to nonoccupational, non-dietary exposure

(e.g., for lawn and garden pest control,

indoor pest control, termiticides, and

flea and tick control on pets).

No acute dietary, cancer, short-term,

intermediate-term, or chronic dermal or

inhalation endpoints were identified by

the Agency. Spinosad is currently

registered on turf grass, creating a

potential for non-dietary oral exposure

to children who ingest grass. To

calculate a quantitative dietary risk from

a potential ingestion of grass (in the

absence of acute-, short-, or

intermediate-term oral endpoints), the

Agency would need to default to the

chronic dietary endpoint. This scenario

would represent a child eating grass for

> 6 months continuously. Based on the

low application rate for spinosad on turf

(0.41 lbs.ai./A.), its non-systemic nature,

its short half-life (especially in

sunlight), and the rapid incorporation of

spinosad metabolites into the general

carbon pool, the Agency believes that

residues of spinosad on turf grass after

application would be low and decrease

rapidly over time. The Agency believes

that it is inappropriate to perform a

quantitative dietary risk representing a

chronic scenario from children eating

spinosad residues on turf grass.

Qualitatively, the risk from children

eating spinosad residues on turf grass

does not exceed the Agency’s level of

concern.

4. Cumulative exposure to substances

with a 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.’’

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 this

tolerance action, therefore, EPA has not

assumed that spinosad has a common

mechanism of toxicity with other

substances. For information regarding

1596 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

EPA’s efforts to determine which

chemicals have a common mechanism

of toxicity and to evaluate the

cumulative effects of such chemicals,

see the final rule for Bifenthrin Pesticide

Tolerances (62 FR 62961, November 26,

1997).

C. Safety Factor for Infants and Children

1. In general. 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 prenatal

and postnatal toxicity and the

completeness of the data base on

toxicity and exposure 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 margin

of exposure (MOE) analysis or through

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans.

2. Developmental toxicity studies.

There were no developmental effects

that could be attributed to

administration of spinosad technical to

either rats or rabbits. The NOAEL for

developmental toxicity is greater than or

equal to 200 mg/kg/day (highest dose

tested) for rats and greater than or equal

to 50 mg/kg/day (highest dose tested) for

rabbits.

3. Reproductive toxicity study. The

LOAEL for reproductive toxicity is 100

mg/kg/day based on both maternal and

reproductive effects in rats 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. The NOAEL for

reproductive (offspring and dams) and

systemic (parental) toxicity is the same

and is 10 mg/kg/day.

4. Conclusion. There is a complete

toxicity data base for spinosad and

exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. The

Agency has removed the 10x Safety

Factor to account for enhanced

sensitivity of infants and children based

on (i) the completeness of the

toxicological database, (ii) no indication

of increased susceptibility of rat or

rabbit fetuses to in utero and/or

postnatal exposure, and (iii) no

requirement for a developmental

neurotoxicity study.

D. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

calculates DWLOCs which are used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water (EECs). DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

acceptable exposure (i.e., the PAD) is

available for exposure through drinking

water e.g., allowable chronic water

exposure (mg/kg/day) = cPAD - (average

food + chronic non-dietary, nonoccupational exposure). This allowable

exposure through drinking water is used

to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking water

consumption, and body weights. Default

body weights and consumption values

as used by the USEPA Office of Water

are used to calculate DWLOCs: 2L/70 kg

(adult male), 2L/60 kg (adult female),

and 1L/10 kg (child). Default body

weights and drinking water

consumption values vary on an

individual basis. This variation will be

taken into account in more refined

screening-level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: acute, short-term,

intermediate-term, chronic, and cancer.

When EECs for surface water and

groundwater are less than the calculated

DWLOCs, OPP concludes with

reasonable certainty that exposures to

spinosad in drinking water (when

considered along with other sources of

exposure for which OPP has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because OPP considers the

aggregate risk resulting from multiple

exposure pathways associated with a

pesticide’s uses, levels of comparison in

drinking water may vary as those uses

change. If new uses are added in the

future, OPP will reassess the potential

impacts of spinosad on drinking water

as a part of the aggregate risk assessment

process.

1. Acute risk. No acute toxicological

endpoint was identified by the Agency,

and therefore this risk assessment is not

required.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to spinosad from food will

utilize 28% of the cPAD for the U.S.

population, 25% of the cPAD for all

infants and 57% of the cPAD for

children 1-6 years of age. Although

spinosad is currently registered on turf

grass, creating a potential for nondietary oral exposure to children who

ingest grass, the Agency believes that it

is inappropriate to perform a

quantitative dietary risk representing a

chronic scenario from children eating

spinosad residues on turf grass.

Qualitatively, the risk from children

eating spinosad residues on turf grass

does not exceed the Agency’s level of

concern. In addition, despite the

potential for chronic dietary exposure to

spinosad in drinking water, after

calculating DWLOCs and comparing

them to conservative model estimated

environmental concentrations of

spinosad in surface and ground water,

EPA does not expect the aggregate

exposure to exceed 100% of the cPAD,

as shown in the following Table 2:

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO SPINOSAD

Population Subgroup cPAD mg/

kg/day

%cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. Population 0.027 28 0.057 0.006 680

All Infants 0.027 25 0.057 0.006 200

Children 1-6 years of age 0.027 57 0.057 0.006 120

Children 7-12 years of age 0.027 40 0.057 0.006 160

Females 13-50 years of age 0.027 24 0.057 0.006 610

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1597

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO SPINOSAD—Continued

Population Subgroup cPAD mg/

kg/day

%cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

Males 13-19 years of age 0.027 26 0.057 0.006 700

Males 20+ years of age 0.027 23 0.057 0.006 730

Seniors 55+ years of age 0.027 24 0.057 0.006 720

3. Short-term risk. Short-term

aggregate exposure takes into account

residential exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Though residential exposure could

occur with the use of spinosad, no

toxicological effects have been

identified for short-term toxicity.

Therefore, the aggregate risk is the sum

of the risk from food and water, which

were previously addressed.

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account non-dietary, nonoccupational exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Though residential exposure could

occur with the use of spinosad, no

toxicological effects have been

identified for intermediate-term toxicity.

Therefore, the aggregate risk is the sum

of the risk from food and water, which

were previously addressed.

5. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, and to infants and children

from aggregate exposure to spinosad

residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate high performance liquid

chromatography using ultra violet

detection and immunoassay methods

exist to enforce tolerances for residues

of spinosad in/on plant and animal

matrices. The method may be requested

from: Calvin Furlow, PRRIB, IRSD

(7502C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW, Washington,

DC 20460; telephone number: (703)

305–5229; e-mail address:

furlow.calvin@epa.gov.

B. International Residue Limits

There are no Codex, Canadian, or

Mexican maximum residue levels

(MRLs) established for spinosad. There

are no international residue limits that

affect this Section 18 exemption.

VI. Conclusion

Therefore, the tolerance is established

for residues of spinosad in or on alfalfa,

forage at 4.0 ppm; alfalfa, hay at 4.0

ppm; beet, sugar at 0.020 ppm; beet,

sugar, tops at 10.0 ppm; beet, sugar,

molasses at 0.250 ppm; grass, forage at

7.0 ppm; grass, hay at 7.0 ppm; peanut

at 0.020 ppm; and peanut, hay at 10.0

ppm. Furthermore, tolerances for

livestock commodities are being

modified, on a time-limited basis, as

follows: meat of cattle, horses, goats,

hogs, and sheep from 0.15 to 0.60 ppm;

fat of cattle, horses, goats, hogs, and

sheep from 3.5 to 15.0 ppm; meat

byproducts of cattle, horses, goats, hogs,

and sheep from 1.0 ppm to 3.50 ppm;

milk, whole from 0.5 to 2.0 ppm; milk,

fat from 5.0 ppm to 20.0 ppm; eggs from

0.02 to 0.03 ppm; and poultry, fat from

0.2 ppm to 0.30 ppm.

VII. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–301097 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before March 12, 2001.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(s) on which a hearing

is requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the objector (40

CFR 178.27). 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.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. The Office of

the Hearing Clerk is open from 8 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The telephone

number for the Office of the Hearing

Clerk is (202) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

1598 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit VII.A., you should also send a copy

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by the docket control

number OPP–301097 to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. In

person or by courier, bring a copy to the

location of the PIRIB described in Unit

I.B.2. You may also send an electronic

copy of your request via e-mail to: oppdocket@epa.gov. Please use an ASCII

file format and avoid the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 6.1/8.0 or

ASCII file format. Do not include any

CBI in your electronic copy. You may

also submit an electronic copy of your

request at many Federal Depository

Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

VIII. Regulatory Assessment

Requirements

This final rule establishes time

limited tolerances under FFDCA section

408. 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) (Public

Law 104–4). Nor does it require any

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); 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 or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

12(d) (15 U.S.C. 272 note). Since

tolerances and exemptions that are

established on the basis of a FIFRA

section 18 exemption under FFDCA

section 408, 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. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on States, on the relationship between

the national government and the States,

or on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

IX. 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 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 this final

rule in the Federal Register. This final

rule is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1599

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: December 21, 2000.

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. 321(q), 346(a) and

371.

2. Section 180.495 is amended by

alphabetically adding commodities to

the table in paragraph (b) to read as

follows:

§ 180.495 Spinosad; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per

million

Expiration/

revocation

date

Alfalfa, forage 4.0 12/31/02

Alfalfa, hay .... 4.0 12/31/02

*****

Beet, sugar ... 0.020 12/31/02

Beet, sugar,

tops ........... 10.0 12/31/02

Beet, sugar,

molasses ... 0.250 12/31/02

Cattle, fat ...... 15.0 12/31/02

Cattle, mbyp 3.50 12/31/02

Cattle, meat .. 0.60 12/31/02

*****

Eggs .............. 0.030 12/31/02

Goats, fat ...... 15.0 12/31/02

Goats, mbyp 3.50 12/31/02

Goats, meat .. 0.60 12/31/02

Grass, forage 7.0 12/31/02

Grass, hay .... 7.0 12/31/02

Hogs, fat ....... 15.0 12/31/02

Hogs, mbyp .. 3.50 12/31/02

Hogs, meat ... 0.60 12/31/02

Horses, fat .... 15.0 12/31/02

Horses, mbyp 3.50 12/31/02

Horses, meat 0.60 12/31/02

Milk, fat ......... 20.0 12/31/02

Milk, whole .... 2.0 12/31/02

Peanut .......... 0.020 12/31/02

Peanut, hay .. 10.0 12/31/02

Poultry, fat .... 0.30 12/31/02

Sheep, fat ..... 15.0 12/31/02

Sheep, mbyp 3.50 12/31/02

Sheep, meat 0.60 12/31/02

* * * * *

[FR Doc. 01–119 Filed 1–8–01; 8:45am]

BILLING CODE 6560–50–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 413 and 489

[HCFA–1005–F3]

RIN 0938–AI56

Medicare Program; Prospective

Payment System for Hospital

Outpatient Services; Correction

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Correcting amendments.

SUMMARY: In the April 7, 2000 issue of

the Federal Register (65 FR 18434), we

published a final rule with a comment

period that implemented a prospective

payment system for hospital outpatient

services furnished to Medicare

beneficiaries. In addition, the final rule

established requirements and standards

for facilities or organizations seeking

provider-based status. This document

corrects technical errors in the preamble

and regulations text made in that part of

the final rule related to provider-based

requirements. (A document published

in the Federal Register on October 3,

2000 (65 FR 58919) delayed the effective

date of the provider-based regulations

from October 10, 2000 to January 10,

2001 and made a conforming change in

the regulations text.)

EFFECTIVE DATE: January 10, 2001.

FOR FURTHER INFORMATION CONTACT:

Linda McKenna, (410) 786–4537.

SUPPLEMENTARY INFORMATION: In FR Doc.

00–8215 of April 7, 2000 (65 FR 18434),

there were several typographical errors.

The provisions in this document are

effective as if they had been included in

the document published in the Federal

Register on April 7, 2000.

Correction of Errors

In FR Doc. 00–8215 on April 7, 2000

(65 FR 18434), make the following

corrections:

Corrections to the Preamble

On page 18434, column 1, in the

DATES section, ‘‘§ 412.24(d)(6)’’ is

corrected to read ‘‘§ 413.24(d)(6)’’,

‘‘§ 489.24(h)’’ is corrected to read

‘‘§ 489.24’’.

Corrections to the Regulations Text

List of Subjects

42 CFR Part 413

Health facilities, Kidney diseases,

Medicare, Puerto Rico, Reporting and

recordkeeping requirements.

42 CFR Part 489

Health facilities, Medicare, Reporting

and recordkeeping requirements.

Accordingly, 42 CFR parts 413 and

489 are corrected by making the

following correcting amendments:

PART 413—PRINCIPLES OF

REASONABLE COST

REIMBURSEMENT; PAYMENT FOR

END-STAGE RENAL DISEASE

SERVICES; PROSPECTIVELY

DETERMINED PAYMENT RATES FOR

SKILLED NURSING FACILITIES

1. The authority citation for part 413

continues to read as follows:

Authority: Secs. 1102, 1812(d), 1814(b),

1815, 1833(a), (i), and (n), 1871, 1881, 1883,

and 1886 of the Social Security Act (42

U.S.C. 1302, 1395f(b), 1395g, 13951,

13951(a), (i), and (n), 1395x(v), 1395hh,

1395rr, 1395tt, and 1395ww).

§ 413.65 [Corrected]

2. In § 413.65, the following

corrections are made:

A. In paragraph (d)(7)(iii), the

reference to paragraph ‘‘(d)(7)’’ is

corrected to read ‘‘(d)(7)(i)’’.

B. In paragraph (f)(3), the reference to

paragraph ‘‘(b)(3)(ii)’’ is corrected to

read ‘‘(d)(3)(ii)’’.

C. In paragraph (j)(3), the reference to

paragraph ‘‘(h)’’ is corrected to read

‘‘(i)’’.

D. In paragraph (j)(4), the reference to

paragraph ‘‘(i)(5)’’ is corrected to read

‘‘(j)(5)’’.

E. In paragraph (j)(5), in the second

sentence, the reference to paragraph

‘‘(i)(5)’’ is corrected to read ‘‘(j)(5)’’.

PART 489—PROVIDER AGREEMENTS

AND SUPPLIER APPROVAL

1. The authority citation for part 489

continues to read as follows:

Authority: Secs. 1102 and 1871 of the

Social Security Act (42 U.S.C. 1302 and

1395hh).

§ 489.24 [Corrected]

2. In § 489.24, in paragraph (i), the

reference to ‘‘§ 416.35’’ is corrected to

read ‘‘§ 413.65’’.

Authority: Section 1833(t) of the Social

Security Act (42 U.S.C. 1395l(t)).

(Catalog of Federal Domestic Assistance

Program No. 93.774; Medicare—

Supplementary Medical Insurance Program)

Dated: December 18, 2000.

Brian P. Burns,

Deputy Assistant Secretary for Information

Resources Management.

[FR Doc. 01–654 Filed 1–8–01; 8:45 am]

BILLING CODE 4120–01–M