Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations 44565

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408 (l)(6), such as the

tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

acations published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has 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 this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: August 15, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.412, by adding text to

paragraph (b) to read as follows:

§ 180.412 Sethoxydim: tolerance for

residues.

* * * * *

(b) Section 18 emergency exemptions.

A time-limited tolerance is established

for combined residues of the herbicide

sethoxydim and its metabolites

containing the 2-cyclohexen-1-one

moiety, calculated as the herbicide in

connection with use of the pesticide

under section 18 emergency exemptions

granted by EPA. This tolerance will

expire and is revoked on the date

specified in the following table:

Commodity Parts per million Expiration/revocation date

Horseradish ......................................................................................... 4 September 30, 1998

* * * * *

[FR Doc. 97–22377 Filed 8–21–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300529; FRL–5737–7]

RIN 2070–AB78

Chlorfenapyr; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for chlorfenapyr

in or on cottonseed; cotton gin

byproducts; milk; milk fat; meat of

cattle, goats, hogs, horses, and sheep; fat

of cattle, goats, hogs, horses, and sheep;

and meat byproducts of cattle, goats,

hogs, horses and sheep. This action is in

response to EPA’s granting of emergency

exemptions under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticide on cotton. This regulation

establishes maximum permissible level

for residues of chlorfenapyr in/on these

food commodities pursuant to section

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

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996. These

tolerances will expire and are revoked

on July 31, 1999.

DATES: This regulation is effective

August 22, 1997. Objections and

requests for hearings must be received

by EPA on or before October 21, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300529],

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–

300529], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services 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 Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300529]. No Confidential Business
44566 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations

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: Daniel Rosenblatt, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308-9375, e-mail:

rosenblatt.dan@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e) and (l)(6), is establishing

tolerances for the insecticide

chlorfenapyr in or on cottonseed at 0.5

parts per million (ppm); cotton gin

byproducts at 2.0 ppm; milk at 0.01

ppm; milk fat at 0.15 ppm; meat of

cattle, goats, hogs, horses, and sheep at

0.01 ppm; fat of cattle, goats, hogs,

horses, and sheep at 0.10 ppm; and meat

byproducts of cattle, goats, hogs, horses,

and sheep at 0.3 ppm. These tolerances

will expire and are revoked on July 31,

1999. EPA will publish a document in

the Federal Register to remove the

revoked tolerances from the Code of

Federal Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (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.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL–5572–9).

New section 408(b)(2)(A)(i) of the

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

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

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

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 FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for

Chlorfenapyr on Cotton and FFDCA

Tolerances

Beet armyworm has infested cotton

fields to a high degree in recent growing

seasons. EPA received submissions from

Texas, Mississippi, Alabama, Arkansas,

Florida, Georgia, Louisiana, South

Carolina, and California for a section 18

exemption for the use of the

unregistered pesticide chlorfenapyr to

address the problem. The resistant

tobacco budworm is also negatively

affecting yields in these states. EPA has

reviewed the submissions and has

concluded that these pest situations

represent urgent and non-routine

problems. Therefore, EPA has

authorized under FIFRA section 18 the

use of the new pesticide chlorfenapyr

on cotton for control of beet armyworm

and resistant tobacco budworm in the

listed states.

As part of its assessment of these

emergency exemptions, EPA assessed

the potential risks presented by residues

of chlorfenapyr in or on cottonseed;

cotton gin byproducts; milk; milk fat;

meat of cattle, goats, hogs, horses, and

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

and sheep; and meat byproducts of

cattle, goats, hogs, horses, and sheep. In

doing so, EPA considered the new 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

new safety standard and with FIFRA

section 18. Consistent with the need to

move quickly on the emergency

exemption in order to address an urgent

non-routine situation and to ensure that

the resulting food is safe and lawful,

EPA is issuing these tolerances without

notice and opportunity for public

comment under section 408(e), as

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

these tolerances will expire and are

revoked on July 31, 1999, under FFDCA

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

pesticide not in excess of the amounts

specified in the tolerance remaining in

or on cottonseed; cotton gin byproducts;

milk; milk fat; meat of cattle, goats,

hogs, horses, and sheep; fat of cattle,

goats, hogs, horses, and sheep; and meat

byproducts of cattle, goats, hogs, horses,

and sheep after that date will not be

unlawful, provided the pesticide is

applied in a manner that was lawful

under FIFRA. 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 chlorfenapyr meets EPA’s

registration requirements for use on

cotton 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 chlorfenapyr

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 previously listed to

use this pesticide on this crop under

section 18 of FIFRA without following

all provisions of section 18 as identified

in 40 CFR part 166. For additional

information regarding the emergency

exemption for chlorfenapyr, contact the

Agency’s Registration Division at the

address provided above.
Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations 44567

III. 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

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

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

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

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

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term’’, and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure only are applicable

since there are no residential uses of

chlorfenapyr. For cases in which highend exposure can reasonably be

expected from multiple sources (e.g.

frequent and widespread homeowner

use in a specific geographical area),

multiple high-end risks will be

aggregated and presented as part of the

comprehensive risk assessment/

characterization. Since the toxicological

endpoint considered in this assessment

reflects exposure over a period of at

least 7 days, an additional degree of

conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide
44568 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(infants less than a year old) was not

regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action,

EPA has sufficient data to assess the

hazards of chlorfenapyr and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

chlorfenapyr in or on cottonseed at 0.5

ppm; cotton gin byproducts at 2.0 ppm;

milk at 0.01 ppm; milk fat at 0.15 ppm;

meat of cattle, goats, hogs, horses, and

sheep at 0.01 ppm; fat of cattle, goats,

hogs, horses, and sheep at 0.10 ppm;

and meat byproducts of cattle, goats,

hogs, horses, and sheep at 0.3 ppm.

EPA’s assessment of the dietary

exposures and risks associated with

establishing these tolerances follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by chlorfenapyr are

discussed below.

1. Acute toxicity. For acute dietary

risk assessment, EPA recommends use

of a NOEL for chlorfenapyr of 45 mg/kg/

day from the rat acute neurotoxicity

study. The Lowest Exposure Level (LEL)

of 90 mg/kg/day was based on lethargy

of the rats on the day of treatment. An

MOE of 1,000 is required for all

subgroups. An additional modifying

factor of 10 was applied because the

neurotoxicity study was classified as

supplemental.

2. Short - and intermediate - term

toxicity. For short- and intermediateterm MOE calculations, EPA

recommends the use of a NOEL of 100

mg/kg/day from the 28-day dermal

toxicity study in rabbits. The LEL of 400

mg/kg/day was based on increased

serum cholesterol, increased relative

liver weights, and unspecified

histological lesions. EPA concludes that

an MOE of 1,000 is required.

3. Chronic toxicity. EPA has

established the RfD for chlorfenapyr at

0.003 milligrams/kilogram/day (mg/kg/

day). This RfD is based on an 80-week

feeding study in mice with a NOEL of

2.8 mg/kg/day and an LEL of 16.0 mg/

kg/day based on brain lesions (both

sexes) and scabbing of skin (males) An

uncertainty factor of 1,000 was used

with an additional modifying factor of

10 due to uncertainties regarding

neurological risks in infants and

children.

4. Carcinogenicity. EPA has classified

chlorfenapyr as a Group D (not

classifiable as to human carcinogenicity)

chemical.

B. Exposures and Risks

1. From food and feed uses.

Chlorfenapyr is an unregistered

pesticide. The manufacturer has

submitted registration applications for

approval for chlorfenapyr products,

however, none have been approved to

date. This is the first tolerance-related

action associated with this chemical.

Risk assessments were conducted by

EPA to assess dietary exposures and

risks from chlorfenapyr as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a one day or single exposure. The acute

dietary exposure endpoint of concern

for chlorfenapyr is lethargy the day of

dosing, which would affect all

population subgroups. The acute

analysis assumed tolerance level

residues for all commodities. For all the

population subgroups, the calculated

MOE values are greater than 1,125.

These MOEs do not represent a level of

concern to EPA. Further, it should be

noted that if the analysis were to

incorporate anticipated residue levels

and percent crop-treated, the MOEs

would be even larger.

ii. Chronic exposure and risk. For the

purposes of chronic dietary risk

analysis, EPA assumed tolerance level

residues and 100% crop treated for all

commodities. The Theoretical Residue

Contributions (TMRC) attributable to the

use of this pesticide in accordance with

the section 18 authorizations referenced

in this notice are equivalent to RfD

contributions that range from 23% for

the U.S. population (48 states) to 76%

for non-nursing infants less than a year

old.

2. From drinking water. In examining

aggregate exposure, FQPA directs EPA

to consider available information

concerning exposures from the pesticide

residues in food and all other nonoccupational exposures. The primary

non-food sources of exposure the

Agency looks at include drinking water

(whether from ground or surface water),

and exposure through pesticide use in

gardens, lawns, or buildings (residential

and other indoor uses). Based on data

available to EPA, chlorfenapyr is

considered immobile and has a

relatively high affinity for soil. The

mobility characteristics exhibited by

this compound are not those generally

associated with compounds found in

groundwater. However, the chemical

behavior of chlorfenapyr does present

surface water concerns. Special models

were used by EPA to calculate Tier II

Estimated Environmental

Concentrations (EECs) to estimate the

exposure of chlorfenapyr from surface

water. The values represent an upper

bound estimate of the concentration in

an edge-of-the-field pond with no outlet.

The recommended values for drinking

water exposure for use in human health

risk assessment for surface water are 11

micrograms/L for acute drinking water

exposure and 9 micrograms/L for

chronic drinking water exposure .

i. Acute exposure and risk. EPA

developed acute exposure levels for

adults and children. For children, the

acute exposure from drinking water is

calculated to be 0.0011 mg/kg/day (11

micrograms/L x 10-3 mg/ug x L/day

divided by 10 kg). For adults, the acute

exposure is calculated to be 0.0003 mg/

kg/day.

ii. Chronic exposure and risk. The

chronic exposure form drinking water to

children is calculated to be 30% of the

RfD (9 micrograms/L x 10-3 mg/ug x 1

L/day divided by 10 kg divided by 0.003

mg/kg/day x 100 = 30%). The exposure

for the general U.S. population would

be 10% of the RfD.

iii. Short- and intermediate-term

exposure and risk. Short- and

intermediate-term aggregate exposure

takes into account chronic dietary food

and water (considered to be a

background exposure level) plus indoor

and outdoor residential exposure.

However, since there is no potential

residential indoor/outdoor non-dietary

non-occupational exposure scenarios for
Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations 44569

chlorfenapyr, an aggregate short- and

intermediate-term risk assessment is not

necessary.

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.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

chlorfenapyr 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,

chlorfenapyr 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 chlorfenapyr has a

common mechanism of toxicity with

other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. In order to assess

aggregate risks, EPA combines the acute

MOE calculations for food and water.

EPA’s processes for determining acute

dietary (food only) and surface water

exposures are described elsewhere in

this notice. The most highly exposed

subgroup for chlorfenapyr is infants less

than a year old, with a combined dietary

and drinking water exposure at 0.0153

mg/kg/day. Using the NOEL of 45 mg/

kg/day, produces an aggregate acute risk

assessment MOE of 2,900. Therefore, in

EPA’s judgement, aggregate acute risk to

chlorfenapyr does not exceed levels of

concern.

2. Chronic risk. Using the TMRC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to chlorfenapyr from food and

water will utilize 33% of the RfD for the

U.S. population. The major identifiable

subgroup with the highest aggregate

exposure is infants and children. See

below for a discussion of the analysis of

the risks for that subgroup. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure. However, since there is no

potential residential indoor/outdoor

non-dietary non-occupational exposure

scenarios for chlorfenapyr, an aggregate

short- and intermediate-term risk

assessment is not necessary.

D. Aggregate Cancer Risk for U.S.

Population

Chlorfenapyr has been classified as a

Group D chemical signifying that it is

‘‘not classifiable as to human

carcinogenicity.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

chlorfenapyr, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a two-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard 100-fold

safety factor (usually 100 for combined

inter- and intra-species variability)) and

not the additional tenfold factor when

EPA has a complete data base under

existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard safety factor.

ii. Developmental toxicity studies. In

the rat developmental toxicity study, the

maternal (systemic) NOEL was 25 mg/

kg/day. The LEL of 75 mg/kg/day was

based on decreased body weight gain,

decreased relative feed intake, and

decreased water consumption. The

developmental (pup) NOEL was greater

than 225 mg/kg/day (HDT). In the rabbit

developmental toxicity study, the

maternal (systemic) NOEL was 5 mg/kg/

day. The LEL of 15 mg/kg/day was

based on decreased body weight gain.

The reproductive developmental NOEL

was greater than 30 mg/kg/day (HDT).

iii. Reproductive toxicity study. From

the multigeneration reproductive

toxicity study in the rat, the maternal

(systemic) NOEL was 5 mg/kg/day. The

LEL of 22 mg/kg/day was based on

decreased body weight gain (premating). The reproductive

developmental NOEL was 5 mg/kg/day.
44570 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations

The LEL of 22 mg/kg/day was based on

decreased weight gain during lactation.

iv. Pre- and post-natal sensitivity. The

pre- and post-natal toxicity data base for

chlorfenapyr is complete. EPA notes

that the developmental toxicity NOELs

of greater than 225 mg/kg/day (HDT in

rats) and greater than 30 mg/kg/day

(HDT in rabbits) demonstrate that there

is no developmental (prenatal) toxicity

present at levels which produce

maternal effects. Additionally, these

developmental NOELs are 75- and 10-

fold higher in the rats and rabbits,

respectively, than the NOEL of 1.8 mg/

kg/day from the 1-year feeding study in

dogs (the basis of the RfD).

In the reproductive toxicity study in

the rat, the reproductive developmental

NOEL (5 mg/kg/day) is equal to the

parental NOEL (5 mg/kg/day). Both the

pup LEL and the parental LEL of 22 mg/

kg/day were based on decreased body

weight. This finding suggests that there

is no special post-natal sensitivity

present in the reproductive study and

that young rats have the same sensitivity

to chlorfenapyr as adult animals.

v. Conclusion. The developmental

and reproductive toxicity studies

indicate that infants and children have

no special sensitivity to chlorfenapyr

relative to other population subgroups.

An additional safety factor for infants

and children is not necessary for the use

authorized in association with this

tolerance.

2. Acute risk. To determine acute

dietary and drinking water risks to

children, an MOE approach is used

where the total acute exposure from the

diet and drinking water is compared to

the acute dietary endpoint of concern,

the NOEL of 45 mg/kg/day. Infants less

than a year old are the most highly

exposed subgroup and have a combined

dietary and drinking water exposure at

0.0153 mg/kg/day which yields an MOE

of 2,900. Therefore, in EPA’s judgement,

the aggregate acute risks to children and

infants to chlorfenapyr does not exceed

levels of concern.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to chlorfenapyr

from food will utilize 45% of the RfD for

nursing infants, 106% for non-nursing

infants, 91% for children 1-6 years old,

and 69% for children 7-12 years old.

These figures are quite conservative

since TMRC’s and 100% crop treated

assumptions were used in the

assessment. If anticipated residue and

refined percent crop-treated data were

used, the calculated risk would be much

lower. In addition, the RfD of 0.003 mg/

kg/day was established using an

uncertainty factor (UF) of 1,000. The UF

contains an additional modifying factor

of 10 due to uncertainties regarding

neurological risks in infants and

children. It is EPA’s best scientific

judgment that the aggregate chronic

risks posed by chlorfenapyr do not

exceed our level of concern.

4. Short- or intermediate-term risk.

Since there is no potential residential

indoor/outdoor non-dietary nonoccupational exposure scenarios for

chlorfenapyr, an aggregate short- and

intermediate-term risk assessment is not

necessary.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue of

chlorfenapyr in plants and ruminants is

adequately understood. The residue of

concern is the parent compound. For

chlorfenapyr dietary risk assessments on

ruminant commodities (excluding meat

byproducts), residues of parent only

will be used. However, chlorfenapyr

dietary risk assessments on ruminant

meat byproducts should include the two

metabolites CL 303,268, and CL 325,195

as well as the parent (CL 303,630). The

ruminant meat byproduct risk

assessment will use a factor (i.e. ratio

parent plus metabolites/parent)

multiplied by the parent-based tolerance

determined from the residue levels of

the three moieties in the ruminant

metabolism studies.

B. Analytical Enforcement Methodology

Adequate enforcement methodology

is available to enforce the tolerance

expression. American Cyanamid has

prepared a method for cottonseed, meat,

and milk.

C. Magnitude of Residues

Residues of chlorfenapyr are not

expected to exceed 0.5 ppm in/on

cottonseed as a result of this use. No

concentration of parent residues

(average level of 0.30 ppm in ginned

cottonseed) occurred in crude/refined

cottonseed oil or hulls. Therefore,

separate tolerances for cottonseed

processed commodities are not required.

Cotton gin byproduct field trial data

have not been submitted. In the absence

of these required data, EPA recommends

a tolerance of 2.0 ppm of chlorfenapyr

residues in/on cotton gin byproducts.

Residues of chlorfenapyr in animal

commodities are not expected to exceed:

0.01 ppm in milk; 0.15 ppm in milk fat;

0.01 ppm in meat of cattle, goats, hogs,

horses, and sheep; 0.10 ppm in fat of

cattle, goats, hogs, horses, and sheep;

and 0.3 ppm in meat byproducts of

cattle, goats, hogs, horses, and sheep.

D. International Residue Limits

No Codex, Canadian, or Mexican

Maximum Residue Limits (MRLs) exist.

Therefore, there are no compatibility

issues with respect to this action.

VI. Conclusion

Therefore, tolerances are established

for chlorfenapyr in or on cottonseed at

0.5 ppm; cotton gin byproducts at 2.0

ppm; milk at 0.01 ppm; milk fat at 0.15

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

and sheep at 0.01 ppm; fat of cattle,

goats, hogs, horses, and sheep at 0.10

ppm; and meat byproducts of cattle,

goats, hogs, horses, and sheep at 0.3

ppm.

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 new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by October 21, 1997,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of
Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations 44571

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

EPA has established a record for this

rulemaking under docket control

number [OPP–300529] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(1)(6). The

Office of Management and Budget

(OMB) has exempted these types of

actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408(1)(6), such as the

tolerances in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has 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 this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: August 12, 1997.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.513 is added to read as

follows:

§ 180.513 Chlorfenapyr; tolerances for

residues.

(a) General. [Reserved]

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for the insecticide chlorfenapyr in

connection with use of the pesticide

under section 18 emergency exemption

granted by EPA. These tolerances will

expire and are revoked on the date

specified in the following table:

Commodity Parts per million Expiration/revocation date

Cattle, fat ............................................................................................. 0.10 7/31/99

Cattle, mbyp ........................................................................................ 0.3 7/31/99

Cattle, meat ......................................................................................... 0.01 7/31/99

Cottonseed .......................................................................................... 0.5 7/31/99

Cotton gin byproducts ......................................................................... 2.0 7/31/99

Goats, fat ............................................................................................. 0.10 7/31/99

Goats, mbyp ........................................................................................ 0.3 7/31/99

Goats, meat ......................................................................................... 0.01 7/31/99
44572 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations

Commodity Parts per million Expiration/revocation date

Hogs, fat .............................................................................................. 0.10 7/31/99

Hogs, mbyp ......................................................................................... 0.3 7/31/99

Hogs, meat .......................................................................................... 0.01 7/31/99

Horses, fat ........................................................................................... 0.10 7/31/99

Horses, mbyp ...................................................................................... 0.3 7/31/99

Horses, meat ....................................................................................... 0.01 7/31/99

Milk ...................................................................................................... 0.01 7/31/99

Milk fat ................................................................................................. 0.15 7/31/99

Sheep, fat ............................................................................................ 0.10 7/31/99

Sheep, mbyp ....................................................................................... 0.3 7/31/99

Sheep, meat ........................................................................................ 0.01 7/31/99

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–22396 Filed 8-21-97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300538; FRL–5739–4]

RIN 2070–AB78

Coat Protein of Papaya Ringspot Virus

and the Genetic Material Necessary for

its Production; Exemption From the

Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Rule.

SUMMARY: This rule establishes an

exemption from the requirement of a

tolerance for residues of the biological

pesticide Coat Proteins of Papaya

Ringspot Virus and the genetic material

necessary for its production in or on all

raw agricultural commodities. Cornell

University submitted a petition to EPA

under the Federal Food, Drug and

Cosmetic Act as amended by the Food

Quality Protection Act of 1996

requesting the tolerance exemption.

This regulation eliminates the need to

establish a maximum permissible level

for residues of Coat Proteins of Papaya

Ringspot Virus and the genetic material

necessary for its production.

DATES: This regulation is effective

August 22, 1997. Objections and

requests for hearings must be received

by EPA on or before October 21, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number [OPP–300538],

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–

300538], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services 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 Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

electronic objections and hearing

requests must be submitted as an ASCII

file avoiding 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 5.1 file format

or ASCII file format. All copies of

electronic objections and hearing

requests must be identified by the

docket control number [OPP–300538].

No Confidential Business Information

(CBI) should be submitted through email. Copies of electronic objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Linda Hollis, c/o Product Manager

(PM) 90, Biopesticides and Pollution

Prevention Division (7501W),

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number and

e-mail: Rm. 5th fl., CS#1 2800 Crystal

Drive, Arlington, VA 22202, (703) 308–

8733, e-mail:

hollis.linda@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of April 2, 1997 (62 FR

15689–15690) EPA issued a notice

pursuant to section 408(d), of the

Federal Food Drug & Cosmetic Act

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

the filing of a pesticide tolerance

petition by Cornell University, Geneva,

NY. The notice contained a summary of

the petition prepared by the petitioner

and this summary contained

conclusions and arguments to support

its conclusion that the petition

complied with the Food Quality

Protection Act (FQPA) of 1996. The

petition requested that 40 CFR part 180

be amended by establishing an

exemption from the requirement of a

tolerance for residues of the biological

pest control agent Coat Protein of

Papaya Ringspot Virus and the genetic

material necessary for its production in

or on all raw agricultural commodities.

There were no comments or requests

for referral to an advisory committee

received in response to the notice of

filing.

The data submitted in the petition

and other material have been evaluated.

The toxicology data requirements in

support of this exemption from the

requirement of a tolerance were satisfied

via data waivers from the open scientific

literature.

I. Risk Assessment and Statutory

Findings

New section 408(c)(2)(A)(i) of the

FFDCA allows EPA to establish an

exemption from the requirement for 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(c)(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