56082 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

VII. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the 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 actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VIII. Submission to Congress and the

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: October 10, 1997.

Stephen L. Johnson,

Acting Director, 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 180.516 is added to read as

follows:

§ 180.516 4-(2,2-difluoro-1,3-benzodioxol4-yl)-1H-pyrrole-3-carbonitrile ; tolerances

for residues.

(a) General. A tolerance is established

for residues of the herbicide, 4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile, in or on the

following food commodity:

Commodity Parts per

million

Potatoes .................................... 0.02

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–28644 Filed 10–28–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300567; FRL–5750–8]

RIN 2070–AB78

Avermectin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for the combined

residues of avermectin in or on basil.

This action is in response to an

emergency exemption request under

section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act

permitting use of the pesticide on basil.

This regulation establishes a maximum

permissible level for residues of

avermectin B1 and its delta-8,9-isomer

in this food commodity pursuant to

section 408(l)(6) of the Federal Food,

Drug, and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996.

The tolerance will expire and is revoked

on September 30, 1998.

DATES: This regulation is effective

October 29, 1997. Objections and

requests for hearings must be received

by EPA on or before December 29, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300567],

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–

300567], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, Crystal Mall #2,

1921 Jefferson Davis Hwy., Arlington,

VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300567]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Daniel Rosenblatt, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56083

number, and e-mail address: CM #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

a tolerance for the combined residues of

the miticide avermectin B1 and its delta8,9-isomer, in or on basil at 0.05 parts

per million (ppm). This tolerance will

expire and is revoked on September 30,

1998. EPA will publish a document in

the Federal Register to remove the

revoked tolerance 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

Avermectin on Basil and FFDCA

Tolerances

Basil is a leafy herb that is produced

for the fresh and dried markets.

California submitted information to EPA

that indicates that the leafminer

(Liriomyza sp.) poses a significant threat

to the profitable production of basil.

Basil affected by leafminer can be

rendered unmarketable because they

feed on the plant’s leaves and may also

make them susceptible to disease.

California determined that the

conditions for a leafminer outbreak were

favorable and invoked its authorities

under 40 CFR 166.40 to declare a crisis

situation. After considering the

implications connected with the use of

this pesticide under a crisis situation,

EPA is establishing this tolerance for the

use of avermectin on basil for control of

leafminer in California.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

avermectin in or on basil. In doing so,

EPA considered the new safety standard

in FFDCA section 408(b)(2), and EPA

decided that the necessary tolerance

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 this

tolerance without notice and

opportunity for public comment under

section 408(e), as provided in section

408(l)(6). Although this tolerance will

expire and is revoked on September 30,

1998, under FFDCA section 408(l)(5),

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on basil 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 this tolerance earlier if

any experience with, scientific data on,

or other relevant information on this

pesticide indicate that the residues are

not safe.

Because this tolerance is being

approved under emergency conditions

EPA has not made any decisions about

whether avermectin meets EPA’s

registration requirements for use on

basil or whether a permanent tolerance

for this use would be appropriate.

Under these circumstances, EPA does

not believe that this tolerance serves as

a basis for registration of avermectin by

a State for special local needs under

FIFRA section 24(c). Nor does this

tolerance serve as the basis for any State

other than California 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 avermectin, contact the

Agency’s Registration Division at the

address provided above.

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
56084 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

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, and high-end

residential exposure, are aggregated.

High-end exposures from all 3 sources

are not typically added because of the

very low probability of this occurring in

most cases, and because the other

conservative assumptions built into the

assessment assure adequate protection

of public health. However, for cases in

which high-end exposure can

reasonably be expected from multiple

sources (e.g. frequent and widespread

homeowner use in a specific

geographical area), multiple high-end

risks will be aggregated and presented

as part of the comprehensive risk

assessment/characterization. Since the

toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1–7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

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

(non-nursing infants <1 year old) was

not regionally based.
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56085

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 avermectin and to make a

determination on aggregate exposure,

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

time-limited tolerance for combined

residues of avermectin B1 and its delta8,9-isomer on basil at 0.05 ppm. EPA’s

assessment of the dietary exposures and

risks associated with establishing the

tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by avermectin B1

and its delta-8,9-isomer are discussed

below.

1. Acute toxicity. For acute dietary

risk assessment, EPA recommends use

of a NOEL of 0.06 mg/kg/day from the

developmental toxicity study in mice.

The effects observed at the Lowest Effect

Level (LEL) of 0.10 mg/kg/day involved

cleft palate. For the purposes of this

action, an MOE of 300 is considered

necessary to be adequately protective for

dietary (food only) exposure.

2. Short - and intermediate - term

toxicity. For short- and intermediateterm MOE calculations, EPA

recommends use of the developmental

NOEL of 0.2 mg/kg/day from the oral

developmental toxicity study in mice.

At the LEL of 0.4 mg/kg/day, there was

an increased incidence of cleft palate.

3. Chronic toxicity. EPA has

established the RfD for avermectin at

0.0004 milligrams/kilogram/day (mg/kg/

day). This RfD is based on a 2-

generation rat reproductive toxicity

study with a NOEL of 0.12 mg/kg/day

and an uncertainty factor of 300. In

addition to the uncertainty factor of 100

for inter- and intra-species variations, a

Modifying Factor (MF) of 3 was used.

The MF was used because of the

severity of the effects (pup deaths) and

the steep dose-response curve. At the

LEL of 0.40 mg/kg/day, there was

decreased pup body weight and

viability during lactation as well as an

increased incidence of retinal rosettes in

F2b weanlings.

4. Carcinogenicity. Avermectin has

been classified by EPA as a Group E

(‘‘evidence of non-carcinogenicity for

humans’’) chemical. Therefore, a cancer

risk assessment is not needed.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.449) for the combined residues

of avermectin B1 and its delta-8,9-

isomer, in or on a variety of raw

agricultural commodities, ranging from

0.005 ppm in cottonseed to 0.05 ppm in

celery. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from avermectin B1

and its delta-8,9-isomer 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. In a

separate and earlier registration action,

the Agency required the development of

more highly refined residue and

exposure information to support the

pesticide. In response, in October 1996,

EPA received a Monte Carlo analysis for

all uses of avermectin at that time. Since

that analysis was generated before this

section 18 action was submitted, EPA

does not have information on acute

exposures for basil. Further, the Agency

is not currently updating or revising

Monte Carlo analysis developed by

registrants. Therefore, the acute

exposure assessment for this action does

not include data associated with the

consumption of basil. In spite of the

above exception, data available to EPA

suggest a high-end exposure estimate of

0.000078 mg/kg/day for uses of

avermectin. This results in a dietary

(food only) MOE of 769 for females 13

years and older, the population

subgroup of concern. In EPA’s

judgement, the addition of basil to acute

exposure and risk calculations would

not produce acute risks (food only) that

exceed a level of concern.

ii. Chronic exposure and risk. As part

of this action, EPA reviewed

information that establishes chronic

dietary exposure estimates for

avermectin. This chronic dietary (food

only) risk assessment used anticipated

residue refinement for commodities

with tolerances for avermectin, but did

not incorporate any refinement for

percent of crop treated (default of 100%

was assumed). Therefore, the resulting

exposure estimates should be viewed as

partially refined; further refinement for

percent of crop treated would result in

lower dietary exposure estimates. The

existing avermectin tolerances plus the

proposed tolerances associated with the

section 18 use of the chemical result in

an Anticipated Residue Contribution

that ranges from 5% of the RfD for the

U.S. Population to 12% of the RfD 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, avermectin is

moderately persistent and not very

mobile. It is not likely to be found

extensively in ground water, but could

be found in surface water. Under

anaerobic conditions in the absence of

light, avermectin does not degrade. No

Health Advisories or Maximum

Contaminant Levels for avermectin in

drinking water have been established.

Because the Agency lacks sufficient

water-related exposure data to complete

a comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water-related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause avermectin to exceed the

RfD if the tolerance being considered in

this document were granted. The

Agency has therefore concluded that the

potential exposures associated with

avermectin in water, even at the higher

levels the Agency is considering as a

conservative upper bound, would not

prevent the Agency from determining

that there is a reasonable certainty of no

harm if the tolerance is granted.

3. From non-dietary exposure.

Avermectin is currently registered for

use on the following residential nonfood sites: ornamental crops

(herbaceous and woody), turf,

households (indoor and outdoor), and
56086 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

non-food areas of food handling

establishments.

i. Chronic exposure and risk. Given

the uses for avermectin, a chronic nondietary exposure scenario would not be

expected.

ii. Short- and intermediate-term

exposure and risk. EPA assessed indoor

residential risk characterization data to

evaluate short- and intermediate-term

exposure and risk. Based on the

assumptions for exposure total oral,

dermal, and respiratory estimated

absorbed daily exposure could total

.00023 mg/kg/day. This correlates to a

total short- and intermediate-term

indoor residential MOE of 870 for the

U.S. population.

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

avermectin 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,

avermectin 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 avermectin has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. The population

subgroup of concern is females 13 years

and older. The MOE for this subgroup

from food exposures is 769. Despite the

potential for exposures to avermectin

from drinking water, EPA does not

expect the acute aggregate risk to exceed

levels of concern.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to avermectin from food will

utilize 5% of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is non-nursing infants <1 year

old ‘‘discussed below’’. 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. Based on the nature of

the residential uses, a chronic scenario

would not be expected. Despite the

potential for exposure to avermectin in

drinking water and from non-dietary,

non-occupational exposure, EPA does

not expect the aggregate exposure to

exceed 100% of the RfD. EPA concludes

that there is a reasonable certainty that

no harm will result from aggregate

exposure to avermectin residues.

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.

As referenced above, for short- and

intermediate-term exposures, EPA

assessed information that addresses this

topic in relation to human exposure

associated with residential use through

oral, dermal, and respiratory exposures.

The anticipated MOE was 803 for the

U.S. population. EPA considers this

MOE to be adequately protective.

D. Aggregate Cancer Risk for U.S.

Population

Avermectin has been classified as a

Group E ‘‘evidence of noncarcinogenicity for humans’’ chemical

by EPA. Therefore, a cancer risk

assessment is not needed.

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

avermectin, 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 safety 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 mouse developmental toxicity

analysis, the maternal (systemic) NOEL

was 0.05 mg/kg/day based on mortality
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56087

at the Lowest-observed effect level

(LOEL) of 0.075 mg/kg/day. The

developmental (fetal) NOEL was 0.2 mg/

kg/day based on cleft palate at the LOEL

of 0.4 mg/kg/day. The Delta-8,9-Isomer

was also tested for developmental

toxicity in the mouse. In the mouse

developmental study for the isomer, the

maternal (systemic) NOEL was 0.10 mg/

kg/day, based on mortality at the LOEL

of 0.20 mg/kg/day. The developmental

(fetal) NOEL was 0.06 mg/kg/day, based

on cleft palate at the LOEL of 0.10 mg/

kg/day.

In the rat developmental study, the

maternal (systemic) NOEL was greater

than or equal to 1.6 mg/kg/day. The

developmental (fetal) NOEL was 1.6 mg/

kg/day. In the rabbit developmental

study, the maternal (systemic) NOEL

was 1.0 mg/kg/day, based on decreased

body weight and decreased food and

water consumption at the LOEL of 2.0

mg/kg/day. The developmental (fetal)

NOEL was 1.0 mg/kg/day, based on

clubbed foot, and delayed ossification of

sternebrae, metacarpals, and phalanges

at the LOEL of 2.0 mg/kg/day.

iii. Reproductive toxicity study. In the

2-generation rat reproductive toxicity

study, the maternal (systemic) NOEL

was 0.4 mg/kg/day highest dose tested

(HDT). The developmental (pup) NOEL

was 1.2 mg/kg/day, based on decreased

viability indices, decreased pup body

weight, and retinal fold in weanlings at

the LOEL of 0.4 mg/kg/day. The

reproductive (pup) NOEL was 0.4 mg/

kg/day (HDT).

iv. Pre- and post-natal sensitivity.

Both the delta-8,9-isomer of avermectin

and avermectin per se exhibit cleft

palate in CF1 mouse developmental

studies. The NOEL for cleft plate for the

delta-8,9-isomer is 0.06 mg/kg/day with

the LOEL at 0.10 mg/kg/day. For

avermectin per se, the NOEL for cleft

palate is 0.2 mg/kg/day with the LOEL

at 0.4 mg/kg/day. Therefore, pre-natal

sensitivity to the regulated residue for

avermectin is demonstrated when

considering these developmental

findings in the CF1 Mouse. An

additional 3-fold uncertainty factor has

been added to account for these

developmental findings.

An acute dietary risk assessment is

needed based on the results of the

developmental study in mice with the

delta-8,9-isomer. This risk assessment

will evaluate acute dietary risk to

females 13 years and older. For the

purpose of the section 18, an MOE of

300 is considered necessary to be

adequately protective for dietary (food

only) exposure.

To evaluate the pre-natal risks, the

acute dietary MOE calculations for

females 13 years and older has been

conducted using the lowest NOEL for all

developmental studies for cleft palate

(0.06 mg/kg/day).

The results of the rat reproduction

study required that a Modifying Factor

of 3 be added to the usual uncertainty

factor of 100 used for the RfD. EPA used

this Modifying Factor in developing this

analysis. Typically, the Agency uses a

modifying factor of 10 when no study is

available and uses a modifying factor of

3 when a study exists which shows

effects in the fetus before they appear in

the parent.

2. Acute risk. The acute dietary MOE

for females 13 years and older (accounts

for both maternal and fetal exposure) is

769. This MOE calculation is based on

the developmental NOEL in mice of

0.06 mg/kg/day. This estimate is based

on Monte Carlo modeling incorporating

anticipated residue and percent of crop

treated refinement. In EPA’s judgement,

the large acute dietary MOE provides

assurance that there is a reasonable

certainty of no harm for females 13

years and older and the pre-natal

development of infants.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to avermectin

from food will utilize 12% of the RfD for

non-nursing infants less than a year old

and 8% of the RfD for children 1–6

years old. EPA generally has no concern

for exposures below 100% of the RfD

because the RfD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health.

Based on the nature of the residential

uses, a chronic scenario would not be

expected. Despite the potential for

exposure to avermectin in drinking

water and from non-dietary, nonoccupational exposure, EPA does not

expect the aggregate exposure to exceed

100% of the RfD. EPA concludes that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to avermectin

residues.

4. Short- or intermediate-term risk.

The anticipated MOEs for short- and

intermediate-term exposures for infants

and children do not pose a level of

concern. The calculated MOEs range

from 716 for non-nursing infants to 787

for children 7–12 years old.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in plants

and animals is adequately understood.

As cited at 40 CFR 180.449, the

regulable residues are avermectin B1

and its delta-8,9-isomer.

B. Analytical Enforcement Methodology

Merck Method 10001, rev. 2, a high

pressure liquid chromatography (HPLC)-

fluorescence method, may be used to

enforce the tolerance expression. This

method has been submitted to FDA for

publication in PAM Volume II.

C. Magnitude of Residues

Residues of avermectin B1 and its

delta 8,9-isomer are not expected to

exceed 0.05 ppm on basil as a result of

this section 18 use. Secondary residues

are not expected in animal commodities

as no feed items are associated with this

use.

D. International Residue Limits

No Codex MRLs have been

established for avermectin residues on

basil.

VI. Conclusion

Therefore, the tolerance is established

for combined residues of avermectin B1

and its delta-8,9-isomer in basil at 0.05

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 December 29,

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
56088 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

CBI. Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300567] (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 (7502C), 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 a timelimited tolerance under FFDCA section

408(l)(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

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. 601et

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: October 22, 1997.

James Jones,

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. Section 180.449 is amended in

paragraph (b) by alphabetically adding a

commodity to the table to read as

follows:

§ 180.449 Avermectin B1 and its delta-8,9-

isomer; tolerances for residues.

* * * * *

(b) * * *

Commodity Parts per million Expiration/revocation date

Basil ..................................................................................................... 0.05 ppm 9/30/98

* * * * * * *
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56089

* * * * *

[FR Doc. 97–28641 Filed 10–28–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300480A; FRL–5751–5]

Aminoethoxyvinylglycine; Pesticide

Tolerances; Correction

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule; correction.

SUMMARY: In the Federal Register of

May 7, 1997 (62 FR 24835) (FRL–5713–

5), EPA established time-limited

tolerances for residues of the plant

regulator aminoethoxyvinylglycine in or

on the food commodities apples and

pears. The reference dose (RfD) was

incorrectly stated. This document

corrects the RfD. On page 24836,

column three, third full paragraph, line

11, the RfD was incorrectly stated as

‘‘0.0002’’; the correct RfD is ‘‘0.002.’’

FOR FURTHER INFORMATION CONTACT:

Denise Greenway, Biopesticides and

Pollution Prevention Division (7511W),

Environmental Protection Agency, 401

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

Office location, telephone number, and

e-mail address: Rm. 5-W57, CS #1, 2800

Crystal Drive, Arlington, VA 22202,

703–308–8263, e-mail:

greenway.denise@epamail.epa.gov.

List of Subjects in Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: October 15, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 97–28651 Filed 10–28–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300570; FRL–5752–4]

RIN 2070–AB78

Tebuconazole; Pesticide Tolerances

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

tebuconazole in or on sunflower seed

and sunflower oil. This action is in

response to an emergency exemption

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act authorizing use of the pesticide on

sunflowers. This regulation establishes a

maximum permissible level for residues

of tebuconazole in 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. The

tolerances will expire and are revoked

on September 30, 1998.

DATES: This regulation is effective

October 29, 1997. Objections and

requests for hearings must be received

by EPA on or before December 29, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300570],

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–

300570], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 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–

300570]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: 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 residues of the fungicide

tebuconazole, in or on sunflower seed

and sunflower oil at 0.2 and 0.4 parts

per million (ppm). These tolerances will

expire and are revoked on September

30, 1998. 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