Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations 49925

Commodity Parts per million Expiration/Revocation Date

Summer squash .................................................................................. 4 None

Sweet corn (kernels plus cob with husk removed) ............................. 5 None

Tomatoes ............................................................................................. 4 None

Turnip roots ......................................................................................... 7 None

Turnip tops ........................................................................................... 10 None

Winter squash ...................................................................................... 4 None

(b) Section 18 emergency exemptions.

A time-limited tolerance is established

for residues of the fungicide maneb

(manganous

ethylenebisdithiocarbamate), calculated

as zinc ethylenebisdithiocarbamate, and

its metabolite ethylenethiourea in

connection with use of the pesticide

under a section 18 emergency

exemption granted by EPA. The

tolerance will expire and is revoked on

the date specified in the following table:

Commodity Parts per million Expiration/Revocation Date

Walnuts ................................................................................................ 0.05 6/15/98

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–25097 Filed 9-23-97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180 and 185

[OPP–300544; FRL–5740–8]

RIN 2070–AB78

Endothall; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

endothall in or on canola seed. This

action is in response to EPA’s granting

of an emergency exemption under

section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act

authorizing use of the pesticide on

canola in Minnesota. This regulation

establishes a maximum permissible

level for residues of endothall 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

August 31, 1998.

DATES: This regulation is effective

September 24, 1997. Objections and

requests for hearings must be received

by EPA on or before November 24, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300544],

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–

300544], 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–

300544]. 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: Andrea Beard, 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) 308-9356, e-mail:

beard.andrea@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 residues of the herbicide

endothall, in or on canola seed at 0.3

part per million (ppm). This tolerance

will expire and is revoked on August 31,

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
49926 Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations

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 Endothall

on Canola and FFDCA Tolerances

The Applicant states that over the

past several years, unusually cool and

wet weather during the early part of the

year has delayed planting of canola

which allows smartweed to become

established in fields, both competing

with the canola plants and then

contaminating the seed. The smartweed

seed, about the same size as canola seed,

cannot be removed using standard grain

cleaning equipment. Increasing levels of

conspicuous admixture result in lower

grading of the canola seed, and thus

lower prices for producers. In 1995,

nearly all Minnesota canola was

excluded from the export market due to

dockage attributable to high

contamination with smartweed and

wild buckwheat, which significantly

reduced grower revenues. The

Applicant states that there are no other

products registered for this use, nor are

there effective alternative control

measures available. The Applicant

estimates that significant economic

losses will be suffered by canola

growers if endothall is not available for

control of smartweed. EPA has

authorized under FIFRA section 18 the

use of endothall on canola for control of

smartweeds in Minnesota. After having

reviewed the submission, EPA concurs

that emergency conditions exist for this

state.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

endothall in or on canola seed. 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 August 31,

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 canola seed

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 endothall meets EPA’s

registration requirements for use on

canola 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

endothall 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 Minnesota 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 endothall, 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

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
Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations 49927

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

(Children 1 - 6 years 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 endothall and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

endothall on canola seed at 0.3 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
49928 Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations

toxic effects caused by endothall are

discussed below.

1. Acute toxicity. An acute dietary risk

endpoint has not been identified, and an

acute risk assessment is not required.

2. Short - and intermediate - term

toxicity. For dermal short- and

intermediate- term MOE calculations,

the NOEL of 40.0 mg/kg/day (no effects

seen at this, the Highest Dose Tested)

was chosen from the 21-day dermal

toxicity study in rats.

3. Chronic toxicity. EPA has

established the RfD for endothall at 0.02

milligrams/kilogram/day (mg/kg/day).

This RfD is based on a 2-year feeding

study in dogs with an NOEL of 2.0 mg/

kg/day, using an uncertainty factor of

100. At the lowest observed effect level

(LOEL) of 6.0 mg/kg/day, increased

relative and absolute weight of the

stomach and small intestine was

observed.

4. Carcinogenicity. Endothall has not

yet been reviewed by the Cancer Peer

Review Committee. However, review of

available data indicate that tumors

observed in both the rat and the mouse

studies are within the historical control

range for these species. Thus, there is no

concern for carcinogenic effects at this

time.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.293) for the residues of

endothall, in or on a variety of raw

agricultural commodities, including rice

grain and straw, potatoes, hops,

cottonseed at levels from 0.05 to 0.1

ppm; and 40 CFR 180.319, interim

tolerance for sugarbeets at 0.2 ppm. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

endothall as follows:

Chronic exposure and risk. In

conducting this chronic dietary risk

assessment, refinements used included

percent of crop treated figures for all

crops except canola and sugar beets.

Aside from this, the conservative

assumptions were made that 100% of

the crops would have residues at

tolerance levels. Using these

conservative assumptions, the ARC

estimates occupy the following

percentages of the RfD: Overall U.S.

Population, 1.1%; Nursing Infants <1

Year Old, 0.6%; Non-Nursing Infants <1

Year Old, 1.5%; Children Age 1-6 Years

(highest exposed subgroup), 2.1%; and

Children 7-12 Years Old, 1.6%.

Although these estimates are well below

levels of concern, additional refinement

using anticipated residue levels and

percent of crop treated information for

all crops would result in much lower

dietary exposure estimates.

2. From drinking water. There is an

interim tolerance for residues of

endothall in potable water at 0.2 ppm,

and EPA has also established a

Maximum Contaminant Level (MCL) for

water at 0.1 mg/L.

Chronic exposure and risk. Chronic

exposure levels for the U.S. population

and children were calculated assuming

concentrations at the MCL of 100.0 μg/

L in drinking water; adult and child

body weights of 70 and 10 kg,

respectively; and adult and child

drinking water consumption of 2 and 1

L per day, respectively. Based on these

assumptions, adult exposure was

calculated to be 2.9 x 10-3 mg/kg/day,

and child exposure to be 1.0 x 10-2 mg/

kg/day. These exposure values

correspond to 14.3% of the RfD for

adults, and 50.0% of the RfD for

children.

3. From non-dietary exposure.

Endothall is currently registered for use

on the following residential non-food

sites: Granular formulations of endothall

are applied to lakes and ponds that have

recreational uses. Concentrations of

endothall ranging from 0.5 to 5 mg/L are

used to control various aquatic weeds.

i. Chronic exposure and risk. Chronic

non-dietary exposure is not expected

with this use. Therefore, it is not

necessary to conduct a chronic risk

assessment, in association with the nondietary exposure, which is expected to

be short- and intermediate-term. This

risk is discussed in the following

paragraph.

ii. Short- and intermediate-term

exposure and risk. The non-dietary

swimmer exposure of a child (1-6 years),

while swimming in water treated with

this chemical is estimated as follows:

Dermal Exposure = (Concentration of

endothall) x (Surface area of child) x

(hours exposed) x (body weight (kg)).

Assumptions were used of 0.5 - 5 mg/

L endothall concentrations in the water,

surface area and body weight of the

child 9,000 cm2, and 22 kg, respectively.

Based upon these assumptions, dermal

exposure is estimated at a range of

0.0044 to 0.044 mg/kg/day. Oral

Exposure = (Concentration of endothall)

x (Ingestion rate of water) x (exposure

time) / (body weight(kg)). Assumptions

were 0.05 L/hr ingestion, 5 hr/day

exposure time, and 22 kg bodyweight.

Based on these assumptions, oral

exposure is estimated at a range of

0.0057 to 0.057 mg/kg/day. Total

Exposure, both dermal and oral, for a

child 1-6 years old, is estimated at 0.01

to 0.1 mg/kg/day. From these exposure

estimates, the MOE for short-term and

intermediate-term exposure is

calculated to be a range of 400 to 4,000.

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

endothall has a common mechanism of

toxicity with other substances or how to

include this pesticide in a cumulative

risk assessment. Unlike other pesticides
Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations 49929

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity, EPA

cannot at this time determine whether

endothall produces a toxic metabolite

produced by other substances. For the

purposes of this tolerance action,

therefore, EPA has not assumed that

endothall has a common mechanism of

toxicity with other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to endothall from food and

drinking water will utilize 15.4% of the

RfD for the U.S. population. The major

identifiable subgroup with the highest

aggregate exposure is Children 1 to 6

Years 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. Despite the potential

for exposure to endothall from nondietary, 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

acute aggregate exposure to endothall

residues.

2. 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.

Based upon assumptions given above,

the MOEs for adults from exposures

contributed by food plus drinking water

plus swimming exposure, range from

384 to 3,033. For children, the MOEs

range from 359 to 1,950. Since these

MOEs are well above the acceptable

level of 100, EPA concludes that there

is reasonable certainty that no harm will

result from short- and intermediate-term

exposure to endothall residues.

D. 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

endothall, 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 developmental study in rats, the

maternal (systemic) NOEL was 12.5 mg/

kg/day, based upon decreased body

weight gain at the LOEL of 25.0 mg/kg/

day. The developmental (fetal) NOEL

was 25.0 mg/kg/day, the highest dose

tested.

iii. Reproductive toxicity study. In the

2-generation reproductive toxicity study

in rats, the parental (systemic) NOEL

was not determined since there were

proliferative lesions of the gastric

epithelium in both sexes at the lowest

dose tested (2.0 and 2.3 mg/kg/day for

males and females respectively). The

developmental/reproductive (pup)

NOEL was 9.4 mg/kg/day, based on

decreased pup body weights (both

sexes) at the LOEL of 60.0 mg/kg/day.

iv. Pre- and post-natal sensitivity. The

available developmental and

reproductive toxicity data available do

not indicate that there are pre- or postnatal toxicity concerns for infants and

children.

v. Conclusion. Based on the currently

available developmental and

reproductive toxicity studies discussed

above and best scientific judgment of

EPA scientists, there does not appear to

be an extra sensitivity for pre- or postnatal effects, and an additional tenfold

safety factor is not warranted.

2. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to endothall

from food and drinking water will

utilize 52.1% of the RfD for infants and

children. 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.

Despite the potential for exposure to

endothall 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 endothall

residues.

3. Short- or intermediate-term risk.

Granular formulations of endothall are

applied to lakes and ponds that have

recreational uses. Concentrations of

endothall ranging from 0.5 to 5 mg/L are

used to control various aquatic weeds.

Short- and intermediate-term

exposure and risk. The non-dietary

swimmer exposure estimate for a child

(1-6 years), while swimming in water

treated with this chemical, through both

dermal and oral exposure, results in

MOEs from 400 to 4,000 (further

discussed above).

V. Other Considerations

A. Metabolism In Plants and Animals

The qualitative nature of the residues

of endothall in plants appears to be

adequately understood; the nature of the

residue in animals is adequately

understood based on acceptable studies

with lactating goats and laying hens.

The residue to be regulated is endothall

per se, as stated in 40 CFR 180.293 .

B. Analytical Enforcement Methodology

Adequate analytical methods are

available for tolerance enforcement in

plant commodities ( a GC method with

nitrogen detection is available in the

Pesticide Analytical Manual (PAM) Vol.

II, as Method I.) No tolerances have been

established for animal commodities, or

are required with this section 18 use;

therefore, no analytical methods are

required for livestock commodities.

C. Magnitude of Residues

Residues of endothall are not

expected to exceed 0.3 ppm in canola

and in its processed products canola oil

and meal, as a result of this use.

Secondary resides are not expected in

animal commodities.

D. International Residue Limits

There are no Codex, Canadian, or

Mexican Maximum Residue Levels

(MRLs) established for endothall on

canola.
49930 Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations

E. Rotational Crop Restrictions

There are no rotational crop

restrictions with this use or on the

federal label for endothall.

VI. Conclusion

Therefore, the tolerance is established

for residues of endothall in canola seed

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 November 24,

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

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–300544] (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 a timelimited tolerance 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 (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

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 Parts 180 and

185

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Food

additives, Pesticides and pests,

Reporting and recordkeeping

requirements.
Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations 49931

Dated: September 12, 1997.

Daniel Barolo,

Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

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

b. In § 180.293:

i. By designating the existing text as

paragraph (a)(1) and adding a heading to

paragraph (a).

ii. By adding paragraph (b).

iii. By adding and reserving

paragraphs (c) and (d).

Section 180.293, as amended, reads as

follows:

§ 180.293 Endothall; tolerances for

residues.

(a) General. * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for the residues of the herbicide

endothall, in connection with use of the

pesticide under section 18 emergency

exemptions granted by EPA. The

tolerances will expire on the dates

specified in the following table:

Commodity Parts per

million

Expiration/

Revocation

Date

Canola, seed ... 0.3 8/31/98

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 346a and 348.

§ 185.2650 [Removed]

b. In § 185.2650:

i. By desginating the existing text as

paragraph (a)(2) to § 180.293.

ii. By removing § 185.2650.

[FR Doc. 97–25236 Filed 9-23-97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185 and 186

[OPP–300556; FRL–5745–6]

RIN 2070–AB78

Fenarimol; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

fenarimol in or on hops . This action is

in response to EPA’s granting of an

emergency exemption under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on hops. This regulation

establishes a maximum permissible

level for residues of fenarimol 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

December 31, 1998.

DATES: This regulation is effective

September 24, 1997. Objections and

requests for hearings must be received

by EPA on or before November 24, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300556],

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–

300556], 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–

300556]. 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: Olga Odiott, 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) 308-9363, e-mail:

odiott.olga@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 residues of the fungicide

fenarimol, in or on hops at 5 part per

million (ppm). This tolerance will

expire and is revoked on December 31,

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–55729).

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