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
49932 Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations

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 Fenarimol

on Hops and FFDCA Tolerances

The States of Washington, Oregon and

Idaho availed themselves of the

authority to declare a crisis exemption

to use fenarimol for control of the

Powdery mildew (Sphaeroteca

macularis) in hops. Powdery mildew is

a serious hop disease in many hop

growing areas in the world. The

elimination of commercial hop

production in New York during the

early part of this century is largely

blamed on this disease. Since this

disease has not been observed in the

Pacific Northwest until very recently, no

effective fungicides are registered to

control it. Sulfur is the only pesticide

available, but does not provide effective

control. The pathogen is airborne and

spreads very quickly, primarly during

the months of July and August, which

are critical to hop production. EPA has

authorized under FIFRA section 18 the

use of fenarimol on hops for control of

powdery mildew in Washington,

Oregon and Idaho. After having

reviewed their submissions, EPA

concurs that emergency conditions exist

for these States .

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

fenarimol in or on hops. 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 December 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 hops 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 fenarimol meets EPA’s

registration requirements for use on

hops 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 fenarimol 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 Washington, Oregon and

Idaho 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 fenarimol,

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

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
Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations 49933

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.

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 fenarimol and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

fenarimol on hops at 5 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 fenarimol are

discussed below.

1. Acute toxicity. The Agency

determined that the NOEL of 13 mg/kg/

day, based on hydronephrosis at the

lowest effect level (LEL) of 35 mg/kg/

day, from a developmental study in rats

should be used to assess acute dietary

risks from residues of fenarimol. This

risk assessment will evaluate risk to

females 13+ years old, the population

subgroup of concern.

2. Short - and intermediate - term

toxicity. The Agency determined that

the NOEL of 13 mg/kg/day from the rat

developmental study should be used to

assess risks from short- and

intermediate-term exposures to residues
49934 Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations

of fenarimol. At the LEL of 35 mg/kg/

day, there was hydronephrosis.

3. Chronic toxicity. EPA has

established the RfD for fenarimol at

0.065 milligrams/kilogram/day (mg/kg/

day). This RfD is based on a 2 year rat

feeding study with a NOEL of 6.5 mg/

kg/day and an uncertainty factor of 100

based on fatty change in the liver at the

LEL of 13 mg/kg/day.

4. Carcinogenicity. The Agency’s

Carcinigenicity Peer Review Committee

(CPRC) has classified fenarimol as a

Group E (non-carcinogenic in humans)

chemical.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.421) for the residues of

fenarimol (alpha-(2 chlorophenyl)-

alpha-(4-chlorophenyl)-5-

pyrimidinemethanol), in or on a variety

of raw agricultural commodities at

levels ranging from 0.003 ppm in milk

to 0.1 ppm in apples, pears and pecans.

Tolerances have also been established

(40 CFR 180.421(b)) for residues of

fenarimol and its metabolites (alpha-(2-

chlorophenyl)-alpha-(4-chlorophenyl)-

1,4-dihydro-5-pyrimidinemethanol, and

5-[2-chlorophenyl)-(4-chlorophenyl)methyl]-3,4-dihydro-4-

pyrimidinol measured as the total of

fenarimol and 5-[(2- chlorophenyl)-(4-

chlorophenyl)methyl]-3,4-dihydro-4-

pyrimidine (calculated as fenarimol))

ranging from 1.0 ppm for cherries to

0.02 ppm for grapes. For this Section 18

only, the Agency determined that the

residue of concern in hops is parent

fenarimol. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from fenarimol as

follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a one day or single exposure. The acute

dietary (food only) risk assessment used

TMRC estimates. The resulting high-end

exposure estimate of 0.01 mg/kg/day

results in a dietary (food only) MOE of

1300 for females 13+ years. This MOE

should be viewed as a conservative risk

estimate. Refinement of the risk

assessment using anticipated residue

values and percent crop-treated data

would result in a lower acute dietary

risk estimate.

ii. Chronic exposure and risk. For the

chronic dietary ( food only) risk

assessment, the Agency assumed that

100% of hops and all other commodities

having fenarimol tolerances will contain

fenarimol residues and those residues

would be at the tolerance level. These

assumptions result in an over estimate

of human dietary exposure. Thus, in

making a safety determination for this

tolerance, HED is taking into account

this conservative exposure assessment.

The existing fenarimol tolerances

(published and pending, and including

the necessary Section 18 tolerance)

result in a TMRC that is equivalent to

percentages of the RfD that range from

1% for the U.S. population to 3% for

non-nursing infants < 1 year old.

2. From drinking water. Based on

available data used in EPA’s assessment

of environmental risk, fenarimol is not

expected to leach to groundwater.

Information on its persistence is

inconclusive. There is no information

on the persistence/mobility of fenarimol

metabolites/degradates. There are no

established Maximum Contaminant

Levels for residues of fenarimol in

drinking water and no Health Advisory

Levels for this active ingredient in

drinking water have been issued.

Chronic exposure and risk. Because

the Agency lacks sufficient waterrelated 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 fenarimol 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

fenarimol 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.

Fenarimol is currently registered for use

on the following residential non-food

sites: ornamentals, turf and lawns.

There are no indoor residential uses for

fenarimol. Based on the nature of the

outdoor residential uses, the EPA

concludes that chronic residential

exposure scenarios do not exist for

fenarimol. Short and/or intermediate

term exposure scenarios may exist.

However, the Agency currently lacks

sufficient residential-related exposure

data to complete a comprehensive

residential risk assessment for many

pesticides, including fenarimol.

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
Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations 49935

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

fenarimol has a common mechanism of

toxicity with other substances or how to

include this pesticide in a cumulative

risk assessment. For the purposes of this

tolerance action, therefore, EPA has not

assumed that fenarimol has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. For the population

subgroup of concern, females 13+ years,

the Agency estimated an MOE value of

1300 for the acute aggregate dietary

(food only) risk from exposures to

fenarimol residues. Despite the potential

for exposure to fenarimol in drinking

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

expect the aggregate exposure to exceed

the Agency’s level of concern.

2. Chronic risk. Using the TMRC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to fenarimol from food will

utilize 1% of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is non-nursing infants < 1 year

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.

Despite the potential for exposure to

fenarimol in drinking water, 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 fenarimol 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.

Based on the registered uses of

fenarimol short and/or intermediate

term exposure scenarios may exist.

However, the Agency currently lacks

sufficient residential-related exposure

data to complete a comprehensive

residential risk assessment for many

pesticides, including fenarimol.

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

fenarimol, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a 3-generation

reproduction study in the rat and

reproduction studies in mice and guinea

pigs. 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 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—

Rats: The maternal (systemic) NOEL

was 13 mg/kg/day, based on decreased

weight gain at the lowest observed effect

level (LOEL) of 35 mg/kg/day. The

developmental (fetal) NOEL was 13 mg/

kg/day based on hydronephrosis at the

LOEL of 35 mg/kg/day.

Rabbits: The maternal (systemic)

NOEL was 35 mg/kg/day, the highest

dose tested (HDT). The developmental

(fetal) NOEL was 35 mg/kg/day (HDT).

iii. Reproductive toxicity study—

Rats: In a 3-generation rat reproduction

study, the maternal (systemic) NOEL

was 5.0 mg/kg/day, based on increased

gestation time, and delayed onset of

parturition at the LOEL of 17.5 mg/kg/

day. The developmental (pup) NOEL

was 5.0 mg/kg/day, based on decreased

pup survival and hydronephrosis at the

LOEL of 17.5 mg/kg/day. The

reproductive NOEL was 2.5 mg/kg/day,

based on anti-fertility effects in males,

and dystocia in females at the LEL of 5.0

mg/kg/day.

iv. Pre- and post-natal sensitivity.

Based on the developmental toxicity

studies discussed above, for fenarimol

there does not appear to be a special

sensitivity for pre-natal effects.

However, based on the developmental

finding of hydronephrosis in the rat

study, an acute dietary risk assessment

was performed for females 13+ years of

age.

Based on the reproductive toxicity

studies discussed above and other

reviewed data for fenarimol, there does

not appear to be a special sensitivity for

post-natal effects. The major

reproductive findings in the rat (postnatal male infertility and dystocia and

related effects in females) were

concluded to be species-specific

findings by the Agency. Reproduction

studies in mice, rabbits, and guinea pigs

did not demonstrate the reproductive

concerns. Mechanistic data also

substantiate the species-specific

conclusion.

v. Conclusion. The EPA concludes

that reliable data support use of the

standard 100-fold margin of exposure/

uncertainty factor and that an additional

margin/factor is not needed to protect

infants and children.

2. Acute risk. The acute dietary MOE

(food only) was calculated to be 1300 for

females 13+ years (accounts for both

maternal and fetal exposure). These

MOE calculations were based on the

developmental NOEL in rats of 13 mg/

kg/day. This risk assessment assumed

100% crop-treatment with tolerance

level residues on all treated crops

consumed, resulting in an over-estimate

of dietary exposure. The large acute

dietary MOE calculated for females 13+

years provides assurance that there is a

reasonable certainty of no harm for

females 13+ years. Despite the potential

for exposure to fenarimol in drinking

water, the Agency does not expect the

aggregate exposure (food plus water) to

exceed the Agency’s level of concern for

acute dietary exposure.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to fenarimol

from food will utilize a percentage of

the RfD that ranges from 1% for

children (1-6 yrs.), up to 3% for nonnursing infants <1 year 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. Despite the potential

for exposure to fenarimol in drinking

water, 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
49936 Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations

chronic aggregate exposure to fenarimol

residues.

4. Short- or intermediate-term risk.

Based on the registered uses of

fenarimol short and/or intermediate

term exposure scenarios may exist.

However, the Agency currently lacks

sufficient residential-related exposure

data to complete a comprehensive

residential risk assessment for many

pesticides, including fenarimol.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue of fenarimol

in hops has not been directly

determined. Metabolism studies with

fenarimol in apples and cherries

indicate that the parent compound is

the only significant residue. For the

purpose of this tolerance, EPA will

translate these data to hops. For this

tolerance only, EPA concludes that the

residue of concern in hops is parent

fenarimol. According to Table 1 (OPPTS

860.1000), there are no livestock

feedstuffs derived from hops. Thus, the

livestock metabolism and magnitude of

residues in meat, milk, poultry and eggs

are not a concern for this Section 18 .

B. Analytical Enforcement Methodology

Analytical methodology exists for the

enforcement of currently established

tolerances for fenarimol. The method

(GC/ECD) is published in PAM vol II

(Method R039). For the purposes of this

tolerance, Method R039 may be used to

enforce the required tolerance for

fenarimol in hops.

C. Magnitude of Residues

Residues of fenarimol are not

expected to exceed 5 ppm in/on dried

hop cones as a result of this Section 18

use.

D. International Residue Limits

There are no Mexican or Canadian

Maximum Residue Limits (MRL) for

fenarimol in/on hops. Thus,

harmonization with Mexico and Canada

is not an issue for this Section 18. A

CODEX MRL of 5 ppm is established for

fenarimol per se in/on hops. As EPA has

concluded that a tolerance level of 5

ppm should be established for residues

of fenarimol in/on hops as a result of

this Section 18 exemption,

harmonization with CODEX is not an

issue.

VI. Conclusion

Therefore, the tolerance is established

for residues of fenarimol in hops at 5

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–300556] (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 (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
Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations 49937

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

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

tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

acations published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

information to the U.S. Senate, the U.S.

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Environmental protection, Food

additives, Pesticides and pests.

40 CFR Part 186

Environmental protection, Animal

feeds, Pesticides and pests.

Dated: September 16, 1997.

James Jones,

Acting Director, Registration Division, 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. Section 180.421 is amended as

follows:

i. By adding a heading to paragraph

(a) and designating the existing text as

paragraph (a)(1).

ii. By redesignating paragraph (b) as

paragraph (a)(2) and by adding a new

paragraph (b).

iii. By adding and reserving

paragraphs (c) and (d).

Section 180.421, as amended, reads as

follows:

§ 180.421 Fenarimol; tolerances for

residues.

(a) General. * * *

(b) Section 18 emergency exemptions.

A time-limited tolerance is established

for residues of the fungicide fenarimol

in connection with use of the pesticide

under section 18 emergency exemptions

granted by EPA. The tolerance will

expire and be revoked on the date

specified in the following table:

Commodity Parts per million Expiration/Revocation Date

Hops .................................................................................................... 5 December 31, 1998

(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.

§ 185.3200 [Removed]

b. In § 185.3200:

i. The entries in the table are

transferred and alphabetically added to

the table in paragraph (a)(2) of

§ 180.421.

ii. The remainder of § 185.3200 is

removed.

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority: 21 U.S.C. 342, 348, and 701.

§ 186.3200 [Removed]

b. In § 186.3200:

i. The entry in the table of paragraph

(a) is transferred and alphabetically

added to the table in paragraph (a)(1) of

§ 180.421.

ii. The entries in the table of

paragraph (b) are transferred and

alphabetically added to the table in

paragraph (a)(2) of § 180.421.

iii. The remainder of § 186.3200 is

removed.

[FR Doc. 97–25235 Filed 9-23-97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 473

[BPD–453–CN]

Rin 0938–AG18

Medicare Program; Medicare Appeals

of Individual Claims; Correction

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Correction to final regulation.

SUMMARY: In the May 12, 1997 issue of

the Federal Register, we published a

regulation titled, ‘‘Medicare Appeals of

Individual Claims, BPD–453–FC.’’ That

final rule concerned individual claims

appeals under part A and part B. We

made an error in that regulation and this

document corrects that error.