63662 Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations

Control of Emission of Organic

Compounds, submitted by the Governor

on December 15, 1995.

(i) Incorporation by reference.

(A) LAC, Title 33, Part III, Chapter 21,

Section 2147, Limiting Volatile Organic

Compound Emissions from Reactor

Processes and Distillation Operations in

the Synthetic Organic Chemical

Manufacturing Industry, adopted in the

Louisiana Register on April 20, 1995 (LR

21:380).

(B) LAC, Title 33, Part III, Chapter 21,

Section 2149, Limiting Volatile Organic

Compound Emissions from Batch

Processing, adopted in the Louisiana

Register on April 20, 1995 (LR 21:387).

(C) LAC, Title 33, Part III, Chapter 21,

Section 2151, Limiting Volatile Organic

Compound Emissions from Cleanup

Solvent Processing, adopted in the

Louisiana Register on April 20, 1995 (LR

21:391).

(ii) Additional material.

(A) Letter of negative declaration for

wood furniture dated January 21, 1997,

from the State of Louisiana Department

of Environmental Quality.

3. Section 52.994 is amended by

designating the existing text as

paragraph (a) and adding paragraph (b)

to read as follows:

§ 52.994 Conditional approvals.

* * * * *

(b) Reasonable Available Control

Technology for the Synthetic Organic

Chemical Manufacturing Industry Batch

Processing Source Category. A letter

dated June 17, 1997 from the Assistant

Secretary of the Louisiana Department

of Environmental Quality to the EPA

Regional Administrator commits the

State to make corrections in LAC

33.III.2149.A.2.b to restore the general

single unit operation exemption to 500

pounds per year or less. The State

commits to make the above rule change

within one year from the Federal

Register publication of the conditional

approval of the batch processing

Reasonable Available Control

Technology rule.

[FR Doc. 97–31408 Filed 12–1–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 64, 70, and 71

[FRL–5928–5]

RIN 2060–AD18

Compliance Assurance Monitoring

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule; availability of

guidance document.

SUMMARY: On October 22, 1997 (62 FR

54900), EPA published a final

Compliance Assurance Monitoring Rule

(CAM). The final rule preamble

described a Guidance Development

Process in which the Agency would

develop non-prescriptive examples of

the types of monitoring that can be used

to satisfy part 64 for various types of

control devices and emissions units. In

order to provide an opportunity for

source owners or operators and other

interested parties to submit suggestions,

review drafts and generally clarify the

part 64 requirements, a Draft CAM

Technical Guidance Document is now

available. The Agency emphasizes that

the development of example monitoring

approaches in this guidance document

is intended to assist both regulated

industry and permitting authorities to

streamline permit review in those

instances where a source owner or

operator proposes monitoring based on

one of the examples. These examples

should not be considered as an implied

limitation on the owner or operator’s

ability to propose a different approach

that the owner or operator can

demonstrate satisfies the part 64

requirements or on the permitting

authority’s authority to require

additional monitoring. A final CAM

Technical Guidance Document should

be available by the end of March 1998.

DATES: Comments on the Draft CAM

Technical Guidance Document should

be received no later than January 5,

1998.

ADDRESSES: Comments should be sent

to: Dan Bivins, U.S. Environmental

Protection Agency, Office of Air Quality

Planning and Standards, MD–19, RTP,

NC 27711, or to:

Bivins.Dan@epamail.epa.gov

The Draft CAM Technical Guidance

Document is available on U.S.

Environmental Protection Agency’s

EMTIC Homepage on the Technology

Transfer Network (via the Internet at

‘‘http://ttnwww.rtpnc.epa.gov/html/

emticwww/index.htm’’, 24 hours a day,

7 days a week , except Monday, 8–12

a.m. EST).

FOR FURTHER INFORMATION CONTACT: Dan

Bivins at (919) 541–5244.

Henry C. Thomas,

Acting Director, Office of Air Quality Planning

and Standards.

[FR Doc. 97–31576 Filed 12–1–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180

[OPP–300589; FRL–5758–7]

Pyrimethanil; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

import tolerance for residues of the

fungicide 4,6-dimethyl-N-phenyl-2-

pyrimidinamine expressed as

pyrimethanil in or on the raw

agricultural commodity (RAC) wine

grapes at 5.0 ppm. AgrEvo USA

Company submitted a petition to EPA

under the Federal Food, Drug, and

Cosmetic Act (FFDCA) as amended by

the Food Quality Protection Act of 1996

(Pub. L. 104-170) requesting the

tolerance.

DATES: This regulation becomes

effective December 2, 1997. Objections

and requests for hearings must be

received by EPA on or before February

2, 1998.

ADDRESSEES: Written objections, and

hearing requests identified by the

docket control number, OPP–300589,

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–

300589, must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticides 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 5.1/6.1 file

format or ASCII file format. All copies
Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations 63663

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300589]. 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: Mary Waller, 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) 308–9354, e-mail:

waller.mary@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 1, 1997 (62

FR 41379) (FRL–5732–4), EPA issued a

notice pursuant to section 408 of the

Federal Food, Drug, and Cosmetic Act

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

the filing of a pesticide tolerance

petition (PP 4E4384) by AgrEvo USA

Company, Little Falls Center One, 2711

Centerville Rd., Wilmington, DE 19808.

The notice included a summary of the

petition prepared by AgrEvo USA

Company. There were no comments

received in response to the notice of

filing. The petition requested that 40

CFR part 180 be amended by

establishing a tolerance for residues of

the fungicide 4,6-dimethyl-N-phenyl-2-

pyrimidinamine expressed as

pyrimethanil in or on the raw

agricultural commodity wine grapes at

5.0 parts per million (ppm).

I. Risk Assessment and Statutory

Findings

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 if 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 of 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. . . .’’

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 more 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 to pose a reasonable

certainty of no harm. EPA generally uses

the RfD to evaluate chronic risks posed

by pesticide exposure. For shorter term

risks, which could occur for residential

uses of a pesticide, 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. The MOE is a measure of how

close the exposure comes to the NOEL.

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 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,’’

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 enactment

of FQPA, this risk 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

reassessment, risks from average food

and water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

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,
63664 Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations

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

risks 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

ground water 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

pesticide. 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 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 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. Review of this regional data

allows EPA to be reasonably certain that

no regional population is exposed to

residue levels higher than those

estimated by the Agency.

II. 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 pyrimethanil and to make the

determination on aggregate exposure,

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

tolerance for pyrimethanil on wine

grapes at 5.0 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 pyrimethanil are

discussed below.

1. A battery of acute toxicity studies

resulted in an acute oral LD50 = 4,149

milligrams/kilograms (mg/kg) (males)

and 5,971 mg/kg (females); an acute

dermal LD50 >5,000 mg/kg for both

sexes; an acute inhalation LC50 >1.98

mg/L; slight eye irritation; no dermal

irritation; and a finding that

pyrimethanil is not a sensitizer.

2. A subchronic oral toxicity study in

rats fed pyrimethanil at dose levels of 0,

80, 800, or 8,000 ppm for 13 weeks.

Those doses were equivalent to daily

intake of 0, 5.4, 54.5, 529.1 milligrams/

kilograms/day (mg/kg/day) for males

and 0, 6.8, 66.7, 625.9 mg/kg/day for

females. A supplementary control and a

high dose (8,000 ppm) group were

similarly treated for 13 weeks then

maintained off-dose for 28 days to

investigate the reversibility of any

findings. Treatment of pyrimethanil did

not affect mortality, clinical signs, water

intake, ophthalmology, hematology,

blood chemistry, or macroscopic

pathology.

Under the conditions of this study,

the No Observed Effect Level (NOEL)

was estimated to be 80 ppm (equivalent

to a daily intake of 5.4 mg/kg/day for

males and 6.8 mg/kg/day for females).

The Lowest Observed Effect Level

(LOEL) was estimated to be 800 ppm

(54.5 mg/kg/day for males and 66.7 mg/

kg/day for females). The LOEL is based

on decreased body weight gains in

females, changed coloration of urine

specimens, and increased incidence of

hypertrophy of centrilobular

hepatocytes in males.

3. A subchronic oral toxicity in mice

fed technical pyrimethanil at dose levels

of 0, 80, 900, or 10,000 ppm for 13

weeks. Those doses were equivalent to

0, 12, 139, or 1,864 mg/kg/day for males

and 0, 18, 203, or 2,545 mg/kg/day for

females, respectively. There were no

treatment-related effects in mortality,

clinical signs, water intake, or

hematological parameters.

The NOEL was estimated to be 900

ppm, equivalent to daily intake of 139

and 203 mg/kg/day for males and

females, respectively. The LOEL was

estimated to be 10,000 ppm, equivalent

to daily intake of 1,864 and 2,545 mg/

kg/day for males and females,

respectively. The LOEL is based on

decreased body weight gains, clinical

chemistry data, necropsy, and

histopathological findings.

4. A subchronic oral toxicity study in

dogs dosed with technical pyrimethanil

by gavage at dose levels of 0, 6, 80, or

1,000/800 mg/kg/day for 13 weeks. The

highest dose was reduced from 1,000

mg/kg/day to 800 mg/kg on day 7 due

to persistent vomiting seen in all dogs

receiving 1,000 mg/kg. Concentrations

of dosing suspension (0.5% (w/v)

methyl cellulose in distilled water) were

within ranges of 82.5% to 121.7% of

nominal. There were no treatment

related effects on mortality, organ

weights, necropsy findings,

histopathological, ophthalmoscopical,

or hematological parameters.
Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations 63665

Under the conditions of this study,

the NOEL was estimated to be 6 mg/kg.

The LOEL was estimated to be 80 mg/

kg. The LOEL is based on the increased

incidence of vomiting and diarrhea,

salivation, cream coloration of feces,

hypoactivity, and decreased water

consumption.

5. A chronic oral toxicity study in

dogs dosed with pyrimethanil by gavage

at doses of 0, 2, 30, or 400/250 mg/kg/

day for 12 months. Administration of

the test material at 400 mg/kg/day

caused a high incidence of vomiting/

emesis during week 1 of the study. For

this reason, the dose regimen was

decreased to 250 mg/kg/day on day 8 of

the study. At this dose (250 mg/kg)

vomiting was decreased to about 1% in

all animals.

Based on the results of this study, the

NOEL is 30 mg/kg/day and the LOEL is

250 mg/kg/day, based on the decrease in

body weight, food consumption, feed

efficiency, and water consumption,

reduced clotting times, and increases in

white blood cells, (mainly neutrophils).

6. A carcinogenicity feeding study in

mice fed technical pyrimethanil at dose

levels of 0, 16 ppm (males 2.0, females

2.5 mg/kg/day), 160 ppm (males 20.0,

females 24.9 mg/kg/day), or 1,600 ppm

(males 210.9, females 253.8 mg/kg/day)

for 80 weeks resulted in a dose-related

increase in the percentage (24%, 38%,

40%, and 67% in control, low-, mid-,

and high-dose males, respectively) of

deaths occurring prior to week 56 in

males but there was no dose-related

adverse effect on survival in either sex

and adequate numbers of mice (both

sexes) were available at study

termination.

Treated males displayed a higher

incidence of urinary bladder distension

at necropsy, and urogenital tract lesions

were increased at the high-dose level

compared to the control values. Since

all urogenital tract tissues of the lowand mid-dose males were not examined,

a dose-response cannot be determined.

The NOEL for systemic effects can be set

at 1,600 ppm (males 210.9, females

253.8 mg/kg/day), the highest dose

tested (HDT). There was no increase in

the incidence of any tumor type in

either sex.

7. A combined chronic toxicity/

carcinogenicity study in rats fed

pyrimethanil at dose levels of 0, 32, 400,

or 5,000 ppm for 52 weeks (interim kill)

or 104 weeks (main study). Those doses

were equivalent to daily intake of 0, 1.3,

17, or 221 mg/kg/day for males and 0,

1.8, 22, or 291 mg/kg/day for females.

At the interim kill (52 weeks), relative

liver/body weight ratios of animals

given 5,000 ppm were siginificantly

higher than controls. Necropsy revealed

dark thyroids in 5,000 ppm treated

animals only. Microscopic pathology

showed minimal to moderate

hypertrophy of centrilobular

hepatocytes in animals given 5,000

ppm. In the thyroid gland, at 5,000 ppm,

there were higher incidences of minimal

to slight colloid depletion and

hypertrophy of the follicular epithelium

in males and females. A single focus of

follicular hyperplasia was seen in males

only. There were minimal to moderate

intra-epithelial depositions of brown

pigment (lipofuscin).

At the terminal kill (104 weeks), at

5,000 ppm, an increase of absolute liver

weight was observed in males only

while increases of relative liver/body

weight ratios were seen in both sexes.

Non-neoplastic findings included

minimal to slight hypertrophy of

centrilobular hepatocyes. There were

higher incidences of eosinophilic foci in

the liver of males and females compared

with controls. Minimal to moderate

focal cystic degeneration of the liver

was also observed in males and females.

In the thyroid gland, colloid depletion

and hypertrophy of the follicular

epithelium was seen in males and

females compared to controls.

Depositions of intra-cytoplasmic brown

pigment (lipofuscin) within the thyroid

follicular epithelium were seen only in

animals given 5,000 ppm (38/50 males

and 47/50 females).

The only tissue showing a higher

incidence of tumors than controls was

the thyroid gland with benign follicular

cell adenomas in both sexes. A pairwise comparison for the incidence in

high dose (5,000 ppm) treated males

was not statistically higher than the

control. The incidence in both sexes

was higher than the historical control

range. A positive trend of the incidence

for both sexes was noted. In addition,

thyroid follicular cell adenocarcinomas

were seen in animals treated at 32 ppm

(males) and 5,000 ppm (1 male only);

however, the incidence was within the

historical control range.

At 400 ppm, a statistically significant

increase of serum GGT level in males

only was observed at week 102.

Increased absolute liver weight (the

relative liver/body weight ratio was

comparable to control) in males was

reported in the terminal necropsy

findings. However, these parameters are

considered to be of no toxicological

significance because no corresponding

significant histopathological finding

was seen.

No treatment-related significant

effects were seen in animals given 32

ppm.

Under the condition of this study, the

NOEL was estimated to be 400 ppm.

(equivalent to 17 mg/kg/day for males

and 22 mg/kg/day for females). The

LOEL was estimated to be 5,000 ppm

(equivalent to 221 mg/kg/day for males

and 291 mg/kg/day for females). The

LOEL was based on decreased body

weight gains, increased serum

cholesterol and GGT levels, increased

relative liver/body weight ratios,

necropsy, and histopathological

findings.

8. An oral development toxicity study

in rats gavaged with pyrimethanil

suspensions (1% (w/v) aqueous methyl

cellulose at doses of 0, 7, 85, or 1,000

mg/kg/day from gestation days 6

through 15. Maternal toxicity (hunched

body posture, emaciation, and hair loss)

were noted in high-dose animals.

Treatment-related, statistically

significant decreases in body weights

and body weight gains were observed in

high-dose animals. Except for

statistically significant decreased in

mean litter weight and mean fetal

weight of high-dose animals, all other

caesarian section data were comparable

to control values. The maternal NOEL

was 85 mg/kg/day and the LOEL was

1,000 mg/kg/day (limit dose), based on

decreases in mean body weight, mean

body weight gain, mean litter weight,

and mean fetal weight. The

developmental NOEL was 1,000 mg/kg/

day (limit dose). The developmental

LOEL was not established.

9. A developmental toxicity

(teratology) study in rabbits gavaged

with pyrimethanil at doses of 0, 7, 45,

or 300 mg/kg/day on gestation day 7

through 19. At 7 mg/kd/day, no

treatment-related maternal or

developmental effects were observed.

The maternal NOEL is 7 mg/kg/day and

the maternal LOEL is 45 mg/kg/day

based on the slight increase in the

number of females with reduced

production and size of fecal pellets. The

developmental NOEL is 45 mg/kg/day

and the LOEL is 300 mg/kg/day based

on decreased fetal weight, increased

incidence of fetal runts, increase in

retarded ossification of fetal bones,

increase in fetuses with 13 thoracic

vertebrae, and 13 pairs of ribs.

10. A reproduction toxicity study in

rats fed pyrimethanil at dose levels of 0,

32, 400, or 5,000 ppm (males: 0, 1.9,

23.1, or 294 mg/kg/day; females: 0, 2.2,

27.4, 343 mg/kg/day) during premating,

gestation, and lactation periods. No

treatment-related differences were noted

in the necropsy findings of parental

animals and their offspring. Treatmentrelated decreases in mean body weights

were limited to high-dose parental

animals and their offspring.

The NOEL for reproductive toxicity is

5,000 ppm (294 mg/kg/day, males; 343
63666 Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations

mg/kg/day, females), the highest dose

tested. The NOEL for developmental/

systemic toxicity is 400 ppm (23.1 mg/

kg/day, males; 343 mg/kg/day, females);

the LOEL was established at 5,000 ppm

(294 mg/kg/day, females), based on

decreased pup body weights on

lactation day 21.

11. Studies on gene mutation and

other genotoxic effects: A bacterial

mutation assay with s. typhimurium; a

bacterial mutation assay with E. Coli; a

mouse micronucleus assay; an in vitro

metaphase chromosomal aberration

assay (human lymphocytes); an in vivo

unscheduled DNA synthesis assay (rats)

showed no evidence of mutagenic

activity.

12. A metabolism study showed that

the majority (≈90%) of the administered

dose of 14C-pyrimethanil following 14

days of repeated oral exposure to

unlabeled pyrimethanil (5/sex) at a dose

level of 10 mg/kg was eliminated within

24 hours, and the major route of

elimination was via the urine (≈72%).

Approximately 17-18% of the dose was

eliminated via feces. Radiolabeled

pyrimethanil was detected only in the

liver, kidney, and blood at study

termination (24 hours post dose). The

highest residue was displayed in the

liver in both sexes. There was no

significant sex difference. The overall

recovery of radiolabeled pyrimethanil

was ≈91%.

13. A metabolism study showed that

the majority of a radiolabeled dose of

pyrimethanil (≈97% low dose; 65% high

dose) administered following single oral

exposures of rats to dose levels of 11.89

or 800 mg/kg of pyrimethanil was

eliminated within 24 hours, and the

major route of elimination was via the

urine (low dose 74%-76%; high dose

65%-67%). Approximately 21%-23% of

the low dose and ≈15%-18% of the high

dose was eliminated via the feces. The

highest residues were displayed in the

liver, kidney, thyroid, and blood at the

high dose. The overall recovery of

radiolabeled pyrimethanil following

single-dose exposure was >94% at the

high dose and >101% at the low dose.

No sex differences were observed. Since

tissue levels were measured at only one

time point, no statement regarding

bioaccumulation can be made.

14. A metabolism study in rats

administered 14C-pyrimethanil orally

once a day over a period of 28 days (10

mg/kg), with periodic sacrifices at days

1, 3, 5, 8, 11, 17, 23, 28, and 32 for

residue analysis of organs/tissues

showed detectable levels of radiolabeled

pyrimethanil in adrenals, blood, kidney,

liver, spleen, and thyroid. Blood and

liver displayed detectable levels of

radiolabeled pyrimethanil after a single

dose (24-hour sample). Four days after

the last dose, detectable levels of

radiolabeled pyrimethanil were found

in the liver, kidney, and thyroids. It

appeared that the levels in the blood,

kidney, and thyroid continued to

increase with increased exposure time,

while the level in the adrenal appeared

to reach a plateau, and levels in the liver

appeared to decline.

B. Toxicological Endpoints

1. Acute toxicity. To assess acute

dietary exposure, the Agency used a

NOEL of 45 mg/kg/day and a LOEL of

300 mg/kg/day from a developmental

toxicity study in rabbits for evaluating

acute risk to females 13+, the

subpopulation of concern.

2. Chronic toxicity. A RfD of 0.2 mg/

kg was established based on a long-term

rat toxicity study with a NOEL of 400

ppm and an uncertainty factor of 100.

3. Carcinogenicity. Pyrimethanil was

classified as a Group C chemical -

possible human carcinogen. The

Agency’s Carcinogenicity Peer Review

Committee (CPRC) chose a non-linear

approach (MOE) based on a NOEL of 17

mg/kg/day for increased incidences of

thyroid tumors in rats. The MOE

methodology was selected because of

thyroid tumors associated with

administration of pyrimethanil in the rat

which may be due to a disruption in the

thyroid-pituitary status.

4. Toxicity endpoints for non-dietary

exposure. A toxicity endpoint for nondietary exposure is not required as the

Agency is only considering the import

tolerance on wine grapes.

C. Exposure and Risks

1. From food and feed uses. This is

the first tolerance for residues of

pyrimethanil in or on a raw agricultural

commodity. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from pyrimethanil

as follows:

i. Acute dietary exposure and risk. An

acute dietary endpoint for females 13+

and the general public were assessed

because of potential oral consumptions.

For the subpopulation of concern,

females 13+, the estimated acute Margin

of Exposure (MOE) of 405 demonstrates

no acute dietary concern.

ii. Chronic exposure and risk. The RfD

used for the chronic dietary analysis

was 0.20 mg/kg/day. A tolerance of 5.0

ppm in or on wine grapes was used.

Using the tolerance level residue (5.0

ppm) and assuming that 100% of the

crop is treated, the risk assessment

resulted in use of less than 1% of the

RfD for the general population and all

22 subgroups, including infants under 1

year and children under 13 years of age.

No feed items are associated with wine

grapes and therefore, secondary residues

are not expected. In the best judgement

of the Agency, the pyrimethanil chronic

dietary risk does not exceed the level of

concern.

2. From drinking water. Since this is

an import tolerance and there are no

U.S. registrations for this chemical,

there are not risks associated with

drinking water.

3. From non-occupational non-dietary

exposure. As stated, this is an import

tolerance and there are no U.S.

registrations, therefore no nonoccupational non-dietary exposure and

risk are expected.

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
Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations 63667

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

pyrimethanil has a common mechanism

of toxicity with other substances or how

to include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

pyrimethanil does not appear to

produce a toxic metabolite produced by

other substances. For the purposes of

this tolerance action, therefore, EPA has

assumed that pyrimethanil does not

have a common mechanism of toxicity

with other substances.

D. Aggregate Risks and Determinations

of Safety for U.S. Population

1. Chronic risk. Using the TMRC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to pyrimethanil from food will

utilize less than 1% of the RfD for the

U.S. population and the 22 subgroups,

including 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 exposure over a lifetime

will not pose appreciable risks to

human health. EPA concludes that there

is a reasonable certainty that no harm

will result from aggregate exposure to

pyrimethanil residues.

2. Acute risk. Acute dietary margins of

exposure greater than 100 tend to cause

no dietary concern. The estimated MOE

value of 450 does not exceed the

Agency’s level of concern and therefore,

EPA has a reasonable certainty that no

harm will result from acute dietary

exposure.

E. Aggregate Cancer Risk for the U.S.

Population

This chemical has been classified as

a Group C - chemical (possible human

carcinogen) and a non-linear

methodology (MOE) was applied for the

estimation of human cancer risk. Cancer

MOEs are estimated by dividing the

carcinogenic NOEL of 17 mg/kg/day

from the rat chronic feeding study by

the chronic exposure (TMRC). The

cancer MOE was estimated for the U.S.

population as 40,380. The estimated

MOE does not exceed the Agency’s level

of concern and therefore, EPA has a

reasonable certainty that no harm will

result from exposures to residues of

pyrimethanil.

F. 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

pyrimethanil, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a 2-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development to one or both parents.

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 data base unless

EPA determines that a different margin

of safety will be safe for infants and

children. The developmental and

reproductive toxicity data base for

pyrimethanil is considered to be

complete. The data base includes an

acceptable 2-generation reproduction

study in rats and acceptable pre-natal

developmental toxicity studies in rats

and rabbits. The data did not suggest

any additional sensitivity to the embryo

or neonate following in utero or early

post-natal exposure to pyrimethanil.

The maternal NOEL was 85 mg/kg/day

and the developmental NOEL was 1,000

mg/kg/day (highest dose tested) in the

rat developmental toxicity study. In the

developmental toxicity study in rabbits,

the maternal NOEL was 7 mg/kg/day

and the developmental NOEL was 45

mg/kg/day. Results from the 2-

generation reproduction toxicity study

in rats indicated a reproductive toxicity

NOEL of 294 mg/kg/day for males and

343 mg/kg/day for females (highest dose

tested). The developmental toxicity

NOEL was established at 23.l mg/kg/day

for males and 27.4 mg/kg/day for

females. The developmental and

reproductive NOEL are at least 1,000

fold higher than the RfD (0.2 mg/kg/

day), and should be protective for

infants and children. No additional

safety factors are warranted.

2. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to pyrimethanil

from food will utilize less than 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. EPA concludes that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to pyrimethanil

residues.

III. Other Considerations

A. Metabolism in Plants and Animals.

The metabolism in plants is

adequately understood for the purposes

of this use of pyrimethanil on wine

grapes. The residue of regulatory

concern is the parent compound only,

pyrimethanil. Since it has been

determined that secondary residues in

livestock commodities are not likely to

result from this use, metabolism of

pyrimethanil in animals is not relevant

to this requested use on wine grapes.

B. Analytical Enforcement Methodology

The method accepted by EPA for

enforcement of pyrimethanil in wine

grapes is AgrEvo USA’s Method (R2/2)

Analytical Method for the

Determination of Residues of

Pyrimethanil in Wine by HPLC (MRID #

433450-10). This method is available

from the Docket under docket control

number [OPP–300589] at the address

stated above.

C. Magnitude of Residues.

Fifty-seven field trials consisting of

different applications and

concentrations of pyrimethanil were

performed in Italy, Germany, South

Africa, France, Spain, and Greece.

HPLC/UV was the analytical method

used for residue determination. Grape

and wine samples were stored at -20 °C

and 4 °C, respectively, until analysis.

Maximum storage period was 9 months

and 12 months for wine and grape

samples, respectively. The storage

period, as indicated by the storage

stability data, is considered adequate for

storage samples. Residues of

pyrimethanil for grapes ranged from

0.74 to 4.14 ppm. The maximum value

of 4.14 ppm was obtained after a

maximum total application rate of 4 kg

ai/Ha and a PHI of 26 days.

Additionally, one study showed a

maximum residue for grapes of 6.2 ppm

(PHI = 0 days, Total application rate =

2.4 kg ai/Ha) and another maximum

residue of 9.5 ppm (PHI = 26 days, Total

application rate = 3.0 kg ai/Ha).

However, most of the residue in wine

grapes were less than 4.14 ppm. For
63668 Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations

grape must, residues ranged from 0.41 to

1.3 ppm. For wine, residues ranged from

<0.05 to 1.8 ppm.

A processing study was conducted in

Fresno, California in which one

application of pyrimethanil (40 SC) was

made at a nominal rate of 1 kg ai/Ha at

each of the following growth stages:

flowering, grape closure, color change,

and 21 days pre-harvest. Applications

were made by airblast ground rig

sprayer and all plots were harvested at

normal harvest time.

Residues of pyrimethanil in whole

grapes concentrated in all processed

commodities produced from those

grapes except juice. Raisins and juice

are considered to be the only processed

commodities. Raisin waste, wet and dry

grape pomace are not considered

processed commodities for the purposes

of this petition in/on wine grapes.

However, since this petition is for wine

grapes and not for table grapes, a

tolerance in/on raisins is not needed at

this time. For future tolerance petitions

in grapes grown for fresh consumption,

a tolerance will be required for raisins.

D. Codex Considerations

There are no Mexican, Canadian, or

Codex listings for residues of

pyrimethanil; therefore, there are no

harmonization issues.

IV. Conclusion

Therefore, the tolerance is established

for pyrimethanil in or on wine grapes at

5.0 ppm.

V. 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 the new

section 408(e) and (1)(6) as was

provided in the old section 408 and in

section 409. However, the period of

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

its current procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by February 2, 1998,

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.

VI. Public Docket

EPA has established a record for this

rulemaking under docket control

number OPP–300589 (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at: oppdocket@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.

VII. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

(408(d), such as the tolerance in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility At (RFA) (5

U.S.C.601 et. seq.) do not apply.

Nevertheless, the Agency 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
Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations 63669

to the Chief Counsel for Advocacy of the

Small Business Administration.

VIII. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Parts 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pest, Reporting and recordkeeping

requirements.

Dated: November 21, 1997.

Linda A. Travers,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

a. The authority citation for part 180

continues to read as follows:

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

b. Section § 180.518 is added to read

as follows:

§ 180.518 Pyrimethanil; tolerances for

residues.

(a) General. [Reserved]

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

(e) Import. Import tolerances are

established for residues of the fungicide

4,6-dimethyl-N-phenyl-2-

pyrimidinamine expressed as

pyrimethanil in or on the following raw

agricultural commodity:

Commodity Parts per million

Wine grapes .............. 5.0 ppm

[FR Doc. 97–31552 Filed 12-1-97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 417

[HCFA–1911–IFC]

RIN 0938–AI35

Medicare+Choice Program; Collection

of User Fees From Medicare+Choice

Plans and Risk-Sharing Contractors

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Interim final rule with request

for comments.

SUMMARY: This interim final rule with a

request for comments establishes the

methodology that will be employed to

assess fees applicable to Medicare risksharing contractors for fiscal year (FY)

1998. Under section 4002 of the

Balanced Budget Act of 1997, these

contractors must contribute their pro

rata share of costs relating to beneficiary

enrollment, dissemination of

information, and certain counseling and

assistance programs. The

Medicare+Choice regulation to be

published in June of 1998 will

implement this requirement for

Medicare+Choice plans.

DATES: Effective Date: These regulations

are effective on January 1, 1998.

Comment Date: Comments will be

considered if we receive them at the

appropriate address, as provided below,

no later than 5 p.m. on February 2,

1998.

ADDRESSES: Mail an original and 3

copies of written comments to the

following address: Health Care

Financing Administration, Department

of Health and Human Services,

Attention: HCFA–1911–IFC, P.O. Box

7517, Baltimore, MD 21207–5187.

If you prefer, you may deliver an

original and 3 copies of your written

comments to one of the following

addresses:

Room 309–G, Hubert H. Humphrey

Building, 200 Independence Avenue,

SW., Washington, D.C. 20201, or

Room C5–09–26, 7500 Security

Boulevard, Baltimore, Maryland

21244–1850.

Comments may also be submitted

electronically to the following e-mail

address: HCFA–1911–IFC@hcfa.gov. Email comments must include the full

name and address of the sender, and

must be submitted to the referenced

address in order to be considered. All

comments must be incorporated in the

e-mail message because we may not be

able to access attachments.

Electronically submitted comments will

be available for public inspection at the

Independence Avenue address, below.

Because of staffing and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. In

commenting, please refer to file code

HCFA–1911–IFC. Comments received

timely will be available for public

inspection as they are received,

generally beginning approximately 3

weeks after publication of a document,

in Room 309-G of the Department’s

offices at 200 Independence Avenue,

SW., Washington, D.C., on Monday

through Friday of each week from 8:30

a.m. to 5 p.m. (phone: (202) 690–7890).

FOR FURTHER INFORMATION CONTACT:

Randy Ricktor, (410) 786–4632, Marty

Abeln, (410) 786–1032.

SUPPLEMENTARY INFORMATION:

I. Background

Section 4001 of the Balanced Budget

Act of 1997 (BBA) (Public Law 105–33),

added a new section 1857(e)(2) to the

Social Security Act (the Act), that

establishes a fee requirement that

Medicare+Choice plans must contribute

their pro rata share, as determined by

the Secretary, of costs relating to

enrollment and dissemination of

information and certain counseling and

assistance programs. Section 4002(b) of

the BBA makes this requirement

applicable to those managed care plans

with risk sharing contracts under

section 1876 of the Act. Any amounts

collected are authorized to be

appropriated only for the purpose of

carrying out section 1851 of the Act

(relating to enrollment and

dissemination of information) and

section 4360 of the Omnibus Budget

Reconciliation Act of 1990 (Public Law

103–66, OBRA 1990), relating to the

health insurance counseling and

assistance program.

For any Federal fiscal year (FY), the

fees authorized under section

1857(e)(2)(B) of the Act are contingent

upon enactment in an appropriations

act of a provision specifying the

aggregate amount of fees the Secretary is

directed to collect in that fiscal year.

The BBA fees collected during any FY

are to be credited as offsetting

collections. Under section 1857(e)(2)(D),

the fees authorized under section

1857(e)(2)(B) are not to be established at

any amount greater than the lesser of the

estimated costs to be incurred by the

Secretary in the FY in carrying out the

activities described in sections 1851 of

the Act and 4360 of the OBRA 1990; or

$200 million in Federal fiscal year 1998;

$150 million in fiscal year 1999; and

$100 million in fiscal year 2000 and