64294 Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations

Commodity Parts per million Expiration/Revocation Date

Sheep, liver .......................................................................................... 7 9/30/98

Sheep, kidney ...................................................................................... 32 9/30/98

Sheep, meat ........................................................................................ 2.5 9/30/98

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

PART 185—[Amended]

2. In part 185:

i. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 348.

§ 185.3900 [Removed]

ii. Section 185.3900 is removed.

[FR Doc. 97–31553 Filed 12–4–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300586; FRL–5756–5]

RIN 2070–AB78

Fluorine Compounds; Time-Limited

Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

the insecticidal fluorine compounds

cryolite and/or synthetic cryolite

(sodium aluminum fluoride) in or on

the raw agricultural commodity (RAC)

potatoes and in the processed animal

feed commodity, potato waste. A

petition requesting these tolerances was

submitted by The Cryolite Task Force

under the Federal Food Drug and

Cosmetic Act (FFDCA) as amended by

the Food Quality Protection Act of 1996

(Pub. L. 104–170). The tolerance will

expire on November 21, 2001.

DATES: This regulation is effective

December 5, 1997. Objections and

requests for hearings must be received

by EPA on or before February 3, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, OPP–

300586, 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 document control number, [OPP–

300586], must be submitted to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, Crystal Mall #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202.

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 number [OPP–300586]. 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: Jacqueline Mosby, Environmental

Scientist, 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) 305-6792, e-mail: mosbyromney.jackie2epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued notices as follows regarding

petitions for pesticide tolerances for

insecticidal fluorine compounds in or

on potatoes and in the processed animal

feed, potato waste.

1. March 23, 1989 (54 FR 12009); PP

9F3739; filing notice;

2. April 3, 1991 (56 FR 13643); PP

1F3959 and FAP 1H5604; filing notice.

3. May 5, 1993 (58 FR 26687); PP

9F3739 and FAP 1H5604; final rule for

time-limited tolerances.

4. May 8, 1996 (61 FR 20781) (FRL–

5362–6); PP 9F3739 and FAP 1H5604);

proposed rule for permanent tolerances.

The Agency did not publish a final

rule establishing permanent tolerances

prior to the enactment of the Food

Quality and Protection Act (FQPA) of

1996. Because of new procedures under

FQPA, The Cryolite Task Force, c/o

Gowan Company, P.O. Box 5569, Yuma,

AZ 85336 was required to submit a

notice of filing requesting issuance of

these tolerances in compliance with

FQPA.

In the Federal Register of March 12,

1997 (62 FR 11437) EPA issued a notice

of filing 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 petition (PP) for

tolerance by The Cryolite Task Force.

This notice contained a summary of the

petition prepared by The Cryolite Task

Force.

The petition requested that 40 CFR

180.145 be amended by establishing

tolerances for residues of the

insecticidal fluorine compounds

cryolite and synthetic cryolite in or on

potatoes at 2.0 parts per million (ppm)

and processed potato waste at 22.0 ppm.

These tolerances will expire on

November 21, 2001.

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 that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical
Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations 64295

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 commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all 3 sources

are not typically added because of the

very low probability of this occurring in

most cases, and because the other

conservative assumptions built into the

assessment assure adequate protection

of public health. However, for cases in

which high-end exposure can

reasonably be expected from multiple

sources (e.g. frequent and widespread

homeowner use in a specific

geographical area), multiple high-end

risks will be aggregated and presented

as part of the comprehensive risk

assessment/characterization. Since the

toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established
64296 Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations

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.

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 cryolite and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

cryolite on potatoes at 2.0 ppm, and

processed potato waste at 22.0 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 cryolite are

discussed below.

1. Acute toxicity studies. Oral, dermal,

and inhalation studies place cryolite in

toxicity category III, for acute dermal

and in category IV for acute oral, and

inhalation. No effects are observed in a

skin irritation study, the eye irritation

study shows it to be a moderate irritant

to the eyes; and results of the dermal

sensitization study shows it to be a nonsensitizer.

2. Subchronic toxicity studies. i. A 28-

day range-finding feeding study

conducted with cryolite in rats at dose

levels of 0, 250, 500, 1,000, 2,000, 4,000,

10,000, 25,000 and 50,000 ppm in the

diet (representing approximately 0, 25,

50, 100, 200, 400, 1,000, 2,500 and 5,000

milligrams/kilograms/day) (mg/kg/day)

with the only compound related effect

being a change in coloration and

physical property of the teeth.

The NOEL was not determined. The

LOEL is 250 ppm (25 mg/kg/day) based

on dental fluorosis.

ii. A 90-day rat feeding study

conducted with cryolite at dose levels of

0, 50, 5,000, and 50,000 ppm

(corresponding to 0, 3.8, 399.2 and

4172.3 mg/kg/day in males and 0, 4.5,

455.9 and 4758.1 mg/kg/day in females).

The NOEL is 50 ppm (3.8 mg/kg/day)

for effects other than fluoride

accumulation. The LOEL is 5,000 ppm

(399.2 mg/kg/day) based on lesions

observed in the stomach. Fluoride

accumulated at all dose levels.

iii. A 90-day dog feeding study

conducted with cryolite at dose levels of

0, 500, 10,000, and 50,000 ppm

(corresponding to 0, 17, 368 and 1692

mg/kg/day).

The NOEL is 10,000 ppm (368 mg/kg/

day). The LOEL is 50,000 ppm (1,692

mg/kg/day) for effects other than

fluoride accumulation. Fluoride

accumulation occurred at all dose

levels.

3. Chronic/carcinogenicity studies. i.

A 2-year rat bioassay conducted by the

National Toxicology Program (NTP)

using sodium fluoride as the test

material at dose levels of 0, 25, 100, and

175 ppm, in water, representing 0, 1.3,

5.2 and 8.6 mg/kg/day in males and 0,

1.3, 5.5 and 9.5 mg/kg/day in females.

Osteosarcoma of the bone was only

observed in one male in the 100 ppm

group and in three males in the 175

ppm group. NTP considers this to be

equivocal evidence of carcinogenicity in

male F344/N rats. The NOEL is less than

25 ppm (1.3 mg/kg/day). The LOEL is 25

ppm (1.3 mg/kg/day) based on mottling

of teeth, dentine incisor dysplasia,

increased serum, urine and bone

fluoride levels in males and females and

incisor odontoblast and incisor

ameloblast degeneration in males. There

was ‘‘equivocal evidence’’ of

carcinogenic activity in male rats and

‘‘no evidence’’ of carcinogenic activity

in female rats.

The NTP study utilizing sodium

fluoride as the test material in lieu of

cryolite or synthetic cryolite satisfies the

guideline study requirement for both the

rodent chronic feeding study and the rat

carcinogenicity study. Fluoride has been

identified as the residue of toxicological

concern in cryolite and synthetic

cryolite and the available data show that

these compounds act as free fluoride.

ii. A 2-year mouse bioassay conducted

by the NTP utilizing sodium fluoride as

the test material at dose levels of 0, 25,

100, and 175 ppm, in water,

representing 0, 2.4, 9.6 and 16.7 mg/kg/

day in males and 0, 2.8, 11.3 and 18.8

mg/kg/day in females.

The NOEL is less than 25 ppm (2.4

mg/kg/day). The LOEL is 25 ppm (2.4

mg/kg/day) based on attrition of the

teeth in males, discoloration and

mottling of the teeth in males and

females and increased bone fluoride in

both sexes. There was ‘‘no evidence’’ of

carcinogenic activity in male and female

mice.

This study utilizing sodium fluoride

in lieu of cryolite or synthetic cryolite

as the test material satisfies the

guideline study requirement for a mouse

carcinogenicity study for the reason

described above under item 3.i.

iii. A 1-year chronic dog feeding study

conducted with Cryolite at dose levels

of 0, 3,000, 10,000 and 30,000 ppm,

representing 0, 95, 366 and 1,137 mg/

kg/day in males and 0, 105, 387 and

1,139 mg/kg/day in females (in terms of

fluoride the doses are 0, 51, 198, and

614 mg F/kg/day for males and 0, 57,

209 and 615 mg F/kg/day for females).

The NOEL (in terms of Cryolite) is

less than 3,000 ppm (95 mg/kg/day in

males and 105 mg/kg/day in females).

The LOEL is 3,000 ppm (95 mg/kg/day)

based on increases in emesis, nucleated

cells in males, renal lesions and a

decrease in urine specific gravity in

females.

4. Other studies/documents. i.

Mutagenicity studies including an Ames

test (negative) at dose levels of 167, 500,

1670, 5,000, 7,500 and 10,000 ug/plate;

an in vitro assay in human lymphocytes

(negative) at 100, 500, and 1,000 μg/ml;

and an unscheduled DNA synthesis

study in rat hepatocytes (negative) at

dose levels up to and including 50 μg/

ml.

ii. Drinking water Criteria Document

on Fluoride. Fluoride has been

identified as the residue of toxicological

concern in cryolite and synthetic

cryolite and the available data show that

these compounds which are

approximately 52.8% fluoride, act as

free fluoride.

The EPA Office of Drinking Water

issued a Drinking Water Criteria

Document on Fluoride (October 21,

1985) which presents summaries of

experimental and clinical data on the

health effects of fluoride in animals and

humans. In general, the health effects of

fluoride (F) include dental fluorosis and

skeletal fluorosis.

B. Toxicological Endpoints

1. Acute toxicity. Based on the

available toxicity data, EPA has

determined that cryolite does not

exhibit any adverse health effects

occurring as a result of a one day or

single dietary or non-dietary exposure.

2. Short and intermediate-term

toxicity. Based on the available data,

EPA has determined that cryolite does

not exhibit any adverse heath effects

occurring as a result of short- or

intermediate-term dietary and nondietary exposure.
Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations 64297

3. Chronic toxicity. Rather than the

establishment of the traditional

Reference Dose (RfD), a weight-of-theevidence risk assessment was

determined by the Agency to be a more

appropriate approach for the assessment

of the dietary exposure to fluoride

residues as a result of agricultural uses

of cryolite for the following reasons:

i. National and international

regulatory organizations (U.S. EPA

Office of Water, U.S. DHHS, the

Canadian Government, and the World

Health Organization) have assessed

potential health risks from exposure to

fluoride. The endpoints and estimated

effect levels documented by these

organizations are similar.

ii. The U.S. Surgeon General (Koop,

1984 and Elders, 1994) has

recommended a guideline level of

exposure that should provide an

adequate ‘‘margin of safety’’ based on a

large amount of human data, including

epidemiology studies.

iii. Animal data considered in

evaluating the proposed regulations are

consistent with human data with

respect to dose related skeletal effects.

4. Carcinogenicity. Fluoride has been

the subject of a comprehensive review

by the National Research Council

(National Academy of Sciences

Subcommittee of Health Effects of

Ingested Fluoride) who concluded that

‘‘... the available laboratory data are

insufficient to demonstrate a

carcinogenic effect of fluoride in

animals.’’ and that ‘‘... the weight of

evidence from more than 50

epidemiological studies does not

support the hypothesis of an association

between fluoride exposure and

increased cancer risk in humans.’’ EPA

is in agreement with the conclusions

reached by the National Academy of

Science (NAS).

The available information does not

support the regulation of cryolite as a

carcinogen and it has been classified as

a Group D chemical (not classifiable as

to human carcinogenicity).

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.145) for the residues of cryolite

In or on a variety of raw agricultural

commodities. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from cryolite as

follows:

i. Acute exposure and risk. Based on

the available acute toxicity data, EPA

has determined that cryolite does not

pose any acute dietary risk.

ii. Chronic exposure and risk. The

weight-of-the-evidence dietary risk

assessment was conducted utilizing the

following factors. All calculations are

based on 2 L/day water consumption

and 70 kg adult.

a. There exists no directly applicable

scientific documentation of adverse

medical effects at levels of fluoride

below 8 mg/L 0.23 mg/kg/day. (U.S.

EPA. 1985. National Primary Drinking

Water Regulations; Fluoride. Proposed

Rulemaking. May 14, 1985, 50 FR

20166).

b. Less than 0.4% of the U.S.

population (on public water supplies) is

exposed to greater than 2 mg/L fluoride

0.057 mg/kg/day in the public water

supply. (U.S. EPA. 1985. drinking Water

Criteria Document on fluoride. U.S. EPA

Office of Drinking Water, Washington,

DC TR-832-5. pg. IV-3, Table IV-1.)

The dietary exposure estimates used

reassessed tolerances and percent of

crop treated. These exposure estimates

are conservative since average residues

were not calculated and monitoring data

were not used to refine residue

estimates.

Section 408(b)(2)(F) allows the

Agency to use data n the actual percent

of crop treated when establishing a

tolerance only where the Agency can

make the following findings:

(a) That data used are reliable and

provided a valid basis for showing the

percentage of food derived from a crop

that is likely contain residues.

(b) That the exposure estimate does

not underestimate the exposure for any

significant subpopulation.

(c) Where data on regional pesticide

use and food consumption are available,

that the exposure estimate does not

understate exposure for any regional

population. In addition, the Agency

must provide for periodic evaluation of

any estimates used.

Percent of crop treated estimates are

derived from federal and market survey

data. EPA considers these data reliable.

Typically a range of estimates are

supplied and the upper end of this

range is used for the exposure

assessment. By using this upper end

estimate of percent crop treated, EPA is

reasonably certain that exposure is not

underestimated for any significant

subpopulation. 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. 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 EPA.

EPA has made these findings when

appropriate with respect to the

proposed tolerance. EPA has not

provided for periodic reevaluation of

the data on percent crop treated because

this tolerance has a time-limitation.

2. From drinking water— i. Acute

exposure and risk. Based on the

available acute toxicity data, EPA has

determined that fluoride does not pose

any acute dietary risk.

ii. Chronic exposure and risk.

Fluoride levels in public drinking water

are regulated under the Safe Drinking

Water Act. EPA has established a

Maximum Concentration Limit (MCL) at

4.0 mg/L 0.114 mg/kg/day to protect

against crippling skeletal fluorosis

(April 2, 1986) (51 FR 11396). The MCL

established on April 2, 1986 finalizes

interim regulations set in the Federal

Register of November 14, 1985 (50 FR

47142), and proposed in the Federal

Register of May 14, 1985 (50 FR 20164).

In addition, these Federal Register

notices established a Secondary

Maximum Contaminant Level (SMCL) at

2.0 mg/L 0.057 mg/kg/day for cosmetic

effects (objectionable dental fluorosis)

which are not considered to be adverse

health effects by the Surgeon General.

As described above, less than 0.4% of

the U.S. population (on public water

supplies) is exposed to greater than 2

mg/L fluoride 0.057 mg/kg/day in the

public water supply.

3. From non-dietary exposure.

Cryolite is registered for use on

ornamentals, a use which could result

in residential, non-occupational

exposure. It is not registered for indoor

use. EPA has not estimated non-dietary

or residential exposure from registered

ornamental uses of cryolite because

i. There are no toxicological

endpoints identified for cryolite.

ii. Fluoride occurs naturally in the

environmental background and there

would not be significant exposure to

fluoride from the use of cryolite.

iii. It would not be appropriate since

the available information regarding

solubility and degradation indicates that

there would likely be no appreciable

dermal absorption. The Agency does not

anticipate significant non-dietary

exposure from the use of cryolite.

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
64298 Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

cryolite 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, cryolite

does not appear to produce a toxic

metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not

assumed that cryolite has a common

mechanism of toxicity with other

substances. For the purpose of this timelimited tolerance, the Agency has

considered risks from cryolite and from

fluoride in intentionally fluoridated

water.

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. Based on the available

acute toxicity data, EPA has determined

that cryolite does not pose any acute

dietary risk.

2. Chronic risk. Fluoride is ubiquitous

and may be present at low levels in air,

soils and in foodstuffs that have not

been treated with cryolite and/or

synthetic cryolite as well as in drinking

water. The atmospheric levels of

fluoride and incidental dietary

exposures to fluoride as a toothpaste

additive or as a dental treatment

contribute relatively little to the average

level of dietary fluoride exposure and

are not further considered in the

exposure estimate.

Dietary exposure estimates using

reassessed tolerance/including the

subject tolerance for potatoes ( which is

estimated as approximately 0.00016 mg/

kg/day) and percent of crops treated are

approximately 0.020 mg/kg/day for the

U.S. population and 0.028 mg/kg/day

for the highest exposed subgroup

(females 13 years old and over, nursing).

These exposure estimates are

conservative since average residues

were not calculated and monitoring data

were not used to refine residue

estimates.

Therefore, it can be concluded that

levels of fluoride in/on food from the

agricultural use of Cryolite plus fluoride

levels in U.S. drinking water supplies

(0.057 mg/kg/day) results in a high-end

daily dietary intake of fluoride of

approximately 0.085 mg/kg/day. This is

less than the Maximum Concentration

Limit (MCL) of 4.0 mg/L 0.114 mg/kg/

day, a level which provides no known

or anticipated adverse health effect as

determined by the Surgeon General.

Due to the fact that fluoride naturally

occurs at low levels in food and air as

well as drinking water, there is a low

percentage of the population (0.4%)

exposed to levels above the secondary

Maximum Contaminant Level (2 mg/L)

and below the MCL, dietary exposure

from agricultural uses is low (typically

much less than ca. 66% of the levels

found in intentionally fluoridated

water), and aggregate high-end exposure

is estimated to be below the MCL, EPA

concludes there is a reasonable certainty

that no harm will result from aggregate

exposure to fluoride residues.

3. Short-and intermediate -term risk.

Short-and intermediate-term risk

aggregate exposure takes into account

chronic dietary food and water

(considered to be a background

exposure level) plus indoor and outdoor

residential exposure. As explained

above, EPA does not anticipate

significant non-dietary (residential)

exposure from the use of cryolite.

E. Aggregate Cancer Risk for U.S.

Population

As described above, the available

information does not support the

regulation of cryolite as a carcinogen

and it has been classified as a Group D

chemical (not classifiable as to human

carcinogenicity).

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

cryolite, EPA considered data from oral

developmental toxicity studies in the rat

and mouse; and a range-finding study in

the rabbit as well as data from 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 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 margin

of exposure 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 MOE and uncertainty

factor (usually 100 for combined interand intra-species variability) and not the

additional tenfold MOE/uncertainty

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 MOE/safety factor.

ii. Developmental toxicity studies. A

developmental toxicity study conducted

with cryolite in rats at dose levels of 0,

750, 1,500, and 3,000 mg/kg/day

(gavage) in which the NOEL for both

developmental and maternal toxicity

was 3,000 mg/kg/day. At this dose level,

the only observation was whitening of

the teeth of dams.
Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations 64299

A developmental toxicity study

conducted in female mice with Cryolite

at dose levels of 0, 30, 100 and 300 mg/

kg/day (gavage) in which the NOEL for

maternal toxicity was 30 mg/kg/day and

the LOEL was 100 mg/kg/day based on

the occurrence of dark red contents of

the stomach. Fetuses at the highest dose

tested, 300 mg/kg/day exhibited bent

ribs and bent limb bones.

A range-finding developmental

toxicity study conducted in female

rabbits with Cryolite at dose levels of 0,

10, 30, 100, 300 and 1,000 mg/kg/day

(gavage) which showed only severe

maternal effects at all doses. There were

no developmental findings in the

fetuses up to 30 mg/kg/day. At doses

greater than 30 mg/kg/day,

developmental findings were not

observed due to the severe maternal

toxicity.

A new rabbit developmental study is

not required at this time since there are

two acceptable rodent developmental

studies (rat and mouse) showing no

specific adverse developmental effects.

In addition, the National Academy of

Sciences (NAS) report supports this

decision. It is unlikely that an

additional rabbit developmental study

would alter the risk evaluation for

cryolite.

The rabbit range-finding study

suggested that severe maternal toxicity

occurred at lower doses than external

developmental toxicity. However,

following an extensive literature

evaluation, the National Research

Council (National Academy of Sciences

Subcommittee of Health Effects of

Ingested Fluoride) (NAS) determined

that:

There have been reports of adverse effects

on reproductive outcomes associated with

high levels of fluoride intake in many animal

species. In most of the studies, however, the

fluoride concentrations associated with

adverse effects were far higher than those

encountered in drinking water. ...

Based on these findings, the subcommittee

concludes that the fluoride concentrations

associated with adverse reproductive effects

in animals are far higher than those to which

human populations are exposed.

Consequently, ingestion of fluoride at current

concentrations should have no adverse

effects on human reproduction.

iii. Reproductive toxicity study. A 2-

generation reproduction study

conducted with Cryolite in the diet of

rats at dose levels of 0, 200, 600, and

1,800 ppm (representing 0, 14, 42, and

128 mg/kg/day for males and 0, 16, 49,

and 149 mg/kg/day for females,

respectively, during premating) in

which the LOEL for systemic toxicity

was 200 ppm (15 mg/kg/day) based on

dental fluorosis. The NOEL for

decreased pup body weight was 46 mg/

kg/day and, at the lowest dose tested (8

mg/kg/day) there was parental toxicity.

Therefore, there was pup toxicity only

in the presence of parental toxicity.

iv. Pre- and post-natal sensitivity.

Based on current data requirements, the

database relative to pre- and post-natal

toxicity is complete. These data taken

together suggest minimal concern for

developmental or reproductive toxicity

and do not indicate any increased preor post-natal sensitivity.

v. Conclusion. Therefore, EPA

concludes that reliable data support use

of the weight-of-the-evidence risk

assessment approach for the assessment

of risks to infants and children

associated with the use of cryolite and

that an additional safety factor is not

needed.

2. Acute risk. As described above,

based on available acute toxicity data,

EPA has determined that cryolite does

not pose any acute dietary risk.

3. Chronic risk. The high end dietary

exposure estimate for infants and

children using reassessed tolerances and

percent of crops treated is 0.024 mg/kg/

day. This is lower than the exposure

estimate of 0.028 mg/kg/day which was

used in the Agency’s determination of

safety for the U.S. population described

above.

EPA concludes that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to fluoride residues.

4. Short- or intermediate- term risk.

As described above, EPA has

determined that cryolite does not

exhibit any adverse health effects

occurring as a result of short- or

intermediate-term dietary and nondietary exposure.

III. Other Considerations

A. Metabolism In Plants and Animals

The metabolism of the subject

insecticides in plants and animals is

adequately understood.

Open literature studies show that

human and animal metabolism of

cryolite and/or synthetic cryolite

manifests itself as normal free fluoride

metabolism. That is, dissociation

occurs, producing free fluoride ions

which are assimilated into bone. The

residue of concern in animals is total

fluoride.

Plant residues are inorganic surface

residues of cryolite which are measured

as total fluoride. Uptake and

translocation of cryolite residues from

soil is unlikely due to the low water

solubility of cryolite.

B. Analytical Enforcement Methodology

An adequate analytical method

(fluoride specific electrode) is available

for enforcement purposes for plant and

animal residues. The limit of

quantitation is 0.05 ppm. Because

cryolite is an inorganic ionic compound,

the requirement for data using the

multi-residue protocols in the Pesticide

Analytical Manual (PAM) Vol. I is not

applicable.

Because of the long lead time from

establishing these tolerances, to

publication of the enforcement

methodology in the PAM Vol. II, the

analytical methodology is being made

available in the interim to anyone

interested in pesticide enforcement

when requested from; Calvin Furlow,

Public Information Branch, Field

Operations Division (H7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St.,

SW.,Washington, DC 20460. Office

location and telephone number; Rm.

1128, CM #2, 1921 Jefferson Davis Hwy.,

VA 22202, (703)-305-5232.

C. Magnitude of Residues

It has been determined that residues

of cryolite are not expected to exceed

2.0 ppm in potatoes and 22.0 ppm in

processed potato waste.

Data submitted in support of the

subject petition show background levels

of fluoride in untreated potatoes ranged

from 0.14 ppm to 0.31 ppm and are

consistent with the ranges reported in

the open literature. Levels of fluoride

found in the treated potatoes ranged

from 0.18 ppm to 0.94 ppm. The residue

analytical method used for enforcing the

subject tolerance and regulation cannot

distinguish between the naturally

occurring fluoride and the fluoride

resulting from use of cryolite and/or

synthetic cryolite.

A potato processing study showed

that cryolite residues did not

concentrate in potato chips, flakes or

granules. Therefore, tolerances on these

commodities are not required.

There is no reasonable expectation of

finite fluoride residues in ruminant or

poultry tissues as a result of livestock

ingestion of cryolite and this situation

falls under 40 CFR 180.6 (a)(3).

Therefore, tolerances for cryolite

residues in meat, milk, poultry, and eggs

are not required.

D. International Residue Limits

No Codex Maximum Residue Limits

(MRLs) for fluorine compounds

(cryolite) exist. Therefore, there are no

questions of compatibility with respect

to Codex MRLs and U. S. tolerances.

E. Rotational Crop Restrictions

The residue available to rotational

crops is expected to be negligible with
64300 Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations

respect to the amount of free fluorine

occurring naturally in soil.

F. Endocrine Effects

No evidence of such effects were

reported in the toxicology studies

described above. There is no evidence at

this time that cryolite causes endocrine

effects.

IV. Conclusion

Therefore, the tolerance is established

for residues of cryolite in or on potatoes

at 2.0 ppm and in potato waste from

processing at 22.0 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 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 February 3, 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

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

A record has been established for this

rulemaking under docket control

number [OPP–300586] (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.

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 these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the tolerance in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

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

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VIII. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: November 21, 1997.

Linda A. Travers,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:
Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations 64301

PART 180—[AMENDED]

a. The authority citation for part 180

continues to read as follows:

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

b. In § 180.145:

i. By designating paragraph (a) as

paragraph (a)(1), by adding paragraph

(a)(2), and by adding a heading to

paragraph (a).

ii. By removing paragraph (c) and

redesignating paragraph (b) as new

paragraph (c) and adding a heading.

iii. By adding and reserving new

paragraphs (b) and (d) with headings.

The amendments to § 180.145 read as

follows:

§ 180.145 Fluorine compounds: tolerances

for residues.

(a) General. * * *

(2) Time-limited tolerances are

established for residues of the

insecticidal fluorine compounds

cryolite and synthetic cryolite (sodium

aluminum fluoride) in or on the

commodities as follows:

Commodity Parts per million Expiration/revocation date

Potatoes ................................................... 2.0 11/21/2001

Potatoes, waste from processing ............. 22.0 11/21/2001

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. * * *

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–31920 Filed 12–4–97; 8:45 am]

BILLING CODE 6560–50F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

45 CFR Parts 205, 232, 233, 235, 250,

251, 255, 256, and 257

RIN 0970–AB84

Repeal of Obsolete Title IV–A and IV–

F Program Rules

AGENCY: Administration for Children

and Families (ACF), HHS.

ACTION: Final rule; removal.

SUMMARY: This document removes

regulations governing certain programs

repealed or eliminated under the

Personal Responsibility and Work

Opportunity Reconciliation Act of 1996,

including: Emergency Assistance; Job

Opportunities and Basic Skills Training;

and three child care programs

authorized under title IV–A of the

Social Security Act. It also repeals some

administrative rules of the AFDC

program, because the program was

repealed effective July 1, 1997.

DATES: Effective date is December 5,

1997.

FOR FURTHER INFORMATION CONTACT:

Mack Storrs, Director, Division of SelfSufficiency Programs, Office of Family

Assistance, ACF, at 202–401–9289.

SUPPLEMENTARY INFORMATION: On August

22, 1996, President Clinton signed The

Personal Responsibility and Work

Opportunity Reconciliation Act of

1996—or PRWORA—into law. This law

replaced the nation’s largest public

assistance program, known as Aid to

Families with Dependent Children, and

affiliated programs, with a new block

grant to States. It also made substantial

changes to the Federal child care

programs that served welfare recipients

and other low-income families.

This legislation made a number of our

existing regulations obsolete, effective

July 1, 1997, or earlier. The purpose of

this rulemaking is to remove many of

the obsolete rules. Thus, this

rulemaking reflects ACF’s continuing

commitment to the Administration’s

regulatory reinvention initiative. In

particular, it responds to the first

directive in the President’s strategy—to

‘‘cut obsolete regulations.’’ Through this

rulemaking, we are eliminating

approximately 82 pages of obsolete rules

from the Code of Federal Regulations.

Aid to Families With Dependent

Children and Emergency Assistance

Section 103(a) of PRWORA (Pub. L.

104–193) repealed the provisions in the

existing part A of title IV of the Social

Security Act and replaced them with

provisions governing the new welfare

block grant. Under section 116 of

PRWORA, this change took effect on

July 1, 1997, except in States that chose

to implement their new welfare

programs at an earlier date. The

provisions that were repealed governed

the existing programs of Aid to Families

with Dependent Children (AFDC) and

Emergency Assistance (EA).

The regulations for the Emergency

Assistance program are found at 45 CFR

233.120. This rulemaking would remove

this section of the regulation in its

entirety.

The regulations for the AFDC program

are found throughout Chapter II of Title

45 in the Code of Federal Regulations.

In this rulemaking we are removing

only a limited number of administrative

rules. They are those AFDC rules that

address the AFDC Quality Control

System (authorized under section 408 of

the Social Security Act, as in effect

under prior law), some provisions

related to child support requirements

and fraud control, and certain

provisions related to financial penalties

against the States under prior law.

We will make other conforming

changes to the AFDC regulations at a

later date. We must exercise care in

repealing the AFDC rules because: (1)

eligibility for other programs, such as

title IV–E (Foster Care) and title XIX

(Medicaid), retain a direct connection to

the AFDC rules in effect prior to

PRWORA; and (2) many of the AFDC

provisions are intertwined with

provisions for other assistance programs

that were not repealed. (The most

notable example of this latter problem is

the overlap between the AFDC rules and

the rules for the adult programs

operated by the Territories under titles

I, X, IV, and XVI of the Social Security

Act.) To address these more sensitive

and complicated conforming changes,

we need to engage in additional analysis

and consult with other Federal agencies

and other interested groups. Thus, most

of the conforming changes to the AFDC

regulations will be reserved for future

rulemaking efforts.

The IV–A Child Care Programs

Section 103(c) of PRWORA

eliminated the child care provisions that

were in title IV–A of the Social Security

Act at the time of enactment. Under

section 116(c) of PRWORA, the

elimination of those provisions took

effect on October 1, 1996. The new child

care provisions in title VI of PRWORA

took effect that same day.

The programs eliminated by

PRWORA were: child care for AFDC

recipients and JOBS participants under

section 402(g) of the Act, transitional

child care for former AFDC recipients

under section 402(g) of the Act, and

child care for at-risk families under