43284 Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Rules and Regulations

11Alabama, Alaska, Arizona, Arkansas,

California, Colorado, District of Columbia, Idaho,

Illinois, Iowa, Indiana, Kansas, Kentucky,

Louisiana, Maryland, Massachusetts, Minnesota,

Mississippi, Nebraska, New Mexico, Oklahoma,

Oregon, Pennsylvania, Texas, Utah, Vermont,

Virginia, Washington, West Virginia, Wyoming.

Procedural Requirements

This final rule does not meet the

criteria for a ‘‘significant regulatory

action’’ pursuant to Executive Order

12866. The notice and public comment

procedures requirements of the

Administrative Procedure Act are

inapplicable, pursuant to 5 U.S.C.

553(a)(2).

As no notice of proposed rulemaking

was required, the provisions of the

Regulatory Flexibility Act (5 U.S.C. 601,

et seq.) do not apply.

There are no collections of

information contained in this final rule.

Therefore, the Paperwork Reduction Act

does not apply.

List of Subjects in 31 CFR Part 357

Bonds, Electronic funds transfer,

Federal Reserve System, Government

securities, Incorporation by reference,

Securities.

For the reasons set forth in the

preamble, Title 31, Chapter II,

Subchapter B, Part 357 is amended as

follows:

PART 357—REGULATIONS

GOVERNING BOOK-ENTRY

TREASURY BONDS, NOTES AND

BILLS

1. The authority citation for Part 357

continues to read as follows:

Authority: 31 U.S.C. chapter 31; 5 U.S.C.

301; 12 U.S.C. 391.

Appendix B to Part 357—[Amended]

2. Appendix B to part 357 is amended

by redesignating the second footnote 9

through footnote 17 as footnote 10

through 18.

3. Appendix B to part 357 is further

amended in the Section-by-Section

Analysis for § 357.11(b), in the third

paragraph, by revising the fourth

sentence and redesignated footnote 11

to read as follows:

Appendix B to Part 357—TRADES

Commentary

* * * * *

Section-by-Section Analysis

* * * * *

Section 357.11—Law Governing Other

Interests

* * * * *

(b) Limited Scope of Federal Preemption

* * * * *

* * * Treasury has determined that the

versions of Article 8 passed by 30 11 states

that have enacted Article 8 meet this

standard. * * *

Dated: July 17, 1997.

Gerald Murphy,

Fiscal Assistant Secretary.

[FR Doc. 97–21405 Filed 8–12–97; 8:45 am]

BILLING CODE 4810–39–W

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD08–97–024]

RIN 2115–AE46

Special Local Regulations;

Steubenville Regatta, Steubenville,

Ohio

AGENCY: Coast Guard, DOT.

ACTION: Notice of implementation.

SUMMARY: This notice implements the

special local regulations of 33 CFR

100.201, ‘‘Annual marine events within

the Second Coast Guard District’’ for the

‘‘Steubenville Regatta.’’ 33 CFR 100.201

(Table One, No. 35). In 1996, the Second

Coast Guard District was disestablished,

and the Eighth District boundaries were

expanded to include the prior Second

District area of responsibility. The

Eighth District Commander now

exercises authority over the combined

geographical region. 61 FR 29958 (June

13, 1996). This event will be held in

Steubenville, Ohio at Ohio River mile

65.0–67.0 from August 15–17, 1997.

Implementation of section 33 CFR

100.201 (Table One, No. 35) is necessary

to provide for the safety of life on

navigable waters during the event.

EFFECTIVE DATES: Section 33 CFR

100.201 (Table One, No. 35) is effective

on the following dates/times:

8 a.m. until 11 p.m. on August 15, 1997

8 a.m. until 11 p.m. on August 16, 1997

8 a.m. until 11 p.m. on August 17, 1997

FOR FURTHER INFORMATION CONTACT: LT

T.J. Ferring, Marine Safety Office,

Pittsburgh, PA, Tel: (412) 644–5808.

SUPPLEMENTARY INFORMATION: The

Steubenville Regatta is an annual river

festival sponsored by the Steubenville

Regatta and Racing Association, Inc.

These special local regulations permit

the Coast Guard to control vessel traffic

in order to ensure the safety of

spectators and participants. Spectators

will be able to view the event from areas

designated by the sponsor. Nonparticipating vessels will be able to

transit the area during breaks between

scheduled events.

Dated: July 29, 1997.

T.W. Josiah,

Rear Admiral, U.S. Coast Guard Commander,

Eighth Coast Guard District.

[FR Doc. 97–21358 Filed 8–12–97; 8:45 am]

BILLING CODE 4910–14–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300525; FRL–5735–2]

RIN 2070–AB78

Propiconazole; Pesticide Tolerances

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for combined

residues of propiconazole and its

metabolites determined as 2,4-

dichlorobenzoic acid (DCBA) in or on

grain sorghum, grain; grain sorghum,

stover; and sorghum aspirated grain

fractions . This action is in response to

EPA’s granting of emergency

exemptions under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticide on grain sorghum. This

regulation establishes maximum

permissible levels for residues of

propiconazole in this food commodity

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerances

will expire and are revoked on July 31,

1998.

DATES: This regulation is effective

August 13, 1997. Objections and

requests for hearings must be received

by EPA on or before October 14, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300525],

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–

300525], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of
Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Rules and Regulations 43285

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300525]. 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: Stephen Schaible, 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) 308–9362, e-mail:

schaible.stephen@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

408(e) and (l)(6) of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e) and (l)(6), is establishing

tolerances for combined residues of the

fungicide propiconazole, 1-[[2-(2,4-

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl]methyl]-1H-1,2,4-triazole and its

metabolites determined as 2,4-

dichlorobenzoic acid (DCBA), in or on

grain sorghum, grain at 0.2 parts per

million (ppm); grain sorghum, stover at

1.5 ppm; and sorghum aspirated grain

fractions at 20 ppm . These tolerances

will expire and are revoked on July 31,

1998. After July 31, 1998, EPA will

publish a document in the Federal

Register to remove the revoked

tolerances from the Code of Federal

Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq. The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL-5572-9).

New section 408(b)(2)(A)(i) of the

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue***.’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for

Propiconazole on Grain Sorghum and

FFDCA Tolerances

Sorghum ergot (Claviceps africana) is

a new disease to grain sorghum in the

United States. It was detected on

sorghum in the Rio Grande Valley of

Texas in February and March of 1997.

The fungus infects unfertilized flower

ovaries, with the resulting fungal growth

eventually producing a sticky fluid

known as honeydew. In sorghum grown

for hybrid seed production, the disease

reduces seed yield by decreasing the

availability of viable pollen. In sorghum

grown for grain, the disease lowers grain

yield and quality, makes threshing

difficult, and reduces seed germination.

Currently there are no products

registered for sorghum which are

effective in controlling ergot, nor are

there feasible alternative control

practices. Efficacy data from Brazil

show that the triazole group of

fungicides was most successful at

controlling the disease; based on limited

data submitted by the registrant,

propiconazole appears effective against

sorghum ergot. EPA has authorized

under FIFRA section 18 the use of

propiconazole on grain sorghum for

control of sorghum ergot in Illinois,

Kansas, Nebraska, New Mexico,

Oklahoma, and Texas. After having

reviewed these submissions, EPA

concurs that emergency conditions exist

for these states.

As part of its assessment of these

emergency exemptions, EPA assessed

the potential risks presented by residues

of propiconazole in or on grain sorghum

commodities. In doing so, EPA

considered the new safety standard in

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

decided that the necessary tolerances

under FFDCA section 408(l)(6) would be

consistent with the new safety standard

and with FIFRA section 18. Consistent

with the need to move quickly on the

emergency exemptions in order to

address an urgent non-routine situation

and to ensure that the resulting food is

safe and lawful, EPA is issuing these

tolerances without notice and

opportunity for public comment under

section 408(e), as provided in section

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

expire and are revoked on July 31, 1998,

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

of the pesticide not in excess of the

amounts specified in the tolerances

remaining in or on grain sorghum, grain;

grain sorghum, stover; and sorghum

aspirated grain fractions after that date

will not be unlawful, provided the

pesticide is applied in a manner that

was lawful under FIFRA. EPA will take

action to revoke these tolerances earlier
43286 Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Rules and Regulations

if any experience with, scientific data

on, or other relevant information on this

pesticide indicate that the residues are

not safe.

Because these tolerances are being

approved under emergency conditions

EPA has not made any decisions about

whether propiconazole meets EPA’s

registration requirements for use on

grain sorghum or whether permanent

tolerances for this use would be

appropriate. Under these circumstances,

EPA does not believe that these

tolerances serve as a basis for

registration of propiconazole by a State

for special local needs under FIFRA

section 24(c). Nor do these tolerances

serve as the basis for any State other

than Illinois, Kansas, Nebraska, New

Mexico, Oklahoma, and Texas to use

this pesticide on this crop under section

18 of FIFRA without following all

provisions of section 18 as identified in

40 CFR part 166. For additional

information regarding the emergency

exemptions for propiconazole, contact

the Agency’s Registration Division at the

address provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

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 hundredfold MOE is

based on the same rationale as the

hundredfold 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 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,

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
Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Rules and Regulations 43287

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(non-nursing infants less than 1 year

old) was not regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action,

EPA has sufficient data to assess the

hazards of propiconazole and to make a

determination on aggregate exposure,

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

time-limited tolerances for combined

residues of propiconazole, 1-[[2-(2,4-

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl]methyl]-1H-1,2,4-triazole and its

metabolites determined as 2,4-

dichlorobenzoic acid (DCBA) on grain

sorghum, grain at 0.2 ppm; grain

sorghum, stover at 1.5 ppm; and

sorghum aspirated grain fractions at 20

ppm. EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerances 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 propiconazole

are discussed below.

1. Acute toxicity. For acute dietary

risk assessment, EPA recommends use

of the developmental NOEL of 30 mg/

kg/day from a developmental toxicity

study in rats. The LEL of 90 mg/kg/day

was based on the increased incidence of

unossified sternebrae, rudimentary ribs,

and shortened or absent renal papillae.

This risk assessment will evaluate acute

dietary risk to the population of

concern, females 13 years and older.

2. Short - and intermediate - term

toxicity. For short- and intermediateterm dermal MOE calculations, EPA

recommends use of the developmental

NOEL of 30 mg/kg/day from the

developmental toxicity study in rats.

For short- and intermediate-term

inhalation MOE calculations, EPA

recommends use of the NOEL of 92.8

mg/kg/day, the highest dose tested

(HDT) from the 5-day inhalation toxicity

study in rats.

3. Chronic toxicity. EPA has

established the RfD for propiconazole at

0.013 milligrams/kilogram/day (mg/kg/

day). This RfD is based on a NOEL of

1.25 mg/kg/day taken from a 1–year

feeding study in dogs. The effect seen at

the LEL of 6.25 mg/kg/day is mild

irritation of the gastric mucosa. An

uncertainty factor of 100 was added to

take into account interspecies and

intraspecies variation.

4. Carcinogenicity. Propiconazole has

been classified as a Group C, ‘‘possible

human carcinogen,’’ chemical by the

Agency. EPA recommends using the RfD

approach for quantitation of human risk.

Therefore, the RfD is deemed protective

of all chronic human health effects,

including cancer.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.434) for the combined residues

of propiconazole, 1-[[2-(2,4-

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl]methyl]-1H-1,2,4-triazole and its

metabolites determined as 2,4-

dichlorobenzoic acid (DCBA), in or on

a variety of raw agricultural

commodities. Secondary residues in

animal commodities are not expected to

exceed existing tolerances as a result of

the proposed use. Risk assessments

were conducted by EPA to assess

dietary exposures and risks from

propiconazole as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a 1 day or single exposure. The acute

dietary (food only) risk assessment

assumed tolerance level residues and

100% crop treated. The resulting highend exposure estimate of 0.01 mg/kg/

day, which results in a dietary (food

only) MOE of 3,000 for females 13+

years old, should be viewed as

conservative; refinement using

anticipated residue values and percent

crop-treated data in conjunction with

Monte Carlo analysis would result in a

lower acute dietary exposure estimate.

ii. Chronic exposure and risk. For the

purpose of assessing chronic dietary

exposure from propiconazole, EPA

assumed anticipated residues and

percent of crop treated refinements for

many of the existing uses to estimate the

Anticipated Residue Contribution (ARC)

from existing and proposed uses. While

more refined than TMRC exposure

estimates, the assumptions of tolerance

level residues and 100% of crop treated

for the proposed use and numerous

existing uses still result in

overestimation of exposure. Based on

the above assumptions, chronic dietary

exposure to the U.S. population

represents 7% of the RfD. Dietary

exposure to the subgroup most highly

exposed, non-nursing infants less than 1

year, utilizes 20% of the RfD.

2. From drinking water. Review of

terrestrial field dissipation data

indicates that propiconazole is

persistent and leaches into groundwater.

There is no established Maximum

Contaminant Level (MCL) for residues

of propiconazole in drinking water. No

drinking water health advisory levels

have been established for

propiconazole.

Because the Agency lacks sufficient

water-related exposure data to complete

a comprehensive drinking water risk
43288 Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Rules and Regulations

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water-related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause propiconazole to exceed

the RfD if the tolerance being

considered in this document were

granted. The Agency has therefore

concluded that the potential exposures

associated with propiconazole in water,

even at the higher levels the Agency is

considering as a conservative upper

bound, would not prevent the Agency

from determining that there is a

reasonable certainty of no harm if the

tolerance is granted.

3. From non-dietary exposure.

Propiconazole is currently registered for

use on the following residential nonfood sites: a preservative treatment for

finished wood (window moldings,

fences, etc.), and for ornamental turf and

lawns. While EPA does not consider

that these types of outdoor residential

uses constitute a chronic residential

exposure scenario, EPA acknowledges

that there may be short- and

intermediate-term, non-occupational

exposure scenarios. Toxicological

endpoints have been identified for

short- and intermediate-term risk

assessment. However, no acceptable,

reliable data to assess these potential

risks are available at this time. Given the

time-limited nature of this request, the

need to make emergency exemption

decisions quickly, and the significant

scientific uncertainty at this time about

how to aggregate non-occupational

exposure with dietary exposure, the

Agency will make the safety

determination for these tolerances based

on those factors which it can reasonably

integrate into a risk assessment. What

limited data are available to the Agency

suggest that residential use of

propiconazole by homeowners is quite

limited.

4. Cumulative exposure to substances

with common mechanism of toxicity.

Propiconazole is a member of the

triazole class of pesticides. Other

triazoles include bitertanol,

cyproconazole, diclobutrazole,

difenoconazole, diniconazole,

fenbuconazole, flusilazole,

hexaconazole, myclobutanil,

penconazole, tebuconazole,

tetraconazole, triadimefon, and

triadimenol. 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

commonmechanism 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

propiconazole 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, propiconazole

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 propiconazole has a

common mechanism of toxicity with

other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. For the population

subgroup of concern, females 13+ years

and older, the calculated MOE is 3,000.

The Agency acknowledges the potential

for exposure to propiconazole in

drinking water, but does not expect that

exposure would result in an aggregate

MOE (food plus water) that would

exceed the Agency’s level of concern for

acute dietary exposure.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to propiconazole from food

will utilize 7% of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is non-nursing infants less

than 1 year (discussed below). EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Despite the potential

for exposure to propiconazole in

drinking water and from non-dietary,

non-occupational exposure, EPA does

not expect the aggregate exposure to

exceed 100% of the RfD. EPA concludes

that there is a reasonable certainty that

no harm will result from aggregate

exposure to propiconazole residues.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

risk estimates take into account

exposure from chronic dietary food and

water (considered to be a background

exposure level) plus potential indoor

and outdoor residential exposures.

Based on the large acute dietary MOE

for the subgroup of concern (3,000 for

females 13+), the small percentage of

the RfD occupied for the U.S.

population (7%), and the minimal nondietary exposure, in our best scientific
Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Rules and Regulations 43289

judgment, the short- and intermediateterm aggregate risk from exposure to

propiconazole will not exceed the

Agency’s level of concern.

D. Aggregate Cancer Risk for U.S.

Population

Propiconazole has been classified as a

Group C, ‘‘possible human carcinogen,’’

chemical by the Agency. EPA

recommends using the RfD approach for

quantification of human risk. Human

health risk concerns due to long-term

exposure to propiconazole residues are

adequately addressed by the aggregate

chronic exposure analysis using the

RfD.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— a. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

propiconazole, EPA considered data

from developmental toxicity studies in

the rat and rabbit and a two-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard hundredfold

safety factor (usually 100 for combined

inter- and intra-species variability)) and

not the additional tenfold safety factor

when EPA has a complete data base

under existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard MOE/safety factor.

b. Developmental toxicity studies. In

the developmental toxicity study in rats,

the maternal (systemic) NOEL was 30

mg/kg/day. The maternal LEL of 90 mg/

kg/day was based on reduced body

weight gain and rales in females. The

developmental NOEL was also 30 mg/

kg/day. The developmental LEL of 90

mg/kg/day was based on the increased

incidence of unossified sternebrae,

rudimentary ribs, and shortened or

absent renal papillae. In the rabbit

developmental toxicity study, the

maternal (systemic) NOEL was 100 mg/

kg/day. The maternal LEL of 250 mg/kg/

day was based on decreased food

consumption and body weight gain.

There was also an increased incidence

of abortion at 400 mg/kg/day. The

developmental NOEL was 400 mg/kg/

day (HDT), based upon the lack of

developmental delays or alterations.

c. Reproductive toxicity study. From

the 2-generation reproductive toxicity

study in rats, the parental (systemic)

LEL of 5 mg/kg/day (lowest dose tested)

was based on the increased incidence of

hepatic ‘‘clear-cell change’’ at all dose

levels; additionally, at 25 and 125 mg/

kg/day, decreased body weights,

decreased food consumption, and/or an

increased incidence of hepatic cellular

swelling were observed. A NOEL for

parental toxicity was not determined.

The reproductive/ developmental NOEL

was 25 mg/kg/day. The reproductive

LEL of 125 mg/kg/day was based on

decreased offspring survival of second

generation (F2) pups, and on decreased

body weight throughout lactation, and

an increase in the incidence of hepatic

cellular swelling for both generations of

offspring (F1 and F2 pups).

d. Pre- and post-natal sensitivity. The

pre- and post-natal toxicology data base

for propiconazole is complete with

respect to current toxicological data

requirements. There are no pre- or postnatal toxicity concerns for infants and

children, based on the results of the rat

and rabbit developmental toxicity

studies and the 2-generation rat

reproductive study. Based on the

developmental and reproductive

toxicity studies discussed above, for

propiconazole there does not appear to

be an extra sensitivity for pre- or postnatal effects.

EPA notes developmental toxicity

NOELs of 30 mg/kg/day in rats and 400

mg/kg/day (HDT) in rabbits.

Developmental toxicity was observed in

rats at 90 mg/kg/day; these effects

occurred in the presence of maternal

toxicity. The significant developmental

effects in the rat study required an acute

dietary risk assessment for females 13+

years of age. The calculated MOE of

3,000 demonstrated that the

developmental risks were below HED’s

level of concern. In rabbits, no

developmental delays or alterations

were noted; however, increased

abortions were observed at the

maternally toxic dose of 400 mg/kg/day.

The developmental NOELs are more

than 24- and 320-fold higher in rats and

rabbits, respectively, than the NOEL of

1.25 mg/kg/day from the 1-year feeding

study in dogs, which is the basis of the

RfD.

e. Conclusion. EPA concludes that

reliable data support use of the standard

hundredfold uncertainty factor and that

an additional uncertainty factor is not

needed to protect the safety of infants

and children.

2. Acute risk. The calculated acute

dietary (food only) MOE for females 13+

years old (accounts for both maternal

and fetal exposure) is 3,000. This MOE

calculation was based on the

developmental NOEL in rats of 30 mg/

kg/day. This risk assessment assumed

100% crop treated and tolerance level

residues on all treated crops consumed,

resulting in a significant over-estimate

of dietary exposure. The Agency does

not expect any significant exposure

from the residential use of

propiconazole. Despite the potential for

exposure to propiconazole in drinking

water, EPA does not expect the acute

aggregate exposure to exceed our level

of concern. The large acute dietary MOE

calculated for females 13+ years old

provides assurance that there is a

reasonable certainty of no harm for both

females 13+ years and the pre-natal

development of infants.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to

propiconazole from food will utilize

20% of the RfD for non-nursing infants

less than 1 year old and 13% of the RfD

for children 1 through 6 years old. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Despite the potential

for exposure to propiconazole in

drinking water and from non-dietary,

non-occupational exposure, EPA does

not expect the aggregate exposure to

exceed 100% of the RfD. EPA concludes

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

propiconazole residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in plants

and animals is adequately understood.

The residues of concern are

propiconazole (1-[[2-(2,4-

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl]methyl]-1H-1,2,4-triazole), and its

metabolites determined as 2,4-
43290 Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Rules and Regulations

dichlorobenzoic acid (DCBA) and

expressed as parent compound as

specified in 40 CFR 180.434 .

B. Analytical Enforcement Methodology

Adequate enforcement methodology

is available to enforce the tolerance

expression. Analytical methodologies

for the determination of propiconazole

and its metabolites in plant and animal

commodities (Ciba-Geigy Analytical

Methods AG-454 and AG-517,

respectively) have been successfully

validated by the Agency’s Analytical

Chemistry Laboratory and have been

approved for publication in PAM II for

enforcement purposes. These methods

have not as of this time appeared in

PAM II, but a copy of the methods may

be obtained from the Information

Resources and Services Division of OPP,

at the address provided above.

C. Magnitude of Residues

Residues of propiconazole are not

expected to exceed 0.2 ppm in grain

sorghum, grain or 1.5 ppm in grain

sorghum, stover as a result of the

proposed section 18 use. Residues are

not expected to exceed 20 ppm on

sorghum aspirated grain fractions based

on the expected tolerance level for grain

sorghum grain, 0.2 ppm, and the

maximum concentration factor, of 100x,

for sorghum aspirated grain fractions.

D. International Residue Limits

There are no CODEX, Canadian, or

Mexican maximum residue limits for

propiconazole on sorghum; therefore,

international harmonization is not an

issue for this action.

E. Rotational Crop Restrictions

Do not rotate to any crop intended for

food, grazing, or any component of

animal feed or bedding within 105 days

of product application, unless the crop

appears on the product label.

VI. Conclusion

Therefore, tolerances are established

for combined residues of propiconazole,

1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-

dioxolan-2-yl]methyl]-1H-1,2,4-triazole,

and its metabolites determined as 2,4-

dichlorobenzoic acid (DCBA) in grain

sorghum, grain at 0.2 ppm; grain

sorghum, stover at 1.5 ppm; and

sorghum aspirated grain fractions at 20

ppm.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by October 14, 1997,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300525] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(d). 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,
Federal Register / Vol. 62, No. 156 / Wednesday, August 13, 1997 / Rules and Regulations 43291

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408 (d), such as the

tolerances in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: August 5, 1997.

Peter Caulkins,

Acting Director, Registration Divison, Office

of Pesticide Programs.

Therefore, 40 CFR Chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.434, in the table to

paragraph (b), by removing the entries

for ‘‘grain sorghum,’’ and ‘‘grain

sorghum stover,’’ and by adding entries

for ‘‘sorghum, aspirated grain fractions,’’

‘‘sorghum, grain, grain,’’ and ‘‘sorghum,

grain, stover,’’ to read as follows:

§ 180.434 1-[[2-(2,4-dichlorophenyl)-4-

propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-

triazole; tolerances for residues.

* * * * *

(b) * * *

Commodity Parts per million Expiration/Revocation Date

* * * * *

Sorghum, aspirated grain fractions ..................................................... 20 July 31, 1998

Sorghum, grain, grain .......................................................................... 0.2 July 31, 1998

Sorghum, grain, stover ........................................................................ 1.5 July 31, 1998

* * * * *

[FR Doc. 97–21145 Filed 8–12–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL EMERGENCY

MANAGEMENT AGENCY

44 CFR Part 64

[Docket No. FEMA–7670]

Suspension of Community Eligibility

AGENCY: Federal Emergency

Management Agency, FEMA.

ACTION: Final rule.

SUMMARY: This rule identifies

communities, where the sale of flood

insurance has been authorized under

the National Flood Insurance Program

(NFIP), that are suspended on the

effective dates listed within this rule

because of noncompliance with the

floodplain management requirements of

the program. If the Federal Emergency

Management Agency (FEMA) receives

documentation that the community has

adopted the required floodplain

management measures prior to the

effective suspension date given in this

rule, the suspension will be withdrawn

by publication in the Federal Register.

EFFECTIVE DATES: The effective date of

each community’s suspension is the

third date (‘‘Susp.’’) listed in the third

column of the following tables.

ADDRESSES: If you wish to determine

whether a particular community was

suspended on the suspension date,

contact the appropriate FEMA Regional

Office or the NFIP servicing contractor.

FOR FURTHER INFORMATION CONTACT:

Robert F. Shea Jr., Division Director,

Program Implementation Division,

Mitigation Directorate, 500 C Street,

SW., Room 417, Washington, DC 20472,

(202) 646–3619.

SUPPLEMENTARY INFORMATION: The NFIP

enables property owners to purchase

flood insurance which is generally not

otherwise available. In return,

communities agree to adopt and

administer local floodplain management

aimed at protecting lives and new

construction from future flooding.

Section 1315 of the National Flood

Insurance Act of 1968, as amended, 42

U.S.C. 4022, prohibits flood insurance

coverage as authorized under the

National Flood Insurance Program, 42

U.S.C. 4001 et seq., unless an

appropriate public body adopts

adequate floodplain management

measures with effective enforcement

measures. The communities listed in

this document no longer meet that

statutory requirement for compliance

with program regulations, 44 CFR part

59 et seq. Accordingly, the communities

will be suspended on the effective date

in the third column. As of that date,

flood insurance will no longer be

available in the community. However,

some of these communities may adopt

and submit the required documentation

of legally enforceable floodplain

management measures after this rule is

published but prior to the actual

suspension date. These communities

will not be suspended and will continue

their eligibility for the sale of insurance.

A notice withdrawing the suspension of

the communities will be published in

the Federal Register.

In addition, the Federal Emergency

Management Agency has identified the

special flood hazard areas in these

communities by publishing a Flood

Insurance Rate Map (FIRM). The date of

the FIRM if one has been published, is

indicated in the fourth column of the

table. No direct Federal financial