Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Rules and Regulations 15615

2. Section 701.118, is amended by

removing and reserving paragraph (h),

and revising paragraph (i), and revising

the heading and introductory text of

paragraph (n) as follows:

§ 701.118 Exemptions for specific Navy

record systems.

* * * * *

(h) [Reserved].

(i) System identifier and name:

N05041–1, Inspector General (IG)

Records.

(1) Exemption: Portions of this system

of records may be exempt from the

provisions of 5 U.S.C. 552a(c)(3); (d);

(e)(1); (e)(4)(G), (H), and (I); and (f).

(2) Authority: 5 U.S.C. 552a(k)(1) and

(k)(2).

(3) Reasons: (i) From subsection (c)(3)

because the release of the disclosure

accounting would permit individuals to

obtain valuable information concerning

the nature of the investigation and

would present a serious impediment to

the orderly conduct of any investigative

activities. Such accounting could result

in the release of properly classified

information which would compromise

the national defense or disrupt foreign

policy.

(ii) From subsections (d) and (f)

because access to the records would

inform individuals of the existence and

nature of the investigation; provide

information that might result in the

concealment, destruction, or fabrication

of evidence; possibly jeopardize the

safety and well-being of informants,

witnesses and their families; likely

reveal and render ineffectual

investigatory techniques and methods

and sources of information; and

possibly result in the invasion of the

personal privacy of third parties. Access

could result in the release of properly

classified information which could

compromise the national defense or

disrupt foreign policy. Amendment of

the records would interfere with the

ongoing investigation and impose an

impossible administrative burden by

requiring investigations to be

continually reinvestigated.

(iii) From subsection (e)(1) because in

the course of the investigation it is not

always possible, at least in the early

stages of the inquiry, to determine

relevance and or necessity as such

determinations may only occur after the

information has bee evaluated.

Information may be obtained concerning

the actual or potential violation of laws

or regulations other than those relating

to the ongoing investigation. Such

information should be retained as it can

aid in establishing patterns of improper

activity and can provide valuable leads

in the conduct of other investigations.

(iv) From subsection (e)(4)(G) and (H)

because this system of records is exempt

from individual access pursuant to

subsection (k)(1) and (k)(2) of the

Privacy Act of 1974.

(v) From subsection (e)(4)(I) because it

is neccessary to protect the

confidentiality of sources and to protect

the privacy and physical safety of

witnesses. Although the system is

exempt from this requirement, the

Department of the Navy has published

a notice in broad, generic terms in the

belief that this is all that subsection

(e)(4)(I) of the Act requires.

* * * * *

(n) System identifier and name:

N05520–5, Personnel Security Program

Management Records System. * * *

Dated: March 26, 1997.

L. M. Bynum,

Alternate OSD Federal Register Liaison

Officer, Department of Defense.

[FR Doc. 97–8138 Filed 3–31–97; 8:45 am]

BILLING CODE 5000–04–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300464; FRL–5597–2]

RIN 2070-AC78

Propamocarb Hydrochloride; Pesticide

Tolerance for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

the fungicide propamocarb

hydrochloride in or on the raw

agricultural commodities potatoes, milk;

and meat, meat by-products, and fat of

cattle, goat, horse, sheep, and hogs in

connection with EPA’s granting of

emergency exemptions under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

propamocarb hydrochloride on potatoes

in the states of California, and Texas.

This regulation establishes maximum

permissible levels for residues of

propamocarb hydrochloride in these

foods 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 be revoked by EPA on

March 15, 1999.

DATES: This regulation becomes

effective April 2, 1997. Objections and

requests for hearings must be received

by EPA on or before June 2, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300464],

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–

300464], must also be submitted to:

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

In person, bring a copy of objections

and hearing requests to Rm. 1132, CM

#2, 1921 Jefferson Davis Hwy.,

Arlington, VA. A copy of objections and

hearing requests filed with the Hearing

Clerk may also be submitted

electronically by sending electronic

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300464]. 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: Libby Pemberton, Registration

Division (7505W), Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location,

telephone number, and e-mail: Sixth

Floor, Crystal Station #1, 2800 Jefferson

Davis Highway, Arlington, VA 22202.

(703) 308-8326, e-mail:

pemberton.libby@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 residues of propamocarb

hydrochloride on potatoes at 0.5 parts

per million (ppm) and in milk; and

meat, meat by-products, and fat of

cattle, goat, horse, sheep, and hogs at 0.1
15616 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Rules and Regulations

ppm. These tolerances will expire on

March 15, 1999.

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) 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, 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.

Section 408(l)(6) also requires EPA to

promulgate regulations by August 3,

1997, governing the establishment of

tolerances and exemptions under

section 408(l)(6) and requires that the

regulations be consistent with section

408(b)(2) and (c)(2) and FIFRA section

18.

Section 408(l)(6) allows EPA to

establish tolerances or exemptions from

the requirement for a tolerance, in

connection with EPA’s granting of

FIFRA section 18 emergency

exemptions, without providing notice or

a period for public comment. Thus,

consistent with the need to act

expeditiously on requests for emergency

exemptions under FIFRA, EPA can

establish such tolerances or exemptions

under the authority of section 408(e)

and (l)(6) without notice and comment

rulemaking.

In establishing section 18-related

tolerances and exemptions during this

interim period before EPA issues the

section 408(l)(6) procedural regulation

and before EPA makes its broad policy

decisions concerning the interpretation

and implementation of the new section

408, EPA does not intend to set

precedents for the application of section

408 and the new safety standard to other

tolerances and exemptions. Rather,

these early section 18 tolerance and

exemption decisions will be made on a

case-by-case basis and will not bind

EPA as it proceeds with further

rulemaking and policy development.

EPA intends to act on section 18-related

tolerances and exemptions that clearly

qualify under the new law.

II. Emergency Exemptions for

Propamocarb Hydrochloride on

Potatoes and FFDCA Tolerances

EPA has authorized use under FIFRA

section 18 of propamocarb

hydrochloride on potatoes for control of

late blight. Recent failures to control late

blight in potatoes as well as tomatoes

with the registered fungicides, have

been caused almost exclusively by

immigrant strains of late blight

(Phytophthora infestans), which are

resistant to the control of choice,

metalaxyl. Before the immigrant strains

of late blight arrived, all of the strains

in the U.S. were previously controlled

by treatment with metalaxyl. Presently,

there are no fungicides registered in the

U.S. that will provide adequate control

of the immigrant strains of late blight.

After having reviewed their submission,

EPA concurs that an emergency

condition exists.

As part of its assessment of these

specific exemptions, EPA assessed the

potential risks presented by residues of

propamocarb hydrochloride on potatoes

and milk; and meat, meat by-products,

and fat of cattle, goat, horse, sheep, and

hogs. 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 clearly be

consistent with the new safety standard

and with FIFRA section 18. These

tolerances for residues of propamocarb

hydrochloride will permit the marketing

of potatoes treated in accordance with

the provisions of the section 18

emergency exemptions and the

marketing of milk; and meat, meat byproducts, and fat of cattle, goat, horse,

sheep, and hogs with secondary

residues resulting from the feeding of

the feedstuffs of treated potatoes.

Consistent with the need to move

quickly on these emergency exemptions

in order to address an urgent nonroutine 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

tolerances will expire and be revoked by

EPA on March 15, 1999, under FFDCA

section 408(l)(5), residues of

propamocarb hydrochloride not in

excess of the amount specified in these

tolerances remaining in or on potatoes

and milk; and meat, meat by-products,

and fat of cattle, goat, horse, sheep, and

hogs after that date will not be unlawful,

provided the pesticide is applied during

the term of, and in accordance with all

the conditions of, the emergency

exemptions. EPA will take action to

revoke these tolerances earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicates that the residues are

not safe.

EPA has not made any decisions

about whether propamocarb

hydrochloride meets the requirements

for registration under FIFRA section 3

for use on potatoes or whether a

permanent tolerance for propamocarb

hydrochloride for potatoes and milk;

and meat, meat by-products, and fat of

cattle, goat, horse, sheep, and hogs

would be appropriate. This action by

EPA does not serve as a basis for

registration of propamocarb

hydrochloride by a State for special

local needs under FIFRA section 24(c).

Nor does this action serve as the basis

for any States other than California,

Texas and States which are

subsequently granted specific

exemptions for this use to use this

product 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

propamocarb hydrochloride, contact the
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Rules and Regulations 15617

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.

For many of these 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.

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 margin of exposure

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.

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, and other

non-occupational exposures, such as

where residues leach into groundwater

or surface water that is consumed as

drinking water. 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. 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.

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 these actions.

Propamocarb hydrochloride is

registered by EPA for turf and

ornamental use. EPA believes it has

sufficient data to assess the hazards of

propamocarb hydrochloride and to

make a determination on aggregate

exposure, consistent with section

408(b)(2), for the time-limited tolerances

for residues of propamocarb

hydrochloride on potatoes at 0.5 parts

per million (ppm) and in milk; and

meat, meat by-products, and fat of

cattle, goat, horse, sheep, and hogs at 0.1

ppm. EPA’s assessment of the dietary

exposures and risks associated with

establishing these tolerances follows.

A. Toxicological Profile

1. Chronic toxicity. Based on the

available chronic toxicity data, EPA’s

Office of Pesticide Programs (OPP) has

established the RfD for propamocarb

hydrochloride at 0.11 milligrams (mg)/

kilograms (kg)/day. The RfD was

established based on a threshold LOEL

(lowest observable effect level) of 33.31

mg/kg/day in males and 33.27 mg/kg in

females in a 11–year dog feeding study.

The LOEL was based on body weight

gain depression, decreased food

efficiency and gastritis. An uncertainty

factor (UF) of 100 was used to account

for both inter-species extrapolation and

intra-species variability. An additional

UF of 3 was used to account for the lack

of a NOEL.

2. Acute toxicity. Agency toxicologists

have recommended that the

developmental NOEL of 150 mg/kg/day

from the rabbit developmental toxicity

study be used for acute dietary risk

calculations. The developmental LOEL

of 300 mg/kg/day is based on increased

post-implantation loss (developmental)

and decreased body weight gain

(maternal). The population of concern

for this risk assessment is females 13+

years old.

3. Short-term non-dietary inhalation

and dermal toxicity. OPP recommends

use of the developmental toxicity study

in rabbits for short- and intermediate

term MOE calculations. The maternal

NOEL was 150 mg/kg/day and the LOEL

of 300 mg/kg/day was based on

decreased body weight gain during

gestation days 6-18. The developmental

NOEL was 150 mg/kg/day. The

developmental LOEL of 300 mg/kg/day

was based on increased postimplantation loss.

4. Carcinogenicity. Propamocarb

hydrochloride is classified as a ‘‘Group

D,’’ not classifiable as to human

carcinogenicity due to inadequacy of the

data. Dietary rodent studies conducted

in 1983 in Germany showed no

evidence of carcinogenicity. The

registrant is currently conducting

studies in accordance with U.S.

protocols.

B. Aggregate Exposure

There are no established U.S.

tolerances for propamocarb

hydrochloride, and there are no

registered uses for propamocarb

hydrochloride on food or feed crops in

the United States.

For the purpose of assessing chronic

dietary exposure from propamocarb

hydrochloride, EPA assumed tolerance

level residues and 100% of crop treated

for the proposed use of propamocarb

hydrochloride. These conservative

assumptions result in overestimation of

human dietary exposures.

In examining aggregate exposure,

FQPA directs EPA to consider available
15618 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Rules and Regulations

information concerning exposures from

the pesticide residue in food and all

other non-occupational exposures. The

primary non-food sources of exposure

the Agency looks at include drinking

water (whether from groundwater or

surface water), and exposure through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses).

Because the Agency lacks sufficient

water-related exposure data to complete

a comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

consumption of contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause propamocarb

hydrochloride to exceed the RfD if the

tolerances being considered in this

document were granted. The Agency

has therefore concluded that the

potential exposures associated with

propamocarb hydrochloride 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

tolerances are granted.

Based on the available studies used in

EPA’s assessment of environmental risk,

propamocarb hydrochloride is relatively

non-persistent and mobility varies as a

function of soil texture and soil

reaction. There is no entry for

propamocarb hydrochloride in the

‘‘Pesticides in Groundwater Data Base’’

(EPA 734-12-92-001, September 1992).

There is no established Maximum

Concentration Level (MCL) for residues

of propamocarb hydrochloride in

drinking water. No drinking water

health advisory levels have been

established for propamocarb

hydrochloride.

Propamocarb hydrochloride is

registered for uses, such as lawn and

ornamental, that could result in nonoccupational exposure and EPA

acknowledges that there may be short-

, intermediate-, and long-term nonoccupational, non-dietary exposure

scenarios. At this time, the Agency has

insufficient information to assess the

potential risks from such exposure.

However, available data for

propamocarb hydrochloride indicate no

evidence of toxicity by the dermal or

inhalation routes.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

propamocarb hydrochloride 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, propamocarb

hydrochloride 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 propamocarb

hydrochloride has a common

mechanism of toxicity with other

subtances.

C. Safety Determinations For U.S.

Population

Taking into account the completeness

and reliability of the toxicity data, EPA

has concluded that dietary exposure to

propamocarb hydrochloride in food

from published tolerances will utilize

2% of the RfD for the U.S. population.

A dietary (food only) MOE of greater

than 118 would not be of Agency

concern. A MOE of 30,000 was

calculated.

EPA does not believe exposure to

propamocarb hydrochloride in drinking

water or from residential uses would

raise the percent of RfD utilized or

lower the MOE, to such extent that there

was not an adequate margin of

exposure. While EPA has not yet

pinpointed the appropriate bounding

figure for consumption of contaminated

water, the ranges the Agency is

continuing to examine are all below the

level that would cause propamocarb

hydrochloride 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

propamocarb hydrochloride 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. An appropriate

bounding figure for residential exposure

is expected to be lower than for drinking

water. Therefore, EPA concludes that

there is a reasonable certainty that no

harm will result from aggregate

exposure to propamocarb hydrochloride

residues.

D. Determination of Safety for Infants

and Children.

FFDCA section 408 provides that EPA

shall apply an additional ten-fold
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Rules and Regulations 15619

margin of exposure (safety) for infants

and children in the case of threshold

effects to account for pre-and post-natal

toxicity and the completeness of the

data base unless EPA determines that a

different margin of exposure (safety)

will be safe for infants and children.

Margins of exposure (safety) are often

referred to as uncertainty (safety)

factors. EPA believes that reliable data

support using the standard margin of

exposure (usually 100x for combined

inter- and intra-species variability)) and

not the additional ten-fold margin of

exposure 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 margin of exposure. Based

on current toxicological data

requirements, the data base for

propamocarb hydrochloride relative to

pre- and post-natal toxicity is not

complete.

The pre- and post-natal toxicology

data base for propamocarb is not

complete with respect to current

toxicological data requirements.

Although two acceptable prenatal

developmental toxicity studies (in rats

and rabbits) have been submitted to the

Agency, the available rat reproductive

toxicity study is not adequate. The RfD

Committee considered it to be

supplementary and not upgradeable

based on the lack of systemic toxicity at

dose levels, which did not achieve the

limit dose, indicating inadequacy of the

high dose for reproductive toxicity.

Thus conclusions concerning post-natal

sensitivity cannot be made.

In the developmental toxicity study in

rabbits, the developmental and maternal

NOELs were both 150 mg/kg/day. The

developmental and maternal LOELs of

300 mg/kg/day were based on increased

post-implantation loss (developmental)

and decreased body weight gain

(maternal). The NOELs and LOELs

occurred at the same doses for

developmental and maternal findings;

there was no indication of pre-natal

sensitivity for infants and children.

In the developmental toxicity study in

rats, the developmental NOEL was 221

mg/kg/day and was below the maternal

NOEL (740 mg/kg/day). The

developmental LOEL of 740 mg/kg/day

was based on increased fetal death, and

an increased incidence of minor skeletal

anomalies (incomplete ossification of

some vertebrae and sternebrae). The

maternal NOEL was 740 mg/kg/day,

based on increased maternal death,

spastic gait and decreased body weight

at the LOEL of 2,210 mg/kg/day. These

findings indicate the possibility of

increased prenatal sensitivity of fetuses

to in utero exposure to propamocarb. An

additional uncertainty factor of 10x for

infants and children would be deemed

appropriate for propamocarb, based

upon the lack of data to evaluate

postnatal exposure (due to the

inadequate reproduction study) and

based upon the increased sensitivity to

prenatal exposure (indicated by the rat

developmental study NOELs). However,

considering the large dietary MOE

calculated for females 13+ years (MOE

= 30,000), even if an additional ten-fold

uncertainty factor were applied,

aggregate acute risk estimates would not

exceed the margin of exposure.

Therefore, EPA concludes that this

tolerance will pose reasonable certainty

of no harm to infants and children.

EPA has concluded that the percent of

the RfD that will be utilized by chronic

dietary (food) exposure to residues of

propamocarb hydrochloride ranges from

2% for nursing infants (<1 year old) up

to 7% for non-nursing infants (<1 year

old). However, this calculation assumes

tolerance level residues for all

commodities and is therefore an overestimate of dietary risk. Refinement of

the dietary risk assessment by using

anticipated residue data would reduce

dietary exposure. The addition of

potential exposure from propamocarb

hydrochloride residues in drinking

water is not expected to result in an

exposure which would exceed the RfD.

V. Other Considerations

The metabolism of propamocarb

hydrochloride in potatoes is adequately

understood for the purposes of this

tolerance. There are no Codex maximum

residue levels established for residues of

propamocarb hydrochloride. The

residue of concern, for the purposes of

this tolerance, is propamocarb

hydrochloride. The proposed

enforcement method designated UPSR

22/91 (MRID No. 439840-04) submitted

with petition 6F4707 is adequate to

support the proposed time-limited

tolerances. The method has been

adequately radiovalidated for recovery

of parent compound; however, an

independent laboratory validation has

not been submitted. Further the method

has not undergone Agency method

validation. The method is available to

anyone who is interested in pesticide

residue enforcement from: By mail,

Calvin Furlow, Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location

and telephone number: Crystal Mall #2,

Rm. 1128, 1921 Jefferson Davis Hwy.,

Arlington, VA 22202, 703-305-5805.

VI. Conclusion

Therefore, tolerances in connection

with the FIFRA section 18 emergency

exemptions are established for residues

of propamocarb hydrochloride in or on

potatoes at 0.5 parts per million (ppm)

and in milk; and meat, meat byproducts, and fat of cattle, goat, horse,

sheep, and hogs at 0.1 ppm. These

tolerances will expire and be revoked by

EPA on March 15, 1999.

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 June 2, 1997, file

written objections to any aspect of this

regulation (including the revocation

provision) 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
15620 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Rules and Regulations

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

A record has been established for this

rulemaking under docket number [OPP–

300464]. A public version of this record,

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 Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

The official record for this

rulemaking, as well as the public

version, as described above, is kept in

paper form. Accordingly, in the event

there are objections and hearing

requests, 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. The official rulemaking record is

the paper record maintained at the

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not ‘‘a significant regulatory action’’

and, since this action does not impose

any information collection requirements

as defined by the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq., it is not

subject to review by the Office of

Management and Budget.

This action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104-4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, 1993), entitled Enhancing

the Intergovernmental Partnership, or

special consideration as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

Because FFDCA section 408(l)(6)

permits establishment of this regulation

without a notice of proposed

rulemaking, the regulatory flexibility

analysis requirements of the Regulatory

Flexibility Act, 5 U.S.C. 604(a), do not

apply. Nonetheless, the Agency has

previously assessed whether

establishing tolerances or exemptions

from tolerances, raising tolerance levels,

or expanding exemptions adversely

impact small entities and concluded, as

a generic matter, that there is no adverse

impact (46 FR 24950, May 4, 1981).

Under 5 U.S.C. 801(a)(1)(A) of the

Administrative Procedure Act (APA) as

amended by the Small Business

Regulatory Enforcement Fairness Act of

1996 (Title II of Pub. L. 104-121, 110

Stat. 847), EPA 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 rule is not a ‘‘major rule’’ as

defined by 5 U.S.C. 804(2) of the APA

as amended.

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: March 17, 1997.

Stephen L. Johnson,

Director, Registration Division, 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. By adding § 180.499 to read as

follows:

§ 180.499 Propamocarb hydrochloride,

tolerances for residues.

Time-limited tolerances are

established for residues of the fungicide

propamocarb hydrochloride in

connection with use of the pesticide

under section 18 emergency exemptions

granted by EPA. The tolerances are

specified in the following table. The

tolerances expire and will be revoked on

the date specified in the table by EPA.

Commodity

Parts

per

million

Expiration/

Revocation

Date

Potatoes 0.5 March 15,

1999

Cattle, fat 0.1 March 15,

1999

Cattle, meat 0.1 March 15,

1999

Cattle, mbyp (except

kidney and liver)

0.1 March 15,

1999

Goats, fat 0.1 March 15,

1999

Goats, meat 0.1 March 15,

1999

Goats, mbyp (except

kidney and liver)

0.1 March 15,

1999

Hogs, fat 0.1 March 15,

1999

Hogs, meat 0.1 March 15,

1999

Hogs, mbyp (except

kidney and liver)

0.1 March 15,

1999

Horse, fat 0.1 March 15,

1999

Horse, meat 0.1 March 15,

1999

Horse, mbyp (except

kidney and liver)

0.1 March 15,

1999

Sheep, fat 0.1 March 15,

1999

Sheep, meat 0.1 March 15,

1999

Sheep, mbyp (except

kidney and liver)

0.1 March 15,

1999

Milk 0.1 March 15,

1999

[FR Doc. 97–8387 Filed 4–1–97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 29

RIN 2105–AC25

Nonprocurement Debarment and

Suspension

ACTION: Final rule.

DATES: This document is effective April

2, 1997.

FOR FURTHER INFORMATION CONTACT: Paul

B. Larsen, Office of the General Counsel,

C–10, Room 10102, (202) 366–9161,

Department of Transportation, 400

Seventh Street, SW., Washington, DC

20590.

SUPPLEMENTARY INFORMATION:

Background

On June 26, 1995 the Department of

Transportation joined in the

governmentwide common rule on