Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations 45741

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408 (1), such as the

tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

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 17, 1997.

James Jones,

Acting 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. Section 180.414 is revised to read

as follows:

§ 180.414 Cyromazine; tolerances for

residues.

(a) General. (1) Tolerances are

established for combined residues of the

insecticide cyromazine (N-cyclopropyl1,3,5-triazine-2,4,6-triamine) and its

metabolite melamine (1,3,5-triazine2,4,6-triamine) in or on the following

food commodities:

Commodity Parts per

million

Celery ........................................ 10.0

Cucurbit vegetables .................. 2.0

Eggs .......................................... 0.25

Leafy vegetables (except Brassica) ....................................... 10.0

Lettuce, head ............................ 5.0

Mushrooms ............................... 10.0

Peppers ..................................... 4.0

Tomato ...................................... 1.0

(2) Tolerances are established for

residues of the cyromazine metabolite

melamine (1,3,5-triazine-2,4,6-triamine)

in or on the following food

commodities:

Commodity Part per million

Fat, poultry (from chicken layer

hens and chicken breeder

hens only) .............................. 0.05

Meat, poultry (from chicken

layer hens and chicken

breeder hens only) ................ 0.05

Meat byproducts (from chicken

layer hens and chicken

breeder hens only) ................ 0.05

(3) Tolerances are established for

residues of the insecticide cyromazine

(N-cyclopropyl-1,3,5-triazine-2,4,6-

triamine) in or on the following food

commodities:

Commodity Part per million

Fat, poultry (from chicken layer

hens and chicken breeder

hens only) .............................. 0.05

Meat, poultry (from chicken

layer hens and chicken

breeder hens only) ................ 0.05

Meat byproducts (from chicken

layer hens and chicken

breeder hens only) ................ 0.05

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for the combined residues of the

insecticide cyromazine (N-cyclopropyl1,3,5-triazine-2,4,6-triamine) and its

metabolite, melamine (1,3,5-triazine2,4,6-triamine), in connection with use

of the pesticide under section 18

emergency exemption granted by EPA.

The tolerances are specified in the

following table. These tolerances expire

and are revoked on the date specified in

the table.

Commodity Parts per million Expiration/revocation date

Onion, dry bulb .................................................................................... 0.3 July 31, 1998

(c) Tolerances with regional

registrations. Tolerances with regional

registration, as defined in § 180.1(n), are

established for the combined residues of

the insecticide cyromazine (Ncyclopropyl-1,3,5-triazine-2,4,6-

triamine) and its metabolite melamine

(1,3,5-triazine-2,4,6-triamine),

calculated as cyromazine, in or on the

following food commodities:

Commodity Parts per

million

Cabbage, Chinese .................... 3.0

Commodity Parts per

million

Mustard, Chinese ...................... 3.0

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–23098 Filed 8–28–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300532; FRL–5738–5]

RIN 2070–AB78

Desmedipham; Pesticide Tolerances

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for the herbicide

desmedipham in or on garden beet roots
45742 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations

and tops. This action is in response to

EPA’s granting of an emergency

exemption under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticide on garden beet roots and tops.

This regulation establishes a maximum

permissible level for residues of

desmedipham in this food commodity

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

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and is revoked on August 30,

1998.

DATES: This regulation is effective

August 29, 1997. Objections and

requests for hearings must be received

by EPA on or before October 28, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300532],

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–

300532], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300532]. 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: Pat Cimino, 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) 308-9357, e-mail:

cimino.pat@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 the herbicide

desmedipham, in or on garden beet

roots and tops at 0.2 and 15.0 part per

million (ppm) respectively. These

tolerances will expire and are revoked

on August 30, 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

Desmedipham on Garden Beet Roots

and Tops and FFDCA Tolerances

The New York State Department of

Environmental Conservation requested

the use of the herbicide desmedipham

(Betanex 1.3 EC) for postemergence

control of hairy galinsoga, redroot

pigweed, common ragweed, common

lambsquarters, wild mustard, eastern

black nightshade, hairy nightshade and

velvetleaf weeds in red garden beets in

New York. These weeds were controlled

by diethatyl-ethyl (Antor); however, this

product was voluntarily canceled in

1993 and existing stocks have been

exhausted. Alternatives do not provide

effective control and growers will

experience significant economic losses

without the use of desmedipham. After

having reviewed the submission, EPA

concurs that emergency conditions exist

for this state.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

desmedipham in or on garden beet roots

and tops. 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

exemption in order to address an urgent
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations 45743

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 tolerances will expire and are

revoked on August 30, 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 garden beet roots and tops 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

if any experience with, scientific data

on, or other relevant information on this

pesticide indicate that the residues are

not safe.

Because this tolerance is being

approved under emergency conditions

EPA has not made any decisions about

whether desmedipham meets EPA’s

registration requirements for use on

garden beet roots and tops 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 desmedipham 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 New York to use this pesticide on

this crop under section 18 of FIFRA

without following all provisions of

section 18 as identified in 40 CFR part

166. For additional information

regarding the emergency exemption for

desmedipham, contact the Agency’s

Registration Division at the address

provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

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

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

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

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term’’, and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all 3 sources

are not typically added because of the

very low probability of this occurring in

most cases, and because the other

conservative assumptions built into the

assessment assure adequate protection

of public health. However, for cases in

which high-end exposure can

reasonably be expected from multiple

sources (e.g. frequent and widespread

homeowner use in a specific

geographical area), multiple high-end

risks will be aggregated and presented

as part of the comprehensive risk

assessment/characterization. Since the

toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this
45744 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

children (1-6 years 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 desmedipham and to make a

determination on aggregate exposure,

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

time-limited tolerances for

desmedipham on garden beet roots and

tops at 0.2 and 15.0 ppm respectively.

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 desmedipham

are discussed below.

1. Acute toxicity. For acute dietary

risk assessment, the Agency

recommended use of the NOEL of 150

mg/kg/day, based on slight increase in

skeletal variations in developing pups at

the lowest effect level (LEL) of 450 mg/

kg/day, from the developmental study

in rabbits. This NOEL is used to

evaluate the Margin of Exposure (MOE)

from the acute dietary risk to pregnant

women (females 13+ years or older).

2. Short - and intermediate - term

toxicity. No short- or intermediate-term

non-dietary, non-occupational exposure

scenario exists for desmedipham.

3. Chronic toxicity. EPA has

established the RfD for desmedipham at

0.04 milligrams/kilogram/day (mg/kg/

day). This RfD is based on a

reproduction study in rats with a NOEL

of 4 mg/kg/day and an uncertainty

factor of 100. The effects observed at the

LEL of 20 mg/kg/day were significant

increases in splenic weights and

compensatory functioning of the

thyroid.

4. Carcinogenicity. Cancer risks have

not been identified by the Agency.

Desmedipham has been classified as a

Group ‘‘E’’ chemical, no evidence of

carcinogenicity, based on the results

from two acceptable studies with two

species.

B. Exposures and Risks

1. From food and feed uses. A

permanent tolerance of 0.2 ppm has

been previously established (40 CFR

180.353) for negligible residues of the

herbicide desmedipham, in or on sugar

beet roots and tops. Risk assessments

were conducted by EPA to assess

dietary exposures and risks from

desmedipham as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a one day or single exposure. The acute

dietary exposure endpoint of concern

for desmedipham is a slight increase in

skeletal variations in developing pups

which was observed in the rabbit

developmental study. The population

subgroup of concern is females 13+

years old (women of childbearing age).

Acute dietary exposure (food only) was

calculated using the high end exposure

value and TMRC (worst case)

assumptions. Therefore, this risk

assessment is considered conservative.

Despite the potential for acute exposure

to desmedipham in drinking water, EPA

does not expect the aggregate acute

exposure to exceed the Agency’s level of

concern.

ii. Chronic exposure and risk. In

conducting exposure assessments for

this section 18 request, EPA used

tolerance level residues and assumed

that 100% of the crop would be treated

with the pesticide (TMRC worst-case

analysis assumptions, as described

above).

2. From drinking water. Based on

information from the Weed Science

Society Handbook (7th ed., 1994),

desmedipham has the following

environmental fate characteristics: 1)

soluble in water to the extent of 7 mg/

L at 20 C and pH 7; 2) half-life of ≤1

month in silty loam, sandy loam, and

silty clay loam soils; and 3) exhibits no

appreciable leaching with residues

remaining in the top 2 inches of soil.

No Maximum Concentration Level or

Health Advisory Level has been

established for residues of

desmedipham in drinking water. There

is no entry for desmedipham in the

‘‘Pesticides in Groundwater Database’’

(EPA 34-12-92-001, Sept. 1992).

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
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations 45745

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 desmedipham 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 desmedipham 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.

3. From non-dietary exposure. Nondietary, non-occupational exposure is

not expected because desmedipham is

not registered for indoor or outdoor

residential uses.

4. Cumulative exposure to substances

with common mechanism of toxicity.

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

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

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

desmedipham 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, desmedipham

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 desmedipham 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 US population

subgroup of concern, pregnant females

(13+ years of age), an MOE value of

375,000 was calculated using the high

end human exposure value of 0.0004

mg/kg/day. The Agency generally

considers MOEs over 100 (food only)

acceptable. This acute dietary (food

only) risk assessment used tolerance

level residues and assumed 100% croptreated (TMRC worst-case analysis,

described above).

Despite the potential for risk from

acute exposure to desmedipham in

drinking water, the Agency does not

expect acute aggregate exposure to

exceed its level of concern. EPA

concludes that there is a reasonable

certainty that no harm will result from

acute aggregate exposure to

desmedipham.

2. Chronic risk. Using the TMRC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to desmedipham from food

will utilize less than 1.0% of the RfD for

the U.S. population. Aggregate exposure

to desmedipham from food utilizes less

than 1% of the RfD for all major

identifiable subgroups, including

infants and children. EPA generally has

no concern for exposures below 100%

of the RfD because the RfD represents

the level at or below which daily

aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health.

Despite the potential for exposure to

desmedipham 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

desmedipham residues.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure. Because no short- or

intermediate-term non-dietary, nonoccupational exposure scenario exists

for desmedipham, a short- or

intermediate-term aggregate risk

assessment is not required.

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

desmedipham, 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

pesticide exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE
45746 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard MOE and

uncertainty factor (usually 100 for

combined inter- and intra-species

variability) and not the additional

tenfold MOE/uncertainty factor when

EPA has a complete data base under

existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard MOE/safety factor.

b. Developmental toxicity studies— i.

Rat developmental toxicity. The

maternal (systemic) NOEL was 100 mg/

kg/day, based on decreased weight gain

at the lowest observed effect level

(LOEL) of 1,000 mg/kg/day. The

developmental (pup) NOEL was 100

mg/kg/day, based on decreased fetal

body weight and increased incidence of

skeletal anomalies at the LOEL of 1,000

mg/kg/day.

ii. Rabbit developmental toxicity. The

maternal (systemic) NOEL was 150 mg/

kg/day, based on decreased weight gain

at the LOEL of 450 mg/kg/day. The

developmental (pup) NOEL was 150

mg/kg/day, based on a slight increase in

skeletal variations at the LEL of 450 mg/

kg/day.

c. Reproductive toxicity study— Rat

reproduction toxicity. The maternal

(systemic) NOEL was 4 mg/kg/day,

based on decreased body weight and

hemolytic anemia at the LOEL of 20 mg/

kg/day. The reproductive/

developmental (pup) NOEL was 4 mg/

kg/day, based on decreased pup body

weight and reduced litter size at the LEL

of 20 mg/kg/day.

d. Pre- and post-natal sensitivity. In

the rat and rabbit developmental

studies, both the developmental and

maternal NOELs and LOELs (100 and

1,000 mg/kg/day for rats and 150 and

450 mg/kg/day for rabbits), respectively,

occurred at the same dose levels which

demonstrates that there is no special

pre-natal sensitivity in infants and

children exposed to desmedipham.

In the rat reproductive study, both the

pup and parental NOEL and LOEL of 4

and 20 mg/kg/day, respectively,

occurred at the same dose level which

demonstrates that there is no special

post-natal sensitivity in infants and

children exposed to desmedipham.

e. Conclusion. The Agency concluded

that the developmental and

reproductive findings in rats did not

demonstrate any pre-natal or post-natal

acute risk concerns for infants and

children.

The Agency concluded that the

observed developmental effects in the

rabbit study, a slight increase in skeletal

variations in developing pups, presents

a pre-natal acute risk concern for infants

and children. An acute dietary risk

assessment evaluating margin of

exposure (MOE) for pregnant women

13+ years or older is required when the

Agency determines that there is a preor post- natal acute risk effect of

concern.

2. Acute risk. As described above, the

acute dietary MOE for pregnant women

13+ years old is 375,000 based on the

rabbit developmental NOEL of 150 mg/

kg/day and the high end human

exposure value of 0.0004 mg/kg/day.

This MOE is much higher than the

minimal acceptable MOE of 100 for

acute exposure to food. Despite the

potential for acute exposure to

desmedipham in drinking water, the

Agency does not expect acute aggregate

exposure to exceed its level of concern.

EPA concludes that there is a reasonable

certainty that no harm will result to

infants and children from acute

aggregate exposure to desmedipham.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate chronic exposure to

desmedipham from food will utilize less

than 1% of the RfD for infants and

children. EPA generally has no concern

for exposures below 100% of the RfD

because the RfD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health.

Despite the potential for chronic

exposure to desmedipham in drinking

water, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD. EPA concludes that there is a

reasonable certainty that no harm will

result to infants and children from

chronic aggregate exposure to

desmedipham residues.

4. Short- or intermediate-term risk.

Because no short- or intermediate-term

non-dietary, non-occupational scenario

exists for desmedipham, a short- or

intermediate-term aggregate risk

assessment is not required.

V. Other Considerations

A. Metabolism In Plants and Animals

The qualitative nature of the

desmedipham residue in plants is

adequately understood. The residue of

concern is desmedipham per se.

B. Analytical Enforcement Methodology

A desmedipham-specific analytical

method (HPLC UV/VIS) is available for

enforcement.

C. Magnitude of Residues

Residues of desmedipham are not

expected to exceed 0.2 ppm in garden

beet roots and 15.0 ppm in garden beet

tops (leaves) as a result of this Section

18 use. Secondary residues of

desmedipham are not expected in

animal commodities as no livestock feed

items are associated with this Section 18

use.

D. International Residue Limits

There are no Codex, Canadian, or

Mexican international residue limits

established for use of desmedipham on

red (garden) beets.

VI. Conclusion

Therefore, the tolerances are

established for desmedipham in garden

beet roots and tops at 0.2 and 15.0 ppm

respectively.

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 28, 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
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations 45747

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–300532] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408 (d), such as the 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 acations published on May 4,

1981 (46 FR 24950), and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

X. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: August 13, 1997.

James Jones,

Acting 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. Section 180.353 is amended to read

as follows:

a. By designating the existing text as

paragraph (a) and adding a heading.

b. By adding paragraph (b).

c. By adding the headings and

reserving paragraphs (c) and (d).

The added text reads as follows:

§ 180.353 Desmedipham; tolerances for

residues.

(a) General . * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for residues of the herbicide

desmedipham in connection with use of

the pesticide under section 18

emergency exemptions granted by EPA.

The tolerances will expire and are

revoked on the date specified in the

following table:

Commodity Parts per

million

Expiration/

revocation

date

Garden beet

roots ............... 0.2 8/30/98

Garden beet

tops ................ 15.0 8/30/98

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–23096 Filed 8–28–97; 8:45 am]

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