45748 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185 and 186

[OPP–300542; FRL–5739–8]

RIN 2070–AB78

Paraquat; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for paraquat

(1,1′-dimethyl-4,4′-bipyridinium-ion) in

or on dry peas and mustard seed. This

action is in response to EPA’s granting

of emergency exemptions under section

18 of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on dry peas in Idaho,

Oregon and Washington, and mustard

seed in Washington. This regulation

establishes maximum permissible levels

for residues of paraquat in these food

commodities pursuant to section

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

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996. The

tolerances will expire and are revoked

on November 15, 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–300542],

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–

300542], 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–

300542]. 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/desiccant/

defoliant paraquat, in or on dry peas at

0.3 parts per million (ppm) and mustard

seed at 5.0 ppm. These tolerances will

expire and are revoked on November 15,

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 Exemptions for Paraquat

on Dry Peas and Mustard Seed and

FFDCA Tolerances

The Idaho Department of Agriculture

requested a regional emergency

exemption for use of paraquat

dichloride (Gramoxone Plus Herbicide)

for desiccation of weeds infesting green

peas grown for seed and dry peas in

Idaho, Oregon and Washington in

March, 1997. Unusually cold, wet

weather delayed the pea planting season

resulting in late pea emergence and

higher incidence of weed infestations in

fields. Continued moist, cool weather

has contributed to weeds remaining

green at harvest. Weeds plug harvesting

equipment delaying harvest and the
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations 45749

delays result in downgraded or

unmarketable peas due to shattered

pods, bleached and sloughed seed coats

and sprouting. There are currently no

registered pesticides or alternative

methods of control which can provide

desiccation of weeds and permit harvest

of the crops. After having reviewed the

submission, EPA concurs that

emergency conditions exist for these

states.

The Washington Department of

Agriculture requested a specific

exemption for use of paraquat

(Gramoxone Extra Herbicide) for

desiccation of weeds in mustard seed

grown for processing (condiment). An

early season freeze coupled with

continuous cool, early season growing

conditions stunted this years’ mustard

crop and allowed weeds, predominantly

Russian thistle, to become established in

the crop. Affected growers will be

unable to harvest infested mustard

fields without the use of a desiccant

harvest aid. After having reviewed the

submission, EPA concurs that

emergency conditions exist for this

state.

As part of its assessment of these

emergency exemptions, EPA assessed

the potential risks presented by residues

of paraquat in or on dry peas and

mustard seed. In doing so, EPA

considered the new safety standard in

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

decided that the necessary tolerance

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 non-routine situation

and to ensure that the resulting food is

safe and lawful, EPA is issuing this

tolerance 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 Nov 15, 1998,

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

of the pesticide not in excess of the

amounts specified in the tolerance

remaining in or on dry peas and

mustard seed 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 this tolerance 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 paraquat meets EPA’s

registration requirements for use on dry

peas and mustard seed or whether

permanent tolerances for these uses

would be appropriate. Under these

circumstances, EPA does not believe

that these tolerances serve as a basis for

registration of paraquat 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 Idaho,

Oregon, and Washington for dry peas

and Washington for mustard seed to use

this pesticide on these crops 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 paraquat, contact the

Agency’s Registration Division at the

address provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

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

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

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

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

or less of the RfD) is generally

considered acceptable by EPA. EPA

generally uses the RfD to evaluate the

chronic risks posed by pesticide

exposure. For shorter term risks, EPA

calculates a margin of exposure (MOE)

by dividing the estimated human

exposure into the NOEL from the

appropriate animal study. Commonly,

EPA finds MOEs lower than 100 to be

unacceptable. This 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
45750 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

non-nursing infants (less than 1 year

old) was not regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action,

EPA has sufficient data to assess the

hazards of paraquat and to make a

determination on aggregate exposure,

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

time-limited tolerances for paraquat

(1,1′-dimethyl-4,4′-bipyridinium-ion) on

dry peas at 0.3 ppm and mustard seed

at 5.0 ppm. EPA’s assessment of the

dietary exposures and risks associated

with establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by paraquat are

discussed below.

1. Acute toxicity. Based on the

proposed and existing use patterns and

tolerances and available toxicological

data, there are no acute dietary exposure

endpoints of concern for paraquat.

2. Short - and intermediate - term

toxicity. 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 uses. There are no indoor

residential uses of paraquat and based

on the nature of the non-food outdoor

uses, the Agency does not expect

significant exposure from the registered

outdoor residential uses (spot treatment

of vegetation for ornamental crop

production) of paraquat. Therefore, a

short- and intermediate-term aggregate

risk assessment has not been performed.

3. Chronic toxicity. EPA has

established the RfD for paraquat at

0.0045 milligrams/kilogram/day (mg/kg/

day). This RfD is based on a one year

dog feeding study with a NOEL of 15

ppm (0.45 mg/kg/day) and an

uncertainty factor of 100. Chronic

pneumonitis was observed at the next

dose of paraquat tested, 30 ppm (0.93

mg/kg/day, expressed as paraquat

cation).

4. Carcinogenicity. Using its

Guidelines for Carcinogen Risk

Assessment published September 24,

1986 (51 FR 33992), EPA has classified

paraquat as Group ‘‘E’’ for

carcinogenicity (evidence of

noncarcinogenicity for humans.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.205) for the herbicide/

desiccant/defoliant paraquat (1,1′-

dimethyl-4,4′-bipyridinium-ion) , in or

on a variety of plant raw agricultural

commodities ranging from 0.05 ppm in

broccoli to 30 ppm in bean straw, and

animal commodities ranging from 0.01

ppm (non-detectable residues) in milk

and eggs to 0.30 ppm for cattle kidney.

Risk assessments were conducted by

EPA to assess dietary exposures and

risks from paraquat 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
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations 45751

a one day or single exposure. Based on

the proposed and existing use patterns

and tolerances and available

toxicological data, there are no acute

dietary exposure endpoints of concern

for paraquat.

ii. Chronic exposure and risk. For the

purpose of assessing potential chronic

dietary exposure from paraquat, EPA

assumed tolerance levels for all uses

and percent of crop treated refinements

for some commodities to estimate the

Anticipated Residue Contribution (ARC)

from the proposed and existing food

uses of paraquat. The use of percent of

crop treated data for some of the

existing food uses in this analysis

results in a more refined estimate of

exposure than the TMRC.

2. From drinking water. Review of

terrestrial field dissipation data by the

Environmental Fate and Effects Division

indicates that paraquat is persistent and

very soluble in water but has a high

affinity to bind to sediment. As noted in

‘‘Pesticides in Groundwater Database’’

(EPA 734–12–92–001, Sept. 1992), 971

wells were sampled in 5 states from

1983 to 1990. Eleven of the 971 wells

exhibited positive hits, up to 0.1 mg/L

(ppm). However, the two wells that

exhibited concentrations at 0.1 mg/L

were in Missouri, with a detection limit

which was also 0.1 mg/L. The next

highest concentration of paraquat was

0.018 mg/L from a well in Virginia,

where the detection limit of the

analytical method was 0.00001 mg/L.

Based on the poor analytical

methodology used, the Agency believes

that the Missouri data are unreliable.

There is no established Maximum

Concentration Level for residues of

paraquat in drinking water. The

following health advisory levels for

paraquat in drinking water have been

established: children (short-term

exposure) 0.1 mg/L; children (longerterm exposure) 0.05 mg/L; adult

(intermediate-term exposure) 0.2 mg/L;

and adult (lifetime exposure) 0.03 mg/

L.

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

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause paraquat 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

paraquat in water, even at the higher

levels the Agency is considering as a

conservative upper bound, would not

prevent the Agency from determining

that there is a reasonable certainty of no

harm if the tolerance is granted.

3. From non-dietary exposure.

Paraquat is registered for use in federal

conservation reserve programs and for

weed control in ornamental crop

production; however, the Agency does

not expect significant exposure from

these registered outdoor non-food 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

paraquat 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,

paraquat 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 paraquat has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. No acute toxicity effect

of concern was identified by the

Agency, so this risk assessment is not

required.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to paraquat from dietary (food

only) sources will utilize 10 % of the

RfD for the U.S. population. The major

identifiable subgroup with the highest

aggregate exposure is non-nursing

infants less than 1 year old. The chronic

risk for infants and children is

discussed below. EPA generally has no

concern for exposures below 100% of

the RfD because the RfD represents the

level at or below which daily aggregate

dietary exposure over a lifetime will not

pose appreciable risks to human health.

Despite the potential for exposure to

paraquat 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 paraquat residues.
45752 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations

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. There are no indoor

residential uses for paraquat and based

on the nature of the outdoor non-food

uses, the Agency does not expect

significant exposure from the registered

outdoor residential uses (spot treatment

of vegetation for ornamental crop

production) of paraquat. Therefore, a

short- and intermediate-term aggregate

risk assessment has not been performed.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children. i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

paraquat, EPA considered data from

developmental toxicity studies in the rat

and mouse 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

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.

ii. Developmental toxicity studies— a.

Rats. The maternal NOEL was 1 mg/kg/

day. The maternal LOEL of 5 mg/kg/day

(expressed as paraquat cation) was

based on clinical signs of thin and

hunched appearance, and decreased

body weight gains. Developmental

toxicity was manifested as decreases in

fetal body weight and delayed

ossification in forelimb and hindlimb

digits; the NOEL and LOEL were 1 mg/

kg/day and 5 mg/kg/day, respectively.

b. Mice. The maternal NOEL was 1

mg/kg/day expressed as paraquat

cation). The maternal LOEL of 5 mg/kg/

day was based on a reduction in body

weight gain. The NOEL for

developmental toxicity was also 1 mg/

kg/day. The LOEL of 5 mg/kg/day was

based on partially ossified 4th

sternebrae.

iii. Reproductive toxicity study—Rats.

The NOEL for systemic toxicity in the

adults was 25 ppm (1.25 mg/kg/day).

The LOEL of 75 ppm (3.75 mg/kg/day),

expressed as paraquat cation, was based

on the increased incidence of alveolar

histiocytosis in the parents. The

reproductive/developmental toxicity

NOEL was considered to be > 150 ppm

(7.5 mg/kg/day, expressed as paraquat

cation) at the highest dose tested since

no reproductive effects were presented

in this study.

iv. Pre- and post-natal sensitivity. The

pre- and post-natal toxicology data base

for paraquat is complete with respect to

current toxicological data requirements.

In the rat developmental study, the

maternal (systemic) NOEL and the

developmental NOEL are both 1 mg/kg/

day. The LOELs are 5 mg/kg/day for

both maternal and developmental

effects. The developmental results at 5

mg/kg/day do not indicate any severe

effects compared to the maternal effects

at the LOEL. In the mouse

developmental study, the maternal

(systemic) and developmental NOELs

were established at 1 mg/kg/day with

the LOELs set at 5 mg/kg/day. The

developmental effects at the LOEL of 5

mg/kg/day do not demonstrate any

special pre-natal sensitivity for infants

and children which would require an

additional safety factor.

In both studies, maternal and

developmental NOEL/LOEL levels and

effects at the LOEL suggest that there is

no increased sensitivity for infants and

children from exposure to paraquat

residues in the diet.

In the rat reproduction study the

parental (systemic) NOEL was 1.25 mg/

kg/day. The pup NOEL was considered

to be > 7.5 mg/kg/day at the highest

dose tested which suggests that there is

no increased post-natal sensitivity to

paraquat.

v. Conclusion. The effects observed in

the mouse and rat developmental

studies and the rat reproductive study

did not demonstrate any special pre- or

post-natal sensitivity for infants and

children.

The Agency concludes that reliable

data support use of the standard 100-

fold uncertainty factor and that an

additional uncertainty factor is not

needed to protect infants and children.

2. Acute risk. No acute effect endpoint

of concern was identified by the Agency

so this risk assessment is not required.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that the percentage of the RfD that will

be utilized from dietary (food only)

exposure to paraquat ranges from 12%

for nursing infants to 31% for nonnursing infants less than 1 year old. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Under current

guidelines, the registered residential

uses (weed control in ornamental crop

production) do not fall under a chronic

scenario. Despite the potential for

exposure to paraquat in drinking water

and from non-dietary, non-occupational

exposure, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD. EPA concludes that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to paraquat residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The qualitative nature of the residue

in plants and animals has been

determined. The residue of concern is

the parent compound, paraquat, only, as

specified in 40 CFR 180.205.

B. Analytical Enforcement Methodology

Method I of PAM, Vol. II

(spectrophotometric), is adequate for

tolerance enforcement purposes. In

addition, the Agency concluded that

Method 1B adequately recovers

paraquat cation residues from samples

of potatoes and soybeans treated with

radiolabeled paraquat.

C. Magnitude of Residues

Residues of paraquat are not expected

to exceed 0.3 ppm in/on dry peas and

5.0 ppm in/on mustard seed as a result

of these section 18 uses. For the

purposes of the dried pea section 18

requests only, the Agency is willing to

accept the proposed prohibition for

feeding the pea byproducts. No animal

feed items are associated with the

proposed use on mustard seed.
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations 45753

D. International Residue Limits

No CODEX, Canadian, and/or

Mexican MRLs/tolerances have been

established for residues of paraquat on

peas or mustard seed.

E. Rotational Crop Restrictions.

As noted in the residue chemistry

chapter of the Paraquat Reregistration

Eligibility Document, no plantback

restrictions or field rotational crop

studies are required.

VI. Conclusion

Therefore, tolerances are established

for paraquat (1,1′-dimethyl-4,4′-

bipyridinium-ion) in/on dry peas at 0.3

ppm and mustard seed at 5.0 ppm in 40

CFR 180.205. In addition, § 180.205 was

restructured in a final rule published in

the Federal Register on May 2, 1997 (62

FR 24045)(FRL-5713-2) to combine the

tolerances for food and feed

commodities and raw agricultural

commidities into the same section. At

that time the food and feed additive

tolerances in §§ 185.4700 and 186.4700

were combined with the tolerances in

§ 180.205(a). Therefore, §§ 185.4700 and

186.4700 are no longer necessary and

are removed in this rule.

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

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–300542] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a time

limited tolerance on EPA’s own

initiative, under FFDCA section 408(d).

The Office of Management and Budget

(OMB) has exempted these types of

actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

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 time limited

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
45754 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Rules and Regulations

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

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Environmental protection, Food

additives, Pesticides and pests.

40 CFR Part 186

Environmental protection, Animal

feeds, Pesticides and pests.

Dated: August 18, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I, parts

180, 185, and 186 is amended as

follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

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

b. In § 180.205, the table in paragraph

(b) is amended by ordering

alphabetically the existing entries, and

by adding alphabetically entries for

‘‘peas, (dry),’’ and ‘‘mustard, seed,’’ to

read as follows:

§ 180.205 Paraquat; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per million Expiration/Revocation Date

* * * * *

Peas (dry) ............................................................................................ 0.3 November 15, 1998

Mustard, seed ...................................................................................... 5.0 November 15, 1998

* * * * *

* * * * *

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority : 21 U.S.C. 346a and 348.

§ 185.4700 [Removed]

b. Section 185.4700 is removed.

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority : 21 U.S.C. 346a and 348.

§ 186.4700 [Removed]

b. Section 186.4700 is removed.

[FR Doc. 97–23094 Filed 8–28–97; 8:45 am]

BILLING CODE 6560–50–F

LEGAL SERVICES CORPORATION

45 CFR Part 1602

Procedures for Disclosure of

Information Under the Freedom of

Information Act

AGENCY: Legal Services Corporation.

ACTION: Final rule.

SUMMARY: This final rule makes

technical revisions to the Legal Services

Corporation’s (‘‘Corporation’’ or ‘‘LSC’’)

rule concerning the disclosure of

information under the Freedom of

Information Act by revising the

Corporation’s address and deleting

outdated references to regional offices.

Other minor technical revisions are also

made.

EFFECTIVE DATE: This final rule is

effective on August 29, 1997.

FOR FURTHER INFORMATION CONTACT:

Office of the General Counsel, (202)

336–8817.

SUPPLEMENTARY INFORMATION: Pursuant

to the Freedom of Information Act, the

Corporation is required to publish

current information in the Federal

Register that provides guidance to the

public regarding how to obtain

information about and from the

Corporation. See 5 U.S.C. 552. The

Corporation’s Operations and

Regulations Committee (‘‘Committee’’)

of the Corporation’s Board of Directors

(‘‘Board’’) met on July 13, 1997, in Los

Angeles, California, and voted to

recommend technical changes to the

rule so that it would conform to this

FOIA requirement. On July 14, 1997, the

changes were recommended to the

Board, which adopted the revisions and

directed that they be published as final

with an effective date on the date of

publication.

This final rule makes several

technical revisions to the Corporation’s

FOIA regulation to correct inaccurate

and misleading information, so that the

Corporation is in compliance with the

FOIA. The corrections include changing

the Corporation’s address to reflect its

current location and deleting references

to regional offices that no longer exist.

Related stylistic and grammatical

changes are also made. None of the

changes are substantive, and therefore

the changes do not require a public

notice and comment period. The

revisions are effective on the date of

publication.

List of Subjects in 45 CFR Part 1602

Grant programs, Legal services.

For the reasons set forth in the

preamble, LSC amends 45 CFR part

1602 to read as follows:

PART 1602—PROCEDURES FOR

DISCLOSURE OF INFORMATION

UNDER THE FREEDOM OF

INFORMATION ACT

1. The authority citation for part 1602

is revised to read as follows:

Authority: 5 U.S.C. 552 and 42 U.S.C.

2996d(g).

2. Section 1602.4 is revised to read as

follows:

§ 1602.4 Index of records.

The Corporation will maintain a

current index identifying any matter

within the scope of § 1602.5(b) (1)

through (3) which has been issued,

adopted, or promulgated by the

Corporation, and other information