Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations 64287

LOUISIANA—OZONE—Continued

Designated area

Designation Classification

Date 1 Type Date Type

* * * * * * *

1This date is November 15, 1990, unless otherwise noted.

[FR Doc. 97–31912 Filed 12–4–97; 8:45 am]

BILLING CODE 6560–50–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180 and 185

[OPP–300587; FRL–5754–5]

RIN 2070–AB78

Maleic hydrazide; Pesticide Tolerances

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

maleic hydrazide (1,2-dihydro-3,6-

pyridazinedione) in or on rice

commodities as well as tolerances for

secondary residues in animal

commodities. 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 rice in Louisiana. This

regulation establishes a maximum

permissible level for residues of maleic

hydrazide 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

September 30, 1998.

DATES: This regulation is effective

December 5, 1997. Objections and

requests for hearings must be received

by EPA on or before February 3, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300587],

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–

300587], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, 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 5.1/6.1 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–

300587]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Stephen Schaible, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308–9362, e-mail:

schaible.stephen@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

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

tolerances for residues of the herbicide

maleic hydrazide (1,2-dihydro-3,6-

pyridazinedione), in or on rice, grain at

105 part per million (ppm); rice, straw

at 75 ppm; rice, hulls at 240 ppm; and

rice, bran at 180 ppm. Additionally, the

Agency is establishing tolerances for

secondary residues in milk at 1.0 ppm;

at 2.5 ppm in meat, 7 ppm in liver, 32

ppm in kidney, and 3 ppm in fat of

cattle, goats, hogs, horses, and sheep; at

0.5 ppm in meat, liver, and fat of

poultry; 1.4 ppm in poultry meat

byproducts; and 0.5 ppm in eggs. These

tolerances will expire and are revoked

on September 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
64288 Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations

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 Maleic

Hydrazide on Rice and FFDCA

Tolerances

On June 19, 1997, the Louisiana

Department of Agriculture and Forestry

availed of itself the authority to declare

the existence of a crisis situation within

the State, thereby authorizing use under

FIFRA section 18 of maleic hydrazide

on rice to control red rice. Red rice is

normally controlled by flood water

management and rotating the rice crop

to soybeans, where soybean herbicides

are used that control red rice but are

also phytotoxic to commercial rice. Over

the last 5 years, farm land to be rotated

into rice in 1997 has experienced three

consecutive soybean seasons with poor

control of red rice. This has resulted in

increasing red rice infestations in the

two intervening rice crop seasons, and

a buildup of red rice seed in the soil.

This situation gives rise to the

possibility of an unprecedentedly high

red rice infestation in 1997. Economic

loss due to red rice occurs both through

reductions in the yield of the rice crop

and through reductions in the quality of

the harvested crop. Because red rice and

cultivated rice are closely related, there

are few selective herbicides available;

those that are have limited efficacy

against red rice. The use of maleic

hydrazide would not only increase yield

and quality of the harvested crop this

year, but would reduce red rice seed in

the soil and therefore reduce the level

of red rice infestation in the next rice

crop. EPA has authorized under FIFRA

section 18 the use of maleic hydrazide

on rice for control of red rice in

Louisiana. 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

maleic hydrazide in or on rice. 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

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 September 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 rice grain, bran, hulls and straw

or in meat, milk, poultry or eggs 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 these tolerances are being

approved under emergency conditions

EPA has not made any decisions about

whether maleic hydrazide meets EPA’s

registration requirements for use on rice

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 maleic

hydrazide 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 Louisiana 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 maleic hydrazide, contact

the Agency’s Registration Division at the

address provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

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

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

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

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

or less of the RfD) is generally

considered acceptable by EPA. EPA

generally uses the RfD to evaluate the

chronic risks posed by pesticide

exposure. For shorter term risks, EPA

calculates a margin of exposure (MOE)

by dividing the estimated human

exposure into the NOEL from the

appropriate animal study. Commonly,

EPA finds MOEs lower than 100 to be

unacceptable. This hundredfold MOE is

based on the same rationale as the

hundredfold uncertainty factor.
Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations 64289

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term,’’ and ‘‘chronic,’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all 3 sources

are not typically added because of the

very low probability of this occurring in

most cases, and because the other

conservative assumptions built into the

assessment assure adequate protection

of public health. However, for cases in

which high-end exposure can

reasonably be expected from multiple

sources (e.g. frequent and widespread

homeowner use in a specific

geographical area), multiple high-end

risks will be aggregated and presented

as part of the comprehensive risk

assessment/characterization. Since the

toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1–7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

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 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 maleic hydrazide and to

make a determination on aggregate

exposure, consistent with section

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

residues of maleic hydrazide (1,2-

dihydro-3,6-pyridazinedione) on rice,

grain at 105 ppm; rice, straw at 75 ppm;

rice, hulls at 240 ppm; rice, bran at 180

ppm; time-limited tolerances are set at

2.5 ppm in meat, 7.0 ppm in liver, 32.0

ppm in kidney, and 3.0 ppm in fat of

cattle, goats, hogs, horses, and sheep;

1.0 ppm in milk; 0.5 ppm in meat, liver,

and fat of poultry; 1.4 ppm in poultry

meat byproducts (except liver), and 0.5

ppm in eggs. 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 maleic hydrazide

are discussed below.
64290 Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations

1. Acute toxicity. The Agency has

determined that an acute dietary risk

assessment is not required for this

chemical.

2. Short - and intermediate - term

toxicity. Based on the available data

base, the Agency has concluded that

determination of short-term Margin of

Exposure (MOE) calculations is not

required. For intermediate-term MOE

calculations, the Agency recommends

use of the NOEL of 29 milligrams/

kilogram/day (mg/kg/day) from the 1–

year feeding study in dogs. Decreased

weight gain and reduced heart weight

are the effects observed at the Lowest

Effect Level (LEL) of 87 mg/kg/day.

3. Chronic toxicity. EPA has

established the RfD for maleic hydrazide

at 0.25 mg/kg/day. This RfD is based on

a NOEL of 25 mg/kg/day taken from a

2–year feeding study in rats in which

decreased weight gain in males was the

effect observed at the LEL of 500 mg/kg/

day. An uncertainty factor of 100 was

assigned to allow for inter- and intraspecies variability.

4. Carcinogenicity. Maleic hydrazide

has been classified as a Group E--

evidence of non-carcinogenicity for

humans in two species--chemical by the

Agency. A carcinogenic risk assessment

is not required.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.175) for the residues of maleic

hydrazide (1,2-dihydro-3,6-

pyridazinedione), in or on dry bulb

onions, potatoes and cranberries. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

maleic hydrazide as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a 1 day or single exposure. The Agency

has determined that this risk assessment

is not required.

ii. Chronic exposure and risk. Refined

residue and percent of crop treated

information were used in the chronic

exposure analysis to calculate the

Anticipated Residue Contribution (ARC)

from published and proposed uses of

maleic hydrazide. The use of tolerance

level residues for potatoes and dry bulb

onions as well as the use of high end

anticipated residues for animal

commodities results in overestimation

of chronic dietary risk.

2. From drinking water. Review of

available data indicate that maleic

hydrazide is neither mobile nor

persistent. There is no established

Maximum Contaminant Level for

residues of maleic hydrazide in drinking

water. Health advisory levels for maleic

hydrazide in drinking water have been

established at the following levels: for a

10 kg child, 10 mg/liter (1–day and 10–

day levels) and 5 mg/liter (long term

level); for a 70 kg adult, 20 mg/liter

(long term level).

Chronic exposure and risk. Because

the Agency lacks sufficient waterrelated 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 maleic hydrazide 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 maleic hydrazide 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. Maleic

hydrazide is currently registered for use

on the following residential non-food

sites: outdoor non-food sites such as

non-bearing citrus and ornamentals.

i. Chronic exposure and risk. Based

on the uses registered, a chronic, nondietary exposure scenario is not

expected.

ii. Short- and intermediate-term

exposure and risk. Maleic hydrazide is

currently registered for use on outdoor

non-food sites such as non-bearing

citrus, ornamental shade trees and

plants, turf, lawns, utility and highway

rights of way, industrial areas and

airports. There are no indoor 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).

Maleic hydrazide is a member of the

hydrazide class of pesticides; another

member of this class is Alar

(daminozide). EPA does not have, at this

time, available data to determine

whether maleic hydrazide 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
Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations 64291

risk approach based on a common

mechanism of toxicity, maleic

hydrazide 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 maleic hydrazide has a

common mechanism of toxicity with

other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Chronic risk. Using the ARC

exposure assumptions described in Unit

IV.B. of this preamble, EPA has

concluded that aggregate exposure to

maleic hydrazide from food will utilize

14% of the RfD for the U.S. population.

The major identifiable subgroup with

the highest aggregate exposure is nonnursing infants less than 1 year old

(discussed in Unit IV.E. of this

preamble). 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

maleic hydrazide 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 maleic

hydrazide residues.

2. 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. Data to quantify intermediateterm exposure from non-occupational,

non-dietary uses are not available at this

time. In the absence of a quantitative

estimate of exposure, the Agency

believes that the large MOEs calculated

for mixers, loaders and applicators of

the product (1,000 to 1,800, where 100

is considered to be the level at which

the Agency has reasonable certainty of

no harm resulting from occupational

exposure to the chemical) demonstrate

that intermediate aggregate risk from

non-occupational uses of maleic

hydrazide is below the Agency’s level of

concern.

D. Aggregate Cancer Risk for U.S.

Population

Maleic hydrazide has been classified

as a Group E chemical. A carcinogenic

risk assessment is not required for this

chemical.

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

maleic hydrazide, 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

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. In

the developmental toxicity study in rats,

the maternal (systemic) NOEL was 1,600

mg/kg/day, the highest dose tested

(HDT). The developmental NOEL was

1,200 mg/kg/day, based on minor

skeletal variations at the LOEL of 1,600

mg/kg/day. In a second developmental

toxicity study in rats, the maternal and

developmental NOELs were greater than

1,000 mg/kg/day, the HDT. The Agency

concluded that skeletal variations

observed in the first study occurred at

doses above 1 mg/kg/day, the limit dose,

and therefore were of minimal concern.

In the developmental toxicity study in

rabbits, the maternal and developmental

NOELs were 1,000 mg/kg/day, the HDT.

iii. Reproductive toxicity study. In the

2-generation reproductive toxicity study

in rats, the maternal NOEL was 500 mg/

kg/day, based on decreased body weight

at the LOEL of 1,500 mg/kg/day. The

reproductive/developmental NOEL was

500 mg/kg/day, based on post-natal

decrease in body weight of pups during

lactation at the LOEL of 1,500 mg/kg/

day.

iv. Pre- and post-natal sensitivity. The

toxicity data base for evaluating preand post-natal toxicity for maleic

hydrazide is complete with respect to

current data requirements. There are no

pre- or post-natal toxicity concerns for

infants and children, based on the

results of the rat and rabbit

developmental toxicity studies and the

2-generation rat reproductive toxicity

study.

v. Conclusion. Based on review of the

required studies, EPA concludes that

reliable data support use of the standard

hundredfold MOE/uncertainty factor

and that an additional margin/factor is

not needed to protect infants and

children.

2. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to maleic

hydrazide from food will utilize

between 14 and 54% 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 exposure to maleic hydrazide 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

maleic hydrazide residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in plants is

adequately understood. The residue of

concern is maleic hydrazide (as

specified in 40 CFR 180.175). The

nature of the residue in animals is

adequately understood for this section

18. The residue of concern is maleic

hydrazide .

B. Analytical Enforcement Methodology

Adequate enforcement methodology

(with spectrophotometric detection) for

plants is available in PAM II to enforce

the tolerance expression. An

enforcement method has not been

validated for animal commodities.

However, a method for animal

commodities is available, see Wood,
64292 Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations

P.R., ‘‘Determination of Maleic

Hydrazide Residues in Plant and

Animal Tissue,’’ Analytical Chemistry,

25, 1879 (1953).

C. Magnitude of Residues

Residues of maleic hydrazide at a 14–

day PHI are not expected to exceed

105.0 ppm on rice grain, 75.0 ppm on

rice straw, 240.0 ppm on rice hulls,

180.0 ppm on rice bran, and 75.0 on the

processed commodity polished rice as a

result of this section 18 use. Timelimited tolerances should be established

for rice grain, straw, bran, and hulls at

these levels.

No tolerances on animal commodities

have been established for maleic

hydrazide. Secondary residues in

animal commodities resulting from this

use on rice and the registered use on

potatoes are not expected to exceed 2.5

ppm in meat, 7.0 ppm in liver, 32.0 ppm

in kidney, and 3.0 ppm in fat of cattle,

goats, hogs, horses, and sheep; 1.0 ppm

in milk; 0.5 ppm in meat, liver, and fat

of poultry; 1.4 ppm in poultry meat

byproducts (except liver), and 0.5 ppm

in eggs.

D. International Residue Limits

There are currently no Codex,

Canadian, or Mexican limits for residues

of maleic hydrazide in or on rice or

animal commodities. Therefore,

establishment of time-limited tolerances

will not pose a concern for international

harmonization.

E. Rotational Crop Restrictions.

There are no rotational crop

restrictions in the section 18 or Federal

label.

VI. Conclusion

Therefore, tolerances are established

for residues of maleic hydrazide (1,2-

dihydro-3,6-pyridazinedione) in rice,

grain at 105 ppm, rice, straw at 75 ppm,

rice, hulls at 240 ppm, and rice, bran at

180 ppm. Additionally, tolerances are

established for secondary residues of

maleic hydrazide at 2.5 ppm in meat, 7

ppm in liver, 32 ppm in kidney, and 3

ppm in fat of cattle, goats, hogs, horses,

and sheep; 1 ppm in milk; 0.5 ppm in

meat, liver and fat of poultry; 1.4 ppm

in poultry meat byproducts; and 0.5

ppm in eggs.

In addition because FQPA has

eliminated the distinctions between

tolerances for raw and processed food,

OPP is transferring the food additive

tolerances now found in § 185.3900 to

§ 180.175, and is removing

§ 185.3900.Therefore, to accomplish the

transfer, and for the convenience of the

user, OPP is revising § 180.175 in its

entirety, although only paragraph (b) of

§ 180.175 is new.

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 February 3, 1998,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

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 and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300587] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis 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 action finalizes a tolerance

requirement under FFDCA section

408(e). 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). In addition, 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
Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations 64293

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 special 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, under the Regulatory

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

seq.), the Agency 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

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,

Reporting and recordkeeping

requirements.

Dated: November 21, 1997.

Linda A. Travers,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. In part 180:

i. The authority citation for part 180

continues to read as follows:

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

ii. Section 180.175 is revised to read

as follows:

§ 180.175 Maleic hydrazide; tolerances for

residues.

(a) General. (1) Tolerances for

residues of the herbicide and plant

regulator maleic hydrazide (1,2-dihydro3,6-pyridazinedione) are established in

or on the following raw agricultural

commodities:

Commodity Parts per

million

Onions, dry bulb ........................... 15.0

Potatoes ........................................ 50.0

(2) A food additive known as maleic

hydrazide (1,2-dihydro-3,6-

pyridazinedione) may be present in

potato chips when used in accordance

with the following conditions:

(i) The food additive is present as a

result of the application of a pesticide

formulation containing maleic

hydrazide to the growing potato plant in

accordance with directions registered by

the U.S. Environmental Protection

Agency.

(ii) The label of the pesticide

formulation containing the food

additive conforms to labeling registered

by the U.S. Environmental Protection

Agency.

(iii) The food additive is present in an

amount not to exceed 160 parts per

million by weight of the finished food.

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for residues of the herbicide maleic

hydrazide (1,2-dihydro-3,6-

pyridazinedione) in connection with

use of the pesticide under section 18

emergency exemptions granted by EPA.

The tolerances will expire and are

revoked on the dates specified in the

following table.

Commodity Parts per million Expiration/Revocation Date

Cattle, fat ............................................................................................. 3 9/30/98

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

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

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

Eggs ..................................................................................................... 0.5 9/30/98

Goats, fat ............................................................................................. 3 9/30/98

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

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

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

Hogs, fat .............................................................................................. 3 9/30/98

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

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

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

Horses, fat ........................................................................................... 3 9/30/98

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

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

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

Milk ...................................................................................................... 1 9/30/98

Poultry, fat ........................................................................................... 0.5 9/30/98

Poultry, liver ......................................................................................... 0.5 9/30/98

Poultry, meat ....................................................................................... 0.5 9/30/98

Poultry, meat byproducts (except liver) ............................................... 1.4 9/30/98

Rice, bran ............................................................................................ 180 9/30/98

Rice, grain ........................................................................................... 105 9/30/98

Rice, hulls ............................................................................................ 240 9/30/98

Rice, straw ........................................................................................... 75 9/30/98

Sheep, fat ............................................................................................ 3 9/30/98
64294 Federal Register / Vol. 62, No. 234 / Friday, December 5, 1997 / Rules and Regulations

Commodity Parts per million Expiration/Revocation Date

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

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

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

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

PART 185—[Amended]

2. In part 185:

i. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 348.

§ 185.3900 [Removed]

ii. Section 185.3900 is removed.

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

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300586; FRL–5756–5]

RIN 2070–AB78

Fluorine Compounds; Time-Limited

Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

the insecticidal fluorine compounds

cryolite and/or synthetic cryolite

(sodium aluminum fluoride) in or on

the raw agricultural commodity (RAC)

potatoes and in the processed animal

feed commodity, potato waste. A

petition requesting these tolerances was

submitted by The Cryolite Task Force

under the Federal Food Drug and

Cosmetic Act (FFDCA) as amended by

the Food Quality Protection Act of 1996

(Pub. L. 104–170). The tolerance will

expire on November 21, 2001.

DATES: This regulation is effective

December 5, 1997. Objections and

requests for hearings must be received

by EPA on or before February 3, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, OPP–

300586, must be submitted to: Hearing

Clerk (1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the document control number, [OPP–

300586], must be submitted to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, Crystal Mall #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket number [OPP–300586]. No

Confidential Business Information (CBI)

should be submitted through e-mail.

Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Jacqueline Mosby, Environmental

Scientist, Registration Division 7505C,

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number, and

e-mail address: Crystal Mall #2, 1921

Jefferson Davis Hwy., Arlington, VA,

(703) 305-6792, e-mail: mosbyromney.jackie2epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued notices as follows regarding

petitions for pesticide tolerances for

insecticidal fluorine compounds in or

on potatoes and in the processed animal

feed, potato waste.

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

9F3739; filing notice;

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

1F3959 and FAP 1H5604; filing notice.

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

9F3739 and FAP 1H5604; final rule for

time-limited tolerances.

4. May 8, 1996 (61 FR 20781) (FRL–

5362–6); PP 9F3739 and FAP 1H5604);

proposed rule for permanent tolerances.

The Agency did not publish a final

rule establishing permanent tolerances

prior to the enactment of the Food

Quality and Protection Act (FQPA) of

1996. Because of new procedures under

FQPA, The Cryolite Task Force, c/o

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

AZ 85336 was required to submit a

notice of filing requesting issuance of

these tolerances in compliance with

FQPA.

In the Federal Register of March 12,

1997 (62 FR 11437) EPA issued a notice

of filing pursuant to section 408 of the

Federal Food, Drug and Cosmetic Act

(FFDCA), 21 U.S.C. 346a(e) announcing

the filing of a pesticide petition (PP) for

tolerance by The Cryolite Task Force.

This notice contained a summary of the

petition prepared by The Cryolite Task

Force.

The petition requested that 40 CFR

180.145 be amended by establishing

tolerances for residues of the

insecticidal fluorine compounds

cryolite and synthetic cryolite in or on

potatoes at 2.0 parts per million (ppm)

and processed potato waste at 22.0 ppm.

These tolerances will expire on

November 21, 2001.

I. Risk Assessment and Statutory

Findings

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical