63858 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Rules and Regulations

IX. Unfunded Mandates

Under Section 202 of the Unfunded

Mandates Reform Act of 1995

(‘‘Unfunded Mandates Act’’), EPA must

prepare a budgetary impact statement to

accompany any proposed or final rule

that includes a federal mandate that

may result in estimated costs to state,

local, or tribal governments in the

aggregate, or to the private sector, of

$100 million or more. Under Section

205, EPA must select the most cost

effective and least burdensome

alternative that achieves the objectives

of the rule and is consistent with

statutory requirements. Section 203

requires EPA to establish a plan for

informing and advising any small

governments that may be significantly

or uniquely impacted by the rule.

EPA has determined that the

exemption in this notice does not

include a federal mandate that may

result in estimated costs of $100 million

or more to those entities mentioned

above. This federal action approves a

request for exemption by petitioners in

CNMI to reduce the cost of

implementing the Clean Air Act.

Accordingly, no additional costs to

state, local, or tribal governments, or to

the private sector result from this action.

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, EPA

submitted a report containing this

decision 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 the

decision in today’s Federal Register.

This action is not a ‘‘major rule’’ as

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

XI. Electronic Copies of Decision

A copy of this action is available on

the Internet at www.epa.gov/

OMSWWW under the title: ‘‘EPA

Decision to Grant Conventional

Gasoline Anti-dumping Exemption to

the Commonwealth of the Northern

Mariana Islands.’’

XII. Statutory Authority

Authority for the action described in

this notice is in section 325(a)(1) (42

U.S.C. 7625–1(a)(1)) of the Clean Air Act

as amended.

Dated: November 25, 1997.

Carol M. Browner,

Administrator.

[FR Doc. 97–31736 Filed 12–2–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300574; FRL–5754–1]

RIN 2070–AB78

Sodium Chlorate; Exemption From

Pesticide Tolerance for Emergency

Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited exemption from the

requirement of a tolerance for residues

of sodium chlorate in or on wheat. This

action is in connection with crisis

exemptions declared by the states of

Arkansas and Mississippi under section

18 of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on wheat in Arkansas and

Mississippi. This regulation establishes

an exemption from the requirement of a

tolerance for residues of sodium

chlorate in this food commodity

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

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The exemption

will expire and is revoked on July 31,

1998.

DATES: This regulation is effective

December 3, 1997. Objections and

requests for hearings must be received

by EPA on or before February 2, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300574],

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–

300574], 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, Crystal Mall #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–

300574]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Libby Pemberton, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number, and e-mail address: CM #2,

1921 Jefferson Davis Hwy., Arlington,

VA, (703) 308–9364, e-mail:

pemberton.libby@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

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

an exemption from the requirement of a

tolerance for residues of the defoliant/

desiccant sodium chlorate, in or on

wheat. This exemption will expire and

is revoked on July 31, 1998. EPA will

publish a document in the Federal

Register to remove the revoked

exemption 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(c)(2)(A)(i) of the

FFDCA allows EPA to establish an
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Rules and Regulations 63859

exemption from tolerance (the legal

limit for a pesticide chemical residue in

or on a food) only if EPA determines

that the exemption from tolerance is

‘‘safe.’’ Section 408(c)(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. New section

408(c)(2)(B) requires EPA to take into

account, among other relevant

conditions, the considerations set forth

in 408(c)(2)(C) and (D). Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for Sodium

Chlorate on Wheat and FFDCA

Tolerances

On May 27 and June 6, 1997, the

states of Mississippi and Arkansas,

respectively, availed themselves of the

authority to declare the existence of a

crisis situation within each state,

thereby authorizing use under FIFRA

section 18 of sodium chlorate on wheat

as a defoliant or desiccant to aid in the

harvest of wheat. A cool, wet spring

delayed the wheat harvest in these

states. Continued heavy rains resulted

in the need for a harvest aid to desiccate

winter weeds which developed in the

thin stands of an already diminished

wheat crop.

As part of its assessment of these

crisis exemptions, EPA assessed the

potential risks presented by residues of

sodium chlorate in or on wheat. In

doing so, EPA considered the new safety

standard in FFDCA section 408(c)(2),

and EPA decided that an exemption

from the requirement for a 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

exemption from the requirement of a

tolerance without notice and

opportunity for public comment under

section 408(e), as provided in section

408(l)(6). Although this exemption from

the requirement of a tolerance will

expire and is revoked on July 31, 1998,

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

of the pesticide remaining in or on

wheat 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 exemption earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

Because this exemption from the

requirement of a tolerance is being

approved under emergency conditions

EPA has not made any decisions about

whether sodium chlorate meets EPA’s

registration requirements for use on

wheat or whether a permanent

exemption from the requirement of a

tolerance for this use would be

appropriate. Under these circumstances,

EPA does not believe that this

exemption serves as a basis for

registration of sodium chlorate by a

State for special local needs under

FIFRA section 24(c). Nor does this

exemption serve as the basis for any

State other than Arkansas and

Mississippi 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 sodium

chlorate, contact the Agency’s

Registration Division at the address

provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

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

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

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

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.
63860 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Rules and Regulations

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g., frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(children 1-6 years old) was not

regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action,

EPA has sufficient data to assess the

hazards of sodium chlorate and to make

a determination on aggregate exposure,

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

time-limited exemption from the

requirement of a tolerance for residues

of sodium chlorate on wheat. EPA’s

assessment of the dietary exposures and

risks associated with establishing the

tolerance exemption 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 sodium chlorate

are discussed below.

1. Acute toxicity. No acute dietary

endpoint was identified. This

conclusion was based on a

developmental toxicity study in which

rats were dosed at the limit dose of

1,000 mg/kg/day without any ill effects

to the dams or their fetuses.

2. Short - and intermediate - term

non-dietary toxicity. The available acute
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Rules and Regulations 63861

dermal and inhalation studies are of

dilute mixtures with other active

ingredients. The Toxicity Categories

were III for the dermal studies, and IV

for the inhalation studies. Aqueous

sodium chlorate has been used as an

antiseptic wash for the skin and mucous

membranes. Considering the low

toxicity of sodium chlorate, non-dietary

exposure is not a concern.

3. Chronic toxicity. EPA has not

established an RfD for sodium chlorate.

For purposes of this exemption, based

upon available toxicity data, an RfD for

sodium chlorate of 0.1 milligrams/

kilogram/day (mg/kg/day) was used.

This RfD is based on a 90-day oral

toxicity study in rats with a NOEL of

100 mg/kg/day and an uncertainty factor

of 1,000 (10-fold each for inter and

intra-species extrapolation, and use of a

less-than-chronic endpoint) based on

anemia, reticulocytosis, and depressed

adrenal weights at the LOEL of 1,000

mg/kg/day.

4. Carcinogenicity. Sodium chlorate is

used as a desiccant. Because it is

chemically similar to chlorine dioxide

and chlorite which are not carcinogenic,

and dietary exposure is virtually

eliminated by hydrolysis during

cooking, carcinogenicity is not a

concern.

B. Exposures and Risks

1. From food and feed uses.

Exemptions from the requirement of

tolerances have been established (40

CFR 180.1020) for the residues of

sodium chlorate, in or on a variety of

raw agricultural commodities, including

corn, rice, safflower, and sorghum. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

sodium chlorate as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a one day or single exposure.

ii. Chronic exposure and risk. Field

trial residue values were non-detectable

at the limit of detection of 2 ppm, even

at the 2× rate. The risk assessment

assumed that 100% of all wheat

commodities will contain sodium

chlorate residues and those residues

would all be at 2 ppm, which results in

an overestimate of human dietary

exposure. Additionally, residues of

sodium chlorate would likely be

substantially reduced through

hydrolysis during cooking, although this

reduction was not taken into account for

this conservative risk assessment.

2. From drinking water. There is no

established Maximum Concentration

Level for residues of sodium chlorate in

drinking water. No drinking water

health advisory levels have been

established for sodium chlorate.

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 (RfDs or acute

dietary NOELs) 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 sodium chlorate to exceed

the RfD if the exemption being

considered in this document were

granted. The Agency has therefore

concluded that the potential exposures

associated with sodium chlorate 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

exemption is granted.

3. From non-dietary exposure.

Sodium chlorate is currently registered

for use on the following residential nonfood sites: wood treatment, outdoor turf,

and ornamental perennials, shrubs, and

trees. The available acute dermal and

inhalation studies are of dilute mixtures

with other active ingredients. The

Toxicity Categories are III for the dermal

studies, and IV for the inhalation

studies. Aqueous sodium chlorate has

been used as an antiseptic wash for the

skin and mucous membranes.

Agricultural workers would be exposed

to aqueous solutions containing a low

percentage of sodium chlorate.

Considering the low toxicity of sodium

chlorate, non-dietary exposure is not a

concern.

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

sodium chlorate 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, sodium chlorate

does not appear to produce a toxic

metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not
63862 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Rules and Regulations

assumed that sodium chlorate 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 very

conservative TMRC exposure

assumptions described above, EPA has

concluded that aggregate exposure to

sodium chlorate from food will utilize

3% of the RfD for the U.S. population.

The major identifiable subgroup with

the highest aggregate exposure is

children (1-6 years old) 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

sodium chlorate 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

sodium chlorate 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.

D. 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

sodium chlorate, EPA considered data

from developmental toxicity studies in

the rat. The developmental toxicity

studies are designed to evaluate adverse

effects on the developing organism

resulting from maternal pesticide

exposure during gestation.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard 100-fold

safety factor (usually 100 for combined

inter-and intra-species variability)) and

not the additional tenfold safety factor

when EPA has a complete data base

under existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard safety factor.

ii. Developmental toxicity studies. In

the developmental study in rats, the

maternal (systemic) NOEL was >1,000

mg/kg/day. The developmental (fetal)

NOEl was also >1,000 mg/kg/day.

iii. Pre- and post-natal sensitivity.

Sodium chlorate is not a developmental

toxicant in rats. EPA has already

applied an additional 10-fold

uncertainty factor (resulting in a total

1,000-fold uncertainty factor) to the

NOEL used to set the RfD. This

additional 10-fold uncertainty factor

should be adequate to protect infants

and children.

2. Chronic risk. Using the very

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to sodium

chlorate from food will utilize from 1%

of the RfD for nursing infants up to 6%

for children 1-6 years old. EPA generally

has no concern for exposures below

100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Despite the potential

for exposure to sodium chlorate 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

sodium chlorate residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The metabolism of sodium chlorate in

plants is adequately understood. The

residue of concern is sodium chlorate

and sodium chloride. The nature of the

residue in animals is not applicable due

to no reasonable expectation of transfer

of residues to meat/milk/poultry/eggs.

B. Analytical Enforcement Methodology

Analytical methods for detecting and

measuring the levels of the pesticide

residue are not needed. The Agency

proposes to establish an exemption from

the requirement of a tolerance without

any numerical limitation; therefore, the

Agency has concluded that analytical

methods are not required for

enforcement purposes for sodium

chlorate.

C. Magnitude of Residues

No detectable residues were found in

wheat grain or straw from wheat treated

at the 2× rate. Considering that no

detectable residues were found in wheat

grain, it is unlikely that significant

residues will occur in the processed

fractions of wheat. There is no

likelihood of transfer of residues to

meat/milk/poultry/eggs. Therefore,

magnitude of the residue data in those

commodities is not required.

D. International Residue Limits

No CODEX, Canadian, or Mexican

maximum residue levels have been

established for residues of sodium

chlorate.

E. Rotational Crop Restrictions

Considering the phytotoxic nature of

sodium chlorate, which would preclude

the planting of a crop soon after

treatment of a previous crop, coupled

with the fact that residues are below the

limit of quantitation shortly after

application to target crops, EPA does

not believe measurable residues would

be detected in rotational crops. For the

purposes of this section 18 use,

rotational crop tolerances and/or plant

back restrictions will not be necessary.

VI. Conclusion

Therefore, the exemption from the

requirement of a tolerance is established

for residues of sodium chlorate in

wheat.

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 2, 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
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Rules and Regulations 63863

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

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 Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300574] (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, CM #2, 1921 Jefferson Davis

Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ADDRESSES at the beginning

of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a timelimited exemption from the tolerance

requirement under FFDCA section

408(l)(6). 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 under

FFDCA section 408 (l)(6), such as the

exemption in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: 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. The authority citation for part 180

continues to read as follows:

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

2. Section 180.1020 is amended by

designating the existing text as

paragraph (a) and by adding paragraph

(b) to read as follows:

§ 180.1020 Sodium chlorate; exemption

from the requirement of a tolerance.

* * * *

*

(b) A time-limited exemption from the

requirement of a tolerance is established

for residues of the defoliant/desiccant in

connection with use of the pesticide

under section 18 emergency exemptions

granted by EPA. The exemption will

expire and is revoked on the date

specified in the following table:

Commodity Parts per

million

Expiration/

revocation

date

Wheat .............. NA 7/31/98

[FR Doc. 97–31547 Filed 12–2–97; 8:45 am]

BILLING CODE 6560–50–F