Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56095

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 (1)(6), such as the

tolerances in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

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: October 17, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180— [AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.474, paragraph (b)(1) is

amended by alphabetically adding the

following commodities to the table to

read as follows:

§ 180.474 Tebuconazole; tolerances for

residues.

* * * * *

(b) Section 18 emergency exemptions.

(1) * * *

Commodity Parts per million Expiration/Revocation Date

* * * * * * *

Sunflower oil ........................................................................................ 0.4 9/30/98

Sunflower seed .................................................................................... 0.2 9/30/98

* * * * * * *

* * * * *

[FR Doc. 97–28656 Filed 10–28–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300555; FRL–5745–5]

RIN 2070–AB78

Lambda-cyhalothrin; Pesticide

Tolerances for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for combined

residues of lambda-cyhalothrin and its

epimer in or on barley grain, barley

bran, barley hay and straw, canola seed,

and sugarcane. This action is in

response to EPA’s granting of emergency

exemptions under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticide on barley, canola, and

sugarcane in Louisiana and Montana.

This regulation establishes maximum

permissible levels for residues of

lambda-cyhalothrin in the abovementioned 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.

DATES: This regulation is effective

October 29, 1997. Objections and

requests for hearings must be received

by EPA on or before December 29, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, OPP–300555,

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–300555], 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 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–300355.

No Confidential Business Information

(CBI) should be submitted through email. Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.
56096 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

FOR FURTHER INFORMATION CONTACT: By

mail: Virginia Dietrich, 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) 308–9359, e-mail:

dietrich.virginia@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 combined residues of the

insecticide lambda-cyhalothrin and its

epimer, in or on barley grain, barley

bran, barley hay and straw, canola seed

and sugarcane at 0.05, 0.2, 2.0, 0.10, and

0.03 part per million (ppm),

respectively. These tolerances will

expire and are revoked on August 30,

1998. EPA will publish a document in

the Federal Register to remove the

revoked tolerances from the Code of

Federal Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq. The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996) (FRL–5572–9).

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for Lambdacyhalothrin on Barley, Canola, and

Sugarcane and FFDCA Tolerances

Cutworms are serious pests of small

grains in Montana. Infestations can

result in severe damage from the

voracious feeding by the larvae. Since

the cancellation of endrin, barley

production has remained unprotected

with an effective registered chemical.

Unusually high levels of moths caught

during Montana fall cutworm surveys

demonstrated the potential for

infestation at levels that could result in

significant economic losses. This spring,

levels of cutworm infestation exceeded

the threshold for treatment and the

Montana Department of Agriculture

declared a crisis exemption on May 16,

1997.

Feeding on canola by Diamondback

moth larvae is expected to result in

economically significant losses of 40%

in canola grown in Montana unless

adequately controlled. A rapid knockdown of the larvae is necessary to

prevent significant yield loss which

occurs within 2 or 3 days after the

larvae begin feeding on the seed pod.

The registered alternatives, endosulfan

and methyl parathion, both take a week

or longer to match the efficacy of

lambda-cyhalothrin. Another

alternative, ethyl parathion, while

effective in controlling this pest, is

unavailable to most canola growers in

Montana because there are few

commercial applicators with the

required closed loading system.

Sugarcane yield loss from the

sugarcane borer is estimated at 60%

unless adequately controlled. Registered

alternatives either are more toxic to

aquatic environments or cause

secondary outbreaks of aphids due to

toxicity to non-target arthropods

(parasites and predators). After having

reviewed these submissions, EPA

concurs that emergency conditions exist

for these states. EPA has authorized

under FIFRA section 18 the use of

lambda-cyhalothrin on barley, canola,

and sugarcane for control of cutworm in

barley, Diamondback moth in canola,

and Sugarcane borer in sugarcane in

Montana and Louisiana.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

lambda-cyhalothrin in or on barley,

canola, and sugarcane. In doing so, EPA

considered the new safety standard in

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

decided that the necessary tolerance

under FFDCA section 408(l)(6) would be

consistent with the new safety standard

and with FIFRA section 18. Consistent

with the need to move quickly on the

emergency exemption in order to

address an urgent non-routine situation

and to ensure that the resulting food is

safe and lawful, EPA is issuing this

tolerance without notice and

opportunity for public comment under

section 408(e), as provided in section

408(l)(6). Although this tolerance will

expire and is revoked on August 30,

1998, under FFDCA section 408(l)(5),

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on barley,

canola, and sugarcane after that date

will not be unlawful, provided the

pesticide is applied in a manner that

was lawful under FIFRA. EPA will take

action to revoke this tolerance earlier if

any experience with, scientific data on,

or other relevant information on this

pesticide indicate that the residues are

not safe.

Because this tolerance is being

approved under emergency conditions,

EPA has not made any decisions about

whether lambda-cyhalothrin meets

EPA’s registration requirements for use

on barley, canola, and sugarcane or

whether a permanent tolerance for this

use would be appropriate. Under these

circumstances, EPA does not believe

that this tolerance serves as a basis for
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56097

registration of lambda-cyhalothrin by a

State for special local needs under

FIFRA section 24(c). Nor does this

tolerance serve as the basis for any State

other than Montana and 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 lambda-cyhalothrin,

contact the Agency’s Registration

Division at the address provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

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

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

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

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all 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
56098 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(non-nursing infants less than 1 year

old) was not regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

EPA has sufficient data to assess the

hazards of lambda-cyhalothrin and to

make a determination on aggregate

exposure, consistent with section

408(b)(2), for a time-limited tolerance

for combined residues of lambdacyhalothrin and its epimer on barley

grain, barley bran, barley hay and straw,

canola seed and sugarcane at 0.05, 0.2,

2, 0.10, and 0.03 ppm, respectively.

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 lambdacyhalothrin are discussed below.

1. Acute toxicity. EPA’s Office of

Pesticide Programs (OPP) is currently

reassessing time-limited tolerances for

residues of lambda-cyhalothrin in or on

over a dozen commodities established

for conditional registrations. These

tolerances are due to expire November

15, 1997. On July 31, 1997, as part of

this reassessment, the OPP’s Hazard

Identification Assessment Review

Committee identified an acute toxicity

endpoint and recommended use of the

NOEL of 0.5 mg/kg/day for an acute

dietary endpoint, based on gait

abnormalities in dogs in a 1 year oral

toxicity study. The following

assessment for the tolerances in this

document uses this recommended

endpoint of concern as a basis to

evaluate acute dietary risk to population

subgroups.

2. Short - and intermediate-term

toxicity. For short- and intermediateterm margin of exposure (MOE)

calculations, EPA’s Office of Pesticide

Programs (OPP) selected use of the

NOEL of 0.3 ug/l (0.05 milligrams/

kilogram/day (mg/kg/day) from the 21-

day inhalation toxicity study in rats.

The LEL of 3.3 ug/l was based on

decreased body weight gains and

clinical signs of toxicity including paw

flicking, tail erections, and tiptoe gait.

In the 21-day dermal toxicity study,

the NOEL was >1000 mg/kg/day (limit

dose) and therefore the Office of

Pesticide Programs did not select an

endpoint.

3. Chronic toxicity. EPA has

established the RfD for lambdacyhalothrin at 0.001 mg/kg/day. This

RfD is based on a 1-year oral study in

dogs with a NOEL of 0.1 mg/kg/day and

an uncertainty factor (UF) of 100. The

LEL of 0.5 mg/kg/day was based on

clinical signs of neurotoxicity

(convulsions, ataxia, muscle tremors)

and a slight increase in liquid feces.

4. Carcinogenicity. Lambdacyhalothrin has been classified by the

Office of Pesticide Programs as a Group

‘‘D’’ chemical, ‘‘not classifiable as to

human carcinogenicity.’’

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.438, 185.3765, and 186.3765)

for the combined residues of lambdacyhalothrin and its epimer, in or on a

variety of raw agricultural commodities

at levels ranging from 0.01 to 6.0 ppm.

A food additive tolerance has been

established under 40 CFR 185.1310 for

residues on dried hops. Tolerances with

the expiration date of November 15,

1997, have been established under 40

CFR 185.3765 for sunflower hulls, corn

grain flour, and tomato pomace. Timelimited tolerances have been established

for various animal products under 40

CFR 185.3765. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from lambdacyhalothrin as follows:

i. Acute exposure and risk. The

registrant, Zeneca Ag Products, has

submitted a ‘‘Monte Carlo’’ analysis

assessing acute dietary risk for lambdacyhalothrin to support extension of

tolerances due to expire in November

1997. The results of the analysis are

summarized below.

Table 1.—Acute Dietary Exposure

and Risk Analysis Results

Population

Exposure

(mg/kg/day)

99.9th percentile

MOE 99.9th

percentile

U.S. Population0.002108 237

Children 1 - 6

Years

0.003789 132

Children 7 -

12 Years

0.001893 264

Non-Nursing

Infants

0.003281 152

Nursing Infants0.000969 516

Women, 13+

Years

0.000831 601

The Monte Carlo analysis provided by

the registrant has not undergone a

thorough review in the Agency.

However, given the emergency nature of

the section 18 requests, the Agency will

consider the results of the registrant’s

analysis to support the section 18 use of

lambda-cyhalothrin on barley, canola,

and sugarcane.

ii. Chronic exposure and risk. The

existing lambda-cyhalothrin tolerances

plus the proposed section 18 use

resulted in an Anticipated Residue

Contribution (ARC) that is equivalent to

the following percentages of the RfD:

U.S Population—22%

Nursing Infants (<1 year old)—25%

Non-Nursing Infants (<1 year old)—

71%

Children (1-6 years old)—50%

Children (7-12 years old)—33%

Hispanics—25%

Non-Hispanic Others—27%

Northeast Region—23%

Western Region—24%

The subgroups listed above are: (1)

The U.S. population (48 states); (2)

those for infants and children; and (3)
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56099

the other subgroups for which the

percentage of the RfD occupied is

greater than that occupied by the

subgroup U.S. population (48 states).

Further refinement using percent croptreated data for all commodities would

result in lower dietary exposure

estimates.

2. From drinking water. Office of

Pesticide Program studies indicate

lambda-cyhalothrin is moderately

persistent and mobile in surface water,

but not ground water. There is no

established Maximum Contaminant

Level (MCL) for residues of lambdacyhalothrin in drinking water. No health

advisory levels for lambda-cyhalothrin

in drinking water have been established.

There is no entry for lambdacyhalothrin in the ‘‘Pesticides in

Groundwater Database.’’

Because the Agency lacks sufficient

water-related exposure data to complete

a comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water-related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause lambda-cyhalothrin 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 lambda-cyhalothrin 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.

Lambda-cyhalothrin is currently

registered for use on the following

residential non-food sites: general pest

control (crack/crevice/spot), termiticide,

landscape, turf ornamentals,

commercial ornamentals, golf course

turf, and unoccupied agricultural

premises.

The Agency lacks sufficient

residential-related exposure data to

complete a comprehensive residential

risk assessment for many pesticides,

including lambda-cyhalothrin.

However, because: (1) Lambdacyhalothrin has a low vapor pressure (2

x 10-10 torr); (2) no acute toxicity

endpoints were identified by the

Toxicity End-Point Selection

Committee; (3) no short- or

intermediate-term dermal toxicity

endpoint was identified; (4) for

occupationally exposed workers, high

MOEs for inhalation exposure were

calculated (ranging from 1,200 to

13,000); and (5) the low percentage of

the RfD that is occupied for the general

population by the pending and

registered uses of this chemical; in the

best scientific judgement of OPP, nondietary, non-occupational uses of

lambda-cyhalothrin should not pose a

risk that exceeds OPP’s level of concern.

4. Cumulative exposure to substances

with a 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 mechanisms 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

lambda-cyhalothrin has a common

mechanism of toxicity with other

substances or how to include this

pesticide in a cumulative risk

assessment. For the purposes of this

tolerance action, therefore, EPA has not

assumed that lambda-cyhalothrin has a

common mechanism of toxicity with

other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. OPP has concluded that

exposure from existing uses results in

MOE estimates that are not likely to

exceed the Agency’s acceptable level

(less than 100) for acute exposure. OPP

also believes adding the proposed

section 18 tolerances would still result

in acceptable MOEs. Therefore, the

Agency has concluded that these new

temporary tolerances meet the

reasonable certainty of no harm finding

for acute risk. A discussion of the

factors considered for this decision

follows.

Emergency exemptions for three

commodities, sugarcane, barley, and

canola, were issued earlier this year. At

that time, no acute exposure endpoint

had been identified in the Agency’s risk

assessment for the emergency

exemption. However, as a result of

review of new data submitted to support

the extension of temporary tolerances

established for conditional registrations,

an acute exposure endpoint for lambdacyhalothrin was identified (see Unit

IV.A.1. of this document). OPP therefore

revisited the acute risk assessment for

the emergency exemptions. A

preliminary review of the new

information using the Agency’s best

professional judgement supported the

reasonable certainty of no harm finding.

EPA’s conclusions regarding this risk

analysis may change following a more

thorough review.
56100 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

The basis for this risk assessment is

an acute dietary exposure analysis using

a ‘‘Monte Carlo’’ model which reflects

the distribution of possible residues on

the commodities considered in the

analysis as well as percent of crop

treated information. This model was

applied to both food and feed

commodities covered under existing

temporary tolerances. Although this

analysis did not consider the

commodities treated under the

emergency exemption, the Agency

believes that these tolerances are

adequately protective for the following

two reasons. Direct consumption of

lambda-cyhalothrin through these

commodities (barley, sugarcane, and

canola) is expected to be lower than

tolerance levels since the commodities

are consumed as the processed product

and not as the raw agricultural

commodity. Exposure from secondary

residues, those consumed through

eating products from animals fed these

raw agricultural commodities, is nearly

all accounted for because the current

analysis includes wheat, corn, and rice

as well as peanut oil, corn oil,

cottonseed oil, and soybean oil. These

items comprise a much greater portion

of animals diets than do barley, canola,

or sugarcane.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to lambda-cyhalothrin from

food will utilize 22 percent of the RfD

for the U.S. population. The major

identifiable subgroup with the highest

aggregate exposure is Non-Nursing

Infants (<1 year old) and is discussed

later in this document under

Determination of Safety 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

lambda-cyhalothrin 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

lambda-cyhalothrin residues.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure.

D. Aggregate Cancer Risk for U.S.

Population

Lambda-cyhalothrin has been

classified by OPP as a Group ‘‘D’’

chemical, ‘‘not classifiable as to human

carcinogenicity.’’ For this reason, this

risk assessment was not considered

appropriate and was not conducted.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— a. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

lambda-cyhalothrin, EPA considered

data from developmental toxicity

studies in the rat and rabbit and a twogeneration reproduction study 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 10-fold 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 data base 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 uncertainty

factor (usually 100 for combined interand intra-species variability) and not the

additional 10-fold 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 safety factor.

b. Developmental toxicity studies—i.

Rats. From the developmental toxicity

study in rats, the maternal (systemic)

NOEL was 10 mg/kg/day. The maternal

LEL of 15 mg/kg/day was based on

decreased body weight gain and

decreased food consumption. The

developmental (fetal) NOEL was >15

mg/kg/day at the highest dose tested

(HDT).

2. Rabbit. From the developmental

toxicity study in rabbits, the maternal

(systemic) NOEL was 10 mg/kg/day. The

maternal LEL of 30 mg/kg/day was

based on decreased body weight gain.

The developmental (fetal) NOEL was

>30 mg/kg/day (HDT).

c. Reproductive toxicity study—Rats.

From the 3-generation reproductive

toxicity study in rats, both the parental

(systemic) and reproductive (pup)

NOELs were 1.5 mg/kg/day. Both the

parental (systemic) and reproductive

(pup) LELs were 5 mg/kg/day. They

were based on a significant decrease in

parental body weight (systemic) or a

significant decrease in pup body weight

(reproductive). The developmental

NOEL was 5 mg/kg/day (HDT).

d. Pre- and post-natal sensitivity. The

toxicology data base for lambdacyhalothrin is complete with respect to

current toxicological 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

3-generation reproductive toxicity study

in rats.

e. Conclusion. Based on the above,

EPA concludes that reliable data

support the use of the standard 100-fold

margin of uncertainty factor and that an

additional uncertainty factor is not

warranted at this time.

2. Acute risk. OPP has concluded that

exposure from existing uses results in

MOE estimates that are not likely to

exceed the Agency’s acceptable level

(less than 100) for acute exposure. OPP

also believes adding the proposed

section 18 tolerances would still result

in acceptable MOEs. Therefore, the

Agency has concluded that these new

temporary tolerances meet the

reasonable certainty of no harm finding

for acute risk. A discussion of the

factors considered for this decision can

be found in Unit IV.C.1. of this

preamble.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to lambdacyhalothrin from food will utilize from

25% for nursing infants less than 1 year

old, up to 71% for non-nursing infants

less than 1 year old 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 lambda-cyhalothrin 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
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56101

children from aggregate exposure to

lambda-cyhalothrin residues.

V. Other Considerations

A. Metabolism in Plants and Animals

OPP has determined that the nature of

the residue in plants and animals is

adequately understood based on

metabolism studies conducted on

cotton, cabbage, soybeans, and wheat.

The residue of concern is lambdacyhalothrin and its epimer.

B. Analytical Enforcement Methodology

Adequate methods are available for

the enforcement of the current tolerance

expression. The analytical method (GC/

ECD) for determination of lambdacyhalothrin is ICI Method 81 which has

been validated by the Agency and was

found to be adequate for regulatory

purposes.

The petitioner has determined

recoveries of lambda-cyhalothrin and its

metabolites PP890, and 3-PBAcid under

FDA’s multi-residue protocols.

C. Magnitude of Residues

Time-limited tolerances for combined

residues of lambda-cyhalothrin and its

epimer should be established as follows

to support this section 18 exemption:

Barley, grain—0.05 ppm

Barley, bran—0.2 ppm

Barley, straw—2 ppm

Barley, hay—2 ppm

Canola seed—0.10 ppm

Sugarcane—0.03 ppm

Barley grain, straw, and hay are

livestock feed items. The dietary burden

resulting from potential lambdacyhalothrin residues in/on barley

feedstuffs is comparable to that resulting

from other livestock feedstuffs which

have lambda-cyhalothrin tolerances

(such as corn forage at 1.0 ppm and corn

grain at 0.05 ppm). Thus, secondary

residues in animal commodities are not

expected to exceed existing tolerances

as a result of this section 18 use.

D. International Residue Limits

There are no Codex, Canadian, or

Mexican maximum residue limits

(MRLs) for residues of lambdacyhalothrin in/on barley. Therefore,

international harmonization is not an

issue for this section 18 use.

E. Rotational Crop Restrictions

Studies submitted in support of

lambda-cyhalothrin registration showed

that significant residues (<0.01 ppm)

will not be present in crops rotated 30

days after application of parent lambdacyhalothrin. No additional rotational

crop data are needed to support current

registered application rates.

VI. Conclusion

Therefore, the tolerance is established

for combined residues of lambdacyhalothrin and its epimer in barley

grain, barley bran, barley hay and straw,

canola seed and sugarcane at 0.05, 0.2,

2, 0.10, and 0.03 ppm, respectively.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by December 29,

1997, file written objections to any

aspect of this regulation and may also

request a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given above (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

CBI. Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Docket

EPA has established a record for this

rulemaking under docket control

number OPP–300555 (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: oppdocket@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 timelimited tolerances 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
56102 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

Title II of the Unfunded Mandates

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

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(l)(6), such as the tolerance in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply.

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950), and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

X. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: October 21, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR Chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.438, by adding paragraph

(b) to read as follows:

§ 180.438 Lambda-cyhalothrin tolerance

for residues.

* * * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for combined residues of the insecticide

lambda-cyhalothrin (a 1:1 mixture of

(S)-α-cyano-3-phenoxybenzyl-(Z)-

(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2,2-

dimethylcyclopropanecarboxylate and

(R)-α-cyano-3-phenoxybenzyl-(Z)-

(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2,2-

dimethylcyclopropanecarboxylate and

its epimer a 1:1 mixture of (S)-α-cyano3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-

chloro-3,3,3-trifluoroprop-1-enyl)-2,2-

dimethylcyclo-propanecarboxylate and

(R)-α-cyano-3-phenoxybenzyl (Z)-

(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2,2-dimethylcyclopropanecarboxylate 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

barley bran 0.2 8/30/98

barley grain 0.05 8/30/98

barley hay 2 8/30/98

barley straw 2 8/30/98

canola seed 0.1 8/30/98

sugarcane 0.03 8/30/98

* * * * *

[FR Doc. 97–28655 Filed 10–28–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300564; FRL–5749–2]

RIN 2070–AB78

Ferric Phosphate; Establishment of an

Exemption from the Requirement of a

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Rule.

SUMMARY: This rule establishes an

exemption from the requirement of a

tolerance for residues of ferric

phosphate, when used as a molluscicide

in or on all food commodities. W.

Neudorff GmbH KG submitted a petition

to EPA under the Federal Food, Drug

and Cosmetic Act (FFDCA) as amended

by the Food Quality Protection Act

(FQPA) of 1996 requesting the

exemption from the requirement of a

tolerance. This regulation eliminates the

need to establish a maximum

permissible level for residues of this

molluscicide in or on all food

commodities.

DATES: This regulation is effective on

October 29, 1997. Objections and

requests for hearings must be received

by December 29, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number [OPP–300564],

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–

300564], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental