Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62993

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–31104 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180 and 185

[OPP–300584; FRL–5756–2]

RIN 2070–AB78

Deltamethrin and Tralomethrin;

Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of deltamethrin

and tralomethrin in or on: deltamethrin-

-cottonseed at 0.04 parts per million

(ppm) and cottonseed oil at 0.2 ppm;

and tralomethrin--broccoli at 0.50 ppm,

cottonseed at 0.02 ppm, lettuce, head at

1.00 ppm, lettuce, leaf at 3.00 ppm,

soybeans at 0.05 ppm, sunflower seed at

0.05 ppm and cottonseed oil at 0.20

ppm. It also removes time limitations

for tolerances for residues of

deltamethrin and tralomethrin on the

same commodities that expire on

November 15, 1997. AgrEvo USA

Company requested this tolerance under

the Federal Food, Drug and Cosmetic

Act (FFDCA), as amended by the Food

Quality Protection Act of 1966 (Pub. L.

104-170). These tolerances were

established under petition numbers PP

2F4055, PP 6F3436, PP 4F2993, and PP

6F3309.

DATES: This regulation is effective

November 26, 1997. Objections and

requests for hearings must be received

by EPA on or before January 26, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, OPP–300584,

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–

300584, must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number OPP–300584.

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.

FOR FURTHER INFORMATION CONTACT: By

mail: John Hebert, 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) 308–3068, e-mail:

hebert.john@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On August

16, 1995 and September 15, 1985, EPA

established time limited tolerances

under section 408 of the Federal Food

Drug and Cosmetic Act (FFDCA), 21

U.S.C. 346 a(d) and 348 for residues of

deltamethrin (60 FR 42455) (FRL–4966–

3) and tralomethrin (50 FR 37851)

respectively, on cottonseed. These

tolerances expire on November 15,

1997. AgrEvo USA Company, on

September 15, 1997, requested that the

time limitation for tolerances

established for residues of the

insecticides deltamethrin on cottonseed

at 0.04 ppm and cottonseed oil at 0.2

ppm; and tralomethrin on broccoli at

0.50 ppm, cottonseed at 0.02 ppm,

lettuce, head at 1.00 ppm, lettuce, leaf

at 3.00 ppm, soybeans at 0.05 ppm,

sunflower seed at 0.05 ppm and

cottonseed oil at 0.20 ppm, be removed

based on ecological and environmental

effects data that they had submitted as

a condition of the registration and timelimited tolerances. AgrEvo USA

Company also submitted a summary of

its petition as required under the

FFDCA as amended by the Food Quality

Protection Act (FQPA) of 1996 (Pub. L.

104–170). In the Federal Register of

September 25, 1997 (62 FR 50337)

(FRL–5848–2), EPA, issued a notice

pursuant to section 408 of the Federal

Food, Drug, and Cosmetic Act (FFDCA),

21 U.S.C. 346a(e) announcing the filing

of a pesticide petition (PP) for a

tolerance by AgrEvo USA Company.

This notice included a summary of the

petition prepared by AgrEvo USA

Company (acting as registered US agent

for Hoechst Schering AgrEvo, S. A.,

Little Falls Centre, 2711 Centerville

Road, Wilmington, DE 19808, the

registrant. There were no comments

received in response to the notice of

filing.

The basis for time limited tolerances

that expire November 15, 1997, was

given in the October 20, 1993 Federal

Register (58 FR 54094). These timelimited tolerances were predicated on

the expiration of pesticide product

registrations that were made conditional

due to lack of certain ecological and

environmental effects data. The

rationale for using time-limited

tolerances was to encourage pesticide

manufacturers to comply with the

conditions of registration in a timely

manner. There is no regulatory

requirement to make tolerances timelimited due to the conditional status of

a product registration under the Federal

Insecticide, Fungicide, Rodenticide Act

(FIFRA) as amended. It is current EPA

policy to no longer establish time

limitations on tolerance(s) with

expiration dates if none of the

conditions of registration have any

bearing on human dietary risk. The

current petition action meets that

condition and thus the expiration dates

associated with specific crop tolerances

are being deleted.

Deltamethrin and tralomethrin are

being combined for analysis under

FQPA because tralomethrin is rapidly

metabolized by animals to deltamethrin

as a result of debromination. Results of

the rat metabolism study supports this

action.

I. Risk Assessment and Statutory

Findings

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes
62994 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

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. . . .’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

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

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

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

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

or less of the RfD) is generally

considered acceptable by EPA. EPA

generally uses the RfD to evaluate the

chronic risks posed by pesticide

exposure. For shorter term risks, EPA

calculates a margin of exposure (MOE)

by dividing the estimated human

exposure into the NOEL from the

appropriate animal study. Commonly,

EPA finds MOEs lower than 100 to be

unacceptable. This 100-fold MOE is

based on the same rationale as the 100-

fold uncertainty factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

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

ground water 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
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62995

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 <1 year old) was

not regionally based.

II. 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 deltamethrin and

tralomethrin and to make a

determination on aggregate exposure,

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

remove the time limitation for a

tolerances for residues of deltamethrin-

-cottonseed at 0.04 ppm and cottonseed

oil at 0.2 ppm; and tralomethrin--

broccoli at 0.50 ppm, cottonseed at 0.02

ppm, lettuce, head at 1.00 ppm, lettuce,

leaf at 3.00 ppm, soybeans at 0.05 ppm,

sunflower seed at 0.05 ppm and

cottonseed oil at 0.20 ppm. EPA’s

assessment of the dietary exposures and

risks associated with establishing the

tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by deltamethrin and

tralomethrin are discussed below.

Deltamethrin

1. A battery of acute toxicity studies

places technical deltamethrin in

Toxicity Category III for acute dermal

(LD50 > 2,000 milligrams/kilograms (mg/

kg)), acute inhalation (LC50 = 2.2 mg/l)

and primary eye irritation; Category IV

for acute oral (LD50 > 5,000 mg/kg) and

primary dermal (non-irritating).

Deltamethrin is a non-sensitizer. The

NOEL for acute delayed neurotoxicity is

greater than 5,000 mg/kg.

2. In a subchronic oral toxicity study

deltamethrin was administered to 20

Sprague-Dawley rats/sex/dose in

polyethylene glycol 200 by gavage at

dose levels of 0, 0.1, 1.0, 2.5, or 10.0

milligrams/kilograms/day (mg/kg/day)

for 13 weeks. The lowest observed effect

level (LOEL) for males is 2.5 mg/kg/day,

based on depressed body weights and

body weight gains. The LOEL for

females is 10 mg/kg/day, based on some

hypersensitivity observed during

neurotoxicity testing. The NOEL for

males and females is 1.0 and 2.5 mg/kg/

day, respectively. This subchronic oral

toxicity study in rats is classified as core

minimum.

3. In a subchronic oral toxicity study

deltamethrin was administered to 3-5

beagle dogs/sex/dose in polyethylene

glycol in gelatine capsules at dose levels

of 0, 0.1, 1.0, 2.5, or 10 mg/kg/day for

13 weeks. The LOEL is 2.5 mg/kg/day,

based on gastro-intestinal disturbance

and stimulation of the nervous system

as noted in the clinical signs of toxicity

for both sexes. The NOEL is 1.0 mg/kg/

day. This subchronic oral toxicity study

in dogs is classified as core minimum.

A NOEL of 1.0 mg/kg/day is supported.

At higher levels stimulation of the

nervous system is noted (the LOEL is set

at 2.5 mg/kg/day, but effects were more

definite at 10 mg/kg/day).

4. In a 21–day subchronic dermal

toxicity study five Sprague-Dawley rats/

sex/dose were dermally exposed to 6

ml/kg of deltamethrin for 6 hours/day at

dose levels of 0, 100, 300, or 1,000 mg/

kg/day (limit test). The LOEL for males

is 300 mg/kg/day, based on slightly

decreased body weight gain supported

by marginally decreased food

consumption. The NOEL for males is

100 mg/kg/day. The LOEL for females

was not observed. The NOEL for females

is >1,000 mg/kg/day (limit dose).

5. In a 3-week inhalation toxicity

study deltamethrin was administered to

eight CD rats/sex/dose at concentrations

of 0.003, 0.0096, or 0.0563 mg/l for 6

hours/day for 5 days/week (14

exposures total). The LOEL is 0.0096

mg/l, based on signs of irritation (nerve

stimulation) and reduced body weight

gains in males and elevated Na+ levels

in both males and females. The NOEL

is 0.003 mg/l.

6. In a chronic toxicity study

deltamethrin was administered to eight

beagle dogs/sex/dose in the diet at dose

levels of 0, 0.026, 0.261, or 1.134 mg/kg/

day for males and 0, 0.024, 0.271, or

1.061 mg/kg/day for females for 24

months. The NOEL is ≥40 ppm

(equivalent to 1.134 mg/kg/day for

males and 1.061 mg/kg/day for females).

A LOEL was not observed. Sufficient

data to support a NOEL of >40 ppm

have been generated.

7. In a chronic toxicity study

deltamethrin was administered to 80

Charles River CD-1 mice/sex/dose in the

diet at dose levels of 0, 0.12, 0.61, 3.1,

or 12 mg/kg/day for males and 0, 0.15,

0.76, 3.8, or 15 mg/kg/day for females.

The NOEL is ≥12 mg/kg/day for males

or ≥15 mg/kg/day for females. A LOEL

was not observed.

8. In a chronic toxicity study

deltamethrin was administered to 90

Charles River CD rats/sex/dose in the

diet at dose levels of 0, 0.1, 1.0, or 2.5

mg/kg/day. The LOEL is 2.5 mg/kg/day

based on decreased body weight gains

noted in both sexes. The NOEL is 1.0

mg/kg/day. Under the conditions of this

study, there was no evidence of

carcinogenic potential.

9. In a developmental toxicity study

deltamethrin was administered to 16

New Zealand White rabbits/dose in

0.5% carboxymethylcellulose by gavage

at dose levels of 0, 10, 25, or 100 mg/

kg/day from days 7 through 19 of

gestation. The maternal LOEL is 25 mg/

kg/day, based on treatment-related

clinical findings (decreased defecation).

The maternal NOEL is 10 mg/kg/day.

The developmental LOEL is 100 mg/kg/

day, based on treatment-related

increases in the fetal incidence of

several skeletal variations and a positive

trend for litter incidence of two of these

variations (unossified pubic and tail

bones). The developmental NOEL is 25

mg/kg/day. The developmental toxicity

study in the rabbit is classified core

minimum.

10. In a developmental toxicity study

deltamethrin was administered to 25

Charles River Crl:CD VAF/Plus rats/

dose in corn oil by gavage at dose levels

of 0, 1.0, 3.3, or 11 mg/kg/day from days

6 through 15 of gestation. Because of

excessive toxicity at 11 mg/kg/day, an

additional group of 25 rats dosed at 7

mg/kg/day was added. The maternal
62996 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

LOEL is 7 mg/kg/day, based on

treatment-related increases in mortality,

clinical findings (increased salivation),

and decreased body weight gains during

dosing. The maternal NOEL is 3.3 mg/

kg/day. There were no treatment-related

effects on fetal deaths or resorptions,

altered growth, or developmental

malformations or variations (external,

visceral, and skeletal) noted at any dose

level. The developmental NOEL is ≥11

mg/kg/day. A developmental LOEL was

not observed.

11. In three different developmental

toxicity studies deltamethrin was

administered to mice, rats, and rabbits.

Mice: Mice were dosed at 0, 0.1, 1.0, or

10 mg/kg/day on gestational days 6-17

and were sacrificed on day 18. The

maternal NOEL is ≥10 mg/kg/day. There

was no maternal LOEL observed. The

developmental LOEL is 1.0 mg/kg/day

based on increase incidence (fetal and/

or litter) of delayed ossification of the

sternebrae and paws together with

decreased fetal body weights. The

developmental NOEL is 0.1 mg/kg/day.

Rats: Rats were dosed at 0, 0.1, 1.0, or

10 mg/kg/day on days 6-18 of gestation

and were sacrificed on day 21. The

maternal LOEL is 10 mg/kg/day based

on slightly reduced body weights. The

maternal NOEL is 1.0 mg/kg/day. The

developmental LOEL is equivocally set

at 10 mg/kg/day, based only on a

statistically significant increased

incidence (fetal and/or litter) of delayed

ossification of the sternebrae. The

developmental NOEL is 1.0 mg/kg/day.

Rabbits: Rabbits were dosed at 0, 1, 4,

or 16 mg/kg/day on days 6-19 of

gestation and were sacrificed on day 28;

two separate groups of rabbits received

16 mg/kg/day. The maternal NOEL is

≥16 mg/kg/day. There was no maternal

LOEL observed. The developmental

LOEL is 16 mg/kg/day based on

increased fetal losses and decreased

fetal weights. The developmental NOEL

is 4 mg/kg/day.

12. In a 3-generation reproduction

study deltamethrin was administered to

10 male and 20 female Charles River CD

rats/dose in the diet at doses of 0, 0.1,

1.0, or 2.5 mg/kg/day. Parental toxicity

was not demonstrated at any dose level.

The NOEL for systemic toxicity is ≥2.5

mg/kg/day. The LOEL for systemic

toxicity was not observed. Reproductive

toxicity was not demonstrated at any

dose level. The NOEL for reproductive

toxicity is ≥2.5 mg/kg/day. The

reproductive LOEL was not observed.

13. There is no mutagenicity concern.

There are three acceptable studies: one

reverse mutation assay; one in vitro

chromosome aberration study; one UDS

assay in primary rat hepatocytes. All

these studies were negative. A dominant

lethal study is also available but has not

been officially reviewed. A quick

assessment indicated that it is also

negative.

14. Studies on metabolism:

Deltamethrin 14C-labeled at either the

benzyl (BD) or the dimethyl (DMD)

portion of the molecule was relatively

well absorbed. Urine and fecal

excretions were almost complete at 48

hours post-dosing. Seven days after

dosing, 31-56% of the radioactivity

administered was recovered in the

urine, 36-59% recovered in the feces, <

0.2% recovered in tissues (fat was

highest) and < 1.2% recovered in

carcass. Fecal extracts contained mostly

unabsorbed, unchanged deltamethrin

(17-46% of BD dose and 21-35% of

DMD dose).

15. Studies on neurotoxicity: With the

exception of the acute delayed

neurotoxicity study, no neurotoxicity

studies are available.

16. The following studies are

considered data gaps in the toxicology

data base: 2-generation reproduction

study and acute, chronic and

developmental mammalian

neurotoxicity. These studies will be

required under a special Data Call-In

letter pursuant to section 3(c)(2)(B) of

FIFRA. Although these data are lacking,

EPA has sufficient toxicity data base to

support these tolerances and these

additional studies are not expected to

significantly change its risk assessment.

Tralomethrin

1. A battery of acute toxicity studies

places technical tralomethrin in

Toxicity Category II for acute oral (LD50

in males = 84.9 mg/kg; LD50 in females

= 95.4 mg/kg), acute inhalation (LC50 >

2,000 mg/kg) and primary eye irritation

(corneal opacity which reversed within

14 days); Category III for acute dermal

(LD50 > 2,000 mg/kg); Category IV for

primary dermal irritation (nonirritating). Tralomethrin is not a

sensitizer. The NOEL for Acute Delayed

Neurotoxicity is greater than 6,000 mg/

kg.

2. In a rat oral toxicity study,

tralomethrin was administered to 20 CD

rats/sex/dose via gavage at dose levels of

0, 1, 6, or 18 mg/kg/day for 13 weeks (91

days). The LOEL for this 13-week rat

oral toxicity study is 6 mg/kg/day based

on decreased liver weights. The NOEL

is 1 mg/kg/day.

3. In a 13-week dog feeding study,

tralomethrin in polyethylene glycol was

administered to 5 beagle dogs/sex/group

via capsule at dose levels of 0, 0.1, 1.0,

or 10 mg/kg/day. The LOEL for this 13-

week dog feeding study is 10 mg/kg/day

based on neurological and

hematological effects. The NOEL is 1

mg/kg/day.

4. In a 1-year dog feeding study,

tralomethrin in corn oil was

administered to eight beagle dogs/sex/

group by capsule at dose levels of 0.75,

3.0, and 10.0 mg/kg/day. The high dose

level was excessively toxic and was

reduced to 8.0 mg/kg/day at 4 weeks

and to 6.0 mg/kg/day on week 14. The

low dose level was increased from 0.75

to 1.0 mg/kg/day during week 14. The

LOEL in this 1-year dog feeding study

is 3.0 mg/kg/day, based on reduced

body weight gain, tremors, and

ptyalism. The NOEL is 0.75/1.0 mg/kg/

day.

5. In a mouse oncogenicity study,

tralomethrin in corn oil was

administered to 80 CD-1 mice/sex/dose

by gavage at dose levels of 0.75, 3.0, or

10.0 mg/kg/day for up to 2 years. The

systemic LOEL in this mouse

oncogenicity study is 3 mg/kg/day,

based on skin lesions in male and

female mice. The systemic NOEL is 0.75

mg/kg/day. Under the conditions of this

study, there was no evidence of

carcinogenic potential.

6. In a rat chronic toxicity/

oncogenicity study, tralomethrin in corn

oil was administered to 80 CD rats/sex/

dose by gavage at dose levels of 0.75,

3.0, or 12.0 mg/kg/day for up to 2 years.

The LOEL is 3.0 mg/kg/day in male and

female rats based on decreased body

weight gain in males and decreased food

and water consumption in males and

females at 3.0 mg/kg/day. The NOEL is

0.75 mg/kg/day. Under the conditions of

this study, there was no evidence of

carcinogenic potential.

7. In a rat developmental study,

tralomethrin in corn oil was

administered to 25 female SpragueDawley CD rats per group at 0, 2, 6, or

18 mg/kg/day via gavage on days 6-17

of gestation. On day 21 the rats were

sacrificed and pups delivered by

cesarean section. The maternal LOEL 18

mg/kg/day based on one treatmentrelated death at this dose level. The

maternal NOEL is 6 mg/kg/day. There

was no developmental toxicity noted at

any dose level. There were no

treatment-related increases in

malformations or variations found upon

external, internal, and skeletal

examination of the fetuses. A

developmental LOEL was not observed.

The developmental NOEL is ≥18 mg/kg/

day.

8. In a developmental study,

tralomethrin in corn oil was

administered to 15 female New Zealand

white rabbits per group at 0, 2, 8, or 32

mg/kg/day via gavage on days 6-18 of

gestation. There was no maternal

toxicity noted at any dose level. In a
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62997

developmental study, tralomethrin

(purity not indicated) in corn oil was

administered to 15 female New Zealand

white rabbits per group at 0, 2, 8, or 32

mg/kg/day via gavage on days 6-18 of

gestation. On day 28 the dams were

sacrificed and pups delivered. A

maternal LOEL was not observed. The

maternal NOEL is ≥32 mg/kg/day. There

was no developmental toxicity noted at

any dose level. A developmental LOEL

was not observed. The developmental

NOEL is ≥32 mg/kg/day.

9. In a two-generation rat reproductive

toxicity study, tralomethrin in corn oil

was administered to COBS CD rats by

gavage at dose levels of 0, 0.75, 3.0, or

12.0 mg/kg/day. The LOEL for parental

toxicity is 3.0 mg/kg/day, based on

decreased body weight gains. The NOEL

for parental toxicity is 0.75 mg/kg/day.

Reproductive toxicity was demonstrated

at the mid- and high-doses. The LOEL

for reproductive toxicity is 0.75 mg/kg/

day, based on litters with smaller than

normal pups. A reproductive NOEL was

not observed.

10. There does not appear to be a

concern for mutagenicity, however, all

studies should be revisited, particularly,

the mouse lymphoma. There are three

reviewed studies that are not classified

for acceptability: one mouse lymphoma

assay (Accession No. 072115; one in

vitro chromosome aberration study in

CHO cells and one UDS assay in

primary rat hepatocytes (MRID

41138803). The mouse lymphoma assay

tested negatively without activation and

was moderately positive with activation.

The other two assays tested negatively.

11. The metabolism studies indicate

that tralomethrin is rapidly

debrominated to deltamethrin. It is then

further metabolized to alcohols,

carboxylic acids, glucuronides, glycine

and sulfate conjugates.

12. No mammalian neurotoxicity

studies are available. The acute delayed

neurotoxicity study in the hen is

summarized in section one.

13. The following studies are

considered data gaps in the toxicology

data base: acute, chronic and

developmental mammalian

neurotoxicity. These studies will be

required under a special Data Call-In

letter pursuant to section 3(c)(2)(B) of

FIFRA. Although these data are lacking,

EPA has sufficient toxicity data base to

support these tolerances and these

additional studies are not expected to

significantly change its risk assessment.

B. Toxicological Endpoints

Tralomethrin is rapidly metabolized

to deltamethrin. The toxicology data

bases for deltamethrin and tralomethrin

were combined in order to determine

appropriate endpoints for risk

assessment. Results of the rat

metabolism study support this action.

1. Acute toxicity. EPA has established

an NOEL of 1.0 mg/kg/day based on

combined acute dietary dog studies with

a combined deltamethrin/tralomethrin

data base. This NOEL is based on an

uncertainty factor of 100 to account for

both interspecies extrapolation and

intraspecies variability.

2. Short - and intermediate-term

toxicity. There is no concern for shortand intermediate-term toxicity. There is

no dermal or systemic toxicity at 1,000

mg/kg/day in 21–day dermal study in

rats.

3. Chronic toxicity. EPA has

established the RfD for deltamethrin and

tralomethrin at 0.01 (mg/kg/day). This

RfD is based on a NOEL of 0.75/1.0 mg/

kg/day from a 1 year toxicity study in

dogs. The NOEL is based on decreased

body weight gain, tremors, and

ptyalism. This RfD is based on an

uncertainty factor of 100 to account for

both interspecies extrapolation and

intraspecies variability.

4. Carcinogenicity. There is no

evidence of carcinogenicity in either

rats or mice.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.422 and 180.435) for the

residues of tralomethrin and

deltamethrin in or on a variety of raw

agricultural commodities. For purposes

of the risk assessment the data bases for

deltamethrin and tralomethrin have

been combined. EPA notes that the

acute dietary risk assessments used

Monte Carlo modeling (in accordance

with Tier 3 of EPA’s June 1996 ‘‘Acute

Dietary Exposure Assessment’’ guidance

document) incorporating anticipated

residues and percent crop treated

refinements. Field trial data and FDA

monitoring data were used to generate

anticipated residues or residue

distribution for Monte Carlo analyses.

Chronic dietary risk assessments used

anticipated residues and percent crop

treated refinements. Risk assessments

were conducted by EPA to assess

dietary exposures and risks from

deltamethrin and tralomethrin as

follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a 1 day or single exposure. The NOEL

used for the acute dietary exposure was

1.0 mg/kg/day. Potential acute

exposures from food commodities were

estimated using a Tier 3 acute dietary

risk assessment (Monte Carlo Analysis).

The MOE’s (99.9th percentile) for the

U.S. population based on an acute

dietary exposure of 0.000728 mg/kg/day

are 1,373. For children 1-6 years old

(most highly exposed population), the

MOE’s based on an acute dietary

exposure of 0.001855 mg/kg/day are

539. The Agency has no cause for

concern if total exposure calculated for

the 99.9th percentile yields an MOE of

100 or larger.

ii. Chronic exposure and risk.

Potential chronic exposures were

estimated using NOVIGEN’s DEEM

(Dietary Exposure Evaluation Model).

The RfD used for the chronic dietary

analysis is 0.01 mg/kg/day. Using

tolerance values and anticipated

residues discussed above, the risk

assessment resulted in use of 0.2% of

the RfD for the general U.S. population

and 0.5% of the RfD for children 1-6

years.

Section 408(b)(2)(E) authorizes EPA to

consider available data and information

on the anticipated residue levels of

pesticide residues in food and the actual

levels of pesticide chemicals that have

been measured in food. If EPA relies on

such information, EPA must require that

data be provided 5 years after the

tolerance is established, modified, or

left in effect, demonstrating that the

levels in food are not above the levels

anticipated. Following the initial data

submission, EPA is authorized to

require similar data on a time frame it

deems appropriate.

Section 408(b)(2)(F) allows the

Agency to use data on the actual percent

of crop treated when establishing a

tolerance only where the Agency can

make the following findings: (1) That

the data used are reliable and provide a

valid basis for showing the percentage

of food derived from a crop that is likely

to contain residues; (2) that the

exposure estimate does not

underestimate the exposure for any

significant subpopulation and; (3) where

data on regional pesticide use and food

consumption are available, that the

exposure estimate does not understate

exposure for any regional population. In

addition, the Agency must provide for

periodic evaluation of any estimates

used. The percent of crop treated

estimates for deltamethrin and

tralomethrin were derived from federal

and market survey data. EPA considers

these data reliable. A range of estimates

are supplied by this data and the upper

end of this range was used for the

exposure assessment. By using this

upper end estimate of percent crop

treated, the Agency is reasonably certain

that exposure is not underestimated for

any significant subpopulation. Further,
62998 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

regional consumption information is

taken into account through EPA’s

computer-based model for evaluating

the exposure of significant

subpopulations including several

regional groups. Review of this regional

data allows the Agency to be reasonably

certain that no regional population is

exposed to residue levels higher than

those estimated by the Agency. To meet

the requirement for data on anticipated

residues, EPA will issue a Data Call-In

(DCI) notice pursuant to FFDCA section

408(f) requiring submission of data on

anticipated residues in conjunction with

approval of the registration under

FIFRA.

2. From drinking water. Deltamethrin

and tralomethrin are immobile in soil

and will not leach into ground water.

Additionally, due to their insolubility

and lipophilic nature, any residues in

surface water will rapidly and tightly

bind to soil particles and remain with

sediment. A screening evaluation of

leaching potential of a typical potential

of a typical pyrethroid was conducted

using EPA’s Pesticide Root Zone Model

(PRZM1). Based on this screening

assessment, the potential concentrations

of a pyrethroid in ground water at

depths of 1 and 2 meters are essentially

zero (much less than 0.001 ppb).

Therefore, EPA concludes that residues

are not expected to occur in drinking

water.

i. Acute exposure and risk. Acute

drinking water exposure is estimated for

the U.S. population to be 0.000014 mg/

kg/day with an MOE of 69,093. For Nonnursing infants less than 1 year old the

exposure is 0.000028 with and MOE of

35,895.

ii. Chronic exposure and risk. Chronic

drinking water exposure is estimated for

the U.S. population to be zero and for

the non-nursing infants 0.000001 mg/

kg/day. Zero percent of the RfD is

occupied by both population groups.

3. From non-dietary exposure.

Deltamethrin and tralomethrin are broad

spectrum insecticides registered for use

on a variety of food and non-food

agricultural commodities. Nonagricultural registered uses include turf

and lawn care treatments, broadcast

carpet treatments, indoor fogger, spot,

crack and crevice treatment, insect baits,

lawn and garden sprays and indoor and

outdoor residential, industrial, and

food/feed handling establishments.

To evaluate non-dietary exposure, the

‘‘flea infestation control’’ scenario was

chosen to represent a plausible but

worst-case non-dietary (indoor and

outdoor) non-occupational exposure.

This scenario provides a situation where

deltamethrin and/or tralomethrin is

commonly used and they can be used

concurrently for a multitude of uses,

e.g., spot and/or broadcast treatment of

infested indoor surfaces such as carpets

and rugs, treatment of pets and

treatment of the lawn. This hypothetical

situation provides a very conservative,

upper bound estimate of potential nondietary exposures. Consequently, if

health risks are acceptable under these

conditions, the potential risks

associated with other more likely

scenarios would also be acceptable.

Because tralomethrin is rapidly

metabolized to deltamethrin, and the

toxicology profiles of deltamethrin and

tralomethrin are virtually identical, a

non-dietary and aggregate (non-dietary +

chronic dietary) exposure/risk

assessment has been conducted for the

combination of both active ingredients.

The total exposure to both materials was

expressed as ‘‘deltamethrin equivalents’’

and these were compared to the

toxicology endpoints identified from the

combined deltamethrin/tralomethrin

toxicology data base.

The total aggregate non-dietary

exposure including lawn, carpet, and

pet uses (in mg/kg/day) are: 0.00002 for

adults; 0.000503 for children aged 1-6

years; and 0.000543 for infants less than

1 year old.

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).

Although deltamethrin and

tralomethrin are similar to other

members of the synthetic pyrethroid

class of insecticides, EPA does not have,

at this time, available data to determine

whether deltamethrin and tralomethrin

have common methods 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, deltamethrin

and tralomethrin do not appear to

produce a toxic metabolite produced by

other substances. For the purposes of

this tolerance action, therefore, EPA has

not assumed that deltamethrin and

tralomethrin have a common

mechanism of toxicity with other

substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. The acute aggregate risk

assessment takes into account exposure

from food and drinking water. The

potential acute exposure from food and

water to the US population for

deltamethrin and tralomethrin is

0.000742 mg/kg/day with an MOE of

1,348. This acute dietary exposure

estimate is considered conservative,

using anticipated residue values and

percent crop-treated data in conjunction

with Monte Carlo analysis.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to deltamethrin and

tralomethrin from food and drinking

water will utilize 0.2% of the RfD for

the U.S. population. The major
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62999

identifiable subgroup with the highest

aggregate exposure are children 1-6

years old (discussed in Unit II.F. of this

preamble). EPA generally has no

concern for exposures below 100% of

the RfD because the RfD represents the

level at or below which daily aggregate

dietary exposure over a lifetime will not

pose appreciable risks to human health.

3. Short- and intermediate-term risk.

Short- and intermediate aggregate

exposure takes into account chronic

dietary food and drinking water

(considered to be a background

exposure level) plus indoor and outdoor

residential exposure. The potential

short- and intermediate-term aggregate

risk for the U.S. population is an

exposure 0.000042 mg/kg/day with an

MOE of 49,000.

EPA concludes that there is

reasonable certainty that no harm will

result from aggregate exposure to

deltamethrin and tralomethrin residues.

E. Aggregate Cancer Risk for U.S.

Population

Deltamethrin and tralomethrin do not

yet have carcinogenicity classification;

however, there is no evidence of

carcinogenicity in any of the chronic

studies. Therefore, a carcinogenicity risk

analysis is not required.

F. 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

deltamethrin and tralomethrin, EPA

considered data from developmental

toxicity studies in the rat and rabbit and

a two-generation reproduction study in

the rat. The developmental toxicity

studies are designed to evaluate adverse

effects on the developing organism

resulting from pesticide exposure

during prenatal development to one or

both parents. Reproduction studies

provide information relating to effects

from exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the 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 MOE and

uncertainty factor (usually 100 for

combined inter- and intra-species

variability) and not the additional

tenfold MOE/uncertainty factor when

EPA has a complete data base under

existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard MOE/safety factor.

ii. Developmental toxicity studies. See

toxicological profile in Unit II.A. of this

preamble.

iii. Reproductive toxicity study. See

toxicological profile in Unit II.A. of this

preamble.

iv. Pre- and post-natal sensitivity.

There is no evidence of additional

sensitivity to young rats or rabbits

following prenatal exposure to

deltamethrin or tralomethrin.

v. Conclusion. Based on the above,

EPA concludes that reliable data

support use of the standard 100-fold

uncertainty factor, and that an

additional uncertainty factor is not

needed to protect the safety of infants

and children.

2. Acute risk. The potential acute

exposure from food and drinking water

to the most sensitive population

subgroup, children 1-6 years old is

0.001867 mg/kg/day with an MOE of

535. The Agency has no cause for

concern if total acute exposure

calculated for the 99.9th percentile

yields a MOE of 100 or larger.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to deltamethrin

and tralomethrin from food will utilize

0.5% 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.

4. Short- or intermediate-term risk.

EPA has concluded that potential shortor intermediate-term aggregate exposure

of deltamethrin or tralomethrin from

chronic dietary food and water

(considered to be a background

exposure level) plus indoor and outdoor

residential exposure to infants (less than

1 year old) is 0.000057 mg/kg/day with

an MOE of 1,800. For children (1-6 years

old) the exposure is 0.000055 mg/kg/day

with and MOE of 2,700.

5. Special docket. The complete acute

and chronic exposure analyses

(including dietary, non-dietary, drinking

water, and residential exposure, and

analysis of exposure to infants and

children) used for risk assessment

purposes can be found in the Special

Docket for the FQPA under the title

‘‘Risk Assessment for Extension of

Tolerances for Synthetic Pyrethroids.’’

Further explanation regarding EPA’s

decision regarding the additional safety

factor can also be found in the Special

Docket.

EPA concludes that there is

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to deltamethrin and

tralomethrin.

G. Endocrine Disrupter Effects

EPA is required to develop a

screening program to determine whether

certain substances (including all

pesticides and inerts) ‘‘may have an

effect in humans that is similar to an

effect produced by a naturally occurring

estrogen, or such other endocrine effect.

. . .’’ The Agency is currently working

with interested stakeholders, including

other government agencies, public

interest groups, industry and research

scientists in developing a screening and

testing program and a priority setting

scheme to implement this program.

Congress has allowed 3 years from the

passage of FQPA (August 3, 1999) to

implement this program. At that time,

EPA may require further testing of this

active ingredient and end use products

for endocrine disrupter effects.

III. Other Considerations

A. Metabolism In Plants and Animals

The absorption of deltamethrin

appears to be highly dependent upon

the route and vehicle of administration.

Once absorbed, deltamethrin is rapidly

and extensively metabolized and

excreted through urine and feces, almost

completed within the first 48 hours.

Tralomethrin is rapidly metabolized to

deltamethrin after debromination. The

metabolic pattern of the debrominated

tralomethrin is exactly the same as that

of the metabolic pattern of deltamethrin.

B. Analytical Enforcement Methodology

The analytical method designated

HRAV-7B is adequate for enforcement

purposes. Multi residue methods data

for tralomethrin, deltamethrin, and

trans-deltamethrin have been sent to the

Food and Drug Administration.

C. Magnitude of Residues

Based on the low level of

deltamethrin residues expected in the

diet of cattle from the use on cotton, the

ruminant metabolism study, and an

available cattle feeding study,

measurable residues are not expected in

the milk or meat of ruminants. A

poultry metabolism or feeding study is

not required because cottonseed meal is
63000 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

not a major poultry feed item and

deltamethrin residues are predicted to

be non-detectable. For dietary exposure

analyses, field trial data and FDA

monitoring data were used to generate

the appropriate anticipated residues or

residue distribution for Monte Carlo

analysis.

D. International Residue Limits

No CODEX maximum residue levels

(MRL) are established for deltamethrin

and tralomethrin tolerances addressed

in this document. For deltamethrin on

cottonseed, Mexico has an established

tolerance of 0.1 ppm (vs. U.S. tolerance

of 0.04 ppm). For tralomethrin on

broccoli and soybeans Mexico has

established tolerances of 0.02 ppm (vs.

U.S. tolerance of 0.50) and 0.05 ppm (vs.

U.S tolerance of 0.05ppm) respectively.

As indicated above, there are small

differences between the section 408

tolerances and the Codex MRL values

for specific commodities. These

differences could be caused by

differences in methods to establish

tolerances, calculation of animal feed

dietary exposure, and as a result of

different agricultural practices. EPA will

specifically address these differences

when the pesticides are reregistered and

the tolerances made permanent.

IV. Conclusion

Therefore, the tolerance is established

for residues of deltamethrin in

cottonseed at 0.04 ppm and cottonseed

oil at 0.2 ppm and tralomethrin broccoli

at 0.50 ppm, cottonseed at 0.02 ppm,

lettuce, head at 1.00 ppm, lettuce, leaf

at 3.00 ppm, soybeans at 0.05 ppm,

sunflower seed at 0.05 ppm and

cottonseed oil at 0.20 ppm.

In addition to the tolerances being

established, since for purposes of

establishing tolerances FQPA has

eliminated all distinctions between raw

and processed food, EPA is combining

the tolerance for cottonseed oil that now

appears in § 185.1580 with the

tolerances that appear in §180.435.

V. 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 January 26, 1998

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VI. Public Docket

EPA has established a record for this

rulemaking under docket control

number OPP–300584 (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.

VII. Regulatory Assessment

Requirements

This final rule removes time

limitations for tolerances under FFDCA

section 408(d) in response to a petition

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104-4). Nor does it require any

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or special considerations as

required by Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the tolerances in this

final rule, do not require the issuance of
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63001

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.

VIII. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Environmental protection, Food

additives, Pesticides and pests.

requirements.

Dated: November 14, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

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

b. By revising § 180.422 to read as

follows:

§ 180.422 Tralomethrin; tolerances for

residues.

(a) General. (1) Tolerances are

established for the combined residues of

the pesticide chemical tralomethrin ((S)-

alpha-cyano-3-phenoxybenzyl (1R,3S)-

2,2-dimethyl-3-[(RS)-1,2,2,2-

tetrabromoethyl]-

cyclopropanecarboxylate) and its

metabolites (S)-alpha-cyano-3-

phenoxybenzyl (1R,3R)-3(2,2-

dibromovinyl)-2,2-dimethylcyclopropanecarboxylate and (S)-alphacyano-3-phenoxybenzyl(1S,3R)-3-(2,2-

dibromovinyl)-2,2-dimethylcyclopropanecarboxylate calculated as

the parent in or on the following

agricultural commodities:

Commodity Parts per

million

Broccoli ..................................... 0.5

Cottonseed ............................... 0.02

Cottonseed oil .......................... 0.20

Lettuce, head ............................ 1.00

Lettuce, leaf .............................. 3.00

Soybeans .................................. 0.05

Sunflower seed ......................... 0.05

(2) A food additive tolerance of 0.02

part per million is established for the

combined residues of the insecticide

tralomethrin ((S)-alpha-cyano-3-

phenoxybenzyl-(1R,3S)-2,2-dimethyl-3-

[(RS)-1,2,2,2-tetrabromoethyl]

cyclopropanecarboxylate) and its

metabolites cis-deltamethrin [(S-alphacyano-3-phenoxybenzyl-(1R,3R)-3-[2,2-

dibromovinyl)-2,2-

dimethylcyclopropanecarboxylate] and

trans-deltamethrin [(S)-alpha-cyano-3-

phenoxybenzyl (1S,3R)-3-(2,2-

dibromovinyl)-2,2-

dimethylcyclopropanecarboxylate] as

follows:

(i) In or on all food items (other than

those covered by a higher tolerance as

a result of use on growing crops) in

food-handling establishments.

(ii) The insecticide may be present as

a residue from application of

tralomethrin in food-handling

establishments, including food service,

manufacturing, and processing

establishments, such as restaurants,

cafeterias, supermarkets, bakeries,

breweries, dairies, meat slaughtering

and packing plants, and canneries in

accordance with the following

prescribed conditions:

(A) Application shall be limited to a

general surface and spot and/or crack

and crevice treatment in food-handling

establishments where food and food

products are held, processed, prepared,

and served. General surface application

may be used only when the facility is

not in operation provided exposed food

has been covered or removed from the

area being treated. All food-contact

surfaces and equipment must be

thoroughly cleaned after general surface

applications. Spot and/or crack and

crevice application may be used while

the facility is in operation provided

exposed food is covered or removed

from the area being treated prior to

application. Spray concentration shall

be limited to a maximum of 0.06 percent

active ingredient. Contamination of food

and food-contact surfaces shall be

avoided.

(B) To assure safe use of the

insecticide, its label and labelling shall

conform to that registered with the U.S.

Environmental Protection Agency and

shall be used in accordance with such

label and labelling.

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

c. By revising § 180.435 to read as

follows:

§ 180.435 Deltamethrin, tolerances for

residues.

(a) General. Tolerances are

established for the combined residues of

the pesticide chemical deltamethrin

[(1R,3R)-3-(2,2-dibromovinyl)-2,2-

dimethylcyclopropanecarboxylic acid

(S)-alpha-cyano-3-phenoxybenzyl ester

and its major metabolites, trans

deltamethrin [(S)-alpha-cyano-mphenoxybenzyl(1R,3S)-3-(2,2-

dibromovinyl)-2,2-

dimethylcyclopropanecarboxylate] and

alpha-R-deltamethrin [(R)-alpha-cyanom-phenoxybenzyl-(1R,3R)-3-(2,2-

dibromovinyl)-2,2-

dimethylcyclopropanecarboxylate] in or

on the following agricultural

commodities:

Commodity Parts per

million

Cottonseed ............................... 0.04

Cottonseed oil .......................... 0.2

Tomatoes .................................. 0.2

Tomato (products) concentrated.1.0

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

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

§ 185.1580 [Removed]

b. By removing § 185.1580.
63002 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

§ 185.5450 [Removed]

c. By removing § 185.5450.

[FR Doc. 97–31103 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185 and 186

[OPP–300581; FRL–5755–5]

RIN 2070–AB78

Lambda-Cyhalothrin; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for the combined residues of

the pyrethroid lambda-cyhalothrin and

its epimer in or on broccoli, cabbage,

corn (grain, fodder and forage), corn

(sweet), cottonseed, dry bulb onion,

garlic, lettuce, head, peanuts, rice,

soybeans, sorghum, sunflower,

tomatoes, wheat, sunflower, and

livestock commodities. It also removes

time limitations for tolerances for

residues of lambda-cyhalothrin on the

same commodities that expire on

November 15, 1997. The Zeneca Ag

Products requested these tolerances

under the Federal Food, Drug and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996 (Pub. L.

104–170).

DATES: This regulation is effective

November 26, 1997. Objections and

requests for hearings must be received

by EPA on or before January 28, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300581],

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–

300581], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 or

ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300581]. 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: Adam Heyward, 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) 308–6100, e-mail:

heyward.adam@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On May

24, 1988, EPA established a time limited

tolerance under section 408 of the

FFDCA, 21 U.S.C. 346 a(d) and 348 for

residues of lambda-cyhalothrin and its

epimer on cottonseed (53 FR 18558). As

additional crops tolerances were

established, they were also made timelimited. These tolerance expire on

November 15, 1997. Zeneca Ag

Products, on September 15, 1997,

requested that the time limitation for

tolerances for residues of the insecticide

lambda-cyhalothrin and its epimer in or

on the commodities mentioned above be

removed based on environmental effects

data that they had submitted as a

condition of registration. Zeneca Ag

Products also submitted a summary of

its petition as required under the

FFDCA as amended by the Food Quality

Protection Act (FQPA) of 1996 (Pub. L.

104–170).

In the Federal Register of Friday,

September 25, 1997 (62 FR 50337)

(FRL–5748–2), EPA issued a notice

pursuant to section 408 of the Federal

Food, Drug, and Cosmetic Act (FFDCA),

21 U.S.C. 346a(e) announcing the filing

of pesticide petitions (PP 6F3318,

7F3560, 7H5543, 7F3488, 1F3952,

1H5607, 1F3992, 2F4109, 2F4100,

2F4114, 1F3985, 9F3770 and 6F4769)

for tolerances by Zeneca Ag Products,

1800 Concord Pike, P.O. Box 15458,

Wilmington, Delaware 19850–5458.

This notice included a summary of the

petition prepared by Zeneca Ag

Products, the registrant. There were no

comments received in response to the

notice of filing.

The petitions requested that 40 CFR

180.438 be amended by removing time

limitatioins for tolerances for the

combined residue of the insecticide,

lambda-cyhalothrin and its epimer in or

on the following crops and

commodities: broccoli at 0.4 parts per

millions (ppm); cabbage at 0.4 ppm;

cattle, fat at 3.0 ppm; cattle, meat at 0.2

ppm; cattle, meat and meat by-products

(mbyp) at 0.2 ppm; corn, grain (field and

pop) at 0.05 ppm; corn, fodder at 1.0

ppm; corn, forage at 6.0 ppm; corn,

sweet (k+kwhr) at 0.05 ppm; cottonseed

at 0.05 ppm; dry bulb onion at 0.1 ppm;

eggs at 0.01 ppm; garlic at 0.1 ppm;

goats, fat at 3.0 ppm; goats, meat at 0.2

ppm; goats, mbyp at 0.2 ppm, hogs, fat

at 3.0 ppm; hogs, meat at 0.2 ppm; hogs,

mbyp at 0.2 ppm; horses, fat at 3.0 ppm;

horses, meat at 0.2 ppm; horses, mbyp

at 0.2 ppm; lettuce, head at 2.0 ppm;

milk, fat (reflecting 0.2 ppm in whole

milk) at 5.0 ppm; peanuts at 0.05 ppm;

peanuts, hulls at 0.05 ppm; poultry, fat

at 0.01 ppm; poultry, meat at 0.01 ppm;

poultry, mbyp at 0.01 ppm; rice, grain

at 1.0 ppm; rice, hulls at 5.0 ppm; rice,

straw at 1.8 ppm; sheep, fat at 3.0 ppm;

sheep, meat at 0.2 ppm; sheep, mbyp at

0.2 ppm; soybeans at 0.01 ppm;

sorghum, grain at 0.02 ppm; sorghum,

grain dust at 1.5 ppm; sunflower, seeds

at 0.2 ppm; sunflower, forage at 0.2

ppm; tomatoes at 0.1 ppm; wheat, grain

at 0.05 ppm; wheat, forage at 2.0 ppm;

wheat, hay at 2.0 ppm; wheat, straw at

2.0 ppm; wheat, grain dust at 2.0 ppm;

corn, grain flour at 0.15 ppm; sunflower,

oil at 0.30 ppm; sunflower, hulls at 0.50

ppm; tomato pomace (dry or wet) at 6.0

ppm; and wheat, bran at 0.2 ppm.

In the Notice of Filing the established

tolerance level for sorghum grain was

inadvertently listed as 0.02 ppm. The

correct tolerance level for this

commodity if 0.2 ppm. The correct

tolerance was considered by EPA for

risk assessment purposes. In the latest

CFR, 40 CFR 180.438 (revised as of July

1, 1997), the tolerance for garlic was

incorrectly listed as 0.02 ppm. The

correct level if 0.1 ppm. This error

occurred when the CFR was updated.

The 0.1 ppm level was considered by

EPA for risk assessment.

The basis for time limited tolerances

that expire November 15, 1997 was

given in the October 20, 1993 Federal

Register (58 FR 54094). These timelimited tolerances were predicated on

the expiration of pesticide product

registrations that were made conditional