52558 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Notices

are no acceptable, reliable exposure data

available to assess any potential risks.

However, given the small amount of

material that is used, it is concluded

that the potential for non-occupational

exposure to the general population is

unlikely.

D. Cumulative Effects

The potential for cumulative effects of

metolachlor and other substances that

have a common mechanism of toxicity

has also been considered. It is

concluded that consideration of a

common mechanism of toxicity with

other registered pesticides in this

chemical class (chloroacetamides) is not

appropriate. Since EPA has concluded

that the carcinogenic potential of

metolachlor is not the same as other

registered chloroacetamide herbicides,

based on differences in rodent

metabolism (EPA Peer Review of

metolachlor, 1994), it is believed that

only metolachlor should be considered

in an aggregate exposure assessment.

E. Safety Determination

1. U.S. population. Using the

conservative exposure assumptions

described above, based on the

completeness and reliability of the

toxicity data, it is concluded that

aggregate exposure to metolachlor will

utilize 1.3% of the RfD for the U.S.

population. 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.

Therefore, it is concluded that there is

a reasonable certainty that no harm will

result from aggregate exposure to

metolachlor or metolachlor residues.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

metolachlor, data from developmental

toxicity studies in the rat and rabbit and

a 2-generation reproduction study in the

rat have been considered. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

chemical exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to a chemical on the

reproductive capability of mating

animals and data on systemic toxicity.

Developmental toxicity (reduced

mean fetal body weight, reduced

number of implantations/dam with

resulting decreased litter size, and a

slight increase in resorptions/dam with

a resulting increase in post-implantation

loss) was observed in studies conducted

with metolachlor in rats and rabbits.

The NOEL’s for developmental effects in

both rats and rabbits were established at

360 mg/kg/day. The developmental

effect observed in the metolachlor rat

study is believed to be a secondary

effect resulting from maternal stress

(lacrimation, salivation, decreased body

weight gain and food consumption and

death) observed at the limit dose of

1,000 mg/kg/day.

A 2-generation reproduction study

was conducted with metolachlor at

feeding levels of 0, 30, 300 and 1,000

ppm. The reproductive NOEL of 300

ppm (equivalent to 23.5 to 26 mg/kg/

day) was based upon reduced pup

weights in the F1a and F2a litters at the

1,000 ppm dose level (equivalent to 75.8

to 85.7 mg/kg/day). The NOEL for

parental toxicity was equal to or greater

than the 1,000 ppm dose level.

FFDCA section 408 provides that EPA

may apply an additional safety factor for

infants and children in the case of

threshold effects to account for pre- and

post-natal toxicity and the completeness

of the database. Based on the current

toxicological data requirements, the

database relative to pre- and post-natal

effects for children is complete. Further,

for the chemical metolachlor, the NOEL

of 9.7 mg/kg/day from the metolachlor

chronic dog study, which was used to

calculate the RfD (discussed above), is

already lower than the developmental

NOEL’s of 360 mg/kg/day from the

metolachlor teratogenicity studies in

rats and rabbits. In the metolachlor

reproduction study, the lack of severity

of the pup effects observed (decreased

body weight) at the systemic lowest

observed-effect-level (equivalent to 75.8

to 85.7 mg/kg/day) and the fact that the

effects were observed at a dose that is

nearly 10 times greater than the NOEL

in the chronic dog study (9.7 mg/kg/

day) suggest there is no additional

sensitivity for infants and children.

Therefore, it is concluded that an

additional uncertainty factor is not

warranted to protect the health of

infants and children and that the RfD at

0.1 mg/kg/day based on the chronic dog

study is appropriate for assessing

aggregate risk to infants and children

from use of metolachlor.

Using the conservative exposure

assumptions described above, the

percent of the RfD that will be utilized

by aggregate exposure to residues of

metolachlor including the proposed use

on sunflowers is 1.1% for nursing

infants less than 1 year old, 3.3% for

non-nursing infants, 2.7% for children 1

to 6 years old and 2.0% for children 7

to 12 years old. Therefore, based on the

completeness and reliability of the

toxicity data and the conservative

exposure assessment, it is concluded

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

metolachlor residues.

F. International Tolerances

There are no Codex Alimentarius

Commission (CODEX) maximum

residue levels (MRL’s) established for

residues of metolachlor in or on raw

agricultural commodities.

[FR Doc. 97–26535 Filed 10–7–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–769; FRL 5748–6]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of pesticide petitions

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by the

docket control number PF–769, must be

received on or before November 7, 1997.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7506C), Office of Pesticides Programs,

Environmental Protection Agency, 401

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

person bring comments to: Rm. 1132,

CM #2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically to: oppdocket@epamail.epa.gov. Follow the

instructions under ‘‘SUPPLEMENTARY

INFORMATION’’ of this document. No

Confidential Business Information (CBI)

should be submitted through e-mail.

Information submitted as a comment

concerning this document 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 comment 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. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Notices 52559

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: The

product manager listed in the table

below:

Product Manager Office location/telephone number Address

Adam Heyward (PM 13) Rm. 227, CM #2, 703–305–5418, e-mail: heyward.adam@epamail.epa.gov. 1921 Jefferson Davis Hwy, Arlington, VA

Beth Edwards (PM 13) .. Rm. 206, CM #2, 703–305–5400, e-mail: edwards.beth@epamail.epa.gov. Do.

SUPPLEMENTARY INFORMATION: EPA has

received pesticide petitions as follows

proposing the establishment and/or

amendment of regulations for residues

of certain pesticide chemicals in or on

various food commodities under section

408 of the Federal Food, Drug, and

Comestic Act (FFDCA), 21 U.S.C. 346a.

EPA has determined that these petitions

contain data or information regarding

the elements set forth in section

408(d)(2); however, EPA has not fully

evaluated the sufficiency of the

submitted data at this time or whether

the data supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number [PF–769]

(including comments and data

submitted electronically as described

below). 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 official

record is located at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comment and data will

also be accepted on disks in

Wordperfect 5.1 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket number PF–769 and

appropriate petition number. Electronic

comments on notice may be filed online

at many Federal Depository Libraries.

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: September 25, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Summaries of Petitions

Petitioner summaries of the pesticide

petitions are printed below as required

by section 408(d)(3) of the FFDCA. The

summaries of the petitions were

prepared by the petitioners and

represent the views of the petitioners.

EPA is publishing the petition

summaries verbatim without editing

them in any way. The petition summary

announces the availability of a

description of the analytical methods

available to EPA for the detection and

measurement of the pesticide chemical

residues or an explanation of why no

such method is needed.

1. DowElanco

PP 7F4871

EPA has received a pesticide petition

(PP 7F4871) from DowElanco, 9330

Zionsville Road, Indianapolis, IN 46268-

1054, proposing pursuant to section

408(d) of the Federal Food, Drug and

Cosmetic Act, 21 U.S.C. 346a(d), to

amend 40 CFR part 180 by establishing

a tolerance for residues of spinosad in

or on the raw agricultural commoditIies

almonds, nutmeat at 0.02 ppm;

almonds, hulls at 2 ppm; citrus, whole

fruit at 0.3 ppm; citrus, oil at 3 ppm;

citrus, dried pulp at 0.5 ppm; and leafy

vegetables at 8 ppm. Because of the

amount of spinosad residue found in

almonds, hulls and citrus, dried pulp as

well as wet apple pomace (pending

tolerance under PP 6F4761) and the

amount of almond hulls, citrus dried

pulp, and apple pomace potentially

included in livestock rations, a

livestock, fat residue tolerance of 0.7

ppm is also being proposed. The

following meat and milk tolerances for

residues of spinosad are presently

pending under PP 6F4761: meat at 0.04

ppm, kidney and liver at 0.2 ppm, fat at

0.4 ppm, milk at 0.04 ppm, and milk fat

at 0.5 ppm. An adequate analytical

method is available for enforcement

purposes. EPA has determined that the

petition contains data or information

regarding the elements set forth in

section 408(d)(2) of the FFDCA;

however, EPA has not fully evaluated

the sufficiency of the submitted data at

this time or whether the data supports

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of spinosad in plants (apples, cabbage,

cotton, tomato, and turnip) and animals

(goats and poultry) is adequately

understood for the purposes of these

tolerances. A rotational crop study

showed no carryover of measurable

spinosad related residues in

representative test crops.

2. Magnitude of residues. Magnitude

of residue studies were conducted for

almonds (6 sites), citrus (13 sites on

oranges, 6 sites on grapefruit, and 5 sites

on lemons), and leafy vegetables (6 sites

each on head lettuce, leaf lettuce,

spinach, and celery). Residues found in

these studies ranged from ND to 0.008

ppm on almonds, nutmeat; 0.22 to 1.45

ppm on almonds, hulls; 0.01 to 0.21

ppm on citrus, whole fruit; and ND to

6 ppm on leafy vegetables. A processed

products study in citrus at a 5x

application rate showed that residues of

spinosad did not concentrate in citrus

juice; however, there was

aconcentration of spinosad residues in

citrus oil (14x concentration factor) and

citrus dried pulp (2x concentration

factor).

B. Toxicological Profile

1. Acute toxicity. Acute Toxicity

Spinosad has low acute toxicity. The rat

oral LD50 is 3,738 mg/kg for males and

>5,000 mg/kg for females, whereas the

mouse oral LD50 is >5,000 mg/kg. The

rabbit dermal LD50 is >2,000 mg/kg and

the rat inhalation LC50 is >5.18 mg/l air.

In addition, spinosad is not a skin

sensitizer in guinea pigs and does not

produce significant dermal or ocular

irritation in rabbits. End use

formulations of spinosad that are water

based suspension concentrates have

similar low acute toxicity profiles.

2. Genotoxicty. Short term assays for

genotoxicity consisting of a bacterial

reverse mutation assay (Ames test), an
52560 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Notices

in vitro assay for cytogenetic damage

using the Chinese hamster ovary cells,

an in vitro mammalian gene mutation

assay using mouse lymphoma cells, an

in vitro assay for DNA damage and

repair in rat hepatocytes, and an in vivo

cytogenetic assay in the mouse bone

marrow (micronucleus test) have been

conducted with spinosad. These studies

show a lack of genotoxicity.

3. Reproductive and developmental

toxicity. Spinosad caused decreased

body weights in maternal rats given 200

mg/kg/day by gavage (highest dose

tested). This was not accompanied by

either embryo toxicity, fetal toxicity, or

teratogenicity. The no-observed-effect

levels (NOELs) for maternal and fetal

effects in rats were 50 and 200 mg/kg/

day, respectively. A teratology study in

rabbits showed that spinosad caused

decreased body weight gain and a few

abortions in maternal rabbits given 50

mg/kg/day (highest dose tested).

Maternal toxicity was not accompanied

by either embryo toxicity, fetal toxicity,

or teratogenicity. The NOELs for

maternal and fetal effects in rabbits were

10 and 50 mg/kg/day, respectively. The

NOEL found for maternal and pup

effects in a rat reproduction study was

10 mg/kg/day. Neonatal effects at 100

mg/kg/day (highest dose tested in the rat

reproduction study) were attributed to

maternal toxicity.

4. Subchronic toxicity. Spinosad was

evaluated in 13-week dietary studies

and showed NOELs of 4.9 mg/kg/day in

dogs, 6 mg/kg/day in mice, and 8.6 mg/

kg/day in rats. No dermal irritation or

systemic toxicity occurred in a 21–day

repeated dose dermal toxicity study in

rabbits given 1,000 mg/kg/day.

5. Chronic toxicity. Based on chronic

testing with spinosad in the dog and the

rat, the EPA has set a reference dose

(RfD) of 0.0268 mg/kg/day for spinosad.

The RfD has incorporated a 100-fold

safety factor to the NOELs found in the

chronic dog study. The NOELs shown in

the dog chronic study were 2.68 and

2.72 mg/kg/day, respectively for male

and female dogs. The NOELs shown in

the rat chronic study were 2.4 and 3.0

mg/kg/day, respectively for male and

female rats. Using the Guidelines for

Carcinogen Risk Assessment published

September 24, 1986 (51 FR 33992), it is

proposed that spinosad be classified as

Group E for carcinogenicity (no

evidence of carcinogenicity) based on

the results of carcinogenicity studies in

two species. There was no evidence of

carcinogenicity in an 18-month mouse

feeding study and a 24-month rat

feeding study at all dosages tested. The

NOELs shown in the mouse

oncogenicity study were 11.4 and 13.8

mg/kg/day, respectively for male and

female mice. The NOELs shown in the

rat chronic/oncogenicity study were 2.4

and 3.0 mg/kg/day, respectively for

male and female rats. A maximum

tolerated dose was achieved at the top

dosage level tested in both of these

studies based on excessive mortality.

Thus, the doses tested are adequate for

identifying a cancer risk. Accordingly, a

cancer risk assessment is not needed.

6. Animal metabolism. There were no

major differences in the bioavailability,

routes or rates of excretion, or

metabolism of spinosyn A and spinosyn

D following oral administration in rats.

Urine and fecal excretions were almost

completed in 48-hours post-dosing. In

addition, the routes and rates of

excretion were not affected by repeated

administration.

7. Metabolite toxicology. The residue

of concern for tolerance setting purposes

is the parent material (spinosyn A and

spinosyn D). Thus, there is no need to

address metabolite toxicity.

8. Neurotoxicity. Spinosad did not

cause neurotoxicity in rats in acute,

subchronic, or chronic toxicity studies.

9. Endocrine effects. There is no

evidence to suggest that spinosad has an

effect on any endocrine system.

C. Aggregate Exposure

1. Dietary exposure. For purposes of

assessing the potential dietary exposure

from use of spinosad on almonds, citrus,

and leafy vegetables as well as from

other existing and pending uses, a

conservative estimate of aggregate

exposure is determined by basing the

TMRC on the proposed tolerance levels

for spinosad and assuming that 100% of

the almonds, citrus, leafy vegetables,

and other existing and pending crop

uses grown in the U.S. were treated with

spinosad. The TMRC is obtained by

multiplying the tolerance residue levels

by the consumption data which

estimates the amount of crops and

related foodstuffs consumed by various

population subgroups. The use of a

tolerance level and 100% of crop treated

clearly results in an overestimate of

human exposure and a safety

determination for the use of spinosad on

crops cited in this summary that is

based on a conservative exposure

assessment.

2. Drinking water. Another potential

source of dietary exposure are residues

in drinking water. Based on the

available environmental studies

conducted with spinosad wherein it’s

properties show little or no mobility in

soil, there is no anticipated exposure to

residues of spinosad in drinking water.

In addition, there is no established

Maximum Concentration Level for

residues of spinosad in drinking water.

3. Non-dietary exposure. Spinosad is

currently registered for use on cotton

with several crop registrations pending

all of which involve applications of

spinosad in the agriculture

environment. Spinosad is also currently

registered for use on turf and

ornamentals at low rates of application

(0.04 to 0.54 lb a.i. per acre). Thus, the

potential for non-dietary exposure to the

general population is not expected to be

significant.

D. Cumulative Effects

The potential for cumulative effects of

spinosad and other substances that have

a common mechanism of toxicity is also

considered. In terms of insect control,

spinosad causes excitation of the insect

nervous system, leading to involuntary

muscle contractions, prostration with

tremors, and finally paralysis. These

effects are consistent with the activation

of nicotinic acetylcholine receptors by a

mechanism that is clearly novel and

unique among known insecticidal

compounds. Spinosad also has effects

on the GABA receptor function that may

contribute further to its insecticidal

activity. Based on results found in tests

with various mammalian species,

spinosad appears to have a mechanism

of toxicity like that of many amphiphilic

cationic compounds. There is no

reliable information to indicate that

toxic effects produced by spinosad

would be cumulative with those of any

other pesticide chemical. Thus it is

appropriate to consider only the

potential risks of spinosad in an

aggregate exposure assessment.

E. Safety Determination

1. U.S. population. Using the

conservative exposure assumptions and

the proposed RfD described above, the

aggregate exposure to spinosad use on

almonds, citrus, leafy vegetables, and

other existing and pending crop uses

will utilize 20.0% of the RfD for the U.S.

population. A more realistic estimate of

dietary exposure and risk relative to a

chronic toxicity endpoint is obtained if

average (anticipated) residue values

from field trials are used. Inserting the

average residue values in place of

tolerance residue levels produces a

more realistic, but still conservative risk

assessment. Based on average or

anticipated residues in a dietary risk

analysis, the use of spinosad on

almonds, citrus, leafy vegetables, and

other existing and pending crop uses

will utilize 3.2% of the RfD for the U.S.

population. 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
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Notices 52561

pose appreciable risks to human health.

Thus, it is clear that there is reasonable

certainty that no harm will result from

aggregate exposure to spinosad residues

on almonds, citrus, leafy vegetables, and

other existing and pending crop uses.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

spinosad, data from developmental

toxicity studies in rats and rabbits and

a 2-generation reproduction study in the

rat are considered. The developmental

toxicity studies are designed to evaluate

adverse effects on the developing

organism resulting from pesticide

exposure during prenatal development.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability and potential

systemic toxicity of mating animals and

on various parameters associated with

the well-being of pups.

FFDCA Section 408 provides that EPA

may apply an additional safety factor for

infants and children in the case of

threshold effects to account for pre- and

post-natal toxicity and the completeness

of the database. Based on the current

toxicological data requirements, the

database for spinosad relative to preand post-natal effects for children is

complete. Further, for spinosad, the

NOELs in the dog chronic feeding study

which was used to calculate the RfD

(0.0268 mg/kg/day) are already lower

than the NOELs from the developmental

studies in rats and rabbits by a factor of

more than 10-fold.

Concerning the reproduction study in

rats, the pup effects shown at the

highest dose tested were attributed to

maternal toxicity. Therefore, it is

concluded that an additional

uncertainty factor is not needed and that

the RfD at 0.0268 mg/kg/day is

appropriate for assessing risk to infants

and children.

Using the conservative exposure

assumptions previously described

(tolerance level residues), the percent

(RfD) utilized by the aggregate exposure

to residues of spinosad on almonds,

citrus, leafy vegetables, and other

existing and pending crop uses is 36.1%

for children 1 to 6 years old, the most

sensitive population subgroup. If

average or anticipated residues are used

in the dietary risk analysis, the use of

spinosad on these crops will utilize

7.0% of the RfD for children 1 to 6 years

old. Thus, based on the completeness

and reliability of the toxicity data and

the conservative exposure assessment, it

is concluded that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to spinosad residues on

almonds, citrus, leafy vegetables, and

other existing and pending crop uses.

F. International Tolerances

There are no Codex maximum residue

levels established for residues of

spinosad on almonds, citrus, and leafy

vegetables or any other food or feed

crop. (Adam Heyward)

2. Zeneca Ag Products

PP 7F4875

EPA has received a pesticide petition

(PP 7F4875) from Zeneca Ag Products,

1800 Concord Pike, P.O. Box 15458,

Wilmington, DE 19850–5458. The

petition proposes pursuant to section

408(d) of the Federal Food, Drug and

Cosmetic Act, 21 U.S.C. 346a(d), to

amend 40 CFR part 180 to establish

tolerances for residues of the insecticide

lambda-cyhalothrin and its epimer in or

on the raw agricultural commodities

avocados (imported) at 0.2 parts per

million (ppm); cereal grain crop group

(except rice and wild rice): grain, 0.2

ppm, forage (except sorghum) 6.0 ppm,

hay 2.0 ppm, straw 2.0 ppm, aspirated

grain dust 2.0 ppm, bran 0.8 ppm and

flour 0.6 ppm; fruiting vegetable crop

group (except cucurbits) 0.2 ppm; peas

and beans - edible podded crop

subgroup 0.2 ppm; peas and beans -

succulent shelled crop subgroup 0.01

ppm; peas and beans - dried shelled

subgroup (except soybean) 0.1 ppm;

peanut hay 3.0 ppm; sorghum forage 0.3

ppm; sorghum fodder 0.5 ppm; and

sugarcane 0.05 ppm. The names for

lambda-cyhalothrin and its epimer are

as follows: lambda-cyhalothrin, a 1:1

mixture of (S)-alpha-cyano-3-

phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro3,3,3-trifluoroprop-1-enyl)-2,2-

dimethylcyclopropanecarboxylate and

(R)-alpha-cyano-3-phenoxybenzyl-(Z)-

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

dimethylcyclopropanecarboxylate.

Epimer of lambda-cyhalothrin, a 1:1

mixture of (S)-alpha-cyano-3-

phenoxybenzyl- (Z)(1S,3S)-3-(2-chloro3,3,3-trifluoroprop-1-enyl)-2,2-

dimethylcyclopropanecarboxylate and

(R)-alpha-cyano-3-phenoxybenzyl- (Z)-

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

dimethylcyclopropanecarboxylate. EPA

has determined that the petition

contains data or information regarding

the elements set forth in section

408(d)(2) of the FFDCA; however, EPA

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data supports granting of

the petition. Additional data may be

needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of lambda-cyhalothrin has been studied

in cotton, soybean, cabbage, and wheat

plants. The studies show that the

metabolism generally follows that of

other pyrethroid insecticides. The ester

linkage is cleaved to form

cyclopropanecarboxylic acids and the

corresponding phenoxybenzyl alcohol.

Overall the studies show that

unchanged lambda-cyhalothrin is the

principal constituent of the residue on

edible portions of these crops.

2. Analytical method. An adequate

analytical method (gas liquid

chromatography with an electron

capture detector) is available for

enforcement purposes.

3. Magnitude of residues. Avocados -

six trials were conducted at 3 sites

within Mexico. In these trials the

maximum observed residue was 0.11

ppm. Peppers (nonbell) - three trials

were conducted with a maximum

observed residue of 0.13 ppm. Peppers

(bell) - eight trials were conducted with

a maximum observed residue of 0.16

ppm. Edible podded peas - three trials

were conducted with a maximum

observed residue of 0.14 ppm. Edible

podded beans - six trials were

conducted with a maximum observed

residue of 0.035 ppm. Succulent shelled

peas - six trials were conducted with a

maximum observed residue of 0.01

ppm. Succulent shelled beans - six trials

were conducted with a maximum

observed residue of 0.01 ppm. Dried

shelled peas - five trials were conducted

with a maximum observed residue of

0.06 ppm. Dried shelled peas - eight

trials were conducted with a maximum

observed residue of 0.015 ppm. Peanut

hay - eleven trials were conducted with

a maximum observed residue of 2.61

ppm. Sorghum forage and fodder -

thirteen trials were conducted with a

maximum observed residue of 0.3 and

0.42 ppm, respectively, in forage and

fodder. Sugarcane - nine trials were

conducted with a maximum observed

residue of 0.035 ppm. A sugarcane

processing study was conducted to

determine if residues concentrated in

molasses or refined sugar. No

concentration of residues was observed

in either processed commodity.

B. Toxicological Profile

The following toxicity studies have

been conducted to support the request

for a regulation for residues of lambdacyhalothrin in or on rice.

1. Acute toxicity. Acute toxicity

studies with the technical grade of the

active ingredient lambda-cyhalothrin:

oral LD50 in the rat of 79 milligram/
52562 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Notices

kilogram (mg/kg) (males) and 56 mg/kg

(females), dermal LD50 in the rat of 632

mg/kg (males) and 696 mg/kg females,

primary eye irritation study showed

mild irritation, and primary dermal

irritation study showed no irritation.

2. Genotoxicity. The following

genotoxicity tests were all negative: a

gene mutation assay (Ames), a mouse

micronucleus assay, an in vitro

cytogenetics assay, and a gene mutation

study in mouse lymphoma cells.

3. Reproductive and developmental

toxicity—i. A three-generation

reproduction study in rats fed diets

containing 0, 10, 30, and 100 ppm with

no developmental toxicity observed at

100 ppm, the highest dose tested. The

maternal no-observed-effect-level

(NOEL) and lowest-observed-effect-level

(LOEL) for the study are established at

30 (1.5 mg/kg/day) and 100 ppm (5 mg/

kg/day), respectively, based upon

decreased parental body weight gain.

The reproductive NOEL and LOEL are

established at 30 (1.5 mg/kg/day) and

100 ppm (5 mg/kg/day), respectively,

based on decreased pup weight gain

during weaning.

ii. A developmental toxicity study in

rats given gavage doses of 0, 5, 10, and

15 mg/kg/day with no developmental

toxicity observed under the conditions

of the study. The developmental NOEL

is greater than 15 mg/kg/day, the highest

dose tested. The maternal NOEL and

LOEL are established at 10 and 15 mg/

kg/day, respectively, based on reduced

body weight gain.

iii. A developmental toxicity study in

rabbits given gavage doses of 0, 3, 10,

and 30 mg/kg/day with no

developmental toxicity observed under

the conditions of the study. The

maternal NOEL and LOEL are

established at 10 and 30 mg/kg/day,

respectively, based on decreased body

weight gain. The developmental NOEL

is greater than 30 mg/kg/day, the highest

dose tested.

4. Subchronic toxicity—i. A 90–day

feeding study in rats fed doses of 0, 10,

50, and 250 ppm with a NOEL of 50

ppm and a LOEL of 250 ppm based on

body weight gain reduction.

ii. A 21–day study in rabbits exposed

dermally to doses of 0, 10, 100, and

1,000 mg/kg/day, 6 hours/day, 5 days/

week with a systemic NOEL > 1,000 mg/

kg/kg. There were no clinical signs of

systemic toxicity at any dose level

tested.

5. Chronic toxicity—i. A 12–month

feeding study in dogs fed dose (by

capsule) levels of 0, 0.1, 0.5, and 3.5 mg/

kg/day with a NOEL of 0.1 mg/kg/day.

The LOEL for this study is established

at 0.5 mg/kg/day based upon clinical

signs of neurotoxicity.

ii. A 24–month chronic feeding/

carcinogenicity study with rats fed diets

containing 0, 10, 50, and 250 ppm. The

NOEL was established at 50 ppm and

LOEL at 250 ppm based on reduced

body weight gain. There were no

carcinogenic effects observed under the

conditions of the study.

iii. A carcinogenicity study in mice

fed dose levels of 0, 20, 100, or 500 ppm

(0, 3, 15, or 75 mg/kg/day) in the diet

for 2 years. A systemic NOEL was

established at 100 ppm and systemic

LOEL at 500 ppm based on decreased

body weight gain in males throughout

the study at 500 ppm. The Agency has

classified lambda-cyhalothrin as a

Group D carcinogen (not classifiable due

to an equivocal finding in this study).

Zeneca concludes that no treatmentrelated carcinogenic effects were

observed under the conditions of the

study.

6. Animal metabolism. Metabolism

studies in rats demonstrated that

distribution patterns and excretion rates

in multiple oral dose studies are similar

to single-dose studies. There is an

accumulation of unchanged compound

in fat upon chronic administration with

slow elimination. Otherwise, lambdacyhalothrin was rapidly metabolized

and excreted. The metabolism of

lambda-cyhalothrin in livestock has

been studied in the goat, chicken, and

cow. Unchanged lambda-cyhalothrin is

the major residue component of

toxicological concern in meat and milk.

7. Metabolite toxicology. The Agency

has previously determined that the

metabolites of lambda-cyhalothrin are

not of toxicological concern and need

not be included in the tolerance

expression. Given this determination,

Zeneca concludes that there is no need

to discuss metabolite toxicity.

8. Endocrine effects. No evidence of

such effects were reported in the

toxicology studies described above.

There is no evidence at this time that

lambda-cyhalothrin causes endocrine

effects.

C. Aggregate Exposure

1. Dietary exposure—i. Food. For the

purposes of assessing the potential

dietary exposure for all existing and

pending tolerances for lambdacyhalothrin, Zeneca has utilized

available information on anticipated

residues and percent crop treated. For

all existing and pending tolerances the

anticipated residue contribution (ARC)

is estimated at 0.000212 mg/kg/body

weight (bwt)/day.

ii. Drinking water. Laboratory and

field data have demonstrated that

lambda-cyhalothrin and its degradates

are immobile in soil and will not leach

into groundwater. Other data show that

lambda-cyhalothrin is virtually

insoluble in water and extremely

lipophilic. As a result, Zeneca

concludes that residues reaching surface

waters from field runoff will quickly

adsorb to sediment particles and be

partitioned from the water column.

Zeneca concludes that together these

data indicate that residues are not

expected in drinking water.

2. Non-dietary exposure. Other

potential sources of exposure are from

non-occupational sources such as

structural pest control and ornamental

plant and lawn use of lambdacyhalothrin. Zeneca has no data upon

which to estimate exposure from these

uses. However, given the extremely low

vapor pressure of lambda-cyhalothrin

(1.5 x 10-9 millimeters (mm) of mercury

(Hg)) and the low use rates, Zeneca

concludes that inhalation and dermal

exposure from these uses will be

insignificant.

D. Cumulative Effects

At this time, Zeneca cannot make a

determination based on available and

reliable information that lambdacyhalothrin and other substances that

may have a common mechanism of

toxicity would have cumulative effects.

Thus, Zeneca concludes that for

purposes of this tolerance it is

appropriate only to consider the

potential risks of lambda-cyhalothrin in

an aggregate exposure assessment.

E. Safety Determination

The acceptable Reference Dose (RfD)

based on a NOEL of 0.1 mg/kg/bwt/day

from the chronic dog study and a safety

factor of 100 is 0.001 mg/kg/bwt/day. A

chronic dietary exposure/risk

assessment has been performed for

lambda-cyhalothrin using the above

RfD. Available information on

anticipated residues and percent crop

treated was incorporated into the

analysis to estimate the ARC. The ARC

is generally considered a more realistic

estimate than an estimate based on

tolerance level residues.

1. U.S. population. The ARC from

established tolerances and the current

and pending actions are estimated to be

0.000212 mg/kg/bwt/day and utilize

24.9% of the RfD for the U.S.

population.

2. Infants and children. The ARC for

children, aged 1 to 6 years old, and nonnursing infants (subgroups most highly

exposed) utilizes 77% and 48% of the

RfD, respectively. Generally speaking,

the Agency has no cause for concern if

ARC for all published and proposed

tolerances is less than the RfD.
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Notices 52563

F. International Tolerances

There are no Codex maximum residue

levels (MRL) established for residues of

lambda-cyhalothrin in or on avocados;

cereal grain crop group: grain, forage,

hay, straw, aspirated grain dust, bran,

flour; fruiting vegetable crop group; peas

and beans - edible podded crop

subgroup; peas and beans - succulent

shelled crop subgroup; peas and or

beans - dried shelled subgroup. (Beth

Edwards)

[FR Doc. 97–26536 Filed 10–7–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PP 5E4597; FRL–5746–7]

Milliken & Company; Correction of

Pesticide Petition

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of correction.

SUMMARY: This notice corrects and

extends the comment period of

pesticide petition (PP) 5E4597,

submitted by Milliken & Company

proposing to establish an exemption

from the requirement of a tolerance for

Poly(ethylene glycol) modified FD&C

Blue No. 1, Methyl Poly(ethylene glycol)

modified FD&C Blue No. 1, and

Poly(ethylene glycol) modified Methyl

Violet 2B. Pesticide petition 5E4597,

was published in the Federal Register

on August 29, 1997 (62 FR 45804). EPA

is extending the comment period to

allow additional time for comment.

DATES: The comment period is extended

to October 29, 1997.

FOR FURTHER INFORMATION CONTACT: By

mail: Amelia Acierto, Registration

Division, (7505C), Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location and telephone

number: 4th Floor, CS #1, 2800 Crystal

Drive, Arlington, VA (703)–308–8377; email: ascierto.amelia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a Notice of Filing in the Federal

Register of August 29, 1997 (62 FR

45804) (PF–758; FRL–5738–2) for

pesticide petitions (PP) 3E4246, 7F4845,

and 5E4597. This notice corrects PP

5E4597.

In FR Doc. 97-23097, in the issue for

August 29, 1997, on page 45808, in the

third column, in the first paragraph

under PP 5E4597, the phrase ‘‘not to

exceed 0.6 parts per billion (ppb),’’

should be corrected to read ‘‘not to

exceed 1 to 5% of the final

formulation.’’

List of subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Authority: 7 U.S.C. 136a.

Dated: September 25, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

[FR Doc. 97–26534; Filed 10–7–97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Committee on Vital and Health

Statistics: Publication of

Recommendations Relating to HIPA A

Health Data Standards

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

SUMMARY: Section 1172 (f), Subtitle F of

Pub. L. 104–191, the Health Insurance

Portability and Accountability Act of

1996, requires the Secretary of Health

and Human Services to publish in the

Federal Register any recommendation of

the National Committee on Vital and

Health Statistics (NCVHS) regarding the

adoption of a data standard under that

law. On September 9, the NCVHS

submitted recommendations to the

Secretary relating to the unique

identifier for payers, the unique

identifier for individuals, and security

standards. Accordingly, the full text of

the NCVHS recommendations relating

to HIPAA data standards is reproduced

below. The text of the recommendations

is also available on the NCVHS website:

http//aspe.os.dhhs.gov/ncvhs/.

SUPPLEMENTARY INFORMATION: Under the

Administrative Simplification

provisions of the Health Insurance

Portability and Accountability Act of

1996 HIPAA), the Secretary of Health

and Human Services is required to

adopt standards for specified

administrative health care transactions

to enable information to be exchanged

electronically. The law requires that,

within 24 months of adoption, all health

plans, health care clearinghouses and

health care providers who choose to

conduct these transactions

electronically must comply with these

standads. Further, the law requires the

Secretary to submit to Congress detailed

recommendations on standards with

respect to the privacy of individually

identifiable health information. In

preparing these reports and

recommendations, the Secretary is

required to consult with the NCHVHS,

the statutory public advisory body to

HHS on health data, privacy and health

information policy. On September 9, the

Committee submitted recommendations

to the Secretary relating to the unique

identifier for payers, the unique

identifier for individuals, and security

standards.

Accordingly, the full text of the

NCVHS recommendations relating to

HIPAA data standards is reproduced

below.

Recommendations Relating to the

National PAYERID

September 9, 1997.

The Honorable Donna E. Shalala,

Secretary, Department of Health and Human

Services, 200 Independence Avenue,

S.W., Washington, D.C. 20201

Dear Secretary Shalala: On behalf of the

National Committee on Vital and Health

Statistics (NCVHS), I am pleased to forward

to you our recommendations relating to

another of the health data standards being

proposed for adoption in accordance with the

administrative simplification provisions of

the Health Insurance Portability and

Accountability Act of 1996 (HIPAA). The

NCVHS is very pleased to provide support,

advice and consultation to you in this effort.

The NCVHS has been briefed on the

proposal for the national standard for

identifiers for health plans or PAYERID, and

we offer our strong support. The proposal

includes a nine digit numeric identifier that

would be assigned to all health plans. The

identifier includes a check digit and contains

no embedded intelligence. We recommend

that HHS proceed to publish the proposal for

public comment without delay. In the

interests of operational efficiency and

simplification, we suggest that the

Department also leave open the option of

moving to an alphanumeric identifier in the

future. While public comments are likely to

on the technical details of the number and

the optimal approach to enumeration, we

have found broad support for the proposal in

general and urge you to proceed.

The Committee did identify one concern

that we bring to your attention. The

PAYERID, as proposed, replaces the plan ID

and sub ID used in current transactions. The

sub ID is currently used for electronic

routing, and concern has been expressed that

this function will be lost. We recommend

that this functionality be addressed before

the final rule is issued.

We appreciate you national leadership in

health data standards, electronic data

interchange and privacy, and we are

privileged to work with you on these issues.