45804 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Notices

Management Plan, Implementation,

Mogollen Rim, Coconino National

Forest, Coconino County, AZ, Due:

September 29, 1997, Contact: John

Gerritsma (520) 354–2216.

EIS No. 970333, Final EIS, AFS, ID,

Fourmile Timber Sale, Timber

Harvesting and Road Construction,

Payette National Forest, New Meadow

Ranger District, Adam County, ID,

Due: September 29, 1997, Contact:

Debbie Ellis (218) 347–0300.

Dated: August 26, 1997.

B. Katherine Biggs,

Associate Director, Office of Federal

Activities.

[FR Doc. 97–23119 Filed 8–28–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[ER–FRL–5483–9]

Environmental Impact Statements and

Regulations; Availability of EPA

Comments

Availability of EPA comments

prepared August 4, 1997 Through

August 8, 1997 pursuant to the

Environmental Review Process (ERP),

under Section 309 of the Clean Air Act

and Section 102(2)(c) of the National

Environmental Policy Act as amended.

Requests for copies of EPA comments

can be directed to the OFFICE OF

FEDERAL ACTIVITIES at (202) 564–

7167. An explanation of the ratings

assigned to draft environmental impact

statements (EISs) was published in FR

dated April 4, 1997 (62 FR 16154).

Draft EISs

ERP No. D–FHW–K40142–CA Rating

EC2, CA–4 ‘‘GAP’’ Closure Project,

Improvements between I–80 and

Cunninings Skyway, Funding, NPDES

Permit and COE Section 404 Permit,

City of Hercules, Contra Costa County,

CA.

Summary: EPA expressed

environmental concerns due to: a need

for additional information regarding

wetlands, water and biological resources

and air quality data and analysis.

ERP No. D–FHW–K40224–CA Rating

EU3, I–880/CA–92 Interchange

Reconstruction, I–880 from Winton

Avenue to Tennyson Road and CA–92

from Hesperian Boulevard to Santa

Clara Street, Funding, City of Hayward,

Alameda County, CA.

Summary: EPA found the DEIS for the

I–880/92 interchange project to have

inadequate information because the

DEIS did not account for the related SR

92 San Mateo-Hayward bridge widening

project which had been analyzed in a

separate document. EPA believes the

two projects should be analyzed

together as one since both are

dependent on one another, and that the

information did not present a complete

picture of the impacts to the public and

to the decisionmaker.

ERP No. D–FHW–K40225–CA Rating

EC2, Marin US–101 High Occupancy

Vehicle (HOV) Gap Closure Project,

Construction from US 101 I–580 on US–

101 from Lucky Drive to North San

Pedro Road and I–580 from Irene Street

to US–101, Funding, COE Section 404

and Bridge Permits, Marin County, CA.

Summary: EPA expressed

environmental concerns regarding

potential air quality impacts, relocation

of the San Rafael Viaduct, impacts to the

future rail project, minimization of

impacts of coastal zone resources, and

indirect impacts.

ERP No. D–TVA–E09803–MS Rating

EC2, Exercise of Option Purchase

Agreement with LSP Energy Limited

Partnership for Supply of Electric

Energy, Construction and Operation,

Batesville Generation Facility, Funding,

COE Section 10 and 404 Permits and

NPDES Permit, City of Batesville,

Coahoma, Panola, Quitman and

Yalobusha Counties, MS.

Summary: EPA’s primary concern

involves the fact that the proposed

power plant site is not close to

waterbodies required for process water

supply and discharge, so that pipeline

interconnection with associated impacts

(including loss of forested wetlands) are

proposed.

Final EISs

ERP No. F–FHW–J40140–MT, US 93

Highway Transportation Improvements,

between Hamilton (Milepost 49.0) to

Lolo (Milepost 83.2), Funding and COE

Section 404 Permit, Ravalli and

Missoula Counties, MT.

Summary: EPA expressed

environmental concerns regarding

potential induced and hastened changes

in the pattern of land use, population

density or growth rate of the Bitteroot

Valley resulting indirectly from the

project and potential adverse effects to

wetlands, riparian areas, wildlife

habitat, and other natural systems,

including ecosystems.

Dated: August 26, 1997.

B. Katherine Biggs,

Associate Director, Office of Federal

Activities.

[FR Doc. 97–23120 Filed 8–28–97; 8:45 am]

BILLING CODE 6560–50–U

ENVIRONMENTAL PROTECTION

AGENCY

[PF–758; FRL–5738–2]

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–758, must be

received on or before September 29,

1997.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch (7506C),

Information Resources and Services

Division, 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 by following

the instructions under

‘‘SUPPLEMENTARY INFORMATION.’’

No confidential business information

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

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI 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.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: The

contact person listed in the table below:
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Notices 45805

Contact Person Office location/telephone number Address

Beth Edwards, ............... Rm. 211, CM #2, 703–305–5400, e-mail:edwards.beth@epamail.epa.gov. 1921 Jefferson Davis Hwy, Arlington, VA

Amelia Acierto ................ 4th floor, CS1, 703–308–8377, e-mail: acierto.amelia@epamail.epa.gov. 2800 Crystal Drive, Arlington,

VA.

Bipin Gandhi, ................. Rm.4W53, CS1, 703–308–8380, e-mail: gandhi.bipin@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–758]

(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–758] and

appropriate petition number. Electronic

comments on this 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: August 20, 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. American Cyanamid Company

PP 3E4246

EPA has received a pesticide petition

(PP 3E4246) from American Cyanamid

Company, Agricultural Products

Research Division, P.O. Box 400,

Princeton, NJ 08543-0400, 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 to

establish an exemption from the

requirement of a tolerance for residues

of Polyvinyl Chloride (PVC) when used

as an inert ingredient in pesticide

formulations applied to growing crops

or to raw agricultural commodities after

harvest, under 40 CFR 180.1001(c). 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. Toxicity Data

As part of the EPA policy statement

on inert ingredients published in the

Federal Register of April 22, 1987 (52

FR 13305), the Agency set forth a list of

studies which would generally be used

to evaluate the risks posed by the

presence of an inert ingredient in a

pesticide formulation. However, where

it can be determined without the data

that the inert ingredient will present

minimal or no risk, the Agency

generally does not require some or all of

the listed studies to rule on the

proposed tolerance or exemption from

the requirement of a tolerance for an

inert ingredient. Cyanamid believes that

the data and information described

below is adequate to ascertain the

toxicology and characterize the risk

associated with the use of PVC as an

inert ingredient in pesticide

formulations applied to growing crops

and raw agricultural commodities after

harvest.

In the case of certain chemical

substances that are defined as

‘‘polymers’’, the EPA has established a

set of criteria which identify categories

of polymers that present low risk. These

criteria (described in 40 CFR 723.250)

identify polymers that are relatively

unreactive and stable compared to other

chemical substances as well as polymers

that typically are not readily absorbed.

These properties generally limit a

polymer’s ability to cause adverse

effects. In addition, these criteria

exclude polymers about which little is

known. The EPA believes that polymers

meeting the criteria noted below will

present minimal or no risk.

Polyvinyl chloride (PVC) conforms to

the definition of polymer given in 40

CFR 723.250(b) and meets the following

criteria that are used to identify low risk

polymers:

1. PVC is not a cationic polymer, nor

is it reasonably anticipated to become a

cationic polymer in a natural aquatic

environment.

2. PVC contains as an integral part of

its composition the atomic elements

carbon, chlorine, and hydrogen.

3. PVC does not contain as an integral

part of its composition, except as

impurities, any elements other than

those listed in 40 CFR 723.250 (d)(2)(ii).

4. PVC is not designed, nor is it

reasonably anticipated to substantially

degrade, decompose, or depolymerize.

5. PVC is not manufactured or

imported from monomers and/or other

reactants that are not already included

on the Toxic Substance Control Act

(TSCA) Chemical Substance Inventory

or manufactured under an applicable

TSCA section 5 exemption.

6. PVC is not a water absorbing

polymer.
45806 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Notices

7. PVC does not contain any group as

reactive functional groups.

8. The minimum number-average

molecular weight of PVC is listed as

29,000 daltons. Substances with

molecular weights greater than 400

generally are not absorbed through the

intact skin, and substances with

molecular weights greater than 1,000

generally are not absorbed through the

intact gastrointestinal (GI) tract.

Chemicals not absorbed through the

skin or GI tract generally are incapable

of eliciting a toxic response.

9. PVC has a minimum numberaverage molecular weight of 29,000 and

contains less than 2 percent oligomeric

material below molecular weight 500

and less than 5 percent oligomeric

material below 1,000 molecular weight.

In addition, PVC is approved by the

Food and Drug Administration (FDA)

under 21 CFR for contact with food as

a component in adhesives (21 CFR

175.105), coatings (21 CFR 175.320),

and paper and paperboard (21 CFR

176.180). PVC is also approved by FDA

as an indirect food additive used as a

basic component of acrylic (21 CFR

177.1010) and cellophane (21 CFR

177.1200) polymers.

PVC is also cleared for use as water

pipe for potable water as per FFDCA

201(s).

B. Aggregate Exposure

PVC was one of the earliest and still

most widely used plastics. The polymer

is ubiquitous in our every day

environment as it is commonly used in

building materials, furniture, and

textiles. It is also cleared by FDA as an

indirect food additive due to its use in

food packaging materials.

Although exposure to PVC may occur

through dietary (e.g., PVC-containing

food wrapping), non-occupational (e.g.,

contact with PVC furniture), and

drinking water (e.g., potable water

piping, water bottles, etc.) sources, the

chemical characteristics of PVC lead to

the conclusion that there is a reasonable

certainty of no harm from aggregate

exposure to the polymer. Given the

existing widespread use of PVC, any

additional exposure resulting from the

approval of the use of PVC as an inert

ingredient in pesticide formulations for

use on growing crops or to raw

agricultural commodities after harvest

would be trivial.

C. Cumulative Effects

At this time there is no information to

indicate that any toxic effects produced

by PVC would be cumulative with those

of any other chemical. Given the

compound’s categorization as a ‘‘low

risk polymer’’ (40 CFR 723.250) and its

proposed used as an inert ingredient in

pesticide formulations, there is no

reasonable expectation of increased risk

due to cumulative exposure to PVC.

D. International Tolerances

Cyanamid is petitioning that PVC be

exempt from the requirement of a

tolerance based upon its status as a low

risk polymer as per 40 CFR 723.250.

Therefore, an analytical method to

determine residues of PVC in raw

agricultural commodities treated with

pesticide formulations containing PVC

has not been proposed.

There are no Codex maximum residue

levels (MRLs) established for PVC.

Residues of PVC are currently exempt

from the requirement of a tolerance

under 40 CFR 180.1001(e) for use in

pesticide formulations applied to

animals. (Bipin Gandhi)

2. Merck Research Laboratories, Inc.

(Merck)

PP 7F4845

EPA has received a pesticide petition

(PP 7F4845) from Merck Research

Laboratories, Inc. (Merck), P.O. Box 450,

Hillsborough Road, Three Bridges, NJ

08887–0450, 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

tolerances for residues of emamectin

benzoate and certain of its degradates in

or on the fruiting vegetables crop group

(except cucurbits), which includes the

raw agricultural commodities eggplants,

groundcherries, pepinos, peppers (bell,

chili, cooking, and sweet), tomatillos,

and tomatoes. Emamectin benzoate is a

new insecticide designed for use against

the larvae of various Lepidoptera

species when applied in the form of an

emulsifaiable concentrate formulation

(PROCLAIM 0.16 EC Insecticide) or a

soluble granular formulation

(PROCLAIM 5% SG Insecticide).

Merck Research Laboratories, Inc.

(Merck) previously has applied for the

registration under section 3 of the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA) of three

products containing emamectin

benzoate: emamectin benzoate technical

(EPA File Symbol 618-RNI); PROCLAIM

0.16 EC Insecticide (EPA File Symbol

618-RNT); and PROCLAIM 5% SG

Insecticide (EPA File Symbol 618-RNA).

Notice of filing of these applications

was published in the Federal Register

on July 10, 1996 (61 FR 36372). In the

previous petition, Merck proposed that

the end-use products be registered for

use on broccoli, Brussels sprouts,

cabbage, cauliflower, celery, and head

lettuce. Merck has also submitted a

petition under section 408 of the

Federal Food, Drug, and Cosmetic Act

(FFDCA) for the establishment of

permanent tolerances for residues of

emamectin benzoate on the raw

agricultural commodities (RACs)

broccoli, Brussels sprouts, cabbage,

cauliflower, celery, and head lettuce.

EPA has assigned this petition the

number PP 6F4628.

Merck is now submitting this new

petition for the issuance of a tolerance

for residues of emamectin on the

‘‘fruiting vegetables (except cucurbits)’’

crop group, which includes eggplants,

groundcherriees, pepinos, peppers (bell,

chili, cooking, and sweet), tomatillos,

and tomatoes.

The tolerances sought are for the total

toxic residue, consisting of the parent

insecticide (emamectin benzoate) and

four other components that are plant

metabolites or photodegradation

products. For each RAC the proposed

tolerance level is 0.02 ppm. The

pesticide chemical that produces such

residues is the parent insecticide

emamectin benzoate. Further

information on the chemical identity

and composition of these compounds is

set forth in the EPA files for the three

applications discussed in the previous

paragraph above.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of emamectin benzoate in plants has

been studied in lettuce, cabbage, and

sweet corn. The major portion of the

residue is parent compound and its

delta 8,9- photoisomer. Studies of the

metabolism of emamectin in animals are

not required because the commodities

that are the subject of the petition are

not significant animal feed items.

2. Analytical method. Adequate

analytical methods (HPLC-fluorescence

methods) are available for enforcement

purposes.

3. Magnitude of residues. Twentythree field trials have been conducted:

11 on peppers and 12 on tomatoes. A

processing study was also carried out

with tomatoes. These trials were

conducted in the major U.S. growing

areas for these crops.

All trials were conducted under

maximum proposed use rates and

conditions. Raw agricultural commodity

(RAC) samples from all trials were

collected a few hours after the last

treatment (day 0) and on days 3, 7, and

14. In one trial samples were also

collected for use in a processing study.

In day 7 (and later) whole tomato

samples, the highest level of the B1a

component and of the n-formyl

component were each NQ (not

quantifiable, less than 5 ng/g); for the
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Notices 45807

other two components the residues were

less than 1 ng/g. In day 7 (and later)

pepper samples, the highest B1a residue

was 5 ng/g , the highest n-formyl

residue was NQ (less than 5 ng/g), and

the other two components were less

than 1 ng/g in each sample. Thus, the

maximum combined residue was less

than 12 ng/g (less than 0.012 ppm) in

each case. The processing study showed

that the residues did not concentrate in

tomato puree or paste.

These data support the proposed

tolerance of 0.02 ppm for total toxic

residues of emamectin benzoate on

tomatoes, tomato puree, tomato paste, or

peppers, and by extension to remaining

members of the fruiting vegetables

(except cucurbits) group.

B. Toxicological Profile

The primary toxic effect seen in

animal studies of emamectin benzoate is

neurotoxicity. No-observed-effect-levels

(NOELs) for this effect have been well

characterized in multiple studies.

Emamectin benzoate has not been

shown to be oncogenic or teratogenic in

animal studies, it lacks mutagenic

activity, and it is not selectively

developmentally toxic. The petition

refers to toxicity data that establish the

following information about the toxicity

of emamectin benzoate:

1. Acute toxicity. Acute oral LD50: rat,

76–89 mg/kg; CD-1 mouse 107–120 mg/

kg; CF-1 mouse, 22–31 mg/kg. Acute

oral neurotoxicity: rat, NOEL = 5 mg/kg,

LOEL = 10 mg/kg. Acute dermal LD50:

rat and rabbit, >2,000 mg/kg. Dermal

irritation: rabbit, not irritating to skin.

Eye irritation: rabbit, severe eye irritant.

Acute inhalation 4-hour LC50: rat, 2.12–

4.44 mg/l.

2. Mutagenicity. Emamectin benzoate

was tested in a battery of in vitro and

in vivo mutagenicity assays and showed

no evidence of mutagenic potential. The

photodegradates have also been tested

in the Ames bacterial mutagenicity

assay and show no mutagenic potential

in this test system.

3. Reproductive and developmental

toxicity. Developmental toxicity: rat,

maternal NOEL = 2 mg/kg/day,

developmental NOEL = 4 mg/kg/day,

developmental LOEL = maternally toxic

8 mg/kg/day (HDT) for developmental

delay; rabbit, maternal NOEL = 3 mg/kg/

day, developmental NOEL = 6 mg/kg/

day (maternally toxic HDT).

Developmental neurotoxicity: rat,

maternal NOEL = 3.6/2.5 mg/kg/day

(HDT), developmental NOEL = 0.6 mg/

kg/day, developmental LOEL = 3.6/2.5

mg/kg/day for signs of neurotoxicity in

pups. 2-generation reproductive

toxicity: rat, parental and reproductive

NOEL = 0.6 mg/kg/day, parental LOEL

= 3.6/1.8 mg/kg/day (for decreased

weight gain and neuronal lesions);

reproductive toxicity LOEL = 3.6/1.8

mg/kg/day (for decreased fecundity and

signs of neurotoxicity in pups).

4. Subchronic and chronic toxicity

and oncogenicity. With the single

exception of the chronic rat study,

LOELs for the following studies are

based on clinical signs and/or

histopathological evidence of

neurotoxicity (described further below).

Subchronic (90-day) toxicity: rat, NOEL

= 0.5 mg/kg/day, LOEL = 2.5 mg/kg/day;

CD-1 mouse, NOEL = 5.4 mg/kg/day

(TWA), LOEL = 0.5 mg/kg/day; dog,

NOEL = 0.25 mg/kg/day, LOEL = 0.5

mg/kg/day Subchronic (90-day)

neurotoxicity; rat, NOEL = 1 mg/kg/day,

LOEL = 5 mg/kg/day. Chronic (105-

week) toxicity/oncogenicity, rat: NOEL

= 0.25 mg/kg/day, LOEL = 1 mg/kg/day

(based on decreased body weight and

clinical chemistry changes),

neurotoxicity NOEL = 1 mg/kg/day, not

oncogenic. Chronic (79-week) toxicity/

oncogenicity, CD-1 mouse: NOEL = 2.5

mg/kg/day, LOEL = 5 mg/kg (males), 7.5

mg/kg/day (females), not oncogenic.

Chronic (53-week) toxicity, dog: NOEL =

0.25 mg/kg/day, LOEL= 0.5 mg/kg./day.

Exposure to sufficiently high doses of

emamectin benzoate may be associated

with clinical signs of central nervous

system (CNS) toxicity and microscopic

evidence of CNS/peripheral nervous

system (PNS) damage. Neurotoxicity has

generally been the most sensitive

endpoint for toxicity in oral animal

studies with emamectin benzoate.

Clinical signs of CNS toxicity resulting

from emamectin benzoate exposure

include tremors, mydriasis, and changes

in motor activity (e.g., lethargy,

hyperactivity, and/or ataxia). Nervous

system lesions (generally focal and of a

low degree of severity) have been

observed microscopically in white and

gray matter in the brain stem, spinal

cord, and peripheral nerves. Sporadic

lesions of the optic nerve and/or retina

have also been seen at higher dose

levels. NOELs have been determined in

all studies. The lowest toxic dose level

of emamectin benzoate for CNS/PNS

lesions (0.5 mg/kg/day) was identified

in a 1–year study in dogs (NOEL of 0.25

mg/kg/day).

The CF-l mouse is uniquely sensitive

to emamectin benzoate-induced

neurotoxicity. Studies have shown that

a significant fraction of the members of

this strain inherit an inability to

produce a P-glycoprotein- one that most

strains and species do produce- that

functions to resist the entrance of

avermectin-type compounds into the

central nervous system. P-glycoprotein

is also present in the gut of most species

and limits absorption of avermectintype compounds following oral

exposure. In a 16–day feeding study in

the CF-1 mouse, tremors were seen at

0.3 mg/kg/day of emamectin benzoate

with a NOEL of 0.1 mg/kg/day. No

histopathologic evidence of

neurotoxicity was seen in this study up

to the highest dose tested (0.9 mg/kg/

day).

Emamectin benzoate photodegrades

on plants and in soil. The major

photodegradates that are not animal

metabolites were tested in a 15-day

neurotoxicity study in CF-1 mice. Only

one photodegradate showed

neurotoxicity (Merck research number

L-660,599, the N-formyl-N-methyl

degradate). Its NOEL was found to be

0.075 mg/kg/day, slightly lower than the

value for the parent compound in the

same kind of study, and both clinical

signs and peripheral nerve lesions were

observed at levels of 0.1 mg/kg/day and

higher.

5. Endpoint selection. Merck is

proposing that the 0.075 mg/kg/day

NOEL from the CF-1 mouse 15–day

neurotoxicity study with the L–660,599

photodegradate be used as the basis for

acute dietary risk assessment. For

evaluation of chronic dietary risks,

Merck is proposing that the 1-year dog

chronic study NOEL of 0.25 mg/kg/day

be used. The dog appears to be the most

sensitive species to long-term exposure

to emamectin benzoate. Accordingly,

chronic exposure is compared against a

RfD of 0.0025 mg/kg/day, based on the

dog study results and an uncertainty

factor of 100.

C. Aggregate Exposure

1. Dietary exposure. Except for a

temporary tolerance associated with an

experimental use permit, no tolerances

for residues of emamectin benzoate have

been established. Merck projects that by

the year 2,001, emamectin benzoate will

be used on approximately 17% of the

acreage for the cole, leafy non-cole

vegetable, and fruiting vegetable crops.

Chronic dietary exposure analyses were

conducted for the overall U.S.

population and 26 population

subgroups. Assuming 100% of the crops

are treated, chronic exposure for the

overall U.S. population was estimated to

be 0.000005 mg/kg BW/day, and for the

most highly exposed subgroup, children

1 to 6 years of age, 0.000007 mg/kg BW/

day.

2. Non-dietary exposure. No products

containing emamectin benzoate have yet

been registered under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) for any food or nonfood

use. No significant nondietary,
45808 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Notices

nonoccupational exposure is

anticipated.

3. Drinking water. The environmental

fate of emamectin has been evaluated,

and the compound is not expected to

contaminate groundwater or surface

water to any measurable extent.

D. Cumulative Effects

Emamectin is a member of the

avermectin family of natural and

synthetic compounds that includes the

Merck products abamectin (a naturally

occurring compound that is the active

ingredient of several insecticides

registered under FIFRA) and ivermectin

(a human and animal drug made from

abamectin). Emamectin is made from

abamectin but is less similar to

abamectin than is ivermectin. Other

companies produce certain other drugs

that are members of the avermectin

family. Some of the effects seen in

toxicity studies of abamectin and

ivermectin are similar to some of the

effects seen in toxicity studies of

emamectin. See the discussion of

abamectin and ivermectin in 61 FR

65043 (December 10, 1996). Merck is

not aware of any information indicating

what, if any, cumulative effect would

result from exposure to two or more of

these compounds.

E. Safety Determination

1. U.S. population— i. Chronic risk.

Chronic exposures were analyzed with

reference to the chronic effects RfD

NOEL of 0.0025 mg/kg/day. Assuming

100% of the crops are treated, the

chronic exposure estimate was 0.2% of

the RfD for the overall U.S. population,

and 0.3% of the RfD for the most highly

exposed subgroup, children 1 to 6 years

of age. If 25% crop treatment is

assumed, exposure estimates were less

than 0.1% of the RfD for all population

groups.

ii. Acute risk. Acute exposure

analyses were conducted for the overall

U.S. population, and the population

subgroups (1) women 13 years and

older, (2) infants, and (3) children. In

addition, Tier 2 and Tier 3 acute

analyses were conducted assessing

acute exposures against the 0.075 mg/

kg/day NOEL. These analyses showed

that the margins of exposure (MOEs)

calculated from the proposed uses of

emamectin benzoate are acceptable

whether using a highly conservative

approach (Tier 2) or a more realistic

(Tier 3) methodology. In the Tier 2

analysis, MOEs were well over 1,000 up

to the 95th percentile of exposure for all

population groups. In the Tier 3 analysis

and assuming 100% of the crops are

treated, MOEs up to the 99.5th

percentile of exposure were greater than

1,000. Assuming 25% of the crop

treated, MOEs were greater than 1,000

up to the 99.9th percentile of exposure.

Results of both the chronic and acute

dietary exposure analyses clearly

demonstrate a reasonable certainty that

no harm will result from the proposed

uses of emamectin benzoate.

2. Infants and children. It is Merck’s

position that the administration of

emamectin benzoate has not been

shown to cause developmental or

reproductive effects at dose levels below

those that are maternally toxic. Even if

it were decided to use the 0.6 mg/kg

NOEL from the rat developmental

neurotoxicity study as an endpoint from

which to calculate an RfD, the resulting

RfD would not yield a different

regulatory outcome unless a very high

additional uncertainty factor were also

employed. Use of such an extra

uncertainty factor is not justified for

several reasons. Emamectin benzoate is

not a teratogen. In developmental

toxicity testing, the compound caused

no developmental effects in rabbits; in

rats, it caused no malformations, and

caused skeletal effects typical of

developmental delay only at severely

maternally toxic doses. Likewise, no

reproductive toxicity or toxicity to pups

was seen in the 2-generation

reproductive toxicity study except at

parentally toxic doses. In the

developmental neurotoxicity study,

tremors, hind-leg splay, and behavioral

effects were seen in pups at a dose level

(3.6/2.5 mg/kg/day) at which no

maternal clinical signs were noted.

However, the dams in the study were

discarded after the lactation period

without gross necropsy or microscopic

examination. In studies in which rats

dosed at similar levels were examined

microscopically, effects (central and

peripheral neural lesions) were seen.

The clinical signs of avermectinfamily neurotoxicity seen in neonatal

rats are unlikely to be useful predictors

of human risk. Young rats are

considerably more sensitive to

avermectin-type compounds than either

adult rats or humans and other

primates. (In neonatal rats, unlike

humans, the P-glycoprotein levels are

only a small fraction of the levels seen

in adult rats.) Moreover, data from

clinical experience with ivermectin, a

related human drug, and studies on

ivermectin and abamectin, a related

pesticide, demonstrate that both the

neonatal rat and the CF–1 mouse

overpredict the toxicity of the

avermectin-type compounds to humans

and to non-human primates.

F. International Tolerances

No Codex maximum residue levels

(MRLs) have been established for

residues of emamectin benzoate. (Beth

Edwards)

3. Milliken & Company

PP 5E4597

EPA has received a pesticide petition

(PP 5E4597) from Milliken & Company,

M–400, P.O Box 1927, Spartanburg, SC

29304–1927, proposing pursuant to

section 408(d) of the Federal Food, Drug

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

amend 40 CFR 180.1001(c) to establish

an exemption from the requirement of a

tolerance for Poly(ethylene glycol)

modified FD&C Blue No. 1, MethylPoly(ethylene glycol) modified FD&C

Blue No. 1; Poly(ethylene glycol)

modified Methyl Violet 2B; when used

as inert ingredients at the rate not to

exceed 0.6 parts per billion (ppb) to

impart color to pesticidally-treated

seeds. 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. No specific

residue studies have been conducted on

the colorants in raw agricultural

commodities or in processed foods.

However, the aggregate exposure

estimates, discussed above, are based on

the assumption that an exaggerative

level of PEG-modified FD&C Blue No. 1,

Methyl-PEG-modified FD&C Blue No. 1,

and PEG-modified Methyl Violet 2B

applied to seeds will be absorbed by

growing plants and enter the diet. Even

based on this exaggerative assumption,

the maximum potential dietary

exposure to the colorants is minuscule.

2. Analytical method. Section

408(c)(3)(B) provides for circumstances

where no need exists for a practical

method for detecting and measuring

levels of pesticide residue in or on food.

In this instance, because the colorants of

interest are inert ingredients and since

the exemption from the requirement of

a tolerance has no numerical limitation,

analytical methods are not required for

enforcement purposes for these

colorants.

B. Toxicological Profile

1. Acute toxicity. The results of acute

oral toxicity studies indicate that PEGmodified FD&C Blue No. 1 has very low
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Notices 45809

toxicity by the oral route. Specifically,

PEG-modified FD&C Blue No. 1 has an

acute oral LD50 of greater than 5,000

milligrams per kilogram in rats. An

additional test material having slightly

smaller side chain lengths than PEGmodified FD&C Blue No. 1 also showed

an acute oral LD50 of greater than 5,000

milligrams per kilogram in rats. PEGmodified FD&C Blue No. 1 is closely

related to FD&C Blue No. 1; however,

the PEG-modified FD&C Blue No. 1 is of

a higher molecular weight than FD&C

No. 1. FD&C Blue No. 1, itself, is exempt

from the requirement of a tolerance

under 40 CFR 180.1001 and also is

cleared by the Food and Drug

Administration for use in coloring food

and for coloring drugs under 21 CFR

74.101 and 74.1101, respectively. The

acute oral LD50 for FD&C Blue No. 1 has

been determined to be greater than

2,000 mg/kg in rats (Lu and Lavallee,

1964). Thus, the acute toxicity data

submitted in support of this petition

support the conclusion that PEGmodified FD&C Blue No. 1 is of a lower

order of toxicity than FD&C Blue No. 1,

itself. Such a result could be expected

since, in general, compounds of higher

molecular weights are more poorly

absorbed and consequently are typically

less toxic than closely related lower

molecular weight materials.

Along the same lines, it should be

noted that Methyl-PEG-modified FD&C

Blue No. 1, is another material that is

closely related to FD&C Blue No. 1, but

is of a higher molecular weight.

Similarly, PEG-modified Methyl Violet

2B is closely related to Methyl Violet

2B, but is of a higher molecular weight.

Methyl Violet 2B, itself, currently is

exempted from the requirement of a

tolerance under 40 CFR 180.1001.

Additional acute toxicity studies on

the polymeric colorants of interest

include skin and eye irritation studies.

Primary dermal irritation studies in

rabbits on PEG-modified FD&C Blue No.

1 show ‘‘minimally irritating’’ results

and primary eye irritation studies in

rabbits show ‘‘practically non-irritating’’

results. The dermal sensitization studies

on PEG-modified FD&C Blue No. 1 show

that this material is not a skin sensitizer.

In addition, primary dermal irritation

studies on the test material having

slightly shorter side chain lengths than

PEG-modified FD&C Blue No. 1, show

no effects. Finally, primary dermal

irritation studies in rabbits on PEGmodified Methyl Violet 2B show barely

perceptible erythema on abraded sites

only, and primary eye irritation studies

in rabbits show ‘‘non-irritating’’ results.

2. Genotoxicity. In Vitro

Transformation Studies and Mouse

Lymphoma Forward Mutation Studies

on PEG-modified FD&C Blue No. 1 both

show that this test material is inactive.

Furthermore, an Ames study on MethylPEG-modified FD&C Blue No. 1 shows

non-mutagenic results. Mutagenicity

studies have not been conducted on

Methyl Violet 2B, PEG Analog.

3. Reproductive and developmental

toxicity. In Vitro Transformation Studies

and Mouse Lymphoma Forward

Mutation Studies on PEG-modified

FD&C Blue No. 1 both show that this

test material is inactive. Furthermore, an

Ames study on Methyl-PEG-modified

FD&C Blue No. 1 shows non-mutagenic

results. Mutagenicity studies have not

been conducted on Methyl Violet 2B,

PEG Analog.

4. Chronic toxicity. Chronic toxicity

studies have not been conducted on the

three colorants of interest; however,

studies have been conducted on FD&C

Blue No. 1, which is closely related to

the FD&C Blue No. 1 PEG and methyl

PEG analogs. For this substance, a

chronic dietary No-Observed-AdverseEffect Level (NOAEL) in mice has been

shown to be 7,354 milligrams per

kilogram body weight per day for males,

and 8,966 milligrams per kilogram per

day for females. A chronic dietary

NOAEL for rats has been shown to be

1,072 for milligrams per kilogram body

weight per day for males and 631

milligrams per kilogram body weight

per day for females, showing a low

order of chronic toxicity.

C. Aggregate Exposure

1. Dietary exposure. Dietary exposure

to the polymeric colorants, if at all, will

be at de minimis levels. The colorants

are intended to be used as inert

ingredients in pesticides that will be

applied to seeds. (The purpose of the

colorants is to signal users that the seeds

have been treated with a pesticide that

is not the subject of a tolerance or an

exemption from tolerance.) Because the

colorants are polymeric, they are not

expected to be taken up by the growing

plants. Indeed, a determination of the

octanol/water partition coefficient for a

test material identical to PEG-modified

FD&C Blue No. 1, but with slightly

longer side chain lengths, resulted in

low values that demonstrate that the

colorant would have little or no

tendency to concentrate in the fatty

portions of animals or in plants. Even

assuming, however, that the polymeric

colorants are taken up by growing

plants, the potential dietary exposure to

these materials is less than 0.6 parts per

billion (ppb) of the diet. This estimate

is based on data presented in Knott’s

Handbook for Vegetable Growers, O.

Lorenz and D. Maynard (c1988), which

provides data with respect to the

‘‘Approximate Number of Seeds per

Ounce and per Gram and Seeding Rates

for Traditional Plant Densities,’’ and

‘‘Yields of Vegetable Crops.’’

Although the calculated dietary

exposure to the colorants is minuscule,

it is important to note that even this

extremely low calculated exposure

clearly is a gross overestimate, given the

polymeric nature of the colorants.

Furthermore, although an acceptable

daily intake (ADI) for the colorants of

interest has not been established, the

Joint FAO/WHO Expert Committee on

Food Additives (JECFA) has established

an ADI for FD&C Blue No. 1 of 5 mg/

kg body weight/day, or 100 ppm of the

diet. Furthermore, JECFA has

established an ADI for PEG of 10 mg/kg/

person/day, or 200 ppm of the diet. (See

‘‘World Health Organization Technical

Report Series’’, Nos. 557 and 648.) The

estimated dietary exposure to the

colorants of interest is over two orders

of magnitude below these ADIs for

related compounds.

Currently, there are no established

tolerances or exemptions from tolerance

for any of the colorants. However, the

colorants are simply polyethylene

glycol-modified versions of dyes that

currently are exempt from the

requirement of a tolerance (i.e., FD&C

Blue No. 1 and Methyl Violet 2B).

2. Drinking water. There is no

available information regarding

exposure to PEG-modified FD&C Blue

No. 1, Methyl-PEG-modified FD&C Blue

No. 1, or PEG-modified Methyl Violet

2B via drinking water. However, aerobic

soil metabolism studies on PEGmodified FD&C Blue No. 1 and PEGmodified Methyl Violet 2B demonstrate

that these colorants are ‘‘inherently

biodegradable.’’ Furthermore, the results

of aerobic soil metabolism studies on all

three colorants show that between 19%

and 25% of each colorant degrades

within 42 days. Based on these results

and the low use levels of the colorants,

significant exposure to these colorants

in drinking water is not anticipated.

Furthermore, there is no established

Maximum Concentration Level for the

polymeric colorants in drinking water.

3. Non-dietary exposure. The

proposed use of PEG-modified FD&C

Blue No. 1, Methyl-PEG-modified FD&C

Blue No. 1, and PEG-modified Methyl

Violet 2B involves either application to

turf grass seeds or application to seeds

grown in an agricultural environment.

Thus, there is no potential for

significant non-occupational exposure

of the colorants to the general

population.
45810 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Notices

D. Cumulative Effects

There is no reason to suspect that

toxic effects of PEG-modified FD&C

Blue No. 1, Methyl-PEG-modified FD&C

Blue No. 1, PEG-modified Methyl Violet

2B would be cumulative with those of

any other pesticide inert or active

chemical, and there are no data to

indicate that this would be the case.

Thus, Milliken considers it appropriate

to evaluate the potential risks of the

colorants solely in the context of the

aggregate exposure assessment.

E. Safety Determination

1. U.S. population. Data from acute

toxicity studies show FD&C Blue No. 1,

PEG and Methyl PEG Analogs and PEGmodified Methyl Violet 2B to be of a

very low order of toxicity. Furthermore,

two compounds that are closely related

to the colorants of interest, FD&C Blue

No. 1 and Methyl Violet 2B, currently

are exempt from the requirement of a

tolerance under 40 CFR 180.1001

paragraphs (b) and (c), respectively. In

addition, FD&C Blue No. 1 is cleared by

FDA for use in coloring food and drugs.

Use of the polymeric colorants of

interest as inert ingredients in pesticides

applied to turf grass seeds and seeds for

edible plants such as beans, squash, and

soybeans is not expected to result in

significant dietary exposures.

Furthermore, there currently are no

other registered pesticidal uses in which

these polymeric colorants are used.

Because of the de minimis potential

dietary exposures to the polymeric

colorants, there are no dietary risk

concerns associated with the intended

use of the colorants, and there is a

reasonable certainty that no harm will

result from such use.

2. Infants and children. The toxicity

and exposure data in the petition are

sufficiently complete to adequately

address the potential for additional

sensitivity to infants and children.

Specifically, as discussed above,

developmental and reproductive effects

studies on PEG-modified and MethylPEG-modified FD&C Blue No. 1 have

shown no developmental/reproductive

effects. Based on these data, together

with the low potential dietary exposure

to the colorants, there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to PEG-modified FD&C Blue

No. 1, and Methyl-PEG-modified FD&C

Blue No. 1. Furthermore, although

developmental effects studies have not

been conducted on PEG-modified

Methyl Violet 2B, the potential dietary

exposure to this colorant is sufficiently

low as to establish that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to PEG-modified

Methyl Violet 2B.

F. International Tolerances

There are no Codex maximum residue

levels established for residues of PEGmodified FD&C Blue No. 1, Methyl-PEGmodified FD&C Blue No. 1, or PEGmodified Methyl Violet 2B. (Amelia

Acierto)

[FR Doc. 97–23097 Filed 8–28–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY.

[OPPTS–00222; FRL–5740–3]

Regional Training Courses on EPCRA

Section 313 Reporting Requirements

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA will hold a series of 2–

day training courses on the Emergency

Planning and Community Right-toKnow Act of 1986 (EPCRA) section 313.

The training courses are intended

primarily to introduce the reporting

requirements to the staffs of recently

added industry groups that will be

subject to the reporting requirements of

section 313 (62 FR 23834, May 1,

1997)(FRL–5578–3) beginning on

January 1, 1998.

DATES: For the dates of the training

courses see ‘‘SUPPLEMENTARY

INFORMATION.’’

ADDRESSES: For the locations of the

training courses see

‘‘SUPPLEMENTARY INFORMATION.’’

FOR FURTHER INFORMATION CONTACT:

Michael Hart (202) 260–1576, or the

EPCRA Information Hotline at (800)

535–0202. To register call the Hotline

number.

SUPPLEMENTARY INFORMATION: EPA will

hold a series of 2–day training courses

on the Emergency Planning and

Community Right-to-Know Act of 1986

(EPCRA) section 313, which are

intended primarily to introduce the

reporting requirements to facility staff

for facilities recently added (62 FR

23834 May 1, 1997). These newly added

industries include Metal Mining (SIC

code 10, except 1011, 1081, and 1094),

Coal Mining (SIC code 12, except 1241),

Electric Utilities (SIC codes 4911, 4931,

and 4939 [limited to facilities that

combust coal and/or oil for the purpose

of generating electricity for distribution

in commerce]), Commercial Hazardous

Waste Treatment (SIC codes 4953

[limited to facilities regulated under

RCRA Subtitle C, 42 U.S.C. section 6921

et seq.]), Solvent Recovery Services (SIC

code 7389 [limited to facilities primarily

engaged in solvents recovery services on

a contract or fee basis]), Chemical and

Allied Products—Wholesale (SIC code

5169), and Petroleum Bulk Terminal

and Stations—Wholesale (SIC code

5171). The training course consists of a

series of presentations covering the

basic requirements of EPCRA section

313 and the sections of the Pollution

Prevention Act of 1990 (PPA) that relate

to the EPCRA section 313 requirements.

A variety of hands-on exercises using

the EPCRA section 313 reporting Form

R and associated guidance materials

will be used to help participants

understand the EPCRA section 313

reporting process. Guidance documents

being developed to assist the new

industries comply with EPCRA section

313 and PPA requirements will be made

available at the training sessions.

Persons who should consider attending

are staff from facilities which operate in

the newly added industry sectors, staff

from facilities that may be affected by

the recent changes to EPCRA section

313, and Federal and private sector

facility staff responsible for completing

their facilities TRI reporting form(s), and

consulting firms who may be assisting

them.

Registration for the training courses

will be taken on a first-come-first-served

basis until 2–weeks prior to the start

date of each course. EPA intends to

present sector-specific training modules

for each of the new industry sectors

added, but this may be modified for

each of the training sessions based on

responses received. There is limited

space available.

To register, contact The EPCRA

Information Hotline at the telephone

number listed under ‘‘FOR FURTHER

INFORMATION CONTACT.’’ When

registering, give your name, postal (and

electronic, if any) mailing address,

telephone and fax numbers, and the

industry sector in which you are

interested in receiving particular

training. Guidance documents for each

of the newly added industry groups will

be made available at each of the training

sessions whether the training session

contains a reporting module for that

industry or not. Notification will be sent

to each applicant regarding their

acceptance for the training session.

There is no registration fee for this

training. If there is insufficient interest

in any of the course, those courses may

be canceled. Registrants will be notified

in the event a training course is

canceled. The Agency bears no

responsibility for attendees’ decision to