23438 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 / Notices

notice may be filed online at many

Federal Depository Libraries.

List of Subjects

Environmental protection.

Dated: April 13, 1998.

Lois A. Rossi,

Director, Special Review and Reregistration

Division, Office of Pesticide Programs.

[FR Doc. 98–10850 Filed 4–28–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–30452; FRL–5783–2]

Zeneca Ag Products; Applications to

Register Pesticide Products

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces receipt

of applications to register pesticide

products containing new active

ingredients not included in any

previously registered products pursuant

to the provisions of section 3(c)(4) of the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA), as amended.

DATES: Written comments must be

submitted by May 29, 1998.

ADDRESSES: By mail, submit written

comments identified by the document

control number [OPP–30452] and the

file symbols to: Public Information and

Records Intregrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

person, bring comments to:

Environmental Protection Agency, Rm.

119, CM #2, 1921 Jefferson Davis Hwy.,

Arlington, VA.

Comments and data may also be

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

instructions under ‘‘SUPPLEMENTARY

INFORMATION.’’ No Confidential

Business Information (CBI) should be

submitted through e-mail.

Information submitted as a comment

concerning this notice 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. The public

docket is available for public inspection

in Rm. 119 at the Virginia address given

above, from 8:30 a.m. to 4 p.m., Monday

through Friday, excluding holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: James Tompkins, Product Manager

(PM-25), Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number, and

e-mail address: Rm. 257, CM #2, 1921

Jefferson Davis Highway, Arlington, VA

22202, (703 305–7391, e-mail:

tompkins.james@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

received applications as follows to

register pesticide products containing

active ingredients not included in any

previously registered products pursuant

to the provision of section 3(c)(4) of

FIFRA. Notice of receipt of these

applications does not imply a decision

by the Agency on the applications.

I. Products Containing Active

Ingredients Not Included In Any

Previously Registered Products

1. File Symbol: 10182–UEA.

Applicant: Zeneca Ag Products, 1800

Concord Pike, P.O. Box 15458,

Wilmington, DE 19850–5458. Product

Name: Achieve 40DG Herbicide.

Herbicide. Active ingredient:

Tralkoxydim 2-cyclohexen-1-one, 2-[1-

(ethoxyimino)propyl]-3-hydroxy-5-

(2,4,6-trimethylphenyl)-(9Cl) at 40

percent. Proposed classification/Use:

General. For selective control of wild

oats, green and yellow foxtail, annual

ryegrass, and Persian Darnel on wheat

and barley.

2. File Symbol: 10182–UET.

Applicant: Zeneca Ag Products. Product

Name: Achieve 80DG Herbicide.

Herbicide. Active ingredient:

Tralkoxydim 2-cyclohexen-1-one, 2-[1-

(ethoxyimino)propyl]-3-hydroxy-5-

(2,4,6-trimethylphenyl)-(9Cl) at 80

percent. Proposed classification/Use:

General. For selective control of wild

oats, green and yellow foxtail, annual

ryegrass, and Persian Darnel on wheat

and barley.

3. File Symbol: 10182–UEL.

Applicant: Zeneca Ag Products. Product

Name: Tralkoxydim Technical Wet

Paste. Herbicide. Active ingredient:

Tralkoxydim, 2-[1-(ethoxyimino)proply3-hydroxy-5-mesitylcyclohex-2-enone at

81 percent. Proposed classification/Use:

General. For Manufacturing uses only.

Notice of approval or denial of an

application to register a pesticide

product will be announced in the

Federal Register. The procedure for

requesting data will be given in the

Federal Register if an application is

approved.

Comments received within the

specified time period will be considered

before a final decision is made;

comments received after the time

specified will be considered only to the

extent possible without delaying

processing of the application.

II. Public Record and Electronic

Submissions

The official record for this notice, as

well as the public version, has been

established for this notice under docket

number [OPP–30452] (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 notice 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 5.1/6.1 or ASCII file

format. All comments and data in

electronic form must be identified by

the docket number [OPP–30452].

Electronic comments on this notice may

be filed online at many Federal

Depository Libraries.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection, Pesticides

and pest, Product registration.

Dated: April 10, 1998.

Susan Lewis,

Acting Director, Registration Division, Office

of Pesticide Programs.

[FR Doc. 98–10841 Filed 4–28–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–803; FRL–5783–4]

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
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 / Notices 23439

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by the

docket control number PF–803, must be

received on or before May 29, 1998.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), 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

product manager listed in the table

below:

Product Manager Office location/telephone number Address

Bipin Gandhi (PM-5) ...... Rm. 4W53, CS #1, 703–308–8380, e-mail:gandhi.bipin@epamail.epa.gov. 1921 Jefferson Davis Hwy, Arlington, VA

Indira Gairola ................. Rm. 4W57, CS #1, 703–308–8371, e-mail: gairola.indira@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–803]

(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–803) 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: April 13, 1998

Susan Lewis,

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. BFGoodrich Specialty Chemicals

PP 8E4958, 8E4961, 8E4962

EPA has received a pesticide petition

(PP 8E4958,8E4961,8E4962) from

BFGoodrich Specialty Chemicals, 9911

Brecksville Road, Cleveland, OH 44141,

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

acrylic acid terpolymer, partial sodium

salt in or on raw agricultural

commodities when used as inert

ingredients in the pesticide

formulations applied to growing crops,

raw agricultural commodities after

harvest or to animals, under 40 CFR

180.1001(c) and (e). 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. Toxicological Profile

The Acrylate Terpolymers GoodRiteK-781,K-797, and K-798 conform 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. The Acrylate Terpolymers are not

cationic polymers, nor are they

reasonably anticipated to become

cationic polymers in a natural aquatic

environment.

2. The Acrylate Terpolymers contain

as an integral part of their composition

the atomic elements carbon, hydrogen,

oxygen, sulfur and nitrogen. It also

contains the monatomic counterion

Na+.

3. The Acrylate Terpolymers do not

contain as an integral part of their

composition, except as impurities, any

elements other than those listed in 40

CFR 723.250(d)(2)(ii).

4. The Acrylate Terpolymers are not

designed, nor are they reasonably

anticipated to substantially degrade,

decompose, or depolymerize.
23440 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 / Notices

5. The Acrylate Terpolymers are not

manufactured or imported from

monomers and/or other reactants that

are not already included on the Toxic

Substances Control Act (TSCA)

Chemical Substance Inventory or

manufactured under an applicable

TSCA Section 5 exemption.

6. The Acrylate Terpolymers are not

water absorbing polymers.

7. The only reactive functional groups

the Acrylate Terpolymers contain is a

carboxylic acid.

8. The Acrylate Terpolymers have a

number average molecular weight

greater than 1,000 and less than 10,000

Daltons (and oligomer content less than

10 percent below MW 500 and less than

25 percent below MW 1,000).

B. Aggregate Exposure

In the past decade Acrylate

copolymers and terpolymers have been

used in a variety of applications, most

notably water treatment including boiler

and retort waters, cooling waters,

membrane separations systems and are

now de rigor in these applications. In

these and similar applications,

reasonable levels of incidental exposure

to the neat polymer is expected and

accepted without regard. ANSI/NSF

Standard 60 Drinking Water Treatment

Chemical Additives listing has been

extended to similar acrylate co-and terpolymers. The chemical characteristics

of these polymers and the published

health and safety data indicates that

aggregate exposure to Acrylate

terpolymers, as listed in the current

petitions, as inert ingredients in the

preparation and application of pesticide

formulations for use on growing crops,

raw agricultural commodities after

harvest or to animals poses no harm.

C. Cumulative Effects

At this time there is no information to

indicate that any toxic effects produced

by the Acrylate terpolymers would be

cumulative with those of any other

chemical. Given the terpolymers’

categorization as ‘‘low risk polymers’’

(40 CFR 723.250) and their proposed

use an inert ingredients in pesticide

formulations, there is no reasonable

expectations of increased risk due to

cumulative exposure to the Acrylate

terpolymers.

D. International Tolerances

BFGoodrich is petitioning that the

Acrylate terpolymers be exempt from

the requirement of a tolerance based

upon their status as low risk polymers

as per 40 CFR 723.250. Therefore, an

analytical method to determine residues

of the Acrylate terpolymers in raw

agricultural commodities treated with

pesticide forumlations containing the

Acrylate terpolymers has not been

proposed.

There are no Codex maximum residue

levels(MRLs) established for the

Acrylate terpolymers. (Bipin Gandhi)

2. Platte Chemical Company

PP 6E4742

EPA has received a pesticide petition

(PP 6E4742) from Platte Chemical

Company, 419 18th Street, P.O. Box 667,

Greeley, CO 80632, 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 80 to

establish an exemption from the

requirement of a tolerance for residues

of the inert ingredient Modal Alder Bark

(MAB) alder bark flour (ABF) when

used in pesticide formulations applied

to growing crops, or in or on raw

agricultural commodities after harvest.

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. MAB is not

absorbed or metabolized by plants. The

ABF remains on the treated surface,

where it decomposes to its natural

constituents including, cellulose,

hemicelluloses, lignin and various

compounds such as suberins and

phenolic acids. These decomposition

products are further degraded by

various bacteria and fungi to simple

sugars, carbohydrates, gases and other

molecular compounds. Eventually ABF

will be completely decomposed by

natural processes to nutrients which can

be utilized by other plants.

2. Analytical method. No analytical

method is available for determining

MAB, per se. Although various methods

are available to determine the various

components of alder bark (e.g., content

of cellulose, lignin, polysaccharides,

etc.), these methods are not specific to

MAB and can not distinguish whether

the components are derived from ABF

or from other plant or soil sources.

3. Magnitude of residues. Since ABF

is not absorbed or metabolized by

plants, no residues of MAB are expected

to result in or on raw agricultural

commodities. For example, potato

commodities grown from seed potato

pieces treated with formulations

containing MAB do not have residues of

the inert ingredient. Furthermore, any

residues would be associated with the

potato seed pieces, which shrivel as the

daughter plants withdraw nutrients

during ‘‘seedling’’growth. Consequently,

the spent seed pieces are not harvested

and will not be eaten. Finally, any MAB

adhering to the harvested potatoes

would be removed by brushing and

washing.

B. Toxicological Profile

1. Acute toxicity. The use of MAB

(ABF) as an inert ingredient in pesticide

formulations is not expected to result in

adverse effects due to its non-hazardous

character, minimal potential for

exposure, and projected absence of

dietary exposure. There is a wealth of

available information about the absence

of, or minor health effects from,

exposure to various wood flours, dusts,

shavings, and other wood/bark

components. Ingestion of wood flour,

sawdust or wood shavings is neither

lethal, nor toxic, and is even considered

to be a source of non-nutritive dietary

fiber. Dermal contact with wood or bark

flour is not associated with death or

toxicity, although dermal allergies

(contact dermatitis) have been reported

in certain sensitive individuals. Acute

inhalation exposure to wood dusts for a

limited time is not considered to be an

occupational hazard if dust levels are

below established Permissible Exposure

Levels (PEL) for non-toxic particulate

matter (i.e., unspecified dust particles).

MAB is not expected to produce any

more eye irritation than any chemically

inert particulate, such as clay or wheat

flour. In persons who may have a

specific alder wood allergy, eye

irritation or conjunctivitis is possible

even though there are no known reports

of such incidences. Alder wood dust is

not a sensitizer nor is ABF expected to

be a sensitizer.

2. Genotoxicity. Evidence from

studies with wood-related compounds

indicate that MAB is not genotoxic. ABF

is composed mostly of cellulose,

hemicelluloses and lignins, which are

not mutagenic.

3. Reproductive and developmental

toxicity. MAB is not expected to be a

developmental or reproductive toxin,

based on extensive testing of the three

principle components (cellulose,

hemicelluloses and lignins) of ABF.

Additionally, wood flours have been

used for numerous years to increase

dietary fiber in animal feeds and human

diets with no known adverse

reproductive or developmental toxicity.

4. Subchronic toxicity. There is no

subchronic exposure to MAB from its

use as a pesticidally inert ingredient.

However, chronic toxicity data

adequately address possible
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 / Notices 23441

toxicological effects that may result

from subchronic exposure to ABF.

5. Chronic toxicity. There is minimalto-no chronic toxicological risk from the

use of MAB as an inert ingredient in

pesticide formulations. There are no

known adverse reactions to chronic

consumption or ingestion of wood flour.

Ingestion of wood flour, sawdust or

wood shavings for extended periods of

time is not hazardous. Instead, it is

considered to be a non-nutritive dietary

supplement. In fact, the Food and Drug

Administration (FDA) has allowed the

use of wood flours in various prepared

foods, such as bread, to increase dietary

fiber levels and reduce caloric intake.

Adverse effects of exposure to wood

dust are limited to allergic reactions,

such as rhinitis and contact dermatitis,

and from chronic (lifetime) occupational

exposure (via inhalation) to high

concentrations of wood dust. Based on

the absence of chronic effects from

ingestion, the limited irritant and

allergic effects from dermal contact,

limited exposure to ABF from seed

potato treatment, and the absence of

chronic exposure by any route, Platte

Chemical Company concludes that there

is minimal-to-no chronic toxicological

risk from the use of MAB in pesticide

products.

6. Animal metabolism. There is no

known human metabolism or metabolic

products from human ingestion of nonnutritive dietary fiber from wood

products. In humans, the polymers of

plants such as cellulose from plant cell

walls (linkages), some pectins,

hemicellulose, gums, mucilages and

lignin, are not easily digested and are

passed through the gastrointestinal tract

as non-nutritive dietary fiber. Wood

flour and sawdust are commonly used

in animal feeds. In ruminants, such

wood products are reduced to cellulose,

hemicelluloses and lignins by

endogenous bacterial/microbial

populations in the gut. These wood

product degradates are further reduced

to simple sugars, carbohydrates, carbon

dioxide and indigestible biomass. The

indigestible biomass is readily excreted.

7. Metabolite toxicology. There is no

known evidence of metabolite toxicity

from the ingestion of wood or ABF by

either livestock or humans. In humans,

no metabolites are produced after

ingestion of non-nutritive dietary fiber

such as ABF.

8. Endocrine disruption. No endocrine

or estrogenic effects are expected from

the use of MAB for the following

reasons:

i. The production of MAB includes

oven drying the bark, which removes

moisture and volatile organic

compounds.

ii. ABF does not penetrate and will

not be absorbed by skin.

iii. Alder bark is primarily composed

of naturally-occurring, non-digestible

cellulose, hemicelluloses and lignin;

and most importantly.

iv. There is no non-occupational

exposure to MAB when used as a

pesticidally inert ingredient.

C. Aggregate Exposure

1. Dietary exposure. Ingestion of MAB

or its residues would simply increase

the level of non-nutritive fiber in the

diet, which has been shown to have

beneficial health effects by reducing the

incidence of diverticulosis, cancer of the

colon and coronary heart disease as well

as facilitating weight loss. Also, health

claims for fiber-containing foods have

been made for more than a century and

the effects of fiber in promoting bowel

evacuation are widely recognized.

2. Food. The use of MAB in potato

seed piece pesticides does not result in

any significant dietary exposure to ABF.

Residues, if any, surround the potato

seed pieces, which shrivel as the

daughter plants withdraw nutrients

during ‘‘seedling’’ growth.

Consequentially, the spent seed pieces

are not harvested and will not be eaten.

Brushing and washing potatoes to

remove particulates, such as soil, would

simultaneously remove any residues of

MAB. However, should ABF residues

adhere to harvested potatoes, the only

effect would be to increase the level of

non-nutritive dietary fiber. Were this to

be the case, ingestion of MAB residues

would be beneficial and of no

toxicological concern since MAB can be

considered to be a non-nutritive source

of dietary fiber, which has been shown

to improve health and lessen the

incidence of diverticulosis, colon cancer

and coronary heart disease.

3. Drinking water . The use of MAB

as an inert ingredient in pesticide

formulations does not lead to alder bark

particles in the drinking water. Wood

and bark particles do not leach into the

groundwater. Any particles that may be

transported into water bodies will

absorb moisture and either sediment out

of the water column or be removed with

other particulate matter during drinking

water treatment. Similarly, any natural

water-extractable components (humic

acids, fulvic acids, etc.) of MAB are

natural products that will also be

removed during drinking water

treatment.

4. Non-dietary exposure. The only

anticipated human exposure to MAB

from non-dietary sources would be

through occupational exposure during

product use.

D. Cumulative Effects

The use of MAB as an inert ingredient

in pesticide formulations does not result

in any cumulative effects, since there is

no non-occupational exposure to MAB.

E. Safety Determination

1. U.S. population. The use of MAB

does not pose a safety concern for the

US human population due to the nontoxic nature of ABF (oral, dermal and

acute exposure) and the absence of nonoccupational exposure.

2. Infants and children. Infants and

children are not exposed to MAB from

its use in pesticide formulations or the

treatment of potato seed pieces.

F. International Tolerances

No international tolerances have been

established for ABF, wood flour or

wood cellulose.

3. Wheelabrator Water Technologies,

Inc.

PP 6E4732

EPA has received a pesticide petition

(PP 6E4732) from Wheelabrator Water

Technologies, Inc., 8201 Eastern

Boulevard, Baltimore, Maryland 21224.

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

biosolids in or on the raw agricultural

commodity Granulite. 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. Residues in the raw agricultural

commodity and processed food/feed. A

tolerance for substances potentially

present in biosolids for raw or processed

foods is not anticipated to be needed,

based on the very low risk posed by

residues in raw food/feed, as discussed

throughout this application for a

tolerance exemption for Granulite heatdried biosolids.

2. Background information and use

profile. Granulite is a heat-dried

biosolids (sewage sludge) product.

Biosolids are the solid, semi-solid, or

liquid residue generated from domestic

wastewater treatment, and have been

used for centuries as a soil conditioner

and fertilizer. Regulations regarding the

use and disposal of biosolids have been

introduced over the years to protect
23442 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 / Notices

human health and the environment,

culminating in the 40 CFR part 503 rule

promulgated in 1992, which regulates

biosolids based on a comprehensive risk

assessment consucted by EPA. This rule

has since undergone relatively minor

revisions, including the deletion of

chromium from the regulation; changes

to the limits for molybdenum and

selenium; and a narrowing of a focus of

future biosolids rulemaking to dioxins/

furans and polychlorinated biphenyls

(PCBs). Land application of biosolids

enhances soil conditions and plant

growth on agricultural, forest,

reclaimed, and public use (e.g.,

recreational, highway) lands. Over 5

million dry metric tons of biosolids are

generated annually in the U.S. at

publicly owned treatment works. A

minimum of 33% of the biosolids

generated annually are land applied

(this percentage has probably increased

significantly in recent years), while the

remaining are incinerated or disposed of

using surface disposal. Of the biosolids

that are land applied, an estimated 67%

are applies to agricultural lands, 3% to

forests, 9% to reclamation sites, and 9%

to public use sites. Biosolids are land

applied by either incorporating or

injecting the biosolids into the soil or

spreading the biosolids on the soil

surface.

B. Toxicological Profile

EPA has determined that the limits for

inorganic pollutants (metals) calculated

in the EPA biosolids risk assessment

protect humans (including children),

animals, and plants from reasonably

anticipated adverse effects via the 14

different exposure pathways evaluated.

The 40 CFR part 503 rule regulates

metals based on these risk assessment

limits, and regulates pathogens based on

an operational standard requiring

certain pathogen and vector controls

that reduce pathogens to low levels (as

described in ‘‘Safety Determination:

U.S. General Population’’ below). For

biosolids that meet the most stringent

pollutant limits and pathogen controls

of part 503, as Granulite does, only

minimal additional part 503

requirements need to be met because of

the low risk associated with these

biosolids, which therefore are allowed

to be used as freely as any other soil

conditioner. Research indicates that

risks associated with the bioavailability

of metals in biosolids are low when

biosolids are land applied at rates

commonly used in agriculture and when

good management practices commonly

implemented (e.g., soil pH above 5.0)

are followed.

1. Acute toxicity. EPA initially

submitted a list of 200 pollutants

potentially found in biosolids for review

by a panel of experts; this panel

recommended that 50 of these

pollutants be studies further, based on

avaliable toxicity and exposure data.

EPA then developed hazard for each of

these 50 pollutants, derived by dividing

a pollutant’s estimated concentration in

soil, plant or animal tissue, or air by the

lowest concertration of the pollutants

found in the scientific literature to be

toxic to the organism being evaluated

via the most sensetive route of exposure

and dassuming maximum toxic effect. A

hazard index of less than 1 indicated

that the pollutant was not toxic to the

organism (via that particular exposure

pathway), and thus was not analyzed

further. EPA further evaluated

pollutants with a hazard index value of

1 or greater in the biosolids risk

assestment (except for pollutants

deferred of deleted due to insufficient or

limited data). EPA also evaluated

several additional pollutants based in

the addition of four exposure pathways.

This process resulted in EPA evaluating

23 pollutants in its biosolids risk

assestment for land application (see

Table 1).

2. Reproductive and developmental

toxicity. The ingestion of lead by

children, which is associated with

developmental effects (e.g., learning

disabilities), was addressed by the EPA

biosolids risk assessment in a

conservative manner. EPA evaluated the

risk to pica children (children who

regularly eat soil) because it is possible

that children might ingest soil to which

biosolids has been land applied.

However, only a small number of

children are likely to ingest biosolids in

gardens or lawns, especially on a regular

basis, and thus this evaluation is more

conservative than dietary or drinking

water exposures. In addition to lead,

limits for arsenic, cadmium, mercury,

and selenium are also included in the

part 503 rule, based on a child ingesting

biosolids that potentially contain these

pollutants. Granulite meets all of these

limits. For more details, see ‘‘Safety

Determination: Infants and Children’’

below.

3. Chronic toxicity. EPA’s risk

assessment for the land application of

biosolids included the evaluation of

chronic effects based on RfDs or RfCs for

metals and organic substances

potentially found in biosolids. RDAs

were used when RfDs were unavailable,

or analogous no adverse effect levels

were used. Acceptable doses of a

substance were estimated for animals,

using the most sensitive or most

exposed species. The RfDs, RfCs, or

analogous levels were combined with

other variables to calculate the

concentrations of pollutants in biosolids

that are reasonably protective against

adverse impacts. For the ingestion

(dietary) pathways, RfDs were combined

with a relative effectiveness RE variable.

The RE of exposure accounts for

differences in bioavailability depending

on the route of exposure (e.g., ingestion

or inhalation); because of limited

available data, the RE was

conservatively set at 1, which assumes

100% bioavailability intake, and thus

underestimates the allowable dose of

biosolids pollutants and reflects

conservative pollutant limits. The

pollutant concentrations calculated in

the risk assessment were used to

develop the most stringent limits in the

40 CFR part 503 rule, which Granulite

meets.

4. Carcinogenicity. EPA’s risk

assessment for the land application of

biosolids included evaluation of

carcinogenicity based on q1*s for metals

and organic substances potentially

found in biosolids. The q1*s were used

with other variables to calculate the

concentrations of pollutants in biosolids

that are reasonably protective against

adverse impacts; these calculated

concentrations were used to develop the

most stringent pollutant limits in 40

CFR part 503 rule, which Granulite

meets. EPA also conducted a

population-based risk assessment which

indicated that prior to the part 503 rule,

biosolids use and disposal practices

(including land application,

incineration, and surface disposal)

could have contributed 0.9 to 5 cancer

cases annually; the part 503 rule

reduced cancer cases by 0.09 to 0.7

annually. This analysis included

exposure to pollutants potentially found

in biosolids from all sources, including

food, drinking water, residential, and

other non-occupational sources.

5. Endocrine disruption. The EPA

biosolids risk assessment considered all

adverse effects identified in the

scientific literature, including endocrine

effects, if any, and used these to identify

no observed adverse effect levels

(NOAEL) for the pollutants evaluated.

Future research may include additional

impacts on wildlife due to limited

available field data. Although not

specific to endocrine effects, interactive

(synergistic) effects observed with

biosolids reduce (rather than increase)

adverse risks to potential receptors.

Interactions between certain elements

typically found in biosolids hinder the

uptake of metals by plants and the

bioavailability of metals to animals and

humans. See ‘‘Cumulative Risk’’ below

for more information on these

interactive effects.
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 / Notices 23443

C. Aggregate Exposure

The 14 exposure pathways that EPA

evaluated in its biosolids risk

assessment included: children ingesting

biosolids/soil directly (the pica child);

adults ingesting plants grown in soils

amended with biosolids or drinking

ground-water or surface-water

containing substances present in

biosolids; adults ingesting fish from

surface-water containing substances in

biosolids; adults ingesting animal

products derived from animals that

ingested biosolids; animals ingesting

biosolids or plants grown in biosolidsamended soils; and plants grown in

biosolids-amended soils. Thus, the EPA

risk assessment for the land application

of biosolids addressed exposures from

dietary, drinking water, and nonoccupational sources. The most

conservative estimate from the 14

exposure pathways was then selected as

the limit for each of the pollutants

potentially found in biosolids, thus

representing protection based on

aggregate exposure. Granulite meets

these limits.

In addition, the EPA risk assessment

calculations for all 14 pathways initially

included pollutant exposure from

sources other than biosolids (food, air,

and water). Exposures from sources

other than biosolids were then

subtracted from the total allowable dose,

yielding a result that represented the

allowable dose of a pollutant from

biosolids only. This value was then

combined with other variables to derive

a pollutant limit.

1. Dietary exposure. Parameters for

human, animal, or plant health (e.g.,

based on RfDs, q1*s, etc., as described

above in ‘‘Chronic Effects’’ and

(‘‘Carcinogenicity’’) were combined

with pollutant intake information (e.g.,

the amount of a particular food type

consumed) to derive pollutant limits in

the EPA biosolids risk assessment.

Several pollutant limits were based on

a dietary exposure pathway (for the

inorganic chemical molybdenum and

for several organic chemicals). However,

the limits for molybdenum were reevaluated and new limits are expected

to be less stringent, and limits for

organics were not included in the part

503 rule, as discussed in ‘‘Other

Considerations’’ below. For other

pollutants, exposure pathways other

than dietary exposure posed more risks,

and pollutant limits were based on these

higher-risk pathways.

2. Drinking water. The part 503 rule

requires that biosolids be land applied

at the agronomic rate (the rate that

provides the amount of nitrogen needed

by a crop or vegetation to attain a

desired yield while minimizing the

amount of nitrogen that will pass below

the root zone of the crop or vegetation

to ground-water), thus protecting

ground-water from biosolids with

nitrogen levels in excess of estimated

crop needs. In addition, for groundwater, the EPA risk assessment analyzed

the pathway involving: the land

application of biosolids; the leaching

(mobility) of pollutants from soil into

ground-water; and the subsequent

drinking of well water containing these

pollutants by humans. The groundwater pathway evaluation included: a

mass balance (between erosion,

leaching, volatilization, and degradation

persistence); a reference water

concentration (based on the q1* or

MCL); and use of the VADOFT (from

RUSTIC) and the AT123D models. For

surface-water exposure, EPA analyzed

the pathway involving: the land

application of biosolids; the erosion

(mobility) of soil containing pollutants

in biosolids; the transfer of the

pollutants contained in the eroded soil

to surface-water; and the ingestion of

the surface-water and fish living in the

surface-water by humans. The surfacewater pathway evaluation included: a

mass balance (as described above for

ground-water); a reference intake (based

on the q1* or RfD); acute or chronic

freshwater criteria for aquatic life; a

bioconcentration factor; a food chain

multiplier; and a dilution factor, among

other parameters. No pollutant limit was

based on the ground-water pathway

because other exposure pathways

resulted in more restrictive limits. Only

one pollutant limit, for DDT/DDD/DDE,

was based on the surface-water

pathway; however, organics, including

DDT, were deleted from part 503

regulation because they met at least one

of three criteria set by EPA (see ‘‘Other

Considerations’’ below).

While metals potentially present in

biosolids may be persistent, they are

bound in the biosolids-soil matrix for

long periods of time, as discussed in

‘‘Environmental Fate Data Summary’’

below. Also, the dry characteristics of

Granulite, which is heat-dried,

minimize water content and leachability

of metals.

3. Non-dietary exposure. EPA’s

biosolids risk assessment evaluated

exposure to pollutants potentially found

in biosolids that are land applied to

gardens, lawns, and other residential

and non-occupational settings in nondietary pathways.

D. Cumulative Effects

Extensive field data used in EPA’s

risk assessment for biosolids show no

adverse effects of low levels of metals in

land-applied biosolids. Some metals are

not transferred into edible plant parts

(even when their concentrations are

greatly increased in the biosolids/soil

mixture) because these metals (e.g.,

chromium) are insoluble or strongly

bound to the biosolids-soil matrix (by

iron or certain other oxides, organic

matter, or phosphates in biosolids) or to

plant roots (e.g., lead). Or, if other

substances commonly found in

biosolids, such as zinc, calcium, and

iron, are present, these substances will

inhibit absorption of some metals (e.g.,

selenium, molybdenum, and cadmium)

from the ingested food into the

organism’s intestines and blood stream.

Also, the EPA biosolids risk assessment

included bioavailability and

bioaccumulation factors to account for

uptake of pollutants by animals (e.g.,

fish) and subsequently by humans.

E. Safety Determination

1. U.S. population. The EPA biosolids

risk assessment as well as field data

show that certain biosolids that meet

low pollutant limits for metals can be

considered NOAEL biosolids that have

no observed adverse effects on public

health and the environment. Granulite

meets these limits. Human and animal

health protection from pathogens are

addressed in the part 503 regulation

through technology-based requirements

that minimize pathogen densities and

reduce vector attraction. Granulite

meets the most stringent ‘‘Class A’’ part

503 requirements that pathogen

densities be reduced to low levels.

2. Infants and children. For several of

the metals evaluated in EPA’s biosolids

risk assessment, the pollutant limit

identified was based on the exposure

pathway for a pica child ingesting

biosolids/soil. These limits are

conservative because they go beyond

expected dietary and drinking water

exposures (i.e., a very small percentage

of children are expected to consume

biosolids in gardens or on lawns). Also,

the limit for lead in biosolids in the part

503 regulation is 300 ppm, based on

animal data. This number provides an

additional margin of safety for growing

children because it is lower than the 500

ppm limit for lead derived using EPA’s

Integrated Exposure Uptake Biokinetic

(IEUBK) model. In addition, animal (rat)

studies show that the bioavailability of

lead in biosolids is 12-fold lower than

that assumed in the IEUBK model

calculations used; thus the 300 ppm

lead limit provides even more of a

margin of safety. The limits identified

for the other metals (arsenic, cadmium,

mercury, and selenium) based on a

child ingesting biosolids/soil were

calculated in algorithms developed
23444 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 / Notices

specifically for the EPA biosolids risk

assessment. The most stringent part 503

pollutant limits for metals in biosolids

that are land applied are based on these

figures; Granulite meets these limits.

F. Other Considerations

Organic chemicals were evaluated in

the EPA biosolids risk assessment.

However, the part 503 rule did not set

limits for organic chemicals because all

the organic chemicals analyzed met one

or more of the following criteria:

i. The pollutant has been banned or

restricted for use in the U.S. or is no

longer manufactured in the U.S.

ii. The pollutant is infrequently found

in biosolids (e.g., detected less than 5%

of the time).

iii. The limit for the pollutant

identified in the EPA biosolids risk

assessment is not expected to be

exceeded in biosolids that are used or

disposed.

iv. Nearly all of the organic chemicals

evaluated met two or more of these

criteria.

G. Practical Analytical Method

Numerous analytical methods were

used in the hundreds of research studies

on which the EPA risk assessment for

the land application of biosolids was

based. Examples of analytical methods

used for analyzing metals

concentrations in plant and animal

tissue include atomic absorption, X-ray

fluorescence spectroscopy, and

autoradiography.

H. List of All Pending Tolerances and

Exemptions

The only known exemption from

tolerance being proposed for biosolids

as an inert ingredient is this application,

which is based on the health and

environmental protection identified in

EPA’s part 503 risk assessment for the

land application of biosolids, as

discussed throughout this application.

I. Environmental Fate Data Summary

Studies have shown that metals are

bound in the biosolids-soil matrix over

the long-term and that the binding

properties of biosolids are

environmentally stable. The binding of

metals by biosolids renders the metals

less bioavailable to plants, animals, and

humans, and studies have shown no

adverse effects when biosolids

containing metals meeting the part 503

pollutant limits, which includes

Granulite, are land applied.

The EPA risk assessment for the land

application of biosolids included

analysis of ecological risks through

ground-water, surface-water, plants,

livestock, and wildlife (as well as to

humans, including children). Low risks

were found to be associated with the

ground-water pathway and to wildlife,

and thus pollutant limits for chemicals

of concern for these pathways or

endpoints were based on other, more

restrictive risk assessment limits for

other pathways/endpoints. Granulite

meets all of these limits. The one

organic pollutant of concern identified

for the surface-water pathway was

deleted from regulation, as discussed in

‘‘Other Considerations’’ above.

J. International Tolerances

None known. Compatibility with any

existing MRLs should be possible, based

on the low risk of adverse effects

identified in EPA’s risk assessment for

the land application of biosolids. (Bipin

Gandhi)

[FR Doc. 98–10840 Filed 4–28–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS–51894; FRL–5785–8]

Certain Chemicals; Premanufacture

Notices

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: Section 5 of the Toxic

Substances Control Act (TSCA) requires

any person who intends to manufacture

or import a new chemical to notify EPA

and comply with the statutory

provisions pertaining to the

manufacture or import of substances not

on the TSCA Inventory. Section 5 of

TSCA also requires EPA to publish

receipt and status information in the

Federal Register each month reporting

premanufacture notices (PMN) and test

marketing exemption (TME) application

requests received, both pending and

expired. The information in this

document contains notices received

from February 1, 1998 to February 6,

1998.

ADDRESSES: Written comments,

identified by the document control

number ‘‘[OPPTS–51894]’’ and the

specific PMN number, if appropriate,

should be sent to: Document Control

Office (7407), Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, 401 M St., SW., Rm.

ETG–099 Washington, DC 20460.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to:

oppt.ncic@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect in 5.1/

6.1 file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

[OPPTS–51894]. No Confidential

Business Information (CBI) should be

submitted through e-mail. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

under ‘‘SUPPLEMENTARY

INFORMATION’’.

All comments which contain

information claimed as CBI must be

clearly marked as such. Three sanitized

copies of any comments containing

information claimed as CBI must also be

submitted and will be placed in the

public record for this notice. Persons

submitting information on any portion

of which they believe is entitled to

treatment as CBI by EPA must assert a

business confidentiality claim in

accordance with 40 CFR 2.203(b) for

each such portion. This claim must be

made at the time that the information is

submitted to EPA. If a submitter does

not assert a confidentiality claim at the

time of submission, EPA will consider

this as a waiver of any confidentiality

claim and the information may be made

available to the public by EPA without

further notice to the submitter.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, Rm. E–545, 401 M St., SW.,

Washington, DC, 20460, (202) 554–1404,

TDD (202) 554–0551; e-mail: TSCAHotline@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Under the

provisions of TSCA, EPA is required to

publish notice of receipt and status

reports of chemicals subject to section 5

reporting requirements. The notice

requirements are provided in TSCA

sections 5(d)(2) and 5(d)(3). Specifically,

EPA is required to provide notice of

receipt of PMNs and TME application

requests received. EPA also is required

to identify those chemical submissions

for which data has been received, the

uses or intended uses of such chemicals,

and the nature of any test data which

may have been developed. Lastly, EPA

is required to provide periodic status

reports of all chemical substances

undergoing review and receipt of

notices of commencement.

A record has been established for this

notice under docket number ‘‘[OPPTS–

51894]’’ (including comments and data

submitted electronically as described