Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Notices 37545

monetized benefits of reductions in

exposure to HAPs. The first will be a

workshop focusing on developing best

estimates of dose-response functions

that relate changes in HAP exposure to

changes in health outcomes. The second

activity will focus on (1) integrating

these dose-response functions with

appropriate models of HAP

concentrations and human exposure

and (2) translating these into economic

benefits that would estimate changes in

health risks resulting from regulations

that reduce HAP emissions.

The overall goal of these two activities

is to identify methods for the Agency to

consider using in estimating changes in

health risks resulting from HAP

regulations that can be combined with

valuation functions to estimate

monetized benefits of HAP reductions.

Risk assessments for HAPs have been

developed to help decision makers set

health-based standards that are

consistent with EPA’s mission to protect

human health. The quantitative toxicity

values from these assessments (that is,

the cancer slope factors and the

noncancer reference concentrations and

reference doses) are typically based on

animal and epidemiologic studies that

involve higher exposures than those

encountered in the environment. The

gap between environmental doses and

study doses has led to toxicity values

that can put a bound on the actual risk

without being able to provide a reliable

central estimate or distribution of risks.

It is these latter terms (central estimates

and distributions) that economists have

traditionally used to estimate the

economic value of potential changes in

risks.

In contrast, risk assessments for

criteria pollutants have been based on

epidemiologic and clinical studies of

exposures similar to those encountered

in the environment. This has allowed

development of standard statistical

confidence intervals and distributions.

With this information, economists have

been able to develop economic benefit

estimates for many health endpoints

related to criteria pollutants. Criteria

pollutant benefit estimates have been

feasible because of the availability of: (a)

Well-defined health endpoints such as

hospital admissions or premature

mortality; (b) dose-response functions

from epidemiological and clinical

studies which support estimates of risk

reductions in terms amenable to

economic valuation; (c) reliable

estimates of ambient concentration and

population exposure change; and (d)

dose-response functions available from

epidemiological and clinical studies in

which the exposures were similar to

those being experienced in the ambient

environment. Uncertainties related to

the health benefits of criteria pollutants

have generally been represented by

standard confidence intervals based on

measures of within and between study

variation in the estimated health effects.

While mortality from HAP-related

cancer is a well-defined endpoint, there

are very few validated exposureresponse relationships. For the many

other potential health effects from

exposure to HAPs, such as changes in

reproductive functions or mutagenic

effects, there are major information gaps

in all aspects of risk assessment, as well

as in exposure-response and valuation.

The focus of this workshop will be the

development of best-estimates and

uncertainty characterizations for hazard

and dose response functions for use in

benefits analyses of HAP regulations,

with a focus on providing potentially

useful data and tools to support HAPrelated benefit assessments, including

national-scale program evaluations.

For Further Information—Any

member of the public wishing further

information concerning this workshop

should consult the website for this

workshop at http://www.epa.gov/ttn/

ecas/meetings/coverhap.html or contact

Ms. Heather Hodgeman in EPA’s Office

of Air and Radiation via email at

hodgeman.heather@epa.gov or by

telephone at (919) 541–5668.

Dated: June 7, 2000.

John R. Fowle III,

Acting Staff Director, Science Advisory Board.

[FR Doc. 00–15158 Filed 6–14–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[PF–944; FRL–6558–6]

Notice of Filing a Pesticide Petition to

Establish a Tolerance for Certain

Pesticide Chemicals in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–944, must be

received on or before July 17, 2000.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I.C. of the

‘‘SUPPLEMENTARY INFORMATION.’’

To ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–944 in the subject

line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Mike Mendelsohn, Biopesticides

and Pollution Prevention Division

(7511C), Office of Pesticide Programs,

Environmental Protection Agency, Ariel

Rios Bldg., 1200 Pennsylvania Ave.,

NW., Washington, DC 20460; telephone

number: (703) 308–8715; e-mail

address:mendelsohn.mike@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer or pesticide manufacturer.

Potentially affected categories and

entities may include, but are not limited

to:

CategoriesNAICS

codes

Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under ‘‘FOR FURTHER

INFORMATION CONTACT.’’

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

37546 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Notices

2. In person. The Agency has

established an official record for this

action under docket control number PF–

944. The official record consists of the

documents specifically referenced in

this action, any public comments

received during an applicable comment

period, and other information related to

this action, including any information

claimed as confidential business

information (CBI). This official record

includes the documents that are

physically located in the docket, as well

as the documents that are referenced in

those documents. The public version of

the official record does not include any

information claimed as CBI. The public

version of the official record, which

includes printed, paper versions of any

electronic comments submitted during

an applicable comment period, is

available for inspection in the Public

Information and Records Integrity

Branch (PIRIB), Rm. 119, Crystal Mall

#2, 1921 Jefferson Davis Highway,

Arlington, VA, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The PIRIB telephone number

is (703) 305–5805.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–944 in the subject

line on the first page of your response.

1. By mail. Submit your comments to:

Public Information and Records

Integrity Branch (PIRIB), Information

Resources and Services Division

(7502C), Office of Pesticide Programs

(OPP), Environmental Protection

Agency, Ariel Rios Bldg., 1200

Pennsylvania Ave., NW., Washington,

DC 20460.

2. In person or by courier. Deliver

your comments to: Public Information

and Records Integrity Branch (PIRIB),

Information Resources and Services

Division (7502C), Office of Pesticide

Programs (OPP), Environmental

Protection Agency, Rm. 119, Crystal

Mall #2, 1921 Jefferson Davis Highway,

Arlington, VA. The PIRIB is open from

8:30 a.m. to 4 p.m., Monday through

Friday, excluding legal holidays. The

PIRIB telephone number is (703) 305–

5805.

3.Electronically. You may submit your

comments electronically by e-mail to:

‘‘opp-docket@epa.gov,’’ or you can

submit a computer disk as described

above. Do not submit any information

electronically that you consider to be

CBI. Avoid the use of special characters

and any form of encryption. Electronic

submissions will be accepted in

Wordperfect 6.1/8.0 or ASCII file

format. All comments in electronic form

must be identified by docket control

number PF–944. Electronic comments

may also be filed online at many Federal

Depository Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI 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.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under ‘‘FOR FURTHER INFORMATION

CONTACT.’’

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

6. Make sure to submit your

comments by the deadline in this

notice.

7. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition

as follows proposing the establishment

and/or amendment of regulations for

residues of certain pesticide chemical 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 this

petition contains 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.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 24, 2000.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Summary of Petition

The petitioner summary of the

pesticide petition is printed below as

required by section 408(d)(3) of the

FFDCA. The summary of the petition

was prepared by the petitioner and

represents the view of the petitioner.

This summary was prepared by

Mycogen Seeds c/o Dow AgroSciences

LLC. EPA has not fully evaluated the

merits of the pesticide petition. The

summary may have been edited by EPA

if the terminology used was unclear, the

summary contained extraneous

material, or the summary

unintentionally made the reader

conclude that the findings reflected

EPA’s position and not the position of

the petitioner. 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.

I. Mycogen Seeds c/o Dow AgroSciences

LLC

0G6112

EPA has received a pesticide petition

0G6112 from Mycogen Seeds c/o Dow

AgroSciences LLC, 9330 Zionsville

Road, Indianapolis, IN 46268–1054,

proposing pursuant to section 408(d) of

the Federal Food, Drug, and Cosmetic

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

amend 40 CFR part 180 to establish an

exemption from the requirement of a

tolerance for the plant-pesticide Bacillus

thuringiensis Cry1F protein and the

genetic material necessary for its

production in plants in or on all food

commodities.

Pursuant to section 408(d)(2)(A)(i) of

the FFDCA, as amended, Mycogen

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Notices 37547

Seeds c/o Dow AgroSciences LLC has

submitted the following summary of

information, data, and arguments in

support of their pesticide petition.

A. Product Name and Proposed Use

Practices

Mycogen Brand B.t. Cry1F Corn Insect

Resistant Corn used as part of the EPA

experimental use permit no. 68467–

EUP–2

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. The Cry1F gene

was isolated from Bacillus thuringiensis

subspecies aizawai and modified before

it was inserted into corn plants. The

Cry1F Insecticidal protein has been

adequately characterized. Several safety

studies were conducted using a

microbially produced test substance that

contained 11.4% Cry1F protein. Studies

conducted to establish the equivalence

of the Cry1F protein obtained from corn

or from a microbial source demonstrate

that the materials are similar with

respect to molecular weight,

immunoreactivity, lack of posttranslational modification

(glycosylation) N-terminal amino acid

sequence, and spectrum of bioactivity.

2. Analytical method. A statement of

why an analytical method for detecting

and measuring the levels of the

pesticide residue are not needed. No

analytical method is included because

this petition requests a temporary

exemption from the requirement for a

tolerance.

C. Mammalian Toxicological Profile

Cry proteins have been deployed as

safe and effective pest control agents in

microbial Bacillus thuringiensis

formulations for almost 40 years. There

are currently 180 registered microbial

Bacillus thuringiensis products in the

United States for use in agriculture,

forestry, and vector control. The

numerous toxicology studies conducted

with these microbial products show no

significant adverse effects, and

demonstrate that the products are

practically non-toxic to mammals. An

exemption from the requirement of a

tolerance has been in place for these

products since at least 1971 (40 CFR

180.1011).

Toxicology studies conducted to

determine the toxicity of Cry1F insect

control protein demonstrated that the

protein has very low toxicity. In an

acute oral toxicity study in the mouse,

the estimated acute LD50 by gavage was

determined to be >5,050 milligrams/

kilograms (mg/kg) of the microbially

produced test substance. This dose is

12,190 x greater than the estimated 95th

percentile for human dietary exposure

to Cry1F protein resulting from

consumption of foods derived from

Cry1F protected corn. This estimate

assumes that 100% of the corn crop

produces Cry1F protein and that the

protein is not degraded or otherwise

eliminated in food processing. This

extremely conservative estimate of the

margin of exposure further supports the

safety of Cry1F proteins to humans.

In an in vitro study, Cry1F protein

was rapidly and extensively degraded in

simulated gastric conditions in the

presence of pepsin. Cry1F was

completely proteolyzed to amino acids

and small peptide fragments within 5

minutes at molar ratios approximating

1:100 (Cry1F:pepsin). This indicates

that the protein is highly susceptible to

digestion in the human digestive tract

and that the potential for adverse health

effects from chronic exposure is

virtually nonexistent. Moreover,

proteins in general are not known to be

carcinogenic. A search of relevant

databases indicated that the amino acid

sequence of the Cry1F protein exhibits

no significant homology to the

sequences of known allergens or protein

toxins. Thus, Cry1F is highly unlikely to

exhibit an allergic response.

The genetic material necessary for the

production of the Cry1F insect control

protein are nucleic acids (DNA) which

are common to all forms of plant and

animal life. There are no known

instances of where nucleic acids have

caused toxic effects as a result of dietary

exposure.

Collectively, the available data on

Cry1F protein along with the safe use

history of microbial Bacillus

thuringiensis products establishes the

safety of the plant pesticide Bacillus

thuringiensis subspecies aizawai Cry1F

insect control protein and the genetic

material necessary for its production in

all raw agricultural commodities.

D. Aggregate Exposure

Because Bacillus thuringiensis

subspecies aizawai Cry1F insect control

protein is expressed in minute

quantities and is retained within the

plant, there is virtually no potential for

dermal or inhalation exposure to the

protein. Significant dietary exposure to

Cry1F protein is unlikely to occur.

Dietary exposures at very low levels, via

ingestion of processed commodities,

although they may occur, are unlikely to

be problematic because of the low

toxicity and the high degree of

digestibility of the protein. In addition,

the protein is not likely to be present in

drinking water because the protein is

deployed in minute quantities within

the plant, and studies demonstrate that

Cry1F protein is rapidly degraded in

soil. In summary, the potential for

significant aggregate exposure to Cry1F

protein is highly unlikely.

E. Cumulative Exposure

Common modes of toxicity are not

relevant to consideration of the

cumulative exposure to Bacillus

thuringiensis Cry1F insect control

protein. The product has demonstrated

low toxicity and these effects do not

appear to be cumulative with any other

known compounds.

F. Safety Determination

1. U.S. population. The deployment of

the product in minute quantities within

the plant, the very low toxicity of the

product, the lack of allergenic potential,

and the high degree of digestibility of

the protein, are all factors in support of

Mycogen’s assertion that no significant

risk is posed by exposure of the U.S.

population to Bacillus thuringiensis

subspecies aizawai Cry1F insect control

protein.

2. Infants and children. Non-dietary

exposure to infants and children is not

anticipated, due to the proposed use

pattern of the product. Due to the very

low toxicity of the product, the lack of

allergenic potential, and the high degree

of digestibility of the protein, dietary

exposure is anticipated to be at very low

levels and is not anticipated to pose any

harm to infants and children.

G. Effects on the Immune and Endocrine

Systems

Given the rapid digestibility of Cry1F

delta endotoxin, no chronic effects are

expected. Cry1F delta endotoxin, or

metabolites of the endotoxin are not

known to, or are expected to have any

effect on the immune or endocrine

systems. Proteins in general are not

carcinogenic, therefore, no carcinogenic

risk is associated with the Cry1F

protein.

H. Existing Tolerances

There are no existing tolerances or

exemptions from tolerance for Bacillus

thuringiensis subspecies aizawai Cry1F.

I. International Tolerances

There are no existing international

tolerances or exemptions from tolerance

for Bacillus thuringiensis subspecies

aizawai Cry1F.

[FR Doc. 00–15167 Filed 6–14–00; 8:45 am]

BILLING CODE 6560–50–F