28258 Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 /Rules and Regulations

Dated: May 8, 1998.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180— [AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.1001, in paragraph (c), the

table is amended by alphabetically

adding the inert ingredient

‘‘hydroxyethylidine diphosphonic acid

(HEDP)’’ to read as follows:

§ 180.1001 Exemptions from the

requirement of a tolerance.

* * * * *

(c) * * *

Inert ingredients Limits Uses

* * * * * * *

Hydroxyethylidine diphosphonic acid (HEDP) (CAS Reg. No.

2809–21–4).

For use in antimicrobial pesticide formulations at not

more than 1 percent.

Stabilizer, chelator

* * * * * * *

* * * * *

[FR Doc. 98–13603 Filed 5–21–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300659; FRL–5790–3]

RIN 2070–AB78

Bacillus Thuringiensis Subspecies

tolworthi Cry9C Protein and the

Genetic Material Necessary for its

Production in Corn; Exemption from

the Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule amends an

exemption from the requirement of a

tolerance for resid ues of the insecticide,

Bacillus thuringiensis subspecies

tolworthi Cry9C protein and the genetic

material necessary for its production in

corn for feed use only; as well as in

meat, poultry, milk, or eggs resulting

from animals fed such feed. Plant

Genetic Systems (America), Inc.

submitted a petition to the EPA under

the Federal Food, Drug and Cosmetic

Act (FFDCA) as amended by the Food

Quality Protection Act (FQPA) of 1996

requesting the exemption from the

requirement of a tolerance. This

regulation eliminates the need to

establish a maximum permissible level

for residues of this plant-pesticide in or

on corn used for feed; as well as in

meat, poultry, milk, or eggs resulting

from animals fed such feed.

EFFECTIVE DATE: This regulation is

effective May 22, 1998. Objections and

requests for hearings must be received

by EPA on or before July 21, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number [OPP–300659],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300659], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 119, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may be submitted electronically by

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

electronic objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 or

ASCII file format. All copies of

electronic objections and hearing

requests must be identified by the

docket number [OPP–300659]. No

Confidential Business Information (CBI)

should be submitted through e-mail.

Copies of electronic objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Mike Mendelsohn, Regulatory

Action Leader, Biopesticides and

Pollution Prevention Division (7511W),

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number, and

e-mail: Room CS15–W29, 2800 Jefferson

Davis Highway, Arlington, VA, 703–

308–8715, e-mail:

mendelsohn.mike@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Plant

Genetic Systems (America), Inc., 7200

Hickman Road, Suite 202, Des Moines,

IA 50322 has requested in pesticide

petition (PP 7F4826) the establishment

of an exemption from the requirement of

a tolerance for residues of the

insecticide Bacillus thuringiensis

subspecies tolworthi Cry9C protein and

the genetic material necessary for its

production in corn in or on all raw

agricultural commodities. A notice of

filing (FRL–5739–9) was published in

the Federal Register (62 FR 49224,

September 19, 1997), and the notice

announced that the comment period

would end on October 20, 1997; no

comments were received. Plant Genetic

Systems (America), Inc. submitted an

amendment to their petition on April

24, 1998 to request the establishment of

an exemption from the requirement of a

tolerance for residues of the insecticide

Bacillus thuringiensis subspecies

tolworthi Cry9C protein and the genetic

material necessary for its production in

corn only in corn used for feed; as well

as in meat, poultry, milk, or eggs

resulting from animals fed such feed.

This exemption from the requirement of

a tolerance will permit the marketing of

feed corn containing the plant-pesticide;

as well as meat, poultry, milk, or eggs

resulting from animals fed such feed.

The data submitted in the petition and

all other relevant material have been

evaluated. Following is a summary of

EPA’s findings regarding this petition as

required by section 408(d) of the Federal

Food, Drug and Cosmetic Act (FFDCA),

21 U.S.C. 346a, as recently amended by

the Food Quality Protection Act (FQPA),

Pub. L. 104–170.
Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 /Rules and Regulations 28259

I. Risk Assessment and Statutory

Findings

A. Product Identity/Chemistry

The Cry9C gene was originally

isolated from a Bacillus thuringiensis

subsp. tolworthi strain. The gene was

then synthesized with plant preferred

codons before it was stably inserted into

corn plants to produce a truncated and

modified Cry9C protein. The tryptic

core of the microbially produced Cry9C

delta-endotoxin is similar to the Cry9C

protein found in event CBH351 save for

a single amino acid substitution in the

internal sequence and the addition of

two amino acids to the N-terminus. The

Cry9C protein was produced and

purified from a bacterial host to utilize

in the mammalian toxicity studies due

to the bacterium’s greater production

potential. Product analysis that

compared the Cry9C protein from the

two sources included: SDS-PAGE,

Western blots, N-terminal amino acid

sequencing, glycosylation tests (for

possible post- translational

modifications) and insect bioassays. No

analytical method was included since

this petition requests an exemption from

the requirement of a tolerance.

B. Mammalian Toxicological Profile

Consistent with section 408(b)(2)(D)

of FFDCA, EPA has reviewed the

available scientific data and other

relevant information in support of this

action and considered its validity,

completeness and reliability and the

relationship of this information to

human risk. EPA has also considered

available information concerning the

variability of the sensitivities of major

identifiable subgroups of consumers,

including infants and children.

Additionally, section 408(b)(2)(D)(v)

requires that, when considering whether

to establish, modify, or revoke a

tolerance, the Agency consider

‘‘available information’’ concerning the

cumulative effects of a particular

pesticide’s residues and ‘‘other

substances that have a common

mechanism of toxicity.’’ A high-dose

acute oral toxicity study (3,760 mg/kg

body weight) showed no mortalities.

Transient weight losses were seen in

three female treated animals, with one

not recovering her pre-dosing, pre-fast

weight at 14 days after dose

administration. The treated males

showed no weight losses. Transient

weight loss has been observed in similar

studies conducted on other purified Cry

proteins as well as microbial pesticides

containing Cry proteins and is not

considered a significant adverse effect.

The in vitro digestibility study showed

the Cry9C protein to be stable to pepsin

digestion at pH 2.0 for 4 hours. The

Cry9C protein is also heat stable, not

being affected by incubation at 90 ° C for

10 minutes. The Cry9C protein in corn

is the trypsin resistant core and is

therefore stable to tryptic digest. A

search for amino acid homology did not

reveal any significant homology with

known toxins or allergens. The genetic

material necessary for the production of

the plant-pesticide active ingredient is

the nucleic acids (DNA) which comprise

genetic material encoding the Cry9C

protein and its regulatory regions.

Regulatory regions are the genetic

material that control the expression of

the genetic material encoding the

proteins, such as promoters,

terminators, and enhancers. DNA is

common to all forms of plant and

animal life and the Agency knows of no

instance where these nucleic acids have

been associated with toxic effects

related to their consumption as a

component of food. These ubiquitous

nucleic acids as they appear in the

subject plant-pesticide have been

adequately characterized by the

applicant and supports EPA’s

conclusion that no mammalian toxicity

is anticipated from dietary exposure to

the genetic material necessary for the

production of the Cry9C protein.

C. Aggregate Exposure

The available information on the

aggregate exposure levels of consumers

(and major identifiable subgroups of

consumers) to the Cry9C protein residue

include dietary exposure and exposure

from non-occupational sources.

Exposure via the skin or inhalation is

not likely since the Cry9C plantpesticide is contained within plant cells

essentially eliminating these exposure

routes or reducing these exposure routes

to negligible. Drinking water is unlikely

to be significantly contaminated with

Cry9C protein due to the low expression

of the protein in corn tissue,

degradation of plant materials in the soil

and low leaching potential of a protein

from a soil matrix. Minimal to nonexistent oral exposure could occur from

ingestion of meat, poultry, eggs or milk

from animals fed corn containing the

plant-pesticide and from drinking water.

While unlikely, meat, eggs or milk from

animals fed corn containing the plantpesticide could contain negligible but

finite residues. This is viewed as a

remote possibility due to the low Cry9C

expression level in corn tissue (3 to 250

μg/gm dry weight), the anticipated

degradation and elimination of the

Cry9C protein by the animal or the lack

of uptake of such a large protein by the

animal’s intestinal tract. It is not

possible to establish with certainty

whether finite residues will be incurred,

but there is no reasonable expectation of

finite residues. However, the best

available information on the uptake of

intact proteins from the diet would

indicate that the intact Cry9C protein

would not be available in products from

animals fed corn products containing

Cry9C protein.

D. Cumulative Effects

The Agency has considered available

information on the cumulative effects of

such residues and other substances that

have a common mechanism of toxicity.

These considerations included the

cumulative effects on adults as well as

on infants and children of such residues

and other substances with a common

mechanism of toxicity. Since there is no

indication of mammalian toxicity to the

Cry9C protein from the studies

submitted, there is no reason to believe

there would be cumulative toxic effects.

E. Safety Determination

The tolerance exemption is limited to

residues of the Cry9C protein resulting

from feed use only. The basis of safety

for this tolerance exemption includes

both the results of the acute oral study

at high doses indicating no toxicity and

the anticipated minimal to nonexistent

human dietary exposure of the Cry9C

protein via animal feed use. Bt

microbial pesticides, containing Cry

proteins other than Cry9C, have been

applied for more than 30 years to food

and feed crops consumed by the U.S.

population. There have been no human

safety problems attributed to the

specific Cry proteins. An oral dose of

the tryptic core Cry9C protein of at least

3,760 mg/kg was administered to 10

animals without mortality

demonstrating a high degree of safety for

the protein. Transient weight loss in

three female rodents was observed, but

not in any males. Transient weight loss

has been observed in similar studies

conducted on other purified Cry

proteins as well as microbial pesticides

and this is not considered a significant

adverse effect.

A comparison of the amino acid

sequence of the Cry9C protein with

those found in the PIR, Swiss-Prot and

HIV AA data bases did not reveal any

significant homology with known toxins

or allergens. The in vitro digestibility

study showed the Cry9C protein to be

stable to pepsin at pH 2.0. The Cry9C

protein was shown to be stable to heat

at 90 ° C for 10 minutes and the Cry9C

protein in corn is the trypsin resistant

core and is therefore stable to tryptic

digest. The best available information to

date would indicate that edible products

derived from animals such as meat, milk
28260 Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 /Rules and Regulations

and eggs, intended for human

consumption, have not been shown to

be altered in their allergenicity due to

changes in the feed stock utilized. This

information would include no transfer

of allergenic factors from cattle fed

soybeans to the derived meat or milk

eaten by individuals with food

sensitivity to soybeans.

F. Infants and Children

FFDCA section 408(b)(2)(C) provides

that EPA shall assess the available

information about consumption patterns

among infants and children, special

susceptibility of infants and children to

pesticide chemical residues and the

cumulative effects on infants and

children of the residues and other

substances with a common mechanism

of toxicity. In addition, FFDCA section

408 provides that EPA shall apply an

additional tenfold margin of exposure

(safety) for infants and children in the

case of threshold effects to account for

pre- and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of exposure (safety) will be safe for

infants and children. In this instance,

based on all the available information,

the Agency concludes that infants and

children will consume only minimal, if

any, residues of this plant-pesticide and

that there is a finding of no toxicity.

Thus, there are no threshold effects of

concern and, as a result the provision

requiring an additional margin of safety

does not apply. Further, the provisions

of consumption patterns, special

susceptibility, and cumulative effects do

not apply.

G. Other Considerations

1. Analytical method. The Agency is

establishing an exemption from the

requirement of a tolerance without any

numerical limitation; therefore, the

agency has concluded that an analytical

method is not required for enforcement

purposes for this plant-pesticide.

2. Effects on the endocrine systems.

EPA does not have any information

regarding endocrine effects for these

kinds of pesticides at this time. The

Agency is not requiring information on

the endocrine effects of these plantpesticides at this time; and Congress

allowed 3 years after August 3, 1996, for

the Agency to implement a screening

and testing program with respect to

endocrine effects.

H. Existing Tolerances

A temporary exemption from the

requirement of a tolerance for residues

of Bacillus thuringiensis subsp.

tolworthi Cry9C and the genetic material

necessary for the production of this

protein in corn, only in corn used for

feed; as well as in meat, poultry, milk,

or eggs resulting from animals fed such

feed was established on April 10, 1998

under 40 CFR 180.1192 [63 FR 69]. The

exemption from the requirement of a

tolerance in this rule makes permanent

the temporary tolerance exemption of 40

CFR 180.1192.

II. Conclusion

Based on the toxicology data cited

and the limited exposure expected with

animal feed use, there is reasonable

certainty that no harm will result from

aggregate exposure to the U.S.

population, including infants and

children, to residues of Bacillus

thuringiensis subspecies tolworthi

Cry9C protein and the genetic material

necessary for its production in corn.

This includes all anticipated dietary

exposures and all other exposures for

which there is reliable information. The

Agency has arrived at this conclusion

because, as discussed above, the

temporary tolerance exemption is

limited to feed use only. The conclusion

of safety is supported by the lack of

toxicity after administration of a high

oral dose (3,760 mg/kg), the lack of

homology to known toxins or allergens,

and the minimal to nonexistent

exposure via dietary and non-dietary

routes. This exemption from the

requirement of a tolerance will be

revoked if any experience with or

scientific data on this pesticide indicate

that the tolerance is not safe.

III. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

exemption regulation issued by EPA

under new section 408(e) as was

provided in the old section 408.

However, the period for filing objections

is 60 days, rather than 30 days. EPA

currently has procedural regulations

which govern the submission of

objections and hearing requests. These

regulations will require some

modification to reflect the new law.

However, until those modifications can

be made, EPA will continue to use those

procedural regulations with appropriate

adjustments to reflect the new law.

Any person adversely affected by this

regulation may by June 22, 1998, file

written objections to the regulation and

may also request a hearing on those

objections. Objections and hearing

requests must be filed with the Hearing

Clerk, at the address given above (40

CFR 178.20). A copy of the objections

and/or hearing requests filed with the

Hearing Clerk should be submitted to

the OPP docket for this rulemaking. The

objections submitted must specify the

provisions of the regulation deemed

objectionable and the grounds for the

objections (40 CFR 178.25). Each

objection must be accompanied by the

fee prescribed by 40 CFR 180.33(i). If a

hearing is requested, the objections

must include a statement of the factual

issue(s) on which a hearing is requested,

the requestor’s contentions on such

issues, and a summary of any evidence

relied upon by the objector (40 CFR

178.27). A request for a hearing will be

granted if the Administrator determines

that the material submitted shows the

following: There is genuine and

substantial issue of fact; there is a

reasonable possibility that available

evidence identified by the requestor

would, if established, resolve one or

more of such issues in favor of the

requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issue(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

CBI. Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR Part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

IV. Public Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300659] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 119 of the Public Information and

Records Integrity Branch, Information

Resources and Services, Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

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. The official record for
Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 /Rules and Regulations 28261

this rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

V. Regulatory Assessment

Requirements

This final rule establishes an

exemption from the tolerance

requirement under FFDCA section

408(d) in response to a petition

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

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

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

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

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

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

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or special considerations as

required by Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the exemption in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply.

Nevertheless, the Agency previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950), and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VI. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 11, 1998.

Marcia E. Mulkey,

Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.1192 is revised to read

as follows:

§ 180.1192 Bacillus thuringiensis

subspecies tolworthi Cry9C protein and the

genetic material necessary for its

production in corn; exemption from the

requirement of a tolerance.

The plant-pesticide Bacillus

thuringiensis subspecies tolworthi

Cry9C protein and the genetic material

necessary for its production in corn is

exempted from the requirement of a

tolerance for residues, only in corn used

for feed; as well as in meat, poultry,

milk, or eggs resulting from animals fed

such feed.

[FR Doc. 98–13604 Filed 5–21–98; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL EMERGENCY

MANAGEMENT AGENCY

44 CFR Part 65

[Docket No. FEMA–7244]

Changes in Flood Elevation

Determinations

AGENCY: Federal Emergency

Management Agency (FEMA).

ACTION: Interim rule.

SUMMARY: This interim rule lists

communities where modification of the

base (1% annual chance) flood

elevations is appropriate because of new

scientific or technical data. New flood

insurance premium rates will be

calculated from the modified base flood

elevations for new buildings and their

contents.

DATES: These modified base flood

elevations are currently in effect on the

dates listed in the table and revise the

Flood Insurance Rate Map(s) in effect

prior to this determination for each

listed community.

From the date of the second

publication of these changes in a

newspaper of local circulation, any

person has ninety (90) days in which to

request through the community that the

Associate Director for Mitigation

reconsider the changes. The modified

elevations may be changed during the

90-day period.

ADDRESSES: The modified base flood

elevations for each community are

available for inspection at the office of

the Chief Executive Officer of each

community. The respective addresses

are listed in the following table.

FOR FURTHER INFORMATION CONTACT:

Matthew B. Miller, P.E., Chief, Hazards

Study Branch, Mitigation Directorate,

500 C Street SW., Washington, DC

20472, (202) 646–3461.

SUPPLEMENTARY INFORMATION: The

modified base flood elevations are not

listed for each community in this

interim rule. However, the address of

the Chief Executive Officer of the

community where the modified base

flood elevation determinations are

available for inspection is provided.

Any request for reconsideration must

be based upon knowledge of changed

conditions, or upon new scientific or

technical data.

The modifications are made pursuant

to Section 201 of the Flood Disaster

Protection Act of 1973, 42 U.S.C. 4105,

and are in accordance with the National

Flood Insurance Act of 1968, 42 U.S.C.

4001 et seq., and with 44 CFR Part 65.

For rating purposes, the currently

effective community number is shown

and must be used for all new policies

and renewals.

The modified base flood elevations

are the basis for the floodplain

management measures that the

community is required to either adopt

or to show evidence of being already in

effect in order to qualify or to remain

qualified for participation in the

National Flood Insurance Program

(NFIP).