17720 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

§ 180.1175 [Removed]

3. Section 180.1175 is removed.

[FR Doc. 97–9373 Filed 4–10–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300462; FRL–5596–7]

RIN 2070–AB78

Bacillus Thuringiensis Subspecies

Kurstaki CryIA(c) and the Genetic

Material Necessary for Its Production

in All Plants; Exemption From the

Requirement of a Tolerance on All Raw

Agricultural Commodities

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes an

exemption from the requirement of a

tolerance for residues of the plantpesticides CryIA(c) and the genetic

material necessary for its production in

all plants when used as plant-pesticides

in or on all raw agricultural

commodities. Dekalb Genetics

Corporation submitted a petition to EPA

under the Federal Food, Drug and

Cosmetic Act as amended by the Food

Quality Protection Act of l996

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-pesticides in or

on all raw agricultural commodities.

EFFECTIVE DATE: This regulation

becomes effective on April 11, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300462],

may 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 should be

identified by the docket control number

and submitted to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

copy of objections and hearing requests

to: Rm. 1132, CM #2, 1921 Jefferson

Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300462]. No Confidential Business

Information (CBI) should be submitted

through e- mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries. Additional

information on electronic submissions

can be found in Unit VIII. of this

preamble.

FOR FURTHER INFORMATION CONTACT: By

mail: Mike Mendelsohn, Biopesticides

and Pollution Prevention Division

(7501W), Office of Pesticide Programs,

U.S. Environmental Protection Agency,

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

Office location, telephone number, and

e-mail address: 5th Floor Crystal

Station, 2800 Crystal Drive, Arlington,

VA 22202, (703)–308–8715); email:

mendelsohn.mike@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 24, 1997 (62

FR 3682)(FRL–5380–2), EPA issued a

notice pursuant to section 408(d) of the

Federal Food, Drug and Cosmetic Act

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

the filing of a pesticide petition for an

exemption from the requirement of a

tolerance by Dekalb Genetics

Corporation (Dekalb), 3100 Sycamore

Road, Dekalb, IL 60115. The notice

contained a summary of the petition

prepared by the petitioner and this

summary contained conclusions and

arguments to support its conclusion that

the petition complied with the Food

Quality Protection Act (Pub. L. 104–

170). The petition requested that an

exemption from the requirement of a

tolerance be established for the plantpesticides Bacillus thuringiensis

subspecies kurstaki CryIA(c) [CryIA(c)]

and the genetic material necessary for

its production in plants in or on all raw

agricultural commodities (RACS). There

were no comments or requests for

referral to an advisory committee

received in response to the notices of

filing. The data submitted in the

petition and other relevant material

have been evaluated. The toxicology

and other data listed below were

considered in support of this exemption

from the requirement of a tolerance.

I. Toxicological Profile

The data submitted regarding

potential health effects of CryIA(c)

include information on the

characterization of the expressed

protein in corn, the acute oral toxicity

of CryIA(c), and in vitro digestibility

studies of the protein. The results of

these studies were determined

applicable to evaluate human risk and

the validity, completeness, and

reliability of the available data from the

studies were considered. The acute oral

toxicity test of bacterially-derived

CryIA(c) protein showed no test

substance related deaths at a dose of

5,000 mg/kg. Although CryIA(c)

expression level data were required for

an environmental fate and effects

assessment, residue chemistry data were

not required for a human health effects

assessment of the subject plantpesticides ingredients because of the

lack of mammalian toxicity. Both (1)

available information concerning the

dietary consumption patterns of

consumers (and major identifiable

subgroups of consumers including

infants and children) and (2) safety

factors which, in the opinion of experts

qualified by scientific training and

experience to evaluate the safety of food

additives, are generally recognized as

appropriate for the use of animal

experimentation data were not

evaluated because the lack of

mammalian toxicity at high levels of

exposure demonstrate the safety of the

product at levels above possible

maximum exposure levels. This is

similar to the Agency position regarding

toxicity and the requirement of residue

data for the microbial Bacillus

thuringiensis products from which these

plant-pesticides are derived. [See 40

CFR 158.740(b).] For microbial

products, further toxicity testing to

verify the observed effects and clarify

the source of the effects (Tiers II and III)

and residue data are triggered by

significant acute effects in studies such

as the mouse oral toxicity study.

The acute oral toxicity data submitted

support the prediction that the CryIA(c)

protein would be non-toxic to humans.

When proteins are toxic, they are known

to act via acute mechanisms and at very

low dose levels [Sjoblad, Roy D., et al.

‘‘Toxicological Considerations for

Protein Components of Biological

Pesticide Products,’’ Regulatory

Toxicology and Pharmacology 15, 3–9

(1992)]. Therefore, since no effects were

shown to be caused by the plantpesticides, even at relatively high dose
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17721

levels, the CryIA(c) delta-endotoxin

protein is not considered toxic.

Adequate information was submitted

to show that the CryIA(c) test material

derived from microbial cultures was

biochemically and, functionally similar

to the protein produced by the plantpesticide ingredient in corn. Production

of microbially produced protein was

chosen in order to obtain sufficient

material for testing. In addition, the in

vitro digestibility studies indicate the

proteins would be rapidly degraded

following ingestion.

The genetic material necessary for the

production of the plant-pesticides active

and inert ingredients are the nucleic

acids (DNA) which comprise (1) genetic

material encoding these proteins and (2)

their 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 active ingredients has been

adequately characterized by the

applicant. Therefore, no mammalian

toxicity is anticipated from dietary

exposure to the genetic material

necessary for the production of the

subject active and inert plant pesticidal

ingredients.

II. Sensitivity of Subgroups

The Agency has considered available

information on the variability of the

sensitivities of major identifiable

subgroups of consumers including

infants and children and the

physiological differences between

infants and children and adults and

effects of in utero exposure to the plantpesticides. Since CryIA(c) is a protein,

allergenic sensitivities were considered.

Current scientific knowledge suggests

that common food allergens tend to be

resistant to degradation by heat, acid,

and proteases, are glycosylated and

present at high concentrations in the

food. Data has been submitted which

demonstrate that the CryIA(c) deltaendotoxin is rapidly degraded by gastric

fluid in vitro and is non-glycosylated.

Studies submitted to EPA done in

laboratory animals have not indicated

any potential for allergic reactions to

Bacillus thuringiensis or its

components, including the deltaendotoxin in the crystal protein. Despite

decades of widespread use of Bacillus

thuringiensis as a pesticide (it has been

registered since 1961), there have been

no confirmed reports of immediate or

delayed allergic reactions to the deltaendotoxin itself despite significant oral,

dermal and inhalation exposure to the

microbial product. Several reports

under FIFRA section 6(a)2 have been

made for various Bacillus thuringiensis

products claiming allergic reactions.

However, the Agency determined these

reactions were not due to Bacillus

thuringiensis itself or any of the Cry

toxins. Thus, the potential for the

CryIA(c) protein to be a food allergen is

minimal.

III. 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 infants and

children of such residues and other

substances with a common mechanism

of toxicity. Because there is no

indication of mammalian toxicity to

these plant-pesticides, there are no

cumulative effects.

IV. Aggregate Exposures

The Agency has considered available

information on the aggregate exposure

levels of consumers (and major

identifiable subgroups of consumers) to

the pesticide chemical residue and to

other related substances. These

considerations include dietary exposure

under the tolerance exemption and all

other tolerances or exemptions in effect

for the plant-pesticides chemical

residue, and exposure from nonoccupational sources. Exposure via the

skin or inhalation is not likely since the

plant-pesticides are contained within

plant cells which essentially eliminates

these exposure routes or reduces these

exposure routes to negligible. Oral

exposure, at very low levels, may occur

from ingestion of processed corn

products and drinking water. However a

lack of mammalian toxicity and the

digestibility of the plant-pesticides has

been demonstrated. The use sites for

CryIA(c) delta endotoxin are all

agricultural for control of lepidopteran

insects. Therefore, exposure via

residential or lawn use to infants and

children is not expected. Even if

negligible exposure should occur, the

Agency concludes that such exposure

would present no risk due to the lack of

toxicity.

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, EPA believes there is

reliable data to support the conclusion

that the plant-pesticides are not toxic to

mammals, including infants and

children and thus there are no threshold

effects of concern. As a result, the

provision requiring an additional

margin of exposure does not apply.

V. Endocrine Effects

EPA does not have any information

regarding endocrine effects on these

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.

VI. Conclusion

There is a reasonable certainty that no

harm will result from aggregate

exposure to the U.S. population,

including infants and children, to the

CryIA(c) protein and the genetic

material necessary for its production.

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,

no toxicity to mammals has been

observed for the plant-pesticides. As a

result, EPA establishes an exemption

from tolerance requirements pursuant to

FFDCA section 408(j)(3) for Bacillus

thuringiensis CryIA(c) delta-endotoxin

and the genetic material necessary for

its production in all plants.

Bacillus thuringiensis subspecies

kurstaki CryIA(c) delta-endotoxin and

the genetic material necessary for its

production in all plants are exempt from

the requirement of a tolerance when

used as plant-pesticides in all plant raw

agricultural commodities. ‘‘Genetic

material necessary for its production’’

means the genetic material which

comprise (1) genetic material encoding

the CryIA(c) delta-endotoxin and (2) its

regulatory regions. ‘‘Regulatory regions’’

are the genetic material that control the

expression of the genetic material

encoding the CryIA(c) delta-endotoxin,

such as promoters, terminators, and

enhancers.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a regulation

for an exemption from the requirement

of a tolerance issued by EPA under new

section 408(d) as was provided in the

old section 408 and in section 409.
17722 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

However, the period for filing objections

is 60 days, rather than 30 days. EPA

currently has procedural regulations

which governs 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 may, by June 10, 1997 file

written objections to any aspect of this

regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the Virginia

address given under the ADDRESSES

section (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 a 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.

VIII. Public Docket

A record has been established for this

rulemaking under docket control

number [OPP–300462]. A public version

of this record, 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 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

The official record for this

rulemaking, as well as the public

version, as described above, is kept in

paper form. Accordingly, in the event

there are objections and hearing

requests, 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. The official rulemaking record is

the paper record maintained at the

address in ADDRESSES at the beginning

of this document.

IX. Regulatory Assessment

Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a ‘‘significant regulatory action’’ and

since this action does not impose any

information collection requirements

subject to approval under the Paperwork

Reduction Act, 44 U.S.C. 3501 et seq.,

it is not subject to review by the Office

of Management and Budget. In addition,

this action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104–4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, l993), or special

considerations as required by Executive

Order 12898 (59 FR 7629, February 16,

l994).

Because exemptions from the

requirement of a tolerance established

on the basis of a petition under section

408(d) of FFDCA do not require

issuance of a proposed rule, the

regulatory flexibility analysis

requirements of the Regulatory

Flexibility Act (RFA), 5 U.S.C. 604(a),

do not apply. Prior to the recent

amendment of the FFDCA, EPA had

treated such rulemakings as subject to

the RFA; however, the amendments to

the FFDCA clarify that no proposal is

required for such rulemakings and

hence that the RFA is inapplicable.

Nonetheless, the Agency has previously

assesssed whether establishing

tolerances or exemptions from

tolerance, raising tolerance levels, or

expanding exemptions adversely impact

small entities and concluded as a

generic matter, that there is no adverse

impact (46 FR 24950, May 4, 1981).

Pursuant to 5 U.S.C. 801(a)(1)(A), EPA

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 the rule in

today’s Federal Register. This rule 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: March 25, 1997.

Daniel M. Barolo,

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 180.1155 is revised to read

as follows:

§ 180.1155 Bacillus thuringiensis

subspecies Kurstaki CryIA(c) and the

genetic material necessary for its

production in all plants; exemption from the

requirement of a tolerance.

Bacillus thuringiensis subspecies

kurstaki CryIA(c) delta-endotoxin and

the genetic material necessary for its

production in all plants are exempt from

the requirement of a tolerance when

used as plant-pesticides in all plant raw

agricultural commodities. ‘‘Genetic

material necessary for its production’’

means the genetic material which

comprise genetic material encoding the

CryIA(c) delta-endotoxin and its

regulatory regions. ‘‘Regulatory regions’’

are the genetic material that control the

expression of the genetic material

encoding the CryIA(c) delta-endotoxin,

such as promoters, terminators, and

enhancers.

[FR Doc. 97–9376 Filed 4–10–97; 8:45 am]

BILLING CODE 6560–50–F