Federal Register / Vol. 60, No. 85 / Wednesday, May 3, 1995 / Rules and Regulations 21725

Governor Tommy G. Thompson of

Wisconsin submitted two letters dated

April 6, 1994 and August 2, 1994

requesting to opt-in the reformulated

gasoline program. The DFRM published

by EPA on January 11, 1995 (60 FR

2693) extended the reformulated

gasoline program to three moderate

ozone nonattainment areas in

Wisconsin: Sheboygan, Manitowoc, and

Kewaunee counties to be effective May

1, 1995 at the terminal and June 1, 1995

at the retail level. The Agency published

a Direct Final Rule because it viewed

the addition of the three ozone

nonattainment areas in Wisconsin to the

RFG program and the May 1/June 1

effective dates as non-controversial

given the level of coordination between

EPA, Wisconsin, and industry on the

opt-in request and thus, anticipated no

adverse or critical comments.

II. Withdrawal of the Wisconsin Opt-in

DFRM

After publication of the DFRM in the

Federal Register, Governor Tommy G.

Thompson of Wisconsin submitted a

letter dated March 31, 1995 requesting

the termination of the federal

reformulated gasoline program slated for

extension to Wisconsin’s three moderate

ozone nonattainment counties of

Sheboygan, Manitowoc, and Kewaunee.

After publication of the DFRM in the

Federal Register, the Agency also

received adverse comments expressing

concern about the economic impact of

the reformulated gasoline program on

Kewaunee County citizens and small

businesses, as well as border/supply

issues. A copy of these comments can be

found in Public Docket A–94–46.

Since receiving the Governor’s letter

and adverse comments which were

submitted to EPA, as was stipulated in

the DFRM, the final rule adding the

three Wisconsin nonattainment areas to

the RFG program is being withdrawn by

today’s action and is effective

immediately. Today’s withdrawal

affects the amendment of § 80.70,

paragraphs (l) and (l)(1) appearing at 60

FR 2693 (January 11, 1995), which were

to become effective March 13, 1995.

EPA is withdrawing this provision to

the reformulated and conventional

gasoline regulations without providing

prior notice and an opportunity to

comment because it finds there is good

cause within the meaning of 5 U.S.C.

553(b) to do so. For the same reasons,

EPA finds it has good cause under 5

U.S.C. 533(d) to make this withdrawal

immediately effective.

III. Statutory Authority

The statutory authority for the action

finalized today is granted to EPA by

Sections 114, 211(c) and (k) and 301 of

the Clean Air Act, as amended; 42

U.S.C. 7414, 7545(c) and (k), and 7601.

IV. Administrative Requirements

A. Administrative Designation

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to OMB review and the

requirements of the Executive Order.

The Order defines ‘‘significant

regulatory action’’ as one that is likely

to result in a rule that may:

(1) have an annual effect on the

economy of $100 million or more or

adversely affect in a material way the

economy, a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local, or tribal governments or

communities;

(2) create a serious inconsistency or

otherwise interfere with an action taken

or planned by another agency;

(3) materially alter the budgetary

impact of entitlements, grants, user fees,

or loan programs or the rights and

obligations of recipients thereof; or,

(4) raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in the Executive Order.

It has been determined that this

withdrawal is not a ‘‘significant

regulatory action’’ under the terms of

Executive Order 12866 and is therefore

not subject to OMB review.

B. Impact on Small Entities

The Regulatory Flexibility Act of 1980

requires Federal agencies to identify

potentially adverse impacts of federal

regulations upon small entities.

Pursuant to section 605(b) of the

Regulatory Flexibility Act, 5 U.S.C.

605(B) et seq., the Administrator

certifies that this regulation will not

have a significant impact on a

substantial number of small entities.

C. Paperwork Reduction Act

The Paperwork Reduction Act of

1980, 44 U.S.C. 3501 et seq., and

implementing regulations, 5 CFR Part

1320, do not apply to this action as it

does not involve the collection of

information as defined therein.

D. Unfunded Mandates Act

Section 202 of the Unfunded

Mandates Reform Act of 1995

(‘‘Unfunded Mandates Act’’), signed

into law on March 22, 1995, EPA must

prepare a budgetary impact statement to

accompany any proposed or final rule

that includes a Federal mandate that

may result in expenditure by State,

local, and tribal governments, in the

aggregate; or by the private sector, of

$100 million or more. Under Section

205, EPA must select the most costeffective and least burdensome

alternative that achieves the objectives

of the rule and is consistent with

statutory requirements. Section 203

requires EPA to establish a plan for

informing and advising any small

governments that may be significantly

or uniquely impacted by the rule.

EPA has determined that the action

promulgated today does not include a

Federal mandate that may result in

estimated costs of $100 million or more

to either State, local or tribal

governments in the aggregate, or to the

private sector. This action has the net

effect of reducing burden of the

reformulated gasoline program on

regulated entities. Therefore, the

requirements of the Unfunded Mandates

Act do not apply to this action.

List of Subjects in 40 CFR Part 80

Environmental protection, Air

pollution control, Fuel additives,

Gasoline, Motor vehicle pollution.

Dated: April 25, 1995.

Carol M. Browner,

Administrator.

40 CFR part 80 is amended as follows:

PART 80—REGULATION OF FUELS

AND FUEL ADDITIVES

1. The authority citation for part 80

continues to read as follows:

Authority: Sections 114, 211 and 301(a) of

the Clean Air Act as amended, (42 U.S.C.

7414, 7545 and 7601(a)).

§ 80.70 [Amended]

2. In § 80.70 paragraph (l) is removed.

[FR Doc. 95–10882 Filed 5–2–95; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[PP 3F4273/R2132; FRL–4953–2]

RIN 2070–AB78

Plant Pesticide Bacillus Thuringiensis

CryIIIA Delta-Endotoxin and the

Genetic Material Necessary for Its

Production; Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is establishing an

exemption from the requirement of a

tolerance for residues of the plant

pesticide active ingredient Bacillus

thuringiensis CryIIIA delta-endotoxin

and the genetic material necessary for
21726 Federal Register / Vol. 60, No. 85 / Wednesday, May 3, 1995 / Rules and Regulations

its production in potatoes. The

Monsanto Co. requested this 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

potatoes.

EFFECTIVE DATE: Effective on May 3,

1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 3F4273/

R2132], may be submitted to: Hearing

Clerk (1900), Environmental Protection

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

Washington, DC 20460. A copy of any

objections and hearing requests filed

with the Hearing Clerk should be

identified by the document control

number and submitted to: Public

Response and Program 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 22202. Fees

accompanying objections 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 objections and requests for

hearings 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 requests for hearings

must be submitted as an ASCII file

avoiding the use of special characters

and any form of encryption. Copies of

objections and requests for hearings will

also be accepted on disks in

WordPerfect in 5.1 file format or ASCII

file format. All copies of objections and

requests for hearings in electronic form

must be identified by the docket number

[PP 3F4273/R2132]. No Confidential

Business Information (CBI) should be

submitted through e-mail. Electronic

copies of objections and requests for

hearings on this rule may be filed online

at many Federal Depository Libraries.

Additional information on electronic

submissions can be found below in this

document.

FOR FURTHER INFORMATION CONTACT: By

mail: Willie H. Nelson, Biopesticides

and Pollution Prevention Division,

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 51B6, CS #1, 2800 Crystal Drive,

Arlington, VA 22202, (703)-308-8128; email: nelson.willie@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of December 8, 1993

(58 FR 64583), which announced that

the Monsanto Co., 700 Chesterfield

Village Parkway, St. Louis, MO 63198,

had submitted a pesticide petition, PP

3F4273, to EPA requesting that the

Administrator, pursuant to section

408(d) of the Federal Food, Drug and

Cosmetic Act (FFDCA), 21 U.S.C.

346a(d), establish an exemption from

the requirement of a tolerance for the

plant pesticide Bacillus thuringiensis

subsp. tenebrionis (B.t.t) Colorado

potato beetle (CPB) control protein

(CryIIIA).

EPA has assigned the active

ingredient of this product the name

Bacillus thuringiensis CryIIIA deltaendotoxin and the genetic material

necessary for its production. ‘‘Genetic

material necessary for production’’

means the CryIIIA gene and its

regulatory regions. ‘‘Regulatory regions’’

are the genetic material that control the

expression of the gene, such as

promoters, terminators, and enhancers.

Monsanto has genetically modified

potato plants to produce the pesticidal

protein derived from the common soil

bacterium Bacillus thuringiensis subsp.

tenebrionis. The protein produced by

CPB-resistant potatoes is identical to

that found in nature. Monsanto has

genetically engineered potatoes by using

plant-expressed vectors that transferred

the CryIIIA and neomycin

phosphotransferase II (nptII) marker

gene into the genomic DNA of the

potato plants. In the Federal Register of

September 28, 1994 (59 FR 49353), EPA

exempted nptII and the genetic material

necessary for its production in or on all

raw agricultural commodities when

used as an inert. There were no adverse

comments or requests for referral to an

advisory committee received in

response to the notice of filing of the

petition, PP 3F4273 (58 FR 64582, Dec.

8, 1993).

Residue Chemistry Data

Residue chemistry data were not

required because of the lack of toxicity

to this active ingredient. This is similar

to the Agency position regarding the

submission of residue data for the

microbial Bacillus thuringiensis

products from which this plant

pesticide was derived. (See 40 CFR

158.740(b).) For microbial products,

residue data are required only when

Tier II or III toxicology data are

required. The kinds of studies submitted

for this plant pesticide are like those in

Tier I, not Tiers II or III. Submitted data

indicated that the product is of low

mammalian toxicity/pathogenicity and

the kinds of studies required in Tier II

or III were not appropriate. Therefore,

no residue data are required in order to

grant an exemption from the

requirement of a tolerance for

Monsanto’s plant pesticide, Bacillus

thuringiensis Cry IIIA delta-endotoxin

protein, the CryIIIA gene and the genetic

material necessary for its production in

potato.

Product Analysis

Monsanto submitted information

which adequately described the CryIIIA

delta-endotoxin from B.t.t., as expressed

in potato, along with the genetic

material necessary for its production.

Because it would be difficult, or

impossible, to extract sufficient

biologically active toxin from the plants

to perform toxicology tests, Monsanto

used delta-endotoxin produced in

bacteria. Product analysis data were

submitted to show that the microbially

expressed and purified CryIIIA deltaendotoxin is sufficiently similar to that

expressed in the plant to be used for

mammalian toxicological purposes.

1. Molecular characterization of CPBresistant Russet Burbank Potatoes

equivalence of microbially produced

B.t.t. protein. The relative size and

number of copies of the DNA inserted

into potatoes was demonstrated with

endonuclease digested chromosomal

DNA from field-grown potato plants

southern blotted with the entire

introduced plasmid PV-STBT02 as the

probe. These southern blots provided

information about the number of copies

of introduced DNA, the lack of

significant amount of DNA introduced

outside the border regions, and integrity

of the introduced DNA near the

endonuclease cut site. These results

indicate only that the DNA necessary to

produce the CryIIIA delta endotoxin

were introduced into the plant, thus

indicating that exposure would only be

to the CryIIIA delta-endotoxin and the

nucleic acids found in the genetic

material necessary for its production.

Such nucleic acids have not, by

themselves, been associated with toxic

effects to animals or humans and are

regular constituents of the human diet.

2. Equivalence of microbially

produced and plant-produced B.t.t.

protein also called Colorado potato

beetle active protein from Bacillus

thuringiensis subsp. tenebrionis.

Microbially produced delta endotoxin

from the CryIIIA gene as expressed in

Escherichia coli and in potato tubers

were compared. The data consists of

SDS-PAGE comigration, Western blot

analysis, staining for carbohydrate

residues, N-terminal amino acid

sequence analysis, and biological
Federal Register / Vol. 60, No. 85 / Wednesday, May 3, 1995 / Rules and Regulations 21727

equivalence against Leptinotarsa

decemlineata. These data are adequate

to support the equivalence of the

microbially produced and plantproduced protein for use in the

toxicology studies.

3. Characterization of the major

tryptic fragment from Colorado potato

beetle active bacillus thuringiensis

subsp. tenebrionis. The purity and

activity of a 55kD protein released with

tryptic digestion of the B.t.t. delta

endotoxin purified from E. coli was

shown to have a similar size,

immunoreactivity, and amino acid

sequence to the 55kD fragment found in

potato tubers. The 55kD protein had

somewhat higher bioactivity than the

68kD full-length delta endotoxin from

B.t.t. These data support the contention

that both the 55kD and 68kD forms of

the CryIIIA delta-endotoxin found in the

plant were similar to those occurring in

B.t.t.

4. Characterization of Colorado potato

beetle active bacillus thuringiensis

subsp. tenebrionis protein produced in

escherichia coli. The method of

preparing by fermentation the delta

endotoxin from B.t.t. in E. coli was

presented. The protein was

characterized for purity and stability

after purification. These data indicate

that normal fermentation techniques

were used to produce the plant

equivalent, microbial CryIIIA deltaendotoxin.

5. Compositional comparison of

Colorado potato beetle (CPB) active

bacillus thuringiensis subsp. tenebrionis

proteins produced in CPB-resistant

potato plants and commercial microbial

products. The CryIIIA delta-endotoxin

as expressed in potato tissue or an E.

coli alternative gives a similar

immunoreactivity and electrophoretic

mobility to registered microbial

products producing the same deltaendotoxin.

Toxicology Assessment

Toxicity

The delta-endotoxin proteins of B.

thuringinesis have been intensively

studied, and no indications of

mammalian toxicity have been reported.

Furthermore, approximately 176

different B. thuringiensis products have

been registered since 1961, and the

Agency has not received any reports of

dietary toxicity attributable to their use.

This is especially significant because

FIFRA section 6(a)(2) requires

registrants to report any adverse effects

to EPA. Therefore, EPA does not expect

any mammalian toxicity from this

protein in plants based on the use

history of B. thuringiensis products.

The data submitted by Monsanto

support the prediction that this protein

would be nontoxic to humans. Adequate

information was submitted to show that

the test material derived from microbial

cultures was essentially identical to the

protein as produced by the potatoes.

Production of a plant equivalent,

microbial CryIIIA delta-endotoxin, was

chosen to obtain sufficient material for

mammalian testing. In addition, the in

vitro digestibility studies indicate the

protein would rapidly be degraded

following ingestion.

The genetic material necessary for the

production of the Bacillus thuringiensis

CryIII(A) delta endotoxin are the nucleic

acids (DNA and RNA) which comprise

the CryIII(A) gene and its controlling

sequences. DNA and RNA are common

to all forms of life, including plants, and

the Agency knows of no instance where

these nucleic acids have been associated

with toxic effects related to the

consumption of food. These ubiquitous

nucleic acids as they appear in the

subject active ingredient have 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

Bacillus thuringiensis CryIII(A) delta

endotoxin in potatoes.

Allergenicity

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

from exposure. Such incidents, should

they occur, are required to be reported

under FIFRA section 6(a)(2) and as a

data requirement for registration of

microbial pesticides (40 CFR 158.740

and Subdivision M of the FIFRA testing

guidelines, NTIS # PB89-211676).

Studies done in laboratory animals or

as reported in the literature also have

not indicated any potential for allergic

reactions to B. thuringiensis or its

components, including the deltaendotoxin in the crystal protein. Recent

in vitro studies also confirm that the

delta endotoxin would be readily

digestible in vivo.

Current scientific knowledge suggests

that common food allergens tend to be

resistant to degradation by heat, acid,

and proteases, are glycosylated, and are

present at high concentrations in the

food. The delta endotoxins are not

present at high concentrations, are not

resistant to degradation by heat, acid

and proteases, and are apparently not

glycosylated when produced in plants.

The company has submitted data to

indicate that the CryIIIA delta endotoxin

is rapidly degraded by gastric fluid in

vitro, is not present as a major

component of food, and is apparently

nonglycosylated when produced in

plants.

Submitted Data

1. Acute oral toxicity of B.t.t. protein.

The B.t.t. proteins were determined to

be stable and the dosing concentrations

were determined to be 74.9 mg/mL,

14.62 mg/mL, and 7.4 mg/mL. B.t.t.

protein was not toxic by oral gavage

when mice were dosed with up to 5220

mg/kg body weight. These results

placed this protein in Tox Category IV.

2. In-vitro digestibility of B.t.t. protein.

The 68 kD and 55kD B.t.t. proteins

degraded within 30 seconds in

simulated gastric fluid when analyzed

by western blot and were not active

against Colorado potato beetles after

degradation. The 68kD B.t.t. protein

degraded to 55kD within 2 hours of

incubation in simulated intestinal fluid.

The 55 kD form remained unchanged

after 14 hours of incubation and

retained its bioactivity and western blot

results. These results indicate that,

following ingestion by humans, the B.t.t.

proteins will be degraded like other

proteins to amino acids and peptides

similar to those occurring in a normal

human diet.

Scientific Advisory Panel Subpanel on

Plant Pesticides

A Subpanel of the FIFRA Scientific

Advisory Panel (SAP) met on March 1,

1995, to discuss the Agency’s

Preliminary Scientific Review for this

use and concluded that ‘‘The Monsanto

B. t. potato presents little potential for

human dietary toxicity. At a dose of one

million-fold greater than that contained

in a potato (a 150-gram potato contains

about 300 micorgrams B.t. protein, 70 kg

person = 4.5 micrograms/kg), no toxicity

was observed. Moreover, several studies

of B.t. potatoes are indistinguishable

from strains of wild-type potatoes in

nutritive content (total protein, total

sugars, vitamin C, minerals, etc.).

Furthermore, the B.t. toxin is rapidly

digested by pepsin and is inactivated by

heat encountered in cooking.’’

Conclusions

In summary, based upon the

submitted studies and other available

information, the Agency does not

foresee any human health hazards from

the use of the Bacillus thuringiensis

CryIII(A) delta-endotoxin and the

genetic material necessary for its

production.

Based upon submitted data and a

review of its use, EPA has found that

when used in accordance with good
21728 Federal Register / Vol. 60, No. 85 / Wednesday, May 3, 1995 / Rules and Regulations

agricultural practice, this ingredient is

useful for the purpose for which the

tolerance exemption is sought. Based on

the information considered, EPA

concludes that a tolerance is not

necessary to protect the public health.

Therefore, the exemption from the

requirement of a tolerance is established

as set forth below.

Acceptable daily intake (ADI) and

maximum permissible intake (MPI)

considerations are not relevant to this

petition because the data and

information submitted demonstrate that

this active ingredient is not toxic to

mammalian species. No enforcement

actions are expected, based upon the

toxicity for this plant pesticide.

Therefore, the requirement for an

analytical method for enforcement

purposes is not applicable to this

exemption request.

Any person adversely affected by this

regulation may, within 30 days after

publication of this document in the

Federal Register, file written objections

and/ or a request for a hearing with the

Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and 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, and must

conform to the other requirements of 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 each such

issue, 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).

A record has been established for this

rulemaking under docket number [PP

3F4273/R2132] (including copies of any

objections and requests for hearings

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 a.m. to

4:30 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Rm. 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.

An electronic copy of objections and

requests for hearings can be sent

directly to EPA at:

opp-Docket@epamail.epa.gov.

A copy of electronic objections and

requests for hearings must be submitted

as an ASCII file avoiding the use of

special characters and any form of

encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copy of objections and

requests for hearings 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 any

objections and requests for hearings

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Under Executive Order 12866 (58 FR

51735, Oct. 4, 1993), the Agency must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

review by the Office of Management and

Budget (OMB) and the requirements of

the Executive Order. Under section 3(f),

the order defines a ‘‘significant’’

regulatory action’’ as an action that is

likely to result in a rule (1) having an

annual effect on the economy of $100

million or more, or adversely and

materially affecting a sector of the

economy, productivity, competition,

jobs, the environment, public health or

safety, or State, local or tribal

governments or communities (also

referred to as ‘‘economically

significant’’); (2) creating serious

inconsistency or otherwise materially

altering the budgetary impacts of

entitlement, grants, user fees, or loan

programs or the rights and obligations or

recipients thereof; or (3) raising novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in this Executive

Order.

Pursuant to the terms of the Executive

Order, EPA has determined that this

rule is not ‘‘significant’’ and is therefore

not subject to OMB review.

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96-

354, 94 Stat. 1164, 5 U.S.C. 601-612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemption from tolerance

requirements do not have a significant

economic effect on a substantial number

of small entities. A certification

statement to this effect was published in

the Federal Register of May 4,1981 (49

FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: April 25, 1995.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

Therefore, 40 CFR part 180 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 subpart D, by adding new

§ 180.1147, to read as follows:

§ 180.1147 Bacillus thuringiensis CryIIIA

delta-endotoxin and the genetic material

necessary for its production.

Bacillus thuringiensis CryIIIA deltaendotoxin and the genetic material

necessary for its production are

exempted from the requirement of a

tolerance when used as a plant pesticide

in potatoes. ‘‘Genetic material necessary

for its production’’ means the CryIIIA

gene and its regulatory regions.

‘Regulatory regions’’ are the genetic

materials that control the expression of

the gene, such as promoters,

terminators, and enhancers.

[FR Doc. 95–10864 Filed 4–28–95; 12:21 pm]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 4F4317/R2125; FRL–4949–4l

RIN No. 2070–AB78

Myclobutanil; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes a

tolerance for the combined residues of

the fungicide myclobutanil and a

metabolite in or on the raw agricultural