Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations 52505

Authority: 38 U.S.C. 501, 3701–3704, 3707,

3710–3714, 3719, 3720, 3729, 3762, unless

otherwise noted.

2. In § 36.4306a, paragraphs (a)(3)

through (a)(5) are revised and

paragraphs (a)(6) and (a)(7) are added, to

read as follows:

§ 36.4306a Interest rate reduction

refinancing loan.

(a) * * *

(3) The monthly principal and interest

payment on the new loan must be lower

than the payment on the loan being

refinanced, except when the term of the

new loan is shorter than the term of the

loan being refinanced; or the new loan

is a fixed-rate loan that refinances a VAguaranteed adjustable rate mortgage; or

the increase in the monthly payments

on the loan results from the inclusion of

energy efficient improvements, as

provided by § 36.4336(a)(4); or the loan

is approved by the Secretary in advance

after determining that the new loan is

necessary to prevent imminent

foreclosure and the veteran qualifies for

the new loan under the credit standards

contained in § 36.4337.

(4) The amount of the refinancing

loan may not exceed:

(i) An amount equal to the balance of

the loan being refinanced, which must

be current, except in cases described in

paragraph (a)(5) of this section, and

such closing costs as authorized by

§ 36.4312(d) and a discount not to

exceed 2 percent of the loan amount; or

(ii) In the case of a loan to refinance

an existing VA-guaranteed or direct loan

and to improve the dwelling securing

such loan through energy efficient

improvements, the amount referred to

with respect to the loan under

paragraph (a)(4)(i) of this section, plus

the amount authorized by

§ 36.4336(a)(4).

(Authority: 38 U.S.C. 3703, 3710)

(5) In any case where the loan being

refinanced is delinquent, the new loan

will be guaranteed only if it is approved

by the Secretary in advance after

determining that the veteran qualifies

for the loan under the credit standards

contained in § 36.4337. In such cases,

the term ‘‘balance of the loan being

refinanced’’ shall include any past due

installments, plus allowable late

charges.

(6) The dollar amount of guaranty on

the 38 U.S.C. 3710(a)(8) or (a)(9)(B)(i)

loan may not exceed the original dollar

amount of guaranty applicable to the

loan being refinanced, less any dollar

amount of guaranty previously paid as

a claim on the loan being refinanced;

and

(7) The term of the refinancing loan

(38 U.S.C. 3710(a)(8)) may not exceed

the original term of the loan being

refinanced plus ten years, or the

maximum loan term allowed under 38

U.S.C. 3703(d)(1), whichever is less. For

manufactured home loans that were

previously guaranteed under 38 U.S.C.

3712, the loan term, if being refinanced

under 38 U.S.C. 3710(a)(9)(B)(i), may

exceed the original term of the loan but

may not exceed the maximum loan term

allowed under 38 U.S.C. 3703(d)(1).

(Authority: 38 U.S.C. 3703(c)(1), 3710(e)(1))

* * * * *

3. In § 36.4337, paragraph (a) is

revised to read as follows:

§ 36.4337 Underwriting standards,

processing procedures, lender

responsibility and lender certification.

(a) Use of standards. The standards

contained in paragraphs (c) through (j)

of this section will be used to determine

that the veteran’s present and

anticipated income and expenses, and

credit history are satisfactory. These

standards do not apply to loans

guaranteed pursuant to 38 U.S.C.

3710(a)(8) except for cases where the

Secretary is required to approve the loan

in advance under § 36.4306a.

(Authority: 38 U.S.C. 3703, 3710)

* * * * *

[FR Doc. 97–26614 Filed 10–7–97; 8:45 am]

BILLING CODE 8320–01–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300552; FRL–5745–2]

RIN 2070–AB78

Glyphosate Oxidoreductase and the

Genetic Material Necessary for Its

Production in All Plants; Exemption

From Tolerance Requirement 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 plantpesticide inert ingredients glyphosate

oxidoreductase (GOX) and the genetic

material necessary for its production in

all plants when used as plant-pesticides

in or on all raw agricultural

commodities (RACs). Monsanto

Company submitted a petition to EPA

under the Federal Food, Drug, and

Cosmetic Act (FFDCA) as amended by

the Food Quality Protection Act of l996

(FQPA) 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 RACS.

DATES: This regulation is effective on

October 8, 1997. Written objections and

requests for hearings must be received

by EPA on or before December 8, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number OPP–300552,

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

OPP–300552 and submitted to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7506C), 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. 1132, Crystal Mall #2,

1921 Jefferson Davis Highway,

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:

opp-docket@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–300552.

No Confidential Business Information

(CBI) should be submitted through email. Additional information on CBI can

be found in VII. of this document.

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 document.

FOR FURTHER INFORMATION CONTACT: By

mail: Mike Mendelsohn, Biopesticides

and Pollution Prevention Division,

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number, and
52506 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations

e-mail address: 5th Floor Crystal

Station, 2800 Crystal Drive, Arlington,

VA , (703) 308–8715); e-mail:

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

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

the filing of a pesticide petition for an

exemption from the requirement for a

tolerance by Monsanto Company, 700

Chesterfield Parkway, North St. Louis,

MO 63198. 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 FQPA (Pub. L. 104–

170). The petition requested that an

exemption from the requirement of a

tolerance be established for the plantpesticides GOX and the genetic material

necessary for its production in plants in

or on all RACS. There were no

comments or requests for referral to an

advisory committee received in

response to the notice 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. Risk Assessment and Statutory

Findings

New section 408(c)(2)(A)(I) of FFDCA

allows EPA to establish an exemption

from the requirement of a tolerance (the

legal limit for a pesticide chemical

residue in or on a food) only if EPA

determines that the tolerance is ‘‘safe’’

to mean that ‘‘there is a reasonable

certainty that no harm will result from

aggregate exposure to the pesticide

chemical residue, including all

anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(c)(2)(B) of FFDCA requires EPA to

give special consideration to exposure

of infants and children to the pesticide

chemical residue in establishing a

tolerance and to ‘‘ensure that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to the pesticide

chemical residue...’’ EPA performs a

number of analyses to determine the

risks from aggregate exposure to

pesticide residues. First, EPA

determines the toxicity of pesticides.

Second, EPA examines exposure to the

pesticide through food, drinking water,

and through other exposures that occur

as a result of pesticide use in residential

settings.

II. Aggregate Risk Assessment and

Determination of Safety

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 reliablitiy and the

relationship of this information to

human risk. EPA has sufficient data to

assess the hazards of glyphosate

oxidoreductase (GOX), and to make a

determination on aggregate exposure,

consistent with section 408(c)(2) of

FFDCA, for an exemption from the

requirement of a tolerance for residues

GOX in or on all RACS. EPA’s

assessment of the dietary exposures and

risks associated with establishing the

exemption follows.

A. Toxicological Profile

Glyphosate oxidoreductase (GOX)

catalyzes the conversion of glyphosate

to aminomethylphosphonic acid

(AMPA) and glyoxylate in a 1:1

stoichiometry while consuming 1⁄2 mole

of oxygen as a cosubstrate. GOX requires

flavin adenine dinucleotide (FAD) and

magnesium for activity; therefore, it is

more appropriately designated an

apoenzyme.

The gene for Gox was originally

isolated from Achromobacter sp. Strain

LBAA. The GOX protein was then

sequenced and the gene was

synthesized with an added signal

sequence and the codons modified in

the guanine and cytosine nucleic acid

(GC) content to yield higher plant

expression. Two modified GOX proteins

are specified in this rule. They are

designated GOX and GOXv247. Both

versions have an identifier of ‘‘(M4–

C1)’’ in the data submissions which

indicates that the protein was expressed

in E. coli for testing purposes. The GOX

protein retains the same amino acid

sequence as the native protein and has

additional four amino acid sequence Nterminus (reminanats of an added signal

sequence). In GOXv247, the gene

sequence of the native protein was

altered resulting in changes to three

amino acids in the sequence of the

resulting protein along with the remains

of the added signal sequence mentioned

previously. These changes did not

negatively affect the enzymatic activity

of either protein.

The GOX variants GOX and

GOXv247, expressed in E. coli and

originating from the synthetic GOX gene

optimized for protein expression in

plants, showed similarity to the native

GOX protein when expressed in E. coli.

These similarities are seen as

comparable molecular weights,

immunoreactivity, amino acid sequence

and enzymatic activity.

The data submitted regarding

potential health effects of GOX and

GOXv247 includes information on the

characterization of the expression of

GOX in corn, the acute oral toxicity of

GOX and GOXv247, and in vitro

digestibility studies of the proteins. The

applicability of the results of these

studies to evaluate human risk and the

validity, completeness, and reliability of

the available data from the studies were

considered.

Both variants of the GOX protein

(GOX and GOXv247) are rapidly

degraded in simulated gastric fluid (GF)

and simulated intestinal fluid (IF). After

a fifteen-second incubation in GF, both

variants have less than 90% of their

initial protein epitopes by western blot

analysis. Enzyme activity loss is also

greater than 90% in both GOX variants

when assayed after a 1-minute

incubation in GF. Similar results are

seen in simulated IF. Western blot

assays show that both variants are

greater than 90% degraded by 30-second

incubation in IF. However, the enzyme

activity assays show that the GOX

activity lasts longer in IF than variant

GOXv247. After a 10-minute IF

incubation, the activity decreased to

about 48% of initial for GOX whereas

GOXv247 was already greater than 90%

inactive.

Two findings, found in the in vitro

digestibility studies, that are remarkable

are: GOXv247 displays a more rapid

degradation in the IF compared to

unaltered GOX, apparently due to the

single amino acid substitutions; and

antibody recognition is lost prior to a

significant loss of enzyme activity

indicating that western blots may not

always accurately track functional

protein degradation.

None of the amino acid sequences of

known allergens or proteins involved in

coeliac disease were shown to have

similarity to the GOX protein as defined

by eight identical and contiguous amino

acids in a sequence. However, the

assertion that a lack of allergenicity can

be established by comparison of

sequences to known allergens is

questionable. While this is the best

approximation at present, there is no

scientific basis to assume that the

presence of eight contiguous and

homologous amino acids in a protein

will predict its allergenicity. The

assumption is based on the finding that

the presence of an eight amino acid

sequence in one allergen was associated

with the epitope responsible for IgE

recognition. Alteration of this sequence
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations 52507

reduced IgE binding and hence

allergenicity. The converse experiment,

to introduce the sequence into a nonallergenic protein and create an

allergen, has not been attempted

experimentally.

The acute oral toxicity test of

bacterially-derived GOX and GOXv247

proteins showed no test substance

related deaths at doses of 91.3

milligrams per kilogram (mg/kg) and

104 μg/kg respectively. Expression data

on the GOX protein expressed in corn

grains ranges from undetectable levels

to a high of 11.70 micro grams per gram

(mg/g) freshweight. This indicates that it

would require 8,547 kg corn grain per kg

bodyweight to receive the 100 mg/kg

dose that was administered to the mice.

However, residue chemistry data were

not required for a human health effects

assessment of the subject plant-pesticide

inert ingredients because of the lack of

mammalian toxicity. Both available

information concerning the dietary

consumption patterns of consumers

(and major identifiable subgroups of

consumers including infants and

children) and 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. [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 GOX

proteins 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

levels, the GOX protein is not

considered toxic.

Adequate information was submitted

to show that the GOX test materials

derived from microbial cultures was

biochemically and, functionally similar

to the proteins produced by the plantpesticide inert 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 genetic

material encoding these proteins and)

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 plant-pesticide inert 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

subject active and inert plant pesticidal

ingredients.

B. 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 GOX 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 are

present at high concentrations in the

food. Data has been submitted which

demonstrate that the GOX proteins are

rapidly degraded by gastric fluid in vitro

and are non-glycosylated. Thus, the

potential for the GOX proteins to be a

food allergens is minimal.

C. Cumulative Effects

The Agency has considered available

information on the cumulative effects of

such residues and other substances that

have a common mode 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 plantpesticides, there are no cumulative

effects.

D. 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 food

products and drinking water. However a

lack of mammalian toxicity and the

digestibility of the plant-pesticides has

been demonstrated. Regarding exposure

via residential or lawn use to infants

and children, the Agency concludes that

such exposure would present no risk

due to the lack of toxicity.

Section 408 of FFDCA provides that

EPA shall apply an additional 10-fold

margin of exposure (MOE) (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 MOE (safety) will be safe

for infants and children. In this instance

EPA believes there is reliable data to

support the conclusion that the plantpesticides 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 MOE does not

apply.

III. Endocrine Effects

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.

IV. Analytical Method

The Agency is establishing an

exemption from the requirement of a

tolerance without numerical limitation;

therefore, it has concluded that an

analytical method is not required for

enforcement purposes for GOX and the

genetic material necessary for their

production.
52508 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations

V. 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

GOX protein and the genetic material

necessary for that 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 section

408(j)(3) of FFDCA for GOX and the

genetic material necessary for their

production in all plants.

Glyphosate Oxidoreductase [GOX or

GOXv247] and the genetic material

necessary for its production in all plants

are exempt from the requirement of a

tolerance when used as plant-pesticide

inert ingredients in all plant RACs.

‘‘Genetic material necessary for its

production’’ means the genetic material

which comprise genetic material

encoding the GOX proteins and their

regulatory regions. ‘‘Regulatory regions’’

are the genetic material that control the

expression of the genetic material

encoding the GOX proteins, such as

promoters, terminators, and enhancers.

VI. 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) of FFDCA as was

provided in the old section 408 and in

section 409 of FFDCA. 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 December 8, 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 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).

VII. Confidential Business Information

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 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 Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number OPP–300552 (including any

comments and data submitted

electronically). A public version of this

record, including printed, paperversions

of electronic comments, which does not

in 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 Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), 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 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. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

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), 44U.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)

(P.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
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations 52509

to the Chief Counsel for Advocacy of the

Small Business Administration.

X. 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: September 25, 1997.

Stephen L. Johnson,

Acting 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 180.1190 is added to

subpart D to read as follows:

§ 180.1190 Glyphosate Oxidoreductase

[GOX or GOXv247] and the genetic material

necessary for its production in all plants;

exemption from the requirement of a

tolerance.

Glyphosate Oxidoreductase [GOX or

GOXv247] and the genetic material

necessary for its production in all plants

are exempt from the requirement of a

tolerance when used as plant-pesticide

inert ingredients in all plant RACs.

Genetic material necessary for its

production means the genetic material

which comprise genetic material

encoding the GOX proteins and their

regulatory regions. Regulatory regions

are the genetic material that control the

expression of the genetic material

encoding the GOX proteins, such as

promoters, terminators, and enhancers.

[FR Doc. 97–26190 Filed 10–7–97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF THE INTERIOR

Office of the Secretary

43 CFR Part 36

RIN 1093–AA07

Transportation and Utility Systems In

and Across, and Access Into,

Conservation System Units in Alaska

AGENCY: Office of the Secretary, Interior.

ACTION: Final rule.

SUMMARY: The Department of the

Interior is implementing this final rule

to revise and simplify the regulatory

definition of the term ‘‘economically

feasible and prudent alternative route’’

as used in the review of proposed

transportation and utility systems in

Alaska under Title XI of the Alaska

National Interest Lands Conservation

Act (ANILCA).

DATES: Effective date: This rule becomes

effective November 7, 1997.

Compliance date: This rule will apply

to agency decisionmaking under

ANILCA Title XI beginning November 7,

1997.

FOR FURTHER INFORMATION CONTACT:

David A. Funk, Alaska Field Office,

National Park Service, 2525 Gambell

Street, Room 107, Anchorage, AK

99503–2892. Phone: (907) 257–2589.

SUPPLEMENTARY INFORMATION:

Background

On December 2, 1980, the Alaska

National Interest Lands Conservation

Act (ANILCA) was signed into law as

Public Law 96–487 (94 Stat. 2371, 16

U.S.C. 3101, et seq.). Title XI of

ANILCA, which is entitled

‘‘Transportation and Utility Systems In

and Across, and Access Into,

Conservation System Units,’’

established guidelines and procedures

for submitting and processing

applications for transportation and

utility systems (TUS) in Alaska when

any portion of the route or the system

will be within any conservation system

unit, national recreation area, or

national conservation area. In addition,

Title XI authorizes special access,

temporary access, and access to

inholdings.

On July 15, 1983, the Department of

the Interior (Department) proposed

comprehensive regulations to

implement ANILCA Title XI on lands in

Alaska under the jurisdiction of the

National Park Service (NPS), the U.S.

Fish and Wildlife Service (FWS), and

the Bureau of Land Management (BLM)

(48 FR 32506). On September 4, 1986,

the Department published final Title XI

regulations (51 FR 31619).

In early 1987, the Trustees for Alaska

and other groups (Trustees) sued the

Department to challenge the Title XI

regulations as exceeding the authority

granted to the Department by ANILCA.

Parties intervening in the case included

Arctic Slope Regional Corporation, the

Alaska Miners Association, the Alaska

Forest Association, and the Resource

Development Council for Alaska, Inc. In

orders dated April 29, 1991, and March

16, 1993, the U.S. District Court for the

District of Alaska granted summary

judgment to the Department. The

Trustees appealed the lower court’s

decision to the U.S. Court of Appeals for

the Ninth Circuit, which assigned the

case to a mediator to explore whether

review and possible revision of the Title

XI regulations might provide a basis for

settlement.

On September 17, 1996, the

Department proposed (61 FR 48873) one

revision to the 1986 regulations in order

to improve the regulations’ workability

and reduce the opportunities for delays

in decisionmaking. The proposal

followed substantial review and

consultation with interested parties both

within and outside the Department. The

proposal provided an additional

advantage of offering a focus for the

consensus necessary to settle the

longstanding litigation. The litigation

was dismissed on August 30, 1996,

subject to reinstatement if the final

regulations differed from the proposal.

The Department did not propose any

other revisions of the Title XI

regulations. Thus, for example, the 1986

regulations implementing the Title XI

provisions concerning access to

inholdings, special access, and

temporary access will remain intact.

Also, the Department did not propose

any changes to the regulatory provisions

governing access to subsistence

resources under Title VIII of ANILCA

(see 36 CFR 13.46 (NPS) and 50 CFR

36.12 (FWS)). Finally, neither the

proposed nor this final rule concerns

recognition or management of R.S. 2477

rights-of-way.

Summary of Public Comments

Six comments were received in

response to publication of the proposed

rule. None of the responses objected to

the proposed revision of 43 CFR 36.2(h).

The Alaska Department of Law stated

that the revision would be consistent

with the August 30, 1996, Order issued

by the United States Court of Appeals

for the Ninth Circuit in Trustees for

Alaska v. United States Department of

the Interior, No. 93–35493 (Trustees).

The Department of Law added,

however, that the State does not

necessarily concur with the facts and