41874 Federal Register / Vol. 62, No. 149 / Monday, August 4, 1997 / Rules and Regulations

Subpart R—Kansas

3. Subpart R is amended by adding an

undesignated center heading and

paragraph § 62.4177 to read as follows:

Emissions From Existing Municipal

Waste Combustors With the Capacity

To Burn Greater than 35 Megagrams

Per Day of Municipal Solid Waste

§ 62.4177 Identification of plan—negative

declaration.

Letter from the Kansas Department of

Health submitted April 26 1996,

certifying that there are no municipal

waste combustors in the state of Kansas

subject to part 60, subpart Cb of this

chapter.

Subpart AA—Missouri

4. Subpart AA is amended by adding

an undesignated center heading and

paragraph § 62.6356 to read as follows:

Emissions From Existing Municipal

Waste Combustors With the Capacity

To Burn Greater than 35 Megagrams

Per Day of Municipal Solid Waste

§ 62.6356 Identification of plan—negative

declaration.

Letter from the Air Pollution Control

Program of the Department of Natural

Resources submitted June 3, 1996,

certifying that there are no municipal

waste combustors in the state of

Missouri subject to part 60, subpart Cb

of this chapter.

Subpart CC—Nebraska

5. Subpart CC is amended by adding

an undesignated center heading and

paragraph § 62.6912 to read as follows:

Emissions From Existing Municipal

Waste Combustors With the Capacity

To Burn Greater than 35 Megagrams

Per Day of Municipal Solid Waste

§ 62.6912 Identification of plan—negative

declaration.

Letter from the Air Quality Section of

the Nebraska Department of

Environmental Quality submitted May

13, 1996, certifying that there are no

municipal waste combustors in the state

of Nebraska subject to part 60, subpart

Cb of this chapter.

[FR Doc. 97–20475 Filed 8–1–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300526; FRL–5735–6]

RIN 2070–AB78

Bacillus Cereus Strain BP01;

Exemption From the Requirement of a

Tolerance.

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Rule.

SUMMARY: This rule establishes an

exemption from the requirement of a

tolerance for residues of the biological

pesticide Bacillus cereus strain BP01 for

use on cotton. Micro Flo Company,

acting through their agent SRA

International, submitted a petition to

EPA under the Federal Food, Drug and

Cosmetic Act as amended by the Food

Quality Protection Act of 1996

requesting the tolerance exemption.

This regulation eliminates the need to

establish a maximum permissible level

for residues of Bacillus cereus strain

BP01 on growing crops.

DATES: This regulation is effective

August 4, 1997. Objections and requests

for hearings must be received by EPA on

or before October 3, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number [OPP–300526],

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–

300526], must also be 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, 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 file format

or ASCII file format. All copies of

electronic objections and hearing

requests must be identified by the

docket number [OPP–300526]. 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: James J. Boland, c/o Product

Manager (PM) 90, Biopesticides and

Pollution Prevention Division (7501W),

Environmental Protection Agency, 401

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

Office location, telephone number and

e-mail address: 5th fl., CS #1 2800

Crystal Drive, Arlington, VA 22202,

(703) 308–8728, e-mail:

boland.james@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 25, 1997 (62 FR

34277)(FRL–5727–1) EPA issued a

notice pursuant to section 408(d), of the

Federal Food Drug & Cosmetic Act

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

the filing of a pesticide tolerance

petition by SRA International, 1850 M

Street NW., Suite 290, Washington DC,

20036, on behalf of the Micro Flo

Company, P.O. Box 5948, Lakeland

Florida 33807–5948. 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 (FQPA) of 1996.

The petition requested that 40 CFR part

180 be amended by establishing an

exemption from the requirement of a

tolerance for residues of the biological

pest control agent Bacillus cereus strain

BP01 on growing crops.

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 material have been evaluated.

The toxicology data requirements in

support of this exemption from the

requirement of a tolerance were

satisfied.

I. Risk Assessment and Statutory

Findings

New section 408(c)(2)(A)(i) of the

FFDCA allows EPA to establish an

exemption from the requirement for a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is
Federal Register / Vol. 62, No. 149 / Monday, August 4, 1997 / Rules and Regulations 41875

‘‘safe.’’ Section 408(c)(2)(ii) defines

‘‘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) 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. 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.’’ All available

information indicates that Bacillus

cereus strain BP01 when used in cotton

will have no human toxicity based upon

the lack of mammalian toxicity of this

product and the lack of exposure with

the cotton growth regulator use pattern.

All mammalian toxicology data

requirements have been submitted and

adequately satisfy the requirements as

set forth in 40 CFR 158.740 for

microbial pesticides for food, non-food,

domestic outdoor and forestry uses. The

mammalian toxicology data base

includes acute toxicity studies. To date,

none of the active microbial pesticidal

ingredients registered by the Agency

have required subchronic or chronic

exposure studies. Also, for food uses of

microbial pesticides, the acute toxicity/

pathogenicity studies have allowed for

the conclusion that an exemption from

the requirement of a tolerance is

appropriate and adequate to protect

human health, including that of infants

and children. The results of testing done

on Bacillus cereus and the end use

product Mepichlor/BP01 4-2 agree with

this.

III. Aggregate Exposures

In examining aggregate exposure,

FFDCA section 408 directs EPA to

consider available information

concerning exposures from the pesticide

residue in food and all other nonoccupational exposures, including

drinking water from ground water or

surface water and exposure through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses).

1. Dietary exposure— a. Food. While

the proposed use pattern will result in

dietary exposure with possible residues

on food and feed, negligible risk is

expected for both the general population

and infants and children. Submitted

acute toxicology tests confirm that based

upon the use sites, use patterns,

application method, use rates, low

exposure, and lack of significant

toxicological concerns, the potential

risks, if any, to humans are considered

negligible and an exemption from the

requirement of a tolerance is warranted.

Acute exposure could occur from the

proposed outdoor use sites but would be

very low because of the low

applications rates. The application rate

is 2 to 24 fl.oz./A based on growth stage

of the crop and previous application

history. In considering health risk from

microbial pesticides, it is important to

recognize the ubiquitous nature of

microorganisms. Most microorganisms

are considered to be non-pathogenic for

humans, despite the continual exposure

to high numbers of a myriad of airborne,

waterborne, food and soil associated

microorganisms as well as human and

mammalian commensal microbes on a

daily basis. Bacillus cereus has been

implicated in nosocomial infections in

rare instances and in food poisoning

incidents. The quality control

procedures have ensured that the

diarrheal enterotoxin is not present in

this product. In summary, the Agency

believes that the potential aggregate

exposure, derived from dermal and

inhalation exposure via mixing, loading

and applying Bacillus cereus, the oral

dietary exposure drinking water

containing B. cereus strain BP01, should

fall well below the currently tested

microbial safety levels. There have been

no confirmed reports of immediate or

delayed allergic reactions to despite

significant oral, dermal and inhalation

exposure to the microbial product.

Therefore, the lack of toxicity associated

with Bacillus cereus strain BP01, data

relating to the post application die-off of

B. cereus species v background soil

population counts of naturally occurring

microbes provides a scientific rationale

for exempting B. cereus strain BP01

from the requirement of a tolerance.

b. Drinking water exposure. The

microorganism Bacillus cereus is

ubiquitous in many soils throughout the

world. Bacillus cereus is not known as

an aquatic bacterium and therefore is

not expected to proliferate in aquatic

habitats. Although the potential exists

for a minimal amount of the B. cereus

strain BP01 which is applied to enter

ground water or other drinking water

sources, the amount would in all

probability be undetectable or more

than several orders of magnitude lower

than those levels which were tested and

are considered necessary for safety.

Moreover, Bacillus cereus strain BP01 is

not considered to be a risk to drinking

water. Drinking water is accordingly not

being screened for B. cereus as a

potential indicator of microbial

contamination or as a direct pathogenic

contaminant. Both percolation through

soil and municipal treatment of

drinking water would reduce the

possibility of exposure to B. cereus

strain BP01 through drinking water.

Therefore, the potential of significant

transfer to drinking water is minimal to

nonexistent.

2. Other non-occupational exposures.

All mammalian toxicology data

requirements have been submitted and

adequately satisfy the requirements as

set forth in 40 CFR 158.740 for

microbial pesticides for food, non-food,

domestic outdoor and forestry uses. The

mammalian toxicology data base

includes acute toxicity studies. Based

on the use sites, use patterns,

application method, use rates, low

exposure, and lack of significant

toxicological concerns, as demonstrated

in the submitted toxicology studies, the

potential risks, if any, to humans are

considered negligible.

a. Dermal exposure. Exposure via the

skin would be the primary route of

exposure for mixer/loader applicators.

Since unbroken skin is a natural barrier

to microbial invasion of the human

body, dermal absorption could occur

only if the skin were cut, if the microbe

were a pathogen equipped with

mechanisms for entry through or

infection of the skin, or if metabolites

were produced that could be dermally

absorbed. Based on the application

methods, the potential for dermal
41876 Federal Register / Vol. 62, No. 149 / Monday, August 4, 1997 / Rules and Regulations

exposure exists for pesticide handlers

and applicators. The Agency is

requiring the appropriate signal word

and statements of precaution.

b. Inhalation Exposure. Inhalation

would be the primary route of exposure

for mixer/loader applicators. The

pulmonary study showed no adverse

effects; the risks anticipated for this

route of exposure are considered

minimal.

IV. Safety Factors

The toxicity of Bacillus sp. is well

established. No tolerance is needed

since the proposed uses do not include

food/feed uses. The information

submitted to support the acute toxicity

waiver requests, supplemented by

available public data, indicate category

IV for acute oral toxicity, category III for

acute dermal toxicity, category III for

primary eye irritation, category IV for

primary dermal irritation, and that

Bacillus cereus strain BP01 is not a

dermal sensitizer. Bacillus cereus has

been implicated in nosocomial

infections in rare instances and in food

poisoning incidents. The quality control

procedures have ensured that the

diarrheal enterotoxin is not present in

this product.

V. Infants and Children

Consistent with section 408(b)(2)(C) of

the FFDCA, EPA has assessed 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. A

battery of acute toxicity/pathogenicity

studies is considered sufficient by the

Agency to perform a risk assessment for

microbial pesticides. To date, none of

the active microbial pesticidal

ingredients registered by the Agency

have required subchronic or chronic

exposure studies. Also, for food uses of

microbial pesticides, the acute toxicity/

pathogenicity studies have allowed for

the conclusion that an exemption from

the requirement of a tolerance is

appropriate and adequate to protect

human health, including that of infants

and children. The results of testing done

on B. cereus strain BP01 and Mepichlor/

BP01 4-2 agree with this. Quality

control procedures in place during

manufacturing ensure that harmful

levels of contaminating microorganisms

are prevented and the mammalian

enterotoxin is not present. In

considering health risk from microbial

pesticides, it is important to keep the

ubiquitous nature of microorganisms in

mind. Most microorganisms are

considered to be non-pathogenic for

humans, despite the continual exposure

to high numbers of a myriad of airborne,

waterborne, food and soil associated

microorganisms, as well as human and

mammalian commensal microbes, on a

daily basis.

VI. Other Considerations

1. Endocrine disrupters. There is no

known metabolite that acts as an

‘‘endocrine disrupter’’ produced by this

microorganism. As expected from nonpathogenic microorganism, the

submitted toxicity/pathogenicity studies

in the rodent (required for microbial

pesticides) indicate that following

several routes of exposure, the immune

system is still intact and able to process

and clear the active ingredient.

Therefore, no adverse effects to the

endocrine or immune systems are

known or expected. The Agency is not

requiring information on the endocrine

effects of this biological pesticide at this

time; Congress has allowed 3 years after

August 3, 1996, for the Agency to

implement a screening program with

respect to endocrine effects.

2. Analytical method. The Agency

proposes to establish 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 Bacillus cereus strain

BP01.

VII. Determination of Safety for U.S.

Population, Infants and Children

For the U.S. population, including

infants and children, the Agency has not

identified any subchronic, chronic,

immune, endocrine, dietary, or

nondietary exposure issues as they may

affect infants and children and the

general population. Risks to applicators

are mitigated when the product is used

according to label directions. Therefore,

EPA concludes that there is reasonable

certainty that no harm will result to the

U.S. population from aggregate exposure

to residues of Bacillus cereus BP01

microbial plant growth regulator

including 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

Bacillus cereus strain BP01. Thus, a

tolerance for Bacillus cereus strain BP01

is not necessary to protect the public

health. Therefore, 40 CFR part 180 is

amended as set forth below.

VIII. 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.

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 may, by October 3, 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

issues(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

issues(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
Federal Register / Vol. 62, No. 149 / Monday, August 4, 1997 / Rules and Regulations 41877

may be disclosed publicly by EPA

without prior notice.

IX. Public Docket

A record has been established for this

rulemaking under docket control

number [OPP–300526]. 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 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 22202.

Electronic comments can 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, is kept in

paper form. Accordingly, in the event

there are objections and hearing request,

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.

X. 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.

XI. 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: July 30, 1997.

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.C.C. 346a and 371

2. Section 180.1181 is added to read

as follows:

§ 180.1181 Bacillus cereus strain BP01;

exemption from the requirement of a

tolerance.

An exemption from the requirement

of a tolerance is established for residues

of the microbial plant regulator Bacillus

cereus strain BP01 in or on cottonseed.

[FR Doc. 97–20561 Filed 8-1-97 ; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

45 CFR Part 74

Miscellaneous Amendments

AGENCY: Department of Health and

Human Services, (HHS).

ACTION: Final rule.

SUMMARY: This final rule will remove

appendixes I and J, which contain the

text of Office Management and Budget

(OMB) Circulars A–128 and A–133,

from 45 CFR part 74. It will also update

several items to conform them to the

Federal Acquisition Streamlining Act of

1994 and correct a confusing statement

which resulted from two typographical

errors in that portion of OMB Circular

A–110 upon which this statement is

based.

EFFECTIVE DATE: This rule is effective

September 3, 1997.

FOR FURTHER INFORMATION CONTACT:

Charles Gale, Director, Office of Grants

Management, 202–690–6377; for the

hearing impaired only: TDD 202–690–

6415.

SUPPLEMENTARY INFORMATION: Pursuant

to the President’s Regulatory Reform

Initiative, we have identified

appendixes I and J of 45 CFR part 74 as

unnecessary. These appendixes are

being removed because they simply

repeat the texts of Circulars A–133 (an

out-of-date version of the Circular) and

A–128 respectively. In addition, various

references to appendixes I and J are also

being removed.

Copies of Circulars A–128 and A–133

are widely available electronically; they

may also be obtained from OMB and

from the HHS Office of Grants

Management.

We are also making the following

non-substantive changes and

corrections:

1. We are updating the definition of

‘‘small awards’’ in section 74.2 and

changing ‘‘small purchase’’ threshold to

‘‘simplified acquisition’’ threshold

everywhere that it appears. These

actions are to conform these terms to the

Federal Acquisition Streamlining Act of

1994 (FASA) (108 Stat. 3243).