63950 Federal Register / Vol. 69, No. 212 / Wednesday, November 3, 2004 / Rules and Regulations 

* * * * *

[FR Doc. 04–24532 Filed 11–2–04; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0215; FRL–7684–4]

Bacillus Pumilus Strain QST 2808; 

Exemption From the Requirement of a 

Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the Bacillus 

pumilus strain QST 2808 in or on food 

commodities when applied/used in 

accordance with label directions. 

AgraQuest, Inc submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA), requesting an exemption from 

the requirement of a tolerance. 

Notification that EPA had received the 

petition was published on May 5, 2004 

(69 FR 25092) (FRL–7354–4). This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Bacillus pumilus strain 

QST2808.

DATES: This regulation is effective 

November 3, 2004. Objections and 

requests for hearings must be received 

on or before January 3, 2005.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VIII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2004–

0215. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

Barbara Mandula, Biopesticides and 

Pollution Prevention Division (7511C), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–7378; e-mail address: 

mandula.barbara@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to:

• Crop production/Agriculture 

(NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 

32532)

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions. If 

you have any questions regarding the 

applicability of this action to a 

particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information?

In addition to using EDOCKET (http:/

/www.epa.gov/edocket/), you may 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

In the Federal Register of May 5, 2004 

(69 FR 25092) (FRL–7354–4), EPA 

issued a notice pursuant to section 

408(d)(3) of the FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 4F6926) 

by AgraQuest, Inc, 1530 Drew Avenue, 

Davis, CA 95616. This notice included 

a summary of the petition prepared by 

the petitioner AgraQuest, Inc. There 

were no comments received in response 

to the notice of filing.

The petition requested that 40 CFR 

part 180 be amended by establishing a 

permanent exemption from the 

requirement of a tolerance for residues 

of Bacillus pumilus strain QST 2808. 

EPA previously had granted the 

petitioner a temporary exemption from 

the requirement of a tolerance for 

residues of Bacillus pumilus strain QST 

2808, which was published on June 18, 

2003 (68 FR 36476)(FRL–7301–1). That 

temporary exemption is set to expire 

June 30, 2006.

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 exemption is ‘‘safe.’’

Section 408(c)(2)(A)(ii) of the FFDCA 

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. Pursuant to 

section 408(c)(2)(B), in establishing or 

maintaining in effect an exemption from 

the requirement of a tolerance, EPA 

must take into account the factors set 

forth in section 408(b)(2)(C), which 

require 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. . . .’’ Additionally, section 

408(b)(2)(D) of the FFDCA requires that 

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.’’

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. 

III. Toxicological Profile

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

of the FFDCA, EPA has reviewed the 

available scientific data and other 

Federal Register / Vol. 69, No. 212 / Wednesday, November 3, 2004 / Rules and Regulations 63951

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.

Bacillus pumilus strain QST 2808 is a 

ubiquitous and naturally occurring 

bacterium commonly found in soil. The 

results of the acute toxicology and 

pathogenicity studies previously 

submitted by the petitioner in support 

of its petition for a temporary exemption 

from the requirement of a tolerance for 

Bacillus pumilus strain QST 2808 

indicate negligible to no mammalian 

toxicity. In addition, no pathogenicity 

was observed in any of the tests 

conducted with the Bacillus pumilus

strain QST 2808 Technical product. 

Accordingly, the toxicology and 

pathogenicity data generated by 

AgraQuest, Inc in support of the 

temporary exemption from the 

requirement of a tolerance also support 

a permanent exemption from the 

requirements of a tolerance. This data is 

summarized in more detail below.

1. Acute oral toxicity and 

pathogenicity (OPPTS 885.3050; MRID 

451366–04). Fifteen male and fifteen 

female rats each were administered 4.1 

x 109 colony forming unit (cfu) of B. 

pumilus strain QST 2808 Technical and 

observed for 14 days. Based on the data, 

B. pumilus strain QST 2808 does not 

appear to be toxic, infective, and/or 

pathogenic in rats, when dosed at 4.1 x 

109 cfu/animal. Classification: 

Acceptable; Toxicity Category IV.

2. Acute dermal toxicity (OPPTS 

885.3100; MRID 451366–05). Five male 

and five female rabbits were dermally 

treated with 2g/kg body weight B. 

pumilus strain QST 2808 Technical for 

24 hours and observed for the following 

14 days. The acute lethal dose (LD)50 is 

greater than 2,000 mg/kg. Classification: 

Acceptable; Toxicity Category III.

3. Primary eye irritation (OPPTS 

870.2400; MRID 452679–01). Three male 

rabbits each were administered 0.1 

milliliters (mL) of QST 2808 Technical 

in the everted lower lid of one eye and 

then observed for 72 hours. Based on 

the data, QST 2808 Technical showed 

minimal effects to the eye. 

Classification: Acceptable; Toxicity 

Category IV.

4. Acute injection toxicity/

pathogenicity (OPPTS 885.3200; MRID 

451366–07). Eighteen male and eighteen 

female rats each were dosed at 1.6 x 108

cfu Bacillus pumilus strain QST 2808 

Technical intravenously and monitored 

over a period of 28 days. A gross 

necropsy was performed on all rats. 

Based on the data, the test organism was 

not toxic, infective, or pathogenic to 

rats. Classification: Acceptable.

5. Acute pulmonary toxicity/

pathogenicity (OPPTS 885.3150; MRID 

451366–06). Eighteen male and eighteen 

female rats each were administered 1.6 

x 108 cfu Bacillus pumilus strain QST 

2808 Technical in a single intratracheal 

dose and monitored over a period of 35 

days for clinical signs of toxicity. 

Necropsy studies showed no significant 

signs of abnormalities due to the test 

organism. Based on the data, B. pumilus

strain QST 2808 was not toxic, infective, 

and/or pathogenic to rats when dosed at 

1.6 x 108 cfu/animal. Classification: 

Acceptable.

6. Acute inhalation toxicity (OPPTS 

870.1300). Results of the acute 

pulmonary toxicity/pathogenicity 

(MRID 451366–06) performed with 

Bacillus pumilus strain QST 2808 

Technical indicate that it is not toxic, 

infective, and/or pathogenic to rats 

when dosed at 1.6 x 108 cfu/animal. For 

the purposes of this specific action, the 

Agency has determined that the acute 

pulmonary toxicity/pathogenicity data 

are adequate to support and/or fulfill 

this particular data requirement.

7. Primary dermal irritation (OPPTS 

870.2500; MRID 452679–02). Each of 

three male adult rabbits were treated 

dermally with 0.5 mL QST 2808 

Technical for 4 hours and observed for 

the following 72 hours. Based on the 

data, no abnormal clinical signs were 

noted. Approximately 60 minutes after 

patch removal, very slight erythema was 

noted on one of the three rabbits with 

resolution by 24 hours. When dosed 

with QST 2808 Technical at 0.5 mL/

animal, QST 2808 Technical was 

essentially non-irritating. Classification: 

Acceptable; Toxicity Category IV.

8. Hypersensitivity incidents (OPPTS 

885.3400). The registrant has reported 

no incidents to date. Nonetheless, 

pursuant to FIFRA section 6(a)(2), the 

registrant is required to report to the 

Agency any future incidents of 

hypersensitivity associated with 

Bacillus pumilus strain QST 2808.

9. Hypersensitivity study (OPPTS 

870.2600; MRID 460295–09). Twenty 

female guinea pigs were dosed on 

shaved skin once a week for 3 weeks 

with 0.4 mL of QST 2808 Technical. 

When challenged 14 days after the last 

induction, no signs of sensitization 

appeared. Acceptable.

10. Immune response. There is no 

information to suggest that B. pumilus

strain QST 2808 has an effect on the 

immune system. The submitted toxicity/

pathogenicity studies in rodents 

indicated that following several routes 

of exposure, the immune system is still 

intact and able to process and clear the 

active ingredient (MRID 451366–04; 

451366–06, 451366–07).

Based on the data generated in 

accordance with the Tier I data 

requirements set forth in 40 CFR 

§ 158.740(c), the Tier II and Tier III data 

requirements were not triggered and, 

therefore, not required in connection 

with this action. In addition, because 

the Tier II and Tier III data requirements 

were not required, the residue data 

requirements set forth in 40 CFR 

§ 158.740(b) also were not required.

IV. Aggregate Exposures

In examining aggregate exposure, 

section 408 of the FFDCA 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). Most importantly, there is no 

evidence of adverse effects from oral, 

dermal, or inhalation exposure to this 

microbial agent. (See Unit III. 

Toxicological Profile.)

A. Dietary Exposure

Humans and animals are commonly 

exposed to B. pumilus strain QST 2808, 

a ubiquitous microorganism that 

inhabits soil. No toxicological endpoints 

were identified for B. pumilus strain 

QST 2808. The low toxicity and nonpathogenicity/infectivity of B. pumilus 

strain QST 2808 is demonstrated by the 

data summarized in Unit III. of this 

action.

1. Food. While the proposed use 

pattern may result in dietary exposure 

with possible residues in or on 

agricultural commodities, negligible to 

no risk is expected for the general 

population, including infants and 

children, or animals because B. pumilus

strain QST 2808 technical demonstrated 

no pathogenicity or oral toxicity at the 

maximum doses tested, as noted above 

(Unit III.).

2. Drinking water exposure. The 

potential for transfer of B. pumilus

strain QST 2808 to surface or ground 

water during run-off associated with 

intended use applications is considered 

minimal to non-existent, due to its 

percolation through and resulting 

capture in soil. Accordingly, the use of 

this microbial pest control agent on 

terrestrial plants is not anticipated to 

negatively impact the quality of 

drinking water.

63952 Federal Register / Vol. 69, No. 212 / Wednesday, November 3, 2004 / Rules and Regulations 

B. Other Non-Occupational Exposure

Based on the proposed agricultural 

and horticultural use patterns, the 

potential for non-dietary exposures to B. 

pumilus strain QST 2808 pesticide 

residues by the general population, 

including infants and children, is 

unlikely. Accordingly, the Agency 

believes that the potential aggregate 

non-occupational exposure, derived 

from dermal and inhalation exposure 

through the application of B. pumilus

strain QST 2808 as a pesticide, should 

fall well below EPA’s currently tested 

microbial safety levels.

1. Dermal exposure. The potential for 

dermal exposure to B. pumilus strain 

QST 2808 pesticide residues for the 

general population, including infants 

and children, is unlikely because 

potential use sites are agricultural and 

horticultural. However, since B. 

pumilus strain QST 2808 is a naturally 

occurring bacterium in soil, there is a 

great likelihood of prior exposure for 

most, if not all individuals. 

Accordingly, the increase in dermal 

exposure due to pesticidal use of B. 

pumilus strain QST 2808 would be 

negligible. Furthermore, and as 

demonstrated in Unit III. of this action, 

the organism is of low dermal toxicity, 

the acute LD50 is greater than 2,000 mg/

kg, and the QST 2808 Technical was 

essentially non-irritating (Toxicity 

Category IV). Accordingly, the risks 

anticipated for this route of exposure are 

considered minimal.

2. Inhalation exposure. Inhalation 

exposure to B. pumilus strain QST 2808 

pesticide residues for the general 

population, including infants and 

children is unlikely because potential 

use sites are agricultural and 

horticultural. However, since B. 

pumilus strain QST 2808 is a naturally 

occurring bacterium in soil, there is a 

great likelihood of prior exposure for 

most, if not all individuals. 

Accordingly, the increase in exposure 

due to pesticidal use of B. pumilus

strain QST 2808 would be negligible. 

Furthermore, and as demonstrated in 

Unit III. of this action, the acute 

pulmonary toxicity/pathogenicity 

testing performed on the technical 

formulation did not demonstrate 

pathogenicity or toxicity of B. pumilus

strain QST 2808. (See Unit III.) 

Accordingly, the risks anticipated for 

this route of exposure are considered 

minimal.

V. Cumulative Effects

Section 408(b)(2)(D)(v) of FFDCA 

requires the Agency, when considering 

whether to establish, modify, or revoke 

a tolerance, to consider ‘‘available 

information’’ concerning the cumulative 

effects of a particular pesticide’s 

residues and ‘‘other substances that 

have a common mechanism of toxicity.’’

These considerations include the 

possible cumulative effects of such 

residues on infants and children.

The Agency has considered the 

potential for cumulative effects of B. 

pumilus strain QST 2808 and other 

substances in relation to a common 

mechanism of toxicity. B. pumilus strain 

QST 2808 is practically non-toxic to 

mammals. Because no mechanism of 

pathogenicity or toxicity in mammals 

has been identified for this organism 

(see Unit III.), no cumulative effects 

from the interaction of residues of this 

product with other related microbial 

pesticides are anticipated when this 

product is used as directed on the label 

and in accordance with good 

agricultural practices.

VI. Determination of Safety for U.S. 

Population, Infants and Children

There is a reasonable certainty that no 

harm to the U.S. population, including 

infants and children, will result from 

aggregate exposure to residues of B. 

pumilus strain QST 2808 due to its use 

as a microbial pest control agent. This 

includes all anticipated dietary 

exposures and all other exposures for 

which there is reliable information. As 

discussed previously, B. pumilus strain 

QST 2808 is not pathogenic or infective 

and is practically non-toxic to 

mammals. (See Unit III.) Accordingly, 

exempting Bacillus pumilus strain QST 

2808 from the requirement of a 

tolerance should be considered safe and 

pose no significant risk. 

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

that EPA shall apply an additional 

tenfold margin of exposure (safety) for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base on 

toxicity and exposure, unless EPA 

determines that a different margin of 

exposure (safety) will be safe for infants 

and children. Margins of exposure 

(safety) are incorporated into EPA risk 

assessments either by 1) using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans, or 2) using 

a margin of exposure analysis. Due to 

the ubiquitous nature of B. pumilus

strain QST 2808, residues of this 

microbial pesticide in or on agricultural 

commodities are not expected to 

significantly increase exposure to the 

U.S. population, including infants and 

children. Here, EPA concludes that the 

toxicity and exposure data are 

sufficiently complete to adequately 

address the potential for additional 

sensitivity of infants and children to 

residues of B. pumilus strain QST 2808 

and that there is a reasonable certainty 

that no harm will result to infants and 

children from aggregate exposure to B. 

pumilus strain QST 2808 residues. 

Thus, the Agency has determined that 

the additional margin of safety is not 

necessary to protect infants and 

children, and that not adding any 

additional margin of safety will be safe 

for infants and children.

VII. Other Considerations

A. Endocrine Disruptors

EPA is required under section 408(p) 

of the FFDCA, as amended by FQPA, to 

develop a screening program to 

determine whether certain substances 

(including all pesticide active and other 

ingredients) ‘‘may have an effect in 

humans that is similar to an effect 

produced by a naturally-occurring 

estrogen, or other such endocrine effects 

as the Administrator may designate.’’

Following the recommendations of its 

Endocrine Disruptor Screening and 

Testing Advisory Committee (EDSTAC), 

EPA determined that there is no 

scientific basis for including, as part of 

the screening program, the androgen 

and thyroid hormone systems in 

addition to the estrogen hormone 

system. EPA also adopted EDSTAC’s 

recommendation that the program 

include evaluations of potential effects 

in wildlife. For pesticide chemicals, 

EPA will use FIFRA and, to the extent 

that effects in wildlife may help 

determine whether a substance may 

have an effect in humans, FFDCA 

authority to require wildlife evaluations. 

As the science develops and resources 

allow, screening of additional hormone 

systems may be added to the Endocrine 

Disruptor Screening Program (EDSP). 

When the appropriate screening and/or 

testing protocols being considered 

under the Agency’s EDSP have been 

developed, Bacillus pumilus strain QST 

2808 may be subjected to additional 

screening and/or testing to better 

characterize effects related to endocrine 

disruption.

To date, based on available data, the 

Agency has no information to suggest 

that Bacillus pumilus strain QST 2808 

has an effect on the endocrine systems. 

Moreover, as is expected from a nonpathogenic microorganism that is 

practically non-toxic to mammals, the 

submitted toxicity/pathogenicity studies 

in rodents indicate that following 

several routes of exposure, the immune 

system is still intact and able to process 

and clear the active ingredient. (‘‘BPPD 

Review’’- 1/7/02). Thus, there is no 

Federal Register / Vol. 69, No. 212 / Wednesday, November 3, 2004 / Rules and Regulations 63953

impact via endocrine-related effects on 

the Agency’s safety finding set forth in 

this final rule for Bacillus pumilus

strain QST 2808.

B. Analytical Method(s)

The Agency proposes to establish an 

exemption from the requirement of a 

tolerance without any numerical 

limitation for the reasons stated above, 

including Bacillus pumilus strain QST 

2808’s lack of mammalian toxicity. For 

the same reasons, the Agency has 

concluded that an analytical method is 

not required for enforcement purpose 

for Bacillus pumilus strain QST 2808.

C. Codex Maximum Residue Level

There is no Codex Alimentarius 

Commission Maximum Residue Level 

for Bacillus pumilus strain QST 2808.

VIII. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the FFDCA 

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 the FFDCA, as was 

provided in the old sections 408 and 

409 of the FFDCA. However, the period 

for filing objections is now 60 days, 

rather than 30 days.

A. What Do I Need to Do to File an 

Objection or Request a Hearing?

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2004–0215 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before January 3, 2005.

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). 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). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice.

Mail your written request to: Office of 

the Hearing Clerk (1900C), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Rm.104, Crystal Mall #2, 1801 

S. Bell St., Arlington, VA. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (703) 603–0061.

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VIII.A., you should also send a 

copy of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2004–0215, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid 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 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries.

B. When Will the Agency Grant a 

Request for a Hearing?

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).

IX. Statutory and Executive Order 

Reviews

This final rule establishes an 

exemption from the requirement of a 

tolerance under section 408(d) of the 

FFDCA 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). 

Because this rule has been exempted 

from review under Executive Order 

12866 due to its lack of significance, 

this rule is not subject to Executive 

Order 13211, Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use (66 

FR 28355, May 22, 2001). 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) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of the FFDCA, 

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. In 

addition, the Agency has determined 

that this action will not have a 

substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

63954 Federal Register / Vol. 69, No. 212 / Wednesday, November 3, 2004 / Rules and Regulations 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive Order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule.

X. Congressional Review Act

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit 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 United 

States prior to publication of this final 

rule in the Federal Register. This final 

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

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

List of Subjects in 40 CFR Part 180

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements.

Dated: October 13, 2004.

James Jones,

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. 321(q), 346a and 371.

■ 2. Section 180.1255 is added to subpart 

D to read as follows:

§ 180.1255 Bacillus pumilus strain QST 

2808; Exemption from the Requirement of a 

Tolerance.. 

An exemption from the requirement 

of a tolerance is established for residues 

of the microbial pesticide Bacillus 

pumilus strain QST 2808 when used in 

or on all agricultural commodities when 

applied/used in accordance with label 

directions.

[FR Doc. 04–24250 Filed 11–2–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0206; FRL–7683–2]

Thifensulfuron-methyl; Tolerance 

Actions

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is reinstating corn 

tolerances for the herbicide 

thifensulfuron-methyl. These corn 

tolerances were previously established 

but inadvertently removed shortly 

thereafter. Registrations under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) for use of 

thifensulfuron-methyl on corn currently 

exist and have existed for more than 10 

years.

DATES: This regulation is effective 

November 3, 2004. Objections and 

requests for hearings must be received 

on or before January 3, 2005.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit III. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2004–

0206. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

Joseph Nevola, Special Review and 

Reregistration Division (7508C), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001; telephone number: (703) 308–

8037; e-mail 

address:Nevola.joseph@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to:

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 

32532)

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any