67906 Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations 

Correction of Publication 

■ Accordingly, 26 CFR Part 1 is 

corrected by making the following 

correcting amendment: 

PART 1—INCOME TAXES 

■ Paragraph 1. The authority citation 

for part 1 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

§ 1.951–1 [Corrected] 

■ 1. In § 1.951–1(a), the undesignated 

paragraph is designated as paragraph 

(a)(3). 

■ 2. Section 1.951–1(e)(6), paragraph (ii) 

of Example 5, sixth sentence, the 

language ‘‘common shareholders by 

reference to the’’ is removed and the 

language ‘‘common shares by reference 

to the’’ is added in its place. 

■ 3. Section 1.951–1(e)(6), paragraph (i) 

of Example 7, sixth sentence, the 

language ‘‘income of United States 

shareholder under’’ is removed and the 

language ‘‘income of a United States 

shareholder under’’ is added in its 

place. 

■ 4. Section 1.951–1(e)(6), paragraph (i) 

of Example 8, third sentence, the 

language ‘‘Foreign Individual N, a 

foreign individual.’’ is removed and the 

language ‘‘Individual N, a foreign 

individual.’’ is added in its place. 

Cynthia E. Grigsby, 

Acting Chief, Publications and Regulations 

Branch, Legal Processing Division, Associate 

Chief Counsel, (Procedure and 

Administration). 

[FR Doc. 05–22260 Filed 11–8–05; 8:45 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0280; FRL–7743–5] 

2-Bromo-2-Nitro-1,3-Propanediol 

(Bronopol); Exemptions from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

exemptions from the requirement of a 

tolerance for residues of 2-bromo-2- 

nitro-1,3-propanediol, which is also 

known as bronopol (Chemical Abstracts 

Service (CAS) Registry Number (Reg. 

No.) 52–51–7; 1,3-propanediol, 2- 

bromo-2-nitro- (9CI)), when used as an 

inert ingredient in-can preservative at 

0.04% or less by weight of the total 

pesticide formulation when applied to 

growing crops or to raw agricultural 

commodities after harvest under 40 CFR 

180.910, and when applied to animals 

under 40 CFR 180.930. BASF 

Corporation 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 the exemptions from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of 2-bromo-2-nitro-1,3- 

propanediol. 

DATES: This regulation is effective 

November 9, 2005. Objections and 

requests for hearings must be received 

on or before January 9, 2006. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit IX. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2005–

0280. 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: 

Karen Angulo, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 306–0404; e-mail address: 

angulo.karen@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 code 111) 

• Animal production (NAICS code 

112) 

• Food manufacturing (NAICS code 

311) 

• Pesticide manufacturing (NAICS 

code 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 

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 December 

24, 2002 (67 FR 78459) (FRL–7277–5), 

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 2E6475) 

by BASF Corporation, 3000 Continental 

Drive - North, Mount Olive, NJ 07828–

1234. The petition requested that 

exemptions from the requirement of a 

tolerance be established for residues of 

2-bromo-2-nitro-1,3-propanediol under 

40 CFR 180.910 (growing crops or to 

raw agricultural commodities after 

harvest) and under 40 CFR 180.930 

(animals) when it is used as an inert 

ingredient in-can preservative at 0.04% 

or less by weight of the total pesticide 

formulation. This notice included a 

summary of the petition prepared by the 

petitioner BASF. 

For ease of reading in this document, 

2-bromo-2-nitro-1,3-propanediol will be 

referred to as bronopol. The CAS Reg. 

No. of bronopol is 52–51–7 and the CAS 

name is 1,3-propanediol, 2-bromo-2- 

nitro- (9CI). 

Comments were received from the 

United States Food and Drug 

Administration (FDA) in response to the 

notice of filing. FDA’s comments 

pertained to the possible formation of nVerDate Aug<31>2005 15:11 Nov 08, 2005 Jkt 208001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\09NOR1.SGM 09NOR1
Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations 67907 

nitrosoamines, which are potentially 

carcinogenic compounds, when 

pesticide formulations containing 

bronopol also contain a nitrosatable 

amine. Rebuttals to FDA’s comments 

were submitted from two companies. 

EPA acknowledges the concerns of FDA. 

The Agency evaluated the carcinogenic 

potential of bronopol and found there to 

be evidence of non-carcinogenicity for 

humans based on a lack of cancer effects 

in acceptable studies with two animal 

species, the rat and mouse. It should be 

noted that n-nitrosamines are also 

possibly formed by the action of 

bronopol with naturally occurring 

nitrosatable amines that are present in 

the diet of humans or are present as 

bodily constituents. In addition, Agency 

policy requires that pesticidal 

formulations be analyzed for 

nitrosamine content, and limits the 

allowable amount to 1 part per million 

(ppm). Pesticide formulations 

containing bronopol will be subject to 

this requirement. 

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 ‘‘safe.’’

Section 408(c)(2)(A)(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. 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 

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. 

III. 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. The 

nature of the toxic effects caused by 

bronopol are discussed in this unit. 

A Reregistration Eligibility Decision 

(RED) was completed in 1995 for 

bronopol. The RED is available on the 

Agency’s website at www.epa.gov/ 

pesticides/reregistration/status.htm. The 

Agency is not aware of any more recent 

information that changes the risk 

findings of the RED, therefore, the 

toxicity findings of the RED are being 

used here for the evaluation of the 

petition. The following briefly 

summarizes the toxicity findings of the 

RED. 

Bronopol is moderately toxic in acute 

oral toxicity studies with rats, with a 

lethal dose (LD)50 of 307 milligrams/ 

kilogram (mg/kg) for males and 342 mg/ 

kg for females (Toxicity Category II) 

(Toxicity Category I has the highest 

toxicity and Category IV the lowest). In 

an acute inhalation study on the rat, 

bronopol was found to be slightly toxic 

with an lethal concentration (LC)50 of > 

5 mg/liter (L) (Toxicity Category III). 

Results from an acute dermal toxicity 

study (rat) suggest that bronopol is 

highly toxic by the dermal route 

(Toxicity Category I), with an LC50 of 64 

to 160 mg/kg. Slight to moderate 

erythema and slight to severe edema 

was noted, and the results of this study 

determined that bronopol was a slight to 

severe irritant (Toxicity Category II). In 

a study to determine dermal 

sensitization potential (ai >98.8%, 

guinea pigs), bronopol was determined 

not to be a skin sensitizer. In addition, 

bronopol has been shown to be a 

corrosive eye irritation (Toxicity 

Category I). 

A 90-day oral toxicity study using rats 

indicated that bronopol is a severe 

gastrointestinal irritant. The no 

observed adverse effect level (NOAEL) 

and the lowest observed adverse effect 

level (LOAEL) for systemic toxicity, for 

both sexes, are 20 mg/kg/day and 80 

mg/kg/day, respectively. A similar study 

in beagle dogs indicated only treatmentrelated effects of increased liver and 

spleen weights in the high dose group. 

In a 90–day dermal toxicity study in 

rabbits, a NOAEL of 2 mg/kg/day and a 

LOAEL of 5 mg/kg/day were determined 

based on dermal irritation. 

A chronic feeding/carcinogenicity 

study with rats resulted in high 

mortality, stomach lesions, and severe 

reduction in body weight gain. The 

unpalatability of bronopol reduced the 

water intake and urine output in a doserelated manner in all treated groups, 

which may have affected the results of 

the study. Based on the above findings, 

the systemic NOAEL and LOAEL for 

both sexes are 10 mg/kg/day and 40 mg/ 

kg/day, respectively. In a chronic 

dermal/carcinogenicity study, male 

mice exhibited moderate reduction in 

body weight gain in the high dose 

group. Bronopol was not determined to 

be carcinogenic in either study. The 

EPA Office of Pesticide Program’s 

Reference Dose (RfD)/Peer Review 

Committee evaluated the carcinogenic 

potential of bronopol and found there to 

be evidence of non-carcinogenicity for 

humans based on a lack of evidence of 

cancer effects in acceptable studies. In 

addition, bronopol was not mutagenic 

in four mutagenicity studies. 

Developmental toxicity studies were 

conducted using rats and rabbits. The 

results showed marginal to no effects in 

the rat study and effects only at the high 

dose level in the rabbit study. In the 

study on rats, no developmental effects 

could be attributed to the administration 

of bronopol, and the highest dose of >80 

mg/kg/day is considered to be the 

NOAEL for both maternal and 

developmental toxicity. In the study on 

rabbits, the maternal and developmental 

NOAEL and LOAEL are 40 mg/kg/day 

and 80 mg/kg/day (the highest dose 

group), respectively. The effects 

observed only in the 80 mg/kg/day 

group include decreased fetal body 

weight in both sexes (10%), and an 

increase in fetuses with major external/ 

visceral and skeletal abnormalities 

(6.9% – 29.5%). 

A reproductive toxicity study using 

rats reported effects at the mid- to highdose levels, including increases in 

kidney, thyroid, and adrenal weights, 

decreases in liver and body weights. 

The NOAEL and LOAEL for systemic 

toxicity are 25 mg/kg/day and 70 mg/kg/ 

day, respectively. Reproductive toxicity 

was observed only in the high-dose 

group as evidenced by a slight decrease 

in the female fertility index during the 

F1 mating. The NOAEL and LOAEL for 

reproductive toxicity are 70 mg/kg/day 

and 200 mg/kg/day, respectively. 

For metabolism, the results from four 

studies show that bronopol 

administered orally was rapidly 

absorbed and rapidly excreted by the 

rats of both sexes, with urine being the 

major route of excretion. 

67908 Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations 

For ecological risks, bronopol is 

practically nontoxic to slightly toxic to 

birds; slightly to moderately toxic to 

freshwater fish and terrestrial 

invertebrates; moderately to highly toxic 

to estuarine/marine invertebrates; and 

slightly toxic to estuarine/marine fish. 

Based on bronopol’s low octanol/water 

ratio and high solubility in water, it is 

not expected to bioaccumulate. 

Accumulation reportedly does not occur 

in tested mammals and metabolism is 

also reported to be rapid and complete. 

IV. 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). 

A. Dietary Exposure 

1. Food. A dietary exposure analysis 

for the inert ingredient use of bronopol 

was conducted using the generic 

screening model for estimating inert 

ingredient dietary exposure. The dietary 

assessment is unrefined and extremely 

conservative in nature because the 

screening model assumes that the inert 

ingredient is used on all commodities, 

and that 100 percent of crops are treated 

with the inert ingredient. Further, the 

screening model assumes residues will 

be present for every consumed 

commodity (including meat, milk, 

poultry and eggs) that is included in the 

Dietary Exposure Evaluation Model 

(DEEMTM). The screening model does 

not specifically include an application 

rate input, rather it is based on 

tolerances for pesticide active 

ingredients that are typically found in 

agricultural food use products at 

concentrations greater than 50%. 

Therefore, to more accurately estimate 

residues resulting from bronopol’s lower 

application rate limitation of 0.04% (the 

tolerance exemption limitation 

proposed by the petitioner), the results 

from the screening model were adjusted 

by a factor of 1250 (50% ÷ 0.04%). 

The results for acute and chronic 

dietary exposure for all population 

subgroups are considered to be not of 

concern. The highest dietary exposure 

estimate was for children (1–2 years), 

where the acute dietary risk was 

estimated to be 0.0007512 mg/kg/day 

and 0.19% of the acute Population 

Adjusted Dose (aPAD), and where the 

chronic dietary risk was estimated to be 

0.0003376 mg/kg/day and 0.34% of the 

chronic Population Adjusted Dose 

(cPAD). These are well-below any dose 

level at which an adverse effect is 

expected from exposure to bronopol 

when it is used as an inert ingredient incan preservative at 0.04% or less by 

weight of the total pesticide 

formulation. 

2. Drinking water exposure. Bronopol 

is expected to have a relatively short 

half-life upon release into the 

environment. Bronopol is not 

anticipated to be present in drinking 

waterwhen used as an inert ingredient 

in-can preservative at 0.04% or less by 

weight of the total pesticide 

formulation. 

B. Other Non-Occupational Exposure 

Pesticide products containing 

bronopol as an in-can preservative may 

be used in residential settings. 

Considering the small amount of 

bronopol that will be used in pesticide 

formulations (no more than 0.04% by 

weight), inhalation and dermal 

exposures of concern are not anticipated 

from residential uses. 

V. Cumulative Effects 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance or tolerance exemption, the 

Agency consider ‘‘available 

information’’ concerning the cumulative 

effects of a particular chemical’s 

residues and ‘‘other substances that 

have a common mechanism of toxicity.’’

Unlike other pesticide chemicals for 

which EPA has followed a cumulative 

risk approach based on a common 

mechanism of toxicity, EPA has not 

made a common mechanism of toxicity 

finding as to bronopol. For the purposes 

of this tolerance action, therefore, EPA 

has not assumed that bronopol has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative/. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

Based on the information in this 

preamble and on the modeled exposure 

levels that are well-below any dose level 

where adverse effects are expected, EPA 

concludes that there is a reasonable 

certainty of no harm to any population 

subgroup from aggregate exposure to 

residues of bronopol. Accordingly, EPA 

finds that exempting bronopol from the 

requirement of a tolerance will be safe 

for the general population including 

infants and children. 

VII. Other Considerations 

A. Endocrine Disruptors 

FQPA requires EPA to develop a 

screening program to determine whether 

certain substances, including all 

pesticide chemicals (both inert and 

active ingredients), ‘‘may have an effect 

in humans that is similar to an effect 

produced by a naturally occurring 

estrogen, or such other endocrine effect 

. . . .’’ EPA has been working with 

interested stakeholders to develop a 

screening and testing program as well as 

a priority setting scheme. As the Agency 

proceeds with implementation of this 

program, further testing of products 

containing bronopol for endocrine 

effects may be required. 

B. Analytical Method(s) 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

C. Existing Tolerances 

There are no existing tolerances or 

tolerance exemptions for bronopol. 

D. International Tolerances 

The Agency is not aware of any 

country requiring a tolerance for 

bronopol, nor have any CODEX 

maximum residue levels been 

established for any food crops at this 

time. 

VIII. Conclusions 

There is sufficient information on 

bronopol to conduct this assessment. 

Bronopol has been shown to have 

significant dermal acute toxicity, and 

eye and gastrointestinal irritation, but it 

is not a skin sensitizer. Study results 

indicate that bronopol has moderate 

acute and chronic oral toxicity, and 

slight acute inhalation toxicity. It is not 

considered to be carcinogenic. For 

developmental effects, marginal to no 

effects were reported in the rat study 

and effects were observed only at the 

high dose level in the rabbit study. 

Reproductive toxicity was observed 

only in the high-dose group as 

evidenced by a slight decrease in the 

female fertility index during the F1

mating. 

Although, bronopol does have 

toxicity, the small amount that will be 

permitted for use in pesticide 

Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations 67909 

formulations (0.04% or less by weight) 

is expected to result in no effects of 

concern for all endpoints, including 

residential exposures. The results from 

a conservative dietary screening model 

show that acute and chronic dietary 

exposure for all population subgroups 

are considered to be not of concern. The 

highest dietary exposure estimates from 

the conservative screening model are 

well-below any dose level at which an 

adverse effect is expected. Bronopol is 

expected to have a relatively short halflife upon release into the environment, 

therefore, its contribution to drinking 

water is not expected. 

Considering the information above, 

there is a reasonable certainty that no 

harm to any population subgroup will 

result from aggregate exposure to the 

pesticide chemical (bronopol) residue, 

including all anticipated dietary 

exposures and all other exposures for 

which there is reliable information. 

Exemptions from the requirement of a 

tolerance are established for 2-bromo-2- 

nitro-1,3-propanediol; (CAS Reg. No. 

52–51–7;) when used as an inert 

ingredient in-can preservative at 0.04% 

or less by weight of the total pesticide 

formulation when applied to growing 

crops or to raw agricultural 

commodities after harvest under 40 CFR 

180.910, and when applied to animals 

under 40 CFR 180.930. 

IX. 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 of 1996, EPA will 

continue to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new 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 FFDCA sections 408 and 409. 

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–2005–0280 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 9, 2006. 

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 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). 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 (1900L), 

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 Suite 350, 1099 14th St., NW., 

Washington, DC 20005. 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 (202) 564–6255. 

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–2005–0280, 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. 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 e-mail to: oppdocket@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 

issue(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

X. Statutory and Executive Order 

Reviews 

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). 

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 

67910 Federal Register / Vol. 70, No. 216 / Wednesday, November 9, 2005 / Rules and Regulations 

established on the basis of a petition 

under FFDCA section 408(d), such as 

the exemptions 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 

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 FFDCA section 408(n)(4). 

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. 

XI. 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 28, 2005. 

Lois Rossi, 

Director, Registration Division, 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. In § 180.910 the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

Inert Ingredient Limits Uses 

* * * * * * * 

2-Bromo-2-nitro1,3- 

propanediol 

(CAS Reg. 

No. 52–51–7) 

0.04% or 

less by 

weight of 

the total 

pesticide 

formulation 

In-can preservative 

* * * * * * * 

* * * * * 

■ 3. In § 180.930 the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

Inert Ingredient Limits Uses 

* * * * * * * 

2-Bromo-2-nitro1,3- 

propanediol 

(CAS Reg. 

No. 52–51–7) 

0.04% or 

less by 

weight of 

the total 

pesticide 

formulation 

In-can preservative 

* * * * * * * 

* * * * * 

[FR Doc. 05–22255 Filed 11–8–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0254; FRL–7740–8] 

Flucarbazone-sodium; Time-Limited 

Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for combined 

residues of flucarbazone-sodium, 4,5- 

dihydro-3-methoxy-4-methyl-5-oxo-N- 

[2(trifluoromethoxy)phenyl] sulfonyl1H-1,2,4-triazole 1-carboxamide, 

sodium salt and its N-desmethyl 

metabolite in or on wheat, forage at 0.30 

parts per million (ppm); wheat, grain at 

0.01 ppm; wheat, hay at 0.10 ppm; and 

wheat, straw at 0.05 ppm; and combined 

residues of flucarbazone-sodium and its 

metabolites converted to 2- 

(trifluoromethoxy) benzene sulfonamide 

and calculated as flucarbazone-sodium 

in or on milk at 0.005 ppm; meat and 

meat byproducts (excluding liver) of 

cattle, goats, hogs, horses, and sheep at 

0.01 ppm; and liver of cattle, goats, 

hogs, horses, and sheep at 1.5 ppm. 

Arysta LifeScience North America 

Corporation requested this tolerance 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA). The tolerance will expire on 

November 30, 2006. 

DATES: This regulation is effective 

November 9, 2005. Objections and 

requests for hearings must be received 

on or before January 9, 2006. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in