69320 Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Rules and Regulations 

[FR Doc. 04–26291 Filed 11–26–04; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 63 

[OAR–2003–0188; FRL–7841–8] 

RIN 2060–AL87 

List of Hazardous Air Pollutants, 

Petition Process, Lesser Quantity 

Designations, Source Category List; 

Petition To Delist of Ethylene Glycol 

Monobutyl Ether

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: The EPA is amending the list 

of hazardous air pollutants (HAP) 

contained in section 112(b)(1) of the 

Clean Air Act (CAA) by removing the 

compound ethylene glycol monobutyl 

ether (EGBE) (2-Butoxyethanol) 

(Chemical Abstract Service (CAS) No. 

111–76–2) from the group of glycol 

ethers. This action is being taken in 

response to a petition to delete EGBE 

from the HAP list submitted by the 

Ethylene Glycol Ethers Panel of the 

American Chemistry Council (ACC) 

(formerly the Chemical Manufacturers 

Association) on behalf of EGBE 

producers and consumers. Petitions to 

delete a substance from the HAP list are 

permitted under section 112(b)(3) of the 

CAA. 

Based on the available information 

concerning the potential hazards of and 

projected exposures to EGBE, EPA has 

made a determination pursuant to CAA 

section 112(b)(3)(C) that there are 

‘‘adequate data on the health and 

environmental effects [of EGBE] to 

determine that emissions, ambient 

concentrations, bioaccumulation, or 

deposition of the substance may not 

reasonably be anticipated to cause 

adverse effects to human health or 

adverse environmental effects.’’

DATES: Effective November 29, 2004.

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. OAR–2003–0188 and A–99–24. 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 EPA Docket Center (Air 

Docket), EPA/DC, EPA West, Room B–

102, 1301 Constitution Avenue, NW, 

Washington, DC 10460. The Public 

Reading Room is open from 8:30 a.m. to 

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

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the Air Docket is (202) 566–

1742.

FOR FURTHER INFORMATION CONTACT: Ms. 

Kelly Rimer, Office of Air Quality 

Planning and Standards, Emission 

Standards Division, C404–01, U. S. EPA, 

Research Triangle Park, NC 27711; 

telephone number: (919) 541–2962; fax 

number: 919–541–0840; e-mail address: 

rimer.kelly@epa.gov.

SUPPLEMENTARY INFORMATION: Regulated 

Entities. Entities potentially affected by 

this action are those industrial facilities 

that manufacture or use EGBE. The final 

rule amends the list of HAP contained 

in section 112(b)(1) of the CAA by 

removing the compound EGBE. The 

decision to issue a final rule to delist 

EGBE removes EGBE from regulatory 

consideration under section 112(d) of 

the CAA. 

Judicial Review. Under section 

307(b)(1) of the CAA, judicial review is 

available only by filing a petition for 

review in the U.S. Court of Appeals for 

the District of Columbia Circuit by 60 

days from publication in the Federal 

Register. Under section 307(d)(7)(B) of 

the CAA, only an objection to a rule or 

procedure raised with reasonable 

specificity during the period for public 

comment can be raised during judicial 

review. Moreover, under section 

307(b)(2) of the CAA, the requirements 

established by the final rule may not be 

challenged separately in any civil or 

criminal proceeding brought to enforce 

these requirements. 

Outline. The information presented in 

this preamble is organized as follows:

I. Introduction 

A. The Delisting Process 

B. The Present Petition and Rulemaking 

II. Peer Review of New Data on EGBE 

Metabolite, Butoxyacetaldehyde 

III. Public Comments on Proposed Rule to 

Delist EGBE 

IV. Final Rule 

A. Rationale for Action 

B. Effective Date 

V. References 

VI. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

B. Paperwork Reduction Act 

C. Regulatory Flexibility Analysis 

D. Unfunded Mandates Reform Act 

E. Executive Order 13132: Federalism 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

G. Executive Order 13045: Protection of 

Children from Environmental Health & 

Safety Risks 

H. Executive Order 13211: Actions that 

Significantly Affect Energy Supply, 

Distribution, or Use 

I. National Technology Transfer and 

Advancement Act 

J. Congressional Review Act

I. Introduction 

A. The Delisting Process 

Section 112 of the CAA contains a 

mandate for EPA to evaluate and control 

emissions of HAP. Section 112(b)(1) 

includes an initial list of HAPs that are 

composed of specific chemical 

compounds and compound classes to be 

used by EPA to identify source 

categories for which EPA will 

subsequently promulgate emissions 

standards. 

Section 112(b)(2) of the CAA requires 

EPA to make periodic revisions to the 

initial list of HAPs set forth in section 

112(b)(1) and outlines criteria to be 

applied in deciding whether to add or 

delete particular substances. Section 

112(b)(2) identifies pollutants that 

should be listed as: ‘‘* * * pollutants 

which present, or may present, through 

inhalation or other routes of exposure, 

a threat of adverse human health effects 

(including, but not limited to, 

substances which are known to be, or 

may reasonably be anticipated to be 

carcinogenic, mutagenic, teratogenic, 

neurotoxic, which cause reproductive 

dysfunction, or which are acutely or 

chronically toxic) or adverse 

environmental effects whether through 

ambient concentrations, 

bioaccumulation, deposition, or 

otherwise. * * * ’’

To assist EPA in making judgements 

about whether a pollutant causes an 

adverse environmental effect, section 

112(a)(7) defines an ‘‘adverse 

environmental effect’’ as: ‘‘* * * any 

significant and widespread adverse 

effect, which may reasonably be 

anticipated, to wildlife, aquatic life, or 

other natural resources, including 

adverse impacts on populations of 

endangered or threatened species or 

significant degradation of 

environmental quality over broad 

areas.’’

Section 112(b)(3) establishes general 

requirements for petitioning EPA to 

modify the HAP list by adding or 

deleting a substance. Although the 

Administrator may add or delete a 

substance on his or her own initiative, 

the burden is on a petitioner to include 

sufficient information to support the 

Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Rules and Regulations 69321

requested addition or deletion under the 

substantive criteria set forth in CAA 

section 112(b)(3)(B) and (C). The 

Administrator must either grant or deny 

a petition within 18 months of receipt 

of a complete petition. If the 

Administrator decides to grant a 

petition, the Agency publishes a written 

explanation of the Administrator’s 

decision, along with a proposed rule to 

add or delete the substance. If the 

Administrator decides to deny the 

petition, the Agency publishes a written 

explanation of the basis for denial. A 

decision to deny a petition is final 

Agency action subject to review in the 

D.C. Circuit Court of Appeals under 

CAA section 307(b). 

To promulgate a final rule deleting a 

substance from the HAP list, CAA 

section 112(b)(3)(C) provides that the 

Administrator must determine that there 

are: ’’ * * * adequate data on the health 

and environmental effects of the 

substance to determine that emissions, 

ambient concentrations, 

bioaccumulation, or deposition of the 

substance may not reasonably be 

anticipated to cause any adverse effects 

to the human health or adverse 

environmental effects.’’

The EPA will grant a petition to delete 

a substance and publish a proposed rule 

to delete that substance, if it makes an 

initial determination that these criteria 

have been met. After affording an 

opportunity for comment and for a 

hearing, EPA will make a final 

determination whether the criteria have 

been met. 

The EPA does not interpret CAA 

section 112(b)(3)(C) to require absolute 

certainty that a pollutant will not cause 

adverse effects on human health or the 

environment before it may be deleted 

from the list. The use of the terms 

‘‘adequate’’ and ‘‘reasonably’’ indicate 

that the Agency must weigh the 

potential uncertainties and their likely 

significance. Uncertainties concerning 

the risk of adverse health or 

environmental effects may be mitigated 

if EPA can determine that projected 

exposures are sufficiently low to 

provide reasonable assurance that such 

adverse effects will not occur. Similarly, 

uncertainties concerning the magnitude 

of projected exposure may be mitigated 

if EPA can determine that the levels 

which might cause adverse health or 

environmental effects are sufficiently 

high to provide reasonable assurance 

that exposures will not reach harmful 

levels. However, the burden remains on 

a petitioner to resolve any critical 

uncertainties associated with missing 

information. The EPA will not grant a 

petition to delete a substance if there are 

major uncertainties which need to be 

addressed before EPA would have 

sufficient information to make the 

requisite determination. 

B. The Present Petition and Rulemaking 

On August 29, 1997, the ACC’s Glycol 

Ethers Panel submitted a petition to 

delete EGBE (CAS No. 111–76–2) from 

the HAP list in CAA section 112(b)(1), 

42 U.S.C. 7412(b)(1). Following the 

receipt of the petition, we conducted a 

preliminary evaluation to determine 

whether the petition was complete 

according to Agency criteria. To be 

deemed complete, a petition must 

consider all available health and 

environmental effects data. A petition 

must also provide comprehensive 

emissions data, including peak and 

annual average emissions for each 

source or for a representative selection 

of sources, and must estimate the 

resulting exposures of people living in 

the vicinity of the sources. 

In addition, a petition must address 

the environmental impacts associated 

with emissions to the ambient air and 

impacts associated with the subsequent 

cross-media transport of those 

emissions. After receiving additional 

submittals through December 21, 1998, 

we determined the petition to delete 

EGBE to be complete. We published a 

notice of receipt of a complete petition 

in the Federal Register on August 3, 

1999 and requested information to assist 

us in technically reviewing the petition. 

We received eight submissions in 

response to our request for comment 

and information which would aid our 

technical review of the petition. The 

comments made general statements 

encouraging EPA to delist EGBE. None 

of the comments included technical 

information. 

On November 4, 2003, based on a 

comprehensive review of the data 

provided in the petition and otherwise 

provided to EPA, the Agency made an 

initial determination that the statutory 

criteria for deletion of EGBE from the 

HAP list had been met. The EPA, 

therefore, granted the petition by the 

ACC’s Glycol Ethers Panel and issued a 

proposed rule to delist EGBE (68 FR 

65648, November 21, 2003). 

The EPA received a total of 18 

comments on the November 21, 2003 

proposed rule. While three of the 

commenters opposed deleting EGBE 

from the HAP list, they provided no 

substantive arguments to support this 

position. There was no request for a 

public hearing. 

The EPA’s decision to remove EGBE 

from the list of HAP is based on the 

results of a risk assessment 

demonstrating that emissions of EGBE 

may not reasonably be anticipated to 

result in adverse human health or 

environmental effects. In addition to the 

risk assessment, we have considered 

public comments, as well as other 

information related to EGBE in making 

this decision, namely the transformation 

of EGBE into other HAP as it 

decomposes in the ambient air. We 

conclude that ambient concentrations of 

the transformed HAP are very small, 

and that they decompose rapidly. 

Therefore, we do not anticipate that 

EGBE transformation will be significant 

enough to have an adverse impact on 

human health. 

We also considered the fact that EGBE 

is reported to the Toxics Release 

Inventory (TRI) as part of the group of 

glycol ethers. The 2000 TRI shows the 

air emissions of the class of chemicals 

‘‘Certain Glycol Ethers’’ to be ranked 

number 12 by volume. Under the final 

rule, it will no longer be regulated as a 

HAP, but it will continue to be reported 

in the TRI, as part of the group ‘‘Certain 

Glycol Ethers’’ and regulated under 

EPA’s criteria pollutant (ozone) 

program.

The EPA has made a final 

determination, after careful 

consideration of the petition and after 

completing additional analyses, that 

there are adequate data on the health 

and environmental effects of EGBE to 

determine that emissions, ambient 

concentrations, bioaccumulation, or 

deposition of EGBE may not reasonably 

be anticipated to cause any adverse 

effects to the human health or adverse 

environmental effects. 

II. Peer Review of New Data on EGBE 

Metabolite, Butoxyacetaldehyde 

In the preamble to the proposed rule, 

we stated that the Agency believes 

EGBE is not genotoxic and that two 

distinctly different nonlinear modes of 

action are principally responsible for 

the increased forestomach and liver 

tumors reported by NTP (2000a). These 

modes of action are discussed in detail 

in the Interim Final position paper, ‘‘An 

Evaluation of the Human Carcinogenic 

Potential of Ethylene Glycol Butyl 

Ether,’’ available from the Docket for the 

final rule. We also stated that there are 

reports of weak positive effects by EGBE 

at high concentrations in some in vitro 

assays which may indicate the potential 

for genotoxicity by butoxyacetaldehyde 

(BAL), an EGBE metabolite known to 

cause clastogenic changes at high in 

vitro concentrations (see the section on 

‘‘Other Possible Modes of Action for 

Forestomach Tumor Development in 

Female Mice’’ in the Agency’s position 

paper). However, available evidence 

from a published EGBE physiologically 

based pharmacokinetic model that had 

69322 Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Rules and Regulations 

been modified to include kinetics for 

the metabolism of the BAL intermediate 

(Corley, 2003) suggested that the 

concentrations of BAL metabolite 

predicted to occur in vivo would be 

much lower than the concentrations 

used in the in vitro assays. Based on 

this, it appears that genotoxicity is not 

a factor in tumor development in female 

mice. This increases our confidence that 

a nonlinear mechanism is involved in 

tumor formation (versus a linear 

mechanism which would be suggested if 

genotoxicity was involved). As we 

discussed in the preamble to the 

proposed rule, additional research (e.g., 

verification of these PBPK modeling 

results and further genotoxicity research 

using more appropriate assays and 

currently accepted test protocols) would 

be beneficial to provide a more 

definitive determination regarding the 

role of BAL in the formation of 

forestomach tumors in female mice. 

Since the publication of the proposed 

rule, additional research has been 

completed and submitted to EPA. 

Subsequently, we commissioned a peer 

review panel to evaluate the new data 

submitted and EPA’s conclusions of the 

proposed ruling and interim final 

position paper in light of the recent 

research and literature that has been 

submitted to the Agency in response to 

the Agency’s proposed EGBE ruling. 

The peer review was conducted on May 

19, 2004 by an external review panel of 

seven experts. A report on the results of 

this peer review is included in the 

docket for the final rule. In summary, 

the peer review panel was unanimous in 

agreeing that there is enough 

information to support an informed 

decision concerning the significance of 

BAL genotoxicity to the formation of 

EGBE induced liver and forestomach 

tumors. The available information 

support a nonlinear mode of action, not 

a linear mode of action (e.g., 

genotoxicity) for the male mouse liver 

tumors and female mouse forestomach 

tumors observed following EGBE 

exposure. That is, the reviewers 

concluded that genotoxicity is not 

important in the development of these 

tumors. 

The panel also concluded that it is 

reasonable to expect that a lack of 

hemolytic effects in humans would 

preclude the formation of liver tumors 

in humans and that a lack of 

hyperplastic effects in the region of the 

gastroesophogeal junction in humans 

would preclude the formation of 

gastrointestinal tumors in humans. That 

is, the data support the finding that we 

would not expect to find these tumors 

in humans following environmental 

exposures. The RfC and RfD values for 

EGBE have been set at levels that 

prevent both the precursor events that 

would lead to tumors and other 

noncancer effects, and the Agency has 

determined that exposures to EGBE are 

at levels well below the RfC and RfD. 

We can therefore conclude with 

confidence that emissions, ambient 

concentrations, bioaccumulation, or 

deposition of EGBE may not reasonably 

be anticipated to cause any adverse 

effects to the human health. 

III. Public Comments on Proposed Rule 

To Delist EGBE 

Of the 18 written comments we 

received pertaining to the proposed 

delisting of EGBE, 15 were supportive of 

the decision to delist and 3 opposed the 

decision to delist. 

The EPA has considered carefully all 

the comments both supporting and 

opposing the proposed delisting. A 

summary of the comments and EPA 

responses to them has been included in 

the docket for this proceeding. We 

received substantive comments with 

regard to the BAL issue, which we 

discussed in detail above. We received 

no substantive negative comments. Two 

of the comments in support of the 

delisting also asked specific policy 

questions. We respond to those 

questions below. 

Comment: One commenter asked if 

the rule also applies to diethylene glycol 

monobutyl ether (DEGBE). The 

commenter expressed support for 

delisting both chemicals in the rule. 

Response: The final rule applies only 

to EGBE, one of the compounds 

included in the group of glycol ethers 

listed in the section 112(b)(1) HAP list. 

The petition requested that one single 

compound, EGBE, be delisted; it did not 

request EPA to consider removing any 

other compounds in the group of glycol 

ethers. Therefore this action pertains 

only to EGBE. 

Comment: One commenter urged EPA 

to address the ‘‘Once In, Always In’’

policy in the final rulemaking for 

facilities that will no longer be major 

sources for MACT standards once EGBE 

is delisted. This commenter requested 

that the ‘‘Once In, Always In’’ policy not 

apply to delistings in general, since a 

facility that was only over the major 

source threshold due to emissions of a 

subsequently delisted HAP may never 

have been a ‘‘major source’’ from a 

health perspective, and therefore never 

really ‘‘in’’. The commenter argued that 

the purpose of the policy that sources 

not be allowed to backslide from MACT 

standards, is not applicable to delistings 

because in such cases the health and 

environmental protection of a standard 

is not undermined since the delisted 

chemical has been determined not to be 

a health and environmental threat.

Response: This action addresses a 

request to remove a specific pollutant 

from the HAP list. Any questions about 

the ‘‘Once In Always In Policy’’ are 

beyond the scope of today’s action. The 

EPA will address the ‘‘Once In Always 

In Policy’’ in the future. 

IV. Final Rule 

A. Rationale for Action 

The detailed factual rationale for 

supporting the Agency’s initial 

determination that the criteria in Clean 

Air Act section 112(b)(3)(C) had been 

met is set forth in the proposed rule 

published in the Federal Register on 

November 21, 2003 (68 FR 65648). 

However, as described above, EPA 

received additional data during the 

public comment period and had those 

data peer reviewed. The results of the 

peer review strengthen the case for 

delisting. The EPA also received 18 

public comments on the proposed rule, 

none of which caused EPA to revise the 

scientific basis upon which the initial 

determination to delist EGBE was 

predicated. The EPA hereby 

incorporates into its rationale for the 

final rule the substantive assessment of 

potential hazards, projected exposures, 

human risk, and environmental effects 

set forth in the proposed rule to delist 

EGBE. Based on that assessment, the 

Agency’s evaluation of the comments, 

and additional information submitted 

during the rulemaking (as summarized 

above), EPA has made a determination 

that there are adequate data on the 

health and environmental effects of 

EGBE to determine that emissions, 

ambient concentrations, 

bioaccumulation, or deposition of the 

compound may not reasonably be 

anticipated to cause adverse human 

health or environmental effects. 

B. Effective Date 

The final rule will be effective on 

November 29, 2004, the date it is 

published in the Federal Register. 

Although Section 553(d) of the 

Administrative Procedures Act, 5 U.S.C. 

553(d), provides that substantive rules 

must be published at least 30 days prior 

to their effective date, this requirement 

does not apply to this action. First, the 

rule was promulgated pursuant to CAA 

section 307(d), and that provision 

expressly states that the provisions of 

section 553 do not apply to this action. 

Second, even under section 553, the 

requirement that a rule be published 30 

days prior to its effective date does not 

apply to a rule, ‘‘which grants or 

Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Rules and Regulations 69323

recognizes an exemption or relieves a 

restriction.’’

V. References 

References cited in the preamble can 

be viewed in the docket for the final 

rule. 

VI. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), EPA must 

determine whether the regulatory action 

is ‘‘significant’’ and therefore subject to 

Office of Management and Budget 

(OMB) review and the requirements of 

the Executive Order. The Executive 

Order defines ‘‘significant regulatory 

action’’ as one that is likely to result in 

a rule that may: 

(1) Have an annual effect on the 

economy of $100 million or more or 

adverse affect in a material way the 

economy, a sector to the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

state, local or tribal governments or 

communities; 

(2) Create a serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; 

(3) Materially alter the budgetary 

impact of entitlements, grants, user fees, 

or loan programs, or the rights and 

obligation of recipients thereof; or 

(4) Raise novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in the Executive Order. 

Pursuant to the terms of Executive 

Order 12866, it has been determined 

that the final action does not constitute 

a ‘‘significant regulatory action’’ and is, 

therefore, not subject to OMB review. 

B. Paperwork Reduction Act 

This action does not impose an 

information collection burden under the 

provisions of the Paperwork Reduction 

Act, 44 U.S.C. 3501 et seq. The final 

action will remove EGBE from the CAA 

section 112 (b)(1) HAP list and, 

therefore, eliminate the need for 

information collection under the CAA. 

Burden means the total time, effort, or 

financial resources expended by persons 

to generate, maintain, retain, or disclose 

or provide information to or for a 

Federal agency. This includes the time 

needed to review instructions; develop, 

acquire, install, and utilize technology 

and systems for the purposes of 

collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; adjust the 

existing ways to comply with any 

previously applicable instructions and 

requirements; train personnel to be able 

to respond to a collection of 

information; search data sources; 

complete and review the collection of 

information; and transmit or otherwise 

disclose the information. An Agency 

may not conduct or sponsor, and a 

person is not required to respond to a 

collection of information unless it 

displays a currently valid OMB control 

number. The OMB control numbers for 

EPA’s regulations are listed in 40 CFR 

part 9 and 48 CFR chapter 15.

C. Regulatory Flexibility Act (RFA) 

The RFA generally requires an agency 

to prepare a regulatory flexibility 

analysis of any rule subject to notice 

and comment rulemaking requirements 

under the Administrative Procedure Act 

or any other statute unless the agency 

certifies that the rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Small entities include small business, 

small organizations, and small 

governmental jurisdictions. For the 

purposes of assessing the impacts of 

today’s final rule on small entities, 

small entity is defined as: (1) A small 

business that meets the definitions for 

small business based on the Small 

Business Association (SBA) size 

standards which, for this final action, 

can include manufacturing (NAICS 

3999–03) and air transportation (NAICS 

4522–98 and 4512–98) operations that 

employ less 1,000 people and 

engineering services (NAICS 8711–98) 

operations that earn less than $20 

million annually; (2) a small 

governmental jurisdiction that is a 

government of a city, county, town, 

school district or special district with a 

population of less than 50,000; and (3) 

a small organization that is any not-forprofit enterprise which is independently 

owned and operated and is not 

dominant in its field. 

After considering the economic 

impact of today’s final rule on small 

entities, I certify that this final action 

will not have a significant economic 

impact on a substantial number of small 

entities. In determining whether a rule 

has significant economic impact on a 

substantial number of small entities, the 

impact of concern is any significant 

adverse economic impact on small 

entities, since the primary purpose of 

the regulatory flexibility analysis is to 

identify and address regulatory 

alternatives ‘‘which minimize any 

significant economic impact of the final 

rule on small entities.’’ (5 U.S.C. 603 

and 604). Thus, an agency may certify 

that a rule will not have a significant 

economic impact on a substantial 

number of small entities if the rule 

relieves regulatory burden, or otherwise 

has a positive economic effect on all of 

the small entities subject to the rule. 

The final rule will eliminate the burden 

of additional controls necessary to 

reduce EGBE emissions and the 

associated operating, monitoring and 

reporting requirements. We have, 

therefore, concluded that today’s final 

rule will relieve regulatory burden for 

all small entities. We continue to be 

interested in the potential impacts of the 

final rule on small entities and welcome 

comments on issues related to such 

impacts. 

D. Unfunded Mandates Reform Act 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA), Public 

Law 1044, establishes requirements for 

Federal agencies to assess the effects of 

their regulatory actions on State, local, 

and tribal governments and the private 

sector. Under section 202 of the UMRA, 

EPA generally must prepare a written 

statement, including a cost-benefit 

analysis, for final and final rules with 

‘‘Federal mandates’’ that may result in 

expenditures to State, local, and tribal 

governments, in the aggregate, or to the 

private sector, of $100 million or more 

in any 1 year. Before promulgating an 

EPA rule for which a written statement 

is needed, section 205 of the UMRA 

generally requires EPA to identify and 

consider a reasonable number of 

regulatory alternatives and adopt the 

least costly, most cost-effective or least 

burdensome alternative that achieves 

the objectives of the rule. The 

provisions of section 205 do not apply 

when they are inconsistent with 

applicable law. Moreover, section 205 

allows EPA to adopt an alternative other 

than the least costly, most cost-effective 

or least burdensome alternative if the 

Administrator publishes with the final 

rule an explanation why that alternative 

was not adopted. Before EPA establishes 

any regulatory requirements that may 

significantly or uniquely affect small 

governments, including tribal 

governments, it must have developed 

under section 203 of the UMRA a small 

government agency plan. The plan must 

provide for notifying potentially 

affected small governments, enabling 

officials of affected small governments 

to have meaningful and timely input in 

the development of EPA regulatory 

proposals with significant Federal 

intergovernmental mandates, and 

informing, educating, and advising 

small governments on compliance with 

the regulatory requirements. 

Today’s final rule contains no Federal 

mandates for State, local, or tribal 

69324 Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Rules and Regulations 

governments or the private sector. The 

final rule imposes no enforceable duty 

on any State, local or tribal governments 

or the private sector. The EPA has 

determined that the final rule does not 

contain a Federal mandate that may 

result in expenditures of $100 million or 

more for State, local, and tribal 

governments, in the aggregate, or the 

private sector in any 1 year. Because the 

final rule removes a compound 

previously labeled in the CAA as a HAP, 

it actually reduces the burden 

established under the CAA. Thus, 

today’s final rule is not subject to the 

requirements of sections 202 and 205 of 

the UMRA. 

E. Executive Order 13132, Federalism 

Executive Order 13132 (64 FR 43255, 

August 10, 1999) requires 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.’’

Under Executive Order 13132, EPA 

may not issue a regulation that has 

federalism implications, that imposes 

substantial direct compliance costs, and 

that is not required by statute, unless 

the Federal government provides the 

funds necessary to pay the direct 

compliance costs incurred by State and 

local governments, or EPA consults with 

State and local officials early in the 

process of developing the final 

regulation. The EPA also may not issue 

a regulation that has federalism 

implications and that preempts State 

law unless the Agency consults with 

State and local officials early in the 

process of developing the final 

regulation.

Today’s final rule removes the 

substance EGBE from the list of HAP 

contained under section 112(b)(1) of the 

CAA. It does not impose any additional 

requirements on the States and does not 

affect the balance of power between the 

States and the Federal government. 

Thus, the requirements of section 6 of 

the Executive Order do not apply to the 

final rule. 

F. Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

Executive Order 13175, entitled 

‘‘Consultation and Coordination with 

Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), 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.’’ The final rule does not 

have tribal implications, as specified in 

Executive Order 13175. The final rule 

will eliminate control requirements for 

EGBE and, therefore, reduces control 

costs and reporting requirements for any 

tribal entity operating a EGBE source 

subject to control under the CAA. Thus, 

Executive Order 13175 does not apply 

to the final rule. 

G. Executive Order 13045, Protection of 

Children From Environmental Health 

Risks and Safety Risks 

Executive Order 13045 (62 FR 19885, 

April 23, 1997) applies to any rule that: 

(1) Is determined to be ‘‘economically 

significant’’ as defined under Executive 

Order 12866, and (2) concerns an 

environmental health or safety risk that 

EPA has reason to believe may have a 

disproportionate effect on children. If 

the regulatory action meets both criteria, 

the Agency must evaluate the 

environmental health or safety effects of 

the planned rule on children, and 

explain why the planned regulation is 

preferable to other potentially effective 

and reasonably feasible alternatives 

considered by the Agency. 

The EPA interprets Executive Order 

13045 as applying only to those 

regulatory actions that are based on 

health or safety risks, such that the 

analysis required under section 5–501 of 

the Executive Order has the potential to 

influence the regulation. The final rule 

is not subject to Executive Order 13045 

because it is not economically 

significant as defined in Executive 

Order 12866, and because the Agency 

does not have reason to believe the 

environmental health or safety risks 

addressed by this action present a 

disproportionate risk to children. This 

determination is based on the fact that 

the RfC is determined to be protective 

of sensitive sub-populations, including 

children. 

H. Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

Executive Order 13211, ‘‘Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001), requires EPA to prepare and 

submit a Statement of Energy Effects to 

the Administrator of the Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, for 

certain actions identified as ‘‘significant 

energy actions.’’ The final rule is not a 

‘‘significant energy action’’ because it is 

not likely to have a significant adverse 

effect on the supply, distribution, or use 

of energy. 

I. National Technology Transfer and 

Advancement Act 

Section 112(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA), Public Law No. 

104–113, section 12(d) 915 U.S.C. 272 

note), directs all Federal agencies to use 

voluntary consensus standards instead 

of government-unique standards in their 

regulatory activities unless to do so 

would be inconsistent with applicable 

law or otherwise impractical. Voluntary 

consensus standards are technical 

standards (e.g., material specifications, 

test method, sampling and analytical 

procedures, business practices, etc.) that 

are developed or adopted by one or 

more voluntary consensus standards 

bodies. Examples of organizations 

generally regarded as voluntary 

consensus standards bodies include the 

American society for Testing and 

Materials (ASTM), the National Fire 

Protection Association (NFPA), and the 

Society of Automotive Engineers (SAE). 

The NTTAA requires Federal agencies 

like EPA to provide Congress, through 

OMB, with explanations when an 

agency decides not to use available and 

applicable voluntary consensus 

standards. The final rule does not 

involve technical standards. Therefore, 

EPA is not considering the use of any 

voluntary consensus standards. 

J. 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. The EPA will 

submit a report containing the 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 the rule in the Federal 

Register. A major rule cannot take effect 

until 60 days after it is published in the 

Federal Register. However, this action 

is not a major rule as defined by 5 

U.S.C. 804(2). The final rule will be 

effective November 29, 2004.

List of Subjects in 40 CFR Part 63 

Environmental protection, Air 

pollution control, Hazardous 

Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Rules and Regulations 69325

substances, Reporting and 

recordkeeping requirements.

Dated: November 18, 2004. 

Michael O. Leavitt, 

Administrator.

■ For the reasons set out in the preamble, 

part 63, title 40, chapter I of the Code of 

Federal Regulations is amended as 

follows:

PART 63—[AMENDED]

■ 1. The authority citation for part 63 

continues to read as follows:

Authority: 42 U.S.C. 7401, et seq.

Subpart C—[AMENDED]

■ 2. Subpart C is amended by adding 

§ 63.63 to read as follows:

§ 63.63 Deletion of ethylene glycol 

monobutyl ether from the list of hazardous 

air pollutants. 

The substance ethylene glycol 

monobutyl ether (EGBE,2-

Butoxyethanol) (CAS Number 111–76–

2) is deleted from the list of hazardous 

air pollutants established by 42 U.S.C. 

7412(b)(1).

[FR Doc. 04–26071 Filed 11–26–04; 8:45 am] 

BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 73 and 74 

[MB Docket No. 03–185; FCC 04–220] 

Broadcast Services; Television 

Stations

AGENCY: Federal Communications 

Commission.

ACTION: Final rule.

SUMMARY: In this document, the 

Commission adopts rules for digital low 

power television (LPTV) and television 

translator stations, and resolves issues 

related to digital television booster 

stations. This proceeding marks the 

beginning of the digital television 

conversion for these services. The rules 

and policies provide the framework for 

this conversion.

DATES: Effective January 28, 2005, 

except §§ 73.6027, 74.703, 74.705, 

74.707, 74.710, 74.786 through 74.788, 

74.790, and 74.793 through 74.796 of 

the Commission’s rules, which contain 

information collection requirements 

under the Paperwork Reduction Act 

(PRA) and are not effective until 

approved by the Office of Management 

and Budget (OMB). Written comments 

by the public on the new and modified 

information collections are due January 

28, 2005. The Commission will publish 

a document in the Federal Register

announcing the effective date for these 

rules.

FOR FURTHER INFORMATION CONTACT:

Shaun Maher, Shaun.Maher@fcc.gov,

(202) 418–1600. For additional 

information concerning the Paperwork 

Reduction Act information collection 

requirements contained in this 

document, contact Leslie Smith, Federal 

Communications Commission, Room 1–

A804, 445 12th Street, SW., 

Washington, DC 20554, or via the 

Internet to Leslie.Smith@fcc.gov.

ADDRESSES: Federal Communications 

Commission, 445 12th Street, SW., 

Washington, DC 20554.

FOR FURTHER INFORMATION CONTACT:

Shaun Maher, Media Bureau (202) 418–

1600. For additional information 

concerning the information collection(s) 

contained in this document, contact 

Leslie Smith at 202–418–0217, or via 

the Internet at Leslie.Smith @fcc.gov.

SUPPLEMENTARY INFORMATION: This is a 

summary of the Report and Order (R&O)

in MB Docket No. 03–185, FCC 04–220, 

adopted September 9, 2004, and 

released September 30, 2004. This 

proceeding was initiated by the Notice 

of Proposed Rule Making, 68 FR 55566, 

September 26, 2003. The complete text 

of this R&O is available for inspection 

and copying during normal business 

hours in the FCC Reference Center, 

Room CY–A257, 445 12th Street, SW., 

Washington, DC and may also be 

purchased from the Commission’s copy 

contractor, Best Copy and Printing, Inc. 

(BCPI), Portals II, 445 12th Street SW, 

CY–B402, Washington, DC 20554. The 

R&O is also available on the Internet at 

the Commission’s Web site: http://

www.fcc.gov. Alternative formats are 

available to persons with disabilities by 

contacting Brian Millin at (202) 418–

7426 or TTY (202) 418–7365 or at 

Brian.Millin@fcc.gov

Paperwork Reduction Act 

This document contains information 

collection requirements subject to the 

Paperwork Reduction Act of 1995 

(PRA), Public Law 104–13. It will be 

submitted to the Office of Management 

and Budget (OMB) for review under 

section 3507(d) of the PRA. OMB, the 

general public, and other Federal 

agencies will be invited to comment on 

the information collection requirements 

contained in this proceeding. 

Summary of the Report and Order 

1. The R&O adopts definitions and 

permissible use provisions for digital 

TV translator and LPTV stations to 

mirror the analog operation of these 

stations. Digital translators will 

rebroadcast DTV broadcast signals. 

Whenever operating, a digital LPTV 

station must use some of its channel 

capacity to provide a free video 

programming service to the public. 

Upon meeting this requirement, LPTV 

stations may offer ancillary and 

supplementary services on the same 

basis as DTV broadcast licensees. 

2. As to the timing of the digital 

transition for these stations, LPTV, TV 

translator, and Class A stations are 

required to convert to digital operation, 

but the Commission has discretion to set 

the date by which analog operations of 

these stations must cease. The R&O

states that the Commission will seek to 

hasten their transition to digital service 

and will work toward the goal of 

achieving an end-date at, or soon after, 

the end date of the full-power transition. 

Although the Commission intends to 

hasten their transition to digital service, 

certain issues regarding the transition of 

full service stations must be resolved 

before a low-power transition deadline 

can be set. The final transition date of 

these stations will be considered in the 

Commission’s Third DTV periodic 

review proceeding. 

3. Existing LPTV and TV translator 

stations may convert to digital 

operations (‘‘flash cut’’) on their current 

channel. Applications for this purpose 

will be accepted on a first-come, first 

serve basis. Mutually exclusive 

applicants will be resolved by auction. 

In addition, to facilitate their digital 

transition, licensees and permittees of 

LPTV, TV translator, and Class A 

stations will be allowed to seek a digital 

companion channel for their analog 

station operations. A filing window for 

this purpose will be announced at a 

later date. The Commission will 

determine the deadline and process for 

stations’ obtaining a digital companion 

channel to return of one of their 

channels. At a later date, the 

Commission will institute a separate 

first-come-first-served filing procedure 

not limited to incumbent low power 

stations. 

4. Due to limited spectrum 

availability, the R&O makes available 

VHF channels 2–13, inclusive, and UHF 

channels 14–51, inclusive (except 

channel 37) for digital LPTV and TV 

translator operations. The R&O also 

permits the use of channels 52–69 on a 

limited basis. Existing LPTV and TV 

translator stations on channels 52–69 

may flash-cut to digital operations. The 

use of channels 52–59 for digital 

companion channels is limited to those 

stations that can certify the 

unavailability of any in-core channel