76886 Federal Register / Vol. 69, No. 246 / Thursday, December 23, 2004 / Proposed Rules 

drug application from the drug sponsor, 

and has not established and codified a 

tolerance level for the drug, the use of 

such drugs is illegal.

FDA has not evaluated the safety of 

growth promoting implants in nonruminating young calves. Therefore, 

FSIS cannot determine when the edible 

tissues from animals to whom such 

substances have been administered are 

not unfit for human food. If FSIS cannot 

make this determination, it cannot 

determine when the edible product from 

those animals that have been 

administered the unapproved new 

animal drug are not adulterated, and 

thus it cannot apply the mark of 

inspection to such products. 

HACCP Systems 

9 CFR 417.2(a) requires 

establishments to conduct a hazard 

analysis to determine what food safety 

hazards are reasonably likely to occur in 

their process and to identify the 

preventive measures that the 

establishment can apply to control those 

hazards. The hazards may occur before, 

during, or after entry into the 

establishment. FSIS has identified drug 

residues as possible food safety hazards 

(9 CFR 417.2(a)(3)). 

Section 417.2(a)(1) states that a food 

safety hazard that is reasonably likely to 

occur is one for which a prudent 

establishment would establish control 

measures because it historically has 

occurred, or because there is a 

reasonable possibility that it will occur 

in the particular type of product being 

processed, in the absence of those 

controls. Whenever a hazard analysis 

reveals that one or more hazards are 

reasonably likely to occur in the 

production process, the regulations 

require that the establishment develop 

and implement a written HACCP plan 

that includes specific control measures 

for each hazard so identified (417.2(b) 

(1) and (c)). 

Requirement and Basis for 

Reassessment 

Section 417.4(a)(3) states that every 

establishment shall reassess the 

adequacy of its HACCP plan at least 

annually and whenever any changes 

occur that could affect the hazard 

analysis or alter the HACCP plan. The 

finding that new animal drugs have 

been knowingly administered, on a 

widespread basis, to a production class 

of animals in which their use is not 

approved, represents information that 

could alter the hazard analysis, and 

ultimately the HACCP plan, of any 

establishment that slaughters animals of 

that class, in this case young calves, for 

human food. Therefore, establishments 

that slaughter young calves, including 

those young calves marketed, 

slaughtered, and labeled as ‘‘veal,’’ need 

to consider the hazard presented by the 

illegal use of animal drugs in the 

animals they slaughter, and what 

actions they should take to control it if 

they determine that it is reasonably 

likely to occur, as a result of their 

reassessments. 

If reassessment results in a 

determination by the establishment that 

a residue of an unapproved new animal 

drug is a food safety hazard that is 

reasonably likely to occur, this hazard 

must be addressed in the 

establishment’s HACCP plan. However, 

FSIS recognizes that some slaughterers 

employ measures to ensure that they do 

not purchase food animals for slaughter 

with violative animal drug residues. 

These slaughterers should consider 

incorporating these measures into their 

HACCP plans or prerequisite programs. 

FSIS Actions To Enforce and Facilitate 

Compliance With the Reassessment 

The Agency intends to instruct 

inspection program personnel to verify, 

as part of the Agency’s verification of 

the 2005 hazard analysis reassessment, 

that establishments that slaughter young 

calves have considered the hazard of 

illegal residues. Before performing that 

verification, inspection program 

personnel will ensure that all 

establishments that slaughter young 

calves are aware that the Agency has 

issued this notice. They will also ensure 

that those establishments that have not 

yet reassessed their HACCP plans, based 

on the relevant FSIS findings discussed 

earlier, begin their reassessment. By 

looking into establishments’

reassessment actions before the time 

that the establishments are required to 

complete their reassessments, FSIS will 

ensure that all establishments 

slaughtering young calves, including 

establishments that are considered small 

and very small businesses, and those 

that may not belong to a trade 

association, are aware of this notice.

Paperwork Reduction Act 

FSIS has reviewed the paperwork and 

recordkeeping requirements in this 

notice in accordance with the 

Paperwork Reduction Act and has 

determined that the paperwork 

requirements for the regulations that 

require establishments that slaughter 

calves to reassess their HACCP Plans 

have already been accounted for in the 

Pathogen Reduction/HACCP Systems 

information collection approved by the 

Office of Management Budget (OMB). 

The OMB approval number for the 

Pathogen Reduction/HACCP Systems 

information collection is 0583–0103. 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that the public and in particular 

minorities, women, and persons with 

disabilities, are aware of this notice, 

FSIS will announce it on-line through 

the FSIS Web page located at http://

www.fsis.usda.gov.

FSIS also will make copies of this 

Federal Register publication available 

through the FSIS Constituent Update, 

which is used to provide information 

regarding FSIS policies, procedures, 

regulations, Federal Register notices, 

FSIS public meetings, recalls, and other 

types of information that could affect or 

would be of interest to our constituents 

and stakeholders. The update is 

communicated via Listserv, a free e-mail 

subscription service consisting of 

industry, trade, and farm groups, 

consumer interest groups, allied health 

professionals, scientific professionals, 

and other individuals who have 

requested to be included. The update 

also is available on the FSIS Web page. 

Through Listserv and the Web page, 

FSIS is able to provide information to a 

much broader, more diverse audience.

Done at Washington, DC, on December 20, 

2004. 

Barbara J. Masters, 

Acting Administrator.

[FR Doc. 04–28083 Filed 12–22–04; 8:45 am] 

BILLING CODE 3410–DM–P

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52

[R05–OAR–2004–MI–0002; FRL–7849–2] 

Approval and Promulgation of 

Implementation Plans: Michigan: 

Oxides of Nitrogen

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: The EPA is approving a 

revision to the plan prepared by 

Michigan that will limit the emissions 

of oxides of nitrogen (NOX) from large 

stationary sources (i.e. power plants, 

industrial boilers and cement kilns). 

This plan meets all of the requirements 

contained in an EPA rule that was 

published in the Federal Register on 

April 16, 2004. This rule, otherwise 

known as the NOX SIP Call Phase I 

provides for NOX reductions from 

Federal Register / Vol. 69, No. 246 / Thursday, December 23, 2004 / Proposed Rules 76887

sources in 20 States in the eastern half 

of the country. The effect of this 

approval is to ensure federal 

enforceability of the state air program 

plan and to maintain consistency 

between the state-adopted plan and the 

approved State Implementation Plan 

(SIP).

DATES: Written comments must be 

received on or before January 24, 2005.

ADDRESSES: Submit comments, 

identified by Regional Material in 

EDocket (RME) ID No. R05–OAR–2004–

MI–0002 by one of the following 

methods: Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

Agency Web site: http://

docket.epa.gov/rmepub/index.jsp.

Regional Material in EDocket (RME), 

EPA’s electronic public docket and 

comment system, is EPA’s preferred 

method for receiving comments. Once 

in the system, select ‘‘quick search,’’

then key in the appropriate RME Docket 

identification number. Follow the online instructions for submitting 

comments. 

E-mail: bortzer.jay@epa.gov.

Fax: (312) 886–5824. 

Mail: You may send written 

comments to: J. Elmer Bortzer, Chief, 

Air Programs Branch, (AR–18J), U.S. 

Environmental Protection Agency, 77 

West Jackson Boulevard, Chicago, 

Illinois 60604. 

Hand delivery: Deliver your 

comments to: J. Elmer Bortzer, Chief, 

Air Programs Branch (AR–18J), U.S. 

Environmental Protection Agency, 

Region 5, 77 West Jackson Boulevard, 

18th floor, Chicago, Illinois 60604. 

Such deliveries are only accepted 

during the Regional Office’s normal 

hours of operation. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 a.m. to 

4:30 p.m. excluding Federal holidays. 

Instructions: Direct your comments to 

Regional Material in EDocket (RME) ID 

No. R05–OAR–2004–MI–0002. EPA’s 

policy is that all comments received 

will be included in the public docket 

without change, including any personal 

information provided, unless the 

comment includes information claimed 

to be Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. Do 

not submit information that you 

consider to be CBI or otherwise 

protected through Regional Material in 

EDocket (RME), regulations.gov, or email. The EPA Regional Material in 

EDocket (RME) Web site and the federal 

regulations.gov Web site are 

‘‘anonymous access’’ systems, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through RME or 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the public docket and made 

available on the Internet. If you submit 

an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. For additional instructions on 

submitting comments, go to Section I of 

the SUPPLEMENTARY INFORMATION section 

of this document.

Docket: All documents in the 

electronic docket are listed in the 

Regional Material in EDocket (RME) 

index at http://www.epa.gov/rmepub/

index.jsp. Although listed in the index, 

some information is not publicly 

available, i.e., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Publicly available docket materials are 

available either electronically in RME or 

in hard copy at Environmental 

Protection Agency, Region 5, Air and 

Radiation Division, 77 West Jackson 

Boulevard, Chicago, Illinois 60604. 

Please telephone Douglas Aburano at 

(312) 353–6960 before visiting the 

Region 5 Office.

FOR FURTHER INFORMATION CONTACT:

Douglas Aburano, Environmental 

Engineer, Criteria Pollutant Section, Air 

Programs Branch (AR–18J), USEPA, 

Region 5, 77 West Jackson Boulevard, 

Chicago, Illinois 60604, (312) 353–6960. 

aburano.douglas@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information 

A. Does this action apply to me? 

B. What should I consider as I prepare my 

comments for EPA? 

II. What action is EPA taking today? 

III. Where can I find more information about 

this proposal and the corresponding 

direct final rule?

I. General Information 

A. Does This Action Apply to Me? 

This action applies to large stationary 

sources of NOX (such as electric 

generating units that produce electricity 

for sale, other large boilers that produce 

steam and/or electricity but do not sell 

electricity, and cement kilns) in the 

southern counties (Allegan, Barry, Bay, 

Berrien, Branch, Calhoun, Cass, Clinton, 

Eaton, Genesee, Gratiot, Hillsdale, 

Ingham, Ionia, Isabella, Jackson, 

Kalamazoo, Kent, Lapeer, Lenawee, 

Livingston, Macomb, Mecosta, Midland, 

Monroe, Montcalm, Muskegon, 

Newaygo, Oakland, Oceana, Ottawa, 

Saginaw, Saint Clair, Saint Joseph, 

Sanilac, Shiawassee, Tuscola, Van 

Buren, Washtenaw, Wayne) of 

Michigan. This action also applies to the 

unit at DTE Energy’s Harbor Beach 

facility in Huron County. 

B. What Should I Consider as I Prepare 

My Comments for EPA? 

1. Submitting CBI. Do not submit 

Confidential Business Information (CBI) 

to EPA through Regional Material in 

EDocket (RME), regulations.gov or email. Clearly mark the part or all of the 

information that you claim to be CBI. 

For CBI information in a disk or CD 

ROM that you mail to EPA, mark the 

outside of the disk or CD ROM as CBI 

and then identify electronically within 

the disk or CD ROM the specific 

information that is claimed as CBI. In 

addition to one complete version of the 

comment that includes information 

claimed as CBI, a copy of the comment 

that does not contain the information 

claimed as CBI must be submitted for 

inclusion in the public docket. 

Information so marked will not be 

disclosed except in accordance with 

procedures set forth in 40 CFR part 2. 

2. Tips for Preparing Your Comments.

When submitting comments, remember 

to: 

a. Identify the rulemaking by docket 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

b. Follow directions—The agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

c. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

d. Describe any assumptions and 

provide any technical information and/

or data that you used. 

e. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

f. Provide specific examples to 

illustrate your concerns, and suggest 

alternatives. 

g. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

76888 Federal Register / Vol. 69, No. 246 / Thursday, December 23, 2004 / Proposed Rules 

h. Make sure to submit your 

comments by the comment period 

deadline identified.

II. What Action Is EPA Taking Today? 

EPA is proposing to approve the NOX

SIP submitted on April 3, 2003 as 

modified on May 27, 2004. EPA finds 

that Michigan’s submittals are fully 

approvable because the initial April 3, 

2003 submittal was conditionally 

approved and the conditions for full 

approvability were met in the May 27, 

2004 submittal. In combination, these 

two submittals meet the requirements of 

the Phase I NOX SIP Call. 

We are proposing to approve 

Michigan’s revision of the ozone SIP 

that responds to EPA’s Phase I NOX SIP 

Call. This revision consists of Michigan 

Air Pollution Control Rules 803, 805–

810, and 812–817 as submitted on April 

3, 2003 and Michigan Air Pollution 

Control Rules 802, 804 and 811 as 

submitted May 27, 2004. A combined 

package of these rules 802–817 as 

submitted on April 3, 2003 and May 27, 

2004 was submitted as a supplement to 

the May 27, 2004 submittal for ease of 

incorporation by reference. This 

supplemental submittal was sent by 

MDEQ to EPA on August 5, 2004. 

By this action, we are also proposing 

to vacate our April 16, 2004 (69 FR 

20548) conditional approval of 

Michigan’s earlier NOX SIP submittal. 

III. Where Can I Find More Information 

About This Proposal and the 

Corresponding Direct Final Rule? 

For additional information, see the 

Direct Final Rule which is located in the 

Rules section of this Federal Register. 

Copies of the request and the EPA’s 

analysis are available electronically at 

Regional Material in EDocket (RME) or 

in hard copy at the above address. 

Please telephone Douglas Aburano at 

(312) 353–6960 before visiting the 

Region 5 Office.

Dated: December 3, 2004. 

Bharat Mathur, 

Acting Regional Administrator, Region 5.

[FR Doc. 04–27984 Filed 12–22–04; 8:45 am] 

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52

[R03–OAR–2004–DC–0008; FRL–7852–7] 

Approval and Promulgation of Air 

Quality Implementation Plans; District 

of Columbia; VOC Emission Standards 

for Mobile Equipment Repair and 

Refinishing

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to approve 

a State Implementation Plan (SIP) 

revision submitted by the District of 

Columbia establishing regulations for 

the control of volatile organic 

compound (VOC) emissions from 

mobile equipment repair and refinishing 

operations in the District of Columbia. 

In the Final Rules section of this 

Federal Register, EPA is approving the 

District’s SIP submittal as a direct final 

rule without prior proposal because the 

Agency views this as a noncontroversial 

submittal and anticipates no adverse 

comments. A detailed rationale for the 

approval is set forth in the direct final 

rule. If no adverse comments are 

received in response to this action, no 

further activity is contemplated. If EPA 

receives adverse comments, the direct 

final rule will be withdrawn and all 

public comments received will be 

addressed in a subsequent final rule 

based on this proposed rule. EPA will 

not institute a second comment period. 

Any parties interested in commenting 

on this action should do so at this time.

DATES: Comments must be received in 

writing by January 24, 2005.

ADDRESSES: Submit your comments, 

identified by Regional Material in 

EDocket (RME) ID Number R03–OAR–

2004–DC–0008 by one of the following 

methods: 

A. Federal eRulemaking Portal:

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

B. Agency Web site: http://

www.docket.epa.gov/rmepub/ RME, 

EPA’s electronic public docket and 

comment system, is EPA’s preferred 

method for receiving comments. Follow 

the on-line instructions for submitting 

comments. 

C. E-mail: morris.makeba@epa.gov.

D. Mail: R03–OAR–2004–DC–0008, 

Makeba Morris, Chief, Air Quality 

Planning Branch, Mailcode 3AP21, U.S. 

Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

E. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

RME ID No. R03–OAR–2004–DC–0008. 

EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online at http://

www.docket.epa.gov/rmepub/, 

including any personal information 

provided, unless the comment includes 

information claimed to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Do not submit 

information that you consider to be CBI 

or otherwise protected through RME, 

regulations.gov or e-mail. The EPA RME 

and the Federal regulations.gov Web 

sites are an ‘‘anonymous access’’

system, which means EPA will not 

know your identity or contact 

information unless you provide it in the 

body of your comment. If you send an 

e-mail comment directly to EPA without 

going through RME or regulations.gov, 

your e-mail address will be 

automatically captured and included as 

part of the comment that is placed in the 

public docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the 

electronic docket are listed in the RME 

index at http://www.docket.epa.gov/

rmepub/. 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 RME or 

in hard copy during normal business 

hours at the Air Protection Division, 

U.S. Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

Copies of the State submittal are 

available at the District of Columbia 

Department of Public Health, Air