70051 

Rules and Regulations Federal Register

Vol. 69, No. 231 

Thursday, December 2, 2004 

This section of the FEDERAL REGISTER 

contains regulatory documents having general 

applicability and legal effect, most of which 

are keyed to and codified in the Code of 

Federal Regulations, which is published under 

50 titles pursuant to 44 U.S.C. 1510. 

The Code of Federal Regulations is sold by 

the Superintendent of Documents. Prices of 

new books are listed in the first FEDERAL 

REGISTER issue of each week. 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Part 430 

[Docket No. 97–013FE] 

RIN 0583–AC46 

Control of Listeria Monocytogenes in 

Ready-to-Eat Meat and Poultry 

Products 

AGENCY: Food Safety and Inspection 

Service, USDA.


ACTION: Interim final rule; extension of 


comment period. 


SUMMARY: The Food Safety and 

Inspection Service (FSIS) is extending 

the public comment period on the 

interim final rule ‘‘Control of Listeria 

monocytogenes in Ready-to-Eat Meat 

and Poultry Products’’ (68 FR 34208; 

June 6, 2003). The comment period on 

the rule will end on the same date as the 

comment period on the Agency report 

‘‘Assessing the Effectiveness of the 

Listeria monocytogenes Interim Final 

Rule’’ announced in a document 

published elsewhere in this issue of the 

Federal Register. 

DATES: Comments on the interim final 

rule must be received on or before 

January 31, 2005. 

ADDRESSES: Comments may be 

submitted by postal mail/commercial 

delivery or by e-mail. If you use postal 

mail/commercial delivery, please send 

the written comment to FSIS Docket 

Clerk Docket No. 97–013F, U.S. 

Department of Agriculture, Food Safety 

and Inspection Service, Room 102, 

Cotton Annex, 300 12th Street, SW., 

Washington DC 20250–3700. Please 

state that your comment refers to Docket 

No. 97–013F. Comments may also be 

sent electronically. If you use e-mail, 

address your comment to 

FSIS.RegulationsComments@usda.gov. 

For more information on e-rulemaking, 

or to view all open regulations, go to 

Regulations.gov. Your comment must be 

contained in the body of your message; 

do not send attached files. Please 

include your name and address in your 

message and include the Docket No. 97– 

013F on the subject line. All comments 

will be available for public inspection in 

the Docket Clerk’s Office between 8:30 

a.m. and 3:30 p.m., Monday through 

Friday, except Federal holidays. The 

comments may also be viewed on the 

Agency’s Web site at http://www.fsis. 

usda.gov/regulations/Federal_Register_ 

Publications_&_Related_Documents/. 

FOR FURTHER INFORMATION CONTACT: 

Lynn E. Dickey, Ph.D., Director, 

Regulations and Petitions Policy Staff, 

Office of Policy, Program, and Employee 

Development, Food Safety and 

Inspection Service, U.S. Department of 

Agriculture, (202) 720–5627. 

Done in Washington, DC, on November 15, 

2004. 

Barbara J. Masters, 

Acting Administrator. 

[FR Doc. 04–26516 Filed 12–1–04; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Part 430 

[Docket No. 04–032N] 

Availability of the Food Safety and 

Inspection Service Report on 

Assessing the Effectiveness of the 

Listeria Monocytogenes Interim Final 

Rule 

AGENCY: Food Safety and Inspection 

Service, USDA.


ACTION: Notice of availability and 


request for comments. 


SUMMARY: The Food Safety and 

Inspection Service (FSIS) is announcing 

the availability of the report ‘‘Assessing 

the Effectiveness of the Listeria 

monocytogenes Interim Final Rule.’’ The 

report was written by the Agency’s 

Listeria monocytogenes (L. 

monocytogenes) Assessment Team 

(Team) and presents the findings and 

recommendations of the Team which 

was responsible for assessing and 

measuring the effectiveness of the 

regulation to control L. monocytogenes 

in certain ready-to-eat (RTE) meat and 

poultry products. FSIS requests 

comments on the report. FSIS will 

consider the report and the comments 

on it, along with the comments that we 

receive on the interim final rule itself, 

in deriving a final rule on L. 

monocytogenes. 

DATES: To receive full consideration, 

comments should be submitted by 

January 31, 2005. 

ADDRESSES: FSIS invites interested 

persons to submit comments on the 

report ‘‘Assessing the Effectiveness of 

the Listeria monocytogenes Interim 

Final Rule’’. Comments may be 

submitted by any of the following 

methods: 

• Mail, including floppy disks or CDROM’s, and hand-or courier-delivered 

items: Send to Docket Clerk, U.S. 

Department of Agriculture, Food Safety 

and Inspection Service, 300 12th Street, 

SW., Room 102 Cotton Annex, 

Washington, DC 20250. 

All submissions received must 

include the Agency name and docket 

number 04–032N. All comments 

submitted in response to the report, as 

well as research and background 

information used by FSIS in developing 

this document, will be available for 

public inspection in the FSIS Docket 

Room at the address listed above 

between 8:30 a.m. and 4:30 p.m., 

Monday through Friday. The comments 

also will be posted on the Agency’s Web 

site at 

http://www.fsis.usda.gov/regulations/ 

2004_Notices_Index/ 

FOR FURTHER INFORMATION CONTACT: Dr. 

Arshad Hussain, Director, Data Analysis 

and Statistical Support Staff, Food 

Safety and Inspection Service, U.S. 

Department of Agriculture, (202) 720– 

3219. 

SUPPLEMENTARY INFORMATION: 

Background 

FSIS published an interim final rule, 

‘‘Control of Listeria monocytogenes in 

Ready-to-Eat Meat and Poultry 

Products’’, on June 6, 2003 (68 FR 

34208) that was effective on October 6, 

2003. The comment period on the 

interim final rule is being extended 

until January 31, 2005, by another 

document published elsewhere in this 

issue of the Federal Register. The 

interim final rule requires that official 

establishments that produce certain 

ready-to-eat (RTE) meat and poultry 

70052 Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Rules and Regulations 

products prevent product adulteration 

by the pathogenic environmental 

contaminant L. monocytogenes. In 

particular, under the interim final rule, 

establishments that produce RTE meat 

and poultry products that are exposed to 

the environment after lethality 

treatments and that support the growth 

of L. monocytogenes will be required to 

have, in their hazard analysis and 

critical control point (HACCP) plans or 

in their sanitation standard operating 

procedures or other prerequisite 

programs, controls that prevent product 

adulteration by L. monocytogenes. The 

establishments must share with FSIS 

data and information relevant to their 

controls for L. monocytogenes. The 

establishments also must furnish FSIS 

with information on the production 

volume of products affected by the 

regulations. The establishments may 

make claims on the labels of their RTE 

products regarding the processes that 

they use to eliminate or reduce L. 

monocytogenes or to suppress or limit 

its growth in the products. 

Purpose of the L. Monocytogenes 

Interim Final Rule Assessment Team 

The L. monocytogenes Assessment 

Team (Team) was assembled to assess 

and measure the effectiveness of the L. 

monocytogenes interim final rule and to 

report on what the rule has 

accomplished, what could be done to 

improve it, and what criteria should be 

used for long-term evaluations. 

The Team’s report, ‘‘Assessing the 

Effectiveness of the Listeria 

monocytogenes Interim Final Rule’’, 

presents the Team’s major findings and 

recommendations. The Agency will use 

information from this report in deciding 

whether to modify the interim final rule. 

FSIS wants to ensure that the L. 

monocytogenes regulations that are in 

place at the end of this process are as 

well-designed as they can possibly be as 

a tool to protect the public health. The 

Agency also wants to know what it can 

do to enhance the impact of initiatives 

associated with the rule, such as 

consumer education, retail outreach, 

and public health surveillance. 

The Structure of the L. Monocytogenes 

Interim Final Rule Assessment Team 

Out of the main assessment Team, 

FSIS formed seven smaller teams called 

Project Assessment Teams (PAT) to 

review various aspects of the interim 

final rule and related issues. Three 

teams, the Public Health team, the 

Economic Impact team, and the 

Labeling and Consumer Education team 

focused on the impact of the interim 

final rule. Two teams (Sampling 

Verification and Training) focused on 

the Agency’s on-going verification of the 

rule. The teams focused on how the 

Agency verifies that the requirements of 

the interim final rule are met, and on 

how it is preparing its inspection 

program personnel to verify that the 

requirements of the interim final rule 

are met. The Small Plant Guidance 

Team and the Retail Team focused on 

activities that support the effective 

implementation of the interim final rule, 

i.e., the teams focused on what FSIS can 

do to facilitate compliance. 

Each PAT prepared a report of its 

findings and recommendations. A 

summary of the findings of each of the 

seven PATs follows. Also, the PAT 

reports were presented to the National 

Advisory Committee on Meat and 

Poultry Inspection (NACMPI). NACMPI 

made recommendations that were 

considered and addressed by each PAT. 

Summary of the Findings of Each of the 

PAT’s Reports on ‘‘Assessing the 

Effectiveness of the Listeria 

Monocytogenes Interim Final Rule’’ 

Public Health Team 

The Public Health team focused on 

whether it is possible to assess the 

effects of the rule on public health. The 

team recognized that it is early to judge 

these effects. The team investigated 

whether the rule has affected the 

alternatives chosen by establishments to 

control L. monocytogenes in postlethality exposed RTE products. To 

assess whether there have been changes, 

FSIS conducted a survey of 1,490 

Inspectors-in-Charge (IIC) who cover 

over 2,900 establishments that produce 

RTE meat and poultry products. FSIS 

found that more than 87% of the 

establishments have changed their 

operations to more effectively control L. 

monocytogenes. For example, about 

59% have started to test for Listeria or 

Listeria-like organisms on direct food 

contact surfaces; 27% have started using 

an antimicrobial agent to inhibit the 

growth of this organism; and over 17% 

have started using post-lethality 

treatments in RTE products. 

Economic Impact Team 

The Economic Impact team assessed 

the assumptions that the Agency made 

in preparing the economic assessment 

that was part of the interim final rule. 

It also gathered data on the costs and 

benefits of the rule as implemented. For 

example, the team considered whether 

the rule is disproportionately affecting 

small establishments. It found that 56% 

of the L. monocytogenes-related FSIS 

noncompliance records (NRs) have gone 

to very small plants, but that this is not 

a disproportionate share given that very 

small plants represent about 51% of the 

plants that produce RTE product. The 

team found that most of the 

establishments that received a NR had 

chosen the least protective alternative to 

control L. monocytogenes available to 

establishments. 

Labeling and Consumer Education 

Team 

The Labeling and Consumer 

Education Team focused in part on 

incentive labeling. The interim final 

rule stated that establishments can 

declare any processing methodology 

that they use to address L. 

monocytogenes on their label. The team 

found that no establishments are using 

incentive labeling. The team 

recommended that FSIS use focus group 

research to help develop statements that 

would provide flexibility in conveying 

the fact that RTE product has undergone 

post-lethality treatment to destroy 

Listeria. 

Sampling Verification Team 

The Sampling Verification team 

assessed the L. monocytogenes sampling 

that the Agency performs and 

determined whether improvements in 

that sampling are needed. The team 

recommended that the Agency complete 

the development of a risk-based 

sampling regime, including an 

intensified sampling program in 

response to positive findings. The 

Agency’s work on this risk-based 

sampling will begin shortly using the 

information that FSIS collects on the 

volume of RTE products produced by 

establishments. 

Training Team 

The Training team was responsible for 

ensuring that the Agency’s inspection 

program personnel are appropriately 

trained to enforce the interim final rule. 

The team recommended that FSIS’ Food 

Safety Regulatory Essentials (FSRE) 

course be given to all FSIS Consumer 

Safety Inspectors (CSI), and that it be 

supplemented with compact disc (CD) 

training that focuses on the interim final 

rule. FSIS has trained more than half of 

its 1,700 CSIs on FSRE, and it 

continually updates the course. The 

FSRE course has already been updated 

to reflect the interim final rule. The 

team also recommended that the work 

of the CSIs be supplemented by training 

of the FSIS Enforcement, Investigations, 

and Analysis Officers (EIAO) on the 

performance of specialized sampling. 

Small Plant Guidance Team 

The Small Plant Guidance team found 

that the Agency needs to develop better 

ways of ensuring that FSIS Compliance 

Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Rules and Regulations 70053 

Guides reach small and very small 

establishments. The team also suggested 

that, to be useful to small and very small 

plants, the guidelines be simplified. 

Retail Team 

Finally, the Retail team focused on 

possible means of controlling L. 

monocytogenes in RTE products at retail 

establishments. This team found that 

slicing and packaging deli meats at 

retail establishments represents a 

significant source of exposure of L. 

monocytogenes. The team suggested two 

possible strategies for dealing with this 

problem: (1) education and outreach, 

and (2) use of antimicrobial agents in 

products to be sliced and sold at retail 

establishments. The team also pointed 

to efforts already underway in the 

Agency to compare the risk of listeriosis 

from product sliced in plants with the 

risk from those sliced at retail 

establishments. The results of this 

assessment will be used by the Agency 

in developing its strategy for retail 

establishments. 

Availability of the Complete Team 

Report 

The report on ‘‘Assessing the 

Effectiveness of the Listeria 

monocytogenes Interim Final Rule’’, 

with each of the Project Assessment 

Team’s individual reports, is available 

on the Agency Web site at http:// 

www.fsis.usda.gov/Frame/ 

FrameRedirect.asp?main=http:// 

www.fsis.usda.gov/OPPDE/rdad/ 

FRPubs/Docs_97–013F.htm. 

The complete report may also be 

viewed in the FSIS Docket Room, 300 

12th Street, SW., Room 102 Cotton 

Annex, Washington, DC, 20250 between 

8:30 a.m. to 4:30 p.m. 

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 in Washington, DC, on October 29, 

2004. 

Barbara J. Masters, 

Acting Administrator. 

[FR Doc. 04–26515 Filed 12–1–04; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2004–18827; Airspace 

Docket No. 04–ACE–53] 

Modification of Class E Airspace; 

Hannibal, MO 

AGENCY: Federal Aviation 

Administration (FAA), DOT.


ACTION: Direct final rule; confirmation of 


effective date. 


SUMMARY: This document confirms the 

effective date of the direct final rule 

which revises Class E airspace at 

Hannibal, MO. 

DATES: Effective 0901 UTC, January 20, 

2005. 

FOR FURTHER INFORMATION CONTACT: 

Brenda Mumper, Air Traffic Division, 

Airspace Branch, ACE–520A, DOT 

Regional Headquarters Building, Federal 

Aviation Administration, 901 Locust, 

Kansas City, MO 64106; telephone: 

(816) 329–2524. 

SUPPLEMENTARY INFORMATION: The FAA 

published this direct final rule with a 

request for comments in the Federal 

Register on October 8, 2004 (69 FR 

60286). The FAA uses the direct final 

rulemaking procedure for a noncontroversial rule where the FAA 

believes that there will be no adverse 

public comment. This direct final rule 

advised the public that no adverse 

comments were anticipated, and that 

unless a written adverse comment, or a 

written notice of intent to submit such 

an adverse comment, were received 

within the comment period, the 

regulation would become effective on 

January 20, 2005. No adverse comments 

were received, and thus this notice 

confirms that this direct final rule will 

become effective on that date. 

Issued in Kansas City, MO, on November 

16, 2004. 

Anthony D. Roetzel, 

Acting Area Director, Western Flight Services 

Operations. 

[FR Doc. 04–26524 Filed 12–1–04; 8:45 am] 

BILLING CODE 4910–13–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 520 

Oral Dosage Form New Animal Drugs; 

Sulfadiazine/Pyrimethamine 

Suspension 

AGENCY: Food and Drug Administration, 


HHS.


ACTION: Final rule.


SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a new animal drug 

application (NADA) filed by Animal 

Health Pharmaceuticals, LLC. The 

NADA provides for veterinary 

prescription use of an oral suspension of 

sulfadiazine and pyrimethamine for the 

treatment of equine protozoal 

myeloencephalitis (EPM). 

DATES: This rule is effective December 2, 

2004. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7543, email: melanie.berson@fda.gov. 

SUPPLEMENTARY INFORMATION: Animal 

Health Pharmaceuticals, LLC, 1805 Oak 

Ridge Circle, suite 101, St. Joseph, MO 

64506, filed NADA 141–240 for 

veterinary prescription use of 

REBALANCE (sulfadiazine/ 

pyrimethamine) Antiprotozoal Oral 

Suspension for the treatment of EPM 

caused by Sarcocystis neurona. The 

NADA is approved as of November 5, 

2004, and 21 CFR part 520 is amended 

by adding new § 520.2215 to reflect the 

approval. The basis of approval is 

discussed in the freedom of information 

summary. 

In addition, Animal Health 

Pharmaceuticals, LLC, is not currently 

listed in the animal drug regulations as 

a sponsor of an approved application. 

At this time, 21 CFR 510.600(c) is being 

amended to add entries for the firm. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to