Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices 3617 

modeled in our risk and benefit analysis 

was modest. When we modeled actual 

baseline consumption for the range of 

methylmercury concentrations (low to 

high) the assessment indicated a 

significant probability of a net adverse 

effect for 1/10 of 1 percent of children 

for the central estimate. The highest 

estimated net adverse effect was also 

quite modest. For fatal coronary heart 

disease and stroke, commercial fish 

baseline consumption is averting a 

central estimate of over 30,000 deaths 

per year from coronary heart disease 

and over 20,000 deaths per year from 

stroke. The results of our quantitative 

risk and benefit assessment are 

generally consistent with research 

reported in recent years in the scientific 

literature. 

The draft summary of published 

research identifies primarily secondary 

analyses of the large body of scientific 

research on the impact of fish and 

omega-3 fatty acids on cardiovascular 

and neurologic endpoints, including 

research on both prenatal and post-natal 

exposures. In addition to the IOM 

report, these secondary analyses include 

reports by the American Heart 

Association, the European Food Safety 

Authority, the International Society for 

the Study of Fatty Acids and Lipids, the 

World Health Organization and a 

previous investigation by FDA. This 

compendium of research was developed 

by FDA for use in developing its 

quantitative risk benefit assessment and 

provides background for that document. 

The draft summary of published 

research identifies and delineates the 

lines of scientific evidence that indicate 

the association of fish and omega-3 fatty 

acid consumption with cardiovascular 

and neurodevelopmental health 

outcomes. When available, the 

compendium of research also identifies 

reports of quantitative dose-response 

relationships which may be relevant for 

risk and benefit assessment modeling. 

The draft summary of published 

research describes the context of the 

overall body of scientific evidence 

currently available for potential 

application to the risk and benefit 

assessment modeling and the draft risk 

and benefit assessment report. 

The agency designated the draft risk 

and benefit assessment report and the 

draft summary of published research as 

a ‘‘highly influential scientific 

assessment’’ under the Office of 

Management and Budget’s (OMB) Final 

Information Quality Bulletin for Peer 

Review (the Bulletin) (70 FR 2664, 

January 14, 2005). In August 2008, FDA 

submitted a draft of the risk and benefit 

assessment report (which at the time 

also incorporated the draft summary of 

published research) to seven scientific 

experts outside the Federal Government, 

from a range of scientific disciplines, for 

purposes of obtaining each expert’s 

independent, written peer review. The 

draft risk and benefit assessment report 

and the draft summary of published 

research that are being made available 

for public comment reflect revisions 

made to date in response to the peer 

reviewers’ comments and suggestions. 

The Information Quality Act Bulletin for 

Peer Review requires FDA to post at its 

Web site a report of the peer review that: 

(1) Contains the names and credentials 

of the peer reviewers; (2) sets forth the 

‘‘charge,’’ i.e., the scientific questions 

asked of the reviewers; (3) provides the 

verbatim comments submitted by each 

reviewer (without attribution); and (4) 

discusses what FDA has done to the 

documents in response to the peer 

reviewers’ comments. We have posted at 

our Web site an interim draft of this 

report that provides this information at 

http://www.cfsan.fda.gov/~dms/ 

mehg109.html, although we expect and 

plan to finalize this report after revising 

our draft risk and benefit assessment 

report and the draft summary of 

published research, in response to 

further expert and peer review 

comments. 

Separately, FDA solicited and 

received comments from scientists at 

other Federal agencies, including EPA, 

the National Institutes of Health, the 

Centers for Disease Control and 

Prevention, and the National Oceanic 

and Atmospheric Administration during 

a review coordinated by OMB. The draft 

risk and benefit assessment report and 

the draft summary of published research 

being made available for comment have 

been revised to reflect revisions made in 

response to the inter-agency reviewers’ 

comments. 

At the same time we are making these 

draft documents available for public 

comment, we plan to provide a revised 

draft to the original peer reviewers to 

enable them to submit any further 

comments. We will revise the draft risk 

and benefit assessment report and the 

draft summary of published research as 

necessary after considering the public 

comments and any additional comments 

from the independent peer reviewers. 

We also plan to provide the revised 

version of the documents, a summary of 

the public comments that address 

significant scientific issues, and the 

external peer review report to an FDA 

scientific advisory committee. 

After public and advisory committee 

review of these documents are 

complete, appropriate risk management 

actions will then be considered on the 

basis of currently available scientific 

information. The release of these 

documents for public comment and peer 

review do not in any way modify the 

recommendations set forth in the 2004 

advisory on fish consumption. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

The draft documents described in this 

notice are available electronically at 

http://cfsan.fda.gov/~dms/ 

mehg109.html. 

IV. Access to Related Documents 

All references listed in the reports are 

available in FDA’s Division of Dockets 

Management (see ADDRESSES). Computer 

programs used in the risk and benefit 

assessment modeling are available from 

Clark Carrington, Center for Food Safety 

and Applied Nutrition (HFS–301), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740– 

3835, 301–436–1947, e-mail: 

Clark.Carrington@fda.hhs.gov. 

Dated: January 14, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–1081 Filed 1–15–09; 11:15 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0658] 

Risk Assessment of the Public Health 

Impact From Foodborne Listeria 

monocytogenes in Some Ready-to-Eat 

Foods Sliced, Prepared, and/or 

Packaged in Retail Facilities; Request 

for Comments and for Scientific Data 

and Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments 

and for scientific data and information. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

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3618 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices 

comments and scientific data and 

information that would assist the agency 

in its plans to conduct a risk assessment 

of the public health impact of foodborne 

Listeria monocytogenes in some readyto-eat foods sliced, prepared, and/or 

packaged in retail facilities. The 

purpose of the risk assessment is to 

ascertain the impact on public health of 

current practices and potential 

interventions that reduce or prevent L. 

monocytogenes contamination in readyto-eat food. 

DATES: Submit comments and scientific 

data and information by April 21, 2009. 

ADDRESSES: Submit written comments 

and scientific data and information to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments, scientific data, 

and information to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Sherri Dennis, Center for Food Safety 

and Applied Nutrition (HFS–005), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy, College Park, MD 20740, 

301–436–2355, e-mail: 

sherri.dennis@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Department of Health and Human 

Services’ Healthy People 2010 is a 

comprehensive set of disease prevention 

and health promotion objectives for the 

Nation to achieve over the first decade 

of the new century. Created by scientists 

both inside and outside of government, 

it identifies a wide range of public 

health priorities and specific, 

measurable objectives. One of these 

objectives calls on Federal food safety 

agencies to reduce foodborne listeriosis 

(Ref. 1). In support of this goal, in 2003, 

FDA and the Food Safety and Inspection 

Service (FSIS) of the U.S. Department of 

Agriculture (USDA) issued an 

assessment of the relative risk to public 

health from foodborne Listeria 

monocytogenes among selected 

categories of ready-to-eat (RTE) foods 

(Listeria risk assessment, Ref. 2). The 

Listeria risk assessment formed the basis 

of the 2003 FDA and Centers for Disease 

Control and Prevention (CDC) Listeria 

Action Plan (Ref. 3), which identifies 

prevention and control activities that 

FDA and CDC will take to reduce the 

incidence of foodborne listeriosis in the 

United States. 

The 2003 Listeria risk assessment 

provided the first quantitative estimate 

of the relative risk of listeriosis from 

consumption of a variety of RTE foods. 

Among the RTE foods evaluated in the 

2003 risk assessment, deli meats (e.g., 

luncheon meats) were considered to 

present the highest risk per serving and 

the highest risk per annum. This rank 

was the result of a moderate 

contamination frequency, a high 

number of servings consumed and high 

growth rates of L. monocytogenes. 

Additional data obtained in California 

and Maryland showed that L. 

monocytogenes prevalence and levels in 

luncheon meats, deli-style salads, and 

seafood salads were higher for in-storepackaged than for manufacturerpackaged foods (Ref. 4). This 

observation was confirmed for meat and 

poultry products in a study by the 

National Alliance for Food Safety and 

Security performed in northern 

California, Georgia, Minnesota, and 

Tennessee in 2008 (Ref. 5). Using these 

latter results, it was estimated that most 

of the listeriosis cases attributed to 

ready-to-eat meat and poultry deli meats 

are from products sliced and packaged 

at retail (FSIS/USDA, unpublished 

results). 

Little is known about how Listeria 

contamination occurs in retail facilities. 

Retail practices may result in either 

cross-contamination from one product 

to another or through contamination 

from the retail environment. There is 

thus a need to identify potential sources 

and practices that may increase L. 

monocytogenes contamination in retail 

settings and practices or interventions 

that could reduce or eliminate L. 

monocytogenes contamination of food 

products (sold to consumers at the retail 

level) and resulting human illness. 

FDA is engaged in a risk assessment 

that will evaluate the dynamics of L. 

monocytogenes contamination in retail 

facilities contributing to listeriosis. It 

will evaluate how specific practices 

could affect the overall level and 

frequency of contamination, and the 

relative effectiveness of various process 

changes and intervention strategies 

intended to reduce human illness. The 

project will address FDA and USDA 

regulated RTE foods. It will focus on 

RTE foods that are sliced, prepared, 

and/or packaged for the consumer in the 

retail environment and consumed in the 

home. Cheeses, deli meats, and delitype salads (as defined in Ref. 2) will be 

studied as representative examples. 

This risk assessment of the public 

health impact of L. monocytogenes in 

RTE foods sliced, prepared, and/or 

packaged in retail facilities supports the 

agency’s commitment to fulfilling the 

Listeria Action Plan (Ref. 3). 

II. Request for Comments and for 

Scientific Data and Information 

FDA requests comments on the risk 

assessment goals outlined in this 

document and the submission of 

scientific data and information relevant 

to the risk assessment. Specifically, we 

request data and information about the 

following: 

1. Characteristics of ready-to-eat food 

markets in the United States, including: 

a. Volumes of cheeses and deli meats 

sliced by manufacturers and the 

volumes sliced in retail facilities, 

b. Volumes of deli-type salads 

prepared by manufacturers and the 

volumes prepared in retail facilities, and 

c. Volumes of ready-to-eat food sold 

in delicatessen departments of major 

grocery chains (i.e., large supermarket 

facilities) and the volumes sold in other 

groceries (i.e., multipurpose 

independent small or local facilities). 

2. Characteristics of deli departments 

in groceries, including the proportion of 

separated seafood/meat/dairy deli 

departments in groceries. 

3. Product contamination data, 

including: 

a. L. monocytogenes levels and/or 

frequencies in wholesale products (deli 

meats (chubs), cheeses, fresh produce, 

seafood) arriving at retail facilities; and 

b. L. monocytogenes levels and/or 

frequencies in cheeses, deli meats, and 

deli-type salads sold by retail facilities. 

4. Factors that influence the growth of 

L. monocytogenes in cheeses, deli 

meats, and deli-type salads, including: 

a. Growth rates of L. monocytogenes 

in cheeses, deli meats, and deli-type 

salads and the effects of different 

ingredients in and compositions of 

those products; 

b. Chemical characteristics of cheeses, 

deli meats, and deli-type salads that 

could influence L. monocytogenes, 

including pH and water activity; 

c. Proportions of deli meats treated 

with growth inhibitors, the inhibitors 

used, the level of growth inhibitors, and 

their efficiency; 

d. Data on the temperatures to which 

cheeses, deli meats, and deli-type salads 

are exposed at retail, including time and 

temperature for walk-in coolers or 

refrigerators, display cabinets, and 

ambient displays; and 

e. Data on the use of advisory ‘‘useby’’ or ‘‘best by’’ labels for ready-to-eat 

food sold by retail facilities. 

5. Environmental contamination data, 

including: 

a. Data and information on the 

prevalence and levels of L. 

monocytogenes in the retail 

environment including, e.g., drains, 

countertops, walls, and equipment; and 

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Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices 3619 

b. Data on the growth of L. 

monocytogenes on non-food surfaces 

including environmental biofilm 

growth. 

6. Factors that influence the 

environmental contamination and the 

cross-contamination of food by L. 

monocytogenes in retail facilities, 

including: 

a. Data and information on the 

potential transfer of L. monocytogenes to 

food from the retail environment, e.g., 

experimental studies on the transfer to 

food from drains, slicers, food contact 

surfaces, and non-food contact surfaces; 

and 

b. Data and information on food 

handlers’ activities, e.g., observations of 

food handlers’ practices and monitoring 

of specific food safety actions in retail 

facilities (e.g., glove usage, hand 

hygiene practices, and cleaning 

practices). 

7. Identity and effectiveness of control 

measures or interventions intended to 

reduce levels and frequency of L. 

monocytogenes in the retail 

environment, including: 

a. Environmental sanitation 

procedures including the sanitizers and 

protocols used, frequency of 

application, and efficiency; and 

b. Worker sanitation procedures 

including frequencies, protocols, and 

efficiency. 

8. Any other data related to the 

occurrence, growth, and control of L. 

monocytogenes in retail facilities. 

As the project progresses, additional 

data needs may be identified. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. References 

The following references are on 

display in the Division of Dockets 

Management (see ADDRESSES) and may 

be seen by interested persons between 9 

a.m. and 4 p.m., Monday through 

Friday. (FDA has verified the Web site 

addresses, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

1. U.S. Department of Health and Human 

Services, Healthy People 2010, v. 1. 

Washington, DC, 2000, http:// 

healthypeople.gov. 

2. U.S. Department of Health and Human 

Services and U.S. Department of Agriculture/ 

Food Safety and Inspection Service, 

‘‘Quantitative Assessment of Relative Risk to 

Public Health from Foodborne Listeria 

monocytogenes Among Selected Categories 

of Ready-to-Eat Foods,’’ September 2003, 

http://www.foodsafety.gov/~dms/lmr2- 

toc.html. 

3. U.S. Department of Health and Human 

Services, Food and Drug Administration/ 

Centers for Disease Control and Prevention, 

‘‘Reducing the Risk of Listeria 

monocytogenes FDA/CDC 2003 Update of the 

Listeria Action Plan,’’ November 2003, http:// 

www.cfsan.fda.gov/~dms/lmr2plan.html. 

4. Gombas, D.E., Chen, Y., Clavero, R.S., 

and Scott, V.N. (2003). Survey of Listeria 

monocytogenes in ready-to-eat foods. Journal 

of Food Protection, 66(4), 559–569. 

5. Draughon, A.F. (2006). A collaborative 

analysis/risk assessment of Listeria 

monocytogenes in ready-to-eat processed 

meat and poultry collected in four FoodNet 

states. Symposium S–16: Contamination of 

ready-to-eat foods: transfer and risk: Listeria 

monocytogenes and other microorganisms. 

International Association for Food Protection 

93rd Annual Meeting, Calgary, Alberta. 

August 13–16. 

Dated: January 12, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–938 Filed 1–16–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on Migrant 

Health; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: National Advisory Council on 

Migrant Health. 

Dates and Times: February 9, 2009, 8:30 

a.m. to 5 p.m.; February 10, 2009, 8:30 a.m. 

to 5 p.m. 

Place: The Parklawn Building, Twinbrook 

Room, 3rd Floor, 5600 Fishers Lane, 

Rockville, Maryland 20857, Telephone: (301) 

594–4303, Fax: (301) 443–0248. 

Status: The meeting will be open to the 

public. 

Purpose: The purpose of the meeting is to 

discuss services and issues related to the 

health of migrant and seasonal farmworkers 

and their families and to formulate 

recommendations for the Secretary of Health 

and Human Services. 

Agenda: The agenda includes an overview 

of the Council’s general business activities. 

The Council will also hear presentations 

from experts on farmworker issues, including 

the status of farmworker health at the local 

and national levels. 

Agenda items are subject to change as 

priorities indicate. 

For Further Information Contact: Gladys 

Cate, Office of Minority and Special 

Populations, Bureau of Primary Health Care, 

Health Resources and Services 

Administration, 5600 Fishers Lane, Maryland 

20857; telephone (301) 594–0367. 

Wendy Ponton, 

Director, Office of Management. 

[FR Doc. E9–1067 Filed 1–16–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Mice With a Conditional LoxP-Flanked 

Glucosylceramide Synthase Allele 

Controlling Glycosphingolipid 

Synthesis 

Description of Technology: 

Glycosphingolipids are organizational 

building blocks of plasma membranes 

that participate in key cellular 

mstockstill on PROD1PC66 with NOTICES