Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19311 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2010–0035] 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0092] 

Update of the 2003 Interagency 

Quantitative Assessment of the 

Relative Risk to Public Health From 

Foodborne Listeria Monocytogenes 

Among Selected Categories of Readyto-Eat Foods; Request for Comments, 

Scientific Data and Information 

AGENCY: Food Safety and Inspection 

Service, USDA; Food and Drug 

Administration, HHS. 

ACTION: Notice; request for comments 

and for scientific data and information. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) and the Food 

and Drug Administration (FDA) are 

requesting comments and scientific data 

and information that would assist the 

agencies in their plan to update a risk 

assessment on the relationship between 

foodborne Listeria monocytogenes in 

selected categories of ready-to-eat (RTE) 

foods and human health. The purpose of 

the risk assessment is to incorporate 

newly available scientific data and 

information into the risk assessment in 

order to update estimates of the relative 

risk of illness and death associated with 

the consumption of different types of 

RTE foods that may be contaminated 

with L. monocytogenes and to evaluate 

the relative effectiveness of strategies to 

reduce or prevent exposure to L. 

monocytogenes from the consumption 

of RTE foods, including, for example, 

the impact of changing refrigerated time 

and temperature storage prior to 

consumption. 

DATES: Submit electronic or written 

comments and scientific data and 

information by July 6, 2011. 

ADDRESSES: FSIS: Submit electronic 

comments and scientific data and 

information to http:// 

www.regulations.gov. Submit written 

comments and scientific data and 

information to the Docket Clerk, U.S. 

Department of Agriculture, Food Safety 

and Inspection Service, George 

Washington Carver Center, 5601 

Sunnyside Ave., Mailstop 5474, 

Beltsville, MD 20705–5464. All 

submissions must include the Agency 

name and docket number FSIS–2010– 

0035. 

FDA: Submit electronic comments 

and scientific data and information to 

http://www.regulations.gov. 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. 

All submissions must include the 

Agency name and docket number FDA– 

2011–N–0092. 

FOR FURTHER INFORMATION CONTACT: 

FSIS: Janell Kause, Office of Public 

Health Science, Food Safety and 

Inspection Service, United States 

Department of Agriculture, 1400 

Independence Ave., Aerospace 

Maildrop 344, Washington, DC 20250, 

202–690–0286; or 

FDA: Sherri Dennis, Center for Food 

Safety and Applied Nutrition (HFS–06), 

Food and Drug Administration, 5100 

Paint Branch Pkwy., College Park, MD 

20740, 301–436–1914. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Listeria monocytogenes is a bacterium 

that is commonly found in the human 

environment, including food processing 

environments. After ingesting L. 

monocytogenes, humans can develop 

listeriosis, a severe foodborne disease 

with a high case-fatality rate. Listeriosis 

occurs predominantly in high-risk 

population subgroups, including 

pregnant women and their fetuses or 

neonates, immune-compromised 

individuals, and the elderly population 

(defined for the purpose of the risk 

assessment discussed in this notice as 

individuals who are 60 years of age or 

older). Due to the high proportion of 

serious illnesses and the high casefatality rate associated with listeriosis, 

the ‘‘Healthy People 2010’’ goals for 

national disease prevention and health 

promotion specified a reduction in the 

prevalence of foodborne listeriosis by 50 

percent as an important objective (Ref. 

1). (‘‘Healthy People’’ is a national health 

promotion and disease prevention 

initiative that brings together national, 

State, and local government agencies; 

nonprofit, voluntary, and professional 

organizations; and businesses, 

communities, and individuals to 

improve the health and quality of life of 

all Americans, eliminate disparities in 

health, and promote good health and 

quality of life across all life stages (Ref. 

2).) However, despite considerable 

efforts to reduce the number of 

listeriosis cases during the past decade, 

the listeriosis prevalence still exceeds 

the ‘‘Healthy People 2010’’ target of 0.25 

cases per 100,000 population (Ref. 3). 

(Note that then President Clinton’s 

Council on Food Safety, established by 

Executive Order 13100, August 25, 

1998, developed a strategic plan that set 

public health goals including, by 2005, 

reducing foodborne illness by 25 

percent for some pathogens and for 

others to the quantitative targets 

established in ‘‘Healthy People 2010.’’ In 

2005, FoodNet data showed 0.30 L. 

monocytogenes cases per 100,000 

population; the ‘‘Healthy People 2005’’ 

target was 0.25 L. monocytogenes cases 

per 100,000 population.) In 2009, the 

prevalence of listeriosis had decreased 

by only 26 percent compared to the 

baseline period (1996 to 1998) rate, and 

reducing the prevalence of listeriosis 

was retained in the ‘‘Healthy People 

2020’’ objectives, with a target of 0.2 

cases per 100,000 population (Refs. 3 

and 4). 

In 2003, FDA and FSIS published a 

quantitative assessment of the relative 

risk to public health from foodborne L. 

monocytogenes among 23 selected 

categories of RTE foods (the 2003 risk 

assessment) (Ref. 5). This 2003 risk 

assessment provided estimates for the 

median number of listeriosis cases 

attributable to each of 23 RTE food 

categories on a per-annum and perserving basis. This allowed for a relative 

ranking of the 23 food categories based 

on the associated public health risk and 

permitted the evaluation of the likely 

impact of several ‘‘what-if’’ mitigation 

scenarios. 

Since publication of the 2003 risk 

assessment, the food industry has 

changed some practices, including by 

adding growth inhibitors to RTE 

products. L. monocytogenes prevalence 

in some RTE foods has decreased over 

the past decade, and a substantial 

amount of new scientific data has 

become available for potential inclusion 

in risk assessments (Refs. 6, 7, and 8). 

These changes could potentially affect 

the outcomes of the risk assessment and 

alter the relative risk rankings of the 

RTE food categories evaluated in the 

2003 risk assessment. 

Risk assessments can be used to 

evaluate potential risk mitigation 

strategies and can guide, support, and 

enhance an Agency’s risk management 

policies, outreach efforts, data collection 

initiatives, and research priorities. To 

help ensure that risk mitigation 

strategies, risk management policies, 

outreach efforts, data collection 

initiatives, and research priorities aimed 

at controlling L. monocytogenes in RTE 

foods are directed to those RTE foods 

that pose the greatest risk, FDA and 

FSIS have initiated an update to the 

2003 risk assessment. The purpose of 

updating the risk assessment is to 

incorporate newly available scientific 

mstockstill on DSKH9S0YB1PROD with NOTICES

19312 Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 

data and information that reflect 

changes in L. monocytogenes prevalence 

and industry practices into the risk 

assessment in order to: (1) Update 

estimates of the relative risk of 

listeriosis associated with the 

consumption of different types of RTE 

foods that may be contaminated with L. 

monocytogenes and (2) evaluate the 

relative effectiveness of strategies to 

reduce or prevent exposure to L. 

monocytogenes from the consumption 

of RTE foods, including by modeling the 

effect of changing refrigerated storage 

times and temperatures. To fill critical 

data gaps, FDA and FSIS have initiated 

collaborative efforts with the USDA 

Agricultural Research Service, academic 

partners, and private laboratories to 

survey the presence and quantity of L. 

monocytogenes in selected categories of 

RTE foods. RTE foods chosen for this 

survey include: Leafy green vegetables, 

low-acid cut fruits, smoked seafood, 

seafood and deli-type salads, soft 

ripened and semi-soft cheeses, 

sandwiches, raw milk, deli meats, hot 

dogs, paˆte ́, and meat spreads. Estimates 

for other RTE foods to be included in 

the risk assessment will be updated 

using scientific data newly available in 

the literature (if applicable) and 

information provided in response to this 

notice. 

II. Request for Comments and Scientific 

Data and Information 

FSIS and FDA are requesting 

technical comments on the approach 

outlined previously for updating the 

2003 risk assessment. FDA and FSIS are 

also requesting the submission of new 

data and information relevant to this 

risk assessment that was not available 

for inclusion in the previous risk 

assessment and that may reflect changes 

in L. monocytogenes prevalence and 

industry practices that have occurred 

since the previous risk assessment. 

The agencies specifically request new 

data and information concerning, but 

not limited to, the following factors that 

may affect the relative risk of listeriosis 

associated with consumption of the 

types of RTE foods that were considered 

in the 2003 risk assessment: 

1. L. monocytogenes contamination in 

different RTE foods sampled at retail or 

in the processing plant, including: 

• The frequency of detecting the 

presence of L. monocytogenes in RTE 

foods (including sample size, number of 

positives, total number tested for a 

specified time period, and test method); 

and 

• The number of L. monocytogenes 

cells present per amount (unit volume 

or weight) of contaminated RTE food 

(including method used). 

2. L. monocytogenes survival and 

growth dynamics in RTE foods, 

including: 

• Data or models on survival and 

growth of L. monocytogenes in specific 

RTE food matrices, including the 

potential effects of commensal 

microflora; 

• Data or models on survival and 

growth of L. monocytogenes in the 

presence or absence of substances that 

inhibit or retard growth; and 

• Data or models on survival and 

growth of L. monocytogenes at different 

storage temperatures and over different 

storage times. 

3. The relationship between the dose 

of L. monocytogenes ingested with food 

and the frequency of listeriosis, 

including: 

• The effect of age, health status, or 

other characteristics of the consumer on 

the dose-response relationship; 

• The effect of food matrix and 

product formulation on the doseresponse relationship; 

• The effect of genetic characteristics 

of the L. monocytogenes strain on the 

dose-response relationship; and 

• Any other data pertinent to L. 

monocytogenes dose-response 

relationships. 

4. Current food consumption practices 

in the United States, including: 

• The frequency with which different 

RTE foods (e.g., deli meats or cheeses 

manufactured with growth inhibitors) 

are consumed by population subgroups 

(e.g., general adult population, pregnant 

women, the elderly); and 

• Serving sizes for different RTE 

foods. 

5. Food production practices in the 

United States that may impact L. 

monocytogenes prevalence, 

concentration, survival, or growth in 

RTE foods, including: 

• The absolute or relative frequency 

of manufacturing different RTE foods 

with substances that inhibit the growth 

of L. monocytogenes and the types and 

concentrations of growth inhibitor used; 

• The absolute or relative amount of 

specific types of RTE foods that are 

prepared, sliced, cut, or repackaged in 

retail operations as opposed to being 

sold pre-sliced/pre-cut; 

• The absolute or relative amount of 

different RTE foods manufactured 

without growth inhibitors that are 

prepared, sliced, or repackaged at retail; 

• The average shelf life of foods that 

were identified in the 2003 risk 

assessment (Ref. 4) as supporting L. 

monocytogenes growth; 

• The average shelf life of RTE foods 

that were not explicitly identified in the 

2003 risk assessment but that may 

conceivably support L. monocytogenes 

growth; 

• The ability of current production 

practices to prevent or reduce L. 

monocytogenes contamination in 

finished product; 

• The ability of current operational 

practices in retail operations to prevent 

or reduce L. monocytogenes 

contamination in the final product at 

the time of sale; and 

• The ability of current postprocessing practices to prevent L. 

monocytogenes cross-contamination 

after processing. 

6. Storage times and temperatures that 

may affect L. monocytogenes growth 

during transport and storage of foods in 

the consumer’s home. 

7. Other comments, including the RTE 

food categories that should be evaluated 

in the risk assessment. 

III. Request for Comments, Scientific 

Data and Information 

FSIS: Interested persons may submit 

to FSIS’s Docket Clerk (see ADDRESSES) 

either electronic or written comments 

regarding this document. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the FSIS Docket Room between 

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

through Friday. 

FDA: Interested persons may submit 

to FDA’s Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments 

regarding this document. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed comments. Identify 

comments 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. 

IV. 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. We have verified all addresses, 

but we are 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,’’ 

Chapter 10, Food Safety, Washington, 

DC, 2000, http://www.healthypeople.

gov/2010/Document/pdf/Volume1/

10Food.pdf. 

2. U.S. Department of Health and 

Human Services, ‘‘Healthy People 2020,’’ 

HP 2020 Framework, Washington, DC, 

2010, available at http://www.healthy

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19313 

people.gov/2020/Consortium/HP2020

Framework.pdf. 

3. Anonymous, 2010, ‘‘Preliminary 

FoodNet Data on the Incidence of 

Infection With Pathogens Transmitted 

Commonly Through Food—10 States, 

2009,’’ Morbidity and Mortality Weekly 

Report, 59: 418–422, available at 

http://www.cdc.gov/mmwr/preview/

mmwrhtml/mm5914a2.htm. 

4. U.S. Department of Health and 

Human Services, ‘‘Healthy People 2020,’’ 

HP 2020 FS–1.3, Washington, DC, 2010, 

available at http://www.healthypeople.

gov/2020/topicsobjectives2020/pdfs/

HP2020objectives.pdf. 

5. 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 L. monocytogenes Among 

Selected Categories of RTE Foods,’’ 

September 2003, available in Docket No. 

FDA–1999–N–0134 (formerly Docket 

No. 1999N–1168), vols. 23 through 28, 

available at http://www.fda.gov/Food/

ScienceResearch/ResearchAreas/Risk

AssessmentSafetyAssessment/

ucm183966.htm. 

6. Endrikat, S., D. Gallagher, R. 

Pouillot, H. Hicks Quesenberry, D. 

Labarre, C. M. Schroeder, and J. Kause, 

‘‘A Comparative Risk Assessment for L. 

monocytogenes in Prepackaged Versus 

Retail-Sliced Deli Meat,’’ Journal of 

Food Protection, 73:612–9. 

7. U.S. Department of Agriculture, 

Food Safety and Inspection Service, 

2003, 9 CFR part 430, ‘‘Control of 

Listeria monocytogenes in Ready-to-Eat 

Meat and Poultry Products,’’ final rule. 

Federal Register, 68 FR 34208 to 34254. 

8. U.S. Department of Agriculture/ 

Food Safety and Inspection Service, 

‘‘The FSIS Microbiological Testing 

Program for Ready-to-Eat (RTE) Meat 

and Poultry Products, 1990–2009,’’ 

September 2010, available at http://

www.fsis.usda.gov/Science/Micro_

Testing_RTE/index.asp. 

Dated: March 25, 2011. 

Alfred V. Almanza, 

Administrator, FSIS. 

Dated: March 31, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8360 Filed 4–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF AGRICULTURE 

Forest Service 

Chequamegon-Nicolet National Forest, 

Wisconsin, Lakewood Southeast 

Project 

AGENCY: Forest Service, USDA. 

ACTION: Notice of intent to prepare an 

environmental impact statement. 

SUMMARY: The Forest Service will 

prepare an environmental impact 

statement (EIS) to document the 

analysis and disclose the environmental 

impacts of proposed land management 

activities and corresponding alternatives 

within the Lakewood Southeast Project. 

The purpose of the Lakewood Southeast 

Project is to implement land 

management activities that are 

consistent with direction in the 

Chequamegon-Nicolet National Forest 

2004 Land and Resource Management 

Plan and respond to the specific needs 

identified in the project area. The 

project-specific needs include: 

Reintroduction of natural regimes, 

wildlife habitat and stream bank 

improvement, forest age, forest 

composition, and stocking. 

DATES: Comments concerning the scope 

of the analysis must be received by May 

9, 2011 in order to be useful in 

preparation of the draft statement. The 

draft environmental impact statement is 

expected in May 2011 and the final 

environmental impact statement is 

expected August 2011. 

ADDRESSES: Send written comments 

concerning this proposal to Marilee 

Houtler, Attn: Lakewood Southeast 

Project, Lakewood-Laona Ranger 

District, 15085 State Road 32, 

Lakewood, WI 54138. Comments may 

also be sent via e-mail to commentseastern-chequamegon-nicoletlakewood@fs.fed.us, or via facsimile to 

715–276–3594. Comments received in 

response to this solicitation, including 

names and addresses of those who 

comment, will be part of the public 

record for this proposed action. 

Comments submitted anonymously will 

be accepted and considered; however, 

anonymous comments will not provide 

the Agency with the ability to provide 

the respondent with subsequent 

environmental documents. 

FOR FURTHER INFORMATION CONTACT: 

Marilee Houtler, NEPA Coordinator at 

the above address or by phone at 715– 

276–6333. 

Individuals who use 

telecommunication devices for the deaf 

(TDD) may call the Federal Information 

Relay Service (FIRS) at 1–800–877–8339 

between 8 a.m. and 8 p.m., Eastern 

Time, Monday through Friday. 

SUPPLEMENTARY INFORMATION: The 

information presented in this notice is 

included to help the reviewer determine 

if they are interested in or potentially 

affected by the proposed land 

management activities. The information 

presented in this notice is summarized. 

Those who wish to provide comments, 

or are otherwise interested in or affected 

by the project, are encouraged to obtain 

additional information from the contact 

listed above. 

Purpose and Need for Action 

The current conditions of many forest 

stands in the project area vary from 

desired conditions in the ChequamegonNicolet National Forest 2004 Land and 

Resource Management Plan (forest 

plan). Our information shows some of 

the more notable gaps between the 

existing and desired future conditions 

by management area. Of primary 

importance is the need for change in: (1) 

Loss of natural regimes (2) wildlife 

habitat (3) stream improvement (4) 

species age structure (5) species 

composition and (6) stocking densities. 

The dominant habitat in the Lakewood 

Southeast Project area is upland conifer 

forests mixed with other forest 

communities. 

Preliminary analysis of the project 

area indicates that there are certain 

conditions that warrant action to 

accomplish the direction and desired 

conditions identified in the forest plan. 

Proposed Action 

Projected project implementation 

would be spring of 2012. Lakewood 

Southeast Project is located on National 

Forest System lands, administered by 

the Lakewood-Laona Ranger District, 

east of Mountain, WI. The legal 

description of the project is Township 

31–32 North, Range 17 East. The Forest 

Service proposes to reintroduce natural 

regimes in the Northern dry forests and 

Pine Barrens (mainly fire), improve 

wildlife habitat (manage openings, 

improve habitat for Regional Forester 

Sensitive Species) and stream corridors 

(adding long lived species), and use 

timber harvest (selection, clearcut, 

shelterwood, and thinning) to move 

toward desired conditions in the forest 

plan. 

Responsible Official 

The responsible official for this 

project is Lakewood-Laona District 

Ranger, Chequamegon-Nicolet National 

Forest. 

mstockstill on DSKH9S0YB1PROD with NOTICES