7298 Federal Register / Vol. 73, No. 26 / Thursday, February 7, 2008 / Notices 

food as well as surfaces that do not 

contact food), very few would have a 

program in place as thorough as the one 

described in the draft guidance. 

Therefore, FDA estimates that 4,270 

establishments may choose to adopt the 

recommendations to develop a written 

environmental monitoring program, 

keep environmental testing results, and 

record finished product testing results. 

Developing a written environmental 

monitoring program would be a onetime cost and we assume that it would 

take approximately 8 hours. This results 

in a first year burden of about 34,160 

hours (4,270 plants x 8 hours). For 

critical food-contact surfaces, the draft 

guidance recommends that tests be 

conducted on a weekly basis. We 

assume that it would take up to half an 

hour to produce a record of the results 

of the test, depending on the number of 

sites tested and subject to variability 

between firms, resulting in an annual 

burden of about 111,020 hours ((4,270 

plants) x (52 records per year) x (0.5 

hours)). For critical non-food-contact 

surfaces, the draft guidance 

recommends that tests be conducted 

every 2 weeks. As with testing for foodcontact surfaces, we assume that the 

records would take up to half an hour 

to produce, resulting in an annual 

burden of about 55,510 hours ((4,270 

plants) x (26 records per year) x (0.5 

hours)). The draft guidance recommends 

‘‘periodic’’ testing of finished product, 

such as weekly, monthly, or quarterly. 

For purposes of this analysis, FDA 

assumes most firms would conduct 

monthly testing of finished product. As 

with testing of critical surfaces, we 

assume the records would take 

approximately one half hour to produce, 

for an annual burden of about 25,620 

hours ((4,270 plants) x (12 records per 

year) x (0.5 hours)). 

In the draft guidance, FDA is 

recommending that firms that detect 

Listeria species on critical surfaces or in 

the finished product take corrective 

action and keep a record of what was 

done. The time to record the corrective 

actions would vary, but on average FDA 

estimates the record would require one 

half hour to produce. FDA cannot 

accurately predict how often firms 

would detect Listeria species in the 

environment. For the purposes of this 

analysis, and assuming that firms follow 

the rest of the guidance, FDA 

conservatively assumes that firms 

would detect Listeria species on foodcontact surfaces about 20 percent of the 

time that tests are run, producing a total 

of 10 new records per establishment 

annually. Because non-food-contact 

surfaces cover inherently more space 

than food-contact surfaces and may be 

cleaned less stringently, FDA estimates 

that firms would detect Listeria species 

twice as often per test as they do when 

running tests on food-contact surfaces. 

Because these tests are run only half as 

often as food-contact surface tests (every 

2 weeks rather than every week), this 

record would also be produced an 

average of 10 times annually per 

establishment. We assume that Listeria 

species would not often be detected in 

the final product, based on the 

projections of the ‘‘Quantitative 

Assessment of Relative Risk to Public 

Health From Foodborne Listeria 

monocytogenes Among Selected 

Categories of Ready-to-Eat Foods,’’ (the 

Risk Assessment), written jointly by 

USDA and FDA. The Risk Assessment 

projected that 2 percent of RF-RTE food 

is contaminated with L. monocytogenes. 

FDA uses this number to estimate that 

records for corrective action due to 

finished product testing would produce, 

on average, 0.2 new records per 

establishment annually. The total 

annual burden produced by corrective 

action records would be about 43,127 

hours ([(4,270 plants) x (10 records per 

year for corrective actions taken after 

food-contact surface positive) x (0.5 

hours per record)] + [(4,270 plants) x (10 

records per year) x (0.5 hours per record 

for corrective actions taken after nonfood-contact surface positive )] + ((4,270 

plants) x (0.2 records per year for 

corrective actions after finished product 

positive) x (0.5 hours per record)]). 

If a firm does not use one of the 

methods described in FDA’s BAM or by 

ISO, FDA is recommending that the firm 

have a written record of its method to 

enumerate or detect L. monocytogenes. 

FDA assumes most firms would use one 

of the methods described in the BAM or 

by ISO. Therefore, there would be no 

new collection of information. 

FDA estimates that record 

maintenance would require roughly 1 

hour per week for each firm, for a total 

of about 222,040 annual hours ((4,270 

plants) x (52 weeks maintenance) x (1 

hour per week)). 

FDA estimates that each of the 4,270 

establishments expected to keep new 

records would purchase a storage unit 

for the records. A standard file cabinet 

large enough for such records as 

described in the guidance costs about 

$150. Therefore, there would be total 

first year capital costs of about $640,500 

(4,270 plants x $150). 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the draft guidance 

and the collection of information 

provisions. 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. The draft guidance and 

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 Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Government-wide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through the FDMS only. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance from the 

Center for Food Safety and Applied 

Nutrition home page at http:// 

www.cfsan.fda.gov/guidance.html. 

Dated: January 16, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 08–548 Filed 2–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0058] 

Draft Compliance Policy Guide Sec. 

555.320 Listeria monocytogenes; Notice 

of Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting to discuss a Draft 

Compliance Policy Guide Sec. 555.320 

Listeria monocytogenes (the draft CPG) 

that provides guidance for FDA staff on 

the agency’s enforcement policy for L. 

monocytogenes in ready-to-eat (RTE) 

foods that support growth of the 

organism and RTE foods that do not 

support growth of the organism. 

DATES: The meeting will be held on 

March 28, 2008, from 9 a.m. to 4:30 p.m. 

The closing date for requests to make an 

oral presentation is March 7, 2008. The 

closing date for advance registration, for 

notifying the contact person about a 

need for special accommodations due to 

a disability, and for providing a brief 

description of an oral presentation and 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 26 / Thursday, February 7, 2008 / Notices 7299 

1See also, e.g., Young v. Community Nutrition 

Institute, 476 U.S. 974, 982-83 (1986) (citing to 

United States of America v. Lexington Mill & 

Elevator Co. as ‘‘discussing proper interpretation of 

the language that became § 342(a)’’). 

any written material for the presentation 

is March 21, 2008. Persons wishing to 

park onsite should inform the contact 

person of their request by March 24, 

2008. 

ADDRESSES: The meeting will be held at 

the Harvey W. Wiley Federal Bldg., 

Food and Drug Administration, Center 

for Food Safety and Applied Nutrition, 

5100 Paint Branch Pkwy., College Park, 

MD, 20740–3835 (Metro stop: College 

Park on the Green Line). Submit 

electronic registration and requests to 

make an oral presentation to http:// 

www.cfsan.fda.gov/register.html. 

Submit written or oral registration, 

requests to make an oral presentation, 

written material for a presentation, and 

questions in advance of the meeting to 

the contact person for registration (see 

FOR FURTHER INFORMATION CONTACT). A 

transcript of the meeting will be 

available for review at the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD. 

FOR FURTHER INFORMATION CONTACT: For 

registration, requests for oral 

presentation, submission of written 

material for the presentation, and 

submission of questions in advance of 

the meeting: Isabelle Howes, U.S. 

Department of Agriculture Graduate 

School, 600 Maryland Ave., SW., suite 

270, Washington, DC 20024–2520, 202–

314–4713, FAX: 202–479–6801, e-mail: 

isabelle_howes@grad.usda.gov. 

For general questions about the 

meeting, to request onsite parking, or if 

you need special accommodations due 

to a disability: Juanita Yates, Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, 5100 

Paint Branch Pkwy., College Park, MD 

20740, 301–436–1731, e-mail: 

Juanita.Yates@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Registration and Requests for Oral 

Presentations 

Due to limited space and time, we 

encourage all persons who wish to 

attend the meeting or to request an 

opportunity to make an oral 

presentation to register in advance. We 

encourage you to register and request an 

opportunity to make an oral 

presentation electronically, if possible. 

You may also register orally or in 

writing by providing registration 

information (including name, title, firm 

name, address, telephone number, fax 

number, and e-mail address), requests to 

make an oral presentation, and written 

material for the presentation to the 

contact person for registration (see FOR

FURTHER INFORMATION CONTACT). 

II. Background 

FDA has been working with its 

Federal, State, local, and international 

food safety counterparts in an effort to 

reduce the incidence of foodborne 

illness in the United States, including 

illness caused by L. monocytogenes. As 

part of this effort, FDA is announcing 

elsewhere in this issue of the Federal 

Register the availability of, and 

requesting comment on, a draft CPG that 

provides guidance to FDA staff on the 

agency’s enforcement policy for L. 

monocytogenes in RTE foods that 

support growth of the organism and in 

RTE foods that do not support growth of 

the organism. 

FDA is holding this public meeting to 

discuss and share information about the 

enforcement policy in this draft CPG. 

Stakeholders will have an opportunity 

to ask questions about the draft CPG and 

provide oral comments on the draft 

CPG. Stakeholders may send questions 

in advance to the contact person 

identified above (see FOR FURTHER

INFORMATION CONTACT). Any questions 

submitted in advance may be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm, including 

any personal information provided. 

III. Transcripts 

A transcript of the meeting will be 

available for review at the Division of 

Dockets Management (see ADDRESSES) 

between 9 a.m. and 4 p.m. Monday 

through Friday and on the Internet at 

http://www.fda.gov/ohrms/dockets/ 

default.htm, approximately 30 days 

after the hearing. Written transcripts of 

the meeting may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857, 

approximately 15 working days after the 

meeting at a cost of 10 cents per page. 

IV. Background and Rationale for the 

Establishment of the Enforcement 

Policy 

A. Introduction 

This document presents the 

background and rationale for the 

establishment of an enforcement policy 

for L. monocytogenes in RTE foods 

based on whether the food does, or does 

not, support its growth. Under section 

402(a)(1) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

342(a)(1)), a food shall be deemed to be 

adulterated if it bears or contains any 

poisonous or deleterious substance 

which may render it injurious to health, 

except that if the substance is not an 

added substance such food shall not be 

considered adulterated if the quantity of 

such substance in such food does not 

ordinarily render it injurious to health. 

Courts have interpreted the phrase 

‘‘injurious to health’’ as encompassing 

protection of the health of vulnerable 

subpopulations. See United States of 

America v. Lexington Mill & Elevator 

Co., 232 U.S. 399, 411 (1914).1 L. 

monocytogenes is an added deleterious 

substance in food. United States of 

America v. Union Cheese Co., 902 F. 

Supp. 778, 786 (N.D. Ohio 1995). 

We are issuing for public comment a 

draft CPG that, when finalized, would 

provide guidance for FDA staff as 

follows: 

• For RTE foods that support the 

growth of L. monocytogenes, FDA may 

regard the food as adulterated within 

the meaning of section 402(a)(1) of the 

Act (21 U.S.C. 342(a)(1)) when L. 

monocytogenes is present in the food, 

based on an analytical method that can 

detect 1.0 colony forming units (cfu) of 

L. monocytogenes per 25 grams (g) of 

food (i.e., 0.04 cfu/g). 

• For RTE foods that do not support 

the growth of L. monocytogenes, FDA 

may regard the food as adulterated 

within the meaning of section 402(a)(1) 

of the act (21 U.S.C. 342(a)(1)) when L. 

monocytogenes is present at or above 

100 cfu/g of food. 

B. Background on L. monocytogenes 

L. monocytogenes is a pathogenic 

bacterium. Foods that are contaminated 

with L. monocytogenes and consumed 

without thorough cooking have been 

associated with a mild non-invasive 

illness with flu-like symptoms (called 

listerial gastroenteritis) and a rare but 

potential severe disease (called 

listeriosis). Listeriosis predominately 

affects fetuses and neonates who are 

infected after the mother is exposed to 

L. monocytogenes during pregnancy, the 

elderly, and persons with weakened 

immune systems. Listeriosis is 

characterized by a high case-fatality 

rate, ranging from 20 percent to 30 

percent. Most cases of human listeriosis 

occur sporadically—that is, in an 

isolated manner without any apparent 

pattern. However, much of what is 

known about the epidemiology of the 

disease has been derived from outbreakassociated cases, in which there is an 

abrupt increase in reports of the disease. 

Foods that have been implicated in 

sporadic cases or outbreaks of listeriosis 

have been foods (including coleslaw, 

fresh soft cheese made with 


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2Some of the food categories discussed in this 

document (e.g., frankfurters) are under the 

jurisdiction of the Food Safety and Inspection 

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

rather than FDA. 

3Because normal pasteurization will effectively 

eliminate L. monocytogenes, it is generally assumed 

that contamination of products such as pasteurized 

fluid milk is the result of post-pasteurization 

contamination (see Section V of Ref. 1, p. 170). 

4 Intrinsic factors include chemical and physical 

factors that are normally within the structure of the 

food, e.g., pH and water activity. Extrinsic factors 

are those that refer to the environment surrounding 

the food, e.g., storage temperature. Processing 

factors are those that are deliberately applied to 

food to achieve improved preservation, such as the 

addition of acid to lower pH (Ref. 11). 

5Whether a particular antimicrobial substance is 

effective in preventing the growth of L. 

monocytogenes in a given food generally depends 

on a series of factors. Naturally occurring or added 

antimicrobial substances can have an interactive or 

synergistic effect with other parameters of the 

formulation, such as pH, water activity, the 

presence of other preservatives, and processing 

temperature. A concept known as the ‘‘hurdle 

concept’’ states that several inhibitory factors 

(hurdles), while individually unable to inhibit 

microorganisms, will, nevertheless, be effective in 

combination (Refs. 10 and 15). For reasons such as 

these, whether the addition of a particular 

antimicrobial substance to a particular food is 

effective in preventing the growth of L. 

monocytogenes is a case-by-case determination, 

based on available data and information. However, 

a listeristatic control measure is generally 

considered to be effective if growth studies show 

less than one log increase in the number of L. 

monocytogenes during replicate trials with the food 

of interest. For an example of how such studies are 

conducted, see Reference 16. 

6The examples in this document of foods that 

generally fall within a given category do not include 

meat and poultry products because such products 

are under the jurisdiction of FSIS. Unless otherwise 

specified, the reference supporting the 

characterization of the food as to whether it 

supports the growth of L. monocytogenes is 

Appendix 8 in Reference 1. 

unpasteurized milk, frankfurters,2 deli 

meats, and butter) that are RTE. (Ref. 1). 

L. monocytogenes is widespread in 

the environment. It is found in soil, 

water, sewage, and decaying vegetation. 

It has been isolated from humans, 

domestic animals, raw agricultural 

commodities, and food processing 

environments (particularly cool damp 

areas) (Refs. 2 through 4). Control of L. 

monocytogenes in the food processing 

environment has been the subject of a 

number of scientific publications (Refs. 

5 through 7). L. monocytogenes can 

survive longer under adverse 

environmental conditions than many 

other vegetative bacteria that present a 

food safety concern. L. monocytogenes 

tolerates high salt concentrations (such 

as in nonchlorinated brine chiller 

solutions) and survives frozen storage 

for extended periods. It is more resistant 

to nitrite and acidity than many other 

foodborne pathogens. It also is more 

resistant to heat than many other 

nonspore forming foodborne pathogens, 

although it can be killed by heating 

procedures such as those used to 

pasteurize milk3 (Ref. 8). Importantly, L. 

monocytogenes can multiply slowly at 

refrigeration temperatures, thereby 

challenging an important defense 

against foodborne pathogens—i.e., 

refrigeration (Refs. 9 and 10). 

Some foods (such as ice cream and 

pickled fish) are characterized by 

intrinsic or extrinsic factors4 that 

generally prevent the growth of L. 

monocytogenes (i.e., they are 

‘‘listeristatic’’), or are processed to alter 

the normal characteristics of the food. 

For example, it is well established (Refs. 

10 and 12 through 14) that L. 

monocytogenes does not grow when: 

• The pH of the food is less than or 

equal to 4.4; 

• The water activity of the food is less 

than or equal to 0.92; or 

• The food is frozen. 

Foods may naturally have a pH or 

water activity that prevents growth of L. 

monocytogenes or may be deliberately 

processed to achieve those 

characteristics (e.g., by adding acid to 

deli-type salads to bring the pH to less 

than or equal to 4.4). Listeristatic 

control measures, such as some 

antimicrobial substances, can prevent L. 

monocytogenes from growing in food 

(Ref. 10).5

Examples of RTE foods that generally 

are considered to not support the 

growth of L. monocytogenes include:6

• Fish that are preserved by 

techniques such as drying, pickling, and 

marinating; 

• Ice cream and other frozen dairy 

products; 

• Processed cheese (e.g., cheese 

foods, spreads, slices); 

• Cultured milk products (e.g., 

yogurt, sour cream, buttermilk); 

• Hard cheeses (less than 39 percent 

moisture) (e.g., cheddar, colby, and 

parmesan); 

• Some deli-type salads, particularly 

those processed to a pH less than 4.4 

and those containing antimicrobial 

substances such as sorbic acid/sorbates 

or benzoic acid/benzoates under 

conditions of use documented to be 

effective in preventing the growth of L. 

monocytogenes; 

• Some vegetables (such as carrots); 

and 

• Crackers, dry breakfast cereals, and 

other dry foods that have water activity 

less than 0.92 (Ref. 10). 

In contrast, other foods (such as milk 

and crabmeat) do not have factors that 

prevent the growth of L. monocytogenes. 

These foods support the growth of L. 

monocytogenes. Examples of RTE foods 

that support the growth of L. 

monocytogenes include: 

• Milk; 

• High fat and other dairy products 

(e.g., butter and cream); 

• Soft unripened cheeses (greater 

than 50 percent moisture) (e.g., cottage 

cheese and ricotta cheese); 

• Cooked crustaceans (e.g., shrimp 

and crab); 

• Smoked seafood (e.g., smoked 

finfish and mollusks); 

• Raw seafood that will be consumed 

as sushi or sashimi; 

• Many vegetables (such as broccoli, 

cabbage and salad greens); 

• Non-acidic fruit (such as melon, 

watermelon, and papaya) (Ref. 17; and 

• Some deli-type salads and 

sandwiches (particularly those 

containing seafood and those prepared 

at retail establishments without the 

addition of antimicrobial substances). 

Appendix 8 of Reference 1 lists some 

of the available information on the 

growth of L. monocytogenes in specific 

foods, such as several categories of 

cheese, that include some products that 

support growth as well as other 

products that do not support growth. 

Although Appendix 8 of Reference 1 has 

very limited information about the 

growth of L. monocytogenes in fruits, 

Table 3.3 in Reference 10 reports the pH 

of many fruits. Table 3.3 in Reference 10 

also reports the pH of many vegetables. 

For example, Table 3.3 in Reference 10 

reports that the pH of honeydew melons 

is 6.3–6.7, the pH of limes is 1.8–2.0, the 

pH of corn is 7.3, and the pH of 

cucumbers is 3.8. 

C. FDA Activities Addressing L. 

monocytogenes in RTE Food 

Beginning in 1980, a number of 

reports linked listeriosis outbreaks with 

various RTE foods, including coleslaw 

(Ref. 18), pasteurized milk (Ref. 19), and 

Mexican-style soft, white cheese (Ref. 

20). In 1986, FDA revised Compliance 

Policy Guide (CPG) Sec. 527.300 

Pathogens in Dairy Products (7106.08) 

to address L. monocytogenes (Ref. 21). 

CPG Sec. 527.300 provides guidance for 

initiating legal action in cases involving 

dairy products found to be improperly 

pasteurized, contaminated with 

pathogenic microorganisms, or prepared 

and packed under insanitary conditions. 

One criterion for initiating legal action 

is that analysis of the dairy product 

demonstrates that one or more units is 

positive for L. monocytogenes and is 

confirmed. The specimen charge 

recommended by CPG Sec. 527.300 

when this criterion is met is that the 

article is adulterated within the 

meaning of 21 U.S.C. 342(a)(1) in that it 

contains a pathogenic microorganism, 

namely L. monocytogenes, which may 

render it injurious to health. See United 


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7We also have worked with firms who 

voluntarily decide to recall one or more food 

products—e.g., when L. monocytogenes is detected 

by regulatory authorities in the States. However, 

CPG Sec. 527.300 does not address product recalls. 

8Under guidelines established by Health Canada 

for the microbiological safety of food (Ref. 26), a 

Health 1 concern is one in which action is taken 

to ensure that the product is no longer sold and the 

population does not consume what they have at 

home. A Health 2 concern is one in which action 

is taken to limit further distribution of the product. 

States of America v. Union Cheese Co., 

902 F. Supp. 778, 786 (N.D. Ohio 1995) 

(holding that the ‘‘presence of L. 

monocytogenes’’ rendered defendant’s 

cheese products adulterated within the 

meaning of 21 U.S.C. 342(a)(1)). 

Consistent with the guidance in CPG 

Sec. 527.300 and with the Union Cheese 

decision, we issued warning letters or 

sought injunction when we detected L. 

monocytogenes in foods other than 

dairy products, such as cut salad or 

smoked seafood (Ref. 22 and United 

States of America v. Blue Ribbon 

Smoked Fish, Inc., 179 F. Supp. 2d 30 

(E.D.N.Y. 2001)).7

A 1996 paper authored by FDA staff 

and entitled ‘‘U.S. position on Listeria 

monocytogenes in foods’’ (Ref. 23) 

stated that, based on the available 

scientific information, FDA considered 

detection of L. monocytogenes in 

cooked, RTE foods to be a violation of 

section 402(a)(1) of the act, in that the 

food bears or contains an added 

poisonous or deleterious substance 

which may render it injurious to health. 

The authors stated that FDA had 

established a ‘‘zero tolerance’’ for L. 

monocytogenes in cooked, RTE foods. 

The authors used the term ‘‘zero 

tolerance’’ to indicate that FDA 

considered any detectable level of L. 

monocytogenes in cooked, RTE foods to 

be unacceptable from a public health 

perspective. 

FDA uses an analytical method that 

can detect 1.0 cfu of L. monocytogenes 

per 25 g of food to determine whether 

L. monocytogenes is present in the food 

(i.e., 0.04 cfu/g) (Ref. 24). 

D. Microbiological Limits Established 

Internationally for L. monocytogenes 

Some international entities are 

approaching the contamination of foods 

with L. monocytogenes with different 

microbiological limits for the food 

depending on whether the food does, or 

does not, support the growth of L. 

monocytogenes. For example, Canada 

has adopted a three-tiered enforcement 

policy for foods that may be 

contaminated with L. monocytogenes 

(Ref. 25). The first tier addresses L. 

monocytogenes in RTE foods that have 

been associated with an outbreak of 

listeriosis or that were placed in the 

‘‘high risk’’ category in a 2003 

quantitative risk assessment released by 

FDA and FSIS (Ref. 1). For foods in the 

first tier, the presence of L. 

monocytogenes in the food is a Health 

1 concern8 unless the measured pH or 

water activity, or data provided by the 

manufacturer, demonstrates that the 

product does not support the growth of 

L. monocytogenes. The second tier 

addresses L. monocytogenes in RTE 

foods that are capable of supporting the 

growth of L. monocytogenes and have a 

shelf life exceeding 10 days. For foods 

in the second tier, the presence of L. 

monocytogenes in the food is a Health 

2 concern unless data provided by the 

manufacturer demonstrate that the 

product does not support the growth. 

The third tier addresses RTE products 

that: (1) Support growth of L. 

monocytogenes, but have a shelf life of 

equal to or less than 10 days, or (2) do 

not support growth of L. 

monocytogenes. Foods in the third tier 

have the lowest priority, in terms of 

inspection and compliance action, 

unless the product is produced for, or 

targeted or distributed to, sensitive 

populations (such as pregnant women 

or immunocompromised individuals). 

For foods in the third tier, product 

containing greater than 100 cfu/g of L. 

monocytogenes is a Health 2 concern, 

except that the presence of L. 

monocytogenes in product that is 

produced for, or targeted or distributed 

to, sensitive populations is considered a 

Health 1 or Health 2 concern, based on 

consideration of all available 

information. 

As another example, the Commission 

of the European Community has 

established a directive that establishes a 

series of food safety criteria for L. 

monocytogenes depending on the 

intended use of the food and depending 

on whether the food remains under the 

control of the food business operator or 

is in the market (Ref. 27). For example, 

the food safety criterion for RTE foods 

intended for infants or for special 

medical purposes is the presence of L. 

monocytogenes in the food, regardless of 

whether the food supports its growth. 

The food safety criterion for RTE foods 

that do not support the growth of L. 

monocytogenes is 100 cfu/g. The food 

safety criterion for RTE foods (other 

than those intended for infants or for 

special medical purposes) that support 

the growth of L. monocytogenes is the 

presence of detectable L. monocytogenes 

in the food before the food has left the 

immediate control of the food business 

operator, or 100 cfu/g after the food is 

in the market. 

E. Establishing an Enforcement Policy 

for L. monocytogenes in RTE Foods 

In 2001, FDA and USDA/FSIS, in 

consultation with the Centers for 

Disease Control and Prevention of the 

United States Department of Health and 

Human Services, requested comment on 

a draft quantitative assessment (the 2001 

Draft LmRA) (Ref. 28) of relative risk 

associated with consumption of 20 

categories of RTE foods that had a 

history of contamination with L. 

monocytogenes, or that were implicated 

epidemiologically with an outbreak or a 

sporadic case of listeriosis. In 2003, 

FDA and USDA released their final risk 

assessment (the FDA/FSIS LmRA) (Ref. 

1), which includes revisions made after 

review of comments received to the 

2001 Draft LmRA. The FDA/FSIS LmRA 

(Ref. 1) provides the scientific basis for 

the enforcement policy that is the 

subject of the draft CPG. 

In 2004, the Food and Agriculture 

Organization (FAO) and the World 

Health Organization (WHO) of the 

United Nations (FAO/WHO) issued a 

Risk Assessment of Listeria 

monocytogenes in Ready-to-Eat Foods 

(the FAO/WHO LmRA) (Ref. 29). This 

risk assessment, prepared at the request 

of the Codex Committee on Food 

Hygiene (CCFH) was intended to 

provide a scientific basis for the 

development of guidelines for the 

control of L. monocytogenes in foods by 

member countries. Representatives of 

FDA participated in development of this 

FAO/WHO Risk Assessment, which 

relied on data and information in the 

2001 Draft FDA/FSIS LmRA. The FAO/ 

WHO LmRA provides additional 

scientific information that supports the 

enforcement policy that is the subject of 

the draft CPG. 

Both the FDA/FSIS LmRA and the 

FAO/WHO LmRA are quantitative risk 

assessments that use mathematical 

modeling to estimate risk and assume 

that individuals in a population may 

have varying susceptibility to infection. 

The dose-response models developed in 

these risk assessments are nonthreshold 

models that assume that a single cell has 

the potential to infect and provoke a 

response in an individual (Ref. 30). As 

a result, under these models the risk 

presented by foodborne L. 

monocytogenes does not reach zero 

unless the number of L. monocytogenes 

in a food serving is zero. Another 

consequence of the nonthreshold model 

is that an increase in either the 

frequency of contamination (percentage 

of food servings that are contaminated) 

or the level of contamination (cfu/g in 

a contaminated food serving) is 

expected to result in an increase in the 


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9A more virulent strain would have the potential 

to cause listeriosis with fewer cells than a less 

virulent strain. 

10The data in the FDA/FSIS LmRA are reported 

in terms of cfu/serving. However, it would not be 

practical from an operational perspective to 

consider an enforcement policy concerning L. 

monocytogenes in food in terms of cfu/serving, 

because each food category has a different serving 

size. Instead, for purposes of an enforcement policy, 

we would consider L. monocytogenes in terms of 

cfu/g of food based on a uniform serving size. For 

operational purposes, we selected a uniform serving 

size of 100 g because 100 g approximates the 

median serving size for several of the food 

categories that are consumed in relatively large 

amounts (see Table III–3 in Section III, p. 35 of the 

FDA/FSIS LmRA). This is a relatively conservative 

estimate of serving size and increases the relative 

conservativeness of the enforcement policy. 

11FAO/WHO includes the elderly, infants, 

pregnant women and immunocompromised 

patients in the susceptible population (see Part 1, 

p. 5 of the FAO/WHO LmRA). 

12The FDA/FSIS LmRA estimates that Deli-type 

Salads (a category of food defined in the risk 

assessment) present a moderate risk of listeriosis. 

However, the data and analysis presented in the 

FDA/FSIS LmRA do not distinguish between those 

Deli-type Salads that support the growth of L. 

risk of listeriosis (see p. 138 of Part 5 of 

the FAO/WHO LmRA). Conversely, a 

decrease in either the frequency of 

contamination or the level of 

contamination is expected to result in a 

decrease in the risk of listeriosis. 

The FDA/FSIS LmRA and the FAO/ 

WHO LmRA differ in aspects such as 

focus (i.e., the questions that the risk 

assessments addressed), modeling 

assumptions, source of data regarding 

exposure, and estimation of serving size. 

For example, the FAO/WHO LmRA 

relies on the exposure data in the 2001 

Draft LmRA, whereas the FDA/FSIS 

LmRA relies on revised exposure data 

that reflect modified food categories, 

contamination data, growth data, and 

data on how long foods are stored before 

consumption. As another example, the 

FDA/FSIS LmRA used empirical 

distributions derived from consumer 

surveys to describe the serving sizes in 

the food categories. These distributions 

were expressed as a series of population 

percentiles of the amount of food eaten 

per serving, weighted to reflect the 

consumption survey demographics. In 

contrast, the FAO/WHO LmRA assumed 

a uniform serving size of 31.6 g because 

this serving size both approximated a 

typical serving size and simplified the 

calculations in that dose levels were 

estimated in 0.5 log10 increments. 

The FDA/FSIS LmRA and the FAO/ 

WHO LmRA also differ in reported 

output. For example, the FDA/FSIS 

LmRA provides information grouping 

its results as a two-dimensional matrix 

with five overall risk designations (very 

high, high, moderate, low, and very low) 

(see Figure VII–1 in Section VII of the 

FDA/FSIS LmRA, p. 230), whereas the 

FAO/WHO LmRA provides tables that 

report the annual incidence of listeriosis 

estimated to be associated with specific 

ingested doses of L. monocytogenes (see, 

e.g., Table 2.19 in Part 2, p. 58 and 

Table 5.3 in Part 5, p. 137). 

FAO/WHO characterize their doseresponse model as a conservative model 

that assumes maximum virulence of L. 

monocytogenes (see discussions in Parts 

2 and 5 of the FAO/WHO LmRA). One 

factor that FAO/WHO identify as 

relevant to this characterization is their 

assumption that the maximum dose to 

which L. monocytogenes could grow in 

a food is 107.5 cfu/serving.9 In contrast, 

the dose-response model in the FDA/ 

FSIS LmRA assumed a distribution of 

virulent strains and that the maximum 

dose to which L. monocytogenes could 

grow in a food is 1010 cfu/serving. The 

FAO/WHO LmRA includes a table 

(Table 2.19, see Part 2, p. 58 of the FAO/ 

WHO LmRA) that shows the impact of 

these different assumptions about the 

maximum dose to which L. 

monocytogenes could grow in a food on 

their estimate of the annual number of 

illnesses in the susceptible population. 

Their least conservative assumption 

about the maximum dose to which L. 

monocytogenes could grow in a food 

(i.e., 1010.5 cfu/serving) is similar to the 

assumption used in the FDA/FSIS 

LmRA (i.e., 1010 cfu/serving). 

Applying the exposure assessment 

and the dose response model in the 

FDA/FSIS LmRA, we estimate that there 

would be no annual cases of listeriosis 

in the total population if all servings of 

RTE foods were at or below 105 cfu/ 

serving (corresponding to 103 cfu/g or 

less for a 100 g serving of food)10 (see 

Table 5 in Appendix 1 of this 

document). We also estimate that the 

median number of cases of listeriosis 

would be approximately 1 per year in 

the total population from all the 

servings that are contaminated with 107

cfu/serving or less (corresponding to 105

cfu/g or less for a 100 g serving of food) 

and approximately 6 per year in the 

total population from all the servings 

that are contaminated with up to and 

including 108 cfu/serving 

(corresponding to 106 cfu/g for a 100 g 

serving of food). Above doses of 108 cfu/ 

serving, the estimated median number 

of cases of listeriosis in the total 

population per year increases 

exponentially. 

These estimates are in line with the 

estimates reported by FAO/WHO using 

their least conservative assumption 

regarding the maximum dose to which 

L. monocytogenes could grow in a food 

(see Table 2.19 in Part 2, p. 58 of the 

FAO/WHO LmRA). As can be seen from 

FAO/WHO Table 2.19, FAO/WHO 

estimate that there would be no annual 

cases of listeriosis in the susceptible 

population11 if all servings of RTE foods 

were at or below 104.5 cfu/serving 

(corresponding to 103 cfu/g or less for a 

31.6 g serving of food). FAO/WHO also 

estimate that the number of cases of 

listeriosis would be approximately 1 per 

year in the susceptible population from 

all the servings that are contaminated 

with 105.5 cfu/serving or less 

(corresponding to 104 cfu/g or less for a 

31.6 g serving of food) and 

approximately 6 per year in the 

susceptible population from all the 

servings that are contaminated with up 

to and including 106.5 cfu/serving 

(corresponding to 105 cfu/g for a 31.6 g 

serving of food). When the most 

conservative modeling assumptions are 

used, FAO/WHO estimate that there 

would be no annual cases of listeriosis 

in the susceptible population if all 

servings of RTE foods were at or below 

101.5 cfu/serving (corresponding to 1 

cfu/g or less for a 31.6 g serving of food), 

that the number of cases of listeriosis 

would be approximately 1 per year in 

the susceptible population from all the 

servings that are contaminated with 

102.5 cfu/serving or less (corresponding 

to 10 cfu/g or less for a 31.6 g serving 

of food), and that the number of cases 

of listeriosis would be approximately 2 

per year in the susceptible population 

from all the servings that are 

contaminated with up to and including 

103.5 cfu/serving (corresponding to 102

cfu/g for a 31.6 g serving of food). 

The FDA/FSIS LmRA and other 

scientific information cited in that 

document support a conclusion that 

RTE foods that support the growth of L. 

monocytogenes are much more likely 

than other foods to be associated with 

listeriosis. In the United States and 

other countries, both outbreaks and 

sporadic cases of listeriosis have been 

overwhelmingly associated with foods 

that support the growth of L. 

monocytogenes. The FDA/FSIS LmRA 

estimates that only a small percent of 

contaminated servings would be highly 

contaminated (see Table III–17 in 

Section III, p. 75). We estimate that it is 

these higher dose exposures that are 

responsible for most of the reported 

illnesses (See Table 5 in Appendix 1 of 

this document). 

In contrast, the FDA/FSIS LmRA and 

other scientific information cited in that 

document support a conclusion that 

RTE foods that do not support the 

growth of L. monocytogenes present a 

low or very low risk (as those terms are 

defined in the risk assessment) of 

listeriosis.12 The FDA/FSIS LmRA 


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monocytogenes and those that do not support the 

growth of L. monocytogenes. Regardless of this 

limitation, the FDA/FSIS LmRA estimates that Delitype Salads are associated with less than one case 

of listeriosis per billion servings and less than one 

case of listeriosis per year (see Figure V–6 in 

Section V, p. 133 of the FDA/FSIS LmRA). In 

addition, as shown in Table III–16 of the FDA/FSIS 

LmRA (see Section III, p. 73) and Appendix 2 of this 

document, it would be rare to find L. 

monocytogenes in Deli-type Salads at greater than 

100 cfu/g. 

13The FAO/WHO LmRA estimates that 

individuals with serious medical conditions (i.e,, 

transplant and dialysis patients and individuals 

with certain cancers or AIDS), the perinatal 

population, and the elderly have higher relative 

susceptibility than the general population. See the 

discussion and tables in Part 5, pp. 140–142 of the 

FAO/WHO LmRA. Appendix 9 of the FDA/FSIS 

LmRA notes that the population estimated to have 

the greatest sensitivity (i.e., hospitalized transplant 

patients) may have experienced listeriosis at levels 

as low as 5 to 60 cfu/g. However, these patients 

have a temporary status in that the degree to which 

individual patients are immunocompromised 

decreases as time passes relative to the clinical 

procedure that they undergo. While in this 

temporary status, they are under active medical care 

and their diets are carefully controlled—e.g., they 

are unlikely to be consuming Preserved Fish. In 

addition, it would be rare to find L. monocytogenes 

at greater than 10 cfu/g in dairy products that do 

not support the growth of L. monocytogenes (see 

Table III–16 of the FDA/FSIS LmRA in Section III, 

p. 73 and Appendix 2 of this document). 

14E.g., the draft CPG advises FDA staff to use ISO 

11290–2:1998(E) ‘‘Microbiology of food and animal 

feeding stuffs—Horizontal method for the detection 

and enumeration of Listeria monocytogenes—Part 2: 

Enumeration method’’ as the method for 

enumerating L. monocytogenes. ISO methods are 

available from the International Organization for 

Standardization at http://www.iso.org/iso/en/ 

ISOOnline.frontpage. 

estimates that foods that do not support 

the growth of L. monocytogenes are 

associated, in total, with less than one 

case per billion servings and less than 

one case per year (see Table V–6 in 

Section V, p. 133 of the FDA/FSIS 

LmRA). 

Because the difference in risk of 

listeriosis is linked to the ability of a 

RTE food to support the growth of L. 

monocytogenes, it is appropriate under 

a risk-based approach to regard RTE 

foods differently based on whether the 

food does, or does not, support the 

growth of L. monocytogenes. 

Since RTE foods that do not support 

the growth can be expected to have the 

same level of L. monocytogenes at the 

point of consumption that they contain 

at the point when they leave the 

manufacturer, the appropriate public 

health strategy is to establish an 

enforcement policy that is based on the 

risk presented by consumption of 

various doses of L. monocytogenes in 

these foods. The numerical value of the 

microbiological limit used in a number 

of other countries for RTE foods that do 

not support the growth of L. 

monocytogenes, and the numerical 

value supported by the FDA/FSIS 

LmRA, is 100 cfu/g. FDA believes that 

an enforcement policy aimed at 

maintaining L. monocytogenes below 

100 cfu/g for such foods is protective of 

most vulnerable populations, since 

these populations are included in the 

total population considered in the FDA/ 

FSIS LmRA and the susceptible 

population considered in the FAO/ 

WHO LmRA.13 Methods to enumerate L. 

monocytogenes are available.14

In contrast, a RTE food that supports 

the growth of L. monocytogenes may 

pose a risk to public health if it contains 

any detectable L. monocytogenes, 

because the cfu/serving can reasonably 

be expected to increase to a dose that is 

injurious to health during storage 

periods after manufacture. Low levels 

after manufacture may become high 

levels at the time of consumption. 

Therefore, the appropriate public health 

strategy for RTE foods that support the 

growth of L. monocytogenes is to regard 

the food as adulterated if L. 

monocytogenes is present in the food. 

As noted above (see sections IV.A and 

IV.C of this document), FDA uses an 

analytical method that can detect 1.0 cfu 

of L. monocytogenes per 25 g of food 

(i.e., 0.04 cfu/g) (Ref. 24). 

The FDA/FSIS LmRA estimates that it 

would be rare to find L. monocytogenes 

at greater than 100 cfu/g in RTE foods 

that do not support its growth (see Table 

III–16 in the FDA/FSIS LmRA and 

Appendix 2 of this document). Thus, we 

expect that maintaining contamination 

below 100 cfu/g is achievable for RTE 

foods that do not support the growth of 

L. monocytogenes. 

FDA anticipates that the public health 

benefits of this enforcement policy 

include clarifying for FDA staff which 

foods support growth of L. 

monocytogenes and, thus, helping to 

ensure that FDA resources are focused 

on foods that are more likely to pose a 

greater risk to public health. FDA 

anticipates that it may be able to 

increase the number of samples that it 

periodically collects and tests for RTE 

foods that do not support the growth of 

L. monocytogenes while it continues to 

focus its inspection and outreach efforts 

on facilities manufacturing RTE foods 

that support the growth of L. 

monocytogenes. States and local 

governments could adopt this model for 

resource allocation. The policy may also 

indirectly lead to other public health 

benefits, such as verification strategies 

and reformulation of some RTE foods 

(e.g., through addition of antimicrobials, 

manipulation of pH, or other means) so 

that they do not support the growth of 

L. monocytogenes. 

V. References 

We have placed the following 

references on display in the Division of 

Dockets Management (see ADDRESSES). 

You may see them 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 Web sites after 

this document publishes in the Federal 

Register. 1. U.S. Food and Drug Administration and 

U.S. Food Safety and Inspection Service, 

‘‘Quantitative Assessment of the Relative 

Risk to Public Health from Foodborne 

Listeria monocytogenes Among Selected 

Categories of Ready-to-Eat Foods,’’ 2003. 

Available in Docket No. 1999N–1168, vols. 

23 through 28, and at http:// 

www.foodsafety.gov/~dms/lmr2-toc.html. 

Cited page numbers refer to the Portable 

Document File (PDF) version of the 

document on the Web. 

2. National Advisory Committee on 

Microbiological Criteria for Foods 

(NACMCF), ‘‘Listeria monocytogenes: 

Recommendations by the National Advisory 

Committee on Microbiological Criteria for 

Foods,’’ International Journal of Food 

Microbiology, vol. 14, pp. 185–246, 1991. 

Available in Docket No. 1999N–1168, vol. 

0015 bkg1 (12 of 17), Tab 287. 

3. Fenlon, D. R., J. Wilson, and W. 

Donachie, ‘‘The Incidence and Level of 

Listeria monocytogenes Contamination of 

Food Sources at Primary Production and 

Initial Processing,’’ Journal of Applied 

Bacteriology, vol. 81, pp. 641–650, 1996. 

Available in Docket No. 1999N–1168, vol. 

0011 bkg1 (08 of 17), Tab 134. 

4. Fenlon, D. R., ‘‘Listeria monocytogenes 

in the Natural Environment,’’ Listeria, 

Listeriosis, and Food Safety, 2d ed., pp. 21–

37 (E. T. Ryser and E. H. Marth, editors), 

Food Science and Technology, New York, 

Marcel Dekker, Inc., 1999. Available in 

Docket No. 1999N–1168, vol. 0009 bkg1 (06 

of 17), file name bkg0001_5_a.pdf. 

5. Tompkin, R. B., ‘‘Control of Listeria 

monocytogenes in the Food Processing 

Environment,’’ Journal of Food Protection, 

vol. 65, pp. 709–725, 2002. 

6. Moretro, T. and S. Lansgrund, ‘‘Listeria 

monocytogenes: Biofilm Formation and 

Persistence in Food Processing 

Environments,’’ Biofilms, vol. 1, pp. 107–121, 

2004. 

7. Gall, K., V. N. Scott, R. Collette, et al., 

‘‘Implementing Targeted Good 

Manufacturing Practices and Sanitation 

Procedures to Minimize Listeria 

Contamination of Smoked Seafood 

Products,’’ Food Protection Trends, vol. 24, 

No. 5, pp. 302–315, 2004. 

8. Doyle, M. E., A. S. Mazzotta, T. Wang, 

et al., ‘‘Heat Resistance of Listeria 

monocytogenes,’’ Journal of Food Protection, 

vol. 64, No. 3, pp. 410–429, 2001. 

9. Lou, Y. and A. E. Yousef, 

‘‘Characteristics of Listeria monocytogenes 

Important to Food Processors,’’ Listeria, 

Listeriosis, and Food Safety, 2d ed., pp. 131–

224 (E. T. Ryser and E. H. Marth, editors), 

Food Science and Technology, New York, 

Marcel Dekker, Inc., 1999. Available in 


jlentini on PROD1PC65 with NOTICES
7304 Federal Register / Vol. 73, No. 26 / Thursday, February 7, 2008 / Notices 

Docket No. 1999N–1168, vol. 0014 bkg1 (11 

of 17), Tab 245. 

10. Institute of Food Technologists, IFT/ 

FDA Contract No. 223–98–2333, ‘‘Evaluation 

and Definition of Potentially Hazardous 

Foods,’’ 2001. Available at http:// 

www.cfsan.fda.gov/~comm/ift4-toc.html. 

Accessed and printed on April 6, 2007. 

11. Russell, N. J. and G. W. Gould, ‘‘Major 

Preservation Technologies,’’ Food 

Preservatives, 2d ed., p. 15 (N. J. Russell and 

G. W. Gould, editors), Springer Publishing 

Co., New York, 2003. 

12. Sorrells, K. M., D. C. Enigl, and J. R. 

Hatfield, ‘‘Effect of pH, Acidulant, Time, and 

Temperature on the Growth and Survival of 

Listeria monocytogenes,’’ Journal of Food 

Protection, vol. 52, No. 8, pp. 571–573, 1989. 

13. Petran, R. L. and E. A. Zottola, ‘‘A 

Study of Factors Affecting Growth and 

Recovery of Listeria monocytogenes Scott A,’’

Journal of Food Science, vol. 54, No. 2, pp. 

458–460, 1989. 

14. Tienungoon, S., D. A. Ratkowsky, T. A. 

McMeekin, et al., ‘‘Growth Limits of Listeria 

monocytogenes as a Function of 

Temperature, pH, NaCl, and Lactic Acid,’’

Applied and Environmental Microbiology, 

vol. 66, No. 11, pp. 4979–4987, 2000. 

15. Leistner, L., ‘‘Principles and 

Applications of Hurdle Technology,’’ New 

Methods of Food Preservation (G. W. Gould, 

editor), London: Blackie Academic & 

Professional, pp. 1–21, 1995. 

16. Scott, V. N., K. M. J. Swanson, T. A. 

Freier, et al., ‘‘Guidelines for Conducting 

Listeria monocytogenes Challenge Testing of 

Foods,’’ Food Protection Trends, vol. 25, No. 

11, pp. 818–825, 2005. 

17. Penteado, A. L. and M. F. F. Leitao, 

‘‘Growth of Listeria monocytogenes in Melon, 

Watermelon and Papaya Pulps,’’

International Journal of Food Microbiology, 

vol. 92, pp. 89–94, 2004. 

18. Schlech, W. F., III, P. M. Lavigne, R. A. 

Bortolussi, et al., ‘‘Epidemic Listeriosis: 

Evidence for Transmission by Food,’’

Medical Intelligence, vol. 308, pp. 203–206, 

1983. Available in Docket No. 1999N–1168, 

vol. 0018 bkg1 (15 of 17), Tab 363. 

19. Fleming, D. W., S. L. Cochi, K. L. 

MacDonald, et al., ‘‘Pasteurized Milk as a 

Vehicle of Infection in an Outbreak of 

Listeriosis,’’ New England Journal of 

Medicine, vol. 312, pp. 404–407, 1985. 

Available in Docket No. 1999N–1168, vol. 

0011 bkg1 (08 of 17), Tab 139. 

20. Linnan, M. J., L. Mascola, X. D. Lou, 

et al., ‘‘Epidemic Listeriosis Associated with 

Mexican-Style Cheese,’’ New England Journal 

of Medicine, vol. 3, No. 19, pp. 823–828, 

1988. Available in Docket No. 1999N–1168, 

vol. 0014 bkg1 (11 of 17), Tab 241. 

21. Compliance Policy Guide Sec. 527.300 

Pathogens in Dairy Products (CPG 7106.08). 

Accessed and printed on April 8, 2007. FDA 

makes the most recent edition of the CPG 

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

compliance_ref/cpg/cpgfod/cpg527-300.html. 

When a CPG is revised, previous editions are 

no longer available on the Internet. 

22. Letter from J. H. Rahto of FDA, 

Minneapolis District Office to Bradley V. 

Beckman, Custom Cuts Co., March 5, 1999. 

Available at http://www.fda.gov/foi/ 

warning_letters/archive/m2438n.pdf. 

Accessed and printed on September 30, 2005. 

23. Shank, F. R., E. L. Elliot, K. 

Wachsmuth, et al., ‘‘U.S. Position on Listeria 

monocytogenes in Foods,’’ Food Control, vol. 

7, No. 415, pp. 229–234, 1996. Available in 

Docket No. 1999N–1168, vol. 0018 bkg1 (15 

of 17), Tab 374. 

24. U.S. Food and Drug Administration, 

Bacteriological Analytical Manual Online, 

Chapter 10—‘‘Listeria monocytogenes,’’

‘‘Detection and Enumeration of Listeria 

monocytogenes in Foods,’’ 2003. Available at 

http://www.cfsan.fda.gov/~ebam/bam10.html. Accessed and printed on April 10, 

2007. 

25. Health Canada, ‘‘Policy on Ready-to-Eat 

Foods Contaminated with Listeria 

monocytogenes,’’ 2004. Available at http:// 

www.hc-sc.gc.ca/fn-an/alt_formats/hpfbdgpsa/pdf/legislation/policy_listeria_

monocytogenes_politique_toc_e.pdf. 

Accessed and printed on April 6, 2007. 

26. Health Canada, ‘‘Health Products and 

Food Branch (HPFB) Standards and 

Guidelines for Microbiological Safety of 

Food—An Interpretive Summary,’’ 2006. 

Available at http://www.hc-sc.gc.ca/fn-an/ 

res-rech/analy-meth/microbio/volume1/ 

intsum-somexp_e.html. Accessed and 

printed on October 11, 2007. 

27. Commission of the European 

Communities, ‘‘Commission Regulation (EC) 

No 2073/2005 of 15 November 2005 on 

Microbiological Criteria for Foodstuffs,’’

Official Journal of the European Union, 

22.12.2005 L338/1-L338-26, 2005. Available 

at http://europa.eu.int/eur-lex/lex/ 

LexUriServ/site/en/oj/2005/l_338/ 

l_33820051222en00010026.pdf. Accessed 

and printed on May 10, 2007. 

28. U.S. Food and Drug Administration 

and U.S. Food Safety and Inspection Service, 

‘‘Draft Assessment of the Relative Risk to 

Public Health from Foodborne Listeria 

monocytogenes Among Selected Categories 

of Ready-to-Eat Foods,’’ 2001. Available at 

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

lmrisk.html. Accessed and printed on April 

10, 2007. 

29. Food and Agriculture Organization and 

World Health Organization, ‘‘Risk 

Assessment of Listeria monocytogenes in 

Ready-to-Eat Foods,’’ Microbiological Risk 

Assessment Series No. 5. Technical Report, 

2004. Available at http://www.who.int/ 

foodsafety/publications/micro/mra_listeria/ 

en/index.html. Accessed and printed on May 

10, 2007. 

30. Haas, C. N., ‘‘Estimation of Risk Due to 

Low Doses of Microorganisms: A Comparison 

of Alternative Methodologies,’’ American 

Journal of Epidemiology, vol. 118, No. 4, pp. 

573–582, 1983. 

Appendix 1.—Data Output and 

Calculations Relevant to the Annual 

Incidence of Listeriosis Estimated in 

The FDA/FSIS LMRA 

Table IV–12 of the FDA/FSIS LmRA 

(Section IV, p. 110) reports the 

relationship between the dose of L. 

monocytogenes (in cfu/serving) and the 

response (as the estimated median 

mortality rate per serving) for each of 

three age-based national population 

groups. The three population groups are 

the elderly population (60 years and 

older), perinatal population (prenatal 

and neonatal), and the remaining 

population (designated the 

intermediate-aged). 

We took the output data of the model 

used in the FDA/FSIS LmRA and retabulated the data to show our estimates 

of the annual number of cases of 

listeriosis in the elderly population, the 

intermediate-age population, and the 

neonatal population, as well as in the 

total population, as a function of the 

ingested dose (in colony forming units, 

i.e., cfu) per serving. Tables 1 through 

4 report that output data. 

Table 1 reports the estimated 

ascending cumulative percentage of 

contaminated food servings consumed 

annually by the elderly population at a 

series of doses (in cfu/serving) and the 

estimated ascending cumulative 

percentage of illnesses in the elderly 

population. The data are reported at the 

5th, 50th (median), and 95th 

percentiles. Tables 2 through 4 report 

these data for the intermediate-age, 

neonatal, and total populations, 

respectively. 

Table IV–11 of the FDA/FSIS LmRA 

(Section IV, p. 105) reports the 

estimated total number of illnesses for 

each population on an annual basis as 

follows: 

• Elderly population: 1159 

• Intermediate-age population: 702 

• Neonatal population: 216 

• Total population: 2078 

For each population, we calculated 

the incremental increase in the 

estimated percentage of contaminated 

servings and the incremental increase in 

the estimated percentage of illnesses. 

We then multiplied the estimated 

incremental percentage of illnesses by 

the estimated total number of illnesses 

for that population to obtain an estimate 

of the number of listeriosis cases per 

year for each dose. Table 5 reports the 

50th percentile (i.e., median) calculated 

estimates of the annual number of cases 

of listeriosis in the elderly population, 

the intermediate-age population, and 

the neonatal population, as well as in 

the total population, as a function of the 

ingested dose per serving (i.e., cfu/ 

serving). Table 5 also shows the 

calculated level (in cfu/g) corresponding 

to a 100 g serving size. 


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TABLE 1.—OUTPUT FROM THE MODEL IN THE FDA/FSIS LMRA ELDERLY POPULATION

Dose (cfu/serving) Estimated Servings (Cumulative Percentage)a Estimated Illnesses (Cumulative Percentage)b

0 97.91% (92.85%, 98.72%) 0.00% (0.00%, < 0.01%) 

1 x 10 4 97.92% (92.85%, 98.72%) 0.00% (0.00%, < 0.01%) 

3.16 x 10 4 97.92% (92.86%, 98.73%) 0.00% (0.00%, < 0.01%) 

1 x 10 3 97.93% (92.86%, 98.74%) 0.00% (0.00%, < 0.01%) 

3.16 x 10 3 97.94% (92.87%, 98.75%) 0.00% (0.00%, < 0.01%) 

1 x 10 2 97.95% (92.88%, 98.76%) 0.00% (0.00%, < 0.01%) 

3.16 x 10 2 97.96% (92.90%, 98.77%) 0.00% (0.00%, < 0.01%) 

0.1 97.99% (92.93%, 98.80%) 0.00% (0.00%, < 0.01%) 

0.32 98.04% (92.99%, 98.85%) 0.00% (0.00%, < 0.01%) 

1 98.30% (93.27%, 99.03%) 0.00% (0.00%, < 0.01%) 

3.16 98.70% (93.99%, 99.29%) 0.00% (0.00%, < 0.01%) 

10 99.04% (95.02%, 99.51%) 0.00% (0.00%, < 0.01%) 

31.6 99.30% (95.96%, 99.67%) 0.00% (0.00%, < 0.01%) 

100 99.48% (96.74%, 99.784) 0.00% (0.00%, < 0.01%) 

316 99.61% (97.40%, 99.86%) < 0.01% (0.00%, < 0.01%) 

1000 99.71% (97.95%, 99.90%) < 0.01% (0.00%, 0.010%) 

3162 99.79% (98.40%, 99.93%) < 0.01% (0.00%, 0.01%) 

10000 99.84% (98.78%, 99.95%) < 0.01% (0.00%, 0.02%) 

3.16 x 104 99.88% (99.09%, 99.97%) < 0.01% (0.00%, 0.04%) 

1 x 105 99.90% (99.33%, 99.98%) < 0.01% (0.00%, 0.08%) 

3.16 x 105 99.92% (99.51%, 99.98%) 0.01% (0.00%, 0.15%) 

1 x 106 99.94% (99.63%, 99.99%) 0.02% (0.00%, 0.30%) 

3.16 x 106 99.95% (99.74%, 99.99%) 0.05% (0.00%, 0.65%) 

1 x 107 99.96% (99.83%, 99.99%) 0.12% (0.00%, 1.60%) 

3.16 x 107 99.97% (99.91%, 99.99%) 0.25% (0.00%, 3.00%) 

1 x 108 99.97% (99.94%, > 99.99%) 0.56% (0.00%, 4.57%) 

3.16 x 108 99.98% (99.96%, > 99.99%) 1.41% (0.00%, 7.96%) 

1 x 109 99.98% (99.97%, > 99.99%) 2.85% (0.05%, 13.60%) 

3.16 x 109 99.99% (99.98%, > 99.99%) 10.27% (0.62%, 45.11%) 

1 x 1010 100% (99.99%, 100%) 45.74% (8.83%, 86.80%) 

3.16 x 1010 100% (≤ 99.99%, 100%) 85.28% (46.57%, 96.54%) 

1 x 1011 100% (> 99.99%, 100%) 97.23% (79.31%, 100%) 

3.16 x 1011 100% (100%, 100%) 100% (94.58%, 100%) 

1 x 1012 100% (100%, 100%) 100% (100%, 100%) 

a Reported as the median (50th percentile), with the 5th and 95th percentiles in parentheses. 

b Reported as the median (50th percentile), with the 5th and 95th percentiles in parentheses. 


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7306 Federal Register / Vol. 73, No. 26 / Thursday, February 7, 2008 / Notices 

TABLE 2.—OUTPUT FROM THE MODEL IN THE FDA/FSIS LMRA INTERMEDIATE-AGED POPULATION

Dose (cfu/serving) Estimated Servings (Cumulative Percentage)a Estimated Illnesses (Cumulative Percentage)b

0 97.83% (94.30%, 98.70%) 0.00% (0.00%, < 0.01%) 

1 x 10 4 97.84% (94.31%, 98.71%) 0.00% (0.00%, < 0.01%) 

3.16 x 10 4 97.85% (94.33%, 98.73%) 0.00% (0.00%, < 0.01%) 

1 x 10 3 97.87% (94.35%, 98.74%) 0.00% (0.00%, < 0.01%) 

3.16 x 10 3 97.89% (94.37%, 98.76%) 0.00% (0.00%, < 0.01%) 

1 x 10 2 97.91% (94.39%, 98.78%) 0.00% (0.00%, < 0.01%) 

3.16 x 10 2 97.93% (94.40%, 98.79%) 0.00% (0.00%, < 0.01%) 

0.1 97.96% (94.43%, 98.81%) 0.00% (0.00%, < 0.01%) 

0.32 98.01% (94.47%, 98.86%) 0.00% (0.00%, < 0.01%) 

1 98.27% (94.72%, 99.04%) 0.00% (0.00%, < 0.01%) 

3.16 98.64% (95.35%, 99.30%) 0.00% (0.00%, < 0.01%) 

10 98.97% (96.15%, 99.51%) 0.00% (0.00%, < 0.01%) 

31.6 99.22% (96.86%, 99.67%) 0.00% (0.00%, < 0.01%) 

100 99.41% (97.51%, 99.77%) 0.00% (0.00%, < 0.01%) 

316 99.55% (98.02%, 99.84%) < 0.01% (0.00%, 0.01%) 

1000 99.66% (98.45%, 99.89%) < 0.01% (0.00%, 0.01%) 

3162 99.74% (98.79%, 99.92%) < 0.01% (0.00%, 0.01%) 

10000 99.80% (99.07%, 99.94%) < 0.01% (0.00%, 0.02%) 

3.16 x 104 99.84% (99.29%, 99.96%) < 0.01% (0.00%, 0.03%) 

1 x 105 99.87% (99.46%, 99.97%) < 0.01% (0.00%, 0.05%) 

3.16 x 105 99.90% (99.60%, 99.98%) 0.01% (0.00%, 0.10%) 

1 x 106 99.92% (99.70%, 99.98%) 0.02% (0.00%, 0.19%) 

3.16 x 106 99.93% (99.78%, 99.99%) 0.04% (0.00%, 0.41%) 

1 x 107 99.95% (99.86%, 99.99%) 0.09% (0.00%, 0.97%) 

3.16 x 107 99.95% (99.90%, 99.99%) 0.20% (0.00%, 1.81%) 

1 x 108 99.96% (99.93%, 100%) 0.45% (0.00%, 2.94%) 

3.16 x 108 99.97% (99.95%, 100%) 1.19% (0.00%, 5.24%) 

1 x 109 99.98% (99.96%, 100%) 2.29% (0.00%, 10.06%) 

3.16 x 109 99.99% (99.97%, 100%) 8.59% (0.10%, 42.98%) 

1 x 1010 100% (99.98%, 100%) 43.15% (5.55%, 86.92%) 

3.16 x 1010 100% (> 99.99%, 100%) 85.13% (36.41%, 96.46%) 

1 x 1011 100% (> 99.99%, 100%) 97.23% (72.09%, 100%) 

3.16 x 1011 100% (100%, 100%) 100% (94.14%, 100%) 

1 x 1012 100% (100%, 100%) 100% (100%, 100%) 

a Reported as the median (50th percentile), with the 5th and 95th percentiles in parentheses. 

b Reported as the median (50th percentile), with the 5th and 95th percentiles in parentheses. 


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Federal Register / Vol. 73, No. 26 / Thursday, February 7, 2008 / Notices 7307 

TABLE 3.—OUTPUT FROM THE MODEL IN THE FDA/FSIS LMRA NEONATAL POPULATION

Dose (cfu/serving) Estimated Servings (Cumulative Percentage)a Estimated Illnesses (Cumulative Percentage)b

0 97.90% (94.56%, 98.74%) 0.00% (0.00%, < 0.01%) 

1 x 10 4 97.91% (94.57%, 98.75%) 0.00% (0.00%, < 0.01%) 

3.16 x 10 4 97.92% (94.58%, 98.77%) 0.00% (0.00%, < 0.01%) 

1 x 10 3 97.94% (94.59%, 98.79%) 0.00% (0.00%, < 0.01%) 

3.16 x 10 3 97.96% (94.61%, 98.80%) 0.00% (0.00%, < 0.01%) 

1 x 10 2 97.98% (94.62%, 98.81%) 0.00% (0.00%, < 0.01%) 

3.16 x 10 2 98.00% (94.64%, 98.83%) 0.00% (0.00%, < 0.01%) 

0.1 98.03% (94.66%, 98.85%) 0.00% (0.00%, < 0.01%) 

0.32 98.08% (94.72%, 98.90%) 0.00% (0.00%, < 0.01%) 

1 98.33% (94.97%, 99.07%) 0.00% (0.00%, < 0.01%) 

3.16 98.68% (95.57%, 99.33%) 0.00% (0.00%, < 0.01%) 

10 99.01% (96.31%, 99.52%) 0.00% (0.00%, < 0.01%) 

31.6 99.24% (97.01%, 99.67%) 0.00% (0.00%, < 0.01%) 

100 99.43% (97.63%, 99.78%) 0.00% (0.00%, < 0.01%) 

316 99.57% (98.11%, 99.84%) < 0.01% (0.00%, < 0.01%) 

1000 99.67% (98.52%, 99.89%) < 0.01% (0.00%, < 0.01%) 

3162 99.75% (98.85%, 99.92%) < 0.01% (0.00%, 0.01%) 

10000 99.81% (99.11%, 99.95%) < 0.01% (0.00%, 0.03%) 

3.16 x 104 99.85% (99.32%, 99.96%) < 0.01% (0.00%, 0.06%) 

1 x 105 99.88% (99.48%, 99.97%) < 0.01% (0.00%, 0.15%) 

3.16 x 105 99.90% (99.62%, 99.98%) 0.01% (0.00%, 0.35%) 

1 x 106 99.92% (99.71%, 99.98%) 0.02% (0.00%, 0.71%) 

3.16 x 106 99.94% (99.79%, 99.99%) 0.06% (0.00%, 1.53%) 

1 x 107 99.95% (99.86%, 99.99%) 0.13% (0.00%, 3.26%) 

3.16 x 107 99.96% (99.91%, 99.99%) 0.27% (0.00%, 5.81%) 

1 x 108 99.97% (99.94%, 99.99%) 0.61% (< 0.01%, 8.72%) 

3.16 x 108 99.97% (99.95%, > 99.99%) 1.49% (0.02%, 13.16%) 

1 x 109 99.98% (99.96%, > 99.99%) 2.96% (0.19%, 20.08%) 

3.16 x 109 99.99% (99.97%, > 99.99%) 11.09% (0.96%, 51.41%) 

1 x 1010 ≤ 99.99% (99.98%, > 99.99%) 52.05% (11.25%, 90.05%) 

3.16 x 1010 > 99.99% (> 99.99%, 100%) 89.24% (56.05%, 97.60%) 

1 x 1011 100% (> 99.99%, 100%) 98.07% (88.20%, 100%) 

3.16 x 1011 100% (100%, 100%) 100% (96.51%, 100%) 

1 x 1012 100% (100%, 100%) 100% (100%, 100%) 

a Reported as the median (50th percentile), with the 5th and 95th percentiles in parentheses. 

b Reported as the median (50th percentile), with the 5th and 95th percentiles in parentheses. 


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7308 Federal Register / Vol. 73, No. 26 / Thursday, February 7, 2008 / Notices 

TABLE 4.—OUTPUT FROM THE MODEL IN THE FDA/FSIS LMRA TOTAL POPULATION

Dose (cfu/serving) Estimated Servings (Cumulative Percentage) Estimated Illnesses (Cumulative Percentage) 

0 97.85% (94.02%, 98.69%) 0.00% (0.00%, < 0.01%) 

1 x 10 4 97.86% (94.03%, 98.71%) 0.00% (0.00%, < 0.01%) 

3.16 x 10 4 97.87% (94.05%, 98.72%) 0.00% (0.00%, < 0.01%) 

1 x 10 3 97.89% (94.06%, 98.74%) 0.00% (0.00%, < 0.01%) 

3.16 x 10 3 97.91% (94.08%, 98.75%) 0.00% (0.00%, < 0.01%) 

1 x 10 2 97.92% (94.09%, 98.77%) 0.00% (0.00%, < 0.01%) 

3.16 x 10 2 97.93% (94.11%, 98.78%) 0.00% (0.00%, < 0.01%) 

0.1 97.96% (94.14%, 98.80%) 0.00% (0.00%, < 0.01%) 

0.32 98.01% (94.20%, 98.85%) 0.00% (0.00%, < 0.01%) 

1 98.27% (94.44%, 99.04%) 0.00% (0.00%, < 0.01%) 

3.16 98.65% (95.11%, 99.30%) 0.00% (0.00%, < 0.01%) 

10 98.98% (95.92%, 99.51%) 0.00% (0.00%, < 0.01%) 

31.6 99.23% (96.67%, 99.67%) 0.00% (0.00%, < 0.01%) 

100 99.42% (97.36%, 99.77%) 0.00% (0.00%, < 0.01%) 

316 99.56% (97.89%, 99.85%) < 0.01% (0.00%, < 0.01%) 

1000 99.67% (98.35%, 99.89%) < 0.01% (0.00%, 0.01%) 

3162 99.75% (98.73%, 99.92%) < 0.01% (0.00%, 0.01%) 

10000 99.80% (99.01%, 99.95%) < 0.01% (0.00%, 0.02%) 

3.16 x 104 99.85% (99.25%, 99.96%) < 0.01% (0.00%, 0.04%) 

1 x 105 99.88% (99.43%, 99.97%) < 0.01% (0.00%, 0.08%) 

3.16 x 105 99.90% (99.58%, 99.98%) 0.01% (0.00%, 0.14%) 

1 x 106 99.92% (99.69%, 99.98%) 0.02% (0.00%, 0.29%) 

3.16 x 106 99.94% (99.77%, 99.99%) 0.05% (0.00%, 0.66%) 

1 x 107 99.95% (99.85%, 99.99%) 0.12% (0.00%, 1.64%) 

3.16 x 107 99.96% (99.91%, 99.99%) 0.25% (0.00%, 2.75%) 

1 x 108 99.97% (99.93%, 99.99%) 0.55% (< 0.01%, 4.20%) 

3.16 x 108 99.97% (99.95%, > 99.99%) 1.39% (< 0.01%, 7.33%) 

1 x 109 99.98% (99.96%, > 99.99%) 2.73% (0.05%, 12.32%) 

3.16 x 109 99.99% (99.97%, > 99.99%) 9.94% (0.58%, 44.23%) 

1 x 1010 ≤ 99.99% (99.98%, > 99.99%) 45.52% (8.21%, 86.55%) 

3.16 x 1010 > 99.99% (> 99.99%, 100%) 85.45% (44.90%, 96.46%) 

1 x 1011 100% (> 99.99%, 100%) 97.18% (77.62%, 100%) 

3.16 x 1011 100% (100%, 100%) 100% (94.01%, 100%) 

1 x 1012 100% (100%, 100%) 100% (100%, 100.) 

a Reported as the median (50th percentile), with the 5th and 95th percentiles in parentheses. 

b Reported as the median (50th percentile), with the 5th and 95th percentiles in parentheses. 


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Federal Register / Vol. 73, No. 26 / Thursday, February 7, 2008 / Notices 7309 

TABLE 5.—ANNUAL INCIDENCE OF LISTERIOSIS IN THE NATIONAL POPULATION ESTIMATED USING THE MODEL IN THE FDA/ 

FSIS LMRA (50TH PERCENTILE) 

Dose (cfu/serving) Corresponding Level (cfu/g) Assuming a 100 g serving 

Estimated Number of Cases of Listeriosis Per Year (50th Percentile) 

Elderly Intermediate-Age Neonatal Total Population 

0 0 0 0 0 0 

1 0.01 0.0 0.0 0.0 0.0 

10 0.1 0.0 0.0 0.0 0.0 

100 1 0.0 0.0 0.0 0.0 

316 3.16 0.0 0.0 0.0 0.0 

1,000 10 0.0 0.0 0.0 0.0 

3,160 31.6 0.0 0.0 0.0 0.0 

10,000 100 0.0 0.0 0.0 0.0 

31,600 316 0.0 0.0 0.0 0.0 

100,000 1,000 0.0 0.0 0.0 0.1 

316,000 3,160 0.1 0.0 0.0 0.1 

1,000,000 104 0.1 0.1 0.0 0.3 

3,160,000 31,600 0.4 0.2 0.1 0.6 

107 105 0.8 0.4 0.2 1.4 

3.16 x 107 316,000 1.5 0.7 0.3 2.6 

108 106 3.6 1.8 0.7 6.3 

3.16 x 108 3.16 x 106 9.9 5.2 1.9 17.5 

109 107 16.7 7.7 3.2 27.8 

3.16 x 109 3.16 x 107 86.0 44.2 17.6 149.8 

1010 108 411.1 242.6 88.5 739.4 

3.16 x 1010 3.16 x 108 458.3 294.7 80.3 829.7 

1011 109 138.5 84.9 19.1 243.8 

3.16 x 1011 3.16 109 32.1 19.5 4.2 58.5 

1012 1010 0.0 0.0 0.0 0.0 

Total 1159 702 216 2078 

Appendix 2.—Modeled Percentage 

Distribution of Food Servings 

Contaminated with L. monocytogenes at 

Time of Consumption for Foods That 

Do Not Support Growth 

Table III–16 in the FDA/FSIS LmRA 

(see Section III, p. 73) reports the 

modeled distribution of L. 

monocytogenes at time of consumption 

in ‘‘dose bins’’ that combine the 

distribution of L. monocytogenes for 

several doses. For example, in Table III–

16 the column labeled 1–1,000 cfu/ 

serving includes the combined modeled 

distributions for doses of 1, 3, 10, 32, 

100, 316, and 1,000 cfu/serving. To 

provide additional information about 

the distribution at time of consumption 

of L. monocytogenes in servings of foods 

that generally do not support its growth, 

in Table 6 we break the modeled 

distributions from Table III–16 into 

more discrete dose bins within the range 

of 1 cfu/serving to 1,000,000 cfu/ 

serving. In addition, in Table 6 we 

include a contamination level, in cfu/g, 

that would be associated with each 

given dose if there was a uniform 

serving size of 100 g. 


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7310 Federal Register / Vol. 73, No. 26 / Thursday, February 7, 2008 / Notices 

TABLE 6.—MODELED PERCENTAGE DISTRIBUTION OF FOOD SERVINGS CONTAMINATED WITH L. monocytogenes AT TIME

OF CONSUMPTION FOR FOODS THAT DO NOT SUPPORT GROWTH

Food Category 

Median Percentage of Food Servings Contaminated with L. monocytogenes at: 

1 cfu/serving 

(0.01 cfu/ga) 

> 1 - 10 cfu/ 

servingb (> 

0.01-0.1 cfu/g) 

> 10 - 100 cfu/ 

servingc (> 0.1 

- 1 cfu/g) 

100 to 103 cfu/ 

servingd (> 1 - 

10 cfu/g) 

> 103 - 104

cfu/servinge (> 

10 - 100 cfu/g) 

> 104 - 105

cfu/servingf (> 

100 - 1,000 

cfu/g) 

> 105 - 106

cfu/servingg (> 

103 - 104 cfu/ 

g) 

Seafood 

Preserved Fish 0.9 (<0.1, 3.1)h 2.1 (0.1, 8.0) 1.2 (<0.1, 5.8) 0.6 (<0.1, 4.0) 0.2 (<0.1, 2.3) 0.1 (<0.1, 1.2) 0.1 (<0.1, 

<0.7) 

Dairy 

Hard Cheese <0.1 (<0.1, .5) <0.1 (<0.1, 

0.6) 

<0.1 (<0.1, 

0.4) 

<0.1 (<0.1, 

0.2) 

<0.1 (<0.1, 

0.1) 

<0.1 (<0.1, 

<0.1) 

<0.1 (<0.1, 

<0.1) 

Processed Cheese 0.2 (<0.1, 0.6) 0.3 (<0.1, 0.9) 0.1 (<0.1, 0.4) 0.1 (<0.1, 0.2) <0.1 (<0.1, 

0.1) 

<0.1 (<0.1, 

0.1) 

<0.1 (<0.1, 

<0.1) 

Ice Cream/Frozen 

Dairy 

0.1 (<0.1, 0.2) 0.2 (0.1, 0.3) 0.1 (<0.1, 0.1) <0.1 (<0.1, 

<0.1) 

<0.1 (<0.1, 

<0.1) 

<0.1 (<0.1, 

<0.1) 

<0.1 (<0.1, 

<0.1) 

Cultured Milk Products 0.1 (<0.1, 1.1) 0.2 (<0.1, 1.5) 0.1 (<0.1, 0.8) <0.1 (<0.1, 

0.4) 

<0.1 (<0.1, 

0.2) 

<0.1 (<0.1, 

0.1) 

<0.1 (<0.1, 

<0.1) 

Deli-type salads 1.9 (0.7, 3.7) 3.0 (0.9, 5.2) 1.1 (0.3, 1.9) 0.3 (0.1, 0.7) 0.1 (<0.1, 0.2) <0.1 (<0.1, 

0.1) 

<0.1 (<0.1, 

<0.1) 

aAssumes a uniform serving size of 100 g. 

b Includes combined estimates for doses of 3.16 and 10 cfu. 

c Includes combined estimates for doses of 31.6 and 100 cfu. 

d Includes combined estimates for doses of 316 and 1,000 cfu. 

e Includes combined estimates for doses of 3160 and 10,000 cfu. 

f Includes combined estimates for doses of 31,600 and 100,000 cfu. 

g Includes combined estimates for doses of 316,000 and 1,000,000 cfu. 

h Numbers in parentheses denote the 5th and 95th percentile uncertainty levels, respectively. 

Dated: January 23, 2008. 

Margaret O’K. Glavin, 

Associate Commissioner for Regulatory 

Affairs. 

[FR Doc. 08–549 Filed 2–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Radiological Devices Panel of the 

Medical Devices Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Radiological 

Devices Panel of the Medical Devices 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on March 4, 2008, from 8 a.m. to 

5:30 p.m., and March 5, 2008, from 8 

a.m. to 5 p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, Salons A, B, and C, 

620 Perry Pkwy., Gaithersburg, MD. 

Contact Person: Nancy Wersto, Center 

for Devices and Radiological Health 

(HFZ–470), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–3666, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512526. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On March 4 and 5, 2008, the 

committee intends to discuss and make 

recommendations about computer aided 

detection and diagnosis (CAD) devices 

for radiological images, e.g., 

mammograms, chest x-rays, and 

computed tomography (CT) images of 

the lungs or colon. There will be a 

general discussion focusing on the 

general methodologies for CAD, 

including how CAD devices are used in 

clinical decision-making, how the 

devices are tested, and the information 

needed to properly assess their safety 

and effectiveness. The general 

discussion will be followed by specific 

discussions related to mammography 

CAD devices, colon CAD devices, and 

lung CAD devices. These discussions 

will include how the different types of 

CAD devices are used and the literature 

published regarding these devices, with 

focus on testing issues related to the 

different devices. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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


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