Food and Drug Administration, HHS.
Notice; request for comments and for scientific data and information.
The Food and Drug Administration (FDA) is requesting comments and scientific data and information that would assist the agency in its plans to conduct a risk assessment for
Submit comments and scientific data and information by January 28, 2008.
Submit written comments and scientific data and information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments, data, and information to either
Steven M. Gendel, Center for Food Safety and Applied Nutrition (HFS–06), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2290.
The Department of Health and Human Services'
The 2003
The United States (U.S.) and Canada have experienced sporadic illnesses and outbreaks of listeriosis associated with the consumption of cheese. In both countries, there is a strong epidemiological correlation between consumption of soft cheese and listeriosis. For example, a 1985 outbreak of listeriosis associated with the consumption of a Mexican-style soft cheese resulted in 142 illnesses in Los Angeles (Ref. 4), a similar outbreak in 2000 in North Carolina resulted in 12 illnesses, and a 2002 soft cheese-
As a followup to the
Specifically, the objectives of the
FDA requests comments on the risk assessment approach outlined previously in this document and the submission of data and information relevant to the risk assessment. The agency specifically requests information for the following:
(1) Characteristics of the manufacturing and marketing processes for soft-ripened cheese including:
• The number of large and small (artisan) facilities producing soft-ripened cheese in the U.S. and Canada, and
• The amount of soft-ripened cheese produced each year in the U.S. and Canada by large and small facilities including information on different sizes of cheese that are produced and the relative production volumes for these sizes.
(2) Factors that influence the levels of
• On-farm practices that influence the frequency and level of
•
• Bulk tank sizes and mixing practices used by large and small manufacturers,
• Growth of
• Conditions of storage (temperatures and times) encountered by milk prior to cheese manufacture, and
• The identity and effectiveness of processes other than pasteurization used to treat raw milk prior to cheese making.
(3) Factors that influence the levels of
• Changes in
• Conditions of storage (temperatures and times) encountered during post-production holding at the producer; and
• Pathways for transfer of
(4) Factors that influence the levels of
• Levels and/or frequencies of
• The conditions (temperature and time) encountered during transport and storage throughout the distribution process, including at retail, in the U.S. and Canada.
(5) Factors the influence the levels of
• Storage conditions (temperature and times) encountered in consumers' homes, and
• Consumption patterns for soft cheese (including serving size and frequency) in the U.S. and Canada.
(6) The identity and effectiveness of control measures or interventions to reduce levels and frequency of
(7) Any other data related to the occurrence, growth, and control of
Interested persons should submit comments, scientific data, and information to the Division of Dockets Management (see
The following references are on display in the Division of Dockets Management (see
1. U.S. Department of Health and Human Services,
2. U.S. Department of Health and Human Services and U.S. Department of Agriculture/Food Safety and Inspection Service, “Quantitative Assessment of Relative Risk to Public Health from Foodborne
3. U.S. Department of Health and Human Services, Food and Drug Administration/Centers for Disease Control and Prevention, “Reducing the Risk of
4. Linnan et al., “Epidemic Listeriosis Associated With Mexican-Style Cheese,”
5. Gaulin et al., “First Documented Outbreak of