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February 6, 2008
Current FDA Activities Related to the Listeria monocytogenes
Action Plan
Objective
1: Develop and revise guidance for processors that manufacture or prepare
ready-to-eat foods and develop or revise guidance for retail and food service
and institutional establishments.
- On February 6, 2008, FDA
announced that was issuing for public comment a draft "Guidance for
Industry: Control of Listeria monocytogenes in Refrigerated or Frozen
Ready-To-Eat Foods".
- On March 12, 2007, FDA issued draft final guidance for enhancing
the safety of the production of fresh-cut produce,
"Guide to Minimize Microbial
Safety Hazards of Fresh Fruits and Vegetables."
- FDA, in cooperation with Michigan State University, will continue
to examine the levels of Listeria monocytogenes (Lm) transferred in retail food establishments.
Specifically, the project is to study transfer rates between foods contaminated
with Lm and food contact surfaces (i.e., slicing machines, knives, spoons,
etc.). This was a grant awarded through the Center for Food Safety and
Applied Nutrition's (CFSAN) Office of Science collaborative grant process in
2002. The researchers are writing a paper for peer review. These results should
be considered as we move forward and discuss appropriate intervention
strategies at retail.
- FDA reviewed the Model Food Code to determine if provisions
that address preventive controls, such as approved source, date marking, and
cold-holding times and temperatures, warrant revision.
- The
2005 Food Code was modified in Section 3-501.17 to amend the date marking provisions to include exemptions
from date marking of foods prepared and packaged by a food processing plant
inspected by a regulatory authority. The food products exempted included
certain classes of cheeses and deli salads and other
exemptions based on the Lm Risk Assessment (Conference for Food Protection
numbered CFP 2004-III-006; 2004-III-14; 2004-III-017).
- In
the Supplement to the 2005 Food Code, released October 5, 2007, an allowance
was removed that had permitted the cold holding of potentially hazardous foods
at temperatures up to 7°C (45°F) (rather than the prevailing maximum of 5°C
(41°F)) in existing refrigeration equipment under certain conditions.
- The Conference for Food Protection developed a guidance document
detailing the use of targeted sanitation procedures to assist in the control
of Lm entitled "Voluntary Guidelines of Sanitation Practices
Standard Operating Procedures and Good Retail Practices To Minimize
Contamination and Growth of Listeria monocytogenes
Within Food Establishments".
- At their 2004 meeting, the Conference for Food Protection (CFP)
accepted two HACCP Manuals developed by FDA and reviewed by the CFP HACCP
Committee. FDA issued these manuals in April 2006 to the retail and food service
industry and state and local regulatory professionals on the use of HACCP
principles to identify and control risk factors contributing to foodborne
illness. These manuals outline the identification and control of risk factors
by industry operators and the use of risk-based inspections by regulators.
Further, many of the intervention strategies outlined in the Manuals pertain to
the control of Lm and other pathogens. The manuals have been widely
disseminated to state and local regulatory officials and industry. The two Manuals
are:
- FDA will promote the inclusion of Lm control strategies in future
guidance documents that address food processing at retail operations (e.g.,
smoked seafood, specialty meats).
- FDA representatives worked with the Association of Food and Drug
Officials (AFDO), the University of Florida, and Florida A&M University to develop guidance for food processing at retail. These guidance documents have
been finalized and released. The draft guidance documents were specifically
reviewed to assess the risk of Lm and the organism was identified as a hazard
in a number of these guidance documents (e.g., Smoked Seafood, Cured and Hot
Smoked Sausage).
Objective
2: Develop and deliver training and technical assistance for industry and food
safety regulatory employees.
- The
2006 Conference for Food Protection hosted a 1-day workshop on "Interventions
for Listeria monocytogenes in Retail Food
Establishments". The
workshop topics included:
- The
introduction of new and emerging science related to Listeria monocytogenes
- Factors
that affect growth, survival, and control of Listeria monocytogenes
- New
studies that provided information relative to the incidence of consumption of Listeria
monocytogenes in retail food operations as compared to food manufacturing
establishments
- The
control of Listeria monocytogenes at food manufacturing and within a
retail food establishment environment
- Presentation
of guidance documents for control of Listeria monocytogenes from the CFP
Committee and from the Food Marketing Institute.
- Listeria monocytogenes Preventative Controls for
Regulators -satellite course under development. Purpose: To review
existing training for regulators and processors on preventive controls and
guidance and to update and develop training for regulators to reduce Lm related
illnesses. Mode: Satellite/web. Satellite course (3 hours in
length) Web course (1 hour in length) Primary Audience: FDA and
state/local regulators of retail food, milk and manufactured food (includes
seafood, except shellfish) operations. Secondary audience: industry.
Objective
3: Enhance consumer and health care provider information and education efforts.
- Educational programs about the risks of listeriosis have taken
place through the media, health professional organizations, contacts with
authors of books on pregnancy, and educational programs for special at-risk
groups including seniors and pregnant women. During 2003-2005, CFSAN
participated in a program of health fairs utilizing Hispanic radio and
television. Health messages on the risk of listeriosis are delivered over the
Spanish language radio and television programs and information is distributed
at health fairs in Hispanic areas. A further specialized campaign targeted to
the Latino community on the concerns of queso fresco cheese was launched in the
spring of 2005. The program utilizes the Hispanic media and community outreach
workers (promotoras) to get the message out. A public health educational campaign
by the public-private Partnership for Food Safety Education is underway to
advise consumers to keep their refrigerators at 40 degrees Fahrenheit to
prevent foodborne illness, including listeriosis. Information has been released
through the media and is also being disseminated through grocery stores where
refrigerator thermometers are promoted.
Objective
4: Review, redirect, and revise enforcement and regulatory strategies including
microbial product sampling and analytical methods.
- On February 6, 2008, FDA announced that it was
issuing for public comment a draft Compliance Policy Guide (CPG) that, when
finalized, would set two risk-based limits for L. monocytogenes in Ready-To-Eat
(RTE) foods. FDA's enforcement policy for RTE foods that support the growth of L.
monocytogenes would remain unchanged. FDA would continue to consider legal
action, on a case-by-case basis, if L. monocytogenes is detected in a
RTE food that supports growth based on FDA's analytical method, which can
detect 1 cell per 25 grams (g) of food (equivalent to 0.04 cells/g). However,
in light of the Risk Assessment, FDA would now consider legal action, on a case by case basis, if L. monocytogenes
is present in a RTE food that does not support its growth at or above 100
cells/g. This guidance would further protect the public health by more sharply
focusing FDA's resources on areas of greatest risk.
- FDA
has announced a public meeting, to be held March
28, 2008 in College Park, MD, to discuss the draft CPG to set two
risk-based limits for L. monocytogenes in RTE food.
- The National Advisory Committee on Microbiological Criteria for
Foods (NACMCF) adopted these two documents on August 27, 2004 - 1) Requisite
Scientific Parameters for Establishing the Equivalence of Alternative Methods
of Pasteurization and 2) Considerations for Establishing Safety-Based
Consume-By Date Labels for Refrigerated Ready-to-Eat Foods.
- FDA's Bacteriological Analytical Manual (BAM) which presents the
agency's preferred laboratory procedures for microbiological analyses of foods
and cosmetics is updating manual to include quantitative method for Lm.
- On December 24, 2003, Hogan & Hartson, L.L.P filed a Citizens'
Petition on behalf of a coalition of fifteen leading trade associations
pursuant to sections 402(a)(1) and 701(a) of the Federal Food, Drug, and
Cosmetic Act (FFDCA) and 21 C.F.R. § 109.4. The Petition requested that FDA
amend 21 C.F.R. Part 109 to establish a regulatory limit for Listeria monocytogenes
of 100 colony forming units per gram (CFU/g) in foods that do not support
growth of the microorganism. On May 24, 2004, FDA published a notice the
Federal Register announcing the availability of the Petition and requested
comments until August 9, 2004. The Agency is in the process of responding to
the Citizens' Petition.
Objective
5: Enhance Disease Surveillance and Outbreak Response
- FDA participates in PulseNet, a national molecular subtyping
network for foodborne disease surveillance, which was established by the
Centers for Disease Control and Prevention (CDC) in 1996. Food and
environmental bacterial pathogens, including Lm, are subtyped and characterized
using pulsed-field gel electrophoresis (PFGE) by FDA Office of Regulatory
Affairs (ORA) laboratories and the molecular patterns are submitted by FDA
CFSAN to PulseNet. These patterns are routinely compared to the PulseNet
database that primarily consists of patterns from clinical isolates. Patterns
from the food and clinical isolates that "match" suggest a potential
link and are further investigated to determine if there is an epidemiological
association in a foodborne outbreak. FDA CFSAN routinely monitors the PulseNet
listserv as a possible early alert to a foodborne outbreak.
- FDA CFSAN and FDA's ORA are more actively conducting follow-up
investigations when there is a match between a food and clinical PFGE pattern
involving single cases of listeriosis to determine if there is an
epidemiological link with an FDA regulated product.
- FDA CFSAN has a staff person located at CDC's Food Safety office
in Atlanta, Georgia. This on-site relationship facilitates communication and
provides early alerts to foodborne outbreaks involving FDA regulated products.
- FoodNet completed a manuscript based on a 3 year case/control
study for risk factors associated with Lm infection. On multivariate analysis
in the manuscript, melons eaten outside the home and hummus eaten outside the
home were risk factors. The manuscript was published in January, 2007 issue of
Clinical Infectious Diseases.
- The original Healthy People (HP) 2010 baseline line (1997) for Lm
was an incidence of 0.5 cases per 100,000, and the 10 year target was a 50%
reduction to 0.25 cases per 100,000. The National Food Safety Strategic Plan
baseline (1997) for Lm was an incidence of 0.5 cases per 100,000 and the 5 year
goal was a 50% reduction to 0.25 cases per 100,000. - After re-analysis of the FoodNet data, the baselines and targets for HP2010 for Lm have been
revised: The revised HP2010 baseline line (1997) for Lm is an incidence of 0.47
cases per 100,000, and the 10 year target is a 50% reduction to 0.24 cases per
100,000.
- Year
followed by the incidence (per 100,000) of Listeria monocytogenes infections identified in FoodNet:
- Baseline 1997 (0.47)
- 1998 (0.55)
- 1999 (0.46)
- 2000 (0.34)
- 2001( 0.27),
- 2002 (0.26)
- 2003 (0.33)
- 2004 (0.27)
- 2005 (0.30)
- 2006 (0.31)
- 2010 objective (0.24)
- Incidence
in 2002 was close to the 2010 objective and then increased slightly to a
plateau that exceeds the objective by approximately 0.05 cases/100,000/year.
Efforts are necessary to clarify the most important factors for the remaining
unacceptable risk so additional focused interventions can be instituted.
- FoodNet has tested and implemented a new Lm surveillance form
which is applied to each case of Lm occurring in FoodNet sites. Information on
the form obtained in prospective interviews includes food consumption
histories. This information is used to help rapidly identify food vehicles in
Lm outbreaks detected through PulseNet. Many states other than FoodNet sites
are also using this new surveillance form. In 2004-2006, the new case report forms were
completed for 82% of listeriosis cases reported to FoodNet. Of these cases,
40% consumed hot dogs in the month before onset of illness, 38% consumed turkey
deli meat, and 10% consumed Mexican-style soft cheese.
Objective
6: Coordinate research activities to refine the Risk Assessment, enhance
preventative controls, and support regulatory, enforcement, and educational activities.
- Use the Lm risk assessment to focus Lm coverage in field programs
namely to focus on high risk products as determined by the risk assessment.
- Of the 57 Mexican personal cheese importations tested from
September 2 to October 2, 2003 during an FDA blitz at the Mexican border;
39(68%) of the 57 were determined to be made from raw milk, 32(56%) of the 57
were positive for generic Escherichia coli, 32(56%) of the 57
were positive for Staphylococcus aureus, 7(12%) of the 57 were positive
for Salmonella spp., and 5(8%) of the 57 were positive for Lm. All
isolations were confirmed by FDA laboratory analysis.
- Docket No. 2005N-0065. Published 3-4-05. Notice for request for
comments and for scientific data and information concerning foodborne Listeria
monocytogenes in smoked finfish, and evaluation of Food Code provisions that address preventive controls for Lm in retail and foodservice
establishments. Submitted comments are in review at FDA/CFSAN.
- Two research projects are being completed at CFSAN. The first
examines the competition between Lm and spoilage microorganisms in both pure
cultures in broth and in foods. This will help explain the behavioral
interactivity between spoilage flora and Lm. The second modeled the lag
phase of Lm cells that are in different physiological states (i.e., exponential
growth, stationary, desiccated, frozen) when placed in broth under differing
headspace carbon dioxide levels. This research will assist in the understanding
of Lm as it relates to the modified atmosphere packaging area. The manuscript
for the second project has been submitted to a scientific journal for
publication
- Current Lm research at FDA's National Center for Food Safety and
Technology (NCFST). Recovery of Listeria monocytogenes from
environmental swabs (transport media). Same day identification of Lm using
Pathatrix separation and concentration and real-time PCR.
- Joint Institute of Food Safety and Applied Nutrition (JIFSAN)
collaborative work with University of Maryland Eastern Shore (UMES) is
completed. Manuscripts were recently published (Abou-Zeid, K.A., Yoon, K.S., Oscar, T.P.,
Schwarz, J.G., Hashem, F.M. and Whiting, R.C. 2007. Survival and growth of Listeria
monocytogenes in broth as a function of temperature, pH, and potassium
lactate and sodium diacetate concentrations. J. Food Protection 70(11):
2620-2625) and submitted for publication (Abou-Zeid, K.A., Yoon, K.S., Oscar,
T.P. and Whiting, R.C. Development and validation of a predictive model for Listeria
monocytogenes Scott A as a function of temperature, pH and lactate and
diacetate mixture. International J. Food Microbiology (submitted)).
- Supplemental quantitative risk assessment for Lm in smoked seafood
to determine the steps in its production, distribution, sale, and use that
contributes to the risk of listeriosis and the potential risk reduction that
can be controlled by different mitigation strategies
- Docket
No. 2007-0432. Published 11-28-07. Notice for request for comments and for
scientific data and information concerning a risk assessment of the public
health impact from foodborne Listeria Monocytogenes in soft-ripened
cheese. FDA and Health Canada have agreed to develop a model for the
production of soft-ripened cheese that will evaluate the public health impact
of factors such as the microbiological status of milk used in cheese
production, the impact of various cheese manufacturing steps, conditions during
distribution and storage, and cross contamination during processing and
handling. Submitted comments are in review at FDA/CFSAN.
- FDA/CFSAN is developing a risk profile for Lm in fresh-cut
vegetables. The risk profile will provide a review of the available information
and identification of major knowledge gaps for the purpose of research planning
and priority setting. This information will provide background knowledge needed
by Agency risk managers to identify new approaches to controlling this
pathogenic foodborne bacterium, and to develop effective food safety guidance
for the industry and consumers.
- FDA/CFSAN is in the process of developing a risk profile for
pathogens in cheeses to determine potential strategies for risk reduction with
these products.
Quantitative Assessment of Relative Risk to Public Health
from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods
FDA Food Code
Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods February 7, 2008
Draft Compliance Policy Guide Sec. 555.320
Listeria monocytogenes; Notice of Public Meeting Federal Register
Notice, February 7, 2008
Draft Compliance Policy Guide Sec. 555.320
Listeria monocytogenes; Availability Federal Register
Notice, February 7, 2008