6/11/2014 2012 > Finger Lakes Farmstead Cheese Company LLC 10/23/12

http://www.fda.gov/iceci/enforcementactions/warningletters/2012/ucm325714.htm 1/2
Finger Lakes Farmstead Cheese Company LLC 10/23/12

Department of Health and Human Services
Public Health Service
Food and Drug Administration

New York District
158-15 Liberty Avenue
Jamaica, NY 11433


October 23, 2012
WARNING LETTER NYK-2013-1
VIA UNITED PARCEL SERVICE OVERNIGHT MAIL
Nancy Taber Richards, Co-owner
Finger Lakes Farmstead Cheese Company LLC
5491 Bergen Road
Trumansburg, New York 14886-9674
Dear Ms. Taber Richards:
The U.S. Food and Drug Administration (FDA) inspected your cheese processing facility located at 5491 Trumansburg, New York from June 5 -
21, 2012, and again from July 9 - 12, 2012. On June 5, 2012, FDA collected environmental samples from multiple areas in your processing
facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human
pathogen. In addition, during the July inspection, FDA investigators observed serious violations of the Current Good Manufacturing Practice
(CGMP) regulation for food, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. These violations and our findings of L.
monocytogenes in your processing facility cause your ready-to-eat cheese products to be adulterated within the meaning of section 402(a)
(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)] in that they were prepared, packed, or held under
insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health.
You can find the Act and the CGMP regulation for foods through links in FDA's home page at www.fda.gov
1
.
On June 19, 2012, FDA also collected finished product sample 760809 of your Bianco Brie-style Cheese. Laboratory analyses confirmed the
presence of Listeria monocytogenes rendering the cheese adulterated within the meaning of section 402(a)(1) [21 U.S.C. 342(a)(1)] of the
Act, in that it contains a poisonous or deleterious substance which may render it injurious to health. We acknowledge your statement that
you did not distribute this lot of Bianco Brie-Style Cheese, and that the affected product was destroyed.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities without
proper controls, where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening
illness called listeriosis, an atypical foodborne illness of major public health concern due to the severity of the disease, its high case-fatality
rate, long incubation, and predilection for individuals with underlying conditions.
Five environmental swabs collected on June 5, 2012 from your facility tested positive for L. monocytogenes. These swabs were collected
from: inside of a brine tank (right side); cheese rack in the aging cooler; cheese board in the aging cooler; outside of a brine tank (left side);
and a processing room floor drain.
Analysis using Pulsed Field Gel Electrophoresis ("PFGE") showed that the L. monocytogenes isolates obtained from the FDA environmental
samples collected on June 5, 2012, were indistinguishable from each other by both a primary and secondary enzyme. When a PFGE pattern of
an isolate is indistinguishable from the pattern of another isolate from a common source, it is highly likely that two isolates are the same
strain of L. monocytogenes. These PFGE results suggest that L. monocytogenes may have been transported throughout your facility and
established niche areas.
On June 19, 2012, the FDA informed your firm of the environmental sampling results. Your firm indicated that you would stop production to
clean and sanitize your facility. During the July 2012 inspection of your facility, an FDA investigator observed the following significant
violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:
1. You failed to clean food-contact surfaces as frequently as necessary to protect against contamination of food as required by 21
CFR 110.35(d). You failed to clean and sanitize all of the wooden boards used to hold your Gouda-style cheese in the large aging cave
even after FDA informed you of positive L. monocytogenes results found on one of these boards.
2. You failed to clean non-food contact surfaces of your facility as frequently as necessary to protect against contamination of food
as required by 21 CFR 110.35(d)(3). You failed to clean any of the metal racks in the large aging cave used to hold the wooden boards
(used to hold cheese) even after FDA informed you of positive L. monocytogenes results found on one of these racks.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance
with the Act and applicable regulations. Failure to implement lasting corrective action of these violations may result in regulatory action
being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from
operating.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working
days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and
prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason
for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation
demonstrating that corrections have been made.
Inspections, Compliance, Enforcement, and Criminal Investigations
Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters 2012
6/11/2014 2012 > Finger Lakes Farmstead Cheese Company LLC 10/23/12
http://www.fda.gov/iceci/enforcementactions/warningletters/2012/ucm325714.htm 2/2
In addition to the charges above, we have the following comments:
On June 19, 2012, FDA also collected finished product sample 758101 of your Schuyler Gouda Cheese. FDA Laboratory
analyses of that sample found high levels (sub #1 = 150 MPN/g, sub #2 = 93 MPN/g) of generic Escherichia coli (E. coli). Generic
E. coli is an indicator of fecal contamination; its presence suggests that your sanitation practices may be inadequate. We
acknowledge that you initiated a voluntary recall of all three varieties of Gouda cheese you produced on the same day as the
Schuyler Gouda that FDA sampled.
Please be advised that FDA has issued draft guidance entitled Guidance for Industry: Control of Listeria monocytogenes in
Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance. You may submit comments on this draft guidance to the agency as
outlined in the document. We have enclosed a copy of the draft guidance for your information, and it is available online at:
http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodprocessinghaccp/ucm073110.htm
2
.
You may wish to take further safety measures, including but not limited to focusing on animal health, hygienic milk collection
and storage, and microbiological criteria (i.e. a maximum acceptable concentration of coliform bacteria). Further, you may wish
to contract with an expert to assist you with implementing a program to eliminate and prevent further product contamination
with organisms that pose threat to the public health.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDAs costs for certain activities, including
reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance
materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-
related costs means all expenses, including administrative expenses, incurred in connection with FDAs arranging, conducting, and evaluating
the results of the re-inspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA
will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The July 2012 inspection noted
in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover
any reinspection-related costs.
Your written response should be sent to Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite
100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 541-
0324 or E-mail at dean.rugnetta@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
District Director
New York District

cc: Jan Beuzekom, Co-owner
Finger Lakes Farmstead Cheese Company LLC
5491 Bergen Road
Trumansburg, New York 14886-9674
cc: Casey McCue
State of New York
Department of Agriculture and Markets
Division of Milk Control and Dairy Services
10B Airline Drive
Albany, NY 12235

Page Last Updated: 12/17/2012
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Email FDA

For Government For Press
Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International
Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health
Professionals FDA Archive
Links on this page:
1. http://www.fda.gov/
2. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodprocessinghaccp/ucm073110.htm
Product Description: 1 Finger Lakes FARMSTEAD CHEESE..., 2013-29 FDA Enf....
2014 Thomson Reuters. No claim to original U.S. Government Works. 1
2013-29 FDA Enf. Rep. 81 (F.D.A.), 2013 WL 3795943
Food and Drug Administration
*1 FDA Enforcement Report
Mixed Classification Food/Cosmetics Event
Event ID 65326
Status Ongoing
Product Type Food/Cosmetics
July 17, 2013
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 31-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone,
Visit
Recalling Firm Finger Lakes Farmstead Cheese Company Llc, Trumansburg, NY, US
Distribution Pattern 1 firm in NY State.
Associated Products
Product Description: 1 Finger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schuyler County, SCHUYLER Gouda
aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES FARMSTEAD CHEESE CO. 5491 BERGEN ROAD
TRUMANBURG, NY 14886. Ingredients: raw milk, rennet, calcium chloride, culures, salt
Code Info under investigation
Classification Class I
Reason for Recall Listeria monocytogenes contamination.
Product Quantity 5 wheels
Recall Number F-1603-2013
Product Description: 2 Finger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schyler County, BIER MECK Gouda,
aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES FARMSTEAD CHEESE CO. 5491 BERGENT ROAD
TRUMANBURG, NY Ingredients: raw milk, rennet, calcium chrloride, cultures, beer, salt
Code Info under investigation
Classification Class II
Product Description: 1 Finger Lakes FARMSTEAD CHEESE..., 2013-29 FDA Enf....
2014 Thomson Reuters. No claim to original U.S. Government Works. 2
Reason for Recall Listeria monocytogenes contamination.
Product Quantity 7 wheels
Recall Number F-1604-2013
2013-29 FDA Enf. Rep. 81 (F.D.A.), 2013 WL 3795943
End of Document 2014 Thomson Reuters. No claim to original U.S. Government Works.
CHEESE PRODUCER ENTERS CONSENT DECREE..., 23 No. 4 FDA...
2014 Thomson Reuters. No claim to original U.S. Government Works. 1
23 No. 4 FDA Enforcement Manual Newsl. 7
FDA Enforcement Manual Newsletter
June, 2014
CHEESE PRODUCER ENTERS CONSENT DECREE FOLLOWING
REPEATED FINDINGS OF LISTERIA, E. COLI CONTAMINATION
Copyright (c) 2014 by Thompson Information Services
A federal district court April 28 entered a consent decree of permanent injunction between a manufacturer and distributor of
raw cow's milk cheeses and the Department of Justice, acting on behalf of the FDA, following multiple findings of pathogen
contamination at the company's Trumansburg, N.Y., facility (United States v. Finger Lakes Farmstead Cheese Co., No. 1:14-
cv-00053-RJA (W.D.N.Y.)).
The consent decree names as defendants Finger Lakes Farmstead Cheese Co. and one of the company's coowners, who had
overall responsibility for and authority over day-to-day operations at the facility.
In a 19-page complaint filed in January 2014 against the company and co-owner, the U.S. attorney for the Western District
of New York outlined a series of FDA inspections beginning in 2012 that confirmed the presence of Listeria monocytogenes
(Listeria) at the facility. According to the complaint, following a four-day agency inspection in June 2012, environmental
samples revealed the presence of Listeria at the facility, including on the wooden boards used to hold cheese. In response, the
defendants initiated cleaning and sanitation of the facility during a two-week shutdown of the facility, but did not commit
to implementing an in-house monitoring program, the complaint alleged.
A follow-up FDA inspection in July 2012 found not only Listeria in the facility, but also Listeria in a sample of Brie and
nonpathogenic Escherichia coli (E. coli) in a sample of Gouda produced there. Following the issuing of a Form FDA 483 List
of Inspectional Observation after that inspection, the co-owner verbally promised to make corrections, but did not submit a
written response to the Form FDA 483, according to the complaint. In addition, the company initiated a voluntary recall of
Gouda produced at the facility on a particular date. The company determined that no Brie produced there that was represented
by the positive sample was available for recall because the lot had already been destroyed due to discoloration.
Warning Letter
The FDA issued a Warning Letter to the co-owner in October 2012 citing the unsanitary conditions observed during the two
inspections and the sampling results. The co-owner responded to the Warning Letter just over a month later. She listed various
corrective actions taken in response to the alleged violations and said that she was in touch with consultants with the goal of
eliminating or minimizing any potential source of contamination.
Nevertheless, an additional two-day FDA inspection conducted in April and June 2013 again found Listeria and E. coli at the
facility and in the cheese stored there. Among other observations, the Form FDA 483 issued after the 2013 inspection again
noted that the wooden boards used by defendants were problematic because they could not be adequately cleaned and sanitized.
The co-owner responded to the 483, explaining her planned corrective actions. However, the complaint alleged, a follow-up
FDA inspection in August 2013 revealed that necessary corrections had not been implemented. Specifically, cheese production
had continued and no environmental or finished product testing had been completed. Indeed, no plan for such sampling had
been developed and no procedures had been implemented for addressing positive samples. Moreover, the firm continued to use
wooden boards to hold cheese during production.
CHEESE PRODUCER ENTERS CONSENT DECREE..., 23 No. 4 FDA...
2014 Thomson Reuters. No claim to original U.S. Government Works. 2
The government asked the court for injunctive relief, saying, Despite numerous FDA findings of [Listeria] contamination in
environmental and finished product samples, laboratory findings of nonpathogenic E. coli in finished product, a recall, repeated
FDA inspections noting violative conditions and the need for corrective actions, and an FDA Warning Letter, defendants have
failed to institute effective measures to bring their food manufacturing operations into compliance with the law.
Terms of Consent Decree
On March 20 the government and the defendants filed a joint motion to enter a consent decree, which the court granted five
weeks later.
Under the terms of the 22-page document, the defendants are enjoined from producing food products at the Trumansburg facility
until:
the defendants retain an independent laboratory to take and analyze environmental samples to test for the presence of Listeria;
the defendants retain an independent sanitation expert to inspect the facility and determine whether it is operating in conformity
with the FDA's current good manufacturing practice standards for foods (21 C.F.R. Part 110);
the sanitation expert develops a written Listeria monitoring program that includes plans for sanitation control, employee
training, environmental monitoring and testing, and remedial action;
the defendants assign responsibility for the monitoring program to a person who is competent to maintain the facility in a
sanitary condition;
the FDA approves the monitoring program before it is implemented;
the sanitation expert conducts a comprehensive inspection of the facility;
the defendants report to the FDA on the actions that they have taken to bring the facility into compliance;
the defendants destroy all in-process and finished food currently in their possession, or demonstrate to the FDA's satisfaction
that the food is free of pathogenic organisms;
the FDA inspects the facility as necessary and notifies the defendants that they appear to be in compliance with the consent
decree, the Federal Food, Drug and Cosmetic Act, and 21 C.F.R. Part 110; and
the defendants have paid the costs of the FDA's inspections and other actions.
In addition, the defendants are enjoined from producing adulterated food in violation of FDA requirements, and they must
conduct ongoing environmental monitoring and finished product testing as specified in detail in the consent decree.
The FDA may conduct inspections without prior notice and take any other measures necessary to monitor and ensure
continuing compliance with the agency's requirements. If the FDA determines that the defendants are not in compliance, it
may order them to stop their food product operations, recall products, submit samples for testing and take other corrective
actions. The consent decree also specifies the amounts of liquidated damages that the defendants must pay for failure to comply
with the FDA's requirements.
CHEESE PRODUCER ENTERS CONSENT DECREE..., 23 No. 4 FDA...
2014 Thomson Reuters. No claim to original U.S. Government Works. 3
In an agency release announcing the court's approval of the consent decree, Associate Commissioner for Regulatory Affairs
Melinda K. Plaisier said, The FDA repeatedly advised the company and its owner of the insanitary conditions at the facility.
When a company continues to produce food that presents a risk for consumers, the FDA will take regulatory action to protect
the public's health.
End of Document 2014 Thomson Reuters. No claim to original U.S. Government Works.
6/11/2014 Press Announcements > United States enters consent decree with New York cheese producer due to Listeria contamination
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm395339.htm 1/3
U.S. Food and Drug Administration
Protecting and Promoting Your Health
FDA NEWS RELEASE
For Immediate Release: April 29, 2014
Media Inquiries: Lauren Sucher, 240-402-2793, lauren.sucher@fda.hhs.gov
(mailto:lauren.sucher@fda.hhs.gov)
Consumer Inquiries: 888-INFO-FDA
United States enters consent decree with New York cheese
producer due to Listeria contamination
Company required to complete significant corrective action to control foodborne pathogens in
processing facility
On April 28, 2014, United States District Court Judge Richard J. Arcara of the Western District of New
York entered a consent decree of permanent injunction between the United States and Finger Lakes
Farmstead Cheese Company, LLC, of Trumansburg, N.Y. and its co-owner Nancy Taber Richards.
The consent decree was pursued by the U.S. Attorneys Office for the Western District of New York on
behalf of the U.S. Food and Drug Administration.

Under the consent decree, Finger Lakes, the manufacturer and distributor of raw cows milk cheese,
cannot receive, prepare, process, pack, hold or distribute food until it demonstrates that it has
developed a control program to eliminate Listeria monocytogenes from its production facility and
products. Listeria monocytogenes is a foodborne pathogen that can cause serious illness and death.

The company must, among other actions, hire an independent laboratory to collect and analyze
samples for the presence of Listeria; retain an independent sanitation expert; develop a program to
control Listeria in the production facility and to train employees on sanitary food handling; and destroy
all food items currently in the facility. Should the company be permitted to resume operations, the FDA
may require the company to recall products or cease production if future violations occur.

The FDA repeatedly advised the company and its owner of the insanitary conditions at the facility,
said Melinda K. Plaisier, the FDAs associate commissioner for regulatory affairs. When a company
continues to produce food that presents a risk for consumers, the FDA will take regulatory action to
protect the publics health.

6/11/2014 Press Announcements > United States enters consent decree with New York cheese producer due to Listeria contamination
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm395339.htm 2/3
FDA inspections since 2012 have documented serious deficiencies in the companys processing
facility. The FDA issued a warning letter to the company in October 2012. In addition, FDA laboratory
testing in 2012 and 2013 found Listeria monocytogenes in Finger Lakes finished cheese products
and in its facility.

Listeriosis, the illness caused by Listeria monocytogenes, can cause serious illness and potentially
cause fatal infections especially in young children, frail or older people, and others with weakened
immune systems. Although healthy individuals may experience only short-term symptoms, such as high
fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeriosis in pregnant
women can cause miscarriage and stillbirth.

Although no illnesses have been reported from the consumption of Finger Lakes products, individuals
who have eaten these products and experience any of the symptoms of listeriosis, listed above,
should contact their health care professional. Consumers can report
(http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm)
problems with FDA-regulated products to their district office consumer complaint coordinator.
For more information:
October 23, 2012 Warning Letter
(http://www.fda.gov/iceci/enforcementactions/warningletters/2012/ucm325714.htm)
FoodSafety.gov on Listeria
(http://www.foodsafety.gov/poisoning/causes/bacteriaviruses/listeria/)
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public
health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.

# # #

Read our Blog: FDA Voice (https://blogs.fda.gov/fdavoice/)
Use of wooden shelves for cheese aging
Microbial pathogens can be controlled if food facilities engage in good manufacturing practice.
Proper cleaning and sanitation of equipment and facilities are absolutely necessary to ensure that
pathogens do not find niches to reside and proliferate. Adequate cleaning and sanitation procedures are
particularly important in facilities where persistent strains of pathogenic microorganisms like Listeria
monocytogenes could be found. The use of wooden shelves, rough or otherwise, for cheese ripening
does not conform to cGMP requirements, which require that all plant equipment and utensils shall be
so designed and of such material and workmanship as to be adequately cleanable, and shall be properly
maintained. 21 CFR 110.40(a). Wooden shelves or boards cannot be adequately cleaned and sanitized.
The porous structure of wood enables it to absorb and retain bacteria, therefore bacteria generally
colonize not only the surface but also the inside layers of wood. The shelves or boards used for aging
make direct contact with finished products; hence they could be a potential source of pathogenic
microorganisms in the finished products.
Recent publications by Zangerl et al. in 2010 showed that L. monocytogenes survived cleaning
and sanitation on wooden shelves used for cheese ripening. [Zangerl, P., Matlschweiger, C., Dillinger, K.,
& Eliskases-Lechner, F. (2010). Survival of Listeria monocytogenes after cleaning and sanitation of
wooden shelves used for cheese ripening. European Journal of Wood and Wood Products, 68(4), 415-
419]. Another scientific paper by Mariana et al., 2011, does not suffice to overcome the cGMP violation.
[Mariani, C., Oulahal, N., Chamba, J.F., Dubois-Brissonnet, F., Notz, E., Briandet, R. (2011). Inhibition of
Listeria monocytogenes by resident biofilms present on wooden shelves used for cheese ripening. Food
Control 22, 13571362]. More importantly, the data in the Mariani, et al., study showed that despite the
use of unclean and clean native woods, L. monocytogenes strains were not completely inactivated or
eradicated on the woods. The mere fact that L. monocytogenes survived in any wood sample studied
should be of concern. A single surviving L. monocytogenes cell may grow and multiply and thus serve to
contaminate cheese. Noteworthy is the fact that the authors suggested that further studies are
required in order to establish the mechanism of inhibition by the bacteria described in the paper, which,
for now, is only speculative. Thus the paper does not support the proposition for which it was offered,
viz. that wooden shelves prevent contamination of cheeses with L. monocytogenes.
The primary concern for cheeses manufacturers should be prevention of cheese contamination
with pathogens. Pathogenic microorganisms are not inherent natural contaminants of cheeses,
therefore the sanitation of a cheese processing plants equipment and environment play an important
role in preventing pathogen contamination.



After the FDA cited the NY cheesemakers, the NY State Department of Agriculture asked the FDA for
clarification as to whether wooden surfaces were acceptable for the aging of cheese. In response, Monica
Metz, Branch Chief of the FDAs Center for Food Safety and Applied Nutritions Dairy and Egg Branch sent
them the following in January 2014:
6/11/2014 Statement from State Agriculture Commissioner Richard A. Ball on FDA Enforcement of a Ban on the Use of Wood to Age Cheeses
http://www.agriculture.ny.gov/AD/release.asp?ReleaseID=2864 1/2
Share
The Department
Divisions
Programs
Funding Opportunities
Farm & Market Search
Licensing & Registration
News & Publications
Fairs & Events
Contact Us
FOIL Requests
Employment Opportunities
A-Z Index
Related Links
Security Notice

Joe Morrissey, 518-457-0752, Joe.Morrissey@agriculture.ny.gov
Dave Bullard, 315-487-7711 x 1377, Dave.Bullard@agriculture.ny.gov
June 11, 2014
Statement from State Agriculture Commissioner Richard A. Ball on FDA Enforcement
of a Ban on the Use of Wood to Age Cheeses
Governor Cuomo and the Department of Agriculture and Markets have devoted signif icant ef f orts to helping our states
dairy industry grow and thrive. The artisanal cheese industry is a small but rapidly growing part of the dairy sector in New
York State, with more than 125 cheesemakers creating world class dairy products. These businesses create many jobs
and provide diversity to the f ood choices of all New Yorkers.
In 2010, FDA inspectors began conducting environmental assessments of cheesemaking f acilities in New York looking f or
pathogens at these f acilities. These inspections resumed in 2012. In 2013, FDA inspectors cited an Upstate New York
artisanal cheese company f or what it called a repeat violation involving aging cheese on wood. That company
subsequently entered into a consent decree with FDA and has been closed since then to take corrective action.
In September 2013, the Department of Agriculture and Markets Division of Milk Control reached out to FDA to seek
clarif ication of the noted violations relating to aging cheese on wooden boards. In January 2014, an FDA of f icial provided a
document called Use of wooden shelves f or cheese aging, which said, in part:
The use of wooden shelves, rough or otherwise, f or cheese ripening does not conf orm to cGMP [Current Good
Manuf acturing Practices] requirements, which require that all plant equipment and utensils shall be so designed and of such
material and workmanship as to be adequately cleanable, and shall be properly maintained.
Since that time, our Department has been working with Cornell University to assess the science behind FDAs decision and
has also engaged in conversations with FDA around this topic. FDA indicated to our agency that it had no plans to change
its policy.
I am very concerned about the damage this policy could do to these businesses, not only in New York, but across the
country, and respectf ully request a suspension of any enf orcement actions until a f ull science based peer review is
completed. Aging artisanal cheeses on wood is a common practice used by cheesemakers f or centuries. Our inspectors,
as well as the artisans who make these cheeses, work hard to ensure that the process of aging cheese is done saf ely.
I thank Secretarys Burwells of f ice f or engaging Governor Cuomos of f ice and my Department over the past couple of
days. I appreciate the Secretarys commitment to resolving this issue and I am encouraged by FDAs statement yesterday
that it is willing to work with the artisan cheese industry and the cheese loving public. We stand ready to assist the
discussion in any way in which we may be helpf ul to turning this policy around.
2014 Press Releases


FOR IMMEDIATE RELEASE
Contact: Rebecca Sherman Orozco
rorozco@cheesesociety.org
(203) 605-6949 (c) | (720) 328-2788 (o)


American Cheese Society Supports the Use of Wood for Cheese Aging

Denver, CO (June 10, 2014) In response to the recent Food & Drug Administration (FDA) statement on the
use of wooden shelves for cheese aging, the American Cheese Society (ACS) has issued a position
statement on the safety of aging cheese on wood surfaces. The statement follows a Member Alert issued by
the organization on June 6, after Monica Metz, Chief of FDAs Center for Food Safety & Applied Nutritions
Dairy and Egg Branch, clarified that FDAs position is that the use of wooden shelves, rough or otherwise,
for cheese ripening does not conform to cGMP [Current Good Manufacturing Practice] requirements.

The ACS Position Statement on the Safety of Aging Cheese on Wood reads:

For centuries, cheesemakers have been creating delicious, nutritious, unique cheeses aged on wood.
Todays cheesemakerslarge and small, domestic and internationalcontinue to use this material for
production due to its inherent safety, unique contribution to the aging and flavor-development process, and
track record of safety as part of overall plant hygiene and good manufacturing practices. No foodborne
illness outbreak has been found to be caused by the use of wood as an aging surface.

The American Cheese Society (ACS) strongly encourages FDA to revise its interpretation of the Code of
Federal Regulation (21 CFR 110.40(a)) to continue to permit properly maintained, cleaned, and sanitized
wood as an aging surface in cheesemaking as has been, and is currently, enforced by state and federal
regulators and inspectors.

It is ACSs position that:
Safety is paramount in cheesemaking.

Cheeses aged on wood have a long track record of safety, and have long been produced meeting
FDA standards.

Wood can be safely used for cheese aging when construction is sound and in good condition, and all
surfaces are properly cleaned and maintained using sanitation steps that assure the destruction of
pathogens, including but not limited to:
o All surfaces are free of defects;
o Any wood preservatives used are safe and acceptable for direct food contact;
o Inspection and cleaning procedures are followed that specify:
Frequency of inspection and testing
Frequency of cleaning and sanitizing
Methods used that adequately clean boards which might include:
Kiln-drying
Air-drying
Heat-treating
Sanitizing with acceptable products
Inoculation to create and maintain positive biofilm
Raising the core temperature of the wood above pasteurization
temperatures
Ongoing monitoring and verification of the effectiveness of all procedures per the
Hazard Analysis and Risk-based Preventive Controls (HARPC) provision of the
Food Safety Modernization Act (FSMA)
Corrective actions to address any issues
Discarding of wood that is deteriorated and/or in poor repair
Furthermore, ACS believes:

Traditional methods of cheesemaking can and do meet food safety standards.

U.S. consumers should have access to a wide variety of domestic and imported cheeses, including
those safely aged on wood.

State and federal regulators and inspectors must work collaboratively with cheesemakers to
understand how traditional methods and materials can comply with current food safety standards.

Many of the finest and most renowned cheeses from around the world are at risk of disappearing
from the U.S. market if regulatory and enforcement changes under FSMA eliminate traditional
materials and methods.

FDA should provide timely notification, hold proper listening sessions and comment periods, review
all available scientific data, and include consideration of industry stakeholders before modifying long-
standing interpretation or implementation of its regulations which impact American businesses.

ACS is working with allied industry groups in the U.S. and abroad, concerned consumers, producers, and
elected officials to preserve the use of this safe, proven, traditional material in cheesemaking.

For more information, contact the ACS office at 720-328-2788 or info@cheesesociety.org.


####


About the American Cheese Society (ACS)
ACS is the leading organization supporting the understanding, appreciation, and promotion of artisan,
farmstead, and specialty cheeses produced in the Americas. At 1,500 members strong, ACS provides
advocacy, education, business development, and networking opportunities for cheesemakers, retailers,
enthusiasts, and extended industry. ACS strives to continually raise the quality and availability of cheese in the
Americas. Since its founding in 1983, ACS proudly hosts the foremost annual educational conference and
world-renowned cheese judging and competition. The 2014 ACS Conference & Competition will be held in
Sacramento, CA from July 29-August 1, 2014. Visit http://www.cheesesociety.org to learn more.
8
Future Uses of Wooden Boards
for Aging Cheeses
Bndicte Coud & Dr. Bill Wendorff
Wooden boards have been used for many years in
most traditional cheesemaking countries as a shelving
mechanism for aging cheese. In France, more than
300,000 tons of cheese are ripened on wooden boards
each year (Meyer, 2005). Most artisan cheesemakers
feel that wooden shelves favor cheese rind development
and improve the organoleptic qualities of aged
cheeses thanks to the formation of a biolm on the
wood surface. Is this biolm safe? Might it favor the
development of spoilage and potential pathogenic
bacteria? The purpose of this review is to look at the
benets of wooden boards as well as the potential
concerns and how to avoid them.
Experiences with Wooden Shelving for
Aging Cheeses
In a French study on the biolm ecology of shelves
used in ripening raw milk smear cheese (Mariani
et al., 2007), French researchers did a microbial
characterization and found that most of the microora
was composed of microcci-corynebacteria (7.2 to 7.3
log10 cfu/cm2) and yeasts/molds (6.0 to 6.1 log10
cfu/cm2). Based on these ndings, they concluded
traditional methods of cleaning wooden cheese
ripening boards by soaking them in cold water and
brushing them minimized the risk of contamination
by pathogenic microorganisms, thus allowing useful
microora to be preserved. When large-scale pathogen
contamination occurred, however, pathogenic
microorganisms could not be satisfactorily eliminated;
even with the use of disinfectants. In case of heavy
contamination the wooden boards had to be destroyed.
In another French study (Lemoine, 2002), newly sawn
wooden boards were surveyed for potential pathogens.
The study found no evidence of pathogens on the board
surface or within the wood. Processes for cleaning
wooden boards used for aging cheeses were also
evaluated. It was determined that the most effective
cleaning process, in terms of pathogen removal, was to
involve a washing at 179.6F for 30 minutes.
The effect of cleaning and heat disinfection processes
on the survival of Listeria monocytogenes on wooden
shelves used for cheese ripening was also examined
(Zangerl et al., 2010). Listeria monocytogenes is a gram-
positive rod-shaped bacterium that can be found in
fresh cheeses and unpasteurized milk. The cut boards
were inoculated with a suspension containing 5.5X10
7
colony forming units (CFU)/ml of L. monocytogenes.
Survival of L. monocytogenes was investigated in the
wood shavings. During the 24-hour incubation period
in a humidity chamber, Listeria counts increased by
0.8 log units on average (n = 9), compared to results
one hour after incubation, indicating the absence
of antimicrobial properties of the wood in use.
Additionally, after incubation for 24 hours at room
temperature, the boards were cleaned by soaking them
for 15 minutes in a solution of hot alkaline detergent
followed by brushing and rinsing with warm water.
Some of the cleaned boards were subsequently heat
treated at 176F for 5 minutes and at 149F for 15
minutes, respectively. The cleaning procedure alone
was not sufcient to render L. monocytogenes from the
upper 2 mm wood layer inactive. In the case of both
temperature-time combinations for heat disinfection,
however, L. monocytogenes was not detectable. The
present study shows that the use of wooden shelves
does not affect the hygienic safety of cheeses if such
shelves are in good repair and are thoroughly cleaned
and sanitized by heat treatment.
Results from a two-year French research study called
ACTIA (Association de Coordination Technique pour
9
l'Industrie Agro-alimentaire) (2004-2006) involving
professionals, technical centers and research agencies
including INRA (Institute National de la Recherche
Agronomique) may have a signicant impact on
acceptance of wooden boards for aging cheeses.
This study involved two types of soft smear cheeses:
Reblochon and Muenster. The risk of contamination
by pathogenic bacteria was studied by analyzing the
growth of Listeria monocytogenes. The researchers have
shown the presence of a living biolm on wooden
shelves that presents anti-Listeria properties. This
inhibiting effect appeared to be active against two
strains of L. monocytogenes that were chosen for
their different surface properties and their presence
in certain cheesemaking environment. The anti-
Listeria effect was not affected by the level of Listeria
inoculation nor the origin of the cheeses ripened on the
shelves.
Scientists from the INRA/AgroParis Tech center
developed an experimental system reproducing
the anti-Listeria effect to understand the inhibiting
properties. The idea was to analyze the metabolites
produced by the biolm and the two Listeria strains
inoculated. The study showed that competition
occurred when the microbial biolm entered a
stationary phase and stopped the growth of Listeria.
At this stage, it did not appear that the metabolites
produced contain any inhibiting molecules. Further
collaborative research should provide a better
understanding of the inhibiting effect of biolms
against pathogenic microorganisms.
Wooden boards seem to be more sanitary than
plastic boards when using extraction procedures for
assessing number of bacteria retained on the surface
of boards. The bacterial contaminants were bound
tightly enough in the wooden boards to keep them from
being extracted and they actually formed biolms.
Several researchers (Cools et al., 2005; Mariani et al.,
2007) have investigated the potential for pathogens to
be retained in the biolm. Cools et al. (2005) stated
that there is a higher risk for cross-contamination
from Campylobacter jejuni surviving and persisting
at the surface of a polypropylene cutting board than
from C. jejuni being present in the deep interior of the
wood, as the latter has less direct contact with food.
The pathogen is more easily removed from the upper
non-porous surface of the plastic board than from the
interior of the deep crevices and pores in the wood.
The wood used to make the shelves is usually carefully
selected. The caves of Joseph Paccard in Haute-Savoie,
France that make Reblochon use spruce wood that is
cut in December when the sap goes back down from the
top of the tree into the ground. This is really important
for the quality of the wood. In order to be able to age
cheese on wood, the shelves have to be cut close to the
heart of the tree without including the heart otherwise
the wood tends to split and the shelves cannot be used.
Finally, the shelves have to be dried naturally for at least
18 months. In summary, wooden boards, especially
spruce, r, pine and larch, seem to be more effective
than plastic boards in trapping bacteria in pores and
controlling them with possible antimicrobial properties.
Future for Wooden Shelving for Aging Cheeses
Wooden boards have been traditionally used for cheese
ripening shelves because of their moisture retaining
properties and porosity that aids in the retention
of potential bacterial contaminants. The future use
of wooden boards for aging cheeses will depend on
the cleaning and sanitation of those boards. A.K. et
al. (1994b) reports that cleaning with hot water and
detergent generally removes most of the residual
bacteria, regardless of bacterial species, wood species,
and age of the wood. Zangerl et al.(2010) reported
that the cleaning procedure alone was not sufcient
to eliminate Listeria monocytogenes from the upper
2 mm wood layer of wooden shelves used for cheese
ripening. They recommended heating the cleaned
boards to 176F for 5 minutes or 149F for 15 minutes
to eliminate the potential for pathogens. Yang et al.
(2009) reported that quaternary ammonium compound
(QAC) based sanitizers and sodium hypochlorite
sanitizers were effective against L. monocytogenes on
cutting boards.

In general, with the use of softwood boards, e.g., pine
or spruce, along with a hot wash using hot water and
detergent, most boards should be fairly clean. The
freshly cleaned boards should then be sanitized by
heating the boards to 176F for 5 minutes or sanitized
with either a chlorine-based or QAC-based sanitizer to
ensure freedom from any potential pathogens.
Finally, considering the benecial effects of wood
boards on cheese ripening and rind formation, the use
of wood boards does not seem to present any danger
of contamination by pathogenic bacteria as long as a
thorough cleaning procedure is followed.
WMMB
Wisconsin Center for Dairy Research
University of Wisconsin-Madison
1605 Linden Drive
Madison, Wisconsin 53706-1565
ADDRESS SERVICE REQUESTED
Nonproft Org.
U.S. Postage
PAID
Madison, WI
Permit No. 658
Dairy Pipeline
Center for Dairy Research
1605 Linden Dr.
Madison, WI 53706-1565
608-262-5970 | fax: 608-262-1578
We welcome your questions and comments.
Send to: Bekah Gillespie, Editor
8 rgillespie@cdr.wisc.edu | 608-262-8015
Technical Reviewers:
Bndicte Coud, Mark Johnson, Mike Molitor, Dean
Sommer, Marianne Smukowski, Tom Szalkucki, Bill
Wendorff
Newsletter Design & Layout
Tim Hogensen
The Dairy Pipeline is published by the Center for Dairy
Research and funded by the Wisconsin Milk Marketing
Board.
To subscribe to the Pipeline simply phone, fax, or e-mail
your request to CDR. (Form on page 11) You can also
nd the Dairy Pipeline on our website:
www.cdr.wisc.edu
Short Course Calendar:
Cheese Tech Short Course, March 18-22
World of Cheese, April 28-May 2
Cleaning and Sanitation, May 7
HACCP, May 8
Applied Dairy Chemistry, May 14-15
Cheese Grading, June 4-6
For detailed information on each CDR short course
www.cdr.wisc.edu/shortcourses
Events:
WCIC, April 17-18, 2013, LaCrosse WI
WDATCP HTST Pasteurizer Operation and Procedures Training
Workshop, April 23, www.wifoodprotection.org
National Conference On Interstate Milk Shipments, April 19-24,
Indianapolis, Indiana
The Wisconsin Association for Food Protection (WAFP) Spring
Food Safety Workshop, June 12
Holiday Inn Hotel & Suites Madison West
6/11/2014 FDA clarifies that it won' t ban cheese aged on wood
http://www.dairyherd.com/dairy-news/latest/US-FDA-moves-to-dampen-fears-it-will-ban-cheese-aged-on-wood-262673491.html 1/2
cl i ck i mage to zoom
FDA won't ban aging cheese on
wood after all.
FDA clarifies that it won't ban cheese aged on wood
Toni Clarke and Krista Hughes, Reuters | Updated: 06/11/2014
The U.S. Food and Drug Administration moved on Tuesday to tamp down fears among artisanal cheesemakers that it
was poised to ban the practice of aging cheese on wooden boards.
The agency said it did not have a new policy banning wooden shelves in cheese-making, adding there was no
requirement in recent food safety regulations requiring the agency to address the issue.
In January, Monica Metz, an FDA official, responded to questions posed by the New York State Department of
Agriculture and Markets, which sought clarification on the FDA's policy after several cheesemakers in the state were
cited for their use of wooden shelves during FDA inspections.
Metz said the use of the shelves did not conform to good manufacturing practices that require that "all plant
equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained."
Her comments caused a furor in the artisanal cheese-making community, where rumors flew that the FDA was poised to ban the practice.
"A sense of disbelief and distress is quickly rippling through the U.S. artisan cheese community," wrote Cheese Underground blogger Jeanne Carpenter.
The FDA said it had no new policy and had never taken any action against a cheesemaker based solely on the use of wooden shelves. Historically, the
agency has cited cheesemakers when shelves were poorly cleaned.
"In the interest of public health, the FDA's current regulations state that utensils and other surfaces that contact food must be 'adequately cleanable' and
properly maintained," Lauren Sucher, an FDA spokeswoman, said in a statement.
"Historically, the FDA has expressed concern about whether wood meets this requirement and has noted these concerns in inspectional findings," she
said. "FDA is always open to evidence that shows that wood can be safely used for specific purposes, such as aging cheese."
Fears over the rumored ban caused confusion about imports of cheese from Europe, where wood-aging is used to make cheeses such as Comte, Beaufort
and Reblochon.
"Did the FDA just ban European cheese?" Cato Institute trade policy analyst Bill Watson wrote in a blog post on Tuesday.
The European Union and United States are already at odds over Europe's desire to keep the exclusive right to names such as parmigiano reggiano and
asiago, preventing U.S. cheesemakers from marketing their products using those names.
Rebecca Sherman Orozco, a spokeswoman for the American Cheese Society, said that "for centuries, cheesemakers have been creating delicious,
nutritious, unique cheeses aged on wood."
The FDA's Sucher said the agency would "engage with the artisanal cheese-making community to determine whether certain types of cheeses can safely
be made by aging them on wooden shelving."

Your feedback is important to us!
Would you be willing to give us a short (1 minute) feedback?
6/11/2014 Cheese World Fears Crackdown on Wood Boards - ABC News
http://abcnews.go.com/Health/wireStory/cheese-world-fears-crackdown-wood-boards-24078911 1/3
NOW ERIC CANTOR DAVE BRAT CHAINING 6-YEAR-OLD OREGON SCHOOL SHOOTING NORSE APOCALYPSE
4.3m Like SIGN IN Search
HOME VIDEO U.S. WORLD POLITICS ENTERTAINMENT TECH HEALTH LIFESTYLE SHOWS MORE
162 0 0 Comments
Cheese World Fears Crackdown on Wood
Boards
NEW YORK June 11, 2014 (AP)
By CANDICE CHOI AP Food Industry Writer
3 Like
3 Share
Aging cheese on wood boards is a common practice among artisan
cheesemakers at home and overseas. Now, some in the industry are worried
regulators may crack down on it.
In recent communication to the New York regulators, the Food and Drug Administration noted that
wood shelves and boards cannot be adequately cleaned and sanitized, and as such, do not
conform to a particular regulation regarding plant equipment and utensils.
The federal agency also noted that "proper cleaning and sanitation of equipment and facilities are
absolutely necessary to ensure that pathogens do not find niches to reside and proliferate."
In a statement issued Tuesday, however, the FDA seemed to backtrack on the stance. It noted that
it hasn't taken any enforcement action based solely on the use of wood shelves. And while it said it
has expressed concern about whether wood can be adequately cleaned, it added that it is "always
open to evidence that shows that wood can be safely used for specific purposes, such as aging
cheese."
The FDA said it will engage with the artisanal cheesemaking community to determine whether
certain types of cheese can be safely made by aging them on wood shelves.
When asked what that process would entail, FDA spokeswoman Lauren Sucher said in an email
that the agency "can't speculate on immediate next steps."
The note to New York regulators had sparked concern in the cheese world because much of the
cheese that's imported in the U.S. is aged on wood. Robert Ralyea, a senior extension associate at
Cornell University's Department of Food Science, said aging cheese on wood is even a part of the
standard of identity for some cheeses, such as Comte cheese.
Ralyea said he had made the inquiry about wood boards to New York state regulators on behalf
of Finger Lakes Farmstead Cheese, a local cheesemaker. State regulators then requested clarity
from the FDA on the matter. The FDA's communication was posted late last week, sparking the
concerns in the cheese world.
"A sense of disbelief and distress is rippling through the U.S. artisan cheese community," wrote the
blog Cheese Underground.
The American Cheese Society, a trade association based in Denver, also posted an alert to its
members, assuring them it was mobilizing to learn more about the issue. Nora Weiser, executive
director for the society, said the aging of cheese on wood boards has never been an issue in the
past. She said state inspectors have generally just worked with cheesemakers to ensure the wood
is being properly cleaned.
"We can't guess what they'll do. Their goal is safety, and that's our goal as well," Weiser said. But
she added that the American Cheese Society wanted to "preserve this as a method of aging
cheese."
Weiser wasn't immediately available for a comment on the FDA's latest statement.
Nancy Richards, owner of Finger Lakes Farmstead Cheese, said she was shut down seven months
ago after listeria was found in her plant, which uses wood to age cheese. She wasn't certain of the
specific reason, but said she thinks the FDA has never liked wood for aging cheese.
"Do I like being the poster child for the wood board issue? No, not really," she said.
She added that she believes that wood boards that are well kept can be adequately cleaned.

HOT RIGHT NOW

1
How This Year's Biggest
Political Shocker
Changes Everything
2
Meet the Tea Party
Challenger Who Took
Down Eric Cantor
3
'Game of Thrones' Kit
Harington: 'I May Be Out
of a Job'
4
Miley Cyrus Sings 'FU'
While Carrying
Cardboard Cutout of...
5
Boston Twins Born 24
Days Apart
YOU MIGHT ALSO LIKE...
PHOTO GALLERIES

Search for Maddie
McCann Extended
(ABC News)
Baby Rhino Is Glued
to Keeper After
Seeing Poachers Kill
'Slender Man' Attack
Victim Adjusting to
'New Normal'
View: Homes For Sale With Lush Gardens
Business
Monica M. Metz
OFS Dairy and Egg Branch Chief
Former Consumer Safety Officer, FDA/CFSAN/OFS/DPDFS/DEB
Phone: 301-436-2041
Fax: 301-436-2644

Address: FDA
OFS/DPDFS/DEB
5100 Paint Branch Parkway, HFS-316
College Park, MD 20740
Main Telephone: 240 402-1700
Fax: 301 436-2599


Lauren Sucher
FDA Press Officer
Center for Food Safety and Applied Nutrition
Phone: 240-402-4793
Email: lauren.sucher@fda.hhs.gov

Morbidity and Mortality Weekly Report
448 MMWR / June 7, 2013 / Vol. 62 / No. 22
Introduction
Listeria monocytogenes infection (listeriosis), recognized as a
foodborne illness in the 1980s (1), leads to invasive disease during
vulnerable stages of life (2). Older adults and persons with immu-
nocompromising conditions are at higher risk for Listeria bacteremia
and meningitis (3), which can be fatal. Listeriosis usually is a mild
illness in pregnant women, but it can cause severe outcomes for
the fetus or newborn infant, including fetal loss, preterm labor,
and neonatal sepsis, meningitis, and death. Listeriosis is rare (3).
However, hospitalization is much more common than with other
foodborne infections (4), and listeriosis is the third leading cause
of death among major pathogens transmitted commonly by food
(5). Listeriosis incidence decreased by 24% from 1996 through
2001 but has not changed significantly since then (3,4). Although
most cases are sporadic (i.e., not outbreak-related) (6), outbreaks
occur regularly (7). In 2011, contaminated cantaloupe from a
single farm caused the deadliest U.S. foodborne disease outbreak
in nearly 90 years (8). Public health officials rapidly implicated
whole cantaloupe, and their actions prevented additional cases and
deaths. Outbreak investigations also can reveal unrecognized food
sources and food safety gaps that can be closed by regulatory and
industry intervention.
This report provides an overview of recent surveillance data
on listeriosis, highlighting actions needed to protect vulnerable
populations.
Vital Signs: Listeria Illnesses, Deaths, and Outbreaks
United States, 20092011
On June 4, 2013, this report was posted as an MMWR Early Release on the MMWR website (http://www.cdc.gov/mmwr).
Abstract
Background: Older adults, pregnant women, and persons with immunocompromising conditions are at higher risk than
others for invasive Listeria monocytogenes infection (listeriosis), a rare and preventable foodborne illness that can cause
bacteremia, meningitis, fetal loss, and death.
Methods: This report summarizes data on 20092011 listeriosis cases and outbreaks reported to U.S. surveillance systems.
The Listeria Initiative and PulseNet conduct nationwide surveillance to rapidly detect and respond to outbreaks, the
Foodborne Diseases Active Surveillance Network (FoodNet) conducts active, sentinel populationbased surveillance to
track incidence trends, and the Foodborne Disease Outbreak Surveillance System (FDOSS) receives reports of investigated
outbreaks to track foods and settings associated with outbreaks.
Results: Nationwide, 1,651 cases of listeriosis occurring during 20092011 were reported. The case-fatality rate was 21%.
Most cases occurred among adults aged 65 years (950 [58%]), and 14% (227) were pregnancy-associated. At least 74%
of nonpregnant patients aged <65 years had an immunocompromising condition, most commonly immunosuppressive
therapy or malignancy. The average annual incidence was 0.29 cases per 100,000 population. Compared with the overall
population, incidence was markedly higher among adults aged 65 years (1.3; relative rate [RR]: 4.4) and pregnant women
(3.0; RR: 10.1). Twelve reported outbreaks affected 224 patients in 38 states. Five outbreak investigations implicated soft
cheeses made from pasteurized milk that were likely contaminated during cheese-making (four implicated Mexican-style
cheese, and one implicated two other types of cheese). Two outbreaks were linked to raw produce.
Conclusions: Almost all listeriosis occurs in persons in higher-risk groups. Soft cheeses were prominent vehicles, but other
foods also caused recent outbreaks. Prevention targeting higher-risk groups and control of Listeria monocytogenes contamination
in foods implicated by outbreak investigations will have the greatest impact on reducing the burden of listeriosis.
Implications for Public Health Practice: Careful attention to food safety is especially important to protect vulnerable
populations. Surveillance for foodborne infections like listeriosis identifies food safety gaps that can be addressed by
industry, regulatory authorities, food preparers, and consumers.
Morbidity and Mortality Weekly Report
MMWR / June 7, 2013 / Vol. 62 / No. 22 449
Methods
The objectives of this report are to 1) summarize demographic
and clinical characteristics of patients with listeriosis, 2) estimate
incidence overall and in demographic subgroups, and 3) describe
foods associated with outbreaks. Data from three surveillance
systems for the period 20092011 were analyzed to provide this
comprehensive picture. A case of invasive listeriosis was defined
as isolation of L. monocytogenes from a normally sterile site (e.g.,
blood or cerebrospinal fluid) or from products of conception.
When L. monocytogenes was isolated from multiple sites, a single
site is reported (priority order: cerebrospinal fluid, blood, other
normally sterile site, products of conception). A case was con-
sidered pregnancy-associated when it occurred in a pregnant
woman, a fetus, or an infant 31 days old; mother-infant pairs
were counted as a single case. The case-fatality rate (CFR) was
calculated as the percentage of cases with a fatality. Fetal losses
were tallied separately from deaths but were included in CFR
calculations. Live-born infants were assumed to have survived
unless reported to have died.
The primary data source for the first objective was the Listeria
Initiative,* a CDC-led enhanced nationwide surveillance sys-
tem that collects demographic, clinical, and food exposure data
for persons with laboratory-confirmed listeriosis. Patients are
interviewed as they are reported, using a standard question-
naire. Isolates of L. monocytogenes from patients are subtyped
in PulseNet,

the national molecular subtyping network. The

Listeria Initiative facilitates investigation of possible outbreaks
identified by PulseNet. Listeria Initiative participation has
steadily improved since national implementation in 2005; 47
states reported at least one case in 2011.
Also for the first objective, the Foodborne Diseases Active
Surveillance Network (FoodNet)

contributed data on under-

lying conditions. FoodNet is a collaborative program among
CDC, 10 state health departments, the U.S. Department of
Agricultures Food Safety and Inspection Service (USDA-FSIS),
and the Food and Drug Administration (FDA). FoodNet
conducts active, population-based surveillance for laboratory-
confirmed infections with L. monocytogenes and eight other
pathogens among residents of 10 sites covering approximately
15% of the U.S. population (48 million persons in 2011).
FoodNet does not routinely track underlying medical conditions;
they can be reported voluntarily, but reporting is incomplete.
For the second objective, incidence rates were calculated by
dividing FoodNet data on the number of laboratory-confirmed
infections by U.S. Census estimates of the population of the sur-
veillance area, both for the whole population and for subgroups.
FoodNet and Listeria Initiative data were linked to improve com-
pleteness of information on ethnicity and pregnancy.
For the third objective, data from the Foodborne Disease
Outbreak Surveillance System (FDOSS)

were used. State,

local, and territorial health departments submit reports of
investigated foodborne disease outbreaks to CDC. For each
outbreak, FDOSS records the etiology, state(s), size (i.e., num-
ber of illnesses), setting, and food vehicle, among other data. A
listeriosis outbreak was defined as 2 cases linked to a common
source. Outbreaks were considered multistate if exposure to the
implicated food occurred in more than one state.
Results
Nationwide, 1,651 invasive listeriosis cases were reported to
the Listeria Initiative from 2009 through 2011; 292 deaths or
fetal losses were reported (CFR: 21%). Most (58%) cases were
in adults aged 65 years, and 14% were pregnancy-associated
(Table 1). The median age of patients with listeriosis that was
not pregnancy-associated was 72 years (interquartile range [IQR]:
6181 years). Among pregnancy-associated cases with ethnicity
data available, 43% (85 of 198) of mothers were Hispanic. Preterm
labor was reported in 64% of pregnancy-associated cases. Among
nonpregnant patients aged <65 years reported to FoodNet, an
underlying medical condition was recorded for 74% (96 of 130);
immunosuppressive therapy (i.e., steroids, chemotherapy, or
radiation) was most commonly reported (32 cases), followed by
malignancy (24), diabetes mellitus (11), cirrhosis or liver disease
(seven), renal failure or nephrotic syndrome (seven), alcoholism
(six), and human immunodeficiency virus/acquired immunode-
ficiency syndrome (six).
The average annual incidence was 0.29 cases per 100,000
population in FoodNet. In adults aged 65 years, the inci-
dence was 1.3 cases per 100,000 population. The highest rates
were among pregnant women (3.0 per 100,000), especially
* The main purpose of the Listeria Initiative is to facilitate outbreak investigations.
Food exposure frequencies from cases associated with suspected outbreaks
(identified by PulseNet) are compared with food history data from sporadic
cases. This facilitates rapid identification and recall of contaminated foods.
Additional information on the Listeria Initiative is available at http://www.cdc.
gov/listeria/pdf/listeriainitiativeoverview_508.pdf.

PulseNet, the national molecular subtyping network, subtypes all L. monocytogenes

isolates using pulsed-field gel electrophoresis (PFGE). PulseNet is a network
of laboratories in local, state, and federal health and regulatory agencies that
use standard protocols, equipment, and nomenclature to test bacteria and
submit their PFGE pattern combinations to a central database for comparison
with one another. For L. monocytogenes, two patterns are submitted for most
isolates (one for each of two restriction enzymes, AscI and ApaI). Additional
information about PulseNet is available at http://www.cdc.gov/pulsenet. Data
on the proportion of patients with isolates submitted to PulseNet whose illnesses
are reported to the Listeria Initiative are available at http://www.cdc.gov/listeria/
pdf/listeria-annual-summary-2011-508c.pdf.

FoodNet is part of CDCs Emerging Infectious Diseases Program (http://www.

cdc.gov/foodnet).

Additional information on national outbreak reporting is available at http://

www.cdc.gov/nors.
Morbidity and Mortality Weekly Report
450 MMWR / June 7, 2013 / Vol. 62 / No. 22
Hispanics (7.0 per 100,000). Compared with the population as
a whole, rates were four times higher for adults aged 65 years
(RR: 4.4), 10 times higher for pregnant women (RR: 10.1),
and 24 times higher for pregnant Hispanic women (RR: 24.0).
Twelve outbreaks, five of them multistate, and 224 outbreak-
associated cases (14% of cases reported to the Listeria Initiative)
were reported among residents of 38 states (Table 2). The
median size was seven cases (range: two to 147 cases). In
seven (58%), the implicated food was consumed primarily
in private homes. Two were linked to hospital food services,
one to a restaurant, and one to wedding banquets. Ten (83%)
investigations implicated a food vehicle. Cheese was impli-
cated in six outbreaks (50% of outbreaks) with 51 cases (23%
of outbreak-associated cases). Soft cheeses labeled as made
from pasteurized milk were implicated in five outbreaks: four
implicated Mexican-style cheese and one implicated both chive
cheese and ackawi cheese (a white brine cheese). An aged,
blue-vein cheese made from unpasteurized milk was implicated
in the sixth outbreak. Two raw produce items, pre-cut celery
(an ingredient in chicken salad) and whole cantaloupe, were
implicated as listeriosis outbreak vehicles.
Conclusions and Comment
This report details the epidemiology of invasive listeriosis,
which often leads to bacteremia, meningitis, hospitalization,
fetal loss, and death, and calls for actions that could protect
the most vulnerable populations. Older adults and pregnant
women, particularly pregnant Hispanic women, are at much
higher risk than the population at large, as are persons with
weakened immunity (2). Preventing infections in these popula-
tions can have substantial impact in averting these outcomes.
Older adults and persons with weakened immunity, as well as
infants and young children, are also prone to many other food-
borne illnesses, including campylobacteriosis, salmonellosis,
and Shiga toxinproducing E. coli infections (4). Accounting
for underdiagnosis and underreporting, an estimated 1,662
cases of listeriosis occur each year (5). No progress in reducing
the overall incidence of listeriosis has occurred in over a decade
(3,4); renewed prevention efforts are needed from farm to table.
Foods associated with listeriosis outbreaks in this report,** soft
cheese and raw produce items in particular, highlight opportuni-
ties for food safety improvements. Listeria is widespread in many
environments, and reducing contamination of soft cheese and raw
produce with Listeria and other pathogens will require implemen-
tation of proven measures as well as development of new ones. The
Food Safety Modernization Act (FSMA) of 2011

gives FDA
additional authority to regulate food facilities, establish standards
** Listeriosis outbreaks were included in this report based on the date of onset
of the first illness; an outbreak associated with raw sprouts, which began in
2008 and extended into 2009, was not included.

Additional information about FSMA, proposed standards for produce safety,
and preventive controls during food processing is available at http://www.fda.
gov/food/guidanceregulation/fsma/default.htm.
TABLE 1. Demographic and clinical characteristics of cases of invasive Listeria infection (listeriosis), by risk group Listeria Initiative, United
States, 20092011
Characteristic
Pregnancy-associated*
Not pregnancy-associated
Total Patients aged <65 yrs Patients aged 65 yrs
No. (%)

No. (%)

No. (%)

No. (%)

Total 227 (100) 474 (100) 950 (100) 1,651 (100)

Female sex 227 (100) 218 (46) 489 (51) 910 (55)
Hispanic ethnicity

85 (43) 77 (20) 54 (7) 216 (16)

Isolate source

Blood 150 (66)** 334 (70) 824 (87) 1,308 (79)

CSF 41 (18)** 119 (25) 98 (10) 258 (16)
Other sterile site

NA 23 (5) 35 (4) 58 (4)

Product of conception

36 (16) NA NA 36 (2)
Hospitalization

133 (90) 417 (93) 850 (94) 1,400 (93)

Death or fetal loss

46 (21)*** 53 (14) 193 (24) 292 (21)

Abbreviations: CSF = cerebrospinal fluid; NA = not applicable.
* Pregnancy-associated cases include those in pregnant women, fetuses, and infants aged 31 days.

Percentages may not sum to 100 because of rounding.

Among 1,327 (80%) patients with available ethnicity data.

When L. monocytogenes is isolated from multiple anatomical sites, a single site is reported (priority order: CSF, blood, other normally sterile site, and products of
conception).
** Isolates from neonatal blood (n = 72), maternal blood (69), and both (nine); isolates from neonatal CSF (38), maternal CSF (two), and both (one).

For nonpregnancy-associated cases, other sterile sites were pleural fluid (n = 18 isolates), peritoneal or ascites fluid (14), joint or synovial fluid (nine), brain tissue
(three), aortic tissue (one), eye (one), liver abscess (one), lung tissue (one), and pericardial fluid (one). For pregnancy-associated cases, products of conception
were placental tissue (31) and amniotic fluid (five).

Hospitalizations among singleton neonates for 147 pregnancy-associated cases and among 1,358 nonpregnancy-associated cases with data available.

Deaths or fetal losses among singleton neonates for 224 pregnancy-associated cases and among 1,179 nonpregnancy-associated cases with data available.
*** Forty fetal losses and six neonatal deaths.
Morbidity and Mortality Weekly Report
MMWR / June 7, 2013 / Vol. 62 / No. 22 451
for safe produce, recall contaminated foods, and oversee imported
foods. FDA has proposed new standards for produce safety and
for preventive controls during food processing that hold promise
for reducing listeriosis.
Over time, many outbreaks have been linked to soft cheese
made with unpasteurized milk, and FDA and Health Canada

estimate that the risk for listeriosis from soft-ripened cheeses
is 50 to 160 times higher per serving when the cheese is
made with unpasteurized milk rather than pasteurized milk.
Nonetheless, investigations described in this report and else-
where also have implicated cheeses made from pasteurized milk
(911). Pasteurization eliminates Listeria, but contamination
can occur after pasteurization. Listeria grows in moist environ-
ments, even at refrigeration temperatures, so it can thrive when
soft cheeses that support its growth are contaminated. In addi-
tion to using pasteurized milk, soft cheesemaking facilities
need to use strict sanitation and microbiologic monitoring.
In the late 1990s and early 2000s, U.S. listeriosis incidence
declined markedly after outbreak investigations prompted
major industry and regulatory interventions, including using
ingredients that inhibit growth of Listeria (12), to reduce con-
tamination of processed meat (e.g., hot dogs and deli meat)
(7). A risk assessment

presented for public comment by

USDA-FSIS and FDA will inform efforts
to reduce further Listeria contamination of
ready-to-eat foods in retail settings.
FSMA calls on CDC to strengthen food-
borne illness surveillance and outbreak
response. States capacities vary consider-
ably, and many lack sufficient staff and
resources (1315). CDC launched a col-
laborative network called FoodCore*** to
develop methods to make outbreak detec-
tion and response faster, and the Integrated
Food Safety Centers of Excellence,

to
provide technical assistance and training of
public health staff in other states. As more
states use the Listeria Initiative to gather
data on cases quickly, outbreak response
improves. Faster investigations save lives.

During a 2011 multistate outbreak, the
Listeria Initiative led to identification of
cantaloupe as the food vehicle, and halt of
its distribution, in less than 2 weeks (8); the
response was much faster than previous investigations of large
outbreaks of listeriosis, such as a 1985 outbreak associated
with Mexican-style cheese in which 31 days elapsed between
outbreak detection and product recall (16). Advanced labora-
tory methods will modernize diagnostics and surveillance;
more outbreaks might be detected faster using real-time whole
genome sequencing (17).
Consumers at higher risk for listeriosis and those who prepare
their food can reduce their risk. Basic food safety measures
(e.g., Clean, Separate, Cook and Chill

) reduce the risk for

listeriosis and other potentially serious infections. Persons at
higher risk should follow the guidance for the general popu-
lation not to consume unpasteurized milk or dairy products
made from unpasteurized milk (e.g., soft cheese). They also
should be aware that some Mexican-style soft cheeses made
from pasteurized milk, like queso fresco, have been identified
as a source of listeriosis. In addition, health-care providers are
uniquely positioned to provide credible information about
listeriosis prevention to patients at higher risk. Detailed advice
on safely selecting, preparing, and refrigerating foods prone
to Listeria contamination and other pathogens is available in
TABLE 2. Reported outbreaks of Listeria infection (listeriosis) Foodborne Disease
Outbreak Surveillance System, United States, 20092011
Year Multistate Total cases* Consumption setting Implicated food vehicle
2009 Yes 18 Private homes Mexican-style cheese

Yes 8 Private homes

Mexican-style cheese

2010 No 8 Private homes Hog head cheese

No 2 Private homes Sushi rolls (unspecified)

No 4 Hospital food service Undetermined
No 10 Hospital food service Pre-cut celery
Yes 6 Private homes

Mexican-style cheese

2011 No 2 Unknown Undetermined

No 2 Private home and restaurant Chive cheese

and ackawi cheese

**
Yes 147 Private homes Whole cantaloupe
No 2 Private homes Mexican-style cheese

Yes 15

Wedding banquets Aged, blue-veined cheese

* Total cases include laboratory-confirmed and epidemiologically linked cases.

Soft cheese made from pasteurized milk.

L. monocytogenes isolates from these two outbreaks were indistinguishable by pulsed-field gel
electrophoresis. The Food and Drug Administration sought a permanent injunction against the
manufacturer after the first outbreak.The owners moved the manufacturing facility to a nearby location
and reopened under a new name.

Hog head cheese is a meat jelly made from swine heads and feet (i.e., it is not a dairy product).
** Ackawi is a white brine cheese.

Fourteen cases of febrile gastroenteritis (noninvasive, not culture-confirmed) and one case of culture-
confirmed invasive disease reported.

A blue cheese that was made from unpasteurized milk and aged for 60 days.

Information about the Quantitative Assessment of the Risk of Listeriosis From
Soft-Ripened Cheese Consumption in the United States and Canada available at
http://www.fda.gov/downloads/food/foodscienceresearch/ucm338617.pdf.

Additional information is available at http://www.fsis.usda.gov/science/
risk_assessments/index.asp.
*** Additional information available at http://www.cdc.gov/foodcore/about.html.

Additional information available at http://www.cdc.gov/foodsafety/fsma.html.

An estimated 36 illnesses, 35 hospitalizations, and seven deaths were averted
by recall of contaminated cantaloupe and consumer warnings (CDC,
unpublished data, 2013).

Additional information about the basics of food safety available at http://
www.foodsafety.gov/keep/basics.
Morbidity and Mortality Weekly Report
452 MMWR / June 7, 2013 / Vol. 62 / No. 22
English and Spanish at http://www.cdc.gov/listeria, http://
www.fsis.usda.gov/fact_sheets/listeria_monocytogenes/index.
asp, and http://www.fda.gov/food/resourcesforyou/consumers/
ucm079667.htm.
Reported by
Benjamin J. Silk, PhD, Barbara E. Mahon, MD, Patricia M.
Griffin, MD, L. Hannah Gould, PhD, Robert V. Tauxe, MD,
Stacy M. Crim, MPH, Kelly A. Jackson, MPH, Peter Gerner-
Smidt, MD, PhD, Karen M. Herman, MPH, Olga L. Henao,
PhD, Div of Foodborne, Waterborne, and Environmental
Diseases, National Center for Emerging and Zoonotic Infectious
Diseases, CDC. Corresponding contributor: Benjamin J. Silk,
bsilk@cdc.gov, 404-639-0536.
Acknowledgments
Epidemiologists and public health laboratorians at CDC and in
state, local, and territorial health departments; officials from USDA-
FSIS and FDA.
References
1. Schlech WF 3rd, Lavigne PM, Bortolussi RA, et al. Epidemic listeriosis
evidence for transmission by food. N Engl J Med 1983;308:2036.
2. Lund BM, OBrien SJ. The occurrence and prevention of foodborne
disease in vulnerable people. Foodborne Pathog Dis 2011;8:96173.
3. Silk BJ, Date KA, Jackson KA, et al. Invasive listeriosis in Foodborne
Diseases Active Surveillance Network (FoodNet), 20042009: further
targeted prevention needed for higher-risk groups. Clin Infect Dis
2012;54:S396404.
4. CDC. Incidence and trends of infection with pathogens transmitted
commonly through foodFoodborne Diseases Active Surveillance
Network, 10 U.S. sites, 19962012. MMWR 2013;62:2837.
5. Scallan E, Hoekstra RM, Angulo FJ, et al. Foodborne illness acquired in
the United Statesmajor pathogens. Emerg Infect Dis 2011;17:715.
6. Varma JK, Samuel MC, Marcus R, et al. Listeria monocytogenes infection
from foods prepared in a commercial establishment: a case-control study
of potential sources of sporadic illness in the United States. Clin Infect
Dis 2007;44:5218.
7. Cartwright EJ, Jackson KA, Johnson SD, Graves LM, Silk BJ, Mahon
BE. Listeriosis outbreaks and associated food vehicles, United States,
19982008. Emerg Infect Dis 2013;19:19.
8. CDC. Multistate outbreak of listeriosis associated with Jensen Farms
cantaloupeUnited States, AugustSeptember, 2011. MMWR
2011;60:13578.
9. Jackson KA, Biggerstaff M, Tobin-DAngelo M, et al. Multistate outbreak
of Listeria monocytogenes associated with Mexican-style cheese made from
pasteurized milk among pregnant, Hispanic women. J Food Protect
2011;74:94953.
10. Koch J, Dworak R, Prager R, et al. Large listeriosis outbreak linked to
cheese made from pasteurized milk, Germany, 20062007. Foodborne
Pathog Dis 2010;7:15814.
11. CDC. Multistate outbreak of listeriosis linked to imported Frescolina
Marte brand ricotta salata cheese (final update). Atlanta, GA: US
Department of Health and Human Services; 2012. Available at http://
www.cdc.gov/listeria/outbreaks/cheese-09-12/index.html.
12. Endrikat S, Gallagher D, Pouillot R, et al. A comparative risk assessment
for Listeria monocytogenes in prepackaged versus retail-sliced deli meat.
J Food Prot 2010;73:6129.
13. Jones TF, Rosenberg L, Kubota K, Ingram LA. Variability among states
in investigating foodborne disease outbreaks. Foodborne Pathog Dis
2013;10:6973.
14. CDC. Food safety epidemiology capacity in state health departments
United States, 2010. MMWR 2011;60:17014.
15. National Association of County and City Health Officials. Local health
department job losses and program cuts: findings from the January 2012
survey. Washington, DC: National Association of County and City
Health Officials; 2012. Available at http://www.naccho.org/topics/
infrastructure/lhdbudget/upload/research-brief-final.pdf.
16. Linnan MJ, Mascola L, Lou XD, et al. Epidemic listeriosis associated
with Mexican-style cheese. N Engl J Med 1988;319:8238.
17. Kupferschmidt K. Outbreak detectives embrace the genome era. Science
2011;333:18189.
Key Points
Listeria monocytogenes infection (listeriosis) is a rare
foodborne disease that often leads to bacteremia,
meningitis, hospitalization, fetal loss, and death.
Careful attention to food safety is especially important
for older adults, pregnant women, and persons with
immunocompromising conditions because almost all
cases of listeriosis occur among these three groups at
higher risk.
The average annual incidence of listeriosis for the
period 20092011 (0.29 cases per 100,000 population)
indicates that no progress in reducing the rate of
listeriosis has occurred in over a decade.
Foods associated with recent listeriosis outbreaks,
especially soft cheese and raw produce, highlight food
safety gaps that can be addressed by industry, regulatory
authorities, food preparers, and consumers.
Additional information is available at http://www.cdc.
gov/vitalsigns.
Morbidity and Mortality Weekly Report
294 MMWR / April 4, 2014 / Vol. 63 / No. 13
Multistate Outbreak of Listeriosis Linked to
Soft-Ripened Cheese United States, 2013
Mary J. Choi, MD
1,2
, Kelly A. Jackson, MPH
3
,
Carlota Medus, PhD
1
, Jennifer Beal, MPH
4
, Carrie E. Rigdon, PhD
5
,
Tami C. Cloyd, DVM
4
, Matthew J. Forstner
5
, Jill Ball
6
,
Stacy Bosch, DVM
3
, Lyndsay Bottichio, MPH
7
,
Venessa Cantu, MPH
8
, David C. Melka
9
, Wilete Ishow
10
,
Sarah Slette, MS
11
, Kari Irvin, MS
4
, Matthew Wise, PhD
3
,
Cheryl Tarr, PhD
3
, Barbara Mahon, MD
3
,
Kirk E. Smith, DVM, PhD
1
, Benjamin J. Silk, PhD
3
(Author affiliations at end of text)
On June 27, 2013, the Minnesota Department of Health noti-
fied CDC of two patients with invasive Listeria monocytogenes
infections (listeriosis) whose clinical isolates had indistinguish-
able pulsed-field gel electrophoresis (PFGE) patterns. A query
of PulseNet, the national molecular subtyping network for
foodborne disease surveillance, identified clinical and environ-
mental isolates from other states. On June 28, CDC learned
from the Food and Drug Administrations Coordinated
Outbreak Response and Evaluation Network that environmen-
tal isolates indistinguishable from those of the two patients had
been collected from Crave Brothers Farmstead Cheese during
20102011. An outbreak-related case was defined as isolation
of L. monocytogenes with the outbreak PFGE pattern from an
anatomic site that is normally sterile (e.g., blood or cerebrospinal
fluid), or from a product of conception, with an isolate upload
date during May 20June 28, 2013. As of June 28, five cases
were identified in four states (Minnesota, two cases; Illinois,
Indiana, and Ohio, one each). Median age of the five patients
was 58 years (range: 3167 years). Four patients were female,
including one who was pregnant at the time of infection. All five
were hospitalized. One death and one miscarriage were reported.
Casecase analysis of Listeria Initiative*

data (1) was con-
ducted, comparing food exposure frequencies among the five
outbreak-related cases identified by June 28 with food exposure
frequencies in 1,735 sporadic listeriosis cases reported to CDC
during 20042013. The analysis indicated that any soft cheese
consumption during the month before illness onset was associ-
ated with outbreak-related listeriosis: five of five (100%) in the
outbreak-related cases versus 569 of 1,735 (33%) in the sporadic
cases (odds ratio = 10.8; 95% confidence interval = 1.8).
The five patients were reinterviewed to assess their cheese
exposures. All five patients had definitely or probably eaten
one of three varieties of Crave Brothers soft-ripened cheese
(Les Frres, Petit Frre, or Petit Frre with truffles). Three
patients had purchased the cheese at three different restaurants,
and two had purchased the cheese at two different grocery
stores. The cheeses were shipped as intact wheels to the three
restaurants and two grocery stores, where they had been cut
and served or repackaged and sold to customers.
Testing at the Minnesota Department of Agriculture iden-
tified the outbreak pattern of L. monocytogenes in two cheese
wedges (Les Frres and Petit Frre with truffles) collected
from two different grocery stores in Minnesota. Inspection of
the cheese-making facility revealed that substantial sanitation
deficiencies during the cheese-making process itself, after the
milk was pasteurized, likely led to contamination. On July 1,
Crave Brothers halted production of Les Frres, Petit Frre,
and Petit Frre with truffles. On July 3, Crave Brothers issued
a voluntary recall of these products with a production date of
July 1, 2013, or earlier. On July 11, the company voluntarily
halted production of all cheese products manufactured at the
facility. After product recall, one additional case was identified
in Texas through whole genome sequencing, bringing the total
case count for the outbreak to six.
This outbreak was linked to soft cheeses that were likely
contaminated during the cheese-making process (2,3).
Pasteurization eliminates Listeria in milk. However, contami-
nation can occur after pasteurization. Cheese-making facilities
should use strict sanitation and microbiologic monitoring,
regardless of whether they use pasteurized milk.

Persons at greater risk for listeriosis, including older adults,
pregnant women, and those with immunocompromising con-
ditions, should be aware that certain soft cheeses made with
unpasteurized milk, or made under unsanitary conditions,
regardless of whether the milk was pasteurized, have been
shown to cause severe illness. These soft cheeses include fresh
(unripened) cheeses, such as queso fresco (4), and soft-ripened
cheeses, such as the cheeses implicated in this outbreak.
Notes from the Field

Joint Food and Drug Administration/Health Canada quantitative assessment

of the risk of listeriosis from soft-ripened cheese consumption in the United
States and Canada: draft report. Available at http://www.fda.gov/downloads/
food/foodscienceresearch/ucm338617.pdf.
* The Listeria Initiative is an enhanced surveillance system that has routinely
collected data regarding food consumption from all patients with listeriosis
since 2004. Additional information is available at http://www.cdc.gov/listeria/
pdf/listeriainitiativeoverview_508.pdf.
Morbidity and Mortality Weekly Report
MMWR / April 4, 2014 / Vol. 63 / No. 13 295

1
Minnesota Department of Health;
2
EIS officer;
3
Div of Foodborne,
Waterborne, and Environmental Diseases, National Center for Emerging and
Zoonotic Infectious Diseases, CDC;
4
Coordinated Outbreak Response and
Evaluation Network, Food and Drug Administration;
5
Minnesota Department
of Agriculture;
6
Wisconsin Department of Agriculture, Trade, and Consumer
Protection;
7
Ohio Department of Health;
8
Texas Department of State Health
Services;
9
Center for Food Safety and Applied Nutrition, Food and Drug
Administration;
10
Chicago Department of Public Health;
11
Indiana State
Department of Health (Corresponding author: Mary J. Choi, mjchoi@cdc.gov,
651-201-5193)
References
1. McCollum JT, Cronquist AB, Silk BJ, et al. Multistate outbreak of
listeriosis associated with cantaloupe. N Engl J Med 2013;369:94453.
2. CDC. Vital signs: Listeria illnesses, deaths, and outbreaksUnited States,
20092011. MMWR 2013;62:44852.
3. CDC. Multistate outbreak of listeriosis linked to imported Frescolina
Marte brand ricotta salata cheese (final update). Atlanta, GA: US
Department of Health and Human Services, CDC; 2012. Available at
http://www.cdc.gov/listeria/outbreaks/cheese-09-12/index.html.
4. CDC. Outbreak of listeriosis associated with homemade Mexican-style
cheeseNorth Carolina, October 2000January 2001. MMWR
2001;50:5602.
Morbidity and Mortality Weekly Report
MMWR / June 6, 2014 / Vol. 63 / No. 22 ND-297
TABLE I. Provisional cases of infrequently reported notifable diseases (<1,000 cases reported during the preceding year) United States, week ending
May 31, 2014 (22nd week)* (Export data)
Disease
Current
week
Cum
2014
5-year
weekly
average

Total cases reported for previous years

States reporting cases
during current week (No.) 2013 2012 2011 2010 2009
Anthrax 1 1
Arboviral diseases

:
California serogroup virus disease 1 85 81 137 75 55
Eastern equine encephalitis virus disease 7 15 4 10 4
Powassan virus disease 1 15 7 16 8 6
St. Louis encephalitis virus disease 0 1 3 6 10 12
Western equine encephalitis virus disease
Botulism, total 42 3 152 168 153 112 118
foodborne 0 4 27 24 7 10
infant 33 2 136 123 97 80 83
other (wound and unspecified) 9 0 12 18 32 25 25
Brucellosis 19 2 100 114 79 115 115
Chancroid 1 7 0 10 15 8 24 28 NY (1)
Cholera 0 4 17 40 13 10
Cyclosporiasis

22 4 784 123 151 179 141

Diphtheria 1 1
Haemophilus infuenzae,** invasive disease (age <5 yrs):
serotype b 12 0 31 30 14 23 35
nonserotype b 71 4 222 205 145 200 236
unknown serotype 2 119 4 185 210 226 223 178 FL (1), CO (1)
Hansen disease

1 18 2 81 82 82 98 103 NYC (1)

Hantavirus pulmonary syndrome

5 1 16 30 23 20 20
Hemolytic uremic syndrome, postdiarrheal

2 37 5 329 274 290 266 242 TN (1), TX (1)

Hepatitis B, virus infection perinatal 4 20 1 50 40 U U U CA (4)
Infuenza-associated pediatric mortality

1 88 2 164 52 118 61 358 AZ (1)

Leptospirosis 4 0 NN NN NN NN NN
Listeriosis 4 175 14 730 727 870 821 851 NYC (1), PA (2), SC (1)
Measles

29 335 5 186 55 220 63 71 OH (29)

Meningococcal disease, invasive

:
A, C, Y, and W-135 46 4 142 161 257 280 301
serogroup B 29 3 98 110 159 135 174
other serogroup 6 0 18 20 20 12 23
unknown serogroup 2 125 6 301 260 323 406 482 FL (1), OR (1)
Novel infuenza A virus infections*** 435 21 313 14 4 43,774
Plague 1 0 4 4 3 2 8
Poliomyelitis, paralytic 1 1
Polio virus Infection, nonparalytic

Psittacosis

0 6 2 2 4 9
Q fever, total

48 3 153 135 134 131 113

acute 36 3 120 113 110 106 93
chronic 12 1 33 22 24 25 20
Rabies, human 0 1 6 2 4
Rubella

1 4 0 9 9 4 5 3 PA (1)
Rubella, congenital syndrome 0 1 3 2
SARS-CoV

Smallpox

Streptococcal toxic-shock syndrome

3 74 3 223 194 168 142 161 NY (3)

Syphilis, congenital (age <1 yr)

70 6 341 322 360 377 423

Tetanus 7 0 26 37 36 26 18
Toxic-shock syndrome (staphylococcal)

18 2 73 65 78 82 74
Trichinellosis 2 0 20 18 15 7 13
Tularemia 3 14 6 202 149 166 124 93 AR (2), OK (1)
Typhoid fever 108 7 338 354 390 467 397
Vancomycin-intermediate Staphylococcus aureus

1 77 2 244 134 82 91 78 NC (1)

Vancomycin-resistant Staphylococcus aureus

2 2 1
Vibriosis (noncholera Vibrio species infections)

4 144 16 1,199 1,111 832 846 789 OH (1), MD (1), FL (1), WA (1)
Viral hemorrhagic fever

1 NN
Yellow fever
See Table 1 footnotes on next page.
Notifiable Diseases and Mortality Tables
Morbidity and Mortality Weekly Report
ND-298 MMWR / June 6, 2014 / Vol. 63 / No. 22
* Ratio of current 4-week total to mean of 15 4-week totals (from previous, comparable, and subsequent 4-week
periods for the past 5 years). The point where the hatched area begins is based on the mean and two standard
deviations of these 4-week totals.
FIGURE I. Selected notifiable disease reports, United States, comparison of provisional 4-week
totals May 31, 2014, with historical data
TABLE I. (Continued) Provisional cases of infrequently reported notifable diseases (<1,000 cases reported during the preceding year) United States, week
ending May 31, 2014 (22nd week)*
: No reported cases. N: Not reportable. NN: Not Nationally Notifable. Cum: Cumulative year-to-date counts.
* Case counts for reporting years 2013 and 2014 are provisional and subject to change. For further information on interpretation of these data, see http://wwwn.cdc.gov/nndss/document/
ProvisionalNationaNotifiableDiseasesSurveillanceData20100927.pdf.

Calculated by summing the incidence counts for the current week, the 2 weeks preceding the current week, and the 2 weeks following the current week, for a total of 5 preceding years.
Additional information is available at http://wwwn.cdc.gov/nndss/document/5yearweeklyaverage.pdf.

Not reportable in all states. Data from states where the condition is not reportable are excluded from this table except starting in 2007 for the arboviral diseases, STD data, TB data, and influenza-
associated pediatric mortality, and in 2003 for SARS-CoV. Reporting exceptions are available at http://wwwn.cdc.gov/nndss/document/SRCA_FINAL_REPORT_2006-2012_final.xlsx.

Includes both neuroinvasive and nonneuroinvasive. Updated weekly from reports to the Division of Vector-Borne Infectious Diseases, National Center for Zoonotic, Vector-Borne, and
Enteric Diseases (ArboNET Surveillance). Data for West Nile virus are available in Table II.
** Data for H. influenzae (all ages, all serotypes) are available in Table II.

Updated weekly from reports to the Influenza Division, National Center for Immunization and Respiratory Diseases. Since September 29, 2013, 97 influenza-associated pediatric deaths
occurring during the 2013-14 influenza season have been reported.

Of the 29 measles cases reported for the current week, 18 were indigenous and 11 were imported.

Data for meningococcal disease (all serogroups) are available in Table II.
*** CDC discontinued reporting of individual confirmed and probable cases of influenza A (H1N1)pdm09 virus infections on July 24, 2009. During 2009, four cases of human infection with
novel influenza A viruses, different from the influenza A (H1N1)pdm09 virus, were reported to CDC. The four cases of novel influenza A virus infection reported to CDC during 2010, the
fourteen cases reported during 2011, the 313 cases reported in 2012, and the 21 cases reported during 2013 are different from the influenza A (H1N1)pdm09 virus. Total case counts are
provided by the Influenza Division, National Center for Immunization and Respiratory Diseases (NCIRD).

The one rubella case reported for the current week was unknown.

Updated weekly from reports to the Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.

There were no cases of viral hemorrhagic fever reported during the current week. See Table II for dengue hemorrhagic fever.
Notifiable Disease Data Team and 122 Cities Mortality Data Team
Umed Ajani
Deborah A. Adams Willie J. Anderson
Lenee Blanton Rosaline Dhara
Diana Harris Onweh Alan W. Schley
Pearl C. Sharp
32 2 0.5 0.25 1
Beyond historical limits
DISEASE
Ratio (Log scale)*
DECREASE INCREASE
CASES CURRENT
4 WEEKS
Hepatitis A, acute
Hepatitis B, acute
Hepatitis C, acute
Legionellosis
Measles
Mumps
Pertussis
Giardiasis
Meningococcal disease
592
46
98
54
135
171
15
116
787
4 8 16
Morbidity and Mortality Weekly Report
328 MMWR / April 18, 2014 / Vol. 63 / No. 15
Foodborne disease continues to be an important problem in
the United States. Most illnesses are preventable. To evaluate
progress toward prevention, the Foodborne Diseases Active
Surveillance Network* (FoodNet) monitors the incidence of
laboratory-confirmed infections caused by nine pathogens
transmitted commonly through food in 10 U.S. sites, covering
approximately 15% of the U.S. population. This report sum-
marizes preliminary 2013 data and describes trends since 2006.
In 2013, a total of 19,056 infections, 4,200 hospitalizations,
and 80 deaths were reported. For most infections, incidence
was well above national Healthy People 2020 incidence targets
and highest among children aged <5 years. Compared with
20102012, the estimated incidence of infection in 2013 was
lower for Salmonella, higher for Vibrio, and unchanged over-
all.

Since 20062008, the overall incidence has not changed

significantly. More needs to be done. Reducing these infections
requires actions targeted to sources and pathogens, such as
continued use of Salmonella poultry performance standards
and actions mandated by the Food Safety Modernization
Act (FSMA) (1). FoodNet provides federal and state public
health and regulatory agencies as well as the food industry with
important information needed to determine if regulations,
guidelines, and safety practices applied across the farm-to-table
continuum are working.
FoodNet conducts active, population-based surveillance
for laboratory-confirmed infections caused by Campylobacter,
Cryptosporidium, Cyclospora, Listeria, Salmonella, Shiga toxin
producing Escherichia coli (STEC) O157 and non-O157,
Shigella, Vibrio, and Yersinia in 10 sites covering approximately
15% of the U.S. population (an estimated 48 million persons
in 2012).

FoodNet is a collaboration among CDC, 10 state

health departments, the U.S. Department of Agricultures Food
Safety and Inspection Service (USDA-FSIS), and the Food and
Drug Administration (FDA). Hospitalizations occurring within
7 days of specimen collection are recorded, as is the patients
vital status at hospital discharge, or at 7 days after specimen
collection if the patient was not hospitalized. Hospitalizations
and deaths that occur within 7 days are attributed to the
infection. Surveillance for physician-diagnosed postdiarrheal
hemolytic uremic syndrome (HUS), a complication of STEC
infection characterized by renal failure, is conducted through
a network of nephrologists and infection preventionists and
by hospital discharge data review. This report includes 2012
HUS data for persons aged <18 years.
Incidence was calculated by dividing the number of
laboratory-confirmed infections in 2013 by U.S. Census
estimates of the surveillance area population for 2012.

Incidence of culture-confirmed bacterial infections and
laboratory-confirmed parasitic infections (e.g., identified by
enzyme immunoassay) are reported. A negative binomial model
with 95% confidence intervals (CIs) was used to estimate
changes in incidence from 20102012 to 2013 and from
20062008 to 2013 (2). Change in the overall incidence of
infection with six key foodborne pathogens was estimated
(3). For STEC non-O157, only change since 20102012 was
assessed because diagnostic practices changed before then; for
Cyclospora, change was not assessed because data were sparse.
For HUS, incidence was compared with 20062008. The
number of reports of positive culture-independent diagnostic
tests (CIDTs) without corresponding culture confirmation
is included for Campylobacter, Listeria, Salmonella, Shigella,
STEC, Vibrio, and Yersinia.
Cases of Infection, Incidence, and Trends
In 2013, FoodNet identified 19,056 cases of infection,
4,200 hospitalizations, and 80 deaths (Table). The num-
ber and incidence per 100,000 population were Salmonella
(7,277 [15.19]), Campylobacter (6,621 [13.82]), Shigella
(2,309 [4.82]), Cryptosporidium (1,186 [2.48]), STEC non-O157
Incidence and Trends of Infection with Pathogens Transmitted Commonly
Through Food Foodborne Diseases Active Surveillance Network,
10 U.S. Sites, 20062013
Stacy M. Crim, MPH
1
, Martha Iwamoto, MD
1
, Jennifer Y. Huang, MPH
1
, Patricia M. Griffin, MD
1
, Debra Gilliss, MD
2
,
Alicia B. Cronquist, MPH
3
, Matthew Cartter, MD
4
, Melissa Tobin-DAngelo, MD
5
, David Blythe, MD
6
, Kirk Smith, DVM
7
,
Sarah Lathrop, PhD
8
, Shelley Zansky, PhD
9
, Paul R. Cieslak, MD
10
, John Dunn, DVM
11
, Kristin G. Holt, DVM
12
,
Susan Lance, DVM
13
, Robert Tauxe, MD
1
, Olga L. Henao, PhD
1
(Author affiliations at end of text)
* Additional information available at http://www.cdc.gov/foodnet.

The overall incidence of infection combines data for Campylobacter, Listeria,

Salmonella, STEC O157, Vibrio, and Yersinia, six key bacterial pathogens for
which >50% of illnesses are estimated to be transmitted by food.

FoodNet personnel regularly contact clinical laboratories to ascertain all

laboratory-confirmed infections in residents of the surveillance areas.

Final incidence rates will be reported when population estimates for 2013 are
available.
Morbidity and Mortality Weekly Report
MMWR / April 18, 2014 / Vol. 63 / No. 15 329
(561 [1.17]), STEC O157 (552 [1.15]), Vibrio (242 [0.51]),
Yersinia (171 [0.36]), Listeria (123 [0.26]), and Cyclospora
(14 [0.03]). Incidence was highest among persons aged 65
years for Cyclospora, Listeria, and Vibrio and among children
aged <5 years for all the other pathogens.
Among 6,520 (90%) serotyped Salmonella isolates, the top
serotypes were Enteritidis, 1,237 (19%); Typhimurium, 917
(14%); and Newport, 674 (10%). Among 231 (95%) speciated
Vibrio isolates, 144 (62%) were V. parahaemolyticus, 27 (12%)
were V. alginolyticus, and 21 (9%) were V. vulnificus. Among
458 (82%) serogrouped STEC non-O157 isolates, the top
serogroups were O26 (34%), O103 (25%), and O111 (14%).
Compared with 20102012, the 2013 incidence was sig-
nificantly lower for Salmonella (9% decrease; CI = 3%15%),
higher for Vibrio (32% increase; CI = 8%61%) and not sig-
nificantly changed for other pathogens (Figure 1). Compared
with 20062008, the 2013 incidence was significantly higher
for Campylobacter and Vibrio (Figure 2). The overall inci-
dence of infection with six key foodborne pathogens was not
significantly different in 2013 compared with 20102012 or
20062008.
Compared with 20102012, the 2013 incidence of infection
with specific Salmonella serotypes was significantly lower for
Enteritidis (14% decrease; CI = 0.2%25%) and Newport
(32% decrease; CI = 17%44%) and not significantly changed
for Typhimurium. Compared with 20062008, however, the
2013 incidence of infection was significantly changed only for
Typhimurium (20% decrease; CI = 10%28%).
Among 62 cases of postdiarrheal HUS in children aged
<18 years (0.56 cases per 100,000) in 2012, 38 (61%) occurred
in children aged <5 years (1.27 cases per 100,000). Compared
with 20062008, the incidence was significantly lower for
children aged <5 years (36% decrease; CI = 9%55%) and
for children aged <18 years (31% decrease; CI = 7%49%).
In addition to culture-confirmed infections (some with a
positive CIDT result), there were 1,487 reports of positive
CIDTs that were not confirmed by culture, either because the
specimen was not cultured at either the clinical or public health
laboratory or because a culture did not yield the pathogen. For
1,017 Campylobacter reports in this category, 430 (42%) had
no culture, and 587 (58%) were culture-negative. For 247
STEC reports, 59 (24%) had no culture, and 188 (76%) were
culture-negative. The Shiga toxinpositive result was confirmed
for 65 (34%) of 192 broths sent to a public health laboratory.
The other reports of positive CIDT tests not confirmed by
culture were of Shigella (147), Salmonella (69), Vibrio (four),
Listeria (two), and Yersinia (one).
Discussion
The incidence of laboratory-confirmed Salmonella infections
was lower in 2013 than 20102012, whereas the incidence of
Vibrio infections increased. No changes were observed for infec-
tion with Campylobacter, Listeria, STEC O157, or Yersinia, the
other pathogens transmitted commonly through food for which
Healthy People 2020 targets exist. The lack of recent progress
toward these targets points to gaps in the current food safety
system and the need for more food safety interventions.
Although the incidence of Salmonella infection in 2013 was
lower than during 20102012, it was similar to 20062008,
well above the national Healthy People target. Salmonella organ-
isms live in the intestines of many animals and can be transmit-
ted to humans through contaminated food or water or through
TABLE. Number of cases of culture-confirmed bacterial and laboratory-confirmed parasitic infection, hospitalizations, and deaths, by pathogen
Foodborne Diseases Active Surveillance Network, United States, 2013*
Pathogen
Cases Hospitalizations Deaths
No. Incidence

Objective

No. (%) No. (%)

Bacteria
Campylobacter 6,621 13.82 8.5 1,010 (15) 12 (0.2)
Listeria 123 0.26 0.2 112 (91) 24 (19.5)
Salmonella 7,277 15.19 11.4 2,003 (28) 27 (0.4)
Shigella 2,309 4.82 N/A

450 (19) 3 (0.1)

STEC O157 552 1.15 0.6 210 (38) 2 (0.4)
STEC non-O157 561 1.17 N/A 76 (14) 2 (0.4)
Vibrio 242 0.51 0.2 55 (23) 2 (0.8)
Yersinia 171 0.36 0.3 55 (32) 4 (2.3)
Parasites
Cryptosporidium 1,186 2.48 N/A 227 (19) 4 (0.3)
Cyclospora 14 0.03 N/A 2 (14) 0 (0.0)
Total 19,056 4,200 80
Abbreviations: N/A = not available; STEC = Shiga toxinproducing Escherichia coli.
* Data for 2013 are preliminary.

Per 100,000 population.

Healthy People 2020 objective targets for incidence of Campylobacter, Listeria, Salmonella, STEC O157, Vibrio, and Yersinia infections per 100,000 population.

No national health objective exists for these pathogens.
Morbidity and Mortality Weekly Report
330 MMWR / April 18, 2014 / Vol. 63 / No. 15
direct contact with animals or their environments; different
serotypes can have different reservoirs and sources. Enteritidis,
the most commonly isolated serotype, is often associated with
eggs and poultry. The incidence of Enteritidis infection was
lower in 2013 compared with 20102012, but not compared
with 20062008. This might be partly explained by the large
Enteritidis outbreak linked to eggs in 2010.** Ongoing efforts
to reduce contamination of eggs include FDAs Egg Safety Rule,
which requires shell egg producers to implement controls to
prevent contamination of eggs on the farm and during stor-
age and transportation.

FDA required compliance by all egg

producers with 50,000 laying hens by 2010 and by producers
with 3,000 hens by 2012. Reduction in Enteritidis infection
has been one of five high-priority goals for the U.S. Department
of Health and Human Services since 2012.

In 2013, the incidence of Vibrio infections was the highest

observed in FoodNet to date, though still much lower than
that of Salmonella or Campylobacter. Vibrio infections are
most common during warmer months, when waters contain
more Vibrio organisms. Many infections follow contact with
seawater (4), but about 50% of domestically acquired infec-
tions are transmitted through food, most commonly oysters
(5). Foodborne infections can be prevented by postharvest
treatment of oysters with heat, freezing, or high pressure, by
thorough cooking, or by not eating oysters during warmer
months (6). During the summers of 2012 and 2013, many
V. parahaemolyticus infections of a strain previously traced
only to the Pacific Northwest were associated with consump-
tion of oysters and other shellfish from several Atlantic Coast
harvest areas.

V. alginolyticus, the second most common

Vibrio reported to FoodNet in 2013, typically causes wound
and soft-tissue infections among persons who have contact
with water (7).
The continued decrease in the incidence of postdiarrheal
HUS has not been matched by a decline in STEC O157 infec-
tions. Possible explanations include unrecognized changes in
surveillance, improvements in management of STEC O157
diarrhea, or an actual decrease in infections with the most
FIGURE 1. Estimated percentage change in incidence of culture-confirmed bacterial and laboratory-confirmed parasitic infections in 2013
compared with average annual incidence during 20102012, by pathogen Foodborne Diseases Active Surveillance Network, United States
Abbreviations: CI = confidence interval; STEC = Shiga toxinproducing Escherichia coli.
* No significant change = 95% CI is both above and below the no change line; significant increase = estimate and entire CI are above the no change line; significant
decrease = estimate and entire CI are below the no change line.
-100
-80
-60
-40
-20
0
20
40
60
80
Estimated % change
95% confdence interval
100
Campylobacter Listeria Salmonella Shigella STEC O157 STEC Non-O157 Vibrio Yersinia Cryptosporidium
Pathogen
%

c
h
a
n
g
e
*
D
e
c
r
e
a
s
e
I
n
c
r
e
a
s
e
No
change
** Additional information available at http://www.cdc.gov/salmonella/enteritidis/
index.html.

Addi ti onal i nformati on avai l abl e at http: //www. fda. gov/food/
guidanceregulation/guidancedocumentsregulatoryinformation/eggs/
ucm170615.htm.

Additional information available at http://www.hhs.gov/strategic-plan/
appendixb3.html.

Additional information available at http://www.cdc.gov/vibrio/investigations/
index.html.
Morbidity and Mortality Weekly Report
MMWR / April 18, 2014 / Vol. 63 / No. 15 331
virulent strains of STEC O157. It is possible that more stool
specimens are being tested for STEC, resulting in increased
detection of milder infections than in the past. Continued
surveillance is needed to determine if this pattern holds.
CIDTs are increasingly used by clinical laboratories to diag-
nose bacterial enteric infections, a trend that will challenge the
ability to identify cases, monitor trends, detect outbreaks, and
characterize pathogens (8). Therefore, FoodNet began tracking
CIDT-positive reports and surveying clinical laboratories about
their diagnostic practices. The adoption of CIDTs has varied by
pathogen and has been highest for STEC and Campylobacter.
Positive CIDTs frequently cannot be confirmed by culture,
and the positive predictive value varies by the CIDT used. For
STEC, most specimens identified as Shiga toxinpositive were
sent to a public health laboratory for confirmation. However,
for other pathogens the fraction of specimens from patients
with a positive CIDT sent for confirmation likely is low because
no national guidelines regarding confirmation of CIDT results
currently exist. As the number of approved CIDTs increases,
their use likely will increase rapidly. Clinicians, clinical and
public health laboratorians, public health practitioners, regu-
latory agencies, and industry must work together to maintain
strong surveillance to detect dispersed outbreaks, measure the
impact of prevention measures, and identify emerging threats.
The findings in this report are subject to at least five limi-
tations. First, health-careseeking behaviors and other char-
acteristics of the population in the surveillance area might
affect the generalizability of the findings. Second, some agents
transmitted commonly through food (e.g., norovirus) are not
monitored by FoodNet because clinical laboratories do not
routinely test for them. Third, the proportion of illnesses trans-
mitted by nonfood routes differs by pathogen; data provided
in this report are not limited to infections from food. Fourth,
in some fatal cases, infection with the enteric pathogen might
not have been the primary cause of death. Finally, changes in
incidence between periods can reflect year-to-year variation
during those periods rather than sustained trends.
Most foodborne illnesses can be prevented, and progress
has been made in decreasing contamination of some foods
and reducing illness caused by some pathogens since 1996,
FIGURE 2. Relative rates of culture-confirmed infections with Campylobacter, STEC* O157, Listeria, Salmonella, and Vibrio compared with
20062008 rates, by year Foodborne Diseases Active Surveillance Network, United States, 20062013

* Shiga toxinproducing Escherichia coli.

The position of each line indicates the relative change in the incidence of that pathogen compared with 20062008. The actual incidences of these infections cannot
be determined from this figure.
0.5
1.0
2.0
20062008 2009 2010 2011 2012 2013
Campylobacter
STEC O157
Listeria
Salmonella
Vibrio
R
e
l
a
t
i
v
e

r
a
t
e

(
l
o
g

s
c
a
l
e
)
Year
Morbidity and Mortality Weekly Report
332 MMWR / April 18, 2014 / Vol. 63 / No. 15
when FoodNet began. More can be done; surveillance data
provide information on where to target prevention efforts.
In 2011, USDA-FSIS tightened its performance standard for
Salmonella contamination of whole broiler chickens; in 2013,
3.9% of samples tested positive (Christopher Aston, USDA-
FSIS, Office of Data Integration and Food Protection; personal
communication; 2014). Because most chicken is purchased as
cut-up parts, USDA-FSIS conducted a nationwide survey of
raw chicken parts in 2012 and calculated an estimated 24%
prevalence of Salmonella (9). In 2013, USDA-FSIS released
its Salmonella Action Plan that indicates that USDA-FSIS will
conduct a risk assessment and develop performance standards
for poultry parts during 2014, among other key activities
(10). The Food Safety Modernization Act of 2011 gives FDA
additional authority to regulate food facilities, establish stan-
dards for safe produce, recall contaminated foods, and oversee
imported foods; it also calls on CDC to strengthen surveillance
and outbreak response (1). For consumers, advice on safely
buying, preparing, and storing foods prone to contamination
is available online.
1
Division of Foodborne, Waterborne, and Environmental Diseases, National
Center for Emerging and Zoonotic Infectious Diseases, CDC;
2
California
Department of Public Health;
3
Colorado Department of Public Health and
Environment;
4
Connecticut Department of Public Health;
5
Georgia
Department of Public Health;
6
Maryland Department of Health and Mental
Hygiene;
7
Minnesota Department of Health;
8
University of New Mexico;
9
New
York State Department of Health;
10
Oregon Health Authority;
11
Tennessee
Department of Health;
12
Food Safety and Inspection Service, US Department
of Agriculture;
13
Center for Food Safety and Applied Nutrition, Food and
Drug Administration (Corresponding author: Olga L. Henao, ohenao@cdc.gov,
404-639-3393)
Acknowledgments
Workgroup members, Foodborne Diseases Active Surveillance
Network (FoodNet), Emerging Infections Program. Communications
team, Division of Foodborne, Waterborne, and Environmental
Diseases, National Center for Emerging and Zoonotic Diseases;
Enteric Diseases Laboratory Branch, Division of Foodborne,
Waterborne, and Environmental Diseases, National Center for
Emerging and Zoonotic Diseases, CDC.
References
1. Food and Drug Administration. FDA Food Safety Modernization Act.
Washington, DC: US Department of Health and Human Services, Food
and Drug Administration; 2011. Available at http://www.fda.gov/food/
guidanceregulation/fsma/ucm247548.htm.
2. Henao OL, Scallan E, Mahon B, Hoekstra RM. Methods for monitoring
trends in the incidence of foodborne diseases: Foodborne Diseases Active
Surveillance Network 19962008. Foodborne Pathog Dis 2010;
7:14216.
3. Henao OL, Crim SM, Hoekstra RM. Calculating a measure of overall
change in the incidence of selected laboratory-confirmed infections with
pathogens transmitted commonly through food, Foodborne Diseases
Active Surveillance Network (FoodNet), 19962010. Clin Infect Dis
2012;54(Suppl 5):S41820.
4. Shapiro RL, Altekruse S, Hutwagner L, et al. The role of Gulf Coast
oysters harvested in warmer months in Vibrio vulnificus infections in
the United States, 19881996. J Infect Dis 1998;178:7529.
5. CDC. National enteric disease surveillance: COVIS annual summary,
2011. Atlanta, Georgia: US Department of Health and Human Services,
CDC; 2013. Available at http://www.cdc.gov/ncezid/dfwed/pdfs/covis-
annual-report-2011-508c.pdf.
6. Vugia DJ, Tabnak F, Newton AE, et al. Impact of 2003 state regulation
on raw oyster-associated Vibrio vulnificus illnesses and deaths, California,
USA. Emerg Infect Dis 2013;19:127680.
7. Dechet AM, Yu PA, Koram N, Painter J. Nonfoodborne Vibrio
infections: an important cause of morbidity and mortality in the United
States, 19972006. Clin Infect Dis 2008;46:9706.
8. Cronquist AB, Mody RK, Atkinson R, et al. Impacts of culture-
independent diagnostic practices on public health surveillance for
bacterial enteric pathogens. Clin Infect Dis 2012;54(S5):S4329.
9. US Department of Agriculture, Food Safety and Inspection Service. The
Nationwide Microbiological Baseline Data Collection Program: Raw
Chicken Parts Survey, January 2012August 2012. Washington, DC:
US Department of Agriculture, Food Safety and Inspection Service;
2013. Available at http://www.fsis.usda.gov/wps/wcm/connect/
a9837fc8-0109-4041-bd0c-729924a79201/baseline_data_raw_
chicken_parts.pdf?mod=ajperes.
10. US Department of Agriculture, Food Safety and Inspection Service.
Strategic Performance Working Group Salmonella action plan.
Washington, DC: US Department of Agriculture, Food Safety and
Inspection Service; 2013. Available at http://www.fsis.usda.gov/wps/
wcm/connect/aae911af-f918-4fe1-bc42-7b957b2e942a/sap-120413.
pdf?mod=ajperes.
What is already known on this topic?
The incidences of infection caused by Campylobacter,
Salmonella, Shiga toxinproducing Escherichia coli O157, and
Vibrio are well above their respective Healthy People 2020
targets. Foodborne illness continues to be an important public
health problem.
What is added by this report?
In 2013, a total of 19,056 infections, 4,200 hospitalizations, and
80 deaths were reported to the Foodborne Diseases Active
Surveillance Network (FoodNet). For most infections, incidence
was highest among children aged <5 years. In 2013, compared
with 20102012, the estimated incidence of infection was
unchanged overall, lower for Salmonella, and higher for Vibrio
infections, which have been increasing in frequency for many
years. The number of patients being diagnosed by culture-
independent diagnostic tests (CIDT) is increasing.
What are the implications for public health practice?
Reducing the incidence of foodborne infections requires greater
commitment and more action to implement measures to
reduce contamination of food. Monitoring the incidence of
these infections is becoming more difficult because some
laboratories are now using CIDTs, and some do not follow up a
positive CIDT result with a culture.