EdNet February 2013

EdNet, the National Food Safety Educator’s Network, is a monthly, multi-agency electronic news journal from the U.S. Food and Drug Administration (FDA), Food Safety and Inspection Service (FSIS), and the Centers for Disease Control and Prevention (CDC). EdNet provides up-to-date information about food safety and nutrition programs and activities for educators, consumer advocates, government officials, and industry representatives.  

If you have questions or comments about this issue of EdNet, send e-mail to the Center for Food Safety and Applied Nutrition (FDA).

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In this issue:

Advisories, Alerts, and Warnings

• USDA Consumer Alert: Keeping Food Safe During an Emergency

Resources for Educators

•  FDA Statement about Canadian Salmon that were Exposed to the Infectious Salmon Anemia (ISA) Virus
• Statement from Agriculture Secretary Tom Vilsack: World Organization for Animal Health Recommends United States' BSE Risk Status Be Upgraded
• Industry and Consumer Assistance on Food, Cosmetics, and Dietary Supplements
• New Smart Snacks in School Proposal to Ensure Vending Machines, Snack Bars Include Healthy Choices
• The Nutrition Facts Label: Helping Americans Make Heart-Healthy Choices
• Blog by: Janelle Derbis, PharmD, on, Celebrating American Heart Month—Making Heart Healthy Choices in 2013
•  USDA’S Amber Waves App
• Amber Waves Magazine – February 2013                       

Meetings, Conferences, and Workshops

• FDA to Hold Additional Public Meetings on Two Major FSMA Proposed Rules
• Codex Public Meeting              

People in the News

• Faces of Food Safety

Industry

• FDA Highlights Good Agricultural Practices for the Cantaloupe Industry
• FDA Enters into Consent Decree with Chicago Sprout Producer Due to Unsanitary Conditions
• USDA Announces Availabiltiy of Biotechnology Regulatory Petitions and Other Actions
• FDA: Extension of Comment Period (to May 16, 2013) for Information Collection Provisions Associated with Two FSMA Proposed Rules
• FDA and JIFSAN Announce Online Training for Aquaculture Producers and Importers
• U.S. Marshals Seize Drug Products Distributed by a Florida Company
• FDA Publishes a Draft Risk Assessment of Listeriosis from Soft-Ripened Cheese
• FDA Announces Final Rule on Administrative Detention of Food
• FDA: Court Shuts Down U.S. Operations of California Drug, Dietary Supplement Manufacturer
• Michigan Soy Processor is Under Court Order to Meet FDA Food Safety Standards
• FSIS Policy Updates  

Advisories, Alerts, and Warnings

 USDA Consumer Alerts: Keeping Food Safe During an Emergency

Resources for Educators

 FDA Statement about Canadian Salmon that were Exposed to the Infectious Salmon Anemia (ISA) Virus

FDA has recently received inquiries as to whether salmon from Canada that have been exposed to the infectious salmon anemia (ISA) virus, but are not necessarily diseased, would be allowed entry in to the U.S. It is possible for animals to be exposed to and even to be infected with a particular organism and not develop a disease. Disease occurs due to numerous factors, including: the health of the animal, resistance of the animal, environmental factors, the number and concentration of the organism the animal was exposed to, and virulence of the strain of the organism. Therefore, exposure to an infectious organism may or may not result in disease.

To read the entire statement, go to:

http://www.fda.gov/downloads/Food/UCM339044.pdf

 Statement from Agriculture Secretary Tom Vilsack: World Organization for Animal Health Recommends United States' BSE Risk Status Be Upgraded

On February 20, 2013, Agriculture Secretary Tom Vilsack made the following statement about notification received today from the Scientific Commission for the World Organization for Animal Health (OIE) recommending that the United States' risk classification for bovine spongiform encephalopathy (BSE) be upgraded to negligible risk.

Read this statement:

http://www.usda.gov/2013/02/0030.xml

 Industry and Consumer Assistance on Food, Cosmetics, and Dietary Supplements

The purpose of posting the Industry and Consumer Assistance on Food, Cosmetics, and Dietary Supplements page is to provide food industry members and consumers information on food, cosmetic, and dietary supplement topics.

You will find links to popular topics at: 

http://www.fda.gov/Food/ucm334249.htm

 New Smart Snacks in School Proposal to Ensure Vending Machines, Snack Bars Include Healthy Choices

On February 1, 2013, the USDA announced it will seek public comment on proposed new standards to ensure that children have access to healthy food options in school.

Read the news release:

http://www.fns.usda.gov/pressrelease/2013/001913

 The Nutrition Facts Label: Helping Americans Make Heart-Healthy Choices

February is American Heart Month, and the U.S. Food and Drug Administration has a tool to help you achieve a heart-healthy lifestyle. It’s called the Nutrition Facts Label, and it can be found on all packaged foods and beverages. Now in its twentieth year, the Nutrition Facts Label helps you track the various nutrients you are getting from the foods you eat. In fact, it serves as your overall guide for comparing foods and making choices that can affect your long-term health!

To read this News Release, visit:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm338313.htm

 Blog by: Janelle Derbis, PharmD, on, Celebrating American Heart Month—Making Heart Healthy Choices in 2013

Each year, nearly half of all Americans make New Year’s resolutions. They often include losing weight, starting an exercise program, quitting smoking, and making healthier food choices—all of which contribute to a heart-healthy lifestyle. February is American Heart Month, and the timing couldn’t be better to make these lifestyle changes, especially since heart disease is the leading cause of death in the U.S. FDA joins in the commemoration of American Heart Month by highlighting agency initiatives to help Americans reduce their risk of heart disease.

Read the entire blog on FDA Voice at:

 USDA’S Amber Waves App

  Meetings, Conferences, and Workshops

  FDA to Hold Additional Public Meetings on Two Major FSMA Proposed Rules

The FDA is announcing two additional public meetings on the Food Safety Modernization Act (FSMA): Proposed Rules for Produce Safety and for the Preventive Controls for Human Food. These meetings are the second and third in a series of public meetings announced in the

January 31, 2013 Federal Register Notice and on FDA’s FSMA website. The first meeting was held February 28-March 1, 2013, at the USDA in Washington, DC. The purpose of the public meetings is to discuss the proposed rules to establish standards for growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls for human food proposed rule).

For specific information for the second and third public meetings in Chicago, IL and Portland, OR, visit:

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm339102.htm

 Codex Public Meeting

FSIS and the FDA are hosting a public meeting to receive comments and draft U.S. positions that are scheduled to be discussed at the 41st Session of the Codex Committee on Food Labeling (CCFL) in Charlottetown, Canada. The public meeting is scheduled for April 17, from 1-3 p.m. at USDA's Jamie L. Whitten Bldg., 1400 Independence Ave., SW, Rm. 107-A, Washington, DC 20250. Agenda items include: implementation of the World Health Organization Global Strategy on Diet, Physical Activity and Health; proposed draft revision of the guidelines on nutrition and health claims concerning non-addition of sodium salts; and guidelines for the production, processing, labeling and marketing of organically produced foods. For more information about the public meeting, contact Doreen Chen-Moulec at (202) 205-7760 or uscodex@fsis.usda.gov

Documents and agenda items related to the 41st session of the CCFL will be available at: http://www.codexalimentarius.org/meetings-reports/en

For Codex committees scheduled public meetings, visit FSIS at:

http://www.fsis.usda.gov/codex_alimentarius/public_meetings/index.asp

People in the News

  Faces of Food Safety

Consumer confidence in our food supply comes as a result of the work of the men and women of FSIS. "Faces of Food Safety" introduces you to employees who play a key role in making our food safe.

• Meet: Natasha Williams, who since coming to FSIS, program specialist Williams has been focused on building connections and bringing people together to achieve common goals.
• Meet:  Dr. Douglas Fulnechek who says as a Supervisory Veterinary Medical Officer he takes great pride in working to prevent foodborne illness and protecting the public health of consumers.

Read more about Natasha Williams and Dr. Douglas Fulnechek
http://www.fsis.usda.gov/About_FSIS/Faces_Food_Safety/index.asp  

  FDA Highlights Good Agricultural Practices for the Cantaloupe Industry

As the growing and harvest season get underway for cantaloupe grown in the United States, the FDA is working with state partners and the produce industry to promote practices that reduce the risk of harmful contamination. FDA issued a letter  to companies that handle cantaloupe, strongly encouraging them to follow agricultural practices that the agency and the produce industry know to be effective in protecting the safety of their product. The letter also informs the industry that FDA will be inspecting packinghouses over the course of the upcoming growing and packing season to, in part, assess current practices and identify conditions that may adversely affect the safety of cantaloupe.

Read this Constituent Update at:

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm341049.htm

Michael Landa, Director of FDA’s Center for Food Safety and Applied Nutrition, has written a blog on the importance of enhancing the safety of cantaloupe for consumers. Read the entire blog on FDA Voice at:

http://blogs.fda.gov/fdavoice/index.php/2013/02/were-taking-steps-to-enhance-the-safety-of-cantaloupe-for-consumers/

FDA Enters into Consent Decree with Chicago Sprout Producer Due to Unsanitary Conditions
 
U Joo Foods, a Chicago sprout grower and processor and the company’s owner and president, Kiyoung Chin have agreed to enter into a consent decree of permanent injunction sought by the Justice Department on behalf of the FDA. Under the consent decree, U Joo Foods and its owner are prohibited from processing and distributing food until they demonstrate to the FDA that the facility and processing equipment are suitable to prevent contamination in the food that they process, prepare, store, and handle.  In addition, they must routinely test the water where the sprouts are grown for evidence of contamination. U.S. District Judge Robert W. Gettleman of the U.S. District Court for the Northern District of Illinois, signed the consent decree on February 8, 2013.

Read this News Release in its entirety at:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340825.htm

  FDA: Extension of Comment Period (to May 16, 2013) for Information Collection Provisions Associated with Two FSMAProposed Rules

The FDA is extending the comment period for the information collection provisions associated with the proposed rules on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption that appeared in the Federal Register of January 16, 2013.

Read this Constituent Update at:

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm339908.htm

 USDA Announces Availabiltiy of Biotechnology Regulatory Petitions and Other Actions

On February 22, 2013, the USDA’s Animal and Plant Health Inspection Service (APHIS) announced the Agency has sent several biotechnology regulatory actions to the Federal Register for publication in the near future.

Read the entire news release:

http://www.aphis.usda.gov/newsroom/2013/02/brs_combined_petitions.shtml

 FDA and JIFSAN Announce Online Training for Aquaculture Producers and Importers

On February 13, 2013, the FDA announced that it has partnered with the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) at the University of Maryland to offer a training module for aquaculture producers to help them comply with FDA regulations for importing seafood. JIFSAN houses the online training on its website and provides certificates of completion to those who take it.

Read this Constituent Update at:

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm339190.htm

 U.S. Marshals Seize Drug Products Distributed by a Florida Company

On February 14, 2013, U.S. Marshals, acting on behalf of the FDA, seized tainted dietary supplements from Globe All Wellness, LLC (Globe All), in Hollywood, FL. The products may be unsafe because they contain an undisclosed active pharmaceutical ingredient. Several of the seized products contain sibutramine hydrochloride (sibutramine), the active ingredient in the obesity drug Meridia. In December 2010, Meridia was withdrawn from the U.S. market after clinical data demonstrated that the drug increased the risk of heart attack and stroke. The company’s products are drugs that have not been approved by the FDA for their claimed uses.

For detailed information, go to:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm339887.htm

  FDA Publishes a Draft Risk Assessment of Listeriosis from Soft-Ripened Cheese

On February 8, 2013, the FDA announced a draft quantitative assessment of the risk of listeriosis from soft-ripened cheese consumption in the United States and Canada. The risk assessment is a joint effort between FDA and Health Canada. View the Federal Register Notice for the assessment. The new FDA/Health Canada draft risk assessment found that the risk of listeriosis from soft-ripened cheeses made with raw milk is estimated to be 50 to 160 times higher than that from soft-ripened cheese made with pasteurized milk. This finding is consistent with the fact that consuming raw milk and raw milk products generally poses a higher risk from pathogens than do pasteurized milk and its products.

Guidelines for avoiding illness by choosing milk and milk products carefully and instructions on how to submit comments to the FDA can be found at:

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm338706.htm

 FDA Announces Final Rule on Administrative Detention of Food

On February 3, 2013, the FDA announced a final rule amending the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace. This action makes the criteria consistent with changes to the Federal Food, Drug, and Cosmetic Act under the Food Safety Modernization Act (FSMA). The final rule adopts the interim final rule Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption, published in

May 2011, without change. The interim final rule amended the criteria for ordering administrative detention to permit FDA to administratively detain food it believes is adulterated or misbranded. The interim final rule became effective in July 2011.

For more information, visit:

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm337693.htm

 FDA: Court Shuts Down U.S. Operations of California Drug, Dietary Supplement Manufacturer

A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act (the Act). U.S. District Judge Otis D. Wright of the Central District of California signed the order on Dec. 11, 2012, against Titan Medical Enterprises Inc., of Santa Fe Springs, CA, and James L. McDaniel, Titan Medical’s owner and president. The order was entered in response to a complaint filed by the U.S. Department of Justice, on behalf of the FDA. The court found that the company and McDaniel violated the Act by failing to follow current Good Manufacturing Practice for drugs (Drug cGMP) and for dietary supplements (Dietary Supplement cGMP). The court also found that the defendants violated federal law by distributing unapproved new drugs in violation of the Act.

To read how repeated violations prompt government action, visit:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm338879.htm

 Michigan Soy Processor is Under Court Order to Meet FDA Food Safety Standards

Green Hope LLC, which does business as Rosewood Products, and owner, Phi G. Ye, of Ann Arbor, MI, have agreed to a consent decree of permanent injunction for violations of FDA food safety regulations. The consent decree was signed by Judge David M. Lawson of the U.S. District Court for the Eastern District of Michigan, Southern Division, on January 28, 2013. Several FDA inspections found persistent violations involving insanitary conditions at the facility, leading to possible contamination of food. The firm manufactures and distributes organic tofu, soy milk and other products. Under the consent decree, Green Hope must stop operations until the FDA approves the steps taken to bring its operations into full compliance with the Federal Food, Drug and Cosmetic Act and FDA food safety regulations.

For more information, go to:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm337689.htm

 FSIS Policy Updates 

FSIS issues Notices and Directives to protect public health. The following policy updates were recently issued:

• FSIS Notice 18-13: Instructions for Conducting Verification Tasks on Missed Inspection Visits of Processing Establishments
• FSIS Notice 17-03: Responsibilities Related to Establishments Producing Not Ready-To-Eat Comminuted Chicken and Turkey Products
• FSIS Notice 16-03: Preparations for Industry Access to the Public Health Information System (PHIS)
• FSIS Notice 15-13: Change of Egg Products Daily Plant Operations Form Numbers
• FSIS Notice 14-13: Export of Product with a Country Label Designation Different from the Export Certificate Designation
• FSIS Notice 13-13:FSIS Sampling for the National Antimicrobial Resistance Monitoring System

All Notices and Directives are available at:

http://www.fsis.usda.gov/Regulations_&_Policies/index.asp