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| 1:00PM | Registration |
| 1:15PM | Welcome and Orientation |
| Purpose and Introductions | |
| 1:30PM | FDA’s Guide: General Changes and Clarifications |
| 2:00PM | Chapters 1- 6 Overview |
| 2:20PM | Chapter 7 - Scombrotoxin (Histamine) Formation |
| 3:00PM | BREAK |
| 3:15PM | Chapters 8 – 11 Overview |
| 3:30PM | Chapters 12 - 15 Overview |
| 4:00PM | Chapters 16 – 18 Thermal Processing Issues |
| 4:30PM | Chapters 19 -21 Allergens and Physical Hazards |
| 4:50PM | Final Comments & SHA Training Handouts |
| 5:00PM | Adjourn |
Submitted by Pamela Tom, California Sea Grant, University of California
The U.S. Food and Drug Administration (FDA) has inspection authority over imported seafood. Prior to the March 11 earthquake in Japan, scarce information was available on radionuclide contamination. Now, the FDA home page (http://www.fda.gov) includes “Radiation Safety”1 information targeted at food products imported from Japan. FDA does an excellent job of summarizing frequently asked questions and answers regarding FDA activities on screening and testing results, and seafood safety issues related to radiation concerns. Below are excerpted fish and seafood discussions from “Radiation Safety.” [Note: the web address at the bottom of this article takes you to “Radiation Safety” where you can also read about specific tests and methodology along with measures the FDA is taking to ensure the safety of other products imported from Japan.]
What has FDA’s screening and testing shown so far?
As of May 5, 2011, FDA import investigators had performed 9.634 field examinations for radionuclide contamination. FDA had tested 356 samples, 82 of which were seafood or seafood products. 355 samples had no Iodine-131, Cesium-134, Cesium-137 or other gamma-ray emitting radionuclides of concern. One sample contained detectable levels of Cesium, but was below the established Derived Intervention Level and posed no public health concern.
How will water contaminated with radioactive materials affect seafood safety?
Due to a number of factors, FDA does not anticipate any public health effect on seafood safety:
What about fish that swim from the reactor site into U.S. fishing waters?
Japan to U.S. waters would take several days under the best of circumstances. Vessels fishing in waters far off U.S. shores must also travel several days to return to port. It is unlikely that a fish exposed to significant levels of radionuclides near the reactor could travel to U.S. waters and be caught and harvested. If this improbable trip did occur, the level of short-lived radionuclides such as I-131 would drop significantly through natural radioactive decay during the time needed to make the journey. At this time, Japanese tests have detected longer-lived radionuclides such as Cs-137 in only a few samples and at levels below FDA DILs. FDA’s testing of fish imported from Japan has not detected the presence of Cs-137.
In the unlikely scenario that pollutants could affect fish that have traveled to the U.S., FDA will work with the National Oceanic and Atmospheric Administration (NOAA) to test seafood caught in those areas. Together FDA and NOAA will also inspect facilities that process and sell seafood from those areas.
Where would the seafood be analyzed?
FDA's Winchester Engineering and Analytical Center (WEAC) will conduct any needed sample analysis. WEAC can also reach out to the Food Emergency Response Network laboratories that are able to perform this analytical testing for assistance if needed.
Is FDA looking at products that might have traveled through Japan at the time of the explosion?
FDA will be examining both food products labeled as having originated in Japan or having passed through Japan in transit. The same is true for raw ingredients.
There are two types of radioactive elements of concern – iodine-131 (I-131) and cesium-137 (Cs-137). I-131 has a short half-life, which means that it quickly becomes nonradioactive.
Cs-137 has a longer half-life, but research shows it excretes rather than accumulates in fish.
1The direct link to “Radiation Safety” is at:
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm247403.htm
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The Colorado Department of Public Health and Environment’s (CDPHE), Division of Environmental Health and Sustainability (DEHS) has taken a proactive approach to education on the Voluntary National Retail Food Regulatory Program Standards (Standards) over the past year. As an enrolled jurisdiction in the Standards, DEHS applied for and was awarded funding through the Food and Drug Administration (FDA) for our proposed educational outreach related to the Standards. On July 21, 2010, DEHS worked cooperatively with our Southwest Region FDA Retail Food Program Specialist, Mario Seminara, and a Pacific Region FDA Regional Retail Food Program Specialist, John Marcello, to provide a one day seminar involving the Standards. The seminar was offered to all jurisdictions currently enrolled in the Standards, as well as to those interested in enrolling or simply learning more. There were 32 participants representing 17 Colorado regulatory agencies, with 10 of the 13 enrolled jurisdictions in attendance. The seminar opened with an overview of the Standards and then focused on elements of Standard #2, Trained Regulatory Staff. The participants worked interactively to conduct a training plan gap analysis for their agency utilizing the Conference of Food Protection (CFP) Field Training Manual. The seminar was well received and attendees gave excellent feedback, including the desire for additional seminars and assistance on the standards.
As part of the follow-up to this seminar, DEHS provided five seminars throughout the various regions of Colorado. The seminars were held during March in Weld and Pueblo counties and during April in San Juan, Mesa and Eagle counties. A total of 60 attendees representing 24 agencies attended the seminars. The regional seminars provided an in depth review of each Standard and then focused on elements of Standard #2, Trained Regulatory Staff. While the agenda for these regional seminars modeled the July 21st seminar, returning attendees were able to move forward with the work achieved during the previous seminar and were able to mentor those who were receiving the information for the first time.
Additionally, the training analysis discussions for each seminar was captured on the CFP Training Plan and Log and provided to each group. A compilation of the discussions from all five seminars is in process and will be distributed to attendees of all five seminars as each seminar had unique discussions that could benefit all jurisdictions. The seminars received overwhelming positive feedback and attendees indicated the regional outreach is a favorable component of this program. Overall, attendees indicated they were able to build a better understanding of the Standards and Training Program components, share necessary information and resources to assist in achieving the Standards, help establish forward movement in the statewide collaboration, and build on regional networks for communicating and working together on the aspects of the Standards. Several jurisdictions expressed interest in enrolling in the as a result of the seminars and DEHS is actively working with these entities.
For more information contact: Nicole Grisham; Nicole.grisham@state.co.us
Submitted by:
Patricia A. Klocker
Assistant Director
Division Of Environmental Health and Sustainability
Colorado Department of Public Health and Enviornment
4300 Cherry Creek Drive South
Denver, CO 80246-1530
Office:303-692-3637
Fax:303-753-6809
patricia.klocker@state.co.us
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April 5, 2011
On April 4, 2011, the U.S. Food and Drug Administration (FDA) launched a new consumer-friendly Web search1 for use during recalls. Consumers will now be able to search for food and other product recalls easier and quicker on the FDA’s website. To provide greater ease of use for consumers, the search results will now provide data from news releases and other recall announcements in the form of a table2. That table organizes information from news releases on recalls since 2009 by date, product brand name, product description, reason for the recall and the recalling firm. The table also provides a link to the news release on each recall for more detailed information. The news releases were chosen as the source of information for the table because they provide the most up-to-date and user friendly information about any recall.
The Food Safety Modernization Act (FSMA)3, signed into law in January by President Obama, called for a more consumer-friendly recall search engine within 90 days after the law went into effect. Per the requirements of the FSMA, for certain recalls the search results will also provide status information on whether the recall is completed or on-going. The status information will be provided for those recalls that FDA either ordered a mandatory recall or provided the opportunity for a voluntary recall under FDA's FSMA authority.
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Prior to launching the new Web search, the FDA consulted with stakeholder groups, including the Center for Science in the Public Interest, Consumers Union, Food Marketing Institute, Grocery Manufacturers Association, the Pew Health Group, and Safe Tables Our Priority to gain their insights on how to most effectively and easily communicate recall information to consumers.
For more information:
May 4, 2011
The Food and Drug Administration (FDA) and the U.S. Customs and Border Protection (CBP) today issued an interim final rule on “Information Required in Prior Notice of Imported Food”. The interim final rule is a requirement of the FDA Food Safety Modernization Act (FSMA) and it amends the regulation on prior notice of imported food.
FDA issued this interim final rule to require an additional element of information in a prior notice of imported food. This change requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.
The interim final rule, which takes effect on July 3, 2011, can help FDA make better informed decisions in managing the potential risks of food imported into the United States.
The interim final rule does not otherwise change the existing prior notice rule, such as:
For additional information:
The U.S. Food and Drug Administration (FDA) today issued an interim final rule that will allow the agency to detain on its own administrative authority food and feed products it believes are adulterated or misbranded. Previously, FDA’s ability to administratively detain food products for humans or animals applied only when the agency had credible evidence that the food or feed presented a threat of serious adverse health consequences or death to humans or animals.
This interim final rule is authorized by the FDA Food Safety Modernization Act (FSMA), which was signed into law by President Obama in January 2011. The new rule will take effect July 3, 2011.
With this expanded administrative detention authority, FDA will be able to detain food and feed products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed, to ensure they are kept out of the marketplace while the agency determines whether an enforcement action may be required, such as seizure of products or federal injunction against a firm.
Comments about this rule may be submitted to the docket cited in the rule itself.
For more information:
Submitted by:
Mary Ellen Taylor
Public Affairs Specialist
Food and Drug Administration
San Francisco District Office
Alamda, California
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No article submitted.
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2009 Retail Food Code
The Department of Health is wrapping up monthly workgroup discussions with public and private sector partners to develop recommendations regarding the adoption of the 2009 Model Food Code. The current rule is based on the 2001 Food Code. A proposed draft rule will be completed by mid 2011, which will then be shared for further public comment and subsequent approval by the State Board of Health. Implementation of the new rule is expected to be sometime in 2012.
Foodborne Disease Response Meetings and Training
The Department of Health’s Communicable Disease Epidemiology Section and Food Safety Program staff toured the state this spring to facilitate one-day meetings with lead staff from both Food Safety and Communicable Disease programs at local health jurisdictions. The purpose of the meetings was to bring staff together to assess foodborne disease outbreak response strengths at each local health jurisdiction and address areas of improvement. Standards and materials from the Council to Improve Foodborne Outbreak Response (CIFOR) were used to assist in the self assessments. As a follow up to these meetings, our Spring 2011 Food Safety Workshop at five locations across the state in May and June will focus exclusively on ways to improve outbreak response. This one-day workshop is offered for free and is usually attended by 150-200 representatives from local health, other agencies and the food industry.
“Service Animal” Definition Changed for Food Establishments
Governor Gregoire signed a bill that modifies the definition of “service animal” as it applies to food establishments in Washington. The new law incorporates the new ADA definition, which only recognizes trained “dogs” as service animals. The definition also specifically states that animals which only serve as “comfort animals” do not qualify as service animals. This new law should allow the food industry to maintain better control of animals entering its establishments, thus reducing potential animal-borne health and safety issues from non-service animals.
Cottage Food Law in Place
The governor also signed a bill that allows people to make certain foods (e.g. jams, jellies and baked goods) in their home kitchens. These “cottage food operations” will be licensed and inspected by the state department of agriculture (WSDA). The operations are required to meet certain food safety provisions, including all food workers obtaining Food Worker Cards. The food items must be packaged and properly labeled, including stating “Made in a home kitchen that has not been subject to standard inspection criteria.” Cottage food products may only be sold directly from the cottage food operation to the consumer, and each operation may not exceed $15,000 annual gross sales.
Submitted by
Dave Gifford
Food Safety Program Manager
Washington State Department of Health

Press Release
FDA partners with the Association of American Feed Control Officials to develop Animal Feed Regulatory Program Standards
For more information:
Kent Kitade, AAFCO Past President
916-445-2140
kkitade@cdfa.ca.gov
March 22, 2011: The Food and Drug Administration (FDA) will collaborate with the Association of American Feed Control Officials (AAFCO) to develop voluntary regulatory program standards for federal and state agencies responsible for regulating facilities that manufacture, package, distribute, or store animal feed, which includes pet food. The Animal Feed Regulatory Program Standards (AFRPS) will be modeled after the Manufactured Food Regulatory Program Standards that was successfully launched in 2007 and will similarly represent a significant step in promoting uniformity, equivalency and continuous improvement among feed regulatory agencies – all critical in a successful national integrated food safety system.
Joseph Reardon, Director of FDA’s Division of Federal State Relations (FDA/DFSR) made the announcement earlier this year at the 2011 AAFCO Midyear Meeting.
Chad Linton, AAFCO president said, “AAFCO and FDA understand the importance of promoting uniformity across the agencies and will work efficiently and diligently to produce a positive and valuable Animal Feed Regulatory Program Standard that can be used by the states and FDA. We thank the committee members for their dedication and commitment in creating universal standards that will play a critical role in ensuring the safety of our nation’s food supply.
While regulatory priorities, capabilities, capacities, authorities and activities may vary from state to state and district to district, the new AFRPS will provide the uniform basis for measuring and improving performance in reducing food and feed borne risks to human and animal health. The standards will represent the best practices appropriate for all animal feed and pet food regulatory programs and could include the following performance measures:
The committee that is tasked to develop the regulatory program standards will be led by co-chairs AAFCO representative Ali Kashani of the Washington State Department of Agriculture and Jeanette Murphy of the FDA/Center for Veterinary Medicine and project manager Beverly Kent, FDA/DFSR. The committee has already conducted two conference calls and a week-long face-to-face meeting. The goal of the committee is to have the standards available for states to voluntarily implement sometime in 2012.
About AAFCO
AAFCO is a non-regulatory, volunteer, non-profit body that develops model legislation, programs and policies that, when adopted by state agencies, promotes regulatory uniformity and provides the highest assurance possible for the safety of the nation’s food and feed supply. For more information visit www.aafco.org
Submitted by:
Ali Kashani
Feed & Fertilizer Compliance
Registration Services
Pesticide Management Division
Washington State Department of Agriculture
Tel. (360) 902-2028
Fax (360) 902-2093
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