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FDA Updates Strategy for FSMA Training
Today, the Food and Drug Administration (FDA) issued a Constituent Update announcing the Agency has published an updated training strategy related to the FDA Food Safety Modernization Act (FSMA), which reflects the progress that has been made in the past year. The FDA awarded funding for the development of training curricula and delivery to the National Farmers Union Foundation and the University of Arkansas at Fayetteville. Federal grants have also been awarded for the establishment of regional centers to facilitate training at the University of Florida (Southern Regional Center), Oregon State University (Western Regional Center), Iowa State University (North Central Region) and the University of Vermont and State Agricultural College (Northeast Regional Center).
September & October 2016:
Resources from GAEC Presentations at Conference (click to download):
How will the FDA enforce the new FSMA rules? Learn more at the Food Safety Consortium
The FDA takes important steps in modernizing the food safety system
For more information click here
The Senate Committee on Agriculture, Nutrition and Forestry will hold a hearing, "Highly Pathogenic Avian Influenza: The Impact on the U.S. Poultry Sector and Protecting U.S. Poultry Flocks” on July 7, 2015. The hearing announcement is available here.
The United States Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has published a Fact Sheet, "Sourcing Egg Products and Shell Eggs from Foreign Countries,” which can be accessed here.
The Center for Food Integrity has released a webcast regarding the bird flu, Avian Influenza and Its Impact to the Marketplace
Pathogen Testing for Products Produced in Facilities with a HACCP Based Production System
Hazard Analysis and Critical Control Point (HACCP) is a way for industry to control and prevent problems and ensure safe food. HACCP controls the production process from beginning to end, rather than detecting problems after the product enters the market. HACCP is widely recognized by scientific authorities and international organizations and is used extensively in the food industry to produce products in compliance with national and international health and safety requirements.
Under HACCP, a plant analyzes its processes to determine at what point hazards might exist that could affect the safety of its products. These points are called critical control points (CCPs). Examples of critical control points are chilling; the cooking process; processing procedures, such as filling and sealing cans; and certain slaughter procedures, such as removal of internal organs. The location and number of hazards will differ greatly depending on type of facility, foods prepared, processing procedures used, and many other factors.
Once the CCPs are identified, the plant must establish critical limits. Critical limits are usually expressed as numbers representing such parameters as time/temperature, humidity, water activity, pH, salt concentration, and chlorine level. Critical limits may be in the regulations, such as the requirement that poultry be chilled to 40 degrees Fahrenheit, or they may be established by the plant based on the scientific and technical literature or recommendations of experts. Next, the plant establishes monitoring requirements for each CCP and corrective actions to be taken when monitoring indicates there is a deviation from an established critical limit. Examples of corrective actions are adjusting the process, holding and destroying product if it cannot be brought into compliance, and developing an alternative process. The plant must also establish record keeping procedures that document the operation of the HACCP system and verify that controls are working as intended.
In the United States, HACCP plans must conform to the seven HACCP principles established by the National Advisory Committee for Microbiological Criteria for Foods. HACCP plans are required to cover those CCPs that affect product safety, as opposed to those related to economic adulteration, labeling, or quality concerns. Other quality assurance and inspection measures will continue to address these areas. Plants are required to validate that their own HACCP plans do what they were designed to do and ensure the safety of the processed food.
The safety of foods is principally assured by control at the source, product design and process control, and the application of Good Hygienic Practices/Good Manufacturing Practice during production, processing (including labelling), handling, distribution, storage, sale, preparation and use, in conjunction with the application of the HACCP system. This preventive approach offers more control than microbiological testing because the effectiveness of microbiological examination to assess the safety of foods is limited. Microbiological testing should be used in support of a safe process, not as a substitute. Guidance for the establishment of HACCP based systems is detailed in Hazard Analysis and Critical Control Point System and Guidelines for its Application (Annex to CAC/RCP 1-1969, Rev. 3-1997).
There is an ongoing collaborative effort by members of IFSA, Airlines for America (A4A) and the entire onboard industry to align, define and implement industry-wide standards that could be consistently applied across all parties involved. The IFSA's Government Affairs and Education Committee (GAEC) met with the FDA on March 25, followed by a call on April 17, with an FDA representative to answer our questions regarding labeling. A letter with industry feedback was sent to the FDA on May 23.IFSA and Airlines for America members met with the FDA again in July and were assured that the FDA is listening to our concerns and will respond to the industry soon. However, they were unable to give us a timeline. We will continue to support and actively work with the FDA and other agencies to accomplish this aim, as well as continue to create further improvements for the future. In addition, we will continue to update our membership on all regulations and compliance requirements as we receive additional information.
Manual for Agricultural Clearance Update
The mission of the IFSA Government Affairs and Education Committee (GAEC) is to provide information, guidance and education to the IFSA membership regarding food safety and security. IFSA’s GAEC maintains the World Food Safety Guidelines, an effective food safety control concept applicable to airline catering facilities worldwide. The Committee also maintains open dialogue with appropriate regulatory and legislative bodies worldwide to represent IFSA’s interests, and work cooperatively toward the common goal of public health, safety and security.
This year, upon review of the U.S. Department of Agriculture (USDA) "Manual for Agricultural Clearance,” IFSA GAEC members discovered some requirements for catering procedures had been revised. These revisions were not considered to be business as usual and might create additional liability for both caterers and airlines. In May, IFSA surveyed their airline and caterer members to get their feedback on the rule. The intent was that the survey results would be provided to the USDA, and the results would open the door for IFSA’s GAEC to work in conjunction with the agency.
The Committee met with USDA representatives during the APEX/IFSA EXPO in September. Both parties agreed in September to work toward a mutually beneficial solution that addresses safeguarding procedures and requirements. More updates will be provided on this matter as they become available.Revisions to FDA Food Code
Earlier this month, IFSA provided information about a free webinar on revisions to the Food and Drug Administration’s Food Code. The Food Code outlines enforceable provisions for mitigating known risks of foodborne illness in foodservice. A link FDA Retail Food Protection webpage.
The significant Food Code 2013 revisions include:
Use of hand sanitizer alone has not been recommended. Sanitizers require additional contact time with skin and surfaces that is not often present when normal hand washing occurs in a public or food service facility. Use of a hand sanitizer alone without hand washing should only be used in places where safe water and hand wash facilities are not readily available. Hand washing facilities should always be provided to food handlers with water supplies.
The best protection is to wash hands and use a hand sanitizer after thorough hand washing. Click here to read more about hand washing.
New Strain of Bird Flu (H7N9) Discovered in China
On April 1, 2013 the World Health Organization (WHO) reported three human infections with a new strain of the bird flu virus (H7N9) in China. The Centers for Disease Control and Prevention (CDC) are evaluating pandemic risk after the death toll from the new strain of bird flu (H7N9) rose to six on Thursday, April 4.
Joe Bresse, Chief of Epidemiology for CDC's Influenza Division, stated no links or common exposures between these deaths have been identified by the agency. At this time, researchers do not know the source of the infection. The CDC is developing a kit for public health officials to test for the virus and working toward producing a potential vaccine.
The H7N9 virus is usually present in poultry and wild bird populations, and generally does not cause illness in the birds. The virus can either be transmitted between birds or from a bird to a human. Other strains of the bird flue, such as H1N1, have been circulating. The H1N1 virus was responsible for the swine flu pandemic, which was the first global influenza outbreak in over 40 years.
To date, the H7N9 virus has not been detected in people or birds in the U.S. However, several countries around the world including China, Japan, Taiwan and Vietnam, are taking precautions, particularly at airports. While there is no established link between consumption of poultry and contraction of the bird flu virus, catering employees and airline passengers may want to avoid handling ro consuming chicken originating from China for the time being.
IFSA Government Affairs and Education Committee Meeting
The Government Affairs and Education Committee (GAEC) conducted a meeting on January 29 at the Kellen Company’s Washington, D.C. office. An industry committee update was provided. Representatives from the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition provided guidance on allergen labeling of products produced at flight kitchens, general food labeling and a Food Safety Modernization Act (FSMA) update..
Additionally, the U.S. Department of Agriculture, APHIS, provided enforcement information, compliance agreements, current enforcement policy and the issuance of non-compliance fines by inspection staff to catering and airline companies for handling of foreign garbage.
The GAEC committee reviewed the World Food Safety guidelines and is developing the process to update the guidelines to include the new FSMA regulations, labeling, and food code requirements.
Upcoming FDA Public Meetings
On March 27 and 28 in Portland, Oregon, the FDA will hold public meetings to review 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). These rules are the first of five proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA’s FSMA. The meeting is also designed to solicit comments from stakeholders on the proposed rules, inform the public about the rulemaking process (including how to submit comments, data and other information to the rulemaking dockets), and respond to questions about the proposed rules.
The Federal Register announcement of the meetings can be found on the link here: http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm
The meetings will be held at:
For general questions about the Meeting or for special accommodations due to a disability, contact: Juanita Yates, FDA, Center for Food Safety and Applied Nutrition, telephone: 240-402-1731, e-mail: Juanita.firstname.lastname@example.org.
NOTE: A small block of rooms has been reserved at the Crown Plaza Downtown Convention Center in Portland, OR. Additional information is provided on the meeting registration site.
Please note the following important dates:
March 8, 2013: Deadline for verbal comments.
IFSA Members receive a 20% discount on the recording from Food Seminars International's Feb. 14 webinar - Food Retailers' Top 10 Labeling Issues. Click here for more information about the webinar recording.
FSMA's two new proposed rules - the preventative control rule for human food and the produce rule - have been announced. Dr. David Acheson, who has been involved with FSMA since its start, developed a webinar to educate food facilities on what they most need to know and do now.
Some topics reviewed within the webinar include:
What are the key elements of the proposed preventative control and produce rules?
Click here to view the webinar.
Also, click here to view the guidelines for water service vehicle construction (excerpted from 1995 Guide to Inspections of Interstate Carriers and Support Facilities).
The Food Safety Modernization Act (FSMA) contains many instructions to the U.S. Food and Drug Administration (FDA) that require changes to its oversight and regulation of the food industry, including 50 different deliverables in the form of new regulations, guidance and reports to Congress. After an initial burst of activity at FDA the entire process slowed to a crawl in 2012 as the deadlines for major rules on preventive controls, importer verification and produce safety passed while the proposed rules were in the review process. For further information about the FSMA, visit http://www.fda.gov/Food/FoodSafety/FSMA/default.htm.
Facility Registration due by Jan. 31, Prior registration no longer valid
Facilities that are required to register with FDA have to renew their registrations every other year between Oct. 1 and Dec. 31 of each even-numbered year, according to Section 415(a)3 of the USDA’s Federal Food, Drug, and Cosmetic Act (FD&C). Because there was a delay in FDA’s implementation of registration for the 2012 cycle, registration renewal did not become available until Oct. 22, 2012. FDA will exercise enforcement discretion with respect to registration renewals submitted to FDA between Dec. 31, 2012 and Jan. 31, 2013.
While FDA will exercise enforcement discretion, all catering establishments and their suppliers should electronically submit their renewal immediately. Due to the expansion of information requirements, the old registration is no longer valid.
Frequently asked questions and information about the FDA registration renewal process are available on the IFSA website, and the FDA website, http://www.fda.gov/Food/FoodSafety/FSMA/default.htm.
Receive immediate consumer information and recall alerts
Consumer-friendly web search for locating food subject to a recall accomplished April 4, 2011, FSMA § 206, U.S. Code 21 U.S.C. § 3501(note). You may sign up for recall RSS feed at http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/FoodSafety/rss.xml.
Comments for proposed FSMA rules due by May 16
The proposed rules for Preventive Controls for Human Food and Standards for Produce Safety published in the Federal Register on January 4, 2013.
Click here for fact sheets and information that summarize each propose rule. If you would like to see revisions made to the proposed rules, comments will be accepted until May 16, 2013.
Food Safety Regulations Enacted in 2012
Egg Safety Rule, Final Phase: The rule went into effect in 2010 and required shell egg producers with more than 50,000 laying hens to implement Salmonella prevention measures. The past year FDA imposed the same requirements on all producers with more than 3,000 hens while those with fewer are exempt.
U.S. Department of Agriculture beef mandate:Another regulation that went into effect was a U.S. Department of Agriculture (USDA) mandate to ban beef containing a broader group of E. coli strains known as the "Big Six." These include E. coli 026, 045, 0103, 0111, 0121, and 0145 all of which are found less frequently that the 0157 strain which is most responsible for E coli related illness. Despite objection from the industry, USDA called for banning the sale of all products found to contain any of these additional strains.
Food Safety Testing and Compliance
The U.S. Environmental Protection Agency and USDA’s Food Safety Information Service agreed to use the same terminology when referencing microbial risk assessment. In the past, each agency used separate jargon and declined to affirm or incorporate information disseminated by another agency. Now water and food regulators will be using the same terminology with regard to microbial risk assessment.
iRisk, FDA’s new risk assessment tool developed in collaboration with a private company, became available in October 2012. This tool will be useful to help fine tune and develop Food Safety Plans noted under the Preventive Controls regulations. The system allows simultaneous consideration of microbial and chemical hazards. The iRisk software is more robust than previous software, which was limited to researching one potential hazard at a time.
As the IFSA Food Safety Consultant, Dean Davidson represents the onboard services industry and provides updates when governmental regulations are formed or modified. And as a valued IFSA member, you receive access to this important food safety information via OnBoard IFSA and on the IFSA website, www.ifsanet.com. Below is the update Mr. Davidson has to share in this month’s edition of OnBoard IFSA.
FDA Food Facility Biennial Registration: Renewal requirement is now in effect for domestic and foreign suppliers. The link below provides background for the requirement that came into effect October 22, 2012 and links to FAQ, and registration page. Caterers and suppliers should review the requirements and adjust their registration as needed. http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm
October 2012 Update
Meet IFSA's New Government Affairs Consultant
IFSA is pleased to announce Dean Davidson will serve as the Association's new Government Affairs Consultant. IFSA is exploring the possibility of implementing a government-relations based advocacy program to support the communications initiatives of the Communications Advisory Council. The intent of the advocacy program, including the appointment of Mr. Davidson, will be to establish IFSA as a resource representing the onboard services industry when relevant governmental regulations are formed.
As a consultant, Mr. Davidson’s responsibilities include:
Prior to his appointment with IFSA, Mr. Davidson served as the National Manager for the Interstate Travel Program, Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration (FDA). In 2003, he began his work as the senior technical consultant and advisor to FDA District Offices and Center management, and was responsible for all precedent setting agency actions involving interstate conveyances, equipment certifications, regulatory actions and more. Mr. Davidson worked with the Environmental Protection Agency and Federal Aviation Administration to craft the Aircraft Drinking Water Rule and continued working on the technical manuals for the regulated industry. He wrote portions of the regulations implementing the Nutrition Labeling Education Act and Seafood HACCP and their implementing guidance. Mr. Davidson also has previous work experience in inflight catering. Look for more government affairs updates from Mr. Davidson soon.
Any questions that you may have for Dean should be sent to email@example.com.