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PROGRESS REPORT HIGHLIGHTS SHORTCOMINGS OF FSMA






From Wikipedia:




The FDA Food Safety Modernization Act of 2010 (FSMA) was signed into law by President Obama on January 4, 2011. 




It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. 





The FSMA has given the Food and Drug Administration (FDA) new authorities to regulate the way foods are grown, harvested and processed. 




The law grants FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. 





The FSMA requires FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks.





The law was prompted after many reported incidents of food-borne illnesses during the 2000s (decade). Tainted food has cost the food industry billions of dollars in recalls, lost sales and legal expenses.





This bill is similar to the Food Safety Enhancement Act which passed the House in 2009. It is considered the first major piece of federal legislation addressing food safety since 1938.[1]
















Implementation


Now that the Act is in place, the FDA must begin the rulemaking process to codify how they intend to enforce the new laws.[7]






One of the greatest challenges of the law will be the implementation of new requirements for FDA registered food facilities to conduct a hazard analysis and develop preventive control plans. 




Effective June 12, 2011, many food companies will be required to develop food safety plans based on an evaluation of hazards related to food manufactured, processed, packed or held in all registered facilities.[26] 




Following a hazard analysis, firms must identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards. 





Examples of preventive controls include sanitation procedures for food contact surfaces; employee hygiene training; environmental monitoring to verify pathogen controls; a recall plan; supplier verification activities; and a food allergen control program.[26]









Even after the rulemaking process is complete, it will likely be some time before the FDA is fully equipped to enforce the new laws. 






The agency estimates that it will need at least 1,000 more inspectors and $1.4 billion over the next five years, and it is certainly not a sure thing that Congress will appropriate such funds given the current economic climate and calls for spending cuts and smaller government.[7]










FSMA Progress Report


Now, the FDA has planned to make available to the general public and to Congress significant progress they have made towards implementing the FSMA.[27] 




In March 2012, the FDA’s Senior Advisor, Coordinated Outbreak Response and Evaluation Network, Sherri McGarry, on a blog reported the types of foods to be used in the pilot project on tracing products to prevent illnesses.[28] 



The list includes Tomatoes, Frozen Kung Pao-style dishes, and Jarred peanut butter and dry, packaged peanut/spice.[28] Tomatoes both sliced and whole was chosen because of the significant number of outbreaks recorded; it mirrors a multifaceted food supply chain and it was recognized by majority of the food industry associations as the number one food product to be used in the pilot program.[28]








The Frozen Kung Pao-style dishes have ingredients such as chicken, red pepper spice and peanut products which are foods that are involved in outbreaks, for this reason they are in the pilot project.[28] In addition, it is supplied to diverse food chain distribution channels which could be involved in imported and domestic products.[28] To increase the intricacy of the pilot project, the jarred peanut butter and dry, packaged spice peanut were included.[28] This summer, the pilot projects results will be accomplished with hopes of developing a complete product tracing system with the information received.[28]







Funding


The Safety Act was signed into law along with the Government Performance and Results Modernization Act of 2010. The cost for the first five years is projected to be $1.4 billion and is not yet fully funded.[29]













Food facility registration


Since October 22, 2012, the updated food facility registration system by the US FDA is available. This update requires all facilities previously registered prior to October 1, 2012 to renew registration. Failure to do so is a prohibited act and will lead to refusal of entry for foreign products and illegal trade for domestic facilities.[30]




Every 2 years in even numbered years, every registered facility needs to renew its registration between October 1 and December 31. Registration is accepted by fax, mail and electronics means on the FDA food facility registration website.[31]









Reaction and controversy



According to maplight.org,[32] large trade organizations have joined public health advocates in supporting the bill, while groups aligned with individuals and small farms have generally opposed it. 





However, after Senate adoption of Jon Tester's amendment, which allows for the possible exemption of producers that sell less than $500,000 a year,[33] many large food companies objected, arguing that the exemption puts consumers at risk.[34]







A year after enactment the agency has fallen behind on expected progress. It has yet to implement "a specific timetable for issuing" a process to create rule for science-based produce standards, has not completed rules for foreign supplier verification, and must still create a guidance that will help schools and childcare programs lessen allergy risks for school-age children.[35]








A similar set of New Zealand rules, the Food Bill 160-2, is moving towards passage since 2010. 





The primary effects expected are to tie New Zealand to Codex Alimentarius and the World Trade Organization permanently, although those international agreements will be constantly adjusted. 






Despite its 366 pages, Food Bill 160-2 cannot directly resolve many threats to food safety, as there is no added Produce traceability nor methods to control Antibiotic resistance





Controversy has been intense in NZ regarding introduction of genetic engineered plants and animals (GE); concern is that WTO and Codex will require opening up NZ to GE. The Soil & Health Association of New Zealand would not be able to complete their campaign towards making New Zealand organic by 2020.















Additional information on imported goods




The FSMA gives FDA authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers, with the vision that imported foods should be held to the same standards as domestic foods. These standards will be met by implementing the following components:








Importer accountability

For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. (Final regulation and guidance due 1 year following enactment)





Third Party Certification

The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. (Establishment of a system for FDA to recognize accreditation bodies is due 2 years after enactment)
Certification for high risk foodsFDA has the authority to require that high-risk imported foods be accompanied by a credible third party certification or other assurance of compliance as a condition of entry into the U.S.





Voluntary qualified importer program


FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities. (Implementation due 18 months after enactment)






Authority to deny entry


FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located.






http://en.wikipedia.org/wiki/FDA_Food_Safety_Modernization_Act


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Alphonso (mango)
From Wikipedia, the free encyclopedia








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