Posted: Jan 20, 2011
UPPER SADDLE RIVER, NJ (January 20, 2011) - Speaking at a recent Food Institute webinar, Dr. David Acheson, former Commissioner for Food Protection at FDA, described food safety legislation signed earlier this month into law by President Obama as "unquestionably...a game changer in the context of new food safety legislation and the impact on multiple sectors." The webinar, Understanding the New Food Safety Legislation, also featured John Bode, Principal Attorney at law firm Olsson, Frank Weeda Terman Bode Matz PC.
While the food safety act been covered extensively by the national media, particularly the law's granting of mandatory recall authority to the FDA, many issues most relevant to the food industry have been glossed over. The law will grant a more aggressive FDA with greater regulatory authority, including the responsibility for defining "high risk" foods, which will determine the frequency that facilities or food producers are inspected.
As a result, according to the webinar, a facility that processes or holds an article of food particularly susceptible to one type of contamination may result in that facility, regardless of compliance history, being inspected at a similar rate to a facility with a pattern of regulatory noncompliance. Additionally, when FDA believes that there exists a "reasonable belief" that an article of food may cause severe adverse health consequences, a firm must provide access to all records concerning that article. Any articles of food that may have come into contact with the potentially contaminated food, or that may have been impacted in a similar manner, are also subject to total records access by FDA. Essentially, the bar is lowered from the existence of "credible evidence" required to support FDA's claims to "reasonable belief" in accessing records.
Many of the webinar participants were particularly interested in the overwhelming task of establishing a third-party system of accreditation bodies and auditors that FDA was given responsibility for. To clear the target of 600 inspections of foreign facilities, which represents a six-fold increase over the 100 inspections last year, FDA will need to rely on third-party auditors to shoulder the burden. Despite an uncertain amount of resources to accomplish this task, the number of foreign inspections are to double every year, finally reaching 19,200 inspections in 2016, a goal that Dr. Acheson described as "frankly impossible."
Much uncertainty remains surrounding the legislation, as funding is certainly going to determine how successful the government will be in reaching the ambitious goals set in the FDA Food Safety Modernization Act. It is unlikely that the FDA will accomplish its targets for foreign inspections, and the agency will encounter resistance from states and local agencies in accepting a significant portion of the responsibility in domestic inspections. How the agency's budgetary restrictions will affect the initiatives remains to be seen, but many of the fiscal concerns that plagued the bill in its progression through Congress will continue to affect food safety efforts by the government both at home and internationally. Now that the work in passing the bill is concluded, the consequences of the law and its reach over industry remain cloudy, dependent on FDA's ability to accept its new responsibilities while balancing its limited funds.
To purchase of recording of the entire webinar, please visit http://www.foodinstitute.com/foodsafety2011.cfm
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