Much of the anxiety relates to the section of the FSMA requiring manufacturers to produce written food safety plans based on HACCP (hazard analysis critical control point) principles, Shawn Stevens from Milwaukee-based legal firm Gass Weber Mullins told FoodNavigator-USA.
Under FSMA, manufacturers will need to maintain Hazard Analysis and Risk-Based Preventive Controls (HARPC), which require firms to:
- conduct hazard analysis;
- develop and implement preventive controls and monitor the controls effectiveness;
- develop a written plan for controlling the hazards;
- reanalyze processes for potential hazards at least every three years;
- verify the effectiveness of the controls; and,
- maintain records of the verification process
A fair amount of confusion
Said Stevens: “I think there are going to be considerable growing pains in the first couple of years and a fair amount of confusion as there is also no enforcement history, so it is very hard to know exactly if you are compliant until the FDA has inspected your plan or facility.”
He added: “Even when HACCP was made a requirement in the meat industry, it took a long while before there was a consensus on what the relevant critical control points should be given the variation between all the different products and facilities.
“Under FSMA, HACCP will apply to every kind of food, from cereals to yogurts, but no one knows what a HACCP plan that is compliant with FSMA will look like for any given facility.
“Will the FDA guidance on this (due this summer) sort foods into categories and say this is what a HACCP plan for this category of food should look like, or will it be more general?"
Will FSMA be enforced consistently?
As FDA inspectors were not experienced in assessing HARPC plans, many manufacturers also worried that enforcement would not be consistent, he added.
While most large manufacturers were familiar with HACCP methodology and should be able to amend existing HACCP plans to ensure compliance with FSMA, many smaller companies would struggle, he predicted.
“Clearly, large manufacturers with in-house food scientists, regulatory professionals and QC professionals will have a real head start.”
Foreign supplier verification scheme
Meanwhile, the FSMA’s proposed foreign supplier verification scheme – details of which are likely to be published next month according to industry insiders - is also causing a lot of anxiety, said Stevens.
“Put it this way, we’re already scratching our heads over here [in the US] over what a food safety plan demonstrating compliance with FSMA should look like, so expecting overseas suppliers to figure out what to do is going to be a big challenge and puts a lot of additional responsibility on importers.
“I think as a result of this, importers are going to be a lot more selective about where they are sourcing raw materials from.”
Acheson: Importers are ‘all over the map’ on supplier assurance
Former FDA Associate Commissioner of Foods Dr David Acheson, who now heads up the food and import safety division at consultancy Leavitt Partners, said many importers were woefully unprepared for the record-keeping required under the FSMA.
He added: “As things stand, importers are all over the map [when it comes to supplier assurance]. Some have certificates of analysis or audit reports from third parties or a range of other kinds of documentation, but others have very little.”
As for written food safety plans, he said: “While the FDA has always said that the rules will be based on current industry good practice, some smaller companies are going to get a bit of a shock when they see how much record-keeping the FDA expects them to do.
“I think very large companies are less concerned about this aspect of the law but SMEs don’t have the same expertise and knowledge in their business and worry that they can’t afford to hire people to tell them how to comply.”
Kraft: Investing in additional resources …
While food manufacturers we contacted were reluctant to comment on individual aspects of FSMA until more details are released by the FDA, Carol Kellar, senior director for quality, scientific and regulatory affairs at Kraft Foods North America, described FSMA as a ”major step forward in strengthening America’s food safety systems”.
She added: “The law will have a significant impact on the food industry, and while Kraft Foods already has robust food safety programs in place, we welcome the opportunity to make them stronger.
“We are investing in additional resources, such as education, training and hiring new employees to manage the new FDA requirements.”
A General Mills spokesperson said: “We applaud the passage of this bill, which will clearly strengthen America’s food safety system nationally.”
Mitchell: We already have systems in place that work for imported food
But Martin Mitchell, managing director of food analysis specialist Certified Laboratories, was less diplomatic, and accused the FDA of overkill, particularly in relation to the new requirements on importers.
“We already have import alert systems in place that are working; the FDA can institute detention without physical inspection - as we saw with melamine – so dairy products from China were stopped at the border and then only let in if importers were able to provide evidence that their products were safe. This system works.
“But instead they have come up with this.”
Click here to find out more about a new series of webinars hosted by the Food Institute and OFW Law on the implementation of FSMA. The first webinar runs on February 6 at 12.00 EST.