The wait is over for new FSMA rules. .. but questions remain over ‘unfunded mandate from Congress’

By Elaine WATSON

- Last updated on GMT

The wait is over for new FSMA rules, but funding issues remain
News that the Food and Drug Administration (FDA) has finally unveiled two long-awaited proposed rules under the Food Safety Modernization Act (FSMA) has been welcomed by food safety experts, although serious questions remain over the lack of resources to implement them.

Speaking at a press briefing about the new cGMP & preventive controls​ and produce safety rules​ - unveiled on Friday a year behind schedule - FDA deputy commissioner for foods Michael Taylor said the “benefits ​[of FSMA] will substantially outweigh the costs” as ​he expected to see a “significant reduction in foodborne illness​” following its implementation.

But he added: “We will require additional resources to fully implement the law.”

Commissioner Margaret Hamburg also admitted that “resources remain an ongoing concern” ​adding that “it’s very important to the success of this effort to ensure we have adequate resources …I hope we’ll be able to work with Congress to shape the 2013 and 2014 budget.”

Meanwhile, three more rules (on foreign supplier verification, third party audit certification, and preventive controls for the feed industry) are still being reviewed by the Office of Management and Budget, but would be unveiled “soon​”, said Taylor.

Companies already familiar with HACCP will be able to easily comply

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According to the Centers for Disease Control and Prevention (CDC), about 48 million Americans (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die from food-borne diseases, each year.

So what do the experts think?

Former FDA Associate Commissioner of Foods Dr David Acheson, who now heads up the food and import safety division at consultancy Leavitt Partners, welcomed the rules, but said the lack of money to implement what was effectively “an unfunded mandate by Congress​” was troubling.

Shawn Stevens from Milwaukee-based legal firm Gass Weber Mullins told FoodNavigator-USA ​that initially, at least, "there will be a significant short-fall in funding.  Thus, many of the programs FDA is envisioning will not be implemented - at least initially - as designed."

But he added: "The FDA will likely focus its limited resources on a few high-profile non-compliant companies in high-risk sectors to make an example and create a deterrent for the rest of the industry.”

The biggest surprise in the proposed rules was “the detail with which FDA spelled out the reasons why they were being published",​ he said. "I have never seen an agency go to the length the FDA has here in a proposed rule to justify its new regulatory requirements. 

“This also forecasts, I think, the agency's thinking that a large segment of the food will resist the new rules as being too onerous.  With that said, I think most food companies who are already familiar with HACCP, and have written food safety plans already in place, will be able to easily comply.”

FDA inspectors should be qualified to the same level as the qualified industry experts writing the plans

As for how the ‘qualified individuals’ that must write the food safety plans should be defined, he said: “One of the biggest hurdles standing in the way of the successful implementation of the new rules is having enough qualified individuals to both design (at the industry level) and enforce (at the agency level) the new rules. 

“For this reason, I think 'qualified individual’ needs to have a broad definition.  I also think that both industry experience and qualifications are critical. 

“Is a lawyer going to be able to help a company design a food safety system?  Probably not.  Is a lawyer with expensive food safety experience, like I have, going to be able to do it.  Of course.  But, where do we draw the line?”

He added: “Food science is a complicated business, and not anyone is going to be able to design and then implement an adequate food safety plan.  One key component, though, I would argue, is that agency inspectors be qualified to at least the same level (and pursuant to the same standards) that FDA requires of industry."

Foreign supplier verification

Asked what the biggest culture shock firms trying to comply with FSMA will face, he said: “I think the largest challenge for industry under the new rules will be ​[the yet to be published proposed rule on] foreign supplier verification. 

“We have one of the most robust food safety systems in the world, regulated by billion dollar agencies, and we still see multiple recalls of domestically-produced products every single day.  In most countries from which we import, there are very limited rules and no enforcement mechanisms. 

“Since the new rules will obligate importers to ensure that foreign suppliers are meeting the same requirements that food companies are required to meet domestically, this will create substantial logistical hurdles - and substantial potential liabilities - for those suppliers.”

FDA Imports: FDA’s estimated total cost for this aspect of the proposed rule is plainly too low

Qualified individuals must write a food safety plan for each facility

Benjamin England, founder of legal practice Benjamin L. England & Associates and consultancy, said there were not any major surprises in the preventive controls proposed rule (click here​ for his full analysis).

But he added: “However, tucked away in this list of requirements is the requirement that a facility must develop and maintain a recall plan. This is the first time FDA has ever mandated such a requirement for food facilities."

As for the proposed revisions to the current Good Manufacturing Practices (cGMPs) requirements for foods, one of the more significant changes would require those responsible for identifying sanitation failures or food contamination to have adequate education or experience, he said.

“The proposed regulatory requirement will cause hiring and training costs, as well as the related documentation requirements, to skyrocket.

“[However], FDA’s estimated total cost for this aspect of the proposed rule is plainly too low — and perhaps grossly so. For instance, the Agency’s estimated total cost is $93-$101.4 million dollars.

“But if you divide that number by the number of firms that would probably be subject to the new requirement, you end up with only $742 per domestic firm and only $532 per foreign firm. That is one cheap educated and experienced food sanitation expert!”

The proposed rules in more detail...

The proposed rule on preventive control programs requires food manufacturers to produce written risk-based food safety plans designed to identify microbial (eg. Listeria, Salmonella​); chemical (pesticides, drug residues or food allergens); physical (metal fragments); and radiological hazards and then outline how to address them.

The plan, which is based on HACCP principles, must be produced by a ‘qualified individual’ (the FDA has yet to define how to qualify as such), who will identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise.

Facilities will also be required to monitor their controls, verify they are effective, take any appropriate corrective actions, and maintain records documenting these actions.

What is a hazard?

For example, a facility that holds pistachios in storage until they are shelled may identify the potential for growth of aflatoxin-producing molds as a hazard. As a process control to prevent such molds, bosses may dehydrate the nuts to a specific moisture content prior to placing them in storage.

The process control would be ‘drying’ and the associated parameter would be the moisture level (eg. set at a maximum of 7%).

HACCP-based approaches are already required for seafood and juice processors regulated by the FDA and meat and poultry plants regulated by USDA, and many other food manufacturers are already using them - even if they are not fulfilling all the extra record-keeping requirements stipulated by FSMA.

The FDA also invited comment on some issues that are not addressed in the text of the regulation itself on product testing, environmental monitoring, or supplier approval and verification, noted Hyman, Phelps & McNamara attorney Ricardo Carvajal. 

However, these are "extensively discussed in an appendix to the proposed rule, and it is clear that they could yet be integrated into the final rule pending further evaluation", ​he said.

Michael Taylor: We know one-size-fits-all rules won’t work

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The produce rule will not apply to potatoes

The produce rule sets standards associated with potential routes of microbial contamination including agricultural water; biological soil amendments of animal origin (eg. manure); worker health and hygiene; animals in the growing area; and equipment, tools and buildings/packing houses.

It will not apply to raw agricultural commodities that are not consumed raw (such as potatoes) or foods destined for canning.

The public will have 120 days to comment on both rules, which will then go through the normal final rule-making process, which could take up to a year, said the FDA's Taylor. 

Smaller firms will get more time to comply

Larger farms will be expected to comply 26 months after the final produce rule is published, while food manufacturers will have to comply with the preventive controls rule a year after the final version is published.

Small farms and food manufacturers will get more time to comply.

Guidance to help firms comply with both rules will be published shortly, Taylor added: “We know one-size-fits-all rules won’t work. We’ve worked to develop proposed regulations that can be both effective and practical across today’s diverse food system.”

Click here​ to read the preventive controls proposal.

Click here​ to read the produce proposal.

Related topics: Regulation and safety, FSMA

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