It’s Coming! FSMA Decoded So Far…

US Food and Drug AdministrationDuring a salmonella outbreak of 2008 and 2009 nine people died, 166 were hospitalized and more than 700 fell ill. Authorities ultimately traced the contamination of Salmonella Typhimurium back to peanut products manufactured in a Texas plant owned by the Peanut Corporation of America. According to the US CDC an estimated 48 million people each year are affected by food borne illnesses resulting in over 100,000 hospitalization and 3,000 deaths. In this one case, however, there were several factors that caught the general public’s attention:

  • Illnesses were caused all over the US without apparent patterns at first;
  • People died from exposure in nursing homes and other medical facilities;
  • Many different products across different company’s products and brands were found to be contaminated, both commercial and institutional;
  • Ultimately the media found that the peanut processing plant had been operating legally in Texas without EVER having been inspected by state or federal food safety organizations.

As a result of the tremendous publicity and outrage of this embarrassing outbreak a White House Food Safety Working Group was formed to investigate this specific failure in the US food safety network. The result was the Food Safety Modernization Act (FSMA) passed by Congress and to be implemented by the US Food and Drug Administration (FDA).

FSMA has spawned many many efforts at the national level, all of which will interact with every nook and cranny of the US food chain. There are two efforts that will primarily affect Maine cheese makers: a review of the “60 Day Rule” regarding raw milk cheeses; and a sweeping overhaul of how all food processors will be regulated associated with this FDA docket title: “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” or “cGMP” for short.

I have written about the review of the “60 Day Rule” that is currently underway in my overview of the workshops I attended at the 2012 ACS Conference in Raleigh, NC. It is closely tied to an effort by the FDA to understand the level of Lysteria monocytogenes exposure in cheese plants manufacturing “soft” and “semi-soft” cheeses by testing the food and non-food surfaces of a significant number of randomly selected cheese plants (sometimes in an effort dubbed a “Swabathon”) of all sizes across the US (including in Maine). They have already tested hundreds of plants of all sizes, and every licensed cheese plant should be prepared to host a Swabathon at any time in the next year or two. If you have never tested areas of your cheese facility for Listeria (significantly your drains and pipelines/pumps) You would be wise to spend $100 or $200 to do so ahead of any FDA visit. Listeria can be found in facilities that have never had a positive coliform test of their finished products. Listeria colonies tend to form in very clean but constantly moist environments, and once established are VERY difficult to remove. The presence of a Listeria colony obviously increases the likelihood of contaminating your finished product exponentially.

Kevin Burnsteel ( at Pineland Farms Creamery in New Gloucester is quite well informed about plant sanitation including Listeria contamination, the best way to test for it, as well as how to get rid of it if found. He frequently offers to help any Guild member with any questions or concerns on this topic that they might have.

This article will focus on the proposed cGMP, however. “Proposed” means that these rules have not even been approved, and it will be a few years once they are approved before they will actually take effect. In fact there is still time to submit a comment to the FDA on these proposed rules (the extended deadline is now November 15th, 2013).

Our working assumption, however, should be that these rules will be implemented with very few – mostly minor – changes. Therefore I’d like to give you an overview of the Big Points in what I’ve learned about these proposed rules at the ACS Conference in Madison, as well as in my post-conference research.

FDA Is Now Able to Issue Mandatory Recalls
This is not a real issue here in Maine (thankfully), but up to this point the FDA never been able to force a company to recall product even if the FDA had direct proof of contamination specific batch(es). The FDA will be given legal authority (in specific circumstances) to issue a recall on a product whether the product’s manufacturer agrees to do so voluntarily or not.

HAACP Becomes HARPC and is No Longer Voluntary
By now most of us have heard of “HACCP” and roughly know that it’s a written description of all the bad things that can happen when we make cheese, and how we prevent those bad things from happening at each step in the production process. We also ALL know that this kind of document is NOT required for licensed cheese makers, even if we are inspected by the FDA right now. Those of us who have been inspected by the FDA, however, know that having an updated HACCP plan of any kind in place is a great way to make sure that audit goes smoothly because FDA inspectors do not focus on plant equipment (unless they’re swabbing it…) and facilities, they focus on paperwork. The biggest piece of advice for surviving an FDA inspection is “document, Document, DOCUMENT!” This necessarily includes working batch records and labeling, but ultimately involves convincing the inspectors – in writing — that you know what you’re doing. Pointing to a state license certificate is not enough for them.

Moving forward into cGMP, hazards analysis becomes hazards analysis + risk prevention. Ultimately “HARPC” becomes the new “HACCP” and the paperwork becomes mandatory. Risk prevention encompasses not only direct hazards in your production process, but of ALL hazards “reasonably likely” to occur during your production process. An example of this extension to hazards analysis: an employee routinely ignores the policy that they must wash their hands after a visit to the bathroom. How do you detect this? How do you remediate? This paranoia based analysis makes more sense when you understand that the FDA ultimately wants to be able to manage the risk of bioterrorism affecting our national food supply…whether we believe that Maine cheese makers are a lynchpin in the defense against global terrorism will have to be a separate discussion.

Supply Chain Management
Under the cGMP all food producers will be expected to understand how all raw ingredients (and in what condition) arrive at their plant AS WELL AS how their products are treated during shipment, storage, display, and re-packaging before the products reach the end user. We cannot assume that anything arriving in a sealed container is perfect and safe, nor can we assume that once it leaves our hands it will be handled perfectly.

Hazards analysis and documentation of such will be expected for our incoming ingredients, as well as some ability to trace back to specific third-party batches from our product batch codes. For cheese makers who do not produce 100% of their milk, we need to document what milk was used in each batch of cheese. Likewise, which batch code of cultures were used for each batch. And so on.

Regarding care and handling post-manufacturing and before the end user purchases our product, the ACS has done a lot of work on this end resulting in a Certified Cheese Professional (CCP) program that cheese retailers can use to educate their employees as fully knowledgeable about not only receiving a safe product from a producer and keeping it safe until it walks out of their store, but also how to keep exceptionally produced cheese exceptional. When you think about it, a retailer cannot improve our products, but they can easily make them worse. We as producers will be expected to know (and document!) who is handling our products and what their skills and knowledge are at keeping our products at their best.

Finally: Qualified Facilities
In the double-speak of the evolving federal regulations (as I understand them — you should absolutely follow up on this if it applies to you!) this term “Qualified Facility” may be the most important to most of the cheese makers in Maine. In the HARPC cGMP proposed rules a “Qualified Facility” whose revenue is below $250,000 (inflation adjusted into the future) on a three year average would NOT be required to submit a food safety plan expected of ALL OTHER food manufactures. The minimum revenue point is open to comment but there does appear to be an “exemption” of sorts for the “Very Small Businesses” who produce food. I have purposefully left this until the end because I think we should all read the changes summarized above whether or not we will be designated Qualified Facilities. No revenue number has yet been chosen.

The FDA will still require certain things of Qualified Facilities:

  • that they register with the FDA and then regularly submit documentation (financial as well as product based) to show that they remain Qualified Facilities;
  • that they be available for periodic FDA audits/inspections;
  • that they be licensed in good standing with their state and local regulators, and maintain the necessary paperwork to prove that;
  • that they still follow cGMP rules, which (among many other things) means having SOME level of HARPC-like documentation and understanding about their production practices;
  • that Qualified Facilities are still subject to mandatory recalls and/or FDA additional oversight due to public health emergencies, and would no longer be eligible to register for a Qualified Facility exemption after any investigation of a food borne illness that was traced back to one of their products.

In the ACS presentation of the impact of FSMA on cheese makers the last slide in this section said:

“…While family-owned farms, small growers, and small business alliances laud the exemptions…many regulators, inspectors, public health officials and food safety experts do not…Please show due diligence for all of us.”


Food Safety Modernization Act home page:

Comment on the cGMP proposals:

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