After an intense three-year legislative process formulating the Food Safety Modernization Act (FSMA) begun in Congress in 2009, followed by an unusual two full rounds of public comment correcting the Food and Drug Administration’s (FDA) controversial proposed rules, the final Preventative Controls Rule regulating food facilities was issued in late-September, 2015.
At this writing, still to come in mid-November is the final FSMA Produce Rule regulating on-farm food safety. Among the hundreds of pages, the most contentious issues to pay attention to will be the agricultural water quality standards and testing frequencies; the interval between manure and compost application and harvest; extent of record-keeping requirements and reinstatement of farmers’ qualified exemption. There’ll also be a finalized implementation schedule. Depending on how farm and processing operations are classified scale-wise, compliance deadlines will be phased in over the next 5 years. On a parallel track is the development of provisions for requisite food safety training for farmers.
The final FSMA rules also give more tools to FDA to regulate large scale food manufacturers. In the past, for example, FDA could only urge processors to carefully avoid the unintended presence of allergens in foods but any product recalls were purely voluntary. Now the industry is required to avoid the unintended presence of allergens in foods through a series of specific preventive controls – and if they don’t follow these mandates the food will be considered adulterated and misbranded by the FDA. Notably, food corporations are now subject to new enforcement metrics where FDA has full authority to mandate recalls for unsafe food.
All in all, the nationally orchestrated actions against potential one-size-fits-all food safety regulations affecting family-scale farmers and small food businesses have had a significant impact on FDA’s rulemaking process. Thanks in good part to the comment campaigns led by the food safety team at the National Sustainable Agriculture Coalition (NSAC) where NOFA is a founding member – FDA’s proposed food facility rules that were first issued in 2013 and revamped in 2014 have been significantly modified for the better.
However, farmers and food businesses alike must recognize that the final FSMA Rules usher in a new food safety paradigm where every level of the food system will be beholden to a new regulatory landscape once implementation is complete. Small-scale farmers who fall under certain exemptions might find themselves needing to fulfill supplier training and audit requirements if they sign up with aggregators, such as food hubs, for example. And for liability concerns larger food businesses such as supermarkets are instituting further metrics for supplier verification and food safety compliance.
Re-definitions for farms and food facilities
One of the major shifts for the farm vs. food facility classification has to do with FDA’s rewriting the metrics that were hastily put forth in the Bioterrorism Act of 2002. Under those regulatory definitions some farmers were surprised to find that even though farming activities were generally exempted from government oversight, parts of their operations put them in the facilities category, requiring FDA registration for traceability purposes and subjecting their farms to regular inspection. Thanks to the comment feedback these requirements have now been appreciably modified and clarified. Depending on their scale, however, farms will be fully subject to the further Produce Rule regulations coming up in mid-November.
Generally speaking, businesses are a facility if they manufacture, process, pack, or hold food for consumption. The expanded farm exemption classification now includes “primary production farms” and “secondary activities farms”, reflecting modern expanded ownership and management structures. Also key to the farm exemption is sole involvement with raw agricultural commodities, or RACs.
As explained by the NSAC team:
“A primary production farm is: An operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities.
These farms can also do activities within the definition of “harvesting,” “packing,” and “holding” as well as some activities considered processing/manufacturing, but that do not change the raw agricultural product into a processed food.
‘A secondary activities farm is:
An operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities [RACs]. However, this definition only applies if the primary production farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm.
Secondary activities farms can do the same packing and holding and manufacturing/processing activities that primary production farms can do without losing their exemption.
‘So if you are doing activities that fall within the definitions of harvesting, packing, or holding — and you’re doing them on your farm – then you are a primary production farm. And that’s true whether the farm is under an owner-operator, is rented, or is cooperatively or otherwise jointly owned. As long as it’s under one management, it doesn’t matter what the management structure looks like.
‘If you are doing activities that fit the harvesting, packing, and holding definitions but are doing them at a separate location and under a separate business structure (like a cooperatively owned packing shed that aggregates from multiple farms), then it is still considered a farm (a “secondary activities farm”) as long as the primary production farm(s) providing the majority of the products to be packed hold a majority interest in the packing operation.”
Of course there’s a long list of complex and sometimes ambiguous rules that constitute who qualifies for these exemptions. To help chart the course the NSAC team has put together a detailed guide for farmers and small businesses in a three-part series on “Who Is Subject to FDA’s New FSMA Food Facilities Rule”. http://sustainableagriculture.net/blog/pc-rule-analysis-part-1/
Some smaller-scale farms that engage in a degree of food manufacturing and processing activities may fall into a middle ground “mixed-type facility” category where even though they fall under the Preventative Controls Rule and have to register with FDA – they still are not subject to the full requirements of the Rule.
But thanks to an amendment added to FSMA by Senator Bernie Sanders of Vermont, small and very small businesses (under 500 employees or averaging under $1 million a year) – and “qualified facilities” that are involved in certain low risk on-farm processing operations also do not have to comply with the full facility requirements. Here again FDA has extensive lists of allowable low-risk activities, including a wide variation of low pH foods, baked goods, popcorn, jellies, dehydrating herbs and so on. Qualified facilities are required to identify potential hazards as well as to keep records documenting their status and sales records to maintain their compliance with this part of the Rule.
The NSAC team analyzes these exemptions and requirements in Part II:
Requirements for Non-Exempt Facilities
The heart of the full facility definition is centered on the HARPC approach – “Hazard Analysis and Risk-Based Preventative Controls” based on a plan that is written and documented by a qualified individual who has successfully completed FDA sanctioned training. Still unclear at this time is whether an individual’s job experience fulfills the bulk of the training requirements. The facility’s food safety plan must analyze all hazards; document their preventative controls mechanisms; establish a written recall plan and identify their program of approving food chain suppliers (including audits).
Farms Regulated as “Approved Suppliers”
Even though the full facility definitions do not affect farmers directly, these auditing requirements circle back to impact qualified farms and facilities as “approved suppliers”. Once again the extent of the supplier verification requirements depend on the scales of both the aggregator and the farmer – but in general all facilities must identify any hazards requiring preventative controls from their suppliers. And the suppliers must undergo some form of an approval process that may include onsite audits, sampling of raw materials and reviews of a farm’s past food safety performance and compliance.
However, if the supplier is a smaller qualified facility or an exempt or qualified exempt farm under the Produce Rule, then the considerations regarding supplier performance can be limited to just the supplier’s compliance history and further measures such as third-party audits are not required.
FSMA is not the only food safety verification system in the marketplace, of course. To protect themselves from liability, larger scale food businesses including supermarkets also have their own supplier certification requirements, including variations of audit-based GAPs (Good Agricultural Practices) metrics where farmers have to pay to successfully fulfill training course requirements and inspections to become an accepted supplier.
For further details regarding supplier verification metrics and compliance timelines see Part III of NSAC’s “Am I Affected” is here:
Farmer Food Safety Training
In putting together the FSMA legislation, Congress recognized the need for a training component to complete a food safety system that is focused on prevention regulations. But even though they created a competitive grants program, to be administered by USDA’s National Institute for Food and Agriculture (NIFA) to fund farmer and food processor training efforts – subsequent Congresses still have to allocate and authorize scarce funding dollars. Most of the implementation funding that has already been authorized is going to set up National and Regional Centers with state agency and Cooperative Extension participants. These centers are required to partner with grassroots farming groups who have the expertise of dealing with farmers, however.
Another level of “train the trainers” guidance is provided by the Produce Safety Alliance housed at Cornell University and working closely with FDA and USDA food safety personnel. Alternative training modules are also authorized by FSMA to provide more user-effective teaching. Currently some NOFA Chapters are looking into a group Specialty Crop Grant application to investigate if there’s the capacity to take this on as an Interstate NOFA project.
Next up from FDA for release and phased-in implementation is the final Produce Rule in mid-November. After intensive analysis the NSAC team will put forth a series of “Am I Affected” guidelines to help guide farmers and consumers through the maze of new regulations. Finally, even though these final FSMA Rules are now written in stone — when further explanations or clarifications of these rules become warranted, FDA can issue subsequent Guidance documents.
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