Final Food Safety Regulations Released

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”.

Mixed–type Facilities

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.

The Interstate NOFA Policy Program works regionally and nationally on key grassroots organic policy issues important to NOFA members. NOFA Policy is wholly dependent on outside funding to do this work. Donations of all sizes are welcome! Please address contributions to the NOFA Interstate Council (a tax-deductible 501(c)3 organization) c/o IC Treasurer Julie Rawson, 411 Sheldon Road, Barre, MA 01005. Thank you!

We’ve Got Our Policy Work Cut Out For Us

Thanks to an outpouring of support from Members responding to the End of the Year policy funding appeal, the NOFA Interstate Policy Program is alive and functioning, albeit on a part time basis. More support is needed, however, as you’ll see below.

Trump Agenda
Now that we’ve gotten an all-too-clear look at the details of the Administration’s and Congress’ self-serving political agendas – it’s plain to see that much of what NOFA has stood for and worked on since our beginnings in the early 1970’s is under full frontal assault. Many hard fought advances in organic and sus-tainable agriculture, good food availability, environmental protection, health care, climate stability, social justice, and personal freedom are now targeted by a slew of special interests who are now powerfully placed at the top.

Clearly we have our work cut out for us – but we are not alone. As a founding member of the National Organic Coalition, the National Sustainable Agriculture Coalition and the Northeast Sustainable Working Group – NOFA is working regionally and nationally in combination with Chapter work in our seven states. NOFA-IC also recently strategically broadened our affiliations – becoming a member of the newly-formed Organic Farming Association, the National Family Farm Coalition and the HEAL Food Alliance.

The good news is that huge numbers of citizens across the country are roused to resist and reverse these mean-spirited top-down initiatives. Fact is, under our government’s built-in separation of powers those signed Executive Orders are just piles of paper until they can be implemented and/or funded by Congress and carried out by agencies.

Thanks to the 2015 and 2016 policy grants from Farm Aid, our Chapters are building effective working relationships with their Congressional delegations. And here in the Northeast, anyway, many Members are not only really listening for once but are looking for support and alliances with activated concerned citizens.

What we can do
This is where NOFA members come in as we put together a coordinated resistance to the agendas. As one of the oldest organic food and farming organizations in the country, NOFA has earned the public’s trust in leading the way forward. Same as feeding your children and weeding your garden — supporting our state NOFA Chapters, participating in policy alerts and calling your elected officials needs to be on your regular to-do list.

Additional support is also needed for Interstate NOFA Policy. Due to retrenchments from some of our traditional business supporters – the current Policy Coor-dinator compensation only covers 13 hours/week, although the workload remains just as heavy. And although much of the policy work takes place by email and conference call – travel costs to Capitol Hill fly-ins and face-to-face national coalition meetings around the country have increased significantly.

Thank you for considering an individual contribution – we appreciate member support of our important policy work!! If you would like to make a tax-deductible donation please write your checks to the NOFA Interstate Council c/o Treasurer Julie Rawson, 411 Sheldon Road, Barre, MA 01005.

Coalition for Sustainable Profits declares war on National Organic Program at US Senate

Theo Crisantes says it is time to limit the power of the NOSB.

Another blow against Real Organic came last week with the Senate testimony of the misnamed Coalition For Sustainable Organics, which I will henceforth refer to as the Coalition for Sustainable Profits. Only through the extraordinary success of their latest and most expensive lobbyist, Anne MacMillan, was the Coalition able to testify before Congress twice in the last month.

Senate Agriculture Chairman Roberts said at the hearing that the federal National Organic Standards Board and organic regulations were rife with “uncertainty and dysfunction,” and asked “producers” for recommendations on how to improve the advisory board.

“These problems create an unreliable regulatory environment and prevent farmers that choose organics from utilizing advancements in technology and operat-ing their businesses in an efficient and effective manner,” Roberts said in his opening statement during a hearing on local and international markets for organic foods and specialty crops. “Simply put, this hurts producers and economies in rural America.”

The Coalition’s message was clear. Organic standards should be molded to enhance the profitability of the large corporate farms that are quickly coming to dominate “certified organic”. Going far beyond defending hydroponics, the Coalition attacked the NOSB. They also dismissed the proposed rules eliminating CAFO (Contained Animal Feeding Operation) chicken operations as being a minor “outlier issue.” It seems that Roberts, the large CAFO operators, and the Coalition are birds of a feather. The Big Boys have had enough. We are witnessing an attempted hostile takeover of the National Organic Program.

Melody Meyer, a spokesperson for United Natural Foods and one of the leading hydro lobbyists, has described the hydro battle as a conflict between two parts of the organic community: the Trade and the Movement. This is not an accurate description because the Coalition For Sustainable Profits has never been a part of the organic community. And how will the Trade thrive without the community? Who will they peddle their new “organic” products to? How long will peo-ple flock to buy “organic” in Walmart when they hear it is only “sort of organic.”

There has been talk of creating a new label within the USDA for “Certified Hydroponic Organic”. I would suggest a better label: “USDA Certified Fauxganic”. The new Fauxganic label could also include the CAFO dairies, the CAFO eggs, CAFO meat, and the magically transformed conventional grain that has flooded the organic market in recent years. At last, there will be a proper label to clarify so much of what is currently confusing and dismaying the eaters of America. Fauxganic producers can be recognized by their common belief that healthy soil is irrelevant.

Ranking Senator Debbie Stabenow (D. Michigan) and chair Pat Roberts (R. Kansas)  listen to Crisantes’ testimony at hearing of Senate Agriculture Committee.

Ranking Senator Debbie Stabenow (D. Michigan) and chair Pat Roberts (R. Kansas)
listen to Crisantes’ testimony at hearing of Senate Agriculture Committee.

In his Senate testimony, Coalition for Sustainable Profits spokesperson Theo Crisantes didn’t speak much about hydroponics. Moreover what he said about hy-dro was misleading. But what he did speak more about was the need to reform the NOP so the NOSB has much less influence. He claimed there was too much public debate. Decisions need to be made behind closed doors by a few power brokers. It was perfect symbolism that his first Congressional testimony to a House subcommittee was also behind closed doors.

Crisantes also called for change in the makeup of the NOSB so that it better represented the Trade. Right now the members of the NOSB are all selected by the Secretary of Agriculture, and those choices sometimes seem quite distant from the intentions of Senator Leahy and the organic supporters who championed the creation of the NOP.

Clearly, some “farmer representatives” such as recent NOSB member Carmela Beck (a mid-level administrator from Driscoll’s) would not be called “farmers” by most reasonable people. Nonetheless, there are some wonderful people who care deeply about the organic movement currently serving on the NOSB. The de-bates and votes are public. All decisions are open to input from all who are interested.

The Coalition’s comments are in keeping with the written testimony submitted to the NOSB from such corporate farms as Driscoll’s Berries (over 1000 acres of hydroponic “organic “ berries), Nature Sweet (over 1200 acres of conventional greenhouse tomatoes), Houweling Greenhouses (over 250 acres of conventional greenhouse tomatoes), Pura Natura (the umbrella organization for the Dutch greenhouse growers who export their EU conventional hydro produce to the US where it is welcomed as organic), and Scott’s Miracle Gro (what can I say? Welcome to Fauxganics).

Perhaps all these corporations are members of the Coalition, but no one knows for sure, as the Coalition’s membership, like the way they grow their produce and the way they spend their money, is a secret. When I served on the USDA Hydroponic Task Force, we were unable to get a single hydroponic member of the task force to share exactly what they used to fertilize their crop. We were told it was a secret.

These are efficiently run organizations that do what they do well, but they have no business selling their products as organic unless they are willing to pro-foundly change how they farm. And so far they are not willing to do that. They are only interested in using the USDA label for the price premium.

Nate Lewis is one of the chief lobbyists for the OTA, which has worked aggressively to approve hydroponic certification for their clients Driscoll’s Berries and Wholesum Harvest. They also worked closely with Senators Roberts and Stabenow on the Congressional action that destroyed States’ right to label GMOs.

So why would the Coalition publicly call for war on the NOSB? Because they fear losing in the NOSB. They have the lobbying power to get things done their way in Congress. In the spirit of Trump, they are ready to “Just Take It” because they can. The (relatively weak) animal welfare reforms that were worked on for so many years before passage by the USDA were exiled to the oblivion of “further study” by the Trump administration, with the active support of Roberts and Stabenow. So too, the dark forces are not likely to allow us children to deny them their hydroponic profits.

The very fact that Congress was listening to a fringe group like the Coalition for guidance on organics is a clear sign that the organic community is in deep trouble. Senators Pat Roberts and Debbie Stabenow have led the recent Congressional attack on the NOP’s proposed animal welfare standards. Roberts, infamous for his disdain of organic, has become a strong champion for the Fauxganic egg producers in his home state of Kansas.

Roberts called the reform standards (which took years to gain passage in the NOP) “absolutely ridiculous.” He is on record saying, “What is chicken enrichment anyway? It could be yoga, that might be difficult. Video games? They do that for various animals. Sports? A gourmet meal? I think probably music is the best thing we can do to entice the chickens to come out and be happier, you know free range, roaming around. I think probably Ray Price would be the best person. Certainly not Prince. At any rate, something soothing.” Roberts’ contempt for the very concept of animal welfare is profoundly disturbing, as he is the powerful Chair of the Senate Ag Committee.

Roberts seems to be the new best friend of the Coalition, supporting their inclusion in the organic program that he despises. The Coalition testimony included references to the debate on CAFO (feedlot) “organic” chickens as being “a distraction” from important issues. At last Roberts has found a champion in the “or-ganic community” for his appalling vision of irresponsible agriculture. It appears that Roberts and Stabenow have a plan for a new kind of National Organic Program in the upcoming Farm Bill.

OTA said that Roberts’ “recognition of the importance of organic as a choice for farmers that provides economic stability and increased net profits” was posi-tive. Without public engagement and “strict, clear and enforceable industry-designed standards — you risk losing the opportunity for farmers that organic pro-vides. Transparency and accountability — cornerstones of organic — remain the foundation upon which to improve the organic system.”

Wonderful words. For all their calls for transparency, OTA works very hard to keep the issue of hydroponic production as confusing as possible for the NOSB and the consumers. They continually insist that their clients Driscoll’s and Wholesum Harvest are not hydroponic. They claim they are “container growers”. OTA knows perfectly well that ALL of the conventional hydroponic tomato, pepper, cucumber and most of the berry growers are “container growers” as well. While it is possible to grow without hydroponics in a container, Driscoll’s and Wholesum cannot make such a claim. They are hydroponic by any sane defini-tion.

So if you aren’t upset, you aren’t paying attention. The Senate testimony was an amazing coming out for the hydroponic lobby. Why would they attack the NOSB before a crucial vote, even if they believed what they said? Because they are afraid they are going to lose. Again. And they will lose if we keep speaking out.

There are protest rallies coming soon. Contact me ( if you are interested in organizing a local rally in your area this Fall. People are waking up and coming together. The Fauxganic Takeover is out in the open now. It is the same dreary land grab that has happened over and over. If we believe in real organic, our work is far from finished. Real organic is more important than ever.

One thing is for sure. Even if the Fauxganic forces triumph in the regulatory world, they can never win in the end, because Fauxganic is not Organic. It is not what people are looking for, although it might take people a while to figure that out. It will never be organic, no matter what it is called. And there are way too many of us for it to go unnoticed. People are seeking real food. We are seeking an agriculture that will support the planet and nourish us. As we learn about the Fauxganic Takeover, we must not be silent.