Part I: The Preventative Controls Rule governing food processing facilities by Steve Gilman Interstate NOFA Policy Coordinator
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:http://sustainableagriculture.net/blog/pc-rule-analysis-part-2/
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!
- March, 2016
- Category: Advocacy
- By Steve Gilman
Good morning, and welcome. My name is Alexis Simpson. I am a State Representative from Exeter, NH. It was at this event last year that I was encouraged to run for office.
We are here today because it seems our voice hasn't been quite loud enough to get what 90% of New Hampshire citizens want: mandatory GMO Labeling. We know that policymakers are relying on outdated science and myths about genetically modified foods, but we are having trouble being as loud as biotech and grocery manufacturing lobbyists. The fact of the matter is, we are the people, and our combined voices are the only force we have to overcome the mountains of money being spent to protect corporate interests. Aren't we here because for too long we have let chemical companies and the money they spend lobbying our politicians decide our food policy? It's time to take it back.
Today, I want to encourage everyone here to get involved in our democracy. Vote every chance you have, write to your congresspeople, organize and encourage your friends, and if you're ready for the next step, run for office.
We are the people of this country, and we need to be heard more loudly than the multi-national corporations, who, let's face it, are designed to pursue profit at all costs. Our voice is not being taken seriously enough in determining the food policy we need across this country.
Many of you know that I have long been a supporter of small-scale farming, especially organic and sustainable farming as well as GMO Labeling. Citizens in Exeter and the Seacoast care about their food. We care about the food we eat, the food we feed our children, and the system that sets and keeps all this in motion. We want to know where our food comes from, how it's grown, and that we, as a society are making sure that everyone has enough nutritional food to eat. In short, our citizens trust that we have their best interests at heart when we're making policy.
We need to be asking for more from our policy-makers. We need to be asking for, to be working for, to be supporting a food system that recognizes the value of the entire ecosystem. We need to be asking for regulations that limit the amount of toxic chemicals put into our environment. We cannot forget that the primary seed companies in our country are chemical companies. They will always be seeking a profit by selling chemicals.
I don't talk about this often, but my father and grandfather were early-adopters of chemical agriculture. They were given the hard-sell by men going door-to-door selling the new high-tech way of farming. I don't come to having a particular drive to support organic farming without realizing the cost and the need. It tears me apart that we have not figured out as country how to make it possible for more people to buy organic more often. But as often as we can, we need to support organic farming. It's the alternative agriculture system we have available to us, and, it's ours. We have asked the federal government to give us this option, and we need to own it, to continue to participate in the democratic process maintaining its integrity.
Organic farmers forthrightly confront the challenge to farm in a way that least devastates the earth. We need a balanced ecosystem, we need to support farming that supports the long-term health of the environment and humanity. We know that organic farming regenerates the soil. We have come to find out that organic farming practices can indeed reverse climate change. Cutting-edge scientific data shows us that by using organic principles and practices, we can actually remove carbon from the atmosphere and sequester it in the soil.
So what can we as ordinary citizens and consumers do? Seek out farmers who enrich the soil, who minimize the use of chemicals, and who treat their farmworkers with respect. Continue to live out your values by supporting those who share your commitments.
In NH we have a sustainable way of life...NH is the number one state in the nation in farmer direct to consumer sales. We are spending more money per person buying directly from farmers than any other state in the country, but we can do more. We can do better. Let's keep moving forward.
- June, 2015
- Category: Advocacy
- By Alexis Simpson
In a regulatory agency reversal that rarely happens, the Food and Drug Administration (FDA) was forced to take major chunks of their proposed food safety regulations back to the drawing board for a complete rewrite. Thanks to a strong orchestrated outpouring of farmer and citizen comments, Round One went to family scale agriculture and the emerging food movement. Now, with the issuing of the re-regulations for public comment it turns out that the civic response in 2013 was just a dress rehearsal for this final public rule-making phase. The new comment period ends December 15th.
Many farmers and food groups across the country participated in last year's successful effort against FDA's initial one-size-fits-all regulations, including a well-organized national comment campaign mounted by the food safety team with the National Sustainable Agriculture Coalition (NSAC). As a charter coalition member, Interstate NOFA has been working on multiple aspects of the Food Safety Modernization Act (FSMA) since 2009 when the legislation was first introduced in Congress.
With much of FSMA initially formulated by special interests in far-off seats of power, this legislation is the most sweeping reform of our country's food safety laws since the 1930's. Once FDA goes to final rule-making after this public comment period is over, these new food safety regulations will absolutely have a major effect on how farmers farm – and thereby, on how eaters eat.
For a transparent and viable food system farmers must be allowed to utilize their safe sustainable agricultural practices via rigorous scientific risk-based regulations that actually provide bona fide food safety. And FDA's rules should not be allowed to supersede regulations already put forth by law – including the National Organic Program and various U.S. conservation programs. At stake is what fruit and vegetables will be available in the marketplace as these rules will dictate how food is produced and who will produce it.
But because FSMA focuses solely on microbial contamination in food, time-honored organic biological farming practices using compost, manures and other natural amendments to build soil fertility automatically become a regulatory target. Meanwhile, standard industrialized agriculture routines that feature heavy use of toxic pesticides, chemical fertilizers and herbicide-compatible GMO seed are not dealt with at all and under some FSMA interpretations are even considered a "safer" alternative.
Certainly all farmers, food facilities and preparers have a major responsibility for producing safe pathogen-free food. Despite some gains made in Round One, FDA's re-proposed Produce Rule (governing production) and Preventative Controls Rule (governing facilities) still unfairly impacts family-scale farmers' ability to stay in business, jeopardizes organic and sustainable farming practices and drives down the availability of fresh local food in the marketplace. This final comment period is our opportunity to shift food safety rulings to a precise risk-based footing – not one-size-fits-all decrees that favor corporate agribusiness over family farms and food businesses.
Targeted wins and major issues
For Round Two not only do we have to generate even more comments to protect family farms and our sustainable food supply – but we also have to play defense. Because we got a number of positive modifications that we asked for last year – now, as written in the re-proposals those items have a big bull's-eye plastered all over them as targets for various special interest groups.
For farmers who grow, harvest, pack or hold fruit or vegetables – or facilities that process, manufacture, pack or store human food the NSAC team's FSMA website has guidance on who might be immediately affected by the re-proposed rules: http://sustainableagriculture.net/fsma/who-is-affected/ along with easy to use commenting materials and templates. There are specific comment resources posted for consumers as well.
Manure and compost
In Round One some consumer organizations pushed hard for restrictive regulations governing "Biological Soil Amendments" – adversely affecting how farmers use manure and compost to build soil fertility. Bowing to this pressure FDA initially proposed a stringent nine month interval between applying manure and harvesting food crops and a 45 day interval for finished compost.
As successfully challenged in the 2013 comments, however, FDA had to acknowledge they put the rule before the science. Instead of setting arbitrary interval standards, valid scientific assessment are needed to accurately measure the risks posed by differing production practices, growing conditions, sources of manure and organic levels of biological soil activity that apply fairly all around the country. FDA will institute a new regulation when this research is finalized – which could take anywhere from 5-10 years.
But in their re-proposal FDA now has erred in the opposite direction by requiring no interval at all during the research period – which is just as scientifically indefensible. In so doing they have created an easy target for consumer groups wanting tough manure and compost regs. However, in addition to asking for scientific standards in Round One we also pushed for the adoption of the National Organic Program's (NOP) regulations of a 120 day interval for manure that contacts the harvested crop (like strawberries) and 90 days for no-contact crops (like Sweet Corn). And the NOP further mandates a zero interval for properly made compost. Here in Round Two we are enlisting the consumer groups to sign on to this as an interim standard with some success – but many supportive comments are needed!
Restoring the Qualified Exemption
FDA's original proposal featured a one-strike-and-you're-out rule after on-farm investigative rulings that gave farmers little recourse with no due process and no route for re-claiming their exempt status. Some consumer groups would like to reverse the new allowances made in Round Two, saying that by creating a right to reinstatement farmers will feel they will be able to just quickly fix a problem and promptly regain their exempt status. To thwart a rollback this revised provision needs widespread comment support.
Defining farms – and maybe CSAs – as facilities
Although FDA made some clarifications in how they define a "farm" under the present Produce Rule it's still all too easy for a farm to become bumped into the "facility" category designed for industrial food facilities. This would subject them to a slew of costly regulations including annual registration, excessive record keeping, infrastructure enhancements, audit fees and on-premises FDA oversight. And some bona-fide farms may also become beholden to both sets of regulations as a "mixed-type facility".
Despite clear language in FSMA that direct-to-consumer businesses are not facilities, comments are needed to counter FDA's contention that they can reclassify farms as facilities that are involved in light processing and sell directly to consumers at Farmers Markets, CSAs and farm stands. And even though farms are now allowed to pack and store their own and other's raw agricultural commodities without being considered facilities, FDA's re-proposal doesn't go far enough. They have yet to understand that real farms are not defined by activities at a single location – there may be multiple parcels, buildings and structures spread out over a wider area. Above all, FDA's farm definition should be risk-based and not interfere with standard farming practices.
The testing provisions for E coli in surface water irrigation sources have also been modified – from every 7 days to 20 tests a year (every 10 years to establish a baseline) and then at 5 tests per year if your water qualifies. While the revisions are more risk-based and recognize watershed differences they are still very expensive and non-scientifically verified. Since surface water conditions are so variable, perhaps testing closer to the times of harvest is warranted – using the established Good Agricultural Practice (GAPs) protocol of testing three times a year.
FDA's unauthorized supplier verification program
Out of the blue these re-proposals include a new FDA provision that requires growers dealing with aggregators such as food hubs, farm to school programs, auctions, etc. to automatically undergo food safety audits. Not only would this be a major expense for farmers – but also it is specifically not authorized in the FSMA legislation. Farmers who want to do business in specific markets (such as Whole Foods, for example) may voluntarily choose to undergo audits – but adding this as a general requirement would place a cap on farm expansion and the growth of local and regional markets.
All Hands On Deck!
The biggest error for smaller scale farmers and the consumers who rely on them would be to think that since are currently exempt there's no need to comment. In fact the final rulemaking will severely limit future farm growth possibilities, curtail expansion and impact the development of local and regional food security.
Many NOFA members got their feet wet in the commenting process during the 2013 campaign and armed with coalition-prepared information and talking points, discovered how easy and effective it was to officially submit their feedback. However, others that responded to petitions circulating the internet didn't realize that only input submitted individually by mail or though the Regulations.gov website are counted in the all-important final tally – as petition drives that gather even thousands of signatures only count as one single comment.
For complete comment guidance go to: http://sustainableagriculture.net/fsma/ -- or more simply just Google "NSAC FSMA".
- November, 2014
- Category: Advocacy
- By Steve Gilman
Should Soilless Hydroponic Growing Operations be Certified Organic?
Hydroponics is the growing of crops in nutrient solutions, usually indoors and under lights. Organic Standards clearly require that only biologically and ecologically based growing practices qualify as organic.
Organic integrity is at stake here. The National Organic Program (NOP) is already allowing some certifying agencies to OK hydroponic operations and is ready to issue a directive that completely bypasses the National Organic Standards Board (NOSB) 2010 recommendations and review process to give hydroponic operations the full go-ahead.
Some biologically active, ecologically-balanced operations such as aquaponics (utilizing fish-based nutrient systems) may well qualify but it is imperative that the NOP first take on the difficult task of writing standards - based on the required NOSB guideline input - before allowing hydroponics as an organic practice.
A petition to persuade the NOP to undertake this review process was begun by a Vermont farmer earlier this month and is spreading all around the country.
Please Sign this Petition Now to Protect Organic Integrity!!
GO TO: www.keepthesoilinorganic.org
- Jan, 2014
- Category: Advocacy
- By Steve Gilman
by Steve Gilman, NOFA-IC Policy Coordinator
"Some folks rob you with a six-gun, some rob you with a fountain pen." Woody Guthrie
[Note: For regularly updated comment guidance on the Food and Drug Administration's (FDA) proposed regulations based on the Food Safety Modernization Act (FSMA) please go to the materials posted at: <www.sustainableagriculture.net/fsma>
Simply put - food is for promoting our good health, nourishment and growth; not for making us sick or killing us. And food safety is everyone's business - from farms and processing facilities to restaurant kitchens and the home cutting board. But since we all want our food to be wholesome and safe - the question now with regulations looming is how food safety becomes reasonably defined in the marketplace. And, who defines it?
Most people would agree, for instance, that to be fair any regulatory construct should be scale-appropriate - not one-size-fits-all regs that could force smaller entities out of business. While national food corporations can afford (and definitely require) everything from sizeable food safety departments to sanitary stainless steel facilities - but at the local level the farmer often IS the sole time-limited staffer, who relies on much less expensive preventative controls such as linoleum-covered packing benches, which are just as cleanable.
Regulations should also be risk-oriented. Produce that is cooked has a kill step that makes it less risky than vegetables that are usually consumed raw, for instance. Aggregators who co-mingle product from multiple farms present more risk than a single-source farm. And then there's the "fresh cut" produce industry who grow, process and pack huge batches of spinach and lettuce and ship them to outlets all around the country - where a single contamination event can potentially poison tens of thousands of people. Although these operations are inherently much riskier than growers selling fresh produce at the local Farmers Market, for example, this huge magnitude of risk gets lost in FDA's cavernous proposed regs.
Indeed, one of the most attractive aspects for food conscious consumers today is buying "food with a face" - knowing one's farmer and knowing one's food is itself an important aspect of food safety. Local farmers' livelihoods are on the front lines of every sale they make, and unlike the corporations with large legal departments who can just keep on with agribusiness as usual they can be shunned by buyers and quickly put out of business. Further, farm families are often the primary eaters of the food they raise, giving a personal incentive to do things right. However, even though they have a less risky impact serving smaller numbers of customers, smaller scale farmers are just as susceptible to microbial contamination - and All growers have to utilize appropriate food safety practices. This has a lot more to do with appropriate training rather than onerous regulatory oversight, however, as we'll get to in a moment.
Farmers and Food Movement Targeted
So, what are the best food production methods and what are not? For starters, many risky industrialized food practices automatically get a free pass. FDA defines food safety solely in terms of microbial contamination such as pathogenic E coli, Salmonella, Campylobacter, Listeria and other bacterial adulterants. Since the agribusiness industry has already made sure it's legal to use unlabeled pesticides and GMOs in our food production, these toxic substances do not even enter into FDA's definition of contamination. The same goes for a long list of suspect industrial food production chemicals, processing aids, preservatives and synthetic colorings, as well as drugs, hormones, antibiotics, etc. in meat that all lie at the basis of today's food supply.
Analysis of FDA's controversial Proposed Rules for Produce (governing farms) and Preventative Controls (for facilities) that were issued in January for the public comment period will have definite impacts on family farmers. Even those farms that were seemingly exempted by certain alternative statutory provisions of FSMA will be caught up in convoluted fine-print provisions. And while the formidable task of grassroots organic and sustainable food organizations is to provide an insightful analysis of the rules and generate a citizen comment campaign to try and make them much more fair to farmers - there are also groups working to make the regs much more strict than now proposed. There are further concerns that FDA has been put in charge with very little knowledge of farming activities. And this wouldn't be the first time that government regulations were used by powerful special interests to put competitors out of business and stifle popular movements.
Because economically healthy and productive family farms are at the very heart of the food movement, these proposed regulations will have a deep impact on many aspects of the emerging alternative food system. More and more consumers are relying on wider healthy food choices in the marketplace. Farmers Markets are growing and thriving because of the direct connections they provide to farmers and fresh food; delicious farm-based artisanal foods are replacing processed chain store fare; and environmental groups working against pesticides and bad land management practices need a viable sustainable alternative. Also, food co-ops, local restaurants and regional food hubs source their products from area farms; gardeners rely on farmer production for the varieties they don't grow; beginning farmers need a robust local agricultural economy to get a toehold; Farm to School projects utilize local farms for both food and education -- the list goes on and on. Indeed, just about any vision of a healthy, workable food system alternative is built upon having a large diversity of viable family farms securely in place.
The Food Safety Modernization Act is the first major food safety legislation passed by Congress since 1938's Food, Drugs and Cosmetic Act, which set civil and criminal penalties for selling certain foods defined as adulterated. Thanks to a number of scandalous national food contamination outbreaks in meat and produce in the 1990's and early 2000's - together with (wildly inaccurate) food illness and death quesstimates from the Centers for Disease Control - some consumer groups and corporate produce producer associations pushed hard for new regulations to address modern problems - or at least to assure the public that everything is under control and they can just keep buying as usual.
There had already been some legislative activity directed at farms in 2002 when Congress included food oversight in the ambiguously written and hastily passed Bioterrorism Act of 2002 that came as a response to the 9/11/2001 terrorist attacks. Most worrisome, the act included statutory language that redefined a list of standard harvesting operations as processing activities - reclassifying some farms as facilities and requiring farmers to register annually with FDA, comply with increased standards, keep records and maintain paperwork. Although the Bioterrorism Act was not strictly enforced it is still on the books - and it directly informs a number of FDA's proposed FSMA rules.
Under pressure from some consumer groups taking on popular issues to increase their membership rolls and produce associations looking to enhance their tarnished image and put a dent in the competition, in 2009 a food safety bill originating in the agribusiness-friendly House Agricultural Committee basically gave industrial ag a "Get Out of Jail, Free" card while throwing family farmers under the bus. The proposed one-size-fits-all regulations in the House bill took the Bioterrorism Act rules several severe steps further. Seeing the writing on the wall, organic and sustainable agriculture groups from all around the country came together under the auspices (and Capitol Hill expertise) of the National Sustainable Agriculture Coalition (NSAC) to organize a concerted political response.
The next stage was in the Senate with the governing Health, Education, Labor and Pensions (HELP) Committee where, thankfully, NSAC had already built good long-term relationships with Senators. As the legislative process unfolded the Task Force was able to enlist a number of Senators to include several supportive Amendments protecting family farmers, helping to reverse some of the excesses of the Bioterrorism Act. This turned into a policy fight every step of the way, with an opposition led by Big Produce organizations and the consumer group, the Center for Science in the Public Interest (CSPI) who were adept at working behind the scenes to thwart the farmer protections. In a final battle an Amendment by Senator (and organic farmer) Jon Tester of Montana was finally approved, providing alternative oversight provisions and exemptions from the federal rules for certain smaller scale family farmers.
After laborious Congressional horse-trading aligning the House and Senate versions, the controversial Food Safety Modernization Act was finally passed at the 11th hour in late 2010 - ending a two year route through Congress. Then came FDA's rule-writing phase, where FDA staff worked with consultants to translate the intent and particulars of the statute into on-the-ground regulations. Some 1200 pages thick, the controversial proposed rules were not released for public comment until after the November 2012 elections to keep them from becoming an issue in the campaigns. In January, 2013 FDA issued their voluminous Produce Rule (for farmers) and Preventive Controls Rule (for facilities) for public comment. Initially the comment period was due to expire in mid-May - but due to a public outcry over the complexity of the documents it was recently extended until September 16th.
Farmers Bearing the Brunt
The regulations cover everything about how farmers farm including: biological soil amendments, water, on-farm processing, worker health, domestic and wild animals, tools, equipment and buildings. Initial analysis by the Task Force, together with assistance from outside economists, microbiologists, law clinics and other specialists shows these proposed regulations will have a definite impact on family farmers - and thereby on the food movement as well. According to recent economic studies farmer compliance costs to upgrade buildings, buy equipment, maintain records, conduct tests, etc. could easily reach into the $20,000+ range per farm. But since FDA has no overall impact studies many other costs may remain hidden until farmers are required to comply with them.
Further, under the proposed rules, it's the farmer who is often left holding the bag for contamination produced by other entities. If a CAFO moves in next door, it's the produce farmer who must put in buffers and site their crops out of range of any water or windborne pollution. And while the periodic testing of irrigation sources might be a good practice, in reality the farmer is the one who pays for the tests and must bear the economic losses from not be able to use the public water supply (including withered crops) while the contaminators (including periodic municipal sewage facility overflows) continue to pollute for free.
From initial analysis many questions have arisen over particular legal language details - some of which are confusing at best and can produce negative interpretations if the proposed regs get finalized as is. There's a lengthening list of provisions that need to be completely rewritten. Even basic definitions delineating "farms" and "facilities" are murky and conflicting. Further, produce farmers who also grow non-regulated "food items" such as hay get their total farm sales counted, which can easily push them out of an exempted category. Farms can suddenly find themselves classified as facilities. Items covered in the Produce rule do not always jibe with their counterparts in the Preventative Controls rule, and so on. When items such as these are pointed out at meetings, conference calls and webinars with FDA, the officials are sometimes at a loss how to answer them and the questioners are generally instructed to make formal written comments depicting the problems - as well as providing the exact language necessary to fix it.
The most egregious override of Congressional intent is an open-ended, vaguely phrased "material conditions" clause that gives FDA full powers to withdraw a farm's statute-authorized exemptions. Slipped into FSMA at the last moment by CSPI and others, there's no mandated protocols, compliance timeframes or evidence requirements - while the burden of proof is placed completely on the accused farmer. Although a farmer may appeal such a ruling (to FDA, not an outside authority) there's no depiction of what records can stand in as acceptable evidence when the farm was exempt from record-keeping to begin with. Further, there's absolutely no provisions or pathway on how a farmer can reinstate their exemption once the purported material conditions have been addressed or FDA cannot show there is a problem. And beyond FDA's direct action powers against single farms there's no language preventing them from conducting a blanket withdrawal of exemptions from a large number of farms that they deem are engaged in some sort of category of risky production.
A Necessary Evil? As one of the more outspoken advocates for severely limiting the FSMA-mandated farmer exemptions, CSPI is on record saying that additional regulations, fees and paperwork are a "necessary evil" needed to combat the risks and burdens of food contamination in the marketplace and they are working hard behind the scenes to make this a reality. At the same time they publicly advocate the values of organic and sustainable farms and have created an annual national Food Day (Ocober 24th) as a public corporate media event touting these values, even when a United Nations World Food Day (on October 16th) has been in existence since 1945.
However, both Congress (in formulating FSMA) and FDA (in rule-making) recognized that creating one-size-fits-all regulations applied to all scales of farming and to all regions of the county is not only unfair, but futile. Due to this tremendous variability of conditions (a citrus grower in Florida deals with much different conditions than a potato grower in Minnesota, for instance) these proposed regs necessarily allow for considerable producer discretion and interpretation. And since there is scant science to back up more specific metrics, FDA will be following up the FSMA regs with a series of ongoing Guidances, which will also be subject to grower oversight and comment periods.
As we've seen time and time again, a strict regulatory approach to a desired goal is often counter-productive. Sometimes all that is really created is a lot of extra paperwork - and bigger bureaucracies to process it all. However, built into FSMA is an amendment by Michigan Senator Debbie Stabenow, current Chair of the Senate Agriculture Committee, providing for food safety training via a USDA grants program for small and mid-scale farms, beginning farmers and small scale food processors and wholesalers. The catch is Congress must annually fund this provision through the appropriations process, a tough lift in this age of budgetary chicanery.
As it is the NOFA chapters and farming organizations across the country are devoting considerable resources to meet the farmer demand for appropriately scaled food safety training and such funding would be welcome. Attendance is packed at food safety farm tours, field days, state-of-the-art demonstrations and other events. Even though Land Grants and Cooperative Extension provide valuable materials and expertise, their budgets are being constantly whittled down. If advocates for stronger food safety provisions want to make a real difference on the ground - then supporting food safety training is clearly the most effective way to go.
While these proposed rules directly affect farmers, everyone who is part of he Food Movement has a stake in the outcome. Farmers are fully involved in farming and have scarce time to participate in the comment process. That's where the Food Movement needs to step in. There's a wide range of good food organizations and concerned citizens who have the resources and expertise to engage in this process. The future of the food movement depends on it.
- May, 2013 li>Category: Advocacy
- By Steve Gilman
First Proposed FDA Food Safety Rules Released for Comment (and yes, farmers and consumers - this means You)
NOFA Interstate Policy Coordinator
Prepared for the Spring 2013 Issue of The Natural Farmer
After a wild two year ride that finally made it through Congress at the 11th hour, followed by another two years of FDA rule-making and then being held back by the Administration until after the elections - the first proposed rules of the Food Safety Modernization Act (FSMA) have been released for a 120 comment period by the Food and Drug Administration (FDA). This is not a light read - the draft produce safety rule (for farmers) and the draft preventative controls rule (for processing facilities) comprise a stack some 1700 pages deep. And some mixed operations might find themselves beholden to both. At stake is how farmers large and small will be regulated in the name of food safety - and how the galloping growth of our local food sector will be impacted.
The immediate undertaking for the Food Safety Task Force (set up in 2009 to ride herd on the legislation) is to divvy up the pages and analyze the proposed rules section by section, red flagging provisions for the comment process. The process is coordinated by staff at the National Sustainable Agriculture Coalition (NSAC) in Washington, D.C. and economists, microbiologists and lawyers have also been brought in for expert assistance. Phase II in February will be to put together a comprehensive analysis and comments. These will go out in alerts and PR to the grassroots community nationwide in March, April and May in Phase III to help citizens write comments to FDA in the final rule-making process. The comment period closes May 16th.
Key sections in the produce rule deal with worker health and hygiene; agricultural water supply; biological soil amendments; domestic and wild animals; and equipment, tools and buildings - and there are a number of problem areas in each category that we will need to address. Likewise, the processing rule has problems, among others is differentiating between activities that could classify a farm as a facility - such as the distinction between on-farm bagging vs. facility packaging, for example.
Holding on to what we got Not surprisingly, Big Ag and some consumer groups want to see tighter rules on farmers. A good part of the Task Force's challenge is to hold onto the beneficial family farm provisions won in the FSMA language that might not make it intact through FDA's regulatory process into a final rule. Key FSMA amendments were skillfully put in place to prevent a move toward one-size-fits-all regulations that could put smaller scale practitioners out of business and derail the local food movement for grassroots consumers. With this rule-making process the originating Congressional language is now subject to FDA's regulatory interpretation and the devil is hidden in the pages and pages of definitions and compliance details.
For example, the Tester/Hagan Amendment - put forth by Sen. Jon Tester, an organic farmer from Montana, and Kay Hagan, Senator from North Carolina - created some alternative state and local regulatory pathways for smaller scale farmers that by-pass regular direct federal oversight. This amendment covers farms that gross under $500,000 a year that sell more than half of their produce directly to the final consumer (via Farmers Markets, CSAs, farm stands, grocery stores, and restaurants) within the state, and if the farmer sells in an adjoining state it must be within 275 miles of the farm.
While the Tester language is contained in both rules, it is confusingly defined differently in each and we could end up with a situation where part of a farm is subject to one set of rules or the other or a mixture of both. There are also potential entanglements where skewed definitions of standard harvesting activities can push a farm into being classified as a facility - requiring registration and subject to FDA inspection.
When it comes time for producing comments not only do we have to point out what's wrong in the proposed regs but also show them the language that will fix the problems. And while we're compiling a lengthy list of red flag items we also need to underscore what FDA got right. We pushed long and hard for rules that deal with whole categories of produce, for example, not regulating them singly one by one as preferred in the agribusiness model.
FDA's Withdrawal of Exemption powers
However, the bottom line for family scale farmers who might be thinking they are exempt from all this and won't have to bother with the comment process is to think again - as there's this overriding FDA "material conditions" clause. The draft regulations allow FDA to revoke your exemption:
"(b) If we determine that it is necessary to protect the public health and prevent or mitigate a food borne illness outbreak based on conduct or conditions associated with your farm that are material to the safety of the food that would otherwise be covered produce grown, harvested, packed or held at your farm."
And the "Catch-22" here is that exempt farmers who are not required to keep federal records won't have the necessary documentation in place to appeal and exonerate their practices should FDA choose to target one's farm. Undoubtedly this open-ended clause needs to be strictly reformed and clarified with burdens of proof and other legal limitations placed on potential FDA action. But FDA plainly has oversight powers, as FSMA requires there be a mechanism for revoking the exemption in the rules.
At the same time food safety is narrowly defined in this rule to solely address virulent microbial contamination - while chemical or genetic contamination via pesticides or GMOs, for example, are a huge exemption that is totally ignored by FDA as well as Agribusiness and some consumer groups. This requires concerted comment as well.
Overall, much of what is contained in the proposed regulations is based on common sense. While these rules only apply to what is sold in the marketplace (i.e. not produced for personal consumption in the home garden) surely ALL food needs to be safe. Farmers and processors who may be "exempt" (from federal rules) under the regs are just as responsible for not sickening or killing their customers - or family members who are often the most regular consumers of the food produced on small farms.
And while the big industrial producers and processors present a much larger risk in the marketplace because a single contamination event may be co-mingled, bacterially multiplied and distributed to thousands of consumers in numerous states - it is simply not true that smaller operations are any more safe (albeit on a smaller scale) as documented outbreaks attest. Therefore, even though direct-market farmers may not be required to go through formal trainings or document their practices it is incumbent on them to seek out the information and education that will increase their vigilance on the farm. In addition to self assessment and NOFA on-farm workshops, "GAP's-lite" (Good Agricultural Practices) workshops are often available where farmers can learn state-of-the-art techniques and put together a personal farm plan to effectively gear up to address these issues without having to go all the way to the audit process.
After the comment period ends on May 16th FDA will then take them into account and write the final rule, a task requiring months and months. The proposed rule has built in compliance times for farmers from two to four years beyond that, depending where they fall in the regulations. Meanwhile, Interstate NOFA will be posting helpful materials at the www.nofa.org policy website and there will be wide scale outreach and alerts to help citizens with the comment process this spring. And the summer issue of The Natural Farmer will be focused on Food Safety. Stay tuned - this wild ride is not over by a long shot.
- Aapril, 2013
- Category: Advocacy
- By Steve Gilman
On April 5, 2013 the Food Safety Task Force with staff at the National Sustainable Agriculture Coalition (NSAC) posted initial materials to guide farmers and citizens who wish to comment on FDA's proposed produce and processing rules.
Coming in the weeks will be regular website updates and more in-depth guidance on specific regulatory issues such as water testing, manure use, wild and domestic animals, buildings regulations, withdrawal of exemption, etc.
There will also be a national Comment Campaign starting up in the media designed to activate farmers and consumers nationwide -- as these rules could have a profound impact on our emerging alternative food system.
- March, 2013
- By Steve Gilman
NOFA-IC Policy Coordinator
As one of the oldest grassroots organic farming organizations in the country (founded in 1971) NOFA has worked resolutely to promote healthy food, organic farming practices, food system fairness and a cleaner environment. Along the way, however, we've learned that we ignore the food and agricultural policy process at our peril. Accordingly, we've been working to effect change in the food system through educating the powers-that-be and supporting beneficial policy initiatives.
Organic advocates well understand that despite our best stewardship efforts our organic farms, gardens and local food supplies do not exist in a bubble. The reality is that public policies allow huge amounts of industrial toxins to legally pollute our food, soil, air, water and atmosphere on a daily basis - and also enable the polluters to pass on the health and environmental costs to the citizenry while they advance their corporate agendas. Through extensive (and expensive) lobbying and the revolving door between government and industry they've been able to enshrine their special interests into governmental policy - including huge taxpayer subsidies, pesticide and GMO allowances, Farm Bill give-aways, food safety regulations and meager agency oversight.
NOFA's response is to work through our chapters on a state-wide basis and regionally through the NOFA Interstate Council (NOFA-IC) to join forces with other progressive groups nationwide to promote positive coalition-based policy initiatives. NOFA is an active member of the North East Sustainable Agriculture Working Group, the National Organic Coalition, the National Sustainable Agriculture Coalition and the International Federation of Organic Agriculture Movements as well as the Agriculture Justice Project and the Domestic Fair Trade Association. Many of these coalition member groups have extensive organizational assets and professional expertise - but despite a small budget and limited resources, NOFA-IC is able to bring a grassroots legitimacy combined with an activist membership base to the table that is key factor in influencing the policy process.
However, even with wide public support for organic environmental and health benefits and the extraordinary expanding demand for organic food in the marketplace, alternative agriculture policy advocacy is mostly an uphill battle. NOFA and our coalition partners are constantly faced with having to respond to numerous large-scale issues simultaneously. These include preferential U.S. agency treatment for industrialized agriculture, contamination from pesticides and genetically engineered crops, one-size-fits-all food safety regulations, structural injustice for farm workers and anti-organic and conservation initiatives in the Farm Bill.
NOFA works to pull together grassroots input to develop our policy emphasis as well as to alert and activate the membership to take part in policy advocacy activities and to contact state and federal legislators. It employs state and interstate policy representatives as the eyes and ears of the organization to monitor policy developments on a daily basis and keep on top of breaking events. Especially in this time of economic duress, finding funding for NOFA-IC policy expenses and development is a continuing challenge. Expenses such as communications costs, airfare, transportation and lodging have to be paid in order to cover events at home and participate in coalition meetings and events around the country.
Thanks to a $15,000 Ben and Jerry's capacity-building grant in 2011 NOFA-IC was able to create an interstate policy committee consisting of policy reps from each of the seven state NOFA chapters. As led by the IC Policy Coordinator - the committee conducts daily business by phone and email as well as monthly meetings by conference call. A new face-to-face day long meeting is scheduled for the Annual IC Retreat in December.
Further, a policy information and grassroots input session has become a regular feature at the NOFA Summer Conference. Open to all, a number of NOFA members have joined particular issue IC Policy sub-committees (GMOs and Fair Trade so far). And thanks to a number of important gifts in 2012 (see below) NOFA is able to maintain and expand our presence to deal with these critical policy matters.………………………………………………………
Policy Funding Makes a Difference!
We are most grateful for a number of gifts that are keeping NOFA-IC policy work functioning. For 2012 - into 2013 - these include:
- An annual $5,000 dedicated policy gift from the North Pond Foundation who have been supporting NOFA policy endeavors since 2007.
- Income from the member-supported NOFA Credit Card goes directly to IC policy - NOFA receives $50 for each sign up and a percentage of credit card usage, amounting at this point to $5,000 a year.
- An annual $1,500 contribution from the NOFA Interstate Council along with
- $1,500 from NESAWG to support food safety implementation activities
- Horizon/White Wave contributed $5,000 specifically for policy work
- NOFA-IC was awarded $5,000 from the "Farmers Advocating For Organics" program from Organic Valley.
- And most recently, Stonyfield Organic awarded NOFA policy $15,000 under its "Profits for the Planet" program.
- August, 2012
- By Steve Gilman
The harsh glare of floodlights is being directed as never before at the GMO's (Genetically Modified Organisms) lying unlabeled in our food supply. This fall 2011, there are numerous anti-GMO projects, events and rallies taking place all across the country. Over the first half of October participants in the Right2Know March trekked through parts of NOFAland, covering the 300 miles from New York City to the White House generating mega media exposure along the way. California activists are sponsoring events and gathering signatures to put a GMO labeling initiative before voters on the 2012 statewide ballot. And Organic Consumers Association's ongoing Millions Against Monsanto crusade supported hundreds of rallies around the nation on World Food Day, October 16th.
Citizens are responding! In just its first week, a major national campaign launched in early October called "Just Label It" generated over168,000 signatories to a legal petition calling for the Food and Drug Administration (FDA) to utilize their existing authority to require the mandatory labeling of genetically engineered foods. By Halloween that number was 300,000 and growing. The seven NOFA state chapters and the Interstate Council are signed on as partner-sponsors with some 450 other organizations and businesses all around the country. Polling has revealed that fully 93% of Americans believe GMOs should be labeled in the marketplace. Citizens wishing to add their voices to the FDA lawsuit can sign on at www.justlabelit.org/.
As one of the oldest organic farming organizations in the country, NOFA has long been working against the hegemony of the biotech corporations in agriculture. Coordinated at the interstate level through the Interstate Council Policy Committee (IC-PC), earlier this year the seven NOFA state chapters registered as plaintiffs in a major lawsuit challenging Monsanto's patents on genetically modified seed. Titled Organic Seed Growers & Trade Association (OSGATA), et al. v. Monsanto the unprecedented legal action is being brought by the Public Patent (PUBPAT) Foundation with 83 farming groups and individuals from across the nation.
In addition, NOFA is working with fellow regional, national and international coalition members on GMO policy to leverage expertise and coordinate grassroots responses - including the North East Sustainable Agriculture Working Group (NESAWG), the National Organic Coalition (NOC), the National Sustainable Agriculture Coalition (NSAC) and the International Federation of Organic Agriculture Movements (IFOAM). Meanwhile, NOFA chapters are ramping up statewide campaigns and legislative initiatives as well as featuring GMO awareness at their winter conferences and websites.
And as it turns out there's a LOT for citizens to learn about GMOs and their impacts - from health and environmental effects to the machinations of power politics and agribusiness as usual.
Our Right To Know
At the top of the list is Eaters' right to know what's on - and IN - our food. As part of today's Good Food Movement, more and more folks are choosing fresh, healthy food for themselves and their families. Everyday consumers are questioning everything from how commercial crops are grown and processed to the pesticides and other toxins that are part of our daily food. But some aspects remain hidden from view, denying eaters a choice in the marketplace. The bottom line here is flabbergasting: GMOs are present - unlabeled - in over 70% of the groceries on supermarket shelves - including vegetables, fruit and a host of industrially-produced ingredients in processed food.(1)
But for the biotech corporations, labeling is a death knell - their own studies show that consumers would stay away in droves. The reality is that their refusal to identify GMO products means that food safety and health effects remain unidentified and untraceable - thwarting epidemiological investigation and relegating detection to a realm of "unproven" allegations. And, without that smoking gun traceability they are also protected from ruinous product liability claims and lawsuits.
Brand new to the food chain, GMOs are novel life forms created in the laboratory through the gene splicing techniques of biotechnology. Also known as genetic engineering (GE), this novel technology fundamentally differs from classical selective breeding and hybridization techniques. It merges DNA - often from completely different species - creating artificial and transgenic combinations of plant, animal, insect, bacteria, fungi and viral genes that cannot occur in nature. And since the altered gene becomes part of the DNA of the engineered organism, the manipulated traits are passed on to future generations through regular reproduction.
While eons of evolutionary natural selection have developed and closely confined living things to their kingdoms and species, in just the past 20 years biotech scientists have created myriad artificial and transgenic life forms that break down fundamental genetic barriers - such as fusing fish genes into tomatoes and strawberries; spider genes in goats and soil microbes in corn, cotton and soybeans. Further, genetically engineered insects have been released into the wild for field studies and human genes have been recombined into pigs and rice. These wholly new organisms and many other biotechnological inventions just as monstrous have been genetically engineered and released experimentally into the environment - with the lucrative varieties commercialized and processed into the food we eat.
Escaped transgenes are also taking on a life of their own in the environment, creating genetic pollution and worrisome contamination problems for wildlife and farmers. Promiscuous GMO pollen has escaped on the wind and borne by insects into the wild where they're freed to reproduce willy-nilly with their feral plant and bug relatives. With millions of acres planted to GE crops engineered to tolerate herbicides (primarily Monsanto's Roundup ™) and plant-produced GE insecticides, tremendous natural selection pressure has resulted in resistant strains of "superweeds" and "superbugs" that now require much more toxic and expensive controls by the farmer.
Untested and Unregulated:
Just as the biotech industry has managed to prevent labeling of GMO products in the marketplace, they've also circumvented significant governmental regulation and safety oversight. Unlike over 40 countries including much of Europe and Japan the U.S. has never passed a law regulating GMO crop technologies. Instead, thanks to promotional efforts in the 1990's designed to make America Number One in genetic engineering, the US government ruled that GMOs fit into the squishy category of "Generally Regarded As Safe" (GRAS) and incorporated permissive oversight parameters into laws already in existence before biotech crops were developed. As a result, today's GMO supervision is based on fictitious categorizations whereby FDA classifies genetically modified fish as a "drug", EPA oversees GE corn plants as a "pesticide" and USDA labels GE crops as prospective "plant pests" turning biotech into a virtually unregulated industry.
Further, thanks to a supervisory prototype modeled on foxes guarding henhouses, the only testing is self-conducted by the industry or their designees for threats to human or animal safety before they are released for sale.(2) Despite this toothless oversight, the biotech industry is pushing their friends on Capital Hill to de-regulate GMOs altogether. And friends in high places they have a-plenty, thanks to a half a billion dollars spent on lobbying in just the last decade by Monsanto alone.
As a result of a narrow 1980 Supreme Court decision allowing the patenting of life forms, the seed industry has largely been bought up and consolidated by the big biotech companies. Seed purchase contract arrangements with farmers have also been substantially altered - requiring them to sign technology agreements that forbid the traditional practice of saving seed. However - selecting, saving and exchanging seed to enhance locally adapted production traits and insure crop diversity has long been a part of sustainable farming practices - and GE homogenization represents a major threat to our overall food security.
In a perverse exercise of patent rights, Monsanto has also been suing farmers who have accidentally and unknowingly "acquired" their germplasm via cross-pollination, seed company co-mingling, transportation spills and other forms of gene-flow contamination beyond their control.(3) Further, seed retailers are restricted from carrying non-GMO seed - severely limiting farmer choice in what they can plant. Meanwhile, in a classic bait and switch, newly developed "stacked trait" varieties engineered to control multiple insect and weed pests were first sold at a discount, while tried and true regional varieties were being discontinued. Now, with the alternatives no longer in production, seed fees have been jacked up - no longer priced by the bag or bushel - but by the kernel.
Astonishingly, these patent provisions also allow the industry to completely shield their GMO products from outside scientific scrutiny. Independent researchers are legally required to obtain permission from the biotech corporations to conduct research on their proprietary GE seeds and organisms. This has created cadres of industry-beholden scientists who need to remain in Biotech's good graces to maintain their careers, as the industry is today's major agricultural research funder. And while the corporations make great use of less-expensive and very effective classical breeding techniques and work with varieties that have been developed by publically-funded breeders, their modus operandi is to insert an engineered gene to create a proprietary variety - and render it useless for organic farmers, gardeners and others serving sustainable and non-GMO markets.
For Health's Sake
In the U.S. GMO health and food safety studies remain minimally funded and few and far between. However, there have been a number of GE food studies by independent researchers in Europe. Mounting laboratory data indicates serious health effects are connected to consumption of GE foods. The American Academy of Environmental Medicine (AAEM) has assembled citations showing gastrointestinal ailments, organ damage, immune system disorders, problems with insulin regulation, disruptions in cell signaling and protein formation, accelerated aging, infertility, etc. in laboratory test animals. Human studies show that traces of bacterial pesticides used in GE crops can indeed horizontally transfer into the human genome and it has even shown up in the blood of unborn fetuses.(4)
There's also an associated increase in health problems that has accompanied the release of GMOs into the food supply in the mid 1990's. The number of Americans with chronic illnesses has nearly doubled and there are huge increases in food allergies, reproductive disorders and digestive problems. Like many industrially caused diseases and cancers health effects can take years to manifest in individuals and remain exceedingly difficult to trace. The AAEM recommends a strict precautionary approach for medical patients, calling for the avoidance of all GMO foods. Parents are especially wary of today's dramatic 400% increase in children's allergic reactions, as well as major increases in ADHD, autism, asthma and other health effects that are linked to novel proteins in everyday food products marketed to kids.(5)
Clearly, for precautions sake, it's time to Know - and label - GMOs, raise the awareness of others - and reclaim our food system.
(1) Consumer Acceptance of GMO: Survey Results from Japan, Norway, Taiwan, and the United States
Wen S. Chern and Kyrre Rickertsen
(2) No Seeds; No Independent Research, Doug Gurian-Sherman (plant pathologist and senior scientist at the Union of Concerned Scientists)
(3) Organic Trade Groups and Farmers Sue Monsanto
(4) GM food toxins found in the blood of 93% of unborn babies
(5) Genetically Modified Foods: The American Academy of Environmental Medicine Position Paper
Genetic Engineering in Agriculture and Food Systems: Selected Resources
Prepared by Dave Rogers, NOFA-VT Policy Advisor Fall 2011
Just Label It !Campaign Information about GMOs and a recently filed petition to require the FDA to label GE foods. Includes consumer action link.
A Global Citizens Report on the State of GMOs - False Promises, Failed Technologies 2011 report coordinated by Navdanya International, International Commission on the Future of Food and Agriculture, with the participation of The Center for Food Safety (CFS)
GM: Novel Cuisine or Unpalatable Prospect? Bite Magazine, Summer 2011. Food Standards Agency, United Kingdom
Genetically Engineered Food: An Overview September 2011 report from Food and Water Watch
Sorry, NYTimes: GMOs Still Will Not Save the World A nice Grist Magazine rebuttal by Anna Lappe to a NYT Op-Ed by a well-known proponent of GMOs. (August 2011)
Third World Network/Biosafety Information Centre European website: resources on biotech, trade, development, north-south issues, including "Genetic Engineering and Omitted Health Research: Still No Answers to Ageing Questions"
Safety Testing and Regulation of Genetically Engineered Foods , Biotechnology and Genetic Engineering Reviews (2004). Excellent technical review of scientific literature
Union of Concerned Scientists See "Failure to Yield: Evaluating the Performance of Genetically Engineered Crops" (2009) and other resources on food, agriculture and GMO's.
Center For Food Safety CFS is at the center of ongoing GE litigation actions. GE resources and policy comments.
GM Watch Wide selection of videos and information
National Organic Coalition National alliance of organizations (NOFA Vermont included) - GE positions and papers agriculture.
The Organic Center Excellent resources, including "Impacts of Genetically Engineered Crops on Pesticide Use: The First Thirteen Years" (2009)
Institute of Science in Society - "Special Safety Concerns of Transgenic Agriculture and Related Issues-- Briefing Paper for UK Minister of State for the Environment "
GMO Compass - GMO info website supported by the EU
"A decade of EU-funded GMO research (2001 - 2010)" - Report of the European Commission
Non GMO Project - Many GE resources, including "GM Crops - Just the Science: Research documenting the limitations, risks and alternatives".
Institute for Responsible Technology Many resources - online videos, books, podcasts, blogs, reports and information on GMOs
GMO Safety - Genetic Engineering - Plants - Environment Webpage of the EU Federal Ministry of Education and Research
Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects A 2004 National Academies Press report produced by the Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health. Institute of Medicine and National Research Council (USA).
- December, 2011
- By Steve Gilman
NLGMA Comments from the Northeast Organic Farming Association
To: Melissa Schmaedick Agricultural Marketing Service (AMS), USDA
RE: AMS proposed National Leafy Greens Marketing Agreement
From: the Northeast Organic Farming Association, Interstate Council (NOFA-IC), representing the seven state NOFA chapter organizations of NY, VT, NH, MA, CT, RI and NJ and over 5,000 members who strongly protest AMS's efforts to create a National Leafy Greens Marketing Agreement (NGLMA).
In late 2009, NOFA participated with members of the National Organic Coalition, the National Sustainable Agriculture Coalition and many others in a series of seven formal Hearings on NGLMA held at locations across the country. Despite some subsequent changes made by AMS in reaction to the overwhelming criticism at the Hearings - the present alterations are non-substantive and deal mostly with how the NGLMA appears on paper. The basic concerns about AMS jurisdiction, the continuing domination of the western produce industry in the NGLMA power structure and the underlying anti-conservation metrics issues that were raised by the organic and sustainable agriculture community at the Hearings still stand today.
Lack of AMS Jurisdiction
First and foremost, despite AMS' long time expertise providing marketing research, news services, promotion programs and economic data to assist in the orderly marketing and distribution of farm commodities - it does not have the legitimate purview, capability or experience to develop and regulate food safety provisions. This contention is even backed up by top AMS personnel. On record in the Hearings testimony is documentation that both the present and former Administrators of AMS have testified before various House sub-committees, saying succinctly that "AMS is not a food safety agency."
AMS is attempting to exceed its statutory authority to write food safety standards for produce - but that power clearly resides with the Food and Drug Administration (FDA). Furthermore, the FDA is currently in the final rule-making process of developing produce food safety regulations, as required by the comprehensive Food Safety Modernization Act (FSMA) enacted by Congress late last year. Despite this fact, AMS is still proposing to let the industry compose their own food safety standards for leafy greens under the aegis of USDA to define food safety metrics and develop business-friendly regulations - all with favorable government-sanctioned food safety marketing opportunities.
More exactly, safe food is (and should be) a fundamental, pre-competitive condition and the basis for all food in the marketplace. As such, food safety has no place as a specified value-added governmental label or designation intended for price-enhancement and promotion, let alone by a government-backed marketing message that says this food is safer than that food because a marketing agreement with the industry defines it as such.
Domination of the western produce industry
USDA began the process of setting up a NGLMA in response to the direct request from western produce industry handlers and shippers (but not growers) in June, 2009. It is directly modeled after the California and Arizona Leafy Greens Marketing Agreements - and their ensuing metrics - that were put in place by handlers in reaction to the devastating 2006 E.coli spinach outbreak in California, which heavily impacted consumer perceptions about the safety of its industrialized "fresh-cut" leafy greens production.
Although this revised NGLMA draft more sensibly redraws the districts from the original convoluted compilations in the initial version, the fact remains that the western handler-shippers still retain the majority vote. And while large and small scale growers alike are given a bit more representation, their numbers are completely dwarfed in the overall construct, rendering their vote meaningless. Since the weighted votes will decide who creates the metrics and "best management practices" that growers will have to adhere to - the western handlers remain in the drivers seat - as they already are in the CA and AZ LGMAs.
Further, the NGLMA is incorrectly characterized by USDA as "voluntary." Rather, it is devised as purely a handler's agreement and they are the sole signatories. Depending on business pressures, signing onto the NGLMA may or may not be completely voluntary for the handlers/shippers. But for the growers who rely on handler contracts this construct is in fact totally mandatory - as the handlers are legally bound to purchase only from growers who fully utilize the NGLMA practices. For the growers - who have no say in the development and implementation of the standards and growing practices - this "agreement" is a completely obligatory condition for securing contracts and staying in business.
This one-sided marketing agreement also impacts leafy greens growers of every scale across the whole country - because once there is a NGLMA designation in the marketplace wholesalers and retailers will be under competitive and liability/insurance pressure to do business solely with those who are signed up to comply with the USDA-sanctioned so-called "safer" metrics. While the NLGMA is primarily designed to cover the western "fresh-cut" lettuce and spinach trade it also applies to a widely expanded list of leafy green vegetables that will have further impact on diversified small producers. And because the LGMA construct has been developed for industrialized monocropping practices, small scale diversified growers are forced to develop multiple management plans and compliances - placing them at a major economic disadvantage.
Environmentally and economically detrimental metrics
We also have great concern over the metrics and management practices already developed for CA and AZ growers by the western handlers that are proposed as the model for the NLGMA. Those requirements take an ecologically ruinous "bare-earth" buffer lands approach that destroys decades of beneficial publicly-financed conservation enhancements. Since the virulent E. coli strains originate in cattle or humans there is no documented scientific basis for removing habitat and targeting wild animals such as frogs and deer.
These metrics also represent a major built-in bias against the biodiversity provisions in the National Organic Program that preclude the participation of organic growers in a NLGMA. The NLGMA purview is narrowly restricted to microbial contamination and does not consider or deal with the food safety dangers of the wide-spread toxic pesticide applications used by industry on a daily basis. Finally, the costs of compliance, already a huge expense for large-scale growers, are simply not able to be borne by smaller farmers and would therefore severely restrict their participation in any NLGMA-dominated marketing arenas.
In conclusion, the NLGMA distorts the development of legitimate food safety efforts into a USDA-sanctioned, industry-dominated marketing mechanism. It would unfairly institute large-scale west coast standards as the dominant compliance construct for all U.S. growers of leafy greens, large and small, to comply with. It would become a de facto liability-protection standard for wholesalers and retailers and thereby restrict unregistered grower access to those markets. And, the NLGMA is also inherently unfair to consumers - who would be led to believe these provisions represent a safer food supply.
NOFA-IC Policy Director
- June 17, 2011
- By Steve Gilman
Ending a month-long charade begun over the Christmas holidays, USDA completely caved to the demands of the biotech industry, first deregulating Genetically Engineered (GE) Roundup Ready alfalfa and then sugar beets - turning them loose for widespread planting this spring. The White House apparently played a role in the acquiescence after Secretary Vilsack was called to a Congressional Hearing and taken to the woodshed by the new Republican-led, biotech-dominated House Ag Committee for not deregulating the "perfectly safe" GE crops at the outset. Despite a number of Higher Court rulings prohibiting such plantings and an immediate public protest led by Senator Leahy (D-VT) and Representative De Fazio (D-OR) in Congress, the action goes forward.
The rulings assure that there will be certain and amplified contamination of the organic food supply, adversely affecting organic farmers and consumers alike. The GE crop varieties are proven highly promiscuous, spreading by wind-blown pollen and cross-fertilized by bees over long distances. Alfalfa is a mainstay of the organic and GE-free dairy and beef industries - and sugar beets readily cross-pollinate with table beets and chard. And even away from the field, labeling mix-ups and comingling contamination are rife in the seed handling system.
So it comes as no surprise that using a protracted GE crop "coexistence" strategy to cement their corporate hegemony is a stated long term goal of Monsanto and company(1) which essentially means that hitherto pure organic and non-GMO seed stocks will be contaminated out of existence. Adding insult to injury, farmers whose crops have become corrupted by these proprietary GE genes have been regularly sued by Monsanto for "possessing" their technology without a license.
Furthermore, the protracted use of Monsanto's Roundup herbicide in GE corn, soybeans, cotton and canola has already created an explosion of resistant "superweeds" across the country, plus an alarming increase in mycotoxins that can also affect adjoining organic farms. With their Roundup patent protections due to expire in 2014 and faced with the Court orders Monsanto has added impetus to exercise their clout in the inner sanctums of government (thanks to spending more than half a billion dollars on lobbying since 1999) and ram through the rulings.
Consumers also need to become acutely aware that our nation's food supply has become significantly contaminated. GE was given its green light under the Reagan Administration in the 1980's and now there is a widespread unlabeled presence of GE materials in mainstream food products - processed foods, junk foods, and conventional meat and animal products comprising over 70% of the food on supermarket shelves. Standing alone in the marketplace, the USDA organic program is the only federal food label that prohibits the use of GE crops or materials.
Circular firing squad
What's more, the organic community got thrown into disarray over some of its own internal responses to the issue. USDA had already cancelled Option 1 prohibiting GE plantings. Under the initial pretext of deciding between complete GE alfalfa deregulation (Option 2) or exploring a 3rd option of partial-regulation they brought an assemblage of organic and biotech stakeholders to the table and conducted a dialogue to set forth what a coexistence option might look like. However, the resulting list of pre-conditions submitted by the organic contingent, including authentic contamination protections; full compensation - from the manufacturer - for damages; comprehensive biotech labeling and regular monitoring of the purity of seed stocks by USDA were totally unacceptable (of course) to Big Biotech, and any potential coexistence scenarios died on the vine.
But some "watchdog" members of the organic community viewing the proceedings from afar publically accused a so-called "organic elite" for collaborating with the enemy. The simplistic blame game sidetracked the organic community at a time when a cohesive response was clearly called for. And behind the scenes the Biotech Industry was making great strides forward toward the deregulation option.
In an attempt to rally the troops under the flag of responsible action, the National Organic Coalition (NOC) put forth a concerted contamination prevention (not coexistence) plan titled "Seven Steps to Fair Farming" that is posted with other materials at www.nationalorganiccoalition.org. And along with NOFA, numerous organic-friendly groups across the country began joining forces to combat the rulings.
Straight away, the USDA ruling is headed back to the Courts. Although they're stretched thin, the Center for Food Safety which brought one of the original suits all the way to the Supreme Court, has filed for an injunction with the Judge who issued the desist orders, but whether this action will be successful in time to stop spring planting is in question.
GE deregulation can also be stopped by the White House. At this point the strategy is to continue with alerts asking the organic community to come together and to barrage the White House with calls demanding the reversal of the GE deregulation decisions.
Other counter-attacks are gearing up on a number of fronts. A group from the Columbia University law school called the Patent Foundation, is enlisting organizations along with individuals nationwide to challenge Monsanto's originating patents in the Courts. And an initiative called "MVTillions Against Monsanto" is targeting big supermarket retailers, demanding that they label the GE foods on their shelves.
State legislative proposals are also in the offing. A New Mexico bill would protect farmers inadvertently contaminated by GE crops from being sued by the manufacturer and set up local jurisdiction for lawsuits rather than in Monsanto's home court. There have also been nationwide calls for farmers and gardeners to boycott Monsanto seed. Monsanto has acquired oligopoly ownership in the seed business, having bought up 17 of the nation's largest commodity seed producers as well as two major national vegetable seed companies (Seminis and De Ruiter) and a number of regional ones. Farmers are asking their seed retailers to provide listings of the Monsanto seed they carry - and then are ordering other varieties(2). Fedco and Seeds of Change have already scrubbed their catalogs of Monsanto seed.
These brazen demonstrations of raw power reveal the depth of corporate corruption in government. Biotech's actions are highly alarming and represent a major threat to organic integrity, consumer freedom and the safety of our food supply. And there's more to come. Waiting in the wings for commercialization approval are a number of "pharm" crops developed by Monsanto and others that are genetically engineered to cheaply produce pharmaceutical drugs in food crops.
It's high time to end Big Biotech's domination of our seed and food supply. Fully regulating GE plantings and labeling all GE food products (to let consumers decide) is a good place to start.
Please call or email: President Barack Obama
Comment line: (202) 456-1111 Fax: (202) 456-2461
1. see an attendee's report on The Fourth International Conference on Co-existence Between GM and Non-GM Based Agricultural Supply Chains, in Melborne Australia in 2009 at: www.madge.org.au/Docs/overview-coexistence-conference.pdf
2. for a list of organizations and websites providing seed information go to: www.beginningfarmers.org/seeds-finding-choosing-ordering-saving-planting-heirloom-organic-open-pollinated-non-gmo-varieties/
- April, 2011
- By Steve Gilman
We stand united in opposition to the U.S. Department of Agriculture's (USDA) decision to once again allow unlimited, nationwide commercial planting of Monsanto's genetically engineered (GE) Roundup Ready alfalfa, despite the many risks to organic and conventional farmers.
Last spring more than 200,000 people submitted comments to the USDA highly critical of the substance and conclusions of its draft EIS on GE Alfalfa. Instead of responding to these comments and concerns, including expert comments from farmers, scientists, academics, conservationists, and food safety and consumer advocates, the USDA has chosen instead to listen to a handful of agricultural biotechnology companies.
USDA's decision to allow unlimited, nationwide commercial planting of Monsanto's GE Roundup Ready alfalfa without any restrictions flies in the face of the interests of conventional and organic farmers, preservation of the environment, and consumer choice. USDA has become a rogue agency in its regulation of biotech crops and its decision to appease the few companies who seek to benefit from this technology comes despite increasing evidence that GE alfalfa will threaten the rights of American farmers and consumers, as well as damage the environment.
The Center for Food Safety will be suing on this decision. In the coming months, we will be seeing USDA proposals to allow unrestricted plantings of GE sugar beets, and GE corn and soy crops designed to resist toxic pesticides, such as 2-4D and Dicamba, highly toxic pesticides that pose a serious threat to our health and the environment. To win these critical and difficult battles, the entire organic community, and our allies in the conventional food and farming community, will have to work together.
Now is the time to unite in action. We need to work together to restore sanity to our food system, stop the deregulation of GE crops and join together against the forces that are seeking to silence hundreds of thousands of Americans. As we move forward, we are united in opposing genetically engineered organisms in food production and believe that pressure to stop the proliferation of this contaminating technology must be focused on the White House and Congress. The companies responsible for this situation are the biotech companies whose GE technology causes genetic drift and environmental hazards that are not contained as the deregulation of genetically engineered alfalfa goes forward. The organic community stands together with consumer, farmer, environmental and business interests to ensure practices that are protective of health and the environment.
We urge you to join us today.
Sign up to receive action alerts:
Consider making a donation to the legal effort ahead:
Let the White House know that you do not support the deregulation of GE alfalfa:
Christine Bushway, Organic Trade Association
Jay Feldman, Beyond Pesticides
Michael Funk, United Natural Foods Inc (UNFI)
Elizabeth Henderson, NOFA Interstate Council
Gary Hirshberg, Stonyfield Farm
Liana Hoodes, National Organic Coalition
Kristina Hubbard, Organic Seed Alliance
Faye Jones, Midwest Organic Sustainable Education Service
Robby Kenner, Robert Kenner Films
Andrew Kimbrell, Center for Food Safety
Russell Libby, Maine Organic Farmers and Gardeners (MOFGA)
Ed Maltby, Northeast Organic Dairy Producers Alliance (NODPA)
Robyn O'Brien, Allergy Kids
Keith Olcott, Equal Exchange
Maria Rodale, Rodale Inc.
Eric Schlosser, Author
Robynn Schrader, National Cooperative Grocers Association (NCGA)
George Siemon, Organic Valley
Michael Sligh, Rural Advancement Foundation International (RAFI)
Megan Westgate, Non-GMO Project
Maureen Wilmot, Organic Farming Research Foundation (OFRF)
Enid Wonnacott, Northeast Organic Farming Association of Vermont (NOFA-VT)
- March, 2011
USDA Decision On GE ALFALFA Leaves Door Open For Contamination
Rise of superweeds rogue agency chooses "Business as usual" over sound science
center announces immediate legal challenge to USDA'S flawed assesment
The Center for Food Safety criticized the announcement today by the U.S. Department of Agriculture (USDA) that it will once again allow unlimited, nation-wide commercial planting of Monsanto's genetically-engineered (GE) Roundup Ready alfalfa, despite the many risks to organic and conventional farmers USDA acknowledged in its Final Environmental Impact Statement (FEIS). On a call today with stakeholders, Secretary Vilsack reiterated the concerns surrounding purity and access to non-GE seed, yet the Agency's decision still places the entire burden for preventing contamination on non-GE farmers, with no protections for food producers, consumers and exporters.
"We're disappointed with USDA's decision and we will be back in court representing the interest of farmers, preservation of the environment, and consumer choice" said Andrew Kimbrell, Executive Director for the Center for Food Safety. "USDA has become a rogue agency in its regulation of biotech crops and its decision to appease the few companies who seek to benefit from this technology comes despite increasing evidence that GE alfalfa will threaten the rights of farmers and consumers, as well as damage the environment."
On Monday, the Center sent an open letter to Secretary Vilsack calling on USDA to base its decision on sound science and the interests of farmers, and to avoid rushing the process to meet the marketing timelines or sales targets of Monsanto, Forage Genetics or other entities.
CFS also addressed several key points that were not properly assessed in the FEIS, among them were:
- Liability, Implementation and Oversight -- Citing over 200 past contamination episodes that have cost farmers hundreds of millions of dollars in lost sales, CFS demands that liability for financial losses incurred by farmers due to transgenic contamination be assigned to the crop developers. CFS also calls on USDA to take a more active oversight role to ensure that any stewardship plans are properly implemented and enforced.
- Roundup Ready alfalfa will substantially increase herbicide use - USDA's assessment misrepresented conventional alfalfa as utilizing more herbicides than it does, which in turn provided a false rationale for introducing herbicide-promoting Roundup Ready alfalfa. In fact, USDA's own data shows that just 7% of alfalfa hay acres are treated with herbicides. USDA's projections in the FEIS show that substantial adoption of Roundup Ready alfalfa would trigger large increases in herbicide use of up to 23 million lbs. per year.
- Harms from glyphosate-resistant weeds - USDA's sloppy and unscientific treatment of glyphosate-resistant (GR) weeds ignored the significant contribution that RR alfalfa could make to their rapid evolution. USDA failed to analyze how GR weeds fostered by currently grown RR crops are increasing herbicide use; spurring more use of soil-eroding tillage; and reducing farmer income through increased weed control costs, an essential baseline analysis.
"We in the farm sector are dissatisfied but not surprised at the lack of courage from USDA to stop Roundup Ready alfalfa and defend family farmers," said Pat Trask, conventional alfalfa grower and plaintiff in the alfalfa litigation.
The FEIS comes in response to a 2007 lawsuit brought by CFS, in which a federal court ruled that the USDA's approval of GE alfalfa violated environmental laws by failing to analyze risks such as the contamination of conventional and organic alfalfa, the evolution of glyphosate-resistant weeds, and increased use of glyphosate herbicide, sold by Monsanto as Roundup. The Court banned new plantings of GE alfalfa until USDA completed a more comprehensive assessment of these impacts. The Ninth Circuit Court of Appeals twice affirmed the national ban on GE alfalfa planting. In June 2010, the U.S. Supreme Court upheld the ban on Monsanto's Roundup Ready Alfalfa until and unless future deregulation occurs.
"Last spring more than 200,000 people submitted comments to the USDA highly critical of the substance and conclusions of its Draft EIS on GE Alfalfa," said Kimbrell. "Clearly the USDA was not listening to the public or farmers but rather to just a handful of corporations."
- March, 2011