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FSMA comment period extended

May 14, 2013

By Mike Weland

The Food and Drug Administration calls the Food Safety Modernization Act “the most sweeping reform of our food safety laws in more than 70 years.”

Signed into law by President Barack Obama January 4, 2011, critics, particularly small producers, say it’s another nail that could all but seal the coffin on the small ag producer in the United States.

The FDA is currently in the process of implementing these new regulations, which may have slipped under the radars of many were it not for a small but vocal outcry; the public comment period, which had been set to end May 16, has been extended 180 days to September 15 allow more public comment.

If you’re an independent farmer, particularly a small producer who cherishes the life, it would be well worth your time to review the proposed rule changes, because chances are some aspect is going to affect how you farm and get your product to the consumer.

“Two of my highest priorities as FDA commissioner have been strengthening the scientific foundation of FDA’s regulatory decisions and ensuring the safety of an increasingly complex and global food supply,” commissioner Dr. Margaret Hamburg. “That’s why I take such pride in FDA’s proposal of two rules that set science-based standards for the prevention of foodborne illnesses. One will govern facilities that produce food, and the other concerns the safety of produce.”

Two rules.

Can’t be all that difficult to fathom, can they? Well, don’t forget that word, “sweeping.”

For the average small farmer, sweeping might be an apt word. As in “under the rug.”

Even if you currently operate to the best and highest standards, if you sell a product that can be ingested or rubbed onto another person of the human persuasion, these new rules, as proposed, will impact your operation.

The first rule proposed, the Rule for Produce Safety, affects, as the title implies, the production of fruits and vegetables.

The rule is meant “to minimize the risk of serious adverse health consequences or death from consumption of contaminated produce” by establishing “science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption,” designed to “set forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards.”

“We expect that the proposed rule, if finalized as proposed, would reduce foodborne illness associated with the consumption of contaminated produce,” the FDA says.

At well over 150 pages, a quick perusal is impossible, but just a glance shows that, for the small farm families already working sunup to sun down, the administrative requirements, if not tempered, are going to require either an additional 12 hours in each day or the adoption of several additional family members skilled in the arts of paperwork, data entry, law, accounting and documentation.

Rule two, equally lengthy, is “Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,” and it is even more broad in scope.

In its summary, the FDA writes, “The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. FDA also is proposing to revise certain definitions in FDA's current regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for “farms.” FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science-, and risk-based preventive controls the norm across all sectors of the food system.”

“The proposed rule,” they continue, “would implement the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls.”

Specifically, the proposed rule would establish requirements for:

A written food safety plan;
Hazard analysis;
Preventive controls for hazards that are reasonably likely to occur;
Monitoring;
Corrective actions;
Verification; and
Associated records.

“The application of the preventive controls would be required only in cases where facilities determine that hazards are reasonably likely to occur,” they assure. “We do not expect that all possible preventive measures and verification procedures would be applied to all foods at all facilities.”

The attorney you adopt may be able to understand and advise in plain English what the rest of it says. It’s so full of references, citations and qualifications; it’s hard to tell where the hors d’oeuvres end and the main course begins.

The National Sustainable Agriculture Coalition (NSAC), Washington, D.C., has been watching the legislation that led to these proposed reforms since shortly after the Food Safety Enhancement Act of 2009 was passed by the House by a vote of 283-142 on July 9.

“Everyone has a role in ensuring safe food from field to fork,” they wrote. “The Food Safety Modernization Act (FSMA) is the first major overhaul of our nation’s food safety practices since 1938, and it includes new regulations of practices on produce farms and in facilities that process food for people to eat. It represents some big changes to our food system – and it is extremely important for the Food and Drug Administration to get these regulations right.”

Their biggest early concern was that these laws put all farmers on an equal regulatory plane; from the weekend gardener who is more a hobbyist than a farmer to the corporate giants, who have more clerks and accountants working in offices, attorneys on retainer and lobbyists in Washington than they do peopleworking in the field.

And it’s not only the farmers who’ll be affected, they say; this legislation will impact every American who has developed an eating habit.

“If you’re a consumer, these rules could, over the long term, impact the kind of food you are able to find and purchase in your community,” they write. “The proposed rules may also increase the costs of purchasing fresh fruits and vegetables. Ultimately, we want to ensure a safe and affordable food supply, strong on-farm conservation of natural resources, and thriving family farms and small value-added farm and food businesses. That translates into fresh, healthy food for communities across the country, from the farmers’ market to the grocery store to the school cafeteria! As a concerned consumer, you absolutely have a say in these proposed rules and should speak out!”

They say that over the course of development, improvements have been made, but serious concerns persist, four in particular:

Farm facilities which do value-added processing or which co-mingle product with neighboring farms will be subject to a proposed new, extensive and expensive FDA regulatory regime regardless of risk and regardless of scale.
Proposed new requirements for crop traceability beyond the farm gate and related recordkeeping requirements will make it difficult or impossible for farmers to comply.
A produce standard provision threatens wildlife and biodiversity.
Lack of training or technical assistance on food safety appropriate for small and mid-sized value added producers and small scale processors and wholesalers exacerbates the challenges these operations will face to comply with new regulation.

Coming from folks who obviously don’t farm but who look after farmers and growers, that’s likely a fair assessment to the crowd in Washington, D.C., but they speak a different language in such lofty environs.

They don’t go out of an early morning toting feed, or brave all weather to tend to crops and critters. Farmers might grumble on occasion, but they slog through whatever nature throws their way, get up at all hours as the need arises.

They only eat after all others are fed, call in sick only if they’re broken or dying. If their neighbors are farmers, they’re fortunate. Most will drop all but the most needed work to help see a neighbor through.

Farmers take pride in what they do, and suffer to see a sick or struggling animal or a wilting crop. They’ll entertain kids with the wonder of having a hand in helping things grow as their own best memories came from that very thing; planting a seed, seeing an egg hatch … watching things grow.

The small farmer typically not only shares with their family what they grow, but tend to share the bounty with their neighbors as well. They know better than any accountant what good, safe and wholesome food is.

What they send to market is typically equal to or better than what they put on their own table.

If it isn’t good, they’re going to be the first to know and wonder why, and no piece of paper properly filled out and submitted to the FDA will change anything a small farmer lives with or loves.

It may, under these new laws, make the small farmer a criminal.

Learn more

Food Safety Modernization Act (FMSA)

Official FDA site

http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

Overview of proposed rules

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334120.htm

Preventive Controls for Human Food Proposed Rule

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm

Full text

http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0920-0001

Standards for Produce Safety Proposed Rule