FDA Flexes New Muscles

FDA Flexes New Muscles While Becoming Mired in Farm Bill Debates

When Congress passed the Food Safety Modernization Act (FSMA) in 2010, it gave the Food and Drug Administration (FDA) significant new powers. For a couple of years, the agency did very little with its new authority. But now the FDA has proposed rules that fulfill some of the worst predictions of what the agency might do.

The proposed rules address two key provisions of the FSMA:

• On-Farm Produce Standards Rule: Creates requirements for every aspect of growing and harvesting fruits, vegetables and nuts.

• HARPC Rule: Requires businesses (including farms) that pack, store, or process foods to do hazard analysis and risk-based preventative control (HARPC) plans.

These two provisions are explained in greater detail below.

The ultimate effect of these rules will be to reduce the safety of our food supply by increasing our reliance on foreign food sources. The U.S. already imports about 15 percent of our food supply, including nearly 50 percent of fresh fruit and 20 percent of fresh vegetables. Less than 1 percent of this imported food is inspected by the FDA, and the agency itself says that it doesn’t have the capacity to inspect more than 2 percent. This problem is supposedly being addressed through new requirements for importer verification, so that the foreign suppliers will be held to the same standard as domestic. But whatever is written on paper, it is certain that food coming from places such as China and South America will not actually be held to the same standards as will be imposed on U.S. producers.

It’s important to realize that these are only proposed rules. Nothing is final yet. Farmers and consumers have until November 15, 2013 to file comments with the agency, and it is critical to do so. It’s also vital that anyone concerned with the survival of sustainable agriculture and the local food movement should contact their legislators― both before and after the comment deadline―to urge Congress to limit the agency’s power.

The Tester-Hagan Exemption

When Congress passed the FSMA, it included a very important provision―championed by Senators Jon Tester (D-MT) and Kay Hagan (D-NC)―to exempt small-scale, direct marketing producers from the on-farm produce standards and HARPC requirements. Specifically, farmers or food producers who sell less than five hundred thousand dollars per year, and who sell more than half of their products directly to individual consumers or to local restaurants and retailers, are exempted from the produce safety and HARPC rules.

This exemption is vital to the survival of the local foods movement. Unfortunately, in the final negotiations on the Tester-Hagan amendment, Congress included a provision that allows the FDA to revoke the exemption under certain conditions. The revocation must be done on a case-by-case basis; in other words, the FDA can revoke the exemption on Farm A, but cannot revoke the exemption on all the farms in the country or in a state.

Although limited to targeting individual farms, the FDA’s proposed rules implementing this provision are deeply worrisome because FDA claims authority to revoke a farmer’s or processor’s Tester-Hagan exemption based almost entirely on the official’s discretion. If an FDA official decides that a farm or processor is connected to a foodborne illness outbreak or that revocation is “necessary” to “protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated” with the farm or processor, the official can issue a letter revoking the exemption. The farmer or processor has only ten days to respond to the FDA’s actions, including collecting all of the evidence that supports a continued exemption; no other information can be provided after those ten days.

An FDA hearing officer then decides whether or not to hold a hearing. If the hearing officer agrees with the decision to revoke the exemption, the producer has only sixty days from the date of the original letter from the FDA revoking the exemption to come into full compliance with all the newly applicable regulations. In contrast, large-scale industrial farms have two years to come into full compliance. While the producer may appeal the decision to a court, many appeals will be meaningless because the producer will have to comply with all of the regulations during the appeal, which would most likely put them out of business before their appeal is ever heard by the court.

The number of farms targeted this way by the FDA is likely to be small, but it will be devastating for those affected. We have already seen the harm that targeting individual producers can have in the case of raw milk and raw cheese producers. The uncertainty of not knowing who might be the agency’s next target will have a chilling effect on many small producers, unless the FDA is forced to change its proposal to comply with the spirit as well as the letter of the Tester-Hagan provision.

On-Farm Produce Safety Standards Rule

For farmers who don’t qualify for the Tester-Hagan exemption or whose exemption is revoked, the proposed produce safety rules cover every aspect of growing and harvesting crops, including worker training, hygiene, domestic livestock, wildlife, and buildings and equipment. All of these provisions carry record-keeping requirements and give FDA inspectors significant discretion in determining what is “appropriate” or “reasonable.” Thus, the proposed rule not only imposes significant costs, but it also creates significant uncertainty and risk for producers.

Fundamentally, the rules take an approach of “guilty until proven innocent” for natural farming methods, while giving chemical methods a free pass. Thus, the safety and health issues posed by pesticides and herbicides are not addressed at all in the proposed rules, but major barriers are placed in the path of those farmers who wish to use fertilizers such as manure or compost tea, or who integrate livestock with fruit and vegetable production.

Anything involving animals at any stage appears to terrify the FDA. The agency categorizes all animal-based soil amendments as “treated” or “untreated.” In order to be considered “treated,” a manure-based compost must be processed using specific methods and meet specific microbiological standards. Even treated compost requires farmers to wait forty-five days in between application and harvest of the crop. “Untreated” animal-based soil amendments― including raw manure, compost made using alternative processes, vermicompost or worm castings, and compost teas with any additives such as molasses or kelp―have to be applied at least nine months prior to harvest. In practical terms, the use of manure and many other proven organic soil amendments will be forbidden unless the farmer can produce scientific evidence showing, to the FDA’s satisfaction, that his or her methods are safe.

When it comes to having animals on the farm, FDA continues its unscientific and fearbased approach. Until the 1950s, most farms in the U.S. were diversified small farms that had both livestock and crop production. Yet the agency ignores the proven track record of this type of farming, creating extensive regulations for the presence of both domestic livestock and wildlife on the farm. In an effort to avoid the criticisms that have been leveled against the Leafy Greens Marketing Agreement, the agency is careful to say that farmers do not necessarily have to create a sterile, lifeless buffer zone; at the same time, however, it’s unclear how a farmer can meet the regulatory requirements without doing precisely that.

Preventative Controls and the HARPC Rule

As with the produce safety rule, small-scale, direct-marketing producers are exempt from the Preventative Controls rule under the Tester- Hagan amendment. For processors who don’t qualify for the exemption or whose exemption is revoked, the Preventative Controls rule requires that any business that packs, holds, processes or manufactures food creates a Hazard Analysis and Risk-Based Preventative Control (HARPC) plan. This encompasses a large number of low-risk activities that farms, food hubs, and cooperative produce distributors normally conduct, such as packing fruits and vegetables, milling grains and making maple or sorghum syrups.

A few, very limited on-farm post-harvest activities are exempt, but only on the farm’s own produce. All of the following would be subject to the HARPC requirements: two farms running a joint CSA and handling each other’s produce; a farm that stores food from any other farm or producer (even if they do no processing); and all sorts of “food hubs” that distribute food from multiple local producers. In effect, FDA treats a legal event—the change in the possession of a crop—as a safety hazard, despite all scientific evidence to the contrary. In addition, even many low-risk activities conducted by a farm on its own produce would be subject to the rule, such as dehydrating fruits and vegetables or making jam.

A business subject to the Preventative Controls rule must conduct a “hazard analysis” of all its operations to identify potential food safety threats and steps to control them. Estimates of the costs of such plans indicate that they can cost thousands of dollars, up to twenty thousand dollars for a small operation in the first year. The rule then requires annual “verification” that the plan is working, with records of this verification process and its findings.

The scope and complexity of the paperwork that will be required is daunting for both on-farm and off-farm processors. In the early 1990s, similar HACCP requirements resulted in many small- and mid-scale slaughterhouses having to shut their doors. The FDA’s proposed rule has the potential to put an end to many of the exciting innovations taking place right now with local food hubs, community processing facilities and the other infrastructure so vital to re-establishing local food systems.

What Happens Next?

Some members of congress are becoming aware of FDA’s overreaching. Representative Dan Benishek (R-MI) introduced an amendment to the Farm Bill, which was adopted by the House, to require the FDA to do a full analysis of both the science and the economic impact of any rule proposed under FSMA before enforcing it. While the Farm Bill’s future is uncertain (see below), it is important to build support for this amendment so that it is included in some bill, whether the Farm Bill or another.

At the same time, we need to create pressure directly on the FDA to make changes. The agency is accepting public comments on the proposed rules until November 15, 2013. See the sidebar for more details and sample talking points.

Farm Bill Confusion

While we hope that the Benishek Amendment will make it into the final Farm Bill, it’s far from clear that any Farm Bill will pass this year. The Farm Bill is a massive piece of legislation that comes up approximately every five years. Last year was supposed to be a Farm Bill year but, as usually happens when the Farm Bill falls during an election year, Congress did a short-term extension, leaving it to be taken up yet again this year.

The Farm Bill has between ten and twelve titles dealing with a wide range of topics, including conservation, trade, credit, rural development, research and much more. The two titles that draw the most publicity are the commodities and the nutrition and food stamp programs. For decades, these two sections of the Farm Bill have been linked together to ensure its passage; rural legislators support the bill because of the subsidies provided in the commodities title, and urban legislators support the bill because of the food assistance dollars.

The Senate passed its five-year Farm Bill back on June 10. It contained no real surprises, including modest cuts to the food stamp section. The House took up its version of the Farm Bill ten days later and, in a move that shocked most political observers, voted it down.

A few weeks later, the Republican House leadership brought up a controversial idea: split the Farm Bill into two parts and leave the nutrition and food stamp programs out of the bill. In July, the House passed this chopped up version of the Farm Bill, with a vote on party lines.

The House version of the Farm Bill had another, far more radical change. For decades, farm bills have been written so that if they expire, we revert to “permanent law” from the 1930s and 1940s. Up until this year, the threat of reverting to these old laws motivated the Congress to actually finish the farm bill. But the bill as passed by the House took out the permanent law provisions, so if a future farm bill expires, we would revert to the farm policy being debated today. Whether you like the laws from the ‘30s and ‘40s more than the current farm bill or not, removing the threat of permanent law removes the only incentive for a gridlocked Congress to actually pass a new farm bill. This has the potential to end the farm bill process as we have known it for decades, and not in a manner that encourages the sort of deep, systemic changes that are needed.

Splitting the bill makes it harder to actually finish the farm bill process. The House and Senate versions of the Farm Bill must now be reconciled through a conference commit tee. The Senate will not accept a farm bill that omits the nutrition and assistance programs; even if this change somehow got through the Senate, the President has said he would veto the bill the House passed. At the time this article goes to print, the House leadership had not even appointed members for the conference committee, although the Senate members were named before Congress recessed in August. The Farm Bill process is always full of twists and turns, but this year’s developments have been full of surprises that make it impossible to predict what may happen next.

What You Can Do

Whatever happens with the Farm Bill, it is vital that your elected officials know how you feel about your food! You can find out who represents you by going to www.house.gov and www.senate.gov or by calling the Capitol Switchboard at 202-224-3121. Ask to speak to the staffer who handles agricultural issues. Explain that you’re a constituent and that highquality food is very important to you. Ask for their support for the Benishek Amendment in the Farm Bill (or a similar provision in another bill, if the Farm Bill doesn’t pass). It is the responsibility of Congress to rein in the FDA and prevent the damage that would be done by the proposed FSMA regulations.


SIDEBAR
Commenting on the FDA’s Proposed Rules

Below are some talking points that you can use when submitting comments on the FDA’s proposed rules under FSMA. It is important to personalize your comments, so be sure to include at least a couple of sentences about who you are and why these issues are important to you. If you are a farmer or food producer, you will have the greatest impact by pointing out the specific problems these rules will cause for your business and then sending a copy of your comments to your U.S. representative and senators.
To submit comments on each rule, go to:

• On-Farm Produce Rule: www.regulations.gov/#!submitComment;D=FDA-2011-N-0921-0199
• Preventative Controls/HARPC Rule: www.regulations.gov/#!submitComment;D=FDA-2011-N-0920-0188

Tester-Hagan exemption (both rules):

1. The FDA should be held to specific, evidentiary standards before it can revoke a farmer’s or food facility’s Tester-Hagan exemption.
2. A farm or facility that is exempt under the Tester-Hagan amendment should be given at least ninety days to submit evidence and defend its exemption if FDA seeks to revoke it.
3. If the exemption is revoked, the farm or facility should have at least two years to come into compliance with the FSMA rules. The FDA has other mechanisms it can use if there is an immediate threat of foodborne illness.

On-farm produce safety standards rule:

1. The FDA’s approach to traditional farming methods, such as diversified livestock-crop farms, the use of working animals, and the use of biological soil amendments, is fundamentally flawed. The agency should not restrict these sustainable methods of farming absent data showing an actual, verified increased rate of foodborne illness; the simple fact that these methods include diverse microbiological communities is not a sound basis for restricting them.
2. The waiting period between applying manure and harvesting the crop should be no more than one hundred twenty days, as has been the certified organic standard for almost two decades. Similarly, there should be no waiting period between applying compost and harvest. The excellent track record for safety on organic farms shows that this standard is sufficient.
3. Compost teas should be treated the same as compost, whether or not there are additives such as molasses or kelp meal included.
4. Water testing for irrigation and washing water should not be required more often than once a month, and farmers should be able to test less frequently after establishing the safety of their water source through three consecutive negative tests.

Preventative Controls and HARPC rule:

1. Low-risk activities conducted by a farm using its own products, such as making jams, grinding grains, or dehydrating vegetables, should not be subject to these regulations.
2. Low-risk activities, when conducted off-farm or by multiple farms working together, should not be subject to the same requirements as high-risk processing activities.

Judith McGeary is the WAPF chapter leader for Austin, Texas, and is also an attorney and small farmer. She has a B.S. in Biology from Stanford University and a law degree from the University of Texas. After a clerkship with the Fifth Circuit Court of Appeals, she practiced as an attorney in administrative law, litigation and appeals. She left her legal practice to form the Farm and Ranch Freedom Alliance (FARFA), a nonprofit organization dedicated to lobbying on behalf of independent agriculture, representing both farmers and consumers. She and her husband live on a sustainable, pasture-based farm outside of Austin, with heritage poultry, sheep, cattle and horses. For more information, go to www.farmandranchfreedom.org or call 1-866-687-6452.

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