At this time a year ago, political analysts were betting the Senate’s version of the Food/Feed Safety bill, S. 510, would have passed in Q1 of 2010. Now, as we close in on the end of the year, it still hasn’t reached the floor and obstacles continue to hinder its passage.

In July of 2009, the House of Representatives passed the first version of the Food/Feed Safety bill (H.R. 2749) and Congress was slated to vote on the legislation shortly after the Healthcare Reform bill was passed. When it passed in March 2010, S. 510 was on track to be voted on by early October.

But today it is unlikely Senate floor action before November’s elections will be a possibility due to resistance by Sen. Tom Coburn, R-Okla. Coburn believes that any additional appropriations authorized to finance the estimated $1.4 billion cost over the next five years should be fully offset by spending cuts. To this, Senate Majority Leader Harry Reid responded on Sept. 16 by announcing consideration of the bill would be postponed until a lame-duck session of Congress after the November elections.

Certainly much has changed over the past year, and associations such as the American Feed Industry Association (AFIA) and the National Grain and Feed Association (NGFA) have worked diligently with lawmakers to serve the interests of the feed industry.

Richard Sellers, AFIA vice president of feed regulation and nutrition, and Randy Gordon, NGFA vice president, communications and government relations, detail their respective association’s stance on key aspects of the legislation and identify which provisions of the bill may be harmful to feed mills, grain elevators and other facilities.

Clarifying food vs. feed

One of NGFA’s and AFIA’s main priorities in working with Congress on food safety legislation was to ensure that the legislation does not arbitrarily impose restrictions on feed production in the same manner as human food production.

Specifically, AFIA and NGFA worked with both House and Senate staff during development of their respective bills to ensure the legislation authorizes FDA to exempt or modify requirements for hazard analysis, preventive controls and written food/feed safety plans to recognizes the inherent differences between hazards that affect human food and food processing establishments versus those affecting animal feed and pet food manufacturing. Both bills contain several “firewalls” to ensure human food regulation does not inadvertently or arbitrarily constrain feed and pet food manufacturing.

Both bills also expressly recognize the appropriateness of current Good Manufacturing Practices (cGMPs) for developing written feed and pet food safety plans. In addition, the NGFA is working to include in the Senate bill a separate provision that would require FDA to recognize the impracticality of zero tolerances for the existence of certain naturally occurring contaminants when establishing future product-safety standards.

Product tracing and recalls

The House bill requires “full-pedigree” product tracing, including a requirement that FDA within two business days identify each person producing, manufacturing, processing, packing, transporting, storing or selling a food subject to a recall — even if that means tracing all the way back to the farm of origin.

The House bill also would require country-of-origin labeling on imported products until reaching final processing, which Gordon said is a sure-fire way to trigger trade disputes.

The House bill also delegates enormous power to FDA district offices to issue mandatory recalls and subpoenas, dictates prescriptive feed safety practices and access to confidential facility food/feed safety and food/feed defense plans without adequate confidentiality protections – all of which the NGFA opposes strongly, and has worked to avert in the Senate bill.

Industry groups – led by the NGFA – also worked to include language in the Senate bill that would expressly prevent FDA from imposing product-tracing requirements that would dismantle the feed and grain industries’ reliance on commingled handling, storage and manufacturing of ingredients and products obtained from multiple sources.

In the context of new mandatory recall authority, AFIA and NGFA worked to guarantee that administrative protections are incorporated in both bills to ensure new authority to FDA is not arbitrary, and that companies have legal recourse if they believe FDA is acting without sound scientific justification in ordering a recall. At the same time, it is important that records access is limited to those documents which pertain to a specific incident, and that proprietary information is protected.

Small business considerations

AFIA and NGFA worked to include recognition of new regulatory burdens on small entities/businesses as several small businesses, e.g. feed dealers, are included under the registration requirements of both bills. It’s important the compliance challenges for these small businesses are recognized, that assistance is given to small entities by FDA, and that compliance expectations in any new regime are pragmatic. AFIA and NGFA do not support exempting small entities. Both organizations believe further enhancements to food and feed safety enhancement should be a universal effort, in which all parts of the food/feed chain participate.

Fees and funding

The use of facility registration and other fees to fund new FDA authorities is problematic, and the industry opposes registration fees to fund federal food safety programs that provide overall benefit to the general public. Such fees are, in reality, de facto taxes, and such programs are rightly funded by the federal government, NGFA and AFIA believe.

Both associations are also concerned that new authority to FDA to charge fees for re-inspections, export certificates, the cost of recalls and voluntary import programs is too open-ended. These fees should be prescribed by a formula that prohibits FDA from setting fees as an income-generator as opposed to fees that cover the real costs of providing industry-specific services. This is how Congress created animal drug user fees, prescription drug user fees and medical device user fees, and there is no reason why such formulas cannot be included in the final law, Sellers said.

New authorities

NGFA opposes several new authorities proposed in the House bill. For example, the House bill authorizes FDA to short-circuit the regulatory process by issuing regulations through guidance documents, without the requirement for public comment or economic impact analysis.

The House bill also authorizes FDA to suspend a facility’s registration — its license to operate — based on a belief that it “could” pose a danger to human or animal health and would dramatically increases civil penalties, even for unintentional or minor violations that do not pose a danger to human or animal health.

The industry is rightfully concerned over these potential new authorities and is fighting to improve the Food/Feed Safety bill before it is passed.

Fighting for a better bill

For several reasons, AFIA and the NGFA strongly believe the Senate version is a much better bill, and avoids many of the most problematic provisions found in the House bill.

Overall, H.R. 2749 and S. 510 include similar provisions; however, the House bill is far more prescriptive in how FDA should implement new programs, whereas the Senate bill gives FDA authority to create those programs but leaves development up to the agency.

While neither bill is near perfect, there are some improvements contained in the Senate version. H.R. 2749 would require food facilities to re-register and pay an annual registration fee, whereas S. 510 would require facilities to re-register biennially, but would not impose registration fees.

H.R. 2749 would require food importers and customs brokers to register with FDA, and would require food importers to pay an annual registration fee. S. 510 would not require importers or customs brokers to register, but it would require importers wishing to participate to pay fees sufficient to cover FDA’s administrative costs of operating the Voluntary Qualified Importer Program to expedite imports of regulated products..

H.R. 2749 would require FDA to issue regulations creating a “tracing system for food” to enable FDA to identify each person who grows, procures, manufactures, processes, packs, transports, holds or sells an article of food within two business days. S. 510 would require FDA to establish a product tracing system within FDA to improve the agency’s capacity to effectively and rapidly trace food.

The associations will continue to work with Congress to improve the potentially harmful provisions of the bill until it is voted on, which, at the time of this writing in late September, is predicted to be as late as sometime in early 2011. However, the U.S. legislative process is fluid in nature and at any point S. 510 may continue to move forward.

Sidebar: RFR Fails to Recognize Feed Industry Practices

Beginning in September of 2009 the FDA began requiring all food and feed facilities to report contamination incidences through its electronic portal, the Reportable Food Registry (RFR). The intent of the RFR is to further enhance food and feed safety by expediting the FDA’s ability to trace adulterated products that meet the reporting threshold of posing “serious adverse health consequences or death” to humans or animals.

Randy Gordon, National Grain & Feed Association vice president, communications and government relations, said as of early September, only 18 feed-related incidents have been reported. Seven of those involved microbial incidents, six involved physical hazards (such as metal, glass, etc.), and five involved formula or mixing errors.

However, certain definitions contained in the FDA’s draft guidance of the RFR are not practical in the context of a feed or grain operation. Its definitions of “transfer” and “microbial contamination” especially demonstrate the FDA’s lack of knowledge of common feed industry practices.

Feed associations have been working with FDA officials over the past several months to address their concerns over these issues. The American Feed Industry Association (AFIA) filed formal comments on July 21 and The National Grain & Feed Association (NGFA) and National Oilseed Processors Association (NOPA) submitted a joint on that same date suggesting several changes.statement suggesting several changes.

“Transfer:” NGFA noted that FDA’s current interpretation deems that a load of corn has been transferred to a feed mill once a rail car has been decoupled from a locomotive and is on the feed mill’s rail siding, even though the corn has not been inspected to determine if it conforms to contract specifications — included for product safety — and later may be rejected back to the supplier. Likewise, the agency has considered products to have been “transferred” to another party if they are moved via a common carrier (truck, rail car or barge) not owned by the shipper’s company, or if it is stored in a third-party warehouse, even though the company or facility has the ability to retrieve the product and prevent its distribution into commerce.

“FDA needs to change its thinking on what ‘transfer’ means,” said Sellers. “That definition must be predicated upon legal ownership and legal responsibility for the food product or ingredient in question,” he added.

“The feed industry, as well as most other parts of the food industry, routinely sample and test ingredients prior to taking legal ownership. To contend a trailer left by the ingredient supplier for testing shifts responsibility for reporting a contaminated load doesn’t recognize common feed/food industry quality/safety assurance practices, and is inconsistent with earlier FDA statements,” said Sellers.

Recognizing that its interpretation conflicted with industry practices, the FDA sought public comment on the meaning of “transfer.”

NGFA and NOPA urged FDA to change its interpretation as to when products are considered “transferred” to conform to common commercial trade practices. Specifically, they urged that transfer be deemed to have occurred when the receiving facility has “ownership, acceptance and control” of the product. The NGFA-NOPA position also was mirrored in comments submitted by the Grocery Manufacturers Association and Pet Food Institute.

Meanwhile, AFIA asked FDA to revise it to include the following: “No reportable food report is required if a load of incoming product has been sampled, but legal transfer has not occurred, provided the trailer is on the premises of your facility only for as long as is necessary to sample, test and reject the shipment, and no longer. Your facility has not ‘held’ the reportable food. Therefore, you are not a ‘responsible party’ with regard to such food.”

“Microbial contamination:” The definition of ‘microbial contamination’ of animal feeds and raw materials needs particular clarification, AFIA said. The draft guidance implies any positive test result makes the feed or ingredient a reportable food, but it’s well known, based upon studies and testing, that Salmonella found in feed “generally do not make the animals sick and pose little risk to livestock owners.”

The NGFA noted that it is up to the facility to determine whether a particular contaminant, including microbial contamination, meets the reportable threshold based upon current research and scientific understanding.

Sellers points out there isn’t sufficient scientific justification as to the mere presence of Salmonella in feed to conclude any risk rises to the level of having to report the food. He cites a Food & Agriculture Organization (FAO)/World Health Organization (WHO) 2007 report to support the association’s call for clarification that the presence of a human pathogen in a raw ingredient or finished livestock or poultry feed does not cause them to be a reportable food. Sellers acknowledged this would not apply to pet foods.

In addition, Sellers met with two deputy administrators of the USDA’s Agricultural Research Service (ARS) to discuss FDA’s recent release of a new Salmonella Compliance Program Guide (CPG). These FDA guides are Washington directions to the field staff detailing how to enforce FDA laws and rules.

The CPG states specific pathogenic Salmonella found in certain farm animal feed will be considered adulterated and if fed to animals will be reported to USDA for possible recall of the meat, poultry, milk or eggs. Although this appears much better than recalls for any type of Salmonella in feed as in the current policy, The specific salmonellae found in feed could present large potential liability issues for the feed industry given that they are not scientifically proven to be an animal or human health hazard.

The objective of meeting with ARS was to explain the new FDA CPG, ask for assistance in defining infectious dose for the specific Salmonella organisms listed in the guide and determine how industry and ARS could cooperate to create research protocols to address concerns with this policy.

Comments to FDA regarding the Salmonella Compliance Policy Guide are due Nov. 1. AFIA and NGFA will submit comments on this important issue. AFIA plans to continue working with USDA/ARS on a research plan.