The Food Safety Lawyer On Sampling: USDA, FDA and Companion Samples

In recent years, both USDA and FDA have become far more aggressive in their regulatory enforcement activities, inspections of food processing facilities and investigation of outbreaks. As FDA and USDA industry lawyers, we regularly assist companies both avoiding and responding to these issues.

Notably, with respect to meat products, USDA has begun focusing more aggressively on possible connections between slaughter establishments and outbreaks or positive regulatory ground beef samples. Under the Systems Tracking E. coli O157:H7 – Positive Suppliers (“STEPS”) framework, USDA will in many instances take action against establishments that repeatedly appear in the STEPS system. This can take many forms, ranging from intensified sampling to a Food Safety Assessment (“FSA”) for cause.

If USDA decides to conduct environmental sampling, companies are always welcome to take their own “companion” or “sister” samples. With that said, I do not believe there is any benefit to actually doing it. If an USDA environmental sample tests positive, the agency will not care whether a companion sample tests negative. Contamination is not always distributed evenly, and testing sensitivities will often vary. Thus, FSIS will in all instances treat its own result as a “positive finding.”

The same general rules apply with respect to environmental sampling, whether being conducted by USDA or FDA, for other pathogens like Salmonella or Listeria. In the event of a positive, the government will likely not care about a negative companion sample, and will rely on its own results. Moreover, what happens if the agency sample tests negative, and the companion sample tests positive?

Thus, here too, I do not see any compelling benefit to always collect companions. Moreover, this also avoids the complexities of determining whether to hold, test or even destroy companion samples in the event a governmental sample proves negative.

With that said, if a company thinks that it may someday want to take companion samples when USDA or FDA performs its own testing, I would strongly urge that the company adopt a written policy governing the specific circumstances under which such samples will be taken. This, of course, would apply to both FSIS environmental and finished product sampling.

Such a policy should clearly define the limited circumstances under which companion samples will be collected, and state that those samples will ONLY be tested in the event of a FDA or USDA positive. In this regard, the policy should articulate that the company will rely upon the governmental findings (and it really has no choice), while at the same time setting forth the justification for performing companion testing (i.e., in the event of a finished product regulatory positive to assist in the determination of the ultimate source). The policy should also make clear, however, that if the FDA or USDA sample tests negative, the companion sample will be discarded within a set period of time (i.e., 24 hours).

If a company adopts such a policy, and then closely follows that policy, it should be able to avoid any second-guessing from the agency (or a trial lawyer in a future lawsuit) if a subsequent issue arises or a recall later occurs. Moreover, assuming the policy provides the underlying justification for the protocol to be followed (which it should), I also think any moral obligation to test a companion sample in the event of an agency negative simply falls away.

Food Safety Enhancement Act Passes House Vote

After failing to pass a  vote in the House of Representatives on Wednesday (July 29), the Food Safety Enhancement Act of 2009 (H.R. 2749) returned to the House floor for a second vote on Thursday (July 30).  

On the second try, the Dingell-Waxman bill, designed to modernize the FDA’s food safety authority, passed by a vote of 283 - 142. Click on the following link for a summary of the legislation.

Key provisions of the bill include the following:

  • Inspections: Food and Drug Administration inspections of food facilities would increase from about once every 10 years to at least annually for high-risk facilities and at least once every three years for facilities deemed a low risk. FDA inspectors will have access to company records.
  • Registration: Food processors, importers and other food handlers must register annually with the FDA and pay a yearly fee of $500 for each food facility.
  • Recalls: The FDA could mandate the recall of tainted foods, instead of relying on food makers to pull items voluntarily.
  • Safe practices: For the first time, the FDA could set standards for safe production of food on farms, as well as require food manufacturers to meet safety standards.

The 132-page bill now goes to the Senate where Illinois Democrat Dick Durham is waiting with his own bill.   Any differences between the House and Senate versions will likely be resolved by Conference Committee. Reportedly, President Obama already endorsed the House bill before Thursday’s successful vote.

Another Step Forward For The Food Safety Enhancement Act of 2009

Following recent increases in public and media attention focused on food-borne illness, outbreaks and recalls, the House Energy and Commerce Committee has approved the Food Safety Enhancement Act of 2009. The proposed legislation is designed to enhance FDA food safety-related authority. 

The bill, H.R. 2749, passed the committee unanimously with an amendment that would exempt food production facilities and products regulated exclusively by the Federal Meat Inspection Act, the Poultry Products Inspection Act or the Egg Products Inspection Act.  The bipartisan bill, spearheaded by Chairman Henry Waxman (D-CA) and Chairman Emeritus John Dingell (D-MI), has received support from a broad coalition of consumer and public health organizations.

According to reports, the full House is expected to vote on the bill prior to the July 4 recess. Click on the following link to view a copy of the proposed legislation, as amended. If enacted, the bill would give the FDA new authority to create robust food safety standards, to establish rules for enhancing traceability, to increase inspections at high-risk facilities, to mandate food product recalls, and to enforce new penalties for violations of federal food safety requirements.

The legislation would also increase FDA funding to facilitate these efforts by requiring food companies to pay new annual registration fees of $500.

Although proposed food safety initiatives are also planned for debate in the U.S. Senate, these efforts, reportedly, may be stalled as a result of ongoing legislative efforts associated with proposed health care reform.

In any event, we’ll continue to report as the debate continues.

Food Safety Enhancement Act Seeks To Impose New Inspection Fees On Food Companies

The House Energy and Commerce Committee has released a discussion draft of the Food Safety Enhancement Act of 2009 which, if passed, would require food manufacturers to pay an annual fee of $1,000 to fund increased inspections by the FDA.

Under the draft bill, high-risk food production facilities would be inspected by the FDA every 6 to 18 months, while low-risk facilities would be inspected every 18 months to three years. In addition to the annual inspection fee, the legislation would also require food manufacturers to pay for costs associated with any additional inspections triggered by food product recalls.  Click on the following link to view a Summary of the Food Safety Enhancement Act of 2009.

The chairman of the House committee, Rep. Henry Waxman (D-Cal.), stated that the proposed legislation is aimed at protecting the nation's food supply. According to Waxman, the new bill “recognizes that the hallmark of strong food safety legislation must be a shared responsibility for food safety oversight between FDA and industry.”

Although food manufacturers are not currently required to pay FDA inspection fees, current budget requests for the FDA include $260 million in new food safety initiatives, with about 35% of that anticipated to come from fees paid for directly by the food industry. While food industry groups strongly support the broad goals of the new proposed food safety measures, questions have been raised about the timing of new fees. According to industry representatives, new inspection fees are being proposed at a particularly bad time, given the slowing economy, for both food companies and consumers alike.

Among other things, the proposed legislation would also require food manufacturers to better trace the food they manufacture abd sell, and would give the FDA authority to issue mandatory recalls. The bill, if passed, would also strengthen criminal and civil penalties for any food companies that fail to comply with federal regulations.

Proposed Food Safety Legislation Gains Industry Support

Over the last decade, there have been numerous attempts to reform our food safety laws. As our ability to identify food-borne illnesses and outbreaks continues to improve (special thanks to the CDC, PulseNet and OutbreakNet), at least some weaknesses that were rarely, if ever, considered are now being found. Thus, although most meals consumed in this country remain perfectly safe, the recent peanut butter recalls have those advocating the need for additional checks and balances, at least for certain segments of industry, finding growing support.

Prompted by the recent recalls, lawmakers have proposed revised food safety legislation – the new FDA Food Safety Modernization Act -- which would give the FDA additional resources to more closely regulate food safety. The bipartisan bill was sponsored by Senators Dick Durbin (D-Ill.), Judd Gregg (R-N.H.), Ted Kennedy (D-Mass.) and Richard Burr (R-N.C.). A parallel bill, the Safe Food Enforcement, Assessment, Standards and Targeting Act of 2009, was also introduced in the House. The new legislation proposes to increase the frequency of inspections at food facilities, give the FDA expanded access to company records and testing results, and allow the FDA to mandate recalls if a food company fails to follow the agency's recommendations. As reported and summarized by Janie Gabbett, from Meatingplace.com, the new bill will specifically:

  • Require all food production facilities to implement preventive plans to address hazards and prevent adulteration, and give the FDA access to the plans and relevant documentation;
  • Expand the FDA’s access to records in a food emergency;
  • Allow the FDA to recognize laboratory accreditation bodies to ensure food testing labs meet high quality standards, and to require test results to be reported to the FDA;
  • Allow the FDA to enable qualified third-parties to certify that foreign food facilities comply with U.S. food safety standards;
  • Require importers to verify the safety of foreign suppliers and imported food;
  • Allow the FDA to require certification for high-risk foods, and to deny entry to any food that lacks certification;
  • Increase FDA inspections at all food facilities, including annual inspections of high-risk facilities, and inspections of other facilities at least once every four years;
  • Enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses;
  • Require the Secretary of HHS to establish a pilot project to test and evaluate new methods for rapidly and effectively tracking/tracing fruits and vegetables in the event of a food-borne illness outbreak;
  • Give the FDA the authority to order a mandatory recall of a food product when a company fails to voluntarily recall the product upon the FDA's request;
  • Empower the FDA to suspend a food facility's registration if there is a reasonable probability that food from the facility could cause serious adverse health consequences or death;
  • Direct the FDA to help food companies protect their products from intentional contamination, and rapidly respond to food emergencies;
  • Increase funding for the FDA's food safety activities through increased appropriations and fees for domestic and foreign facilities.

In addition to receiving bipartisan support, many food companies and industry organizations have voiced support for the bill as well. Vocal supporters include General Mills, Kraft Foods and Kellogg's, along with the Grocery Manufacturers Association, the National Restaurant Association and the Produce Marketing Association. As reported by FoodNavigator-USA.com, Kirstie Foster, spokesperson for General Mills, stated:

“We are strong advocates for food safety system modernization and reform. Ensuring food safety is the highest priority of our industry. We support reform that includes both greater authority and greater resources to strengthen our ability to prevent and respond to food safety issues.”

In turn, Kraft spokesperson Susan Davison agreed, indicating that “the proposed legislation will make significant improvements . . .” Such comments were also echoed by the GMA, in a statement issued by president and CEO Pamela Bailey:

“Ensuring the safety of our products is the food industry’s most important priority... In particular, GMA supports proposals requiring all food companies to have a comprehensive food safety plan in place. It is absolutely critical that manufacturers take a preventative approach in identifying and evaluating potential hazards, and building food safety into the manufacturing process from the very beginning.”

Finally, according to Supermarketnews.com, Tom O’Brien, a representative for the PMA, also expressed support:

“I think the bills, if they get enacted, will restore consumer confidence in FDA, which in turn restores confidence in the food supply. They modernize FDA’s authorities, and they tell it that they should regulate based on the risk of any particular commodity. Those are very important things that we look for in legislation.”

Although the proposed legislation, if passed, would likely strengthen what already is a robust food safety system, there is unfortunately no solution that can completely eradicate food-borne illness. Like the common cold, flu and other ailments, illness occurs because microscopic pathogens exist in our world and can very easily contaminate our environment, our bodies and our food. Even if present in only small amounts that avoid detection, these organisms can eventually grow and multiply to levels that cause illness (whether introduced at a production facility or anywhere in the distribution chain). Moreover, despite continued best efforts to test for and find these pathogens, nature will continue to do its best to avoid being caught. Thus, although the proposed legislation will not eradicate illness, we are hopeful the new initiatives will, at the very least, help us more proactively identify and solve potential problems before they occur.