Defending Food Safety : Food Safety Defense Lawyer & Attorney : Gass Weber Mullins Law Firm : National Food Product Defense Counsel : Defending Food Safety Blog

Today, more than 15 percent of the food consumed in the United States is imported from foreign shores.  In turn, more and more cosumers are begining to question what is, and what isn't, being done to ensure the safety of foreign food product imports. 

In response, the Department of Homeland Security ("DHS") recently announced the creation of a new group, called the Import Safety Commercial Targeting and Analysis Center ("CTAC"), designed to enhance federal efforts to ensure the safety of imported foods.

Recommended by President Obama’s Food Safety Working Group, the new center will be staffed with about 30 members, will operate under the direction of Customs and Border Protection ("CBP"), and will receive direct assistance from numerous additional governmental agencies, including the FDA, EPA and CPSC. As one of CBP's six commercial targeting centers in the United States, the CTAC will target shipments of imported cargo, including food, for potential safety violations.

"In addition to guarding against terrorism and crime, securing our borders and facilitating legitimate trade involve ensuring the safety of imported [food] products," said DHS Secretary Napolitano. "This new targeting center will enhance the inspection of goods entering our country by centralizing and strengthening federal efforts to protect U.S. consumers."

Agriculture Secretary Tom Vilsack and HHS Secretary Kathleen Sebelius also backed the initiative. “With so much food coming from abroad, we must do all we can to ensure that it conforms to the same safety standards as our own food safety systems,” said Sebelius. “The new CTAC announced today is an important step toward the type of collaboration necessary to ensure that Americans have access to a safe and healthy food supply,” added Vilsack.

As part of its collaboration with CBP, FSIS will also extend its enforcement efforts to target ineligible imports, and investigate suspicious shipments based on manifest information filed prior to the arrival of goods at U.S. ports.

Ultimately, the new facility, which will be located adjacent to CBP's Office of International Trade in Washington, will strive to enhance the safety of foreign food product imports by promoting the three core principles announced by the Food Safety Working Group: Prevention, Surveillance and Response.

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The FDA has announced a new tool it believes will help prevent future cases of food-borne illness – the Reportable Food Registry.

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.

Now that the Reportable Food Registry (“RFR”) is up and running, the mandatory reporting requirements have gone into effect. The new FDA rules apply to any company that is required to submit registration information to the FDA for a food facility “that manufactures, processes, packs, or holds food for human or animal consumption in the United States.” In turn, the rules extend to any food or animal feed regulated by the FDA, except for infant formula and dietary supplements which are covered by other regulatory requirements.

Under the new FDA rules, a food company is now required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

As explained by the FDA, some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

In turn, once a food company discovers a problem with a product it has shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and prevent potential health problems. Companies will also be required to notify relevant suppliers and distributors of any potential safety issues, be ready to submit further data and tests to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, the new reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it discovered the problem before a food product was shipped, and then corrected the problem or destroyed the food.

Although Michael Taylor (senior advisor to the FDA commissioner) stated that industry should be able to easily judge when a food product is “reportable” under the new guidelines, the Grocery Manufacturers Association quickly responded raising concerns over what it called “questions and ambiguities” in the registry. In turn, the GMA urged the FDA to remain flexible, and to help work through potential ambiguities, as the new regulations go into effect.

For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry

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Agriculture Secretary Tom Vilsack and Health and Human Services Secretary Kathleen Sebelius have announced that “prevention and partnership” will guide their departments' efforts to safeguard our food supply. These announcements are based on the public health principles embraced by the White House Food Safety Working Group led by Sebelius and Vilsack.

According to Vilsack, "making prevention a priority is critical to reducing food-borne illness and one of the three food safety principles of President Obama's Food Safety Working Group.” In turn, Vilsack and Sebelius announced the following new initiatives designed to accomplish these goals.

Beef Safety - E. Coli Testing Of Bench Trimmings

For starters, the USDA's Food Safety Inspection Service (FSIS) is issuing guidance for inspectors to begin conducting routine sampling of bench trim for E. coli. In the past, the FSIS had not routinely tested bench trim. Rather, FSIS started E. coli O157:H7 testing with ground beef, and expanded testing to other beef components used in ground beef. Bench trim, which will now be tested as well, includes pieces left over from steaks and other cuts that are then used to make ground beef. FSIS is also issuing streamlined, consolidated instructions to its personnel for inspection, sampling and other actions to help reduce E. coli O157:H7 in beef. Click on the following link to view a copy of the FSIS Sampling Notice.

Produce Safety – New Draft Guidance

Secretary Sebelius also praised new draft guidances prepared by the FDA, an agency within HHS, aimed at minimizing contamination in leafy greens, tomatoes, and melons. According to Sebelius, "the proposed controls provide a guide for growers and processors to follow so they may better protect their produce from becoming contaminated." The draft guidances also represent a shift in strategy for the FDA, from a food safety system that often has been reactive to one that is based on preventing food-borne hazards. Click on the following link for information on the Draft FDA Guidances.

Although the new controls are aimed at preventing contamination in the first instance, Secretary Sebelius also confirmed that consumers play a vital role in ensuring the safety of the fresh produce they eat. In turn, she offered the following tips from the CDC:

• Buy wisely. Don't buy produce that is bruised or damaged. When buying fresh cut produce, choose only items that are refrigerated or surrounded by ice.

• Refrigerate promptly. Certain perishable fresh fruits and vegetables (e.g., strawberries, lettuce, herbs, and mushrooms) should be stored in a clean refrigerator at a temperature of 40ºF or below. If you aren't sure whether an item should be refrigerated, ask your grocer. Produce that is purchased pre-cut or peeled should be refrigerated within two hours.

• Prepare produce with clean hands. Wash hands for 20 seconds with warm water and soap before and after preparing fresh produce.

• Wash produce thoroughly. Rinse fruits and vegetables under running water. Scrub firm produce such as melons and cucumbers with a clean produce brush. All unpackaged fruits and vegetables, as well as those packaged and not marked pre-washed, should be thoroughly rinsed before eating. This includes produce grown conventionally or organically at home, or produce from a grocery store or farmer's market.

• Do not cross contaminate. Don't give bacteria the opportunity to spread from one food to another. Consider using one cutting board only for foods that will be cooked such as raw meat, and another one for ready-to-eat foods such as raw fruits and vegetables.

According to FDA Commissioner Margaret A. Hamburg, the new draft guidances embody the Administration’s and FDA’s prevention-oriented food safety strategy.” She also confirmed that, while the proposals are still in draft form, “they will be made final as soon as possible after public comment, and will be followed within two years by enforceable standards for fresh produce.”

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The President's “Food Safety Working Group,” chaired by the Secretaries of the Department of Health and Human Services (Kathleen Sebelius) and the Department of Agriculture (Tom Vilsack), was conceived to help modernize our food safety system. The group intends to foster “collaborative partnerships with consumers, industry and regulatory partners” and, through a transparent process, “build a food safety system to meet the challenges posed by a global food supply in the 21st century.” Click on the following link to visit the President’s Food Safety Working Group Website.

Last week, the Food Safety Working Group held its first “Listening Session” at the White House. Participants included numerous stakeholders representing a diverse range of organizations. Secretary of Agriculture Vilsack, who delivered the opening remarks, told participants that food Safety is of the highest concern for all of us. Although Vilsack noted that “Americans enjoy one of the safest food supplies in the world,” he also stated that more can should be done to improve food safety at all levels. Vilsack’s remarks are included below:

Welcome. Thank you for taking time to join us this morning.

Food Safety is of the highest concern for all of us here today. While Americans enjoy one of the safest food supplies in the world, we have witnessed too many outbreaks that make us worry that the food on our dinner plate or in our child’s lunch box will harm instead of nourish. This is not acceptable.

Today is the beginning of a significant and critical process that will fully review the safety of our nation’s food supply.

President Obama has pledged his full support in this matter and has charged the Food Safety Working Group with examining all aspects of food safety, be it meat or produce, fresh or frozen, whether it is imported, or produced domestically.

This issue will be one of USDA’s highest priorities. We are in the midst of reviewing all of our statutory authorities, as well as administrative and regulatory steps we can take, to ensure that our actions support public health and consumer safety to the fullest extent.

We have reviewed the Federal Meat Inspection Act, looked over our existing Hazard Analysis and Critical Control Point regulations, reviewed our enforcement authorities, and looked at how we collect data. While we are doing a good job, we at USDA can always do better.

I’d like to outline several specific challenges we need your input on:

•  Prevention. The key to a functioning food safety system is preventing foodborne illness. That means robust standards and sufficient authorities to prevent illnesses from occurring. Both FDA and USDA have embraced this principle and we must have a consistent approach.

•  Surveillance and Response. Our regulatory agencies must actively watch for disease outbreaks and take rapid action to ensure that we have effective and targeted recalls. Such recalls are in the interests of public health and the strength of industry sectors that might otherwise be tarnished by massive recalls.

•  As many people know first hand, in this economy we do not have unlimited resources. Nor can we simply pass higher food production costs onto struggling consumers. We must ensure that we are allocating our food safety resources effectively and efficiently. That means focusing the most attention on the products that have the most potential to cause harm.

•  The safety of a product should not be determined by where it originated. We live in a global community and by working more closely with our partners around the world we can make sure that the food the US is importing is as safe as the food we are exporting.

 •  All parts of the food safety system need to coordinate and work together in a seamless fashion. The FDA and USDA must do a better job of coordinating and I know that Secretary Sebelius and I will drive our agencies to improve coordination.

•  Industry, government, and consumer: each of us brings a piece of the puzzle. We can only solve this if all pieces are represented. It is time for us to set aside past frustrations, collaborate, and move forward together.

Finally, we need to develop a way to measure our success. I am confident that by working together, we will make improvements to the safety of our food supply. But we need a way to track our progress both in the short and long term, so that we do not settle for merely okay, but continually strive for improvement. Lives are at stake and good is simply not good enough.

Thank you again for joining us today.

The Secretary also thanked the participants’ mutual commitment to food safety, highlighted the Administration’s broad support for the modernization of food safety initiatives, and pointed to new and enhanced coordination between HHS and USDA to support this goal.

ViIsack also challenged government, industry and consumers to work more closely to improve food safety. This is good advice.

In the end, we all shoulder responsibility (whether producing or preparing food) to ensure that the meals we serve to our families are, indeed, as safe as they can possibly be.

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Food safety has long been a battle fought on multiple fronts. Once again, the principle proves true. As we continue to report on the absence of effective food safety laws abroad, our colleagues here at home are working feverishly to improve the effectiveness and efficiency of our own food safety system.

Is it possible, some ask, that all federal food safety responsibilities might be integrated into a single food safety agency? Although not likely in the very short-term, it would seem, at the very least, that the table is being set. As the search continues for new solutions to new food safety challenges, Trust for America's Health, along with the Robert Wood Johnson Foundation, released a report advocating significant changes to our national food safety system. The report, Keeping America's Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services, outlines various weaknesses in the current system, and proposes, among other things, numerous improvements to the food safety functions of the  Department of Health and Human Services (“HHS”). In essence, the report advocates (as a first step) the creation of a new, stand-alone food agency within HHS.

Currently, the Food and Drug Administration (“FDA”), an agency within HHS, has responsibility for regulating the safety of drugs, medical devices and many foods. Although the United States Department of Agriculture, through its Food Safety and Inspection Service (“FSIS”), is responsibile for all meat, poultry and egg products sold in interstate commerce, the FDA regulates the safety of virtually all other foods (Learn how our food is currently regulated). To view the current, rather confusing, organizational structure of the FDA, click on the following link :

To increase efficiency (and decrease confusion), the new report urges Congress to quickly create a stand-alone Food Safety Administration (“FSA”) within HHS. Conceptually, the proposal would effectively split the FDA into two seperate agencies, each operating on the same plane - one devoted to food and the other devoted to drugs and medical devices. While the FSA would be responsible for regulating food safety, the drug and device sections of the FDA would become a separate agency called the “Federal Drug and Device Administration.” According to the report, a stand-alone food agency would fix the following key weaknesses under the current  structure:

• Inadequate leadership, prioritization, and coordination within FDA: No FDA official whose full-time job is food safety has line authority over all food safety functions. FDA's three major food safety components are managed separately, hampering efforts to effectively prevent disease outbreaks.

• Inadequate technologies and inspection practices: Current laws and practices are antiquated. Existing laws date back to 1906 and 1938, and policies are disproportionately focused on monitoring food after it has been produced, instead of trying to prevent and detect problems throughout the entire production process. And, there is no system in place to keep inspection practices up-to-date with the constantly modernizing food production technologies and practices.

• Inadequate staffing and resources: The FDA's Science Board found the agency is chronically underfunded. While the U.S. Government Accountability Office reports the turnover rate in FDA science staff in key areas, including food safety, is twice that of other government agencies.

• Inadequate inspection of imports (my favorite): Only one percent of imported foods are currently inspected, even though approximately 60 percent of fresh fruits and vegetables and 75 percent of seafood Americans consume is imported.

A stand-alone food safety agency such as the FSA would also, according to the report's authors, result in integrated and accountable senior leadership, integrated public health and science functions, and integrated compliance and enforcement programs. Click here (or on the picture to the right) to view the proposed organizational structure of a new FSA.  Ultimately, according to Risa Lavizzo-Mourey, president and CEO of RWJF, the proposal contained within the report is needed to ensure that "food safety [becomes] a priority on the prevention menu." 

Notably, in addition to the significant proposed changes to the fundamental structure of FDA, the report advocates (as a second step) potential future changes to FSIS and other agencies as well. Although FSIS in the short-term would likey continue to operate within the USDA as a separate agency, the report ultimately recommends that all current federal food safety functions (including FSIS responsibilities) should eventually be integrated into a single food safety agency. Thus, although the proposed immediate changes to the FDA will likely garner the most attention as the report is studied and considered, pointed advocacy for a single food safety administration (for all federal food regulatory functions) will likely follow.

In any event, as part of its vision, the report also recommends that a spot at the table be cleared (assuming a new food safety agency is created) for a single Food Safety Czar. We, of course, will wait for a response from Congress and the Obama Administration before we offer our comments on potential candidates . . .

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In the coming months, the FDA will likely begin requiring food manufacturers that obtain positive test results from product samples to report such findings to the agency. Although the new rules will likely have a significant impact on industry as adjustments are made to ensure compliance, the rules (once implemented) would likely add an additional layer of safety to our food regulatory system.

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services, no later than September 27, 2008, to establish a Reportable Food Registry. The stated purpose of the amendment was “to provide a reliable mechanism to track patterns of adulteration in food [which] would support efforts by the FDA to [better] target [its] limited inspection resources.” Implementation of the new law, along with its mandatory reporting requirements, however, has been delayed while the FDA continues to develop an effective electronic reporting system.

In its current form, the new food registry will apply to food manufacturers, and will define “reportable foods” as any article of food (other than infant formula) found to contain harmful pathogens, “for which there is a reasonable probability that the use of, or exposure to, such of food will cause serious adverse health consequences or death to humans or animals.” 21.U.S.C. 350f. If a food sample tests positive for any pathogen considered an adulterant for the particular food at issue, manufacturers would be required, within 24 hours, to submit an electronic report to the agency.

Currently, the FDA anticipates that the registry (and the associated reporting requirements) will likely go into effect sometime later this spring.  We, of course, will keep you posted.

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