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The FDA's Reportable Food Registry ("RFR") first went online in September 2009.

Since its inception, numerous questions have been asked regarding the specific circumstances under which a food company is required to inform the FDA about a potentially dangerous food product.

Generally speaking, under the RFR, any food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if the company learns that it has manufactured, received or distributed a potentially implicated food product.

Because the FDA reporting requirements are only triggered under certain defined circumstances, however, a food company uncertain about its reporting obligations under the registry should consider contacting legal counsel to determine the extent and scope of any potential reporting requirements triggered by the FDA rules.

In their current form, the FDA rules extend to any company that is required to submit registration information to the FDA as a manufacturer, processor, packer, or distributor of food. In turn, the rules apply to any food product regulated by the FDA, with the exception of infant formula and dietary supplements which are covered by other regulatory requirements.

Under existing FDA rules, a food company is required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." In turn, a reportable food is defined generally 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 become 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 received, manufactured or shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and contain any potentially affected products. In addition, responsible parties will be required to notify their relevant suppliers, distributors and customers of any potential food safety issues, be ready to submit further data and analysis to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, in addition to other exceptions, the FDA’s 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 was the sole manufacturer of the food product, it discovered the problem internally before the food product was distributed, and it then corrected the problem or destroyed the implicated food.

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

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The FDA's Reportable Food Registry ("RFR") first became active in September 2009. 

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, a food company may be required to alert the FDA (through the RFR Portal) within 24 hours of becoming aware it has received, sold or 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. 

Because reporting is only required under specific circumstances, however, any company uncertian about its reporting duties should seek legal advice to determine the extent and scope of any reporting requirements under the RFR.

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

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Shortly after the 1993 Jack in the Box outbreak, the Food Safety Inspection Service (“FSIS”) issued a policy statement declaring E. coli O157:H7 to be an adulterant in ground beef. Since this announcement, and as things currently stand, no other non-O157 Shiga toxin producing E. coli (“non-O157 STECs”) are considered adulterants in whole-intact and non-intact beef products.

In October 2009, however, Bill Marler (a national plaintiffs’ food lawyer) petitioned FSIS to issue an interpretive rule declaring all enterohemorrhagic (EHEC) Shiga toxin-producing serotypes of E. coli, including all non-O157 serotypes, to be adulterants in ground beef within the meaning of the Federal Meat Inspection Act. Click on the following link to view a copy of the Marler Clark Non-O157 STEC Petition.

According to Marler, there have been numerous food-borne illness outbreaks involving non-O157 STECs over the last 20 years which, in his view, justify a change in current FSIS policy. Despite the underlying implication that non-O157 STECs are and will continue to be a growing national problem, however, very few reported outbreaks have been associated with these pathogens in the United States.

Even FSIS agrees that outbreaks may be rare. At its 2007 non-O157 STEC Policy Meeting, FSIS noted that there have been only 13 outbreaks since 1990 associated with non-O157 STECs in the United States. Notably, of the 13 outbreaks that were reported, many were attributable to fresh produce, and none were associated with ground beef. Additionally, in 2005, CDC reported that there had been only 501 confirmed cases nationwide.  While these low numbers may ultimately be explained in part by limited testing, it may also be premature to conclude outright that non-O157 STECs are so predominant as to justify an overhaul of the current FSIS approach to pathogen testing and regulation.

FSIS agrees that available data is sparse and may not support a change at this point in FSIS policy. In its recent response to the pending petition, FSIS confirmed that “the agency cannot reach a decision about the substance of the petition until it has developed additional laboratory capacity to detect and isolate various non-O157 STEC groups.” Click on the following link to view the FSIS Response to Marler Clark Petition.

Although FSIS plans to conduct additional research in this area, the agency concedes that, given the current limits of available data, it cannot effectively identify or even address the potential issues with these organisms. And, although additional research will eventually be completed, it remains to be seen whether the resulting findings will ultimately support the conclusion that non-O157 STECs are and should be treated as a significant and wide-spread public health concern in the United States.

In any event, based upon FSIS’ response, it does not appear that the agency will be taking any action on the petition soon. Thus, at least in the short-term, we will likely be left watching - with interest - as numerous scientists and public health officials continue to chew on this issue.

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In a recent speech, USDA Deputy Under Secretary for Food Safety Jerold Mande outlined various areas of research he believes will help improve food safety.

During his remarks, Mande noted that he would like to push for more rapid and effective testing. "We need better sampling methods, along with tests that more rapidly detect a broader range of harmful pathogens," he said. "We also need stronger assurance that laboratories used by companies have the expertise and experience to do effective food safety testing."

In addition, Mande stated that FSIS inspectors should be given more sensitive and effective ways to detect food-borne hazards. Here too, Mande opined that the agency “needs to do a better job equipping our inspectors with the means to not let harmful pathogens slip by as we stand watch."

Next, Mande called for additional research to better identify what he referred to as “those unidentified pathogens” which could potentially be responsible for a majority of food-borne illnesses in the United States. According to the CDC, as many as 80 percent of illnesses, 70 percent of hospitalizations and 65 percent of deaths could be caused by agents other than the 30 pathogens CDC currently tracks.

Finally, Mande also suggested, and rightfully so, that additional research was needed to give farmers and ranchers better tools in order to fight food-borne pathogens. "To take the next big step forward on food safety we need to do more to have fewer pathogens on food animals when they arrive at the slaughterhouse gate," he concluded.

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Dr. Elisabeth Hagen has been selected to become the USDA’s newest Under Secretary for Food Safety. If confirmed, Hagen will serve with Agriculture Secretary Tom Vilsack.

"There is no more fundamental function of government than protecting consumers from harm, which is why food safety is one of USDA's top priorities," said Vilsack. " Dr. Hagen brings the background, skills, and vision to lead USDA's efforts to make sure that Americans have access to a safe and healthy food supply."

The Food Safety mission of USDA includes the Food Safety and Inspection Service (FSIS), which is the public health agency in the USDA responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.

Dr. Elisabeth Hagen currently serves as the USDA's Chief Medical Officer, serving as an advisor to USDA mission areas on a wide range of human health issues. Prior to her current post, she was a senior executive at FSIS, where she played a key role in developing and executing the agency's scientific and public health agendas. She has been instrumental in building relationships and fostering coordination with food safety and public health partners at the federal, state, and local level.

Before joining the federal government in 2006, Hagen taught and practiced medicine in both the private and academic sectors, most recently in Washington, DC. She holds an M.D. from Harvard Medical School, and a B.S. from Saint Joseph's University. Dr. Hagen completed her specialty medical training at the University of Texas Southwestern and the University of Pennsylvania, and is board certified in infectious disease. She is married and lives with her husband and two young children in Northern Virginia.

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By Guest Blogger Cathy Crawford

The proposed regulations which are part of the Food Safety Modernization Act include provisions for mandatory recalls. While in rare cases, such provisions could potentially be helpful where a company is reluctant to conduct a recall, the vast majority of recalls are not only voluntary and effective, but often go above and beyond what may soon be defined as “requirements.”

Consider, for instance, the recent recall of various canned Slim-Fast products. Unilever should be commended for its voluntary and precautionary actions. In this regard, it is critical to note that there were no illnesses associated with the consumption of these products. Rather, a potential food safety issue was identified internally by the company and then immediately reported. Thus, this is not a case that demonstrates the importance of, or need for, additional government oversight. Rather, this was a responsible company which, on its own accord, accepted the need to react, and did react, proactively to address possible food safety concerns.

Next, and even more important, is the size of the recall. Large recalls sometimes lead the media and consumers to believe that our great American food supply is unsafe. This recall, however, demonstrates just the opposite. For Unilever, it was likely that the exact cause of the potential problem was not immediately understood. Nevertheless, all of the potentially affected products involved in the recall were simply assumed by the company to be possibly – not factually – contaminated. In truth, there may have been one contaminated container, none, or many. Because the company wanted to react quickly, however, it initiated a very expansive recall, hoping the public would respect its actions, rather than judging it for having produced a suspect product.

Often, the behind the scenes, certain data driving the scope and limits of a recall are not fully available to the public. In turn, what consumers see or believe is only that a company released a food product later subject to a recall, and then had to have it returned so it could be safely discarded. What is rarely explained is that most of the food involved in any recall is completely safe. Because it can’t quickly be "proven" to be either safe or unsafe, however, it is voluntarily recalled, in an abundance of caution, to remove all potential risk.

If, or more likely when, recalls become “mandatory,” most companies will of course strive to comply with those requirements imposed by the relevant federal agencies. In doing so, however, some companies may become dependent upon federal regulators to define the scope of a recall, and thus overlook the opportunity to do more than what is being strictly required. Thus, although we may see routine compliance, we may also witness a potential loss in some of the extraordinary efforts taken by companies when they themselves voluntarily define the scope of a recall and go the extra mile in the name of public confidence and food safety.

Thus, in my view, additional and pointed regulatory power in such circumstances may not be the best answer. Instead, a coordinated effort to increase and enhance industry education may be a better long term solution. Imagine, for instance, the difference of having careful drivers in a school zone where the community uses education and training to instill an authentic sense of care about driving near schools. Compare this to a place where the time allotted for drivers’ education courses has been reduced, but drivers are expected to travel at 25 mph only because it is mandatory. In the end, which environment is safer? In which case are drivers likely to push the limit farther, and drive a bit faster, when no one is looking?

I would rather see additional resources diverted to increased awarness and training than simply trying to legislate a quick solution to a perceived problem by empowering and then expecting regulators to both define and then require “mandatory recalls.” Remember the drivers’ educational videos that may have scared you and convinced you of the power in your hands when at the wheel? Perhaps something similar, along with increased annual Hazard Analysis and Critical Control Point (“HACCP”) and food safety training, would do more for our system than additional legislation.

The food safety systems in many companies include HACCP protocols as well as systems in compliance with globally accepted food safety standards such as the Safe Quality Foods (SQF) or the British Retail Consortium (BRC). There are times when these systems might fail to identify or prevent a hazard. In these cases, however, responsible companies most often act proactively and quickly to implement corrective actions. Those actions include protecting the public, finding the cause of the problem, eliminating that cause, and updating internal systems to ensure any changes are effective. These things don’t happen without training. No legislation can replace that.

Nevertheless, a mandatory recall provision will likely pass. Without robust and effective food safety training at all stages in the food chain, however, this by itself will not likely diminish the need for recalls, nor will future recalls become any more efficient or effective.

* Cathy Crawford serves as a consultant with the HACCP Consulting Group (HCG), based in Fairfax, VA, just outside of Washington, DC.

HCG provides food safety consulting services to the food industry. Founded in 1994, HCG offers food safety training and assistance to both the FSIS and FDA regulated food industry as well as in over 35 countries that export meat and/or poultry to the U.S. Five of HCG’s 10 partners are former FSIS officials with the others from the food industry and state inspection programs. We have basic and advanced HACCP training courses accredited by the International HACCP Alliance in College Station, TX. HCG also provides Serve Safe training to the restaurant industry and has provided food safety training at a well know Culinary Institute. For more information about HCG please visit HCG’s web site at www.haccpcg.com.

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The USDA’s Food Safety and Inspection Service (“FSIS”) has announced the creation of a new help-desk, providing operators of small meat, poultry and egg processing establishments with access to knowledgeable specialists who can help them understand USDA directives, regulations and other information. The help-desk also will provide direct assistance to state and local food regulatory agencies.

"The FSIS is committed to providing assistance to businesses of all sizes that provide American consumers with access to a safe and healthy food supply," said Deputy Under Secretary for Food Safety Jerold R. Mande. "The small plant help-desk will help the development of small, local producers by offering a one-stop shop for questions about how to make sure their meat, poultry and processed egg products are safe, wholesome and properly labeled."

The new help-desk will support USDA's "Know Your Farmer, Know Your Food" initiative by helping small processors to reduce the time and expense of dealing with agency requirements. "Know Your Farmer, Know Your Food" is designed to continue the national conversation about developing local and regional food systems and finding ways to support small and mid-sized producers. It emphasizes the need for a fundamental and critical reconnection between producers and consumers, building on the 2008 Farm Bill, which provides additional flexibility for USDA programs to promote local foods. More information on the "Know Your Farmer, Know Your Food" initiative can be found at: www.usda.gov/knowyourfarmer.

The FSIS small plant help-desk will serve as a "one-stop shop" for plant owners and operators with questions. More than 90% of the 6,000 plants inspected by FSIS are small or very small. FSIS staff will assess callers' requests and provide information and guidance materials that best meet their needs. In situations where the answer is not readily available, the staff will research the issue and follow-up with the caller. As appropriate, the help-desk will provide a portal to other services, such as AskFSIS, FSIS' existing service offering agency responses to inquiries on agency policy.

Inquiries can be made to the small plant help-desk by toll-free telephone or by email. The help-desk is open from 8:00 a.m. - 4:00 p.m. EST, Monday through Friday, excluding Federal holidays. To speak to a staff specialist during this time, call 1-877-FSISHelp (1-877-374-7435). You may also contact the help-desk by email at InfoSource@fsis.usda.gov.

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It's not www.defendingfoodsafety.com.  But, it may be a close second.

Numerous food safety improvement measures have been initiated in the United States this year. One of the latest, unveiled by the FDA, USDA and Department of Health and Human Services, is a food safety website. The website, www.foodsafety.gov will provide a broad variety of information relating to food safety, including recall information and food handling tips. It will include news and information from each of the governmental agencies including FDA, USDA and CDC responsible for overseeing food safety in the United States.

The site, which is described as a gateway to federal food safety information, provides a wide array of information and resources for consumers to utilize. Among the numerous tools available on the site, are food safety educational materials for download, information about pathogens, podcasts and also an “ask a question” link whereby a consumer can receive an answer to a specific question.. The food safety information is broken down by food groups. It is both easily navigable and readily accessible.

According to the Food Safety Working Group, the federal government will continue “to enhance www.foodsafety.gov to better communicate information to the public and include an improved individual alert system allowing consumers to receive food safety information, such as notification of recalls. Agencies will also use social media to expand public communications.”

Future plans include expanding the website to have mobile access and text alerts.

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The USDA has published new rules for a proposed program, under which select State-inspected establishments (with 25 or fewer employees) will be eligible to ship meat and poultry products in interstate commerce. Click on the following link to view the Proposed Rule.

The new program was created as part of the 2008 Farm Bill to supplement the existing Federal-State cooperative inspection program to allow State-inspected plants with 25 or fewer employees to ship products across State lines. This announcement is part of the USDA's new Know Your Farmer, Know Your Food Initiative, which seeks to better connect consumers with local producers to help develop local and regional food systems to spur economic opportunity.

"This new cooperative interstate shipment program will provide new economic opportunities for many small and very small meat and poultry establishments, whose markets are currently limited," said USDA Deputy Under Secretary for Food Safety Jerold Mande. "We can provide new markets for these establishments, while maintaining the integrity of the Federal mark of inspection."

Currently, 27 states operate State Inspection Programs for meat and poultry, and FSIS verifies that the State programs are implementing requirements that are "at least equal to" those imposed under the Federal meat and poultry products inspection acts. Click on the following link to view the Current List of Qualifying States. For these programs, FSIS provides up to 50 percent of the State's operating funds and provides oversight and enforcement of the program.

Under the proposed rule, selected establishments will receive inspection services from federally trained and/or supervised State inspection personnel who will verify that the establishments meet all Federal food safety requirements. Meat and poultry products produced under the voluntary cooperative program will bear an official USDA mark of inspection, thereby enabling interstate shipment of the products.

State-inspected establishments that are not selected for the voluntary cooperative program, including state-inspected establishments with more than 25 employees, are only eligible to sell and ship their products within their State.

Comments must be received on or before Monday, November 16, 2009, through the Federal eRulemaking Portal at www.regulations.gov, by mail to: FSIS Docket Room, USDA, FSIS, OPPD, Docket Clearance Unit, 5601 Sunnyside Avenue, Stop 5272, Beltsville, MD 20705.

All comments must identify FSIS and the docket number FSIS-2008-0039. Once received and published, interested parties will be able to View All Comments Online.

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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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At a recent conference focused on the prevention of E. coli, the USDA came prepared to comment on its current thinking relating to new and emerging policy initiatives. In turn, Dan Engeljohn (Deputy Assistant Administrator of the FSIS Office of Policy and Program Development) offered a number of pointed observations.

In cases involving a further processor which commingles raw materials from multiple suppliers, it can sometimes be difficult to trace the source of a subsequent outbreak to a single supplier. As a result, Engeljohn explained that the USDA is currently analyzing the merits of using the internal microbiological testing data generated by a further processor of product testing positive for pathogens to help the agency trace the pathogen back to the originating slaughter facility.

With respect to slaughter facilities themselves, Engeljohn also announced that the USDA may issue criteria for assessing prudent "high event day determinations.” Although the USDA concedes that 100 percent testing at any large slaughter operation would likely produce at least some positives during any given day of production, Engeljohn noted further that a large number of positives in a short period of time could potentially be a red flag.

Engeljohn also confirmed that the USDA is continuing its work on validating the methodology for testing and identifying non-O157 Shiga Toxin-Producing E. coli (STECS), from six serogroups (O26, O103, O111, O121, O45 and O145), in FSIS samples. Once sufficient baseline data can be collected and assessed, the agency will likely make a determination whether to classify any of these pathogens as adulterants in raw ground product. In addition, although whole-intact cuts of beef containing E. coli O157:H7 are not considered adulterated under current law, Engeljohn suggested that USDA is continuing to consider whether it may someday modify this standard.

Moving forward, we will, of course, continue to report on new and emerging developments.

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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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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.

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The FDA has announced a new regulation which it expects to prevent approximately 80,000 cases of food-borne illness (and 30 deaths) caused each year by Salmonella Enteritidis in eggs.

The final rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (74 FR 33030), requires manufacturers to employ additional preventive measures during the production of shell eggs in poultry houses, and mandates subsequent refrigeration during storage and transportation. Click on the follwing link to view a copy of the FDA Final Egg Rule.  According to the FDA, the implementation of such measures could potentially reduce the number of Salmonella infections from eggs by nearly 60 percent.

“Preventing harm to consumers is our first priority,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “Today's action will prevent thousands of serious illnesses from Salmonella in eggs.”

Salmonella Enteritidis can be found inside eggs that appear perfectly normal. Eggs in the shell can become contaminated on the farm, primarily because of infection in the laying hens. If the eggs are subsequently eaten raw or undercooked, the bacterium can cause illness.

The new rules requires that measures designed to prevent Salmonella be adopted by virtually all egg producers with 3,000 or more laying hens whose shell eggs are not processed with a treatment, such as pasteurization, to ensure their safety.

Producers with at least 3,000 but fewer than 50,000 laying hens must comply within 36 months after the rule’s publication. Producers with 50,000 or more laying hens must be in compliance with the rule within 12 months after its publication in the Federal Register.

Under the rule, egg producers must:

• Buy chicks and young hens only from suppliers who monitor for Salmonella bacteria;

• Establish rodent, pest control, and biosecurity measures to prevent spread of bacteria throughout the farm by people and equipment;

• Conduct testing in the poultry house for Salmonella Enteritidis. If the tests find the bacterium, a representative sample of the eggs must be tested over an 8 week time period (4 tests at 2 week intervals); If any of the four egg tests is positive, the producer must further process the eggs to destroy the bacteria, or divert the eggs to a non-food use;

• Clean and disinfect poultry houses that have tested positive for Salmonella Enteritidis; and

• Refrigerate eggs at 45 degrees Fahrenheit temperature during storage and transportation no later than 36 hours after the eggs are laid.

Egg producers whose eggs receive treatments such as pasteurization must still comply with the refrigeration requirements. Similarly, certain entities such as distributors, packers, or truckers holding or transporting shell eggs also must comply with the refrigeration mandates.

To ensure compliance, egg producers must also maintain a written Salmonella Enteritidis prevention plan and associated records documenting compliance. Producers (except those who have less than 3000 hens or who sell all their eggs directly to consumers) also must register with the FDA. In turn, the FDA will develop guidance and enforcement plans to help egg producers comply with the rule.

The FDA has estimated that the rule would provide $1.4 billion in annual public health benefits, at an annual cost of $81 million to the regulated industry, or less than 1 cent per dozen eggs produced in the United States.

The new rule is part of a coordinated strategy between the FDA and the FSIS. The FDA and the FSIS will continue to work closely together to ensure that egg safety measures are consistent, coordinated, and complementary.

In addition to the new safety measures being taken by industry, consumers can also reduce their risk of food-borne illness by following safe egg handling practices. The FDA reminds consumers to buy eggs that have been refrigerated, to make sure eggs in the carton are clean and not cracked, and to cook eggs (and any foods containing eggs) thoroughly.

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Agriculture Secretary Tom Vilsack has announced the appointment of Jerold R. Mande, M.P.H., as Deputy Under Secretary for Food Safety at the U.S. Department of Agriculture (USDA). In this position, Mande will have responsibility for the Food Safety and Inspection Service (FSIS), the USDA agency which protects public health through food safety and defense by ensuring that the nation's supply of meat, poultry and processed egg products are safe and wholesome.

According to Vilsack, "Jerold Mande brings years of experience in health, nutrition and epidemiology, food safety, and public policy in both government and academia that will greatly serve USDA and the public as we continue to work to protect public health."

Most recently, as Associate Director for Public Policy at the Yale Cancer Center, Yale University School of Medicine, Mande developed a national model to increase support for cancer prevention and control, including diet, exercise, and obesity. He also initiated and helped manage the cancer center disparities program, to improve cancer control and care in underserved populations. He was also a lecturer in public health, and helped train select groups of physicians for careers in public policy.

Prior to this, Mande served on the White House staff as a health policy adviser where he helped lead key food safety, tobacco control and cancer initiatives, including expansion of FoodNet and PulseNet. He was Deputy Assistant Secretary for Occupational Health at the U.S, Department of Labor. He also served as Senior Advisor and Executive Assistant to the Commissioner of the Food and Drug and Administration, where he led design of the Nutrition Facts food label, for which he received the Presidential Award for Design Excellence. Mande began his distinguished career in the U.S. Congress where he was first hired to work on food safety legislation.

Mande holds a Masters Degree in Public Health (M.P.H. Nutrition and Epidemiology) from the University of North Carolina at Chapel Hill and a Bachelor of Science Degree, magna cum laude (B.S. with Distinction in Nutritional Sciences) from the University of Connecticut at Storrs. He also attended the John F. Kennedy School of Government, Harvard University, completing a Program for Senior Managers in Government.

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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 in March 2009 to help modernize our food safety system. In turn, Vice President Biden, Sebelius and Vilsack, have now announced key findings of the Group.

Following numerous meetings, and imput from key stakeholders, the Working Group has recommended a new approach to food safety based on three core principles: (1) prioritizing prevention; (2) strengthening surveillance and enforcement; and (3) improving response and recovery.

"There are few responsibilities more basic or more important for the government than making sure the food our families eat is safe," said Vice President Biden. "Our food safety system must be updated – 1 in 4 people get sick every year due to food-borne illness, and children and the elderly are more at risk. I applaud the Secretaries of HHS and the USDA for tackling this problem head-on, and coming up with key recommendations to ensure the health and safety of our food supply and, with it, the American people."

"Instead of spending their time trying to get kids to eat healthier food, too many parents and families are worrying about whether their food is safe in the first place," said Secretary Sebelius. "In just the past few months since we began work with the Food Safety Working Group, we have seen recalls on everything from spinach to peanut products to now even cookie dough.” According to Sebelius, the Administration believes “that the current system just isn’t working for America’s families, and under the President’s leadership, we are taking action to keep our food supply safe and prevent outbreaks that can impact millions of Americans."

"There isn’t a single American that isn’t impacted by our efforts to protect the food supply," said Secretary Vilsack. "We owe it to the American people to deliver on President Obama’s bold promise to greatly enhance our food safety system, moving our approach into the 21st century, employing the best surveillance techniques available, and ensuring that we are doing all we can to prevent illness before it occurs."

In its announcement, the Working Group outlined specific steps designed to advance its three core principles:

• HHS and USDA are targeting Salmonella contamination by developing tougher standards to protect the safety of eggs, poultry, and turkey.

• To fight the threat of E. coli, USDA is stepping up enforcement in beef facilities and the Food and Drug Administration (FDA) is developing new industry guidance improving protections for leafy greens, melons, and tomatoes.

• The Obama Administration is building a new national traceback and response system including clearer industry guidance, a new unified incident command system, and improved use of technology to deliver individual food safety alerts to consumers.

• Finally, the Administration announced a plan to strengthen the organization of federal food safety functions, including the creation of new positions at key food safety agencies and a continuing oversight role for the Food Safety Working Group.

The Food Safety Working Group is chaired by Secretaries Sebelius and Vilsack, and participating agencies include the FDA, the FSIS, the CDC, the Department of Homeland Security, the Department of Commerce, the Department of State, the Environmental Protection Agency, and several offices of the White House.

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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.

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Nearly five months after the new administration took office, there is still no indication when an undersecretary for food safety will be named. Secretary of Agriculture Tom Vilsack recently confirmed that the delay is due at least in part to the administration's commitment to avoid hiring former lobbyists.

According to Vilsack, those restrictions, coupled with continuing efforts to thoroughly evaluate all potential candidates, has taken significant time. Additionally, some leading candidates formerly under consideration have declined the position. Dr. Mike Doyle, director of the Center for Food Safety at the University of Georgia, for instance, reportedly passed on the invitation, stating he would prefer to continue his role at the University of Georgia.

When named, the new undersecretary will be forced to quickly address numerous emerging food safety initiatives. Although lobbyists claim it is hard for the FSIS to participate fully in the consideration of new initiatives without a sitting undersecretary, Congress nevertheless continues to debate new legislation, and the President's Food Safety Working Group continues to work toward framing new policy.

Thus, we look forward to a formal decision soon, such that all stakeholders can effectively participate in our continuing and collective efforts to strengthen food safety.

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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.

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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 addition to peaches, we all know (now) that Georgia also dabbles in peanuts. Notably, the state is regarded as the nation's leading peanut producer, employing an estimated 50,000 people in an industry worth approximately $2.5 billion. Following the massive recalls of peanut butter products originally announced by the Peanut Corporation of America in January 2009, Georgia lawmakers introduced and passed a new bill that will make Georgia the first state to require food producers to inform state inspectors if test results show that their food products contain trace elements of harmful pathogens. 

Although, in the coming weeks (or months), the FDA will also begin requiring food manufacturers that obtain positive test results to report such findings to the agency, Georgia is the first individual state to enact such rules. Under the proposed legislation, state agriculture officials will be empowered to adopt regulations that will establish how frequently food processors must conduct internal testing. Similar to the looming federal requirements, the new rules will require food processors to report results within 24 hours of any positive test. The laws, as drafted, also exempt (of course) meat, poultry and other manufacturers that fall within the jurisdiction of the USDA.

The legislation has now passed in both the Georgia state Senate and House of Representatives. Governor Sonny Perdue is expected to sign the bill soon. 

Peachy.

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The USDA has granted a conditional license for the nation's first E. coli O157:H7 cattle vaccine. The vaccine is designed to reduce the level of E. coli O157:H7 in the intestines of host cattle, and to prevent the bacteria from spreading in feed lots.

Although additional efficacy tests still need to be conducted, the conditional license granted by the USDA will allow Epitopix LLC, the manufacturer of the vaccine, to begin offering the product for sale. The company developed the vaccine along with researchers from Kansas State University and West Texas A&M University.

During testing, researchers conducted a challenge study, a natural infection trial, and two large-pen field studies of the vaccine at commercial feedlots. According to reports, the vaccine reduced the number of cattle testing positive for the O157:H7 bacteria by 85 percent. Of the animals that did test positive for the pathogen, the vaccine reportedly eliminated 98 percent of the bacteria. "Those are impressive numbers," said Dr. Michael Doyle, director of the University of Georgia's Center for Food Safety. In turn, Jim Sandstrom, of Epitopix, confirmed that the vaccine “represents a significant breakthrough in the beef industry's ongoing effort to reduce E. coli O157:H7."

Following additional studies, Epitopix will likely gain full approval for the vaccine. The company estimates that, eventually, the vaccine will protect as many as 10 million cattle every year (about 1/4 of the country's annual cattle supply), and will likely cost less than $10 per head. One of the country's largest beef producers has already expressed interest in purchasing the vaccine.

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The Food Safety Inspection Service ("FSIS") has issued a new Notice (18-09), detailing its changes in sampling frequency for E. coli O157:H7 in raw ground beef. According to the notice, FSIS will be increasing sampling at high volume ground beef establishments at the following monthly rates:

• Up to four times within a 30-day window for establishments with ground beef product production volumes of greater than 250,000 pounds per day;

• Up to three times within a 30-day window for establishments with ground beef product production volumes of 50,000 to 250,000 pounds per day;

• Up to two times within a 30-day window for establishments with ground beef product production volumes of 1,000 to 50,000 pounds per day; and

• Generally, no more than once within a 30-day window for establishments with ground beef product production volumes of less than 1,000 pounds per day. However, FSIS will ensure that at these establishments at least one sample is collected quarterly.

According to the FSIS, the increase in sampling will allow the Agency to estimate the amount of uncontaminated raw ground beef with a higher degree of certainty. The Office of Public Health Science and the Office of Data Integration and Food Protection will analyze sample results, and will produce a weekly report on findings. According to the notice, the Office of Data Integration and Food Protection will also analyze the sampling data to identify trends (e.g., geographical, seasonal) and to evaluate program effectiveness (e.g. sample scheduling and collection rates). In addition, the data will be used to calculate a quarterly performance measure of E. coli O157:H7 in raw ground beef that will likely be included in the Agency’s quarterly performance report.

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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. 

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Tom Vilsack, Secretary of the United States Department of Agriculture, announced that the final rule (74 FR 2658) for mandatory country-of-origin labeling (“COOL”) will become effective on March 16, 2009. Under the new rule, retailers will be required to notify customers of the country of origin of certain food products. Food products (or, “covered commodities”) included within the COOL program include whole muscle cuts, ground beef, lamb, chicken, goat and pork; wild and farm-raised fish and shellfish; perishable agricultural commodities (specifically fresh and frozen fruits and vegetables); and macadamia nuts, pecans, peanuts and ginseng. Additionally, for food such as fish and shellfish, the method of production, wild or farm-raised, must be specified.

Exempted from COOL, however, are various products (e.g., ingredients) used to manufacture “processed” food items. Processed foods are generally defined as: (1) any retail item derived from a covered commodity that has undergone specific processing resulting in a change in the character of the covered commodity; or (2) any retail item that has been combined with at least one other covered commodity or substantive food component. “Specific processing” that results in a change in the character of food includes cooking (e.g., frying, broiling, grilling, boiling, steaming, baking, roasting), curing (e.g., salt curing, sugar curing, drying), smoking (cold or hot), and restructuring (e.g., emulsifying and extruding). For this reason, Vilsack also expressed concerns, in an open letter to industry, that the definition of processed foods contained within the final rule "may be too broadly" drafted. Because Vilsack was also concerned about the labeling of products of mixed origins, and time allowances for labeling of certain ground meat products, he asked industry to voluntarily adhere to the following additional labeling practices:

• With respect to processed foods, Vilsack suggested that processors voluntarily use country-of-origin labeling for those products that "are subject to curing, smoking, broiling, grilling, or steaming."

• With respect to products derived from animals with multiple countries of origin, Vilsack asked processors to include labeling information identifying what production step -- born, raised and/or slaughtered -- occurred in each country.

• Finally, because final rule allows a label for a ground meat products to bear the name of a country when meat from that country was present in the processor's inventory within the last 60 days, Vilsack suggested that time allowance be reduced to 10 days.

American Meat Institute President J. Patrick Boyle stated that, despite Vilsack’s concerns, the organization was "gratified" that USDA is allowing the final rule to go into effect. Namely, this is because the new rule, in its current form, took nearly six-years (with assistance from industry) to develop. Boyle also noted that, once the rule is effective, nearly 95 percent of beef and pork products would likely be eligible to bear a "Product of the USA" label.

Nevertheless, Boyle also stated that it would ultimately be up to individual companies to decide whether to voluntarily comply with Vilsack’s recommendations. According to Boyle, "to the extent that companies are able and elect to go beyond [the] federal labeling requirements, as requested by Agriculture Secretary Vilsack, [that] is an individual company decision, which will have to be made in collaboration with a company's retail grocery customers . . .."

In any event, Vilsack confirmed that the USDA “will closely review industry compliance with the regulation and its performance in relation to these suggestions for voluntary action.” Depending upon such performance, the USDA “will [then] carefully consider whether modifications to the rule will be necessary to achieve the intent of Congress." The rule had also been under review on the orders of the new presidential administration. Ultimately, Vilsack stated that, allowing the rule to go into effect on March 16, 2009, and then monitoring implementation and compliance by industry, would likely be the most efficient way to evaluate the success of COOL, and also to determine whether additional rulemaking would be necessary.

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The State of California recently enacted a new criminal law, effective January 1, 2009, designed to prevent slaughterhouses from purchasing and processing non-ambulatory animals for human consumption. As enacted, Section 599f amended the California Penal Code to criminalize, without exception, the receipt and use of non-ambulatory animals by slaughter facilities.

In response, the National Meat Association (“NMA”) sought and obtained a preliminary injunction to prevent the State of California from enforcing the new law. NMA, et al. v. Brown et. al, Case No. CV-F-08-1963 (E.D. Cal. 2008). In its briefs, NMA argued that the treatment of non-ambulatory animals was already regulated extensively by the Federal Meat Inspection Act (“FMIA”), which expressly permits, subject to certain requirements, the receipt and use of non-ambulatory animals for slaughter. Under the FMIA (21 U.S.C. § 601, et seq.) and its implementing regulations, non-ambulatory animals may be processed for human consumption if the animals are first inspected for disease and then passed by a federal veterinarian inspector. Because the California law attempted to criminalize what the FMIA permits, NMA argued persuasively that the California initiative was preempted.

Indeed, the FMIA (a distant relative of the 1906 Wholesome Meat Act) regulates virtually every aspect of meat production. The Act requires continuous federal inspection in meat packing plants, often times by multiple inspectors. These federal inspectors are responsible for ensuring that all animals entering slaughter facilities are healthy and free from disease, and that all meat products subsequently produced from such animals are safe, wholesome and not adulterated. Currently, the federal statutory and regulatory scheme is enforced by the Food Safety Inspection Service (a sub-agency of the United States Department of Agriculture).

To ensure that the FMIA and its uniform national requirements are not usurped by the individual states, the FMIA contains an express preemption provision which prevents states from enacting or enforcing any laws that are “different” from the federal standards. 21 U.S.C. § 678. Thus, under the FMIA, any state laws which attempt to penalize a food producer for doing what federal law permits (whether the laws relate to production or product labeling) are strictly preempted.

In this case, the new California criminal law conflicted directly with the federal statutory and regulatory scheme. Because the FMIA permits the use of non-ambulatory animals for slaughter (assuming such animals have been declared to be free from disease by a federal FSIS veterinarian inspector), the Court granted NMA’s request for a preliminary injunction. In its February 19, 2009 Decision, the Court reasoned that the California Penal Code, Section 599f, was both expressly and implicitly preempted under the FMIA and its implementing regulations.

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Agriculture Secretary Tom Vilsack recently announced that, despite previous opposition, he now favors combining the food safety functions of the United States Department of Agriculture (“USDA”) and Food and Drug Administration (“FDA”) into a single food safety agency. Currently, the USDA through it’s Food Safety and Inspection Service (“FSIS”) is responsible for regulating the safety of meat, poultry and egg products. In turn, the FDA has responsibility for most other foods. In his recent comments, Vilsack also stated that he has not yet decided whether a single agency would be best located within the FSIS, the FDA or an independent agency.

As debate continues about merging the food safety responsibilities of the USDA and FDA, Janie Gabbett (from Meatingplace.com) reported that the majority of industry participants in an online survey favored combining the food safety regulatory functions of the USDA and FDA, but only one in five believed that such a merger would result in improved food safety.

Of 289 readers who responded to the survey, 58 percent agreed the two agency functions should be combined, while 42 opposed a merger. When respondents were asked if they thought that a merger of the two agencies would improve food safety, 50 percent believed that food safety would remain unchanged, while 30 percent believed that the quality of food regulation could actually decline.

According to the survey, participants were more concerned with deficiencies in FDA regulation than in FSIS protocols. Namely, this is because, unlike the FDA, FSIS inspectors currently maintain a continuous, on-site presence in meat packing facilities, and also regularly test meat and poultry products for harmful pathogens. As a result, several respondents also concluded that if the agencies were to merge, the FDA would need to become more like FSIS, and not the other way around.

Other suggestions from survey participants included:

• Providing better technology and tools for inspectors;

• Increased laboratory testing;

• Imposing fines on plants with repeated serious violations;

• Requiring all food establishments to adopt and implement Hazard Analysis and Critical Control Point (“HACCP”) plans;

• Requiring all food establishments to adopt and implement sanitation standard operating procedures (“SSOPs”);

• Continuing to improve risk-based analysis of food safety systems in plants;

• Targeting high-risk foods (under FDA jurisdiction) and moving toward to the USDA model of inspection;

• Providing better training for inspectors; and

• Funding additional research to improve food safety.

According to Gabbett, many respondents also believed that, even with a single food safety agency, increasing the funding and number of federal inspectors would likely be needed to improve the effectiveness of regulations. According to one respondent, "simply merging two departments and changing their names . . . won't affect food safety." Rather, "there would need to be fundamental changes at the plant inspection level to actually make a difference."

Currently, the United States is the only industrial nation to have two separate federal food safety regulatory systems. Moving forward, we'll continue to post on emerging developments.

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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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Tom Vilsack, Secretary of Agriculture, promised today to quickly name a new head of the USDA's Food Safety Inspection Service (“FSIS”).

The FSIS, an agency falling within the jurisdiction of the USDA, enforces the Federal Meat Inspection Act, 21 U.S.C. § 601, et seq., by providing continuous on-site federal inspection within meat packing plants. On a daily basis, federal inspectors ensure that all meat products sold in interstate commerce are: (1) produced under sanitary conditions; (2) not adulterated; and (3) properly labeled. In addition to monitoring production, the FSIS also closely regulates meat product labeling. Over the decades, the agency’s policy making and inspection authority has expanded to oversee poultry production under the Poultry Products Inspection Act (21 U.S.C. § 451, et seq.), and egg production under the Egg Products Inspection Act (21 U.S.C. § 1031, et seq).

Leading candidates for the position currently include: (1) Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest; and (2) former FSIS administrator Barbara J. Masters. Ms. Masters currently serves as a senior policy adviser with the Washington law firm Olsson Frank Weeda Terman Bode Matz PC.

Other names that have been considered for the position include Dr. Michael Doyle, Director of the University of Georgia Center for Food Safety (see our post below, highlighting Dr. Doyle’s work on Globalization and Food Safety), Michael Taylor, a veteran of the Food and Drug Administration and George Washington University professor, and Bill Marler, a well-known Seattle-based food-borne illness attorney.

Good luck to all.

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As we continue to comment on food safety litigation avoidance and crisis management, several food industry groups on Friday, in letters to Congress, urged House and Senate leaders to quickly enact enhanced food safety reforms.  The letters announced that, although “Americans continue to enjoy the safest food supplies in the world, . . . new challenges require Congress and the Administration to modernize our food safety net.”  In turn, industry groups urged lawmakers to move forward on the following FDA proposals, originally announced in 2007, as part of the FDA’s Food Protection Plan:

• Require Domestic Food Safety Plans:  As proposed, the initiatives would require domestic food producers to affirmatively identify potential food safety risks associated with production methods and products, identify and implement enhanced production or other controls, and prepare formalized food safety plans (for FDA review) addressing such risks;

• Require Foreign Food Safety Plans:  Adoption of the pending initiatives would also empower the FDA to assist foreign governments seeking to adopt robust food safety regulations, and require foreign food product importers to better police foreign suppliers. The initiatives would also, in part, require domestic foreign food product importers to document food safety controls being implemented by foreign suppliers, and require such records to be available for FDA review; and

• Adopt A More Robust Risk-based Approach to Inspections:  As proposed, the initiatives would also enable the FDA to increase food safety inspections for those facilities and products (both foreign and domestic) that pose, based upon science and risk-based studies, the greatest risk of potential contamination.

In addition to encouraging a more robust food safety inspection system for domestic and foreign products, the letters also urged Congress to better enhance the safety of fruits and vegetables by establishing uniform standards for high-risk products.  In addition, the letters addressed the FDA’s continuing request for mandatory recall authority, which would be available to the agency in those rare circumstances where companies refused, following FDA recommendations, to initiate recalls voluntarily.

The letters were undersigned by numerous industry organizations, including the Grocery Manufacturers Association, the Food Marketing Institute, the American Frozen Food Institute, the International Bottled Water Association, the International Dairy Foods Association, the National Fisheries Institute, the National Restaurant Association, the Retail Industry Leaders Association, the Snack Food Association and the United Fresh Produce Association.  According to Pamela Bailey, President and CEO of the Grocery Manufacturers Association, improved food safety tools would ultimately enable us to better “maintain our position of global leadership and assure consumer confidence.”

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While the USDA and FSIS work hard to protect our meat and poultry supply, the FDA works to ensure that the remaining 78 percent of domestic and imported food remains safe.

Although the FSIS maintains a continuous presence in most meat and poultry plants, the FDA typically only visits food processing facilities once a year. Following a number of highly publicized recalls, however, some began suggesting that the FDA should follow the USDA model, requiring more regulation and a more visible federal presence within FDA-regulated food processing facilities. Thus, the question was called: Would the FDA become more like the USDA?

Maybe just a little. In November 2007, the FDA unveiled a new initiative, called the "Food Protection Plan." The plan avowed three “core elements” - prevention, intervention and response - to better ensure a safer quality of food for all Americans (FDA, “Food Protection Plan: One-Year Progress Summary”). While, as part of these efforts the FDA asked Congress for additional regulatory authority, including new mandatory recall powers, most agree it would be far too impractical, expensive and imprudent to demand or even require a significant increase in domestic inspection. In June, for instance, the Government Accountability Office actually condemned the plan for “failing to provide details on the costs or specific strategies.”

In any event, within the coming months, we will see where these efforts lead. Personally, I expect the FDA’s regulatory control to grow significantly in the coming years (resulting, for instance, in the implementation of a mandated HACCP-based system for many new categories of foods). Thus, although it remains unlikely in the near term that federal inspectors will be physically “moving in” to your food production facility (as occurs in slaughter establishments), you may nevertheless find them knocking on your door more often, at the very least, to critique your HACCP plan.

Stay tuned for new developments.

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