Salmonella in Raw Products – Can FSIS Request a Recall?

By Barbara J. Masters, D.V.M.

I am often asked whether or not the Food Safety and Inspection Service (FSIS) can request a recall for meat or poultry products merely because the products test positive for Salmonella.  The answer to that question today is no.  However, there are times FSIS can request a recall of raw meat and poultry products for Salmonella.  If at any point FSIS determines there is specific product (specific lot, specific product date) in commerce making people sick, it will ask for a voluntary recall of that specific production of product, regardless of whether there is a positive test result.

What is important to understand is that for outbreak recalls, FSIS will use the same thought process regardless of whether the pathogen is considered an adulterant or not.  FSIS would look for the following four factors as part of the outbreak investigation:

  • There are related illnesses (an outbreak) as determined by the DNA analysis of samples from case patients;
  • The evidence supports the conclusion that the likely source of the illnesses was a specific product;
  • The plant produces that specific product; and
  • A specific production of that plant’s product was purchased by, or available to, the case patients at the time and location of the illnesses.

If all of these criteria are met, FSIS will request a recall of the product implicated in the outbreak.  In this circumstance, FSIS is not relying on a positive test result (from the product) to request the product be removed from commerce, rather they are relying on evidence that the specific product has been implicated in causing an outbreak.

In summary, today, FSIS can request an establishment to conduct a voluntary recall for products that test positive for an adulterant (e.g., E. coli O157:H7), but not for product that tests positive for Salmonella.  However, in the case of a foodborne outbreak, FSIS applies the same rules to all pathogens.  If the evidence supports that a specific production of product is the likely source of the illnesses in the outbreak, FSIS will request a voluntary recall (not based on test results of the product).

About Dr. Masters

Mixed in with the attorneys at OFW Law is the former USDA Food Safety Inspection Service’s (FSIS) Administrator, Dr. Barbara Masters.  Dr. Masters is a veterinarian who spent eighteen years with FSIS – the final three years as Acting Administrator and Administrator.  During her rise to the Administrator’s position, Dr. Masters served as the Deputy Assistant Administrator for Office of Field Operations.  While in these key leadership positions at FSIS, Dr. Masters’ primary focus was on the implementation of science-based policies for the protection of public health.

Food Defense Plans

By Barbara J. Masters, D.V.M.

One of the goals of the Food Safety and Inspection Service’s Strategic Plan is to “ensure that facilities implement safeguards and systems to protect food from contamination by people who might try to intentionally and maliciously harm consumers.”  The Agency has a FY 2015 target of 90% of all establishments having a functional food defense plan. Since 2006, annual surveys have been conducted to measure progress.  The largest establishments currently exceed the goal (97% have a functional plan) while the very small establishments are not yet at the target.

The Food Safety Modernization Act (FSMA) requires the Food and Drug Administration (FDA) to implement measures to protect the food supply from intentional contamination.  A proposed rule to address hazards resulting from intentional contamination was issued on December 24, 2013.

Both FSIS and FDA have taken substantial measures to assist the food industry in the development of food defense plans.  The FSIS webpage includes a tool that an establishment can download to select the specific elements appropriate for their facility.  FDA maintains an on-line food defense plan builder free to all users.  Once a plan is documented, the establishment must implement the plan.  Steps to implementing a food defense plan include:

  • Testing the plan (e.g., check locked doors, take unannounced walks around the perimeter), and
  • Reviewing and maintaining the plan (review and update as needed).

Food defense plans should be tailored to the facility.  Small establishments do not need to make the plan overly burdensome.  For example, a plant that only employs family members would not need background checks on employees as a critical element.  However, this establishment could document the use of door locks and outdoor lighting at key locations in the facility.

Areas to be considered in a food defense plan are: outside security, inside security, personnel security measures and incident response security measures.

When I go visit any establishment, I am always asked to show my identification.  I am always escorted during the visit, and I see emergency plans posted at every facility.  These are all elements of a food defense program.  If these elements for secure food are already in place, it is logical that they could easily be documented and verified by the establishment.

I encourage those plants that are not currently maintaining a functional food defense plan to review the FSIS and FDA websites.  I challenge them to consider that they very likely already have all the elements in place for a food defense plan – the plan just needs to be documented.  By documenting the plan – the establishment is taking the necessary steps to ensure all team members are aware of the program and are taking steps to consistently implement it.

If by maintaining a functional food defense plan we can contribute to a safer and more secure food supply, then I am certain we are all in favor of meeting this objective.

Regulatory Round-Up Newsletter, Spring 2015

On behalf of the Agriculture practice group at OFW Law, here is a copy of our Spring newsletter.  We hope you find it useful.  To receive this periodic newsletter by e-mail, please contact Carrie Morgan at cmorgan@ofwlaw.com.

FSIS Poised to Take Action in Response to Increase of Recalls Due to Undeclared Allergens and the Failure to Present Imported Products for Re-inspection

By Brett T. Schwemer

The Food Safety and Inspection Service (FSIS) recently posted on its website a Summary of Recall Cases in Calendar Year 2014.  Comparing this summary with the summaries from 2013 and 2012, a few things immediately stand out.  On a positive side, meat and poultry product recalls for pathogens (Shiga toxin-producing E. coli, Listeria monocytogenes, and Salmonella) and other contaminants collectively decreased in 2014 from years 2012 and 2013.  However, on the negative side, there was a significant increase in recalls in 2014 for undeclared allergens and recalls classified as “other,” which upon closer examination, appear to be largely related to the failure of importers to present imported meat and poultry products to FSIS for re-inspection at the point of entry (otherwise known as a “Failure to Present” (FTP)).  With these trends continuing into 2015, establishments should expect FSIS to respond aggressively.

Undeclared Allergen Recalls

Recalls for undeclared allergens rose from 25 in 2013 to 43 in 2014, a whopping 72 percent increase.  Seven of the recalls in 2014, which occurred at the very end of the year, can be attributed to meat and poultry establishments purchasing cumin that were unknowingly contaminated with peanut protein.  However, the rest appear to be situations where meat or poultry processors failed to properly identify and control incoming ingredients, failed to prevent cross-contamination during processing or failed to ensure that finished products were properly packaged and/or labeled. In short, these recalls were largely preventable.

FSIS has grown frustrated with the continued increase in recalls due to undeclared allergens and has vowed to take action.  Last month, the agency advised the industry that it will be soon be issuing new instructions to inspection program personnel on how to verify that meat and poultry products are correctly labeled.  The new instructions will purportedly contain additional inspection tasks related to label and formula reviews, and provide guidance on what can result in an undeclared allergen in product and what procedures can be adopted in an allergen control plan.  Obviously, if undeclared allergens are found and product has entered commerce, the agency will request a recall.

In anticipation of these new instructions, establishments would be well advised to reassess their current allergen control programs and other procedures to ensure that meat and poultry products are properly labeled with all ingredients listed.  This reassessment should be conducted in light of the FSIS “Compliance Guidelines for Allergens and Ingredients of Public Health Concern: Identification, Prevention and Control and Declaration Through Labeling.”  These guidelines contain certain “best practices” identified by the agency for ensuring that hazards associated with ingredients of public health concern are properly identified, that they are prevented and/or controlled, and that all ingredients are properly declared on product labels.  In addition to these guidelines, establishments should also consider guidance provided by the Food Allergy Research and Resource Program of the University of Nebraska regarding how to develop effective allergen control programs.  Finally, our firm has posted a series of blogs entitled “Steps to Prevent Allergen Recalls – Practice Tips.”

Establishments should also anticipate that, with an increase in inspection tasks related to label review, there will be a heightened risk that inspection personnel will take regulatory control actions for perceived labeling deficiencies that do not arise to a public health concern.  Given that a substantial amount of labels are generically approved these days, many establishments may not be able to point to an FSIS approved label to convince inspection personnel not to take action.  To that extent, it would behoove establishments to get to know officials from the FSIS Labeling and Program Delivery Staff and maintain emergency contact information for these officials in the event that a labeling dispute arises with inspection personnel or there is a need for an emergency temporary label approval.

FTP Recalls

As noted above, 2014 also experienced a dramatic increase in FTP recalls – 6 in 2014 compared to 1 each in 2012 and 2013.  Just two months into 2015, there have already been 7 FTP recalls.

Similar to the recalls for undeclared allergens, it is our understanding that most of the FTP recalls were avoidable.  Pursuant to FSIS regulations, after Customs and Border Protection (CBP) verifies that imported meat and poultry product meets CBP and Animal and Plant Health Inspection Service requirements and releases the shipment, the importer of record is required to have the product presented to FSIS for re-inspection at an official FSIS import inspection establishment.  Unfortunately, in many of the recalls, the importer of record (or broker) failed to ensure that the product was delivered to an official FSIS import inspection establishment for re-inspection or the import inspection establishment inadvertently released the shipment in commerce without the requirement being met.

The increase in FTP recalls, however, is not solely attributable to an increase in mistakes by importers, brokers and import inspection establishments.  Beginning about 7 months ago, FSIS began increasing verification of its import requirements by reviewing data in its Public Health Inspection System (PHIS) twice a week to identify potential FTPs. This increased verification directly correlates to the increase in recalls.

In response, FSIS has indicated that it will continue to, and potentially increase, its review of PHIS data in 2015 to detect FTPs.  If a FTP is detected and product has already entered commerce (i.e., off-loaded at a location other than the official import inspection establishment or other approved located designated on the import inspection application), the agency will likely require the importer of record to conduct a Class I recall of any associated product.   The agency can also withdraw inspection services at the official import inspection establishment until the establishment can provide additional measures to ensure imported product is re-inspected.  Finally, the agency may request CBP to issue a Notice of Redelivery to the importer of record, broker and/or official import establishment demanding that the uninspected product be returned to the custody of CBP. If product is not redelivered to CBP, CBP can initiate action to assess penalties and liquidated damages (additional information regarding FTPs and the actions that FSIS will take in response can be found in the agency’s Prior Notification and Failure to Present: Compliance Guideline for Importing Meat, Poultry and Egg Products to the United States).

Given the increase in verification activities relating to FSIS import requirements and the consequences for failing to meet these requirements, importers of record, brokers and official import inspection establishments would be well advised to work together to implement a system of controls designed to ensure that all imported meat and poultry products are re-inspected at the point of entry.  This should include measures to ensure that the importer of record or designated agent applies for inspection of imported product as far as possible in advance of the anticipated arrival of each consignment, but no later than when entry is filed with CBP, in accordance with FSIS’ prior notification requirement.  It should also include improved means of communication between the respective parties regarding when amenable meat and poultry products may be in a shipment of product and thus require inspection.  Finally, official import inspection establishments should consider implementing more stringent procedures for identifying and controlling imported meat and poultry product that are to be held pending FSIS re-inspection, such as the implementation of new inventory control systems designed to prevent meat and poultry product from being “released” from inventory until re-inspection is complete.  Additional recommendations for adopting an effective hold or retention program can also be found here.

Following the basic recommendations above should go along way towards reducing the number of recalls for undeclared allergens and FTPs each year.  However, if the industry ignores these recommendations and such recalls continue to rise, the industry should fully expect the agency to take additional measures to control what they view as a purely preventable situation.

Don’t Rush the Holiday Preparations – Make Certain the Meat is Properly Cooked

By Barbara J. Masters, D.V.M.

Getting ready for holiday “get togethers”, one often finds themselves in a rush or behind on preparing the food for the party.  Don’t let tardiness be the reason the party attendees end up with a case of foodborne illness.  Don’t rush cooking of product; I am certain the guests would rather wait a few minutes than risk the potential of being sick because the product was not properly cooked.

Always read the product label for specific cooking instructions and follow them!  Be sure to verify whether the product has been pre-cooked and simply needs to be re-heated, or if the product is raw and needs to be thoroughly cooked.   All of this information will be included on the product label.  If there are questions on what temperature to cook a specific product to, USDA’s Food Safety and Inspection Service provides a chart that includes safe minimum internal cooking temperatures:

Cook all food to these minimum internal temperatures as measured with a food thermometer before removing food from the heat source. For reasons of personal preference, consumers may choose to cook food to higher temperatures.

Product Minimum Internal Temperature & Rest Time
Beef, Pork, Veal & Lamb
Steaks, chops, roasts
145 °F (62.8 °C) and allow to rest for at least 3 minutes
Ground meats 160 °F (71.1 °C)
Ham, fresh or smoked (uncooked) 145 °F (60 °C) and allow to rest for at least 3 minutes
Fully Cooked Ham
(to reheat)
Reheat cooked hams packaged in USDA-inspected plants to 140 °F (60 °C) and all others to 165 °F (73.9 °C).

 

Product Minimum Internal Temperature
All Poultry (breasts, whole bird, legs, thighs, and wings, ground poultry, and stuffing) 165 °F (73.9 °C)
Eggs 160 °F (71.1 °C)
Fish & Shellfish 145 °F (62.8 °C)
Leftovers 165 °F (73.9 °C)
Casseroles 165 °F (73.9 °C)

Source: Food Safety and Inspection Service

You can not see or smell bacteria that may be on raw products.  It is important to follow the manufacturer’s cooking instructions to ensure the safety of the product.

Celebrating 35 Years of Success: USDA Practice Team

By Brett T. Schwemer

Recently, Olsson Frank Weeda Terman Matz, P.C., otherwise known as “OFW Law,” celebrated 35 years of business with colleagues, family, friends and clients.  We were extremely proud to share this milestone with those who have helped make OFW Law one of the leading firms practicing USDA and FDA law today.

Although OFW Law has expanded in other areas of law, the origin of OFW Law began in agricultural law and these roots remain strong today. Indeed, OFW Law is one of the most comprehensive agriculture law firms in the country, representing large and small companies and trade associations on a myriad of legal issues, ranging from food safety and nutrition, animal welfare and forestry, to everything in between. Together, our USDA practice team, consisting of 17 attorneys and Senior Policy Advisors, are capable of representing clients before virtually every agency of the USDA.  Our most frequent interactions involve the USDA’s Food Safety and Inspection Service (FSIS), Food Nutrition Service (FNS), Agricultural Marketing Service (AMS), Animal and Plant Health Inspection Service (APHIS), Grain Inspection, Packers and Stockyard Administration (GIPSA), Risk Management Agency (RMA) and Federal Crop Insurance Corporation (FCIC).

One attribute that makes the USDA practice team unique among its peers is its experience.  Many of our professionals have served in high level agricultural positions in the government and/ or have a long history of working in or with the agriculture/food industry   This has allowed our professionals to not only apply real world experience and technical expertise to solve difficult problems, but to identify the right contacts at USDA should issues need to be resolved at the Department.

The experience and expertise of our professionals have allowed the USDA practice team to tally many successes over the last 35 years.  We are proud to share a few of our most notable ones, as follows:

  • Our professionals have assisted numerous meat, poultry and other food clients design, implement and assess food safety, sanitation and quality control programs. With in-plant experience and training in HACCP principles, our professionals have helped clients not only comply with food safety requirements, but exceed them.
  • Our professionals have successfully assisted clients in FSIS enforcement actions (e.g., Notice of Intended Enforcement Actions, Notice of Suspensions), providing advice which has allowed clients to avoid, or minimize the duration of, plant closures.
  • Our practice team has helped numerous clients facilitate the marketing of their food and agriculture products, by assisting in obtaining government approval for new label claims and/or new ingredients/processing aids, or by helping to remove regulatory impediments for marketing their products. For example, we successfully petitioned FSIS to eliminate the standard of identity for pizza, giving frozen pizza manufacturers the flexibility to make more innovative products so they can better compete with pizzeria restaurant chains.
  • Our practice team has successfully defended meat packers, poultry slaughterers, livestock dealers and market agencies in numerous GIPSA enforcements actions under the Packers and Stockyards Act. In one case, GIPSA filed a complaint seeking over $3 million in civil penalties against a packer for failing to notify livestock sellers, prior to purchasing livestock, of a more accurate formula used for grading pork carcasses.   As a result of our representation of the packer, the Administrative Law Judge and Judicial Officer of USDA issued no civil penalties in the case.
  • Following a successful multifaceted campaign by our team, AMS rewrote the Florida Tomato Marketing Order in 2005 to permit the nationwide distribution of the UglyRipe® tomato during the regulated Florida tomato season.
  • When the Congress considered amendments to, and perhaps even repeal of, the Perishable Agricultural Commodities Act (PACA), stakeholders turned to our professionals for counsel. The amendments resulted in preservation of the fair trade statute covering all fresh and frozen fruits and vegetables with more efficient reservation of PACA Trust benefits and a stabilized funding mechanism for USDA’s PACA Branch.
  • Puerto Rico attempted to impose specific labeling requirements for shell eggs imported from outside the Commonwealth, including on the eggs themselves.  We successfully challenged the regulations in federal court at both the district and appellate levels, with the First Circuit holding that Puerto Rico’s regulation violated the Dormant Commerce Clause of the U.S. Constitution.
  • On FCIC Federal crop insurance, we have represented players on every side of the fast-growing program: approved insurance providers (AIPs), agents, farmers, product developers, and grower associations. In just one area, new insurance policies, we assisted in the approval of Livestock Risk Protection (LRP) for cattle, hogs, and lamb, margin protection for wheat and rice, oysters, barley, biotech corn, and many others. This past year, we assisted drought-hit farmers in Oklahoma and Texas on controversial claims, helped two insurance companies address oversight issues with RMA, and successfully urged changes in rules on treatment of indebted farmers.

This is a small snapshot of the long record that our group has assembled over the past 35 years, and we are very proud of it.

Phil Olsson and Rick Frank on 35 Years of Life at OFW

By Philip C. Olsson and Richard L. Frank

Phil: Rick, it’s hard to believe that 35 years have passed since we started this firm as a two-lawyer shop in 1979.

OFW Logo 35th AnniversaryRick: It sure is. I remember working with you at the law firm I joined fresh out of the University of Michigan Law School, and which you had joined several years earlier out of the USDA, where you had been Deputy Assistant Secretary for Marketing and Consumer Services.

In 1979, I was 28, with little experience. You were 40, and a well-known fixture in the agriculture and FDA bar. We decided to take a giant leap of faith and started Olsson and Frank. We persuaded Anita Harris to join us as our all-purpose support staff.

Phil: Our initial clients were food and agriculture companies and trade associations, including American Feed Manufacturers Association [now American Feed Industry Association], National Turkey Federation, Pacific Coast Meat Association [now North American Meat Association], The Quaker Oats Company, and Pueblo International.

Rick: Amazingly, many of those clients from 35 years ago are all still our clients today. We appreciate their loyalty and support over the years.

Phil: Today, food and agriculture are still a major part of our practice. But our practice has evolved and grown to include a wide range of industries regulated by USDA and FDA. We are still primarily a regulatory and counseling practice, with litigation capability.

Rick: We have had some notable successes from the outset.

Phil: Our first big challenge involved the National Turkey Federation, defending recently adopted USDA labeling regulations for “turkey ham,” which was allowed as a product name as long as it was qualified by the phrase “cured turkey thigh meat.” Two meat industry associations challenged that regulation. Before the District Court in Norfolk, we had a particularly unsympathetic judge, who began his opinion with an excerpt from Lewis Carroll about “when pigs have wings.” Fortunately for our client, the Fourth Circuit agreed with us and upheld USDA’s regulation. That win showed that our small firm was a feisty advocate. No one has ever doubted that Rick can be feisty, but that victory showed that our small firm had been inoculated with his feisty DNA.

Rick: The “turkey ham” case was important for the food industry, because it allowed product innovation to proceed without artificial constraints on product names. Along the same vein, for years we successfully fought off efforts by the dairy industry to demonize “imitation cheese” used as an ingredient in a wide variety of refrigerated and frozen meat-topped pizzas regulated by USDA.

Two other victories come to mind. We successfully got “Fresh Choice” orange juice and “Fresh Italian” pasta sauce off the market. Those products, which were made from previously processed, heat-treated concentrates, were anything but “fresh.” We also helped get approvals for lean, finely textured beef, a highly innovative, nutritious, and lower cost meat component widely used in ground beef and related products. (Note: Unfortunately, a disgruntled USDA employee, a “mommy blog,” and a national TV network disparaged this wholesome product as “pink slime” several years ago.)

Phil: One of my favorite clients was an egg distributor. On a trip with him to Cuba, we got to spend about five hours with just Fidel Castro, Castro’s trade director, and Castro’s interpreter. We heard Castro talk at length about improvements in Cuban literacy and life expectancy that had taken place since he took power in 1958. I have a treasured photo of me with El Presidente in my office.

Rick: It’s been a great 35 years, with lots of interesting matters. From the beginning, we always worked hard, tried to develop “creative solutions to difficult problems,” and fought to win our cases. We charged fairly for our services and worked in a very collegial environment. We still follow those guiding principles, which have served us well.

Phil: Indeed, those principles have worked well for us, as we have grown and prospered over the years.

Rick: In our early days, I was usually the youngest person in the room; Phil, you were the tallest. Today, I am often the oldest person in the room, but you are still the tallest. Some things change; some things don’t.

Thirty-five years have sped by. You, Anita, and I are all grandparents. The firm has grown, slowly but steadily, from two lawyers to almost 40 lawyers and Policy Advisors today.

Phil: In the beginning, you and I quickly realized we needed someone with more FDA expertise. In 1981, we were extremely fortunate to be joined by David Weeda, who had worked in FDA’s Office of Chief Counsel. David’s practice focused on drugs and biologics.

Next, Dennis Johnson joined us in 1982 after completing a Food and Drug Law Institute internship with FDA’s Office of Chief Counsel. He rapidly developed a practice representing packing and processing firms on their individual issues with USDA’s Food Safety and Inspection Service. Despite government warnings on each cigarette package, DJ has never been able to give up his Lucky Strikes, and he developed close friendships with a number of FSIS decisionmakers while sharing their smoking breaks.

Rick: David was responsible for recruiting his former FDA Office of Chief Counsel colleagues, Arthur Tsien and Steve Terman, to join us. Both have fit in very nicely. Today, Arthur is the head of our drug practice and our animal food and animal drug practice, while Steve heads our medical device practice.

Phil: Marshall Matz and I have known each other since the days when he was counsel for Senate George McGovern’s Hunger Subcommittee and I was working on hunger issues for the Nixon Administration at USDA. Marshall joined us in 1992 and has built a world-class policy and lobbying practice.

Rick: Marshall’s practice fit in neatly with the non-lawyer Senior Policy Advisors that have joined us over the years. The first was John Block, President Reagan’s first Secretary of Agriculture and the youngest member of the Reagan Cabinet. Jack is to-this-day a corn and hog producer and before coming to Washington he had been the Illinois Secretary of Agriculture. We also have former Congressman Charles Stenholm. Charlie had been the leader of the Blue Dog Coalition in the House, a group of moderate Democrats who worked to build bipartisan consensus.

We are also pleased to have Dr. Barbara Masters, a veterinarian and a former (non‑smoking) Administrator of FSIS. Barb began working for USDA straight out of vet school and burst through several (age and gender) glass ceilings to become FSIS Administrator before she was 40.

Phil: And we’re privileged to have had many other talented individuals join us over the years.

Rick: Absolutely. We have the O’Flaherty Brothers from Chicago. Michael heads our food practice. Neil is a stalwart in our medical device practice. David Durkin and Tish Pahl are an important part of our drug practice. Brett Schwemer and Jolyda Swaim are part of our meat and poultry practice, while Evan Phelps works on medical device matters. Jon Weinrieb is our resident maven on medical privacy. We added Gary Baise and his team to work on agriculture-related litigation. Bob Hahn works on food matters. There are others, of course.

Phil: David Weeda is an “almost founder” of this firm. Unfortunately, David succumbed to lymphoma at an all-too-early age in 2001. We are now fortunate to have a next generation Weeda, David’s son Mason, as one of our up-and-coming associates.

Just as we were in the process of moving our offices to The Watergate in 2011, Marshall persuaded his old friend and mentor Senator McGovern to join us as a Senior Policy Advisor. Marshall liked to point out that we had brought Senator McGovern back to The Watergate. The Senator remained one of us until he passed away.

Rick: In 35 years, much has changed, but much remains the same. We are still a relatively small, quirky boutique, specializing in food, agriculture, drugs, devices, and related litigation.

Phil: Along the way, we’ve done many different kinds of things. Rick has been heavily involved in community activities as the founder of the Lawyers Have Heart 10K foot race and fundraiser, which has raised millions of dollars for the American Heart Association during the 25 years of its existence. He has also worked closely with a number of consumer organizations, building credibility to obtain consumer support for some of our client causes.

In the 35 years since 1979, our country has been led by six presidents. We have seen many of the national and international mega-law firms stumble and disappear. From the beginning, our firm has been fortunate to have had Rick’s prudent management skills, which I believe he absorbed while watching his parents and grandparents run a small family business. Thirty-five years at OFW has been a great ride with a great group of people, both those within the firm and those on the outside, the clients who have made it all possible.

Rick: It sure has been a great ride and it’s not over. We are in the process of grooming tomorrow’s leaders. I still love my view of the Potomac from my office in the Watergate Building – the planes and helicopters and boats coming and going. Our cases were and are challenging and interesting. Washington is a wonderful place to work and raise a family.

On to the future!

Data Driven Decision Making by Dr. Doom

By Barbara J. Masters, D.V.M.

When asked to visit an establishment to assess compliance, my first step is always to ask for data.  Establishment food safety data, laboratory results, regulatory data, audits…. What story is being told?  Is there a trend in the making?  Upward trend?  Downward trend?

It is important for establishments that are regulated by the Food Safety and Inspection Service (FSIS) to recognize that the Public Health Information System (PHIS) provides a tool for the Inspection Personnel to understand what (using data) is happening on a day to day basis at our facilities:

  • Lab data
  • HACCP compliance/non compliance
  • Sanitation compliance/non compliance.

In the past, FSIS relied on managers to generate “alerts” or flag data trends in the PHIS.  However, there is now enough data in PHIS that the system will “send” alerts to inspection program personnel when the data suggest a trend is developing at an establishment that warrants further review.

For example, the Agency focuses on data related to public health NRs for HACCP and sanitation non-compliances.  The Agency has indicated that for 2015, the “cut point” for public health NRs in processing establishments will be 6.55% and in combination (or pure slaughter) establishments, it will be 9.37%.  Establishments that experience higher noncompliance rates than these can expect that the inspection personnel will receive “alerts” within PHIS indicating the need for additional verification.

FSIS also is using the PHIS data to schedule Food Safety Assessments and Hazard Analysis Verification tasks.

As FSIS supervisors are “looking into the system” and gaining a better understanding of what is happening at establishments based on our data, are we doing the same?

  • Are we reviewing our own data?
  • Do we track trends and take actions based on the findings?
  • Have we signed up for PHIS-industry access?
    • A report for public health NRs will be available beginning November 16th.
  • Do we know where we are relative to the FSIS “cut points” for public health NRs?
    • What is our HACCP compliance rate?
    • SSOP compliance rate?
      • If we have had failures, have they been for a specific area, e.g., failing to maintain records?
      • Do we have similar findings in our own data?

I encourage you not only to maintain the necessary records, but to review them and use the data to improve your processes.  The only thing worse than having information and not using it, is having the regulatory agency use it “for” you.

About “Dr. Doom”

Mixed in with the attorneys at OFW Law is the former USDA Food Safety Inspection Service’s (FSIS) Administrator, Dr. Barbara Masters.  Dr. Masters is a veterinarian who spent eighteen years with FSIS – the final three years as Acting Administrator and Administrator.  During her rise to the Administrator’s position, Dr. Masters served as the Deputy Assistant Administrator for Office of Field Operations.  While in these key leadership positions at FSIS, Dr. Masters’ primary focus was on the implementation of science-based policies for the protection of public health.  Dr. Masters issued the initial Federal Register Notices for a systematic approach to humane treatment of livestock and poultry.

Dr. Masters was involved in the drafting of the training of inspection personnel on the Hazard analysis and critical control points (HACCP) and Sanitation Standard Operating Procedures (SSOP) regulations.  She was the lead of the FSIS HACCP Hotline.  In addition, Dr. Masters provided technical review for establishment’s hazard analysis, HACCP plans and supporting documentation.  She started her career at FSIS as a public health veterinarian that had responsibilities for ante-mortem inspection, sanitation inspection and all post-mortem inspection responsibilities.  She has a good understanding of what happens at the in-plant location, because she has spent many of long days working there.

Export Certificates for FDA-Regulated Foods Containing Egg Products as an Ingredient

By Michael J. O’Flaherty

The USDA’s Food Safety and Inspection Service (FSIS) plans, effective November 10, 2014, to halt issuing export certificates for FDA-regulated foods that contain an egg product(s) as an ingredient because USDA’s Agricultural Marketing Service (AMS) now provides this service.

FDA regulates the safe production, sanitary processing, and labeling of food products containing egg products.  Nevertheless, since it assumed responsibility for conducting the federal egg products inspection program from AMS on May 28, 1995, FSIS has been issuing export certificates of wholesomeness for prepared or manufactured food products that contain egg products as an ingredient.

On April 3, 2013, AMS announced the establishment of the Processed Egg and Egg Products Export Program.  The AMS program pertains to FDA-regulated, further processed eggs and egg products and composite foods containing egg products.  Pursuant to a Letter of Agreement between USDA’s Foreign Agricultural Service and the Office of International Affairs at FDA, AMS was provided with the authority to perform onsite verification of public health certification statements and issue export certificates on a fee for service basis.  The extent of the onsite verification process is directly related to the complexity of the certification statements required by the foreign country of destination for the food product.

Establishment of the export certification program is intended to allow U.S. processors access to expanding global markets, supporting AMS’ goal of promoting the marketing of U.S. agricultural products.  Companies interested in requesting the service should file an application with AMS.  Once the application is submitted, AMS will determine the import requirements of the foreign authority(s) for the food product(s) identified in the application.  AMS has established a program for verification of the source of the eggs and egg products used in the production of the food products identified for certification.  Additionally, AMS will verify that the product was produced in a processing facility in accordance with good manufacturing practices under sanitary conditions to certify that the products are fit for human consumption, as well as that the product meets the foreign government import requirements.  The verification of a product will require a minimum of two onsite visits per year.  If AMS determines that a company meets the established certification requirements, the company will be listed as eligible for export by product and country.  An eligible company then may contact AMS for an export certificate covering an accepted product(s) and identifying the foreign country.

Prior to shipping certified food products, exporters should have their importers confirm that the foreign country will accept AMS’ certification statements.  Additional packaging and labeling requirements also may need to be addressed with the importer before the food product will be allowed into the foreign country.

If you are an exporter of a FDA-regulated food that contains an egg product as an ingredient and need an export certificate(s), you should engage the AMS soon.  Please feel free to come to us with any questions related to AMS’ new verification and export certification program.

Ms. Gloom Wants to Know: Does Your Product Hold Program Really “Hold” When Needed?

By Jolyda O. Swaim

Anyone who has been involved in the quality assurance and food safety side of the food business for any length of time knows that one of the top items on the list of those that will keep you awake at night is whether or not your product “hold” or retention program will be effective in preventing the shipment of product when needed.  Product can be held for a number of reasons and many of the reasons can be the trigger for a recall if for some reason the product is shipped.  I had it happen to me at several different companies for several different reasons.  Unless the product is physically “locked up” and you have the only key, you need to ensure you have as many hurdles as possible in place to: (1) account for all product on hold, and (2) make it as difficult as possible to “accidently” ship the product.

It is also important that the correct product is on hold – but that topic will be discussed in a separate blog.

Reasons Why Product May Be Held

Companies have hold or retention programs to retain products for a number of reasons.  Product may be retained – usually by the QA department – for quality reasons that don’t affect the safety of the product, but don’t meet the customers’ or your specifications.  If this product is “accidently” shipped, you may have unhappy customers or consumers but there is no food safety risk and the product does not violate any regulatory requirement.  However, your customer’s brand or your brand could suffer if this happens too many times.

Products held for regulatory violations or food safety reasons are the ones which will get you in trouble if your hold program is treated as an afterthought – especially when the warehouse or distribution center is looking at filling orders.  Product might be held because its labeling is wrong; for example, it doesn’t declare an allergen.  Other reasons include that you or a government agency tested the product or a food contact surface for a pathogen such as Listeria monocytogenes or Salmonella. In fact, when FSIS takes a sample, it is a regulatory requirement that you hold the product until the results are obtained.

If you are a FSIS-inspected establishment, you might also have product on hold because the FSIS inspector has placed a retain tag on the product.  In these situations – whether or not the product is held for a food safety reason – violation of the FSIS retain tag brings on another whole set of problems for you of which a recall maybe the smallest!

What Makes a Robust Hold Program? 

Accurate Inventory

A robust hold program needs a number of hurdles to allow you to sleep at night when there is product you absolutely do not want to leave your control.  Regardless of whether the hold is for quality or food safety reasons, all should begin with an accurate inventory of the amount of product being placed “on hold.”  If this is a hold to control product that a FSIS inspector has also tagged, make sure the product is inventoried with the inspector and you both agree on the amount.

It is important to have a written document or computer-generated form where the product details are recorded.  This should include the product name, product code, date of hold, reason for the hold, the person placing the product on hold, and quantity.  When product is released, the disposition and the number of cases released should be recorded.  If cases are pulled from the hold for testing or any other reason, these also need to be noted.

Contain the Product

Many times the effectiveness of the hold can be determined by the amount of product you need to hold.  For example, if you have several cases of product or maybe even several pallets, you may have a retain cage where these can be placed under lock and key – with you holding the key.  But there are few areas that are large enough to hold a day’s production or more under a physical lock and key.  One way to hold the a large amount of product is to load it on a refrigerated trailer, lock the door, chain the trailer to an unmovable object, and keep all keys! I know at least one General Manager who did this to ensure she could sleep at night and know that no product would “accidently” disappear.   However, there have been a few isolated cases where entire trucks have been stolen so this should also be a consideration!

If the product is being held for food safety reasons and the product cannot be held under lock and key, have it inventoried daily to ensure it is all there.  Document this check.  Many companies with computerized inventory systems have the ability to “lock-out” any hold product from being visible by the warehouse personnel that are filling orders.  This is one good hurdle, but it is important that the product actually be “locked out” in the system or it might still get shipped.  Keep in mind that the product is still physically visible, so make sure you also have visible hold tags on it.

Companies should also ensure that the physical product has hold cards visible to fork truck drivers.  Use large, bright tags, and also bright hold tape such as that used for crime scenes, to tape off the racks.  And if the hold tag is not on the side of the pallet that the driver can see, it does no good; place visible tags on each side of the pallet to prevent the excuse that “didn’t see the tag.”  And again, inventory the product daily to be sure none of it has walked away.

If you are holding product at a public warehouse, you must work with the warehouse to ensure it has a robust hold program.  Make sure that your personnel controlling the product at that location understand the need to ensure the program works.  It is always preferable to keep the hold product at your location where you have control.

Follow the Program

Companies should also make sure that any product on hold is properly released with the hold tags removed and disposition documented.  If no one in the QA department takes the time to remove the tags and you allow just anyone to do so, you have just diluted the effectiveness of your program.  If no one documents disposition and release of product, you have also diluted the effectiveness of your program.

You should also mandate that the product hold inventory is reconciled regularly.  Hold people accountable for violations of the program.  Of course, this can only be done after you provide appropriate training on the program to everyone.  Hold tags, both QA and FSIS, must be respected if you have any chance of ensuring that when product must absolutely remain under your control; that it will.  Remember that Murphy’s Law is always working against you and if product is easy to ship when on hold, it will happen!

About “Ms. Gloom”

In the attorney ranks at OFW Law, there is only one who would raise a hand if all were asked if they had any “hands-on” experience in the operation of a Townsend “Frank-O-Matic” hotdog maker, producing bean sprouts for use in egg rolls or in managing a food facility sanitation crew.  In fact, there are probably no attorneys out there who could raise their hands except Jolyda Swaim.

Prior to law school and OFW Law, Ms. Swaim spent years in the food industry, beginning as a microbiologist and Quality Assurance technician.  In these years, she had direct charge of quality assurance, production, sanitation and consumer affair departments at various companies producing products from pickles, sauerkraut and barbeque sauce, to various meat and poultry products, to frozen entrees, egg rolls and pizza to spices and spice blends.  Her last position at Sara Lee as Director of Food Safety had her auditing its facilities in the United States and Mexico to ensure facilities producing ready-to-eat products were following best practices in sanitation and product handling.