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.

Hand Washing: A Simple Step

By Barbara J. Masters, D.V.M.

How many of you have ever sat in a public location, such as the airport, and watched the number of people that enter the restroom talking on their cell phone?  Creepy, huh?  Not nearly as creepy as the same number of people that exit a very short time later still talking on their cell phone.  I always question how they washed their hands.

According to the Center for Disease and Prevention (CDC), “Washing hands prevents illnesses and spread of infections to others.”  It is a simple step we can all take before, during, and after preparing food, before eating, after using the toilet or assisting a child use the toilet, after blowing your nose, coughing, or sneezing, after touching animals or animal food or animal waste, and after touching garbage.  Washing hands keeps them clean and prevents the spread of bacteria that can make people sick.

It is especially critical to wash your hands when preparing food to prevent the spread of common foodborne bacteria such as E. coli O157:H7 and Salmonella.  To wash your hands, use soap and warm water and lather your hands for at least twenty seconds.  It is important to get the back of your hands, between fingers and under your nails.  If you are not certain how long twenty seconds is, hum “Happy Birthday” two times while washing.

If you are out on a picnic or do not have access to soap and water, then use of a hand sanitizer can be substituted.  If you must use a sanitizer, first wipe hands with a paper towel or a napkin to remove the visible dirt.  Then apply the sanitizer and rub hands together until the sanitizer dries.

The CDC has promotional materials that can be utilized to encourage hand washing at your work site or in schools.  Clean hands are a simple step we can all take to improve public health.

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.

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

FSIS 2014 Annual Performance Plan

By Barbara J. Masters, D.V.M.

FSIS issued their 2014 Annual Performance Plan as a tool to document specific targets for 2014.  In reviewing the plan for FSIS, it is clear that there is one main target for this food safety regulatory agency: Salmonella.

The plan contains eight “goals,” and the steps that FSIS plans to take to meet these goals.  Each of the eight key goals is addressed as to the specific actions to be taken and the expected results.  It is organized in a few ways, but probably most easily viewed by FSIS Program Area.

Highlights from this year’s plan include FSIS’ intent to modernize poultry slaughter inspection, along with the idea of using a meat industry survey to develop economic analysis for a beef slaughter proposed rule consistent with the poultry slaughter modernization regulations.

That said, the focus is Salmonella.  One FSIS action item is the completion of hazard analysis verification (HAV) and food safety assessment (FSA) procedures in at least 75 percent of the eligible comminuted poultry operations.  The agency has also committed to evaluation of research and data on lymph nodes and institution of sampling of all raw beef for Salmonella.  In addition, FSIS will develop verification procedures for sanitary dressing of hog carcasses, as well as assessing whether FSIS’ existing policies on Salmonella are being effectively implemented.  Consumers will find initiatives associated with Salmonella as well.  FSIS will work on ensuring consumers use thermometers continue to proactively change behavior.

It should be noted the entire plan is not limited to Salmonella.  FSIS considers non-O157 STEC, humane handling, food security and other important issues.  But no one will question the Agency priority when reviewing this plan, and that is the reduction of Salmonella in FSIS-regulated products.

Before joining OFW Law, Dr. Masters served as Acting Administrator and then Administrator for the United States Department of Agriculture Food Safety and Inspection Service (FSIS) from March 2004 through January 2007.

Increased FDA Testing of Pet Foods May Provide More Support for the FSMA Proposed Rule on “Preventive Controls for Animal Food”

By Jolyda O. Swaim

When I was growing up on a farm in Pennsylvania, my twin sister and I always savored the sweet feed that we fed to our horses.  We would also occasionally “chew on the oats,” but Sis and I never found our way to eating the dog or cat food.  This was not the case, however, with my son and my nephew—who always tasted the dog and cat food!  At the time, I never thought much of the kids eating the pet food.  Looking back, I realize that we were all very lucky we did not get ill.  While animal food is technically supposed to be free from pathogenic organisms, recent outbreaks prove this is not always the case.

Recently, the FDA’s Center for Veterinary Medicine (CVM) issued a nationwide field assignment to collect samples of domestic pet foods (not including canned pet foods), pet treats and pet nutritional supplements to be analyzed for SalmonellaSee

The CVM issued this assignment because of its concern “about animal feeds serving as vehicles for transmitting pathogenic and antibiotic-resistant bacteria.”  There have been a number of large outbreaks linked to various pet treats and feeds in the past several years – in the United States as well as Canada.  In 2012, an outbreak of Salmonella infantis was linked to dry dog food produced at a facility in South Carolina with 49 associated illnesses.

In the assignment, the Director of the Office of Surveillance and Compliance indicates that Districts are to immediately initiate procedures to remove any pet foods found positive for Salmonella, alert the manufacturer to take corrective action, and recommend the issuance of a Warning Letter.  In addition, investigations of the facility are to occur within 90 days of the confirmation of a positive Salmonella sample.

The above concerns – especially if there are positive product tests and related recalls – provides further support of the need for FDA’s soon-to-be issued proposed rule on Preventive Controls for Animal Food which implements a portion of the Food Safety Modernization Act (FSMA).   The proposed rule is expected to closely mirror the proposed rule for Preventive Controls for Human Food published on January 16, 2013.   In fact, my understanding is that the only notable differences will be that the proposed rule for animal food would establish cGMP’s, would not address allergens, and might have different definitions of a “very small business.”

Based on this information, it would be prudent for any manufacturer of pet treats or foods to spend time now reviewing the proposed rule for Preventive Controls for Human Food, and begin putting together their preventive controls plans based on what is in that proposed rule.  While FDA estimates there are almost 4,500 manufacturers of pet foods and treats, it believes that about 4,440 would be considered small (less than 500 employees) or very small.  Knowing where many small FDA-regulated human food manufacturers are in understanding and developing preventive controls plans, I would expect small pet food manufacturers are even further behind.  With FDA now out in the field testing, many may find they will have a much earlier “deadline” on addressing pet food or treat safety.

USDA-FSIS’ “Test and Hold” Policy

By Jolyda O. Swaim

On February 8, 2013, the United States Department of Agriculture’s Food Safety and Inspection Service’s (FSIS) policy on “Test and Hold” will go into effect.  This policy requires “official establishments and importers of record to maintain control of product tested for adulterants by FSIS and not allow such products to enter commerce until negative results are received.”  The Federal Register publication outlining FSIS’ final policy may be viewed here.

In the past, while FSIS had encouraged establishments to hold product pending receipt of FSIS test results for adulterants, it had not required companies to hold product under their control until FSIS negative results were received.  Many establishments did not follow this guidance and subsequently had to initiate recalls of product shipped in commerce due to positive results.  FSIS adopted its new policy to prevent future recalls due to a company’s unwillingness or inability to hold product pending test results.

It is important to note, however, that FSIS’ new policy only applies to FSIS testing for adulterants and not to establishment testing for adulterants.  However, FSIS continues to advise all establishments to hold product pending their own testing for adulterants.

The FSIS has identified the following adulterants as covered by the policy:  (1) Salmonella, Listeria monocytogenes, E. coli O157:H7 and Non-O157:H7 STEC on ready-to-eat products, (2) E. coli O157:H7 and the six (6) Non-O157 STEC on raw non-intact beef products or products intended for such use, (3) Listeria monocytogenes on food contact surfaces or ready-to-eat products, (4) residues of veterinary drugs or carbadox in livestock and (5) economic adulterants.  If FSIS tests product for one of these adulterants, FSIS would expect the establishment to have documentation and support that the product is controlled pending the results.

However, this does not mean the establishment cannot move the product to another location pending the test results.  The establishment would have to show the product is still within its control as a result of measures such as company seals or “other adequate controls.”  The establishment would also have to demonstrate that it has not yet completed its pre-shipment review of the product represented by the test results, as FSIS will deem this to mean that the product is in commerce and no longer held.

If product is shipped pending FSIS adulterant testing without adequate controls, FSIS would take the position that the establishment shipped uninspected and possibly adulterated product and would likely take enforcement actions, including suspension of inspection or issuance of a Notice of Intended Enforcement – besides requesting a recall of the affected product.  So, come February 8th, it is important that establishments have written procedures and documentation in place to ensure that any product sampled by FSIS for an adulterant is held and that the pre-shipment reviews for these products are not completed until negative FSIS results are obtained.

Updated FSIS Guideline Refocuses Attention on Listeria Control

By Brett T. Schwemer, as published in the October 2012 issue of The National Provisioner.

This summer, the focus of the U.S. Department of Agriculture’s (USDA) Food Safety Inspection Service (FSIS) has clearly been on the control of Shiga-toxin producing E. coli and Salmonella in certain raw meat or poultry products.  However, a recent FSIS Notice announcing the availability of a revised FSIS Listeria Guideline should serve as a reminder that control of Listeria monocytogenes (L.m.) in post-lethality ready-to-eat (RTE) meat and poultry products continues to be a high priority for the agency.

The revised Listeria Guideline replaces previous versions of the Guideline and Q&As (last updated in 2006), and provides recommendations that establishments producing post-lethality RTE products can follow to meet the requirements of 9 C.F.R. Part 430 (the Listeria Rule).  Although the revised Guideline does not contain any major changes to previous recommendations, it has been reformatted and expanded to assist establishments in complying with the Listeria Rule.  Key expansions include:

  • A new appendix (Appendix 2.1) regarding validation of post-lethality treatments and antimicrobial agents;
  • A detailed description of the type of escalated actions that establishments can take during intensified cleaning and sanitation following positive Listeria samples (pg. 2-48);
  • A new appendix (Appendix 2.3) providing suggested employee training programs for implementing the Listeria rule;
  • FSIS’ expectations for Listeria sample collection and laboratory analysis (pgs. 3-9 to 3-12); and
  • Recommendations for identifying and addressing Listeria trends (pgs. 4-8 to 4-9).

FSIS also announces in the Guideline that the agency intends to increase the number of product samples it takes under its routine Risk-based L.m. (RLm) and intensified verification testing (IVT) programs from 3 to 5 samples per sampling unit and intends to composite the five 25 g product samples, increasing the analytical test portion from 25 g to 125 g.  As this will certainly increase the possibility of FSIS finding positive L.m. product results, it is imperative that establishments now take the time to review the revised Guideline carefully and reassess their Listeria control programs to ensure they are doing everything possible to detect, and eliminate, Listeria in their post-lethality environments.

Based on our experience, establishments should pay particular attention to two aspects of their Listeria control program.  First, they should ensure that the frequency and amount of sampling in their post-lethality RTE environment is adequate to detect Listeria that may be present (even if this means surpassing the minimum recommendations in the Guidelines). Establishments will be better off from a regulatory perspective if they find (and eliminate) Listeria before FSIS does.   Second, establishments need to ensure they have procedures in place to identify the potential root cause for each Listeria finding and take corrective and preventive actions based on the potential cause.  Too many establishments simply “clean and sanitize” when Listeria positives are found without identifying a potential cause.  Adequate preventive actions can only be taken when a cause is identified and eliminated.  Establishments should also follow the advice contained in the Guideline for identifying and adequately addressing Listeria trends in their plants.