- Delivery Method:
- VIA UPS
- Animal & Veterinary
Recipient NameMark G. Mann
- Christoferson Meat Company Inc. dba Raws for Paws LLC
2700 26th Avenue South
Minneapolis, MN 55406
- Issuing Office:
- Center for Veterinary Medicine
October 26, 2018
In reply, refer to: WL CMS 555466
Dear Mr. Mann:
In January 2018, the Minnesota Department of Agriculture ("MDA") and the Minnesota Department of Health ("MDH") investigated two reported cases of salmonellosis in children. One of these children was hospitalized with a severe bone infection. The investigation determined that the children's pet ate your Ground Turkey Food for Pets product, which contains raw turkey, manufactured on October 12, 2017. MDH also collected clinical samples from the two sick children on January 18, 2018 and January 25, 2018. Subsequent testing of the clinical samples found that they were positive for Salmonella Reading.
On January 31, 2018, MDA contacted the United States Food and Drug Administration (FDA or "we") and the Centers for Disease Control and Prevention (CDC), who joined the investigation. On the same day, MDA collected four frozen, unopened samples of your Ground Turkey Food for Pets product, manufactured on October 12, 2017, from the children's household. All four samples tested positive for numerous Salmonella strains, including Salmonella Reading. Whole Genome Sequencing (WGS)1 analysis was conducted by MDH on the Salmonella Reading isolated from the children and the Salmonella Reading isolated from the product samples. On February 5, 2018, MDA informed you that the Salmonella Reading isolated from your raw pet food products matched the Salmonella Reading isolated from the sick children. The CDC reviewed the WGS analysis of these Salmonella Reading strains prepared by MDA and their review confirms the link between your Ground Turkey Food for Pets product and the human illnesses.
The presence of Salmonella or other pathogenic bacteria in pet food may result in serious adverse health consequences to animals consuming the pet food and/or humans handling the pet food. Therefore, based on the WGS analysis and the positive sample results for Salmonella Reading in your Ground Turkey Food for Pets manufactured on October 12, 2017, your products are adulterated within the meaning of section 402(a)(l) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they bear or contain a poisonous or deleterious substance which may render such products injurious to health. The introduction or delivery for introduction into interstate commerce of an adulterated food is a violation of section 301(a) of the Act [21 U.S.C. § 331 (a)]. You may find the Act and FDA's regulations through links on FDA's homepage at www.fda.gov.
In response to the Salmonella Reading results, your firm initiated a recall on February 5,2018 of all affected raw turkey pet food products that were manufactured on October 12, 2017. The FDA designated this recall as Class I, based on a reasonable probability that the use of, or exposure to, such products will cause serious adverse health consequences or death (see 21 CFR 7.3(m)(1) and 21 CFR 7.41). On February 6, 2018, your company filed a Reportable Food Registry report with FDA.
Public Health Impact of Pathogens
Unlike other pet foods which are heat-treated or intended to be cooked, your pet food products present particular hazards to human and animal health because they contain uncooked animal proteins in a ready-to-eat product. Raw pet food is produced with minimal processing and is intended to be handled by humans and fed to animals without cooking, that is, without measures routinely used to kill potentially harmful pathogens. It is therefore essential that your firm has measures in place to prevent and reduce pathogenic contamination of your products and facility.
Salmonella is a pathogenic bacterium that can cause serious and sometimes fatal infections in both humans and animals. Pets like dogs and cats may get Salmonella infections from eating contaminated pet foods. People may also contract Salmonella infections from handling these contaminated pet foods, or having contact with infected pets or their feces. Infections can be especially serious in young children, elderly people, and others with weakened immune systems. Healthy individuals, as well as pets, may suffer short-term symptoms such as severe diarrhea, bloody diarrhea, fever, chills, abdominal discomfort, and vomiting. FDA considers a pet food to be adulterated when it is contaminated with Salmonella and will not undergo a commercial heat step or other commercial process to kill the Salmonella, as expressed in FDA's Compliance Policy Guide (CPG) Salmonella in Food for Animals, CPG Sec.690.800, https://www.fda.gov/downloads/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm361105.pdf.
Proposed Corrective Actions
We received your written communication regarding the February recall, dated March 8, 2018. In that response, you stated that you will be (b)(4) for ground turkey pet food and ground chicken pet food from (b)(4). However, we are unable to evaluate the adequacy of your proposed corrective actions, as your response lacks important specific details to demonstrate that the measures described wil1 be effective to control or reduce the presence of pathogens in your raw pet food products. Further, we note any substance that is reasonably expected to become a component of food is a food additive that is subject to premarket approval by FDA, unless the substance is generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use, or meets one of the other exclusions from the food additive definition in section 201(s) of the FD&C Act. (b)(4).
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product(s). You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
In addition to the above violations, we have the following comments:
Please note that facilities that manufacture, process, pack, or hold animal food for consumption must register as a food facility under section 415 of the Act, and are thus subject to Current Good Manufacturing Practice requirements (CGMPs) for food for animals (21 CFR part 507, subpart B), unless an exemption applies. Animal food that is not manufactured, processed, packed, and held in accordance with CGMPs may be considered adulterated (21 CPR 507.1(a) (1) (i-ii) and sections 402(a)(3) and (4) of the FD&C Act). Please see FD A's Guidance for Industry #235, Current Good Manufacturing Practice Requirements for Food for Animals, at https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM499200.pdf.
In addition, most of these facilities must also comply with hazard analysis and risk-based preventive controls requirements (21 CFR part 507, subparts C and E), unless an exemption applies (21 CFR 507.5). To comply with the preventive controls requirements, these finns must develop and implement a food safety plan. Specifically, a preventive controls qualified individual (PCQI) must prepare, or oversee the preparation of, a written hazard analysis to identify known or reasonably foreseeable hazards for each type of animal food produced at these facilities. The PCQI, or designee, must then evaluate the known or reasonably foreseeable hazards to determine if any hazards requiring a preventive control are present, and must implement preventive controls as appropriate to the animal food and facility. We note that Salmonella is a known and reasonably foreseeable hazard in raw meat pet food. For more information on this topic, you may refer to our draft guidance: Guidance for Industry #245, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, at https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Guidanceforlndustry/UCM592870.pdf.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to LCDR Elizabeth Edwards, Ph.D., Compliance Officer, 7519 Standish Place Rockville, MD 20855. If you have questions, you may contact LCDR Edwards at 240-402-8355.
Eric M. Nelson
Division of Compliance.
Center for Veterinary Medicine
1 WGS analysis of bacterial pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness.