Inspections, Compliance, Enforcement, and Criminal Investigations

Environmental Trade Inc. 9/4/18

 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Human and Animal Foods -
Division Ill East
60 Eighth Street N.E.
Atlanta, GA 30309

 

VIA UPS OVERNIGHT DELIVERY

September 04, 2018
 
 
Dean A. Lea, CEO/Owner
Environmental Trade Inc.
106 Maddox Road
Eatonton, Georgia 31024-6009
 
WARNING LETTER
 
Dear Mr. Lea,
 
 
On January 24, 2018, the U.S. Food and Drug Administration (“FDA” or “we”) received a complaint (“January 24 complaint”) from a consumer who reported the death of two kittens from Salmonella septicemia (confirmed by necropsy) after the kittens ate your Blue Ridge Beef (BRB) Kitten Grind for Cats product. In response to this complaint, on January 30, 2018, FDA investigators collected from the consumer an unopened package of BRB Kitten Grind, Lot # GA 1102, manufactured on November 2, 2017 (FDA Sample #1038721). This sample was analyzed by an FDA laboratory and was positive for Salmonella and L. monocytogenes. The FDA laboratory also conducted Whole Genome Sequencing[1] analysis of Sample #1038721 and diagnostic samples collected during the necropsy of one of the kittens that died after eating your product. This analysis revealed that the Salmonella found in the kitten’s spleen, kidney, and small intestine was identical to the Salmonella isolated from BRB Kitten Grind for Cats, FDA Sample #1038721, demonstrating that your BRB Kitten Grind product was the source of illness.  
 
Also, in response to the January 24 complaint, FDA conducted an inspection of your raw pet food manufacturing facility at 106 Maddox Road, Eatonton, GA, on March 6 through 8, 2018. During our inspection, FDA collected an unopened package of BRB Complete, Lot # (b)(4), manufactured on January 31, 2018 (FDA Sample #1002024). This sample was analyzed by an FDA laboratory and was positive for Salmonella and L. monocytogenes.  We also collected an unopened finished product sample of BRB Kitten Grind for Cats, Lot # (b)(4), manufactured on February 8, 2018 (FDA Sample #1002025).   The sample was analyzed by an FDA laboratory and was found positive for Salmonella.  
 
The presence of Salmonella, L. monocytogenes 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, as discussed above, your Blue Ridge Beef Kitten Grind for Cats and Blue Ridge Beef Complete products are adulterated within the meaning of section 402(a)(1) 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.
 
After FDA notified you of the sample results, you recalled BRB Kitten Grind, Lot # GA 1102 and BRB Complete, Lot # GA 0131. The FDA designated these recalls as Class I, based onareasonable 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). You reported that you placed BRB Kitten Grind for Cats, Lot # GA 0208, on hold pending sample results and no portion of the lot was never distributed. 
 
Prior Samples
 
We note that your firm has had prior instances of contamination with L. monocytogenes, Salmonella and Escherichia coli, which indicates ongoing, persistent problems with your manufacturing processes and/or facility. Specifically, in November 2016, FDA received two consumer complaints regarding your products (BRB Kitten Grind and BRB for Dogs). We collected unopened samples of your products in response to these complaints and the table below summarizes the results.
 

Product
FDA Sample Number
Date Collected
Positive Results
BRB Kitten Grind
892533
11/14/2016
Salmonella, Escherichia coli
BRB for Dogs
977933
11/21/2016
Salmonella, L. monocytogenes
BRB for Dogs
915615
11/21/2016
Salmonella, L. monocytogenes
BRB Turkey w/ Bone
959477
12/14/2016
L. monocytogenes
BRB Beef Complete
959478
12/14/2016
Salmonella, L. monocytogenes

 
On June 15, 2017, we sent you an Untitled Letter (ATL-17-U02) notifying you of the results of the 2016 samples; we note that you recalled the lots that you had distributed. The FDA also designated this recall as Class I, based on areasonable 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).
 
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
 
Listeria monocytogenes is a pathogenic bacterium that poses an acute danger to human and animal health. It can proliferate in animal food processing facilities that are not properly sanitized. Handling or consuming these contaminated pet foods can lead to a severe, sometimes life-threatening illness called listeriosis. Pregnant women and people with weakened immune systems, including young children, the elderly, and immune-compromised individuals, are more vulnerable to these infections. Healthy individuals as well as pets may suffer short-term symptoms such as vomiting, diarrhea, and fever. 
 
Antimicrobial Treatments
 
During the FDA inspection in March 2018, you indicated that your firm uses a (b)(4) during manufacturing to reduce the presence of pathogens in your pet foods. 
 
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, meets one of the other exclusions from the food additive definition in section 201(s) of the FD&C Act, or is otherwise permitted for use in animal food. There is no food additive regulation that authorizes use of (b)(4) in animal food, and the agency is unaware of any data or information to demonstrate that the (b)(4) is GRAS under the conditions of intended use (i.e., as an antimicrobial agent). 
 
We received your written response, dated March 29, 2018, following the FDA inspection. In that response, you stated that you have expanded the use of your “active kill agents” during manufacturing, including the use of (b)(4). However, we are unable to evaluate the adequacy of your corrective action, as your response lacks important specific details showing evidence of the safety of your raw pet food products. Also, your response does not address whether you have determined these “kill agents” are in fact GRAS under their intended conditions of use.
 
We also note that you proposed several changes to your cleaning, manufacturing, handling, and processing practices. Some of these changes include but are not limited to updated cleaning procedures, sealing off the facility from outside environmental factors, cleaning throughout various stages of processing, the use of sanitizing foot baths at foot-traffic entrances, and test-hold procedures for final products. These corrective actions will be evaluated during our next inspection of your manufacturing facility.
 
Conclusion
 
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:
 
We note that your facility is subject to Current Good Manufacturing Practice requirements (CGMPs) for food for animals (21 CFR part 507, subpart B), which provide baseline food safety and sanitation standards for facilities manufacturing, processing, packing, and holding animal food.  Animal food that is not manufactured, processed, packed, and held in accordance with CGMPs may be considered adulterated (21 CFR 507.1(a) (1) (i-ii) and sections 402(a)(3) and (4) of the FD&C Act).  Please see FDA’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.   
 
Starting on September 17, 2018, you 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, you 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 hazardsfor each type of animal food produced at your facility.  The PCQI, or designee, must then evaluate the known or reasonably foreseeable hazards to determine if your firm has any hazards requiring a preventive control, and you must implement preventive controls as appropriate to your animal food and facility.  We note that Salmonella and Listeria monocytogenes are known and reasonably foreseeable hazards 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/GuidanceforIndustry/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 the 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:  U.S. Food and Drug Administration, 60 Eighth Street, NE Atlanta, GA 30309, to the attention of Janice L. King, Compliance Officer.  If you have questions, you may contact Ms. King at (843) 746-2990, Ext. 16.
 
 
Sincerely,
/S/ 
Ingrid A. Zambrana
U.S. Food and Drug Administration                                                                                                               
District Director, Atlanta District (GA-NC-SC)
Program Division Director, Office of Human and Animal Foods- Division III East
Office of Regulatory Affairs
U.S. Food and Drug Administration                                                                                                               


[1] Whole Genome Sequencing 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.

 

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