Delivery Method: VIA UPS Product: Animal & Veterinary

Unapproved Animal Drugs

Recipient: Recipient Name Gerald F. Smith, Jr. Recipient Title Chairman, President, & CEO Valley Proteins, Inc. 151 Valpro Drive

Winchester, VA 22603

United States Issuing Office: Division of Human and Animal Food Operations East II (HAFE2) 6000 Metro Drive

Suite 101

Baltimore, MD 21215

United States

Dear Mr. Smith,

On February 5 and 6, and April 3 and April 22, 2019 the U.S. Food and Drug Administration (FDA or “we”) conducted an inspection of your rendering plant located at 1635 Indian Hollow Road, Winchester, Virginia 22603. Your rendering plant produces animal food ingredients distributed to animal food manufacturers. At the conclusion of the inspection you were issued a Form FDA 483, Inspectional Observations. This letter notifies you of the significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our inspection of your operation. We have reviewed your response to the Form FDA 483 and we discuss your significant violations and your corrective actions below.

As explained below, the presence of pentobarbital in your animal fat products causes these products to be adulterated because the animal food contains an unsafe new animal drug. The drug is unsafe because it was not used in conformance with the drug approval, which does not have a tolerance established for the presence of pentobarbital in the edible tissues of animals. In addition, our inspection found you violated FDA’s Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls requirements for animal food, which causes your products to be adulterated. It is a prohibited act to introduce or deliver for introduction into interstate commerce any food that is adulterated or misbranded.

You may find the Federal Food, Drug, and Cosmetic Act and FDA’s regulations through links on the FDA’s website at www.fda.gov. Animal Food Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls (PCAF) requirements are in 21 C.F.R. part 507. In addition, draft guidance on the animal food Preventive Controls requirements can be found in CVM Guidance for Industry # 245, “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals”, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-245-hazard-analysis-and-risk-based-preventive-controls-food-animals.

Adulteration Due to the Presence of Pentobarbital

Pentobarbital sodium is a drug approved for anesthetizing certain animals. There is no established tolerance for the residues of pentobarbital in animal tissues. Therefore, when used in food-producing animals, it can render the tissues of those animals adulterated.

FDA collected a sample of your animal fat product on November 14, 2018, from finished fat tank (b)(4), used to store animal fat distributed for use in animal food. Analysis revealed that it was contaminated with pentobarbital. The presence of pentobarbital causes your animal food to be adulterated because the food contains a new animal drug that is unsafe because it was not used in conformance with the drug approval, which does not have a tolerance for pentobarbital residue in the edible tissue of animals.

Your written response to Form FDA 483 failed to adequately address this problem. In the response, you assert that pentobarbital is an “unavoidable contaminant not known to present a health hazard”. Adulteration of animal food with pentobarbital is not unavoidable. It is your responsibility to prevent adulteration of animal food with unsafe new animal drugs by ensuring that you are not receiving ingredients from your suppliers that contain unsafe new animal drugs or by developing methods to ensure that materials you receive containing unsafe new animal drugs are segregated and not used for animal food. In your response, you also state that a veterinarian could legally use pentobarbital extra-label to euthanize animals. While true, this is not helpful for your rendering facility. Extra-label use of animal drugs is regulated by section 512(a)(4) of the FD&C Act and by 21 C.F.R. part 530 and covers actions by those in a veterinarian-patient-client relationship with regard to the extra-label use. Your firm is not part of the veterinarian-patient-client relationship; thus, 21 C.F.R. part 530 is not applicable to you. Furthermore, it is FDA policy to hold responsible any individual in the production and marketing chain who can be shown to have been responsible, by any act of commission or omission, for having caused illegal drug residues in animal food products. Ultimately, it is your responsibility to produce animal food that is not adulterated.

Adulteration Due to Animal Food Hazard Analysis and Risk-Based Preventive Controls (PC) Violations

You failed to identify and evaluate each known or reasonably foreseeable hazard for each type of animal food you manufacture, process, pack, or hold in your facility. [21 C.F.R. 507.33(a)(1)]

Specifically, our investigation found you did not identify and evaluate hazards that may be specific to the source of your raw material, which included carcasses of animals euthanized with pentobarbital. For example, the Hazard Analysis section of your Animal Food Safety Plan issued on May 8, 2018, did not list Pentobarbital as a known and reasonably foreseeable hazard. Pentobarbital is a known or reasonably foreseeable hazard for your facility and type of animal food because a portion of your raw ingredients are obtained from animals that have died other than by slaughter, and were either diseased or downed animals, which are likely to have been euthanized chemically.

Corrective Actions

Our investigation revealed that once you became aware of the pentobarbital contamination on December 18, 2018, you did not take immediate action to notify customers or recall the product, which are actions specified in your “9.12 Recall Plan” written procedure. On February 11, 2019; April 3, 2019; April 16, 2019; and April 22, 2019, FDA inquired whether you planned to recall the animal food product contaminated with pentobarbital. You stated you did not plan to do so and did not provide FDA with requested information regarding the amount of potentially affected product that was distributed by your firm before you learned of the positive FDA test result.

Your written response to the Form FDA 483 states that you have been conducting cleaning and pentobarbital testing activities since January 2019. While the FDA acknowledges that cleaning and testing are appropriate to ensure removal of residual pentobarbital from your processing and storage equipment, you did not ad-dress how you accounted for, or plan to account for, adulterated product that was distributed before these activities were conducted. In your response to the Form FDA 483 you stated that you believe there is no le-gal requirement for your facility to recall any products due to contamination with pentobarbital.

A recall is a voluntary action to remove products that are in violation of the FD&C Act. As explained above, your animal food (including livestock food) containing pentobarbital is adulterated. It is important to notify affected customers and remove all adulterated animal food from the marketplace.

Your updated Hazard Analysis states that for the known or reasonably foreseeable hazard of Euthanasia Drugs (Pentobarbital) in raw materials, your facility will not accept or process “dead stock”, which includes all euthanized animals. You stated you stopped accepting equine carcasses on January 9, 2019, although you did not notify your dead stock suppliers of the change in writing until January 17, 2019. Your letter to customers, submitted as Attachment D in your May 22, 2019 response to the Form FDA 483, stated that you will accept euthanized animals for collection and disposal, but chemically euthanized animals will not be rendered. FDA requests information on how euthanized animals will be collected and disposed of.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. 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. As a producer of animal food products, you are responsible for ensuring that your firm complies with all requirements of federal law and FDA regulations.



You should take prompt action to correct the violations described in this letter and establish and implement procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action with-out further notice such as seizure and/or injunction.

We also have the following comments:

1. You documented that all outgoing Bills of Lading for your product would contain the statement “not processed to control microbial hazards”. However, our investigation found that you did not include that statement on Bill of Lading documents accompanying some of your finished products. In your response to the Form FDA 483, you explained that you no longer believe such a statement is warranted on your Bills of Lading. As a reminder, if you identify a hazard requiring a preventive control and you rely on your customer to control the hazard, you must disclose in documents accompanying the animal food, in accordance with the practice of the trade, that your finished product is “not processed to control microbial hazards”. (See 21 C.F.R. 507.36.)

2. Preventive controls you identified as process controls, (b)(4), lack adequate parameters for control of some hazards (i.e., Salmonella spp., E. coli, and L. monocytogenes). Process controls are required to include parameters and the associated minimum or maximum values (or combination of values) for the parameter that your firm will use to control the hazard to ensure that it will be significantly minimized or prevented as required under 21 C.F.R. 507.34(c)(1). These parameters must be validated using scientific and technical evidence (or, when such evidence is not available or is inadequate, conducting studies) to determine whether the preventive controls, when properly implemented, will effectively control the hazards under 21 C.F.R.507.47(b)(2).

You established a process control of cooking with parameters of (b)(4) to control these microbial pathogens. These parameters do not match the parameters described in the scientific study you presented as your process validation. Review of your food safety plan further revealed that to monitor the process control, you measured (b)(4), but you did not measure (b)(4). FDA acknowledges that after the inspection your firm revised cooking parameters to align with a 7-log reduction. While you did provide FDA with records documenting the monitoring of cooking time at the close of the inspection on April 22, 2019, they are not adequate. The (b)(4) record does not take into consideration the differences between the validation study process and your current process. Your current process is to measure (b)(4). As such, it is suggested that your firm either conduct a validation study (b)(4) or (b)(4) as a parameter.

3. You became aware of pentobarbital contamination in your finished fat product on December 18, 2018 and you provided a revised food safety plan, as required by 21 C.F.R. 507.50, with your May 10, 2019 written response to Form FDA 483. It documents that your facility will not accept or process dead stock, including euthanized animals. However, the customer notification included in your response documents that you will continue to “collect and dispose of euthanized animals”. You should clarify to your clients the type of carcasses you are excluding from your operation or make clear in your food safety plan how you are identifying and segregating euthanized animals, so they do not become animal food.

Within fifteen (15) working days of receiving 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 (15) working days, state the reason for the delay and the time frame within which you will complete the correction. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent to the attention of Jessica D. Weber, Compliance Officer at U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have questions regarding this letter, please contact Compliance Officer Jessica D. Weber at (410) 779-5407 .

Sincerely,

/S/

Evelyn Bonnin

District Director

Program Division Director



Cc:

Valley Proteins, Inc.

Mr. Curtis R. Robbins, General Manager

1635 Indian Hollow Road

Winchester, Virginia 22603

Virginia Department of Agriculture and Consumer Services

Division of Consumer Protection

Office of Plant Industry Services

Agricultural Commodities Program

Ms. Debra W. Hargrave, Program Supervisor

102 Governor Street

Richmond, Virginia 23219

debra.hargrave@vdacs.virginia.gov