Industry Training: FAQ

Food Safety Modernization Act Presentation by Dr. Marla Keller, FDA

Q: Are restaurants or pet stores required to register as a food facility with FDA?
A: Animal food business that meet the definition of a restaurant or retail food establishment are exempt from registration (21 C.F.R. 1.226). Pet shelters, kennels, and veterinary facilities where animal food is provided are considered restaurants (21. C.F.R. 1.227). Generally, pet stores will meet the definition of retail food establishment because more of their sales will be to consumers (e.g. pet owners) rather than businesses (e.g. veterinarians, kennels, etc.) (21 C.F.R. 1.227).

The Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry ^{[PDF 464 KB]} may help you determine whether your business is defined as a restaurant, retail food establishment or not. In particular, question B.3.2 discusses animal food restaurants and B.2.16 and B.2.19 discuss animal food retail food establishments.

Q: Does a farm that also manufacturers feed for interstate commerce (distributes out of state) need to register as a food facility with FDA?
A: If a farm is manufacturing feed and selling a portion of it to another business or a farm under different management, they would not meet the farm definition. Such an operation would be considered a farm mixed-type facility and must register. The Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry ^{[PDF 464 KB]} may help you determine whether your business is defined as a farm, farm mixed-type facility or not. In particular, question B.1.21 discusses farms that sell animal food and B.1.4 discusses farm mixed-type facilities. 

WSDA Inspection Checklist and PC Tool Presentation by Ashlee-Rose Ferguson RS, WSDA

Q: What kind of documentation is provided to the firm following a WSDA Preventive Controls inspection?
A: Directly following a WSDA inspection, the inspector will provide resources such as the guidance for industry documents and the "Summary of Inspection, Investigation, and/or Sampling" form. Any inital observations and corrective actions needed are included on the summary form. Afterwards, all information is written into reports and checklists, reviewed, processed, and then sent back to the firm generally via email within 45 calendar days.

Q: Are there any plans to develop a tool similar to the one shown to help with compliance with Foreign Supplier Verification Program (FSVP) requirements?
A: WSDA Animal Feed Program did not adopt the FSVP regulation so we do not have the authority to conduct those inspections in Washington State. 

Status of Inspections, Nationally and Statewide by Michael Schuette, FDA

Q : Are qualified facilities required to follow subpart C: Hazard Analysis and Risk-Based Preventive Controls and subpart E: Supply Chain Program? 
A: Qualified facilities that submit and attestation to FDA are exempt from following the hazard analysis and risk-based preventive controls and supply chain program requirements in 21 C.F.R. subparts C and E but must are still subject to subpart B: current good manufacturing practice and the modified requirements for qualified facilities in 21 C.F.R. 507.7. Which part of the modified requirements you will have to comply with will depend on the attestation you choose: in compliance with local requirements (21 C.F.R. 507.7(e)) or controlling the hazard (21 C.F.R. 507.7(f)). The 21 C.F.R. 507 regulation should be reviewed for more information.
This guidance for industry document, "Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals," explains how to determine whether your business meets the definition of "qualified facility" and how to fill out the attestation. The guidance is slightly outdated. You no longer submit a form to FDA because the attestation is now integrated with the food facility registration process. You submit your attestation information when you renew your registration as a food facility. It is important to note that the facility is making this determination and submitting the attestation; FDA does not make the determination.

Q: Is there a publicly available list of facilities that have filed the attestation and have been determined to be qualified?
A: No, there is not a publicly available list of facilities that have submitted a qualified facility attestation. Qualified facility attestations are made during the food facility registration. Section 415(a)(5) of the Food, Drug and Cosmetic Act requires that list and any information derived from such list that would disclose the identity or location of a specific registered person, is not subject to public disclosure under the Freedom of Information Act (FOIA) (5 U.S.C.552).

Q: Are there any considerations given to facilities during inspections that qualify but did not file an attestation?
A: If a firm may meet the definition of qualified facility, that information will be provided by the inspector at the beginning of the inspection. If the firm has not filed an attestation during their food facility registration renewal, they will typically be inspected under both cGMP and PC requirements for animal food. If a firm does meet the criteria of a qualified facility and wants to file an attestation, inspectors are encouraged to work with the firms because that is something that can be completed during the inspection.

Q: Is a hazard analysis a part of the food safety plan or are they separate? Is the food safety plan the general term for the total written plan?
A: A hazard analysis is part of the food safety plan. The food safety plan is the general term for the total written plan. It includes your written hazard analysis and any documentation you relied on for your hazard analysis, such as pre-requisite programs. Then if you have determined you have a hazard requiring a preventive control, it would also include your:​
-Written preventive control(s),
-Written supply chain program (if you determined the hazard needed to be controlled prior to receipt,
-Written procedures for implementing and monitoring, 
-Written corrective action procedures,
-Written verification procedures, and
-Written recall plan (21 C.F.R. 507.31).

Q: If the only hazard identified will be controlled down the supply chain at another manufacturer, would I need a food safety plan?
A: Yes, you would still need a food safety plan. If you plan to use the customer provisions in 21 C.F.R. 507.36 because the hazard will be controlled by another manufacturer/processor, you must still conduct a hazard analysis, which would be part of the food safety plan. Then indicate you are following the customer provisions and implement a process to include the disclosure statement in documents accompanying the animal food. As a reminder, there is currently enforcement discretion for the written assurance portion of the requirements, so you do not have to conduct those. The FDA has draft guidance available that describes current thinking on the disclosure statements.

Q: Who can we contact if we need help in terms of validation?
A: You can refer to FDA Technical Assistance Network (TAN) (https://cfsan.secure.force.com/Inquirypage/) for questions or review Chapter 5 of Guidance for Industry 245 ^{[PDF 1.17 MB]} which has an overview of validation. If you're looking at specific instrumentation, you may be able to reach out to the instrument manufacturer or have industry-specific guidance available to you.

Items Frequently Observed During Inspections by Donald B. McKechnie, FDA and David Beard, WSDA

Q: Are pet cats or feral cats considered pests?
A: It depends. Generally, they will be considered pests if there are feed or feed ingredients that they can contaminate or adulterate. We note on page 20 of "Guidance for Industry #235: cGMP Requirements for Food for Animals," in the section on excluding pests under 21 C.F.R. 507.19(e), that "using cats or other animals as a method of pest exclusion is not acceptable because their presence can also lead to the contamination of food."

Q: Is it true that you must identify the location of the firm on the employee training records?
A: This response is specific to required employee training records (e.g. training in the principles of animal food safety and hygiene and relevant employee heath and hygiene), which are subject to the record keeping requirements in Subpart F. Information adequate to identify the plan or facility (e.g. , the name, and when necessary the location of the plant or facility) is a requirement for records that must be established and maintained under part 507 as noted in 21 C.F.R. 507.202(b)(1). For some facilities, the name of the facility will be enough to identify the plant. Other facilities that share a name with another facility or plant may need to include a location or other descriptor (e.g., plant number) to differentiate their records for a plant with the same name.

Q: Base on data obtained thus far, is it generally common for animal food facilities to conduct a hazard analysis but not identify any hazards requiring a PC?
A: FDA does not collect data on the number of hazards requiring a PC identified in food safety plans. Food safety plans and the conclusions of a facility's hazard analysis are unique to that facility and its animal food. In "draft Guidance for Industry #245 ^{[PDF 1.17 MB]}," FDA recognized that "some facilities may not identify any known or reasonably foreseeable hazards associated with animal food at their facilities, or after evaluation may determine there are no known or reasonably foreseeable hazards requiring a preventive control." The types of hazards and measures put in place to ensure safe animal food varies across the wide variety of animal food establishments and is specific to the facility and their animal food(s).

Industry Perspective of FSMA Rules by David Fairfield, NGFA

Q: When is FSMA enactment determined to be?
A: FSMA was signed into law in 2011. Compliance dates for FSMA-related animal food rules for all sizes of businesses have passed, and businesses are currently expected to be in compliance with the requirements that apply to their operations.

Byproducts of Human Food Processing Plants by Leah Wilkinson, AFIA

Q: Is there a database for hazardous ingredients by species? i.e. Copper with sheep
A: There is no single database available, but there are tools available that can help. Between the National Grain and Feed Association Foundation and the AFIA Foundation, there is a list based on a literature search that identifies hazards in feed and the pet food supply. This is available to members of either association. Please contact either association for further instructions to access this information. In the preamble ^{[PDF 1.12 MB]} (which is the introductory part of a statute or deed, stating its purpose, aims, and justification) of the FSMA regulations, there are also some examples listed.

Q: Who conducts a safety assessment for the foods? Does a firm have to hire an independent consultant to confirm safety?
A:  Regarding the approval of ingredients which includes safety assessments, that can be completed internally. Part of that is identifying what is needed to get the ingredient approved. There are safety assessments that need to be done in order to meet the requirement for getting it approved through FDA or through an AAFCO ingredient review.

Pet Food and Specialty Pet Food Registration Requirements and Observations by Kim Truett, WSDA

Q: Are we able to submit registration applications online, electronically or by phone?
A: WSDA does not have the option to receive online submissions right now, but we are currently working on receiving electronic payments and submissions. Currently, the application form can be submitted by email, USB, or CD.

Q: When we make the changes on the packaging, what are the elements that will make it a new product?
A: Any change to formulation, guarantee analysis or product name, would make the item a new product and it will need to be submitted on a new product application. Changes to the quantity statement, or minor graphic changes can be made without the item being considered a new product.
 

Commercial Feed Licensing, Inspection Fee Reporting, and AAFCO Online Database of Ingredients (ODI) Demonstration by Liz Beckman, WSDA

Q: Is there a fee to access the Online Database of Ingredients (ODI)?
A: ODI is free with your subscription to the AAFCO online Official Publication (OP).
 

Acronyms or Abbreviations
 

AAFCO: Association of American Feed Control Officials
AFIA: American Feed Industry Association
CFR: Code of Federal Regulations
cGMP: current Good Manufacturing Practices
FDA: U.S. Food and Drug Administration
FSMA: Food Safety Modernization Act
FSVP: Foreign Supplier Verification Program
NGFA: National Grain and Feed Association
ODI: Online Database of Ingredients
OP: Official Publication
PC: Preventive Controls
PCAF: Preventive Controls for Animal Food
Q&A: Question and Answer
TAN: Technical Assistance Network
WSDA: Washington State Department of Agriculture