GFI#245 is Final and RAQ (Recently asked Questions)

Final Guidance from FDA was issued on 7/8/2022 (click this link to download the document):  GFI #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

The draft guidance has been discussed in previous blogs and my PCQI training classes over the last few years. Now that this guidance is final, I highly recommend you read this document and potentially reanalyze your Feed Safety Plan in response to some of the changes. Significant changes in the final guidance are as follows:

  • Appendix E: “Aid to Identifying Animal Food Hazards” has been removed. Industry was concerned that the list provided in the draft guidance would lead inspections to expect that each hazard be addresses. Removing this appendix clarified that not all the hazard examples in the guidance are applicable to all animal food or all facilities. Facilities should use the hazard information in Chapter 3 of the guidance as they consider whether particular hazards are known or reasonably foreseeable for their animal food.  
  • This document provides more concrete examples of when a facility may or may not be required to reanalyze their food safety plan. See section 5.8.6 Reanalysis starting on page 119.
  • This document contains more information, resources, and examples of certain hazards in animal food, including information on animal food recalls that occurred since the draft guidance published. This was likely in response to removing Appendix E. Section 2.8 References for Chapter 2 on Page 24 contains links to various resources. As you review the entire document you will see references to many recalls that should be used in evaluating known and reasonably foreseeable hazards in your facility.

If there is any interest in assembling a work group to review this document and the Draft #272 I wrote about in July, I would be open to organizing one. Please email me with any interest in doing so. It could be done in person or virtually via zoom.

A RAQ (Recently Asked Question):

“Can a trailer that hauls bulk commodities such as corn or soymeal also be used to haul hazardous waste?” The short answer is “probably not” but it depends on the “waste” and the “cleaning protocol” that was used after the haul. On this website under “HELPFUL LINKS” you will find a link to the  International Database for Transport for Feed. Under “FREE TRAINING VIDEOS” #5 shows you how to use this database and interpret the results. Basically, you search for the material in the previous haul, to identify the cleaning regiment required prior to hauling a feed product. It will tell you if the previous haul prohibits hauling feed. Since this retrieves results from several international standards, which may differ, it would be prudent to use the most restrictive result.

Re-evaluation of your feed safety plan is coming soon as CVM issues GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover

In my last series I discussed the main elements required by the Preventive Controls for Animal Food rule (21 CFR 507). At this point all animal feed manufacturers need to have a written plan in place. One criterion for re-evaluation of your plan is when “new Information” becomes available. That would include new FDA guidance.

In May of this year the FDA issued draft guidance on Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover. The introduction states that while the guidance does not significantly change the rules in place since the 1970’s (21 CFR 225) but it will result in the replacement of “prior guidance found in the Compliance Policy Guides Sec. 680.500 Unsafe Contamination of Animal Feed from Drug Carryover and 680.600 Sequencing as a Means to Prevent Unsafe Drug Contamination in the Production, Storage, and Distribution of Feeds, (both of which we intend to withdraw after this guidance is finalized), but includes updates and additional information.”.

Comments on this new guidance are due by 8/8/2022 and can be made at the website linked here.

This guidance identifies adherence to 21CFR 225, 507 and the Sanitary Transportation of Food as factors in preventing the unsafe contamination of food across the food chain. It addresses several methods for carry-over prevention, specifically: physical cleanout, flushing and sequencing. All these methods should be discussed in your feed safety plan. The guidance discusses in some detail the various life cycle and intended use considerations that must also be addressed in your plans.

This draft guidance document should be reviewed by all medicated feed manufacturers, licensed and unlicensed. Should it be approved by the FDA, this will require that all medicated feed manufacturers re-evaluate their feed safety plans to ensure compliance with the updated guidance and make changes to any identified deficiencies.

AFIA posts about… FDA CPGs withdrawal…

FDA Withdraws CPGs Related to the Use of Rendered Products in Feed, Pet Food

AFIA published the following information on Tuesday April 30, 2019. It is re-posted with approval…

In response to a citizen petition, the Food and Drug Administration withdrew three compliance policy guides (CGP) today that dictate how certain animal-derived food materials can be used in animal food. The FDA said the action will “clarify” for animal food manufacturers the agency’s regulatory policies and expectations for the use of materials from dead or downer animals.

Since the CPGs were issued 40 years ago, FDA said its “knowledge of, experience with, and focus on preventing safety problems with animal food has increased.” Referencing the Food Safety Modernization Act, which placed sweeping new authorities and requirements on both the human and animal food industries, and its resulting 21 CFR Part 507 (the “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals”), animal food manufacturers, including renderers, are now required to do more than ever before to identify hazards, develop risk-based preventive controls and test and monitor their safe manufacturing protocols in their animal food safety plans.

Given the breadth and depth of FSMA, the FDA stated in its letter that the CPG on Rendered Animal Feed Ingredients (CPG Sec. 675.400) and the one on Canned Pet Food (CGP 690.300) are no longer necessary:

“We have determined that the CPGs that we have withdrawn are outdated because they do not inform animal food manufacturers of the part 507 regulation, a new, integral part of the animal food safety framework. Furthermore, they are incomplete because they highlight only one type of hazard (biological) that has been associated with tissues of animal origin. … since the two withdrawn CPGs were originally released, we have issued regulations and other more extensive guidance and draft guidance that are directly relevant to animal food safety.”

In addition, on the CPG on Uncooked Meat for Animal Food (CPG Sec. 690.500), the FDA said it “simply restates the adulteration provision” of the Federal Food, Drug and Cosmetic Act’s section 402(a)(5) and its ability to “take action on uncooked animal food products derived from ‘diseased animals or animals that died otherwise by slaughter’.”

The FDA reiterated that the use of rendered ingredients in many pet foods, including canned pet food, can provide a safe source of fat and protein. The American Feed Industry Association agrees that the rendering process is sophisticated and regulated to ensure that only quality animal food products are ever used, in accordance with all state and federal laws and regulations, and is one way the industry can be more sustainable.

The FDA’s actions today should not impact animal food manufacturers’ ability to produce safe feed and pet food for animals. The FDA still maintains the same authority it has had to take action against animal food products or manufacturers that could pose a threat to human or animal health.

What does this mean for you?

  • If you are an animal food manufacturing facility that uses rendered ingredients from dead or downer animals, you must ensure that any hazards these ingredients could pose are accounted for in your hazard analysis and animal food safety plans as part of 21 CFR Part 507.
  • If you do not use rendered ingredients from these animal sources, it is still a good policy to know your suppliers and validate your supply stream to ensure you are properly managing hazards and accounting for them in your animal food safety plans.

Environmental Reporting: EPCRA Tier II Reporting for Combustible Dust

The following is the bottom line on methods for reporting combustible dust… It is an excerpt from a longer article published AFIA on 1/15/19
and is used with permission…

“EPA and industry agree on the following approach for combustible
dust reporting:

The EPA agrees that there are two simple, reasonable options to
complete the Tier II form for combustible dust, which ensures
emergency planners have the relevant information they need
about potential combustible concerns at a feed or grain operation.
Depending on the nature or size of your feed or grain operation:

Reporting Option #1 – If combustible dust is likely present at any
level below the 10,000-pound threshold. If a facility has a reasonable
basis to conclude that it has some volume of combustible dust,
but it is below the 10,000-pound threshold, then a facility should:

(1) check the “combustible dust” box in the “physical hazards” column; and
(2) check the “below reporting thresholds” box in the last column
(the “additional reporting information” column) of the Tier II form.

Reporting option #1 is likely most appropriate for most facilities.
EPA has concluded that there is no obligation for a facility to
provide any further information if the “below reporting
thresholds” is checked.

Reporting Option #2 – If combustible dust is likely above the
10,000-pound threshold If a facility has a reasonable basis to
estimate that it may have combustible dust above the 10,000
-pound threshold, then it should:

(1) check the box in the “physical hazards” column;
(2) complete the “inventory” column using an estimation
method or calculations based on the facility’s best
professional judgment.

This option may be more applicable for those facilities that
collect and store combustible dust in a bin or container.

Reminder: Certain local or state jurisdictions may require additional

While the EPA agrees with industry on the two options for reporting
above, facilities may be subject to additional local or state Tier
II reporting requirements for combustible dust. You may need
to check your county or state requirements to determine
whether this may be the case and complete your Tier II
report accordingly.”

FSMA Compliance is NOW!

It is hard to believe that 3 years has past since the rules for FSMA were finalized. But today is Monday, September 17, 2018 and this date is significant!

  • All food facilities must be in compliance with CGMP’s. If you or someone you know is planning on filing for an exemption based on the size of the facility it is important to understand that there is no exemption from CGMP’s.
  • Small business must have or be actively engaged in performing a Hazard Analysis to identify Known and Reasonably Foreseeable Hazards. They than must make a determination if they require a preventive control to mitigate those hazards to an acceptable hazard.

Continue reading “FSMA Compliance is NOW!”

FDA Announcements

The following was posted on the FDA website today…Caution: Do not be complacent. Keep calm and keep busy. The announcement indicates an intention to delay inspections not compliance.

“Jenny Murphy, a consumer safety officer at FDA’s Center for Veterinary Medicine, explains what animal food producers can anticipate in this next phase in the implementation of the rule entitled Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PC Animal Food rule). Continue reading “FDA Announcements”