Step 6: 507.25 Plant Operations

a) Management of the establishment must ensure that:

(1) All operations in the manufacturing, processing, packing, and holding of animal food (including operations directed to receiving, inspecting, transporting, and segregating) are conducted in accordance with the current good manufacturing practice requirements of this subpart;

(2) Animal food, including raw materials, other ingredients, or rework is accurately identified;

(3) Animal food-packaging materials are safe and suitable;

(4) The overall cleanliness of the plant is under the supervision of one or more competent individuals assigned responsibility for this function;

(5) Adequate precautions are taken so that plant operations do not contribute to contamination of animal food, animal food-contact surfaces, and animal food-packaging materials;

(6) Chemical, microbial, or extraneous-material testing procedures are used where necessary to identify sanitation failures or possible animal food contamination;

(7) Animal food that has become adulterated is rejected, disposed of, or if appropriate, treated or processed to eliminate the adulteration. If disposed of, it must be done in a manner that protects against the contamination of other animal food; and

(8) All animal food manufacturing, processing, packing, and holding is conducted under such conditions and controls as are necessary to minimize the potential for the growth of undesirable microorganisms to protect against the contamination of animal food.

(b) Raw materials and other ingredients:

(1) Must be examined to ensure that they are suitable for manufacturing and processing into animal food and must be handled under conditions that will protect against contamination and minimize deterioration. In addition:

(i) Shipping containers (e.g., totes, drums, and tubs) and bulk vehicles holding raw materials and other ingredients must be examined upon receipt to determine whether contamination or deterioration of animal food has occurred;

(ii) Raw materials must be cleaned as necessary to minimize contamination; and

(iii) Raw materials and other ingredients, including rework, must be stored in containers designed and constructed in a way that protects against contamination and deterioration, and held under conditions, e.g., appropriate temperature and relative humidity, that will minimize the potential for growth of undesirable microorganisms and prevent the animal food from becoming adulterated;

(2) Susceptible to contamination with mycotoxins or other natural toxins must be evaluated and used in a manner that does not result in animal food that can cause injury or illness to animals or humans; and

(3) If frozen, must be kept frozen. If thawing is required prior to use, it must be done in a manner that minimizes the potential for the growth of undesirable microorganisms.

(c) For the purposes of manufacturing, processing, packing, and holding operations, the following apply:

(1) Animal food must be maintained under conditions, e.g., appropriate temperature and relative humidity, that will minimize the potential for growth of undesirable microorganisms and prevent the animal food from becoming adulterated during manufacturing, processing, packing, and holding;

(2) Measures taken during manufacturing, processing, packing, and holding of animal food to significantly minimize or prevent the growth of undesirable microorganisms (e.g., heat treating, freezing, refrigerating, irradiating, controlling pH, or controlling aw) must be adequate to prevent adulteration of animal food;

(3) Work-in-process and rework must be handled in such a way that it is protected against contamination and the growth of undesirable microorganisms;

(4) Steps such as cutting, drying, defatting, grinding, mixing, extruding, pelleting, and cooling, must be performed in a way that protects against the contamination of animal food;

(5) Filling, assembling, packaging, and other operations must be performed in such a way that protects against the contamination of animal food and the growth of undesirable microorganisms;

(6) Animal food that relies principally on the control of water activity (aw) for preventing the growth of undesirable microorganisms must be processed to and maintained at a safe aw level;

(7) Animal food that relies principally on the control of pH for preventing the growth of undesirable microorganisms must be monitored and maintained at the appropriate pH; and

(8) When ice is used in contact with animal food, it must be made from water that is safe and must be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this subpart.

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Step 5: 507.22 Equipment and Utensils

(a) The following apply to plant equipment and utensils used in manufacturing, processing, packing, and holding animal food:

(1) All plant equipment and utensils, including equipment and utensils that do not come in contact with animal food, must be designed and constructed of such material and workmanship to be adequately cleanable, and must be properly maintained;

(2) Equipment and utensils must be designed, constructed, and used appropriately to avoid the adulteration of animal food with non-food grade lubricants, fuel, metal fragments, contaminated water, or any other contaminants;

(3) Equipment must be installed so as to facilitate the cleaning and maintenance of the equipment and adjacent spaces;

(4) Animal food-contact surfaces must be:

(i) Made of materials that withstand the environment of their use and the action of animal food, and, if applicable, the action of cleaning compounds, cleaning procedures, and sanitizing agents;

(ii) Made of nontoxic materials; and

(iii) Maintained to protect animal food from being contaminated.

(b) Holding, conveying, manufacturing, and processing systems, including gravimetric, pneumatic, closed, and automated systems, must be designed, constructed, and maintained in a way to protect against the contamination of animal food.

(c) Each freezer and cold storage compartment used to hold animal food must be fitted with an accurate temperature-measuring device.

(d) Instruments and controls used for measuring, regulating, or recording temperatures, pH, aw, or other conditions that control or prevent the growth of undesirable microorganisms in animal food must be accurate, precise, adequately maintained, and adequate in number for their designated uses.

(e) Compressed air or other gases mechanically introduced into animal food or used to clean animal food-contact surfaces or equipment must be used in such a way to protect against the contamination of animal food.

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Step 4: 507.20 Water Supply & Plumbing

a) The following apply to the water supply:

(1) Water must be adequate for the operations and must be derived from an adequate source;

(2) Running water at a suitable temperature, and under suitable pressure as needed, must be provided in all areas where required for the manufacturing, processing, packing, or holding of animal food, for the cleaning of equipment, utensils, and animal food-packaging materials, or for employee hand-washing facilities;

(3) Water that contacts animal food, animal food-contact surfaces, or animal food-packaging materials must be safe for its intended use; and

(4) Water may be reused for washing, rinsing, or conveying animal food if it does not increase the level of contamination of the animal food.

(b) Plumbing must be designed, installed, and maintained to:

(1) Carry adequate quantities of water to required locations throughout the plant;

(2) Properly convey sewage and liquid disposable waste from the plant;

(3) Avoid being a source of contamination to animal food, water supplies, equipment, or utensils, or creating an unsanitary condition;

(4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; and

(5) Ensure that there is no backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for animal food or animal food manufacturing.

(c) Sewage and liquid disposal waste must be disposed of through an adequate sewerage system or through other adequate means.

(d) Each plant must provide employees with adequate, readily accessible toilet facilities. Toilet facilities must be kept clean and must not be a potential source of contamination of animal food, animal food-contact surfaces, or animal food-packaging materials.

(e) Each plant must provide hand-washing facilities designed to ensure that an employee’s hands are not a potential source of contamination of animal food, animal food-contact surfaces, or animal food-packaging materials.

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Step 3: 507.19 Sanitation

(a) Buildings, structures, fixtures, and other physical facilities of the plant must be kept clean and in good repair to prevent animal food from becoming adulterated.

(b) Animal food-contact and non-contact surfaces of utensils and equipment must be cleaned and maintained and utensils and equipment stored as necessary to protect against the contamination of animal food, animal food-contact surfaces, or animal food-packaging materials. When necessary, equipment must be disassembled for thorough cleaning. In addition:

(1) When animal food-contact surfaces used for manufacturing, processing, packing, or holding animal food are wet-cleaned, the surfaces must, when necessary, be thoroughly dried before subsequent use; and

(2) In wet processing of animal food, when cleaning and sanitizing are necessary to protect against the introduction of undesirable microorganisms into animal food, all animal food-contact surfaces must be cleaned and sanitized before use and after any interruption during which the animal food-contact surfaces may have become contaminated.

(c) Cleaning compounds and sanitizing agents must be safe and adequate under the conditions of use.

(d) The following applies to toxic materials:

(1) Only the following toxic materials may be used or stored in the plant area where animal food is manufactured, processed, or exposed:

(i) Those required to maintain clean and sanitary conditions;

(ii) Those necessary for use in laboratory testing procedures;

(iii) Those necessary for plant and equipment maintenance and operation; and

(iv) Those necessary for use in the plant’s operations.

(2) Toxic materials described in paragraph (d)(1) of this section (e.g., cleaning compounds, sanitizing agents, and pesticide chemicals) must be identified, used, and stored in a manner that protects against the contamination of animal food, animal food-contact surfaces, or animal food-packaging materials; and

(3) Other toxic materials (such as fertilizers and pesticides not included in paragraph (d)(1) of this section) must be stored in an area of the plant where animal food is not manufactured, processed, or exposed.

(e) Effective measures must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of animal food by pests. The use of pesticides in the plant is permitted only under precautions and restrictions that will protect against the contamination of animal food, animal food-contact surfaces, and animal food-packaging materials.

(f) Trash must be conveyed, stored, and disposed of in a way that protects against the contamination of animal food, animal food-contact surfaces, animal food-packaging materials, water supplies, and ground surfaces, and minimizes the potential for the trash to become an attractant and harborage or breeding place for pests.

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Step 2 – 507.17 Plant & Grounds

(a) The grounds around an animal food plant under the control of the management of the establishment must be kept in a condition that will protect against the contamination of animal food. Maintenance of grounds must include:

(1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests;

(2) Maintaining driveways, yards, and parking areas so that they do not constitute a source of contamination in areas where animal food is exposed;

(3) Adequately draining areas that may contribute to contamination of animal food; and

(4) Treating and disposing of waste so that it does not constitute a source of contamination in areas where animal food is exposed.

(b) The plant must be suitable in size, construction, and design to facilitate cleaning, maintenance, and pest control to reduce the potential for contamination of animal food, animal food-contact surfaces, and animal food-packaging materials, including that the plant must:

(1) Provide adequate space between equipment, walls, and stored materials to permit employees to perform their duties and to allow cleaning and maintenance of equipment;

(2) Be constructed in a manner such that drip or condensate from fixtures, ducts, and pipes does not serve as a source of contamination;

(3) Provide adequate ventilation (mechanical or natural) where necessary and appropriate to minimize vapors (e.g., steam) and fumes in areas where they may contaminate animal food and in a manner that minimizes the potential for contaminating animal food;

(4) Provide adequate lighting in hand-washing areas, toilet rooms, areas where animal food is received, manufactured, processed, packed, or held, and areas where equipment or utensils are cleaned; and (5) Provide shatter-resistant light bulbs, fix

fixtures, and skylights, or other glass items suspended over exposed animal food in any step of preparation, to protect against the contamination of animal food in case of glass breakage.

(c) The plant must protect animal food stored outdoors in bulk from contamination by any effective means, including:

(1) Using protective coverings where necessary and appropriate;

(2) Controlling areas over and around the bulk animal food to eliminate harborages for pests; and

(3) Checking on a regular basis for pests, pest infestation, and product condition related to safety of the animal food.

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Lets get ready for your inspection… One step at a time…

In my last post I talked about two different inspections. I hope these “tales” encouraged you (neither was as “bad” as the mills expected); I hope these “tales” inspired you (to be “ready” for your inspection). Are you ready? What have you done?  Over the next few months, I will recap the requirements of the FSMA rule. I hope I can encourage and inspire you to get ready for your inspection. Instead of me telling you what you need to do, I want you to tell me what you have done…

The original CFD FSMA project helped you to “say what you do”, by writing Standard Operating Procedures, the focus was on Current Good Manufacturing Practice. In my training classes I highlighted some of the best practices I have seen various mills do to comply with CGMP’s. Over the past few years, I am confident you have come up with some great ideas.

Every two weeks, I will post the text of one CGMP. I hope you will use each 2-week period to focus on your compliance with this part of the rule. Read it and think about your compliance. What have you done, what do you need to do better than briefly share one or two ideas of ways you comply with this CGMP. Here is the schedule:

I will summarize responses (anomalously of course) in an update to each post.

  • 2/28 507.14 Personnel
  • 3/14 507.17 Plant and Grounds
  • 3/28 507.19 Sanitation
  • 4/11 507.20 Water Supply and Plumbing
  • 4/25 507.22 Equipment and Utensils
  • 5/09 507.25 Plant Operations
  • 5/23 507.27 Holding and Distribution

507.14 Personnel – Management of the establishment must take reasonable measures and precautions to ensure that all persons working in direct contact with animal food, animal food-contact surfaces, and animal food-packaging materials conform to hygienic practices as necessary to protect against the contamination of animal food (21 CFR 507.14(a)).

Persons working in direct contact with animal food may include employees, contractors, and visitors. Methods for conforming to hygienic practices and maintaining cleanliness include: maintaining adequate personal cleanliness; washing hands thoroughly in an adequate hand-washing facility as necessary and appropriate to protect against contamination; removing or securing jewelry and other objects that could fall into animal food, equipment, or containers; storing clothing and personal belongings in areas other than where animal food is exposed or where equipment or utensils are cleaned; and taking any other precautions necessary to protect against contamination of animal food, animal food contact surfaces, or animal food-packaging materials (21 CFR 507.14(b)).  

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A Tale of Two Inspections

I recently spoke with two feed mills that I have worked with in different capacities over the years. Each has recently had a FSMA inspection. Without divulging the identity of either mill I would like to summarize the key parts of each inspection:

#1 – FDA conducted this inspection just prior to the March 2020 COVID pause.

  • Our FDA Investigator was very thorough. He first read through all our programs and then toured the Mill Operations. 
  • Next, he came back and started going through records to match up with what we said we were doing in our programs.
  • He was very meticulous in matching up employee training records and what our CGMP program said we would train for. 
  • He then looked for records to see if the individual that was trained had filled out documentation according to our plan.
  • He concentrated on our CGMPs and their supporting pre-requisite programs. 
  • He focused in detail on our pest control program. Looking for trending reports and recommendations by our pest control technician and our own internal walkthroughs.  He did his own physical inspection and found no issues.
  • He was also very interested in all training that was done by our company.
  • He looked at “Sanitary Transportation”: training records, testing, and certificates of completion.
  • He looked at our Hazard Analysis, Flowcharts, and Feed Safety Program and no deficiencies noted.
  • “All in All… it was not a bad experience.” 

#2 – PA Department of Agriculture conducted this inspection in December 2020 on behalf of the FDA. It was a combined inspection for VFD, non-licensed medicated feed and CGMP’s. It did not include Hazard Analysis and Preventive Controls. 

  • For the VFD inspection he selected 3 random orders and went over the paperwork in detail.
  • For the non-licensed medicated feed inspection, he reviewed all our required medication logs.
  • He had notes from a previous state inspection and went over the issues identified in that previous inspection to determine if recommendations were corrected.
  • He asked a long list of questions about CGMP’s and took notes on my answers.
  • He then toured the entire facility from top to bottom to confirm we are doing what we say we are doing. 
  • He focused on housekeeping and pest control. We do pest control ourselves and he was looking for records.
  • He was very interested in any, and all logs we keep.
  • He asked about training since we have had several new employees recently.
  • Although it was not the purpose of this inspection, he asked if we had begun our Hazard Analysis and if we are working on our Feed Safety Plan. He indicated that the state has contracted with FDA for a very limited number of these inspections, but we can expect one in the next couple of years.
  • He was here for about 4 ½ hours.
  • “We have not received our report yet, but I feel it went better than I had anticipated”.

It is difficult to comment on the differences in the inspections because the purpose of each was different. There are similarities and for the most part they included all the elements that we were told to expect from an inspection. Both mills felt like the “educate while they regulate” was indeed what they were doing. They hope this information is helpful.

What I learned at the FSPCA Lead Instructors Conference this month…

  • Inspection FY 2020:
FDA OnlyCGMPHA/PCSanitary TransportationFSVP
FY2020 Domestic Animal Food InspectionsPlanned: 180 Completed: 91 50%Planned: 360 Completed: 7 22%Planned: 84 Completed: 30 36%Planned 75 Completed: 67 89%
The numbers presented at the conference included only FDA inspections:

The time period for the completed inspections was from October 1, 2019 – September 30, 2020, Since inspections were paused in March these were conducted during primarily the first 6 months of this period. The numbers are not surprising, except for FSVP, with almost 90% of the plan inspections completed. This is because the FSVP regulation allows for remote or desk inspections. The others require on-site inspections so COVID-19 had a bigger impact on these types of inspections. Many inspection violations were simply due to the facility not having a Feed Safety Plan and/or conducting the required hazard analysis.

FDA continues to respond to Mission Critical Food Safety Issues. When inspections resumed in July of 2020, FDA developed an Advisory Rating System. They look at the COVID risk in the facilities location and the location of inspectors. Although they did not provide a great deal of information on this process; they have made the unprecedented decision to give advance notice of inspections. They will call approximately 5 days in advance with scripted questions to determine the facilities readiness to safely conduct the inspection.

They are also conducting voluntary Remote Risk Assessments. If you were previously inspected on-site, you may be asked if you would like to participate in a remote assessment of your work towards resolving open issues.

  • The future of training

This conference was for Lead Instructors of Food Safety Training Courses provided by FSPCA (Food Safety Preventive Controls Alliance). Therefore, there was much discussion on training and the opportunities FSPCA has provided to conduct remote training and the rules associated with doing so.  As much as I would love to conduct zoom trainings there is much that needs to be done to gain compliance with the virtual training rules. I have consistently heard from CFD members it is very hard to get things like this done when they are in the mill. I think it would be very hard for students to comply with these new rules as well. As the vaccine has already begun to be distributed, we should be able to resume in-person training in the Spring. I will begin discussions with CFD on the criteria for an in person class.

  • New Tool:  

As I discussed last month, In October FSPCA released this “Abbreviated Guide to Creating a Livestock Food Safety Plan Under the Preventive Controls for Animal Food (PCAF) Rule”. This plan is just an example of a plan for a facility manufacturing Medicated and Non-medicated Feed for Swine and Broilers. Click on the title to view and download the public version of the document.

  • Virtual Office Hours

One idea presented is that instructors are offering virtual office hours. I think this is a fantastic idea and I will be working next week to arrange a schedule for virtual office hours in 2021.  

Coming next month… “A tale of Two Inspections”.  

More updates…

Inspection Statistics:

This summer AFIA published the following statistics on inspections completed in FY2019 (October 2018 – September 2019):

 FY 2019 CGMP*FY 2020 Plan CGMPFY 2019 HA/PC*FY2020 Plan HA/PC
Domestic Inspections964
311 FDA
676 State
589
180 FDA
409 State
221
178 FDA
56 State
455
360 FDA
95 State
# of Violations
(Form 483)
85
75 VAI*
9 OAI*
 44
28 VAI
16 OAI
 
* Current Good Manufacturing Practice
* VAI (Voluntary Action Required)
* OAI (Official Action Required)
* HA/PC (Hazard Analysis and Preventive Controls
 FY 2019FY 2020 Plan
Sanitary Transportation9584
FSVP2875
Expect that inspections will be stacked meaning they will combine CGMP and HA/PC with FSVP, Sanitary Transportation of Food, Medicated Feed CGMP, BSE and VFD inspections as applicable to the facility. The more types of inspections your facility is subject to may increase the likelihood of inspection.

With most of our member feed mills being on NY and PA, it is worth noting that NY Department of Agriculture did not contract with the FDA to perform inspections, but PA Department of Agriculture did contract to do both CGMP and HA/PC. In my opinion, PA members may expect inspections sooner if they have not already been visited but it may take some time for NY to see significant inspections…

Then Came COVID-19:

As we all know by late March of 2020 everything changed as COVID-19 forced the world to “pause”. Our industry is of course essential and had to do its part to keep moving as if the world was “normal”. The FDA briefly halted inspections other than for cause indicating immediate threat to health and safety. Inspections resumed on a very limited basis in July 2020. All inspections are being scheduled so precautions can be taken during the visits. Some work is being done virtually to limit direct contact.

What is next???

Next month, I will attend a virtual conference of FSPCA Lead Instructors for FDA recognized courses in CGMP’s, HA/PC and FSVP. We expect presentations from many sources including the FDA. As with everything else the focus will be on the impact of COVID-19. I will certainly share what I learn. If you have any questions regarding the impact of the virus on your operations, please reach out to me, so I can try to get answers. There will be a breakout session specifically for Animal Food. There will also be a presentation to provide us as lead instructors more information on opportunities for virtual training as the pandemic plays out in the next year.

Training Opportunities:

Winter 2021 may be an opportunity to provide a virtual (or very small in person) Part B of the Blended Hazard Analysis and Preventive Controls for Animal Food. If you, or any of your Feed Safety Team, needs this training, please let me know. If you have taken Part A, you normally must complete Part B within 6 months. This window has been extended due to lack of course availability.

New tools have been released:

 In October FSPCA released an “Abbreviated Guide to Creating a Livestock Food Safety Plan Under the Preventive Controls for Animal Food (PCAF) Rule”. I am in the process of reviewing this guidance and the included example feed safety plan. More information will be forthcoming.

Finally, some reminders from the FDA…

Facility Registration Deadline is December 31, 2020

Have questions on Facility Registration? See my post on November 8th for an FDA FAQ document to get answers…

Getting a flu shot is more important this season than ever before!

November 18, 2020

The FDA wants to remind the millions of men and women on the front lines of growing, processing, preparing, selling and delivering food for both people and animals, to get their seasonal flu shot.   

The Centers for Disease Control and Prevention and the healthcare community are preparing for flu viruses and the virus that causes COVID-19 that will spread this fall and winter. Both are contagious respiratory illnesses, but they are caused by different viruses. One of the most important differences is that there is a vaccine already available that can protect you against the flu. While getting a flu shot will not protect against COVID-19, a flu shot will protect you by reducing your risk of flu illness, hospitalization, and possibly death. Protecting yourself from the flu will also help save medical resources for the care of COVID-19 patients. 
People who have flu often feel some, or all, of these symptoms:

  • fever or feeling feverish/chills
  • cough
  • sore throat
  • runny or stuffy nose
  • muscle or body aches
  • headaches
  • fatigue (tiredness)
  • some people may have vomiting and diarrhea, though this is more common in children than adults.

The best time to get a flu shot is now before the flu begins spreading in your community. It takes about two weeks after getting a vaccine for antibodies to develop in the body and provide protection. 

The same factors that contribute to workplace and community spread of COVID-19– including prolonged close contact with coworkers, congregate housing, shared transportation, and frequent community contact among workers—likely contribute to the spread of the flu. 

When an essential worker gets a flu shot, they protect themselves, their families, co-workers, and their communities. Healthy workers help to ensure the availability of a safe and nutritious food supply. 

To learn more about how and where to get a flu shot, contact your employer or visit: https://www.cdc.gov/flu/.

Flyer for the Workplace (PDF: 2.19MB)