Do you know for sure?

Do you know for sure that your sequencing and flush procedures for medications work? How do you prove it? Many tell me… “it must work because I have never had a problem”… Is that still good enough?

Now that FSMA is here… it is not enough…

So how do you prove it? Elanco can help help… Rumensin has a micro tracer technology built into the product and Elanco provides the test kits for free. There are two types of kits…

1.) Mason Jar Kit – Give a simple YES or NO answer to the question “is there Rumensin in my feed?”. It’s easy to conduct and can be used to prove your sequencing and Flush procedure works!

2.) Rotary Test Kit – Goes a step further and will tell you how much Rumensin is in a feed. It is slightly more complicated to conduct but if you need the answer to how much is there this is a quick way to get the answer without waiting for the lab report.

If you are interested in learning more about this technology, email me at barbsimeon@co-opfeed.com and I will refer to the appropriate Elanco rep to help you out…

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.

Update from AFIA on FSMA Inspections

The following information was provided by AFIA on 3/13/19. Used with permission…

The Food and Drug Administration had a busy year in 2018 conducting inspections for the current good manufacturing practice (CGMP) and the hazard analysis and risk-based preventive controls portions of the Food Safety Modernization Act (FSMA) regulations. In this update, the American Feed Industry Association shares the latest data received through a Freedom of Information Act request.

Current Good Manufacturing Practice Inspections

In 2018, the data indicates that state and/or federal inspectors performed and/or completed 622 CGMP inspections in 47 different states, one U.S. territory (Puerto Rico) and four countries (Canada, Mexico, India and Indonesia). 

The majority of CGMP inspections (58 percent) occurred at feed manufacturers or integrated feed facilities. Ingredient suppliers, renderers, distributors and facilities classified as “other” also received inspections during the same time frame. 

Across the 622 inspections, 28 facilities received a FDA Form 483 (“Notice of Inspectional Observations”). Of the 28 forms issued, 14 were Voluntary Action Indicated (VAI, or minor issues), five were classified as No Action Indicated (NAI) and eight were not classified. One facility failed inspection, receiving an Official Action Indicated (OAI) notice. Issues related to pest control and housekeeping were mentioned on most of the FDA Form 483s, with the most common examples being spilled feed, bird droppings and nests, live and dead rodents, cat excrement and the presence of roaches. Although a facility may consider many of these observations irrelevant, the FDA considers them serious. There are no sanitation standards that specify the number of rodents or droppings that can be present at a feed facility, but AFIA cautions that numerous dead rodents or other sanitary issues may draw FDA’s ire. General sanitation standards apply to animal food establishments under the FSMA CGMPs

Hazard Analysis and Risk-Based Preventive Controls Inspections

Inspections for large-sized animal food facilities (i.e., those firms with more than 500 full-time equivalent employees) on the hazard analysis and risk-based preventive controls regulations began in late 2018. These large-sized firms have been required to be in compliance with the regulations since September 2017, however, the FDA delayed inspections while it trained investigators, allowing firms more time to gather documentation under the system. 

Through the FOIA request, AFIA has learned of seven hazard analysis and risk-based preventive controls inspections that occurred in 2018. The inspections were held in four states at feed manufacturing, integrated feed facilities and pet food facilities. From the seven inspections, six facilities received a FDA Form 483, which is a very high rate. It is believed this high rate of observations can be attributed to the fact that the FDA purposefully sought out these facilities as they may have had recent animal food safety incidents. As industry interprets receiving a FDA Form 483 as very serious, AFIA is in communication with FDA officials regarding this action to help ensure the reasons the agency issued a FDA Form 483 are truly adverse findings versus a simple method of documenting the findings from the inspection.