Comments Invited on FDA's Proposed Rules for Animal Food/Feed Manufacturing Practices

Last Friday, the U.S. Food and Drug Administration (FDA) announced the release of a long-awaited proposed rule required by Section 103 of the Food Safety Modernization Act (FSMA) aimed at ensuring the safety and quality of food for animals. Under this proposed rule, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, most facilities that manufacture, process, pack or hold animal food or food ingredients will be required to comply with newly issued current good manufacturing practice (CGMP) regulations and implement hazard analysis and risk-based preventive controls plans.

Who is Covered?

The proposed rule applies to facilities required to register with FDA that manufacture, process, pack or hold animal food and ingredients for animal food. This can include renderers, pet food manufacturers, grain and oilseed processors, warehouses, grain elevators, and renewable fuel facilities that produce distillers grain or other co-products that are either fed directly to animals or incorporated into other food/feed products. The proposed rule would not apply to farms that manufacture food for their own animals.

What is Required?

CGMPs

Prior to this rule, only animal food facilities producing medicated foods had to comply with FDA-mandated CGMPs. The proposed rule, for the first time, establishes CGMPs for all other covered animal food facilities. The CGMPs address such topics as hygienic and sanitation practices for personnel, facility and grounds, equipment, utensils and food contact surfaces, and water supply.
The proposed CGMPs are very similar in scope and content to the CGMPs currently applicable to human food facilities (21 CFR Part 110) rather than either the commonly-followed model GMP regulations established by the Association of American Feed Control Officials (AAFCO) or the CGMPs applicable to manufacturers of medicated feed (21 CFR Part 225). Unlike the current human food facility CGMPs, however, the proposed animal food CGMPs contain a mixture of mandatory (i.e., "must") requirements and recommended (i.e., "should") procedures/equipment.

Hazard Analysis and Preventive Controls

The proposed rule also requires a "qualified individual" (through training or job experience) at covered facilities to create and implement a written food safety plan that includes as appropriate:

• A hazard analysis to identify known or reasonably foreseeable hazards for each animal food manufactured, processed, packed or held at the facility, which could include biological, chemical, physical and radiological hazards. FDA is seeking comments on whether to include as potential hazards economically motivated adulterants for which there is a widely recognized risk in certain animal food (e.g. addition of melamine to enhance perceived quality and/or protein content).
• Preventive controls to address identified hazards, which may include process and sanitation controls. As with the proposed human foods preventive controls rule, FDA is seeking comments on when and how some elements of a preventive controls system are appropriate to implement, including product testing, environmental monitoring, and supplier approval and verification programs.
• Monitoring procedures to assure preventive controls are being followed.
• Corrective action procedures specifying what actions would be taken to correct problems that may arise from failure to follow preventive controls.
• Verification procedures to ensure preventive controls are consistently implemented and effective.
• A recall plan for animal food with a hazard reasonably likely to occur.

Significant recordkeeping requirements for all of these required activities are included in the proposed rule.

FDA has proposed certain exemptions and modified requirements for preventive controls. For example, grain elevators and warehouse facilities that store only raw agricultural commodities (other than fruits and vegetables covered under the produce safety rule) intended for further distribution are exempt, as are warehouse facilities that only store packaged animal foods for which refrigeration is not required.

Facilities that have animal food sales averaging less than $500,000 per year over the past three years, "very small businesses" based on total annual sales, and warehouse facilities that only store packaged animal foods for which refrigeration is required are subject to modified preventive control requirements. (The proposed rule includes three possible definitions of "very small businesses," ranging from less than $500,000 to less than $2.5 million.)

How Does This Rule Differ from FSMA's Proposed Rule for Human Food?

Although the proposed rule is similar to FDA's Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food released at the beginning of this year (see 78 Fed. Reg. 3646, Jan. 16, 2013), there are some differences in the way the two rules address relevant hazards. For example, the proposed rule for animal food does not address allergen cross-contact in the CGMPs or hazard analysis and preventive control requirements. Unlike the proposed rule for human food, FDA is proposing labeling controls as part of the CGMPs, reasoning that animal food is often the animal's sole source of nutrition and different species of animals can be adversely affected by too low or too high levels of specific nutrients. Another key difference is that the hazard analysis for animal foods needs to take into consideration the various animal species to which a food could be fed – for instance, a particular serotype of Salmonella may be pathogenic to one species but not another. Similarly, certain chemicals or metals may be harmful to some species but not others.

When Does It Go Into Effect?

The rule will go into effect 60 days after the final rule is published – which is not expected until sometime in 2015. Most covered facilities will have one year after the final rule is published in which to comply. "Small businesses" (employing fewer than 500 persons) would have two years to comply and "very small businesses" (as mentioned above) would have three years to comply.

Other Relevant Dates

The proposed rule is scheduled to be published in the Federal Register on October 29, 2013. Comments are due within 120 days after the publication date. FDA announced it will hold three public meetings on the proposed rules: November 21, 2013 in College Park, Maryland; November 25, 2013 in Chicago, Illinois; and December 6, 2013 in Sacramento, California.