- New FDA Current Good Manufacturing Processes Rule Expected for Animal Food Manufacturers
- July 9, 2014 | Authors: Diane J. Romza-Kutz; Fredric E. Roth
- Law Firm: Husch Blackwell LLP - Chicago Office
As part of the Food Safety Modernization Act (FSMA) passed in March of 2011, the FDA was given a mandate to update its regulations to create a new set of regulations/rules that enables it to prevent the introduction of adulterated food into the human and animal food supply in the U.S., as opposed to relying on the reactive approach it has utilized to date. The FDA is nearing the end of its rulemaking procedures to create Current Good Manufacturing Practices (or “cGMPs”) for animal foods. The comment period ended in March, 2014 and a final rule is expected shortly.
With the drafting of this new rule, the FDA has created similar cGMP requirements for manufacturers of animal food products. The rule would establish regulations controlling nearly every aspect of animal food production, from sourcing raw ingredients and on site storage and processing to the packaging, labelling and shipping of final products and waste and even to such seemingly minute details as the landscaping surrounding manufacturing facilities. These cGMPs would require animal food manufacturers to:
Train employees, and ensure their compliance in basic hygiene and preventative measures to protect against the contamination of animal food, including omitting employees from food areas that have certain medical conditions. It would also require that those employees in charge of sanitation have training and an educational background in the area, and would require basic protective clothing for all employees in food animal manufacturing areas.
- Maintain the areas around and attached to animal food manufacturing facilities in such a way as to avoid any sources of animal food contamination. This includes basic maintenance of the grounds to avoid providing rodents and other pests with sources of food, housing and access to the manufacturing area. It would also include the maintenance of structures and roads so that they do not contaminate animal food via seepage or air born particulates, as well as securing the water supply to the facility to prevent contamination.
- Ensure that buildings, fixtures and other physical objects and machinery be maintained in a sanitary condition such that food will not be contaminated or adulterated. Noteworthy is that the new rule contemplates limiting the cleaning agents that can be used on various surfaces as well as requiring cleaning agents be free of any undesirable microorganisms, and that the supplying company guarantee or certify the agents to that effect.
- Establish operations at the facility handling packaged and processed foods, including shipping and receiving, such that packing materials, processes, handling areas and machinery are safe, suitable and sanitary to avoid contamination. This would also require that packaging is clearly labelled to accurately indicate raw materials, processed products and other materials. This labelling requirement is not found in human food cGMPs because, according to the FDA, animal food is often the animal’s sole source of nutrition, and thus can be more sensitive to too much or too little of certain compounds in their food.
Just as cGMPs are important aspects in the production of human food products, the new cGMPs for animal products will represent a real and costly hurdle for animal food manufacturers. New models for operating manufacturing facilities will need to be created, employees will need to be trained, and facility buildings and equipment will need to be refurbished and repaired. Part of this process will also include the creation of a food safety plan related to the prevention, mitigation and reporting of hazards and the implementation of preventive controls. This plan would be created after an analysis of the manufacturer’s risks by a qualified individual, and detail how a manufacturer will address the specific contamination and adulteration risks it faces with particularity to its products and the facilities it operates.
Animal food manufacturers should be particularly focused on the implementation of this plan at all levels of their company, with two specific emphases: First that the plan is diligently followed at in every way and second, that such diligence is recorded. In the event that a product handled or contributed to by a food manufacturer is found to be contaminated or adulterated, having a prepared response and reliable records will be immeasurably important. Being able to provide FDA inspectors with the relevant information as quickly as possible can significantly decrease the costs of such inspections. Identifying any liability for the contamination or adulteration will enable the manufacturer to respond and minimize any costs related to recalls or manufacturing interruptions as well as increase the efficiency of any required corrective actions.
The full applicability of the new cGMPs to food manufacturers will not be clear until the final rule is released. However, the proposed rule indicated that the new cGMPs will not be universally applied. For example, facilities that simply store non-fruit and vegetable agricultural commodities intended for later processing into animal food will be exempt from the new rule. Furthermore, small companies, with revenues less than $2.5 million, or who have limited revenues and at least half result from local sales would not be subject to the new cGMPs. Otherwise any facility and/or manufacturer that must register with the FDA under section 415 of the FDCA will likely be required to implement the new cGMPs.
Finally, it should be noted that once the final rule is enacted, animal food manufacturers may have as little as 1 year, or as many as 3 years, to comply with the terms of the rule. The precise timeline will not be released until the final rule is announced, and will not apply equally to all manufacturers, and will vary with the size of the manufacturer. Either way, manufacturers will not have a significant amount of time to implement the rule, and should begin effecting changes as soon as possible.