The regulatory counsel for the Food Marketing Institute, Erik Lieberman, urged rules that foster food safety without undue burdens.
Photos by Bob Ferguson.
As part of the rules mandated by the Food Safety Modernization Act (FSMA), on October 29, 2013, the Food and Drug Administration (FDA) posted its proposed rule, "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals."
The FDA invites comments on this proposed rule until February 26, 2014. The FDA will review and consider the comments, then issue a final rule.
Michael Taylor, the FDA's deputy commissioner for foods and veterinary medicine, said during the first public meeting on the animal food proposal that it is the fifth of the major FSMA rules. He stressed that these rules are a "comprehensive solution to the challenges of the 21st century." He also said that the rules might be viewed as part of a system - if anything goes wrong in one, all are affected. Taylor noted that two more food rule proposals will be issued soon. One will focus on intentional adulteration of food; the other will cover safe transport of food.
As with the other FSMA proposals, this proposed rule focuses on prevention. The preventive control provisions would cover both domestic and imported animal food, including pet food, animal feed, and raw materials and ingredients. Producers would be required to have written plans that identify hazards and specify steps to minimize or prevent them. Monitoring procedures must be identified and recorded. The actions that would be taken to correct problems must be specified.
In addition, the proposed rule would also establish Current Good Manufacturing Practices (CGMPs) that address animal food specifically.
Facilities that manufacture, process, pack or hold animal food and are required to register as a food facility under section 415 of the Food, Drug & Cosmetic Act fall under the rule. Farms that manufacture food for their own animals, or facilities that are not required to register as a food facility, are generally exempt. Some facilities are subject to modified requirements for either the hazard analysis and risk-based preventive control requirements, the CGMPs, or both.
Facilities with animal food sales averaging less than $500,000 per year during the last three years, and whose sales to qualified end users exceed sales to others, must certify that they are implementing and monitoring preventive controls or complying with applicable nonfederal food safety law, which triggers a labeling requirement. (A qualified end user is a consumer in any location or a restaurant or retail food establishment that is located in the same state or not more than 275 miles away and is purchasing the animal food for sale directly to consumers.) Records to support the certifications must be maintained. These facilities must comply with the CGMPs.
Richard Sellers, AFIA, has held over 85 presentations about the proposed animal food rule. He says the time period for comments is too short to provide the requisite feedback.
The proposal has three possible definitions for a very small business: annual sales less than $500,000, $1 million or $2.5 million. Whatever level is ultimately chosen, these facilities must also certify that they are qualified facilities and comply with CGMPs.
Animal foods subject to the low-acid canned food regulation are exempt from the preventive control requirements. However, this exemption applies only to those microbiological hazards addressed by the low-acid canned food regulation. These facilities must comply with CGMPs.
Activities within the definition of "farm," including farm activities that are covered by the proposed produce safety rule, "Standards for the Growing, Harvesting, Packing and Holding of Produce," are exempt from the preventive controls and CGMP requirements in this animal food proposed rule.
Certain low-risk manufacturing/processing activities, packing or holding activities conducted by small or very small businesses on farms for specific animal foods are exempt from the hazard analysis and risk-based preventive control requirements, but must comply with the CGMPs. Examples include conveying, weighing, sorting, culling or grading grain, oilseed, grain and oilseed byproducts, and forage.
Facilities such as grain elevators and warehouses that store only raw agricultural commodities (other than the fruits and vegetables covered by the produce safety rule) intended for further distribution or processing are exempt from the preventive control requirements, provided they are solely engaged in such storage. Also, they are exempt from CGMPs.
Facilities such as warehouses that only store packaged animal foods not exposed to the environment, and for which refrigeration is not required for safety, are exempt from the preventive controls. However, if refrigeration is required for safety, modified preventive control requirements apply; specifically, there are requirements concerning temperature controls, including monitoring, verification and records. In addition, CGMP compliance is required in both cases.
Hazard analysis and risk-based preventive controls
The owner, operator or agent in charge of a facility would be required to comply with these science and risk-based preventive controls. The facilities have some flexibility if their controls are adequate to significantly minimize or prevent food safety hazards that are reasonably likely to occur. The requirements are similar to hazard analysis and critical control points (HACCP) systems, but the preventive controls may be required at points other than at critical control points. Also, critical limits would not be required for all preventive controls.
The written food safety plan's hazard analysis would evaluate hazards for each type of animal food manufactured, processed, packed or held at the facility. The preventive controls would need to be appropriate for both the facility and the animal food produced. For example, prevention of cross-contamination and sanitation affecting animal food safety would be addressed. With reasonably likely hazards, a recall plan would be required.
Monitoring would need to provide assurance that preventive controls are performing. If ineffective, corrective actions would have to be implemented, and modifications to the food safety plan might be required. Verification activities could include records review or instrument calibration. The FDA also seeks comments on product and environmental testing programs, as well as review of customer and other complaints.
Records on all aspects of the food safety plan are required.
Current Good Manufacturing Practices
Although not identical, the CGMP provisions are similar to the requirements in the human proposed rules. One exception is that allergen cross-contact preventive controls are not addressed in the animal proposed rule.
The CGMP areas include hygienic personnel practices and training; facility operations, maintenance and sanitation; equipment and utensil design, use and maintenance; processes and controls; and warehousing and distribution. Extensive details are set forth in the proposed rule. It can be accessed at http://www.fda.gov/fsma, which has links to the other proposed rules on the right side of the page. This site provides links to current, related information as well. The subscription service, also accessible there, enables the public to stay up-to-date.
The rule will become effective 60 days after the final rule is published. Very small businesses would have to comply three years after publication of the final rule. Small businesses, which employ fewer than 500 people, would have two years. Larger businesses that do not qualify for exemptions would have one year.
Patrick O'Connor, International Warehouse Logistics Association, asked the FDA to clarify the rule on packaged foods that are not exposed to the environment.
The FDA estimates the one-time cost to industry at $100.74 million. Discounting over 10 years at a 7 percent discount rate and adding the annual costs results in a total annualized compliance cost estimated at $128.75 million.
Public hearing comments
As part of the rulemaking process, the FDA holds public hearings at three locations across the country. FDA officials explain the proposed rules, respond to questions and hear comments from the public. These are recorded and available on the FSMA website in the "Public Meetings" section.
At the first hearing in College Park, Md., four public comments were made.
Erik Lieberman, regulatory counsel for the Food Marketing Institute (FMI), commended the FDA for its outreach activities, which the FMI is confident will result in well-informed rulemaking. Regarding the animal food proposal, Lieberman noted that the supermarket industry sells billions of dollars of pet food yearly, and many supermarkets sell human food "waste" into the animal supply chain.
He said, "We believe that the mere holding of pet food in supermarket distribution centers should be exempt from the preventive control requirements." Lieberman said the CGMPs are more than adequate to protect animal health. The FMI supports written CGMPs for holding facilities, but subjecting supermarket distribution centers to the full preventive control requirements would impose immense burdens that would not enhance animal health.
Lieberman added that sustainability is a priority, and one way retailers and supermarkets address it is through selling the food "waste." He said, "A costly regulatory burden imposed by the rule could lead our members to abandon this practice and this food would instead end up in landfills." The FMI hopes that the FDA crafts a regulation with sufficient flexibility to allow the sustainable practice to continue.
Patrick O'Connor, Washington representative, International Warehouse Logistics Association (IWLA), said their members follow the FDA's CGMPs. The IWLA supports the modified exemption for warehouse facilities that store TCS packaged foods. (TCS foods require time and temperature controls for safety, and the proposed rule delineates preventive controls to ensure this safety.) However, O'Connor said that the responsibility should be placed on the party in the best position: the product owners. Also, O'Connor said, "The agency should require this information to be passed to supply chain participants who store the food."
Kirsten Theisen, director of pet care issues, Humane Society of the United States (HSUS), said they continue to hear from pet owners regarding the jerky treats and melamine incidents. Supportive of the FDA's proposed rules, Theisen said the rules' greatest impact on pets and families will be the regulation of intentional ingredient hazards where the purpose is economic gain. Referring to adding ingredients such as melamine to make it appear that the product has more protein, she said, "This cannot be tolerated." She added that the HSUS is working with the FDA to stop economic adulteration of food.
Richard Sellers, the American Feed Industry Association's (AFIA) senior vice president of legislative and regulatory affairs, said their main concern is the FDA's court-mandated comment period. He said, "We believe in food safety and will work with FDA to implement the rules seamlessly." In fact, safety of animal feed was the primary reason for the formation of AFIA in 1909.
At the FDA's hearing in College Park, Md.,economist Eric Nelson explained to attendees how the economic costs were calculated.
Sellers said he hopes the FDA will win its appeal on FSMA's implementation dates. Explaining its unrealistic time frame, Sellers said, "This industry has never seen the magnitude of such rulemaking with such a major impact on all of the feed industry. We are expected to review, answer questions and provide comments in just over four months."
Pointing to the small and medium facilities in the heartland, Sellers said, "The majority of feed mills, not the majority of the feed tonnage, will have difficulty understanding, crafting programs and fully implementing the rules."
However, Sellers applauded the FDA for its "fairly well-constructed set of rules" with a "clear guidepost for compliance that can coalesce the feed industry around a basic feed safety standard." Sellers expressed concern, however, that there are too many similarities between the proposed animal food and human food rules. He said some of the animal food requirements will have little or no benefit from imposing some of the human food requirements on the animal feed industry.
The AFIA, with the National Grain and Feed Association (NGFA) and Feedstuffs, scheduled a comprehensive webinar on the proposal for December 11, 2013. Sellers, David Fairfield, vice president of feed services for the NGFA, and Dr. Daniel G. McChesney of the FDA were featured speakers. The AFIA website, http://www.afia.org, contains detailed information.
How to comment
Comments may be made electronically at http://www.regulations.gov. Mail, hand delivery or courier submissions may be directed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments must include the docket number, FDA-2011-N-0922, and/or the regulatory information number, RIN 0910-AG10. The deadline is February 26, 2014.
Questions to the FDA can be directed to FSMA@fda.hhs.gov.
The author is a writer-researcher specializing in agriculture. She currently resides in central Pennsylvania.