Regulatory - FSMA Update
9/8/2014
Richard Sellers, senior vice president of legislative and regulatory affairs
Monday, September 8, 2014
by: Richard Sellers, senior vice president of legislative and regulatory affairs

Section: Fall 2014




In the last six months, the American Feed Industry Association has submitted comments to the U.S. Food and Drug Administration on five major proposed regulations and notices that affect the animal food industry. The work is ongoing, and the AFIA website has the latest updates, as does www.fda.gov/fsma.
 
GMPs/PCs
 
AFIA submitted comments on March 31 to FDA on the Food Safety Modernization Act proposed rule on “Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals.” Nineteen regional and state feed associations also signed on to AFIA’s letter as a statement of their support. The proposed rule could be the most massive overhaul of the animal food industry regulations since 1958. AFIA’s response to the overhaul was 100-plus pages in length and covered five major areas. Given the time constraints on the comment period due to a court-ordered comment deadline, AFIA focused primarily on how the rule would impact the many varied segments of the industry to strive for practical and easily understood requirements by the industry, FDA and state investigators that will inspect and audit the new requirements.
 
One major area of AFIA’s comments was its focus on Current Good Manufacturing Practices, or CGMPs, which FDA basically copied and pasted from the human food CGMPs. AFIA stated CGMPs should be “more practical and less prescriptive,” which will allow its members and the industry to be more innovative and have a better understanding of these new rules, as it is the first time many companies will use CGMPs, except for those firms regulated under medicated feed CGMPs since 1976.
 
FDA proposed delayed compliance dates based on size (one year for regular mills, two years for small businesses (SBs) and three years for very small businesses (VSBs)) for both the CGMPs rule and preventive control rule. AFIA believes this is impractical given the majority of the industry has never been regulated under CGMPs. AFIA asked FDA to consider a phase-in approach to give small to medium-sized feed mills additional time to implement CGMPs followed by the hazard analysis and preventive controls. AFIA is advocating for one, two and three year implementation periods for CGMPs and two, three and four year periods for preventive controls based on the mills’ size. This will allow firms more time to adjust to basic programs such as CGMPs before having to adhere to more complicated requirements.  Public comments by FDA officials were positive about this approach.
 
AFIA also focused largely on the overall language of the hazard analysis and preventive controls rule, asking FDA to remove all hazard analysis and critical control points, or HACCP, references and requirements throughout the rule, including references to “hazards that are reasonably likely to occur” and return to the statutory language of “known or reasonably foreseeable hazards.”
 
FDA has made public statements that they will reopen and revise items in the rule related to the CGMPs, supplier verification, environmental testing, product testing and some clarifications on the inclusion of by-products from human food facilities and farms. At press time, the reproposal had not yet occurred. 
 
High-Risk Foods
 
On May 22, AFIA submitted comments on FDA’s proposed model that would determine “high-risk” foods (including animal feed and pet food).
 
FDA is required under section 204(d)(2) of FSMA to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary in order to rapidly and effectively track and trace such foods during a foodborne illness outbreak or other events. FDA said it will publish a list of the high-risk foods about the same time the recordkeeping requirements are finalized for the preventive control regulations.
 
After reviewing section 204(d)(2) and the proposed draft model, AFIA told FDA that most of the notice and draft approach appear to be geared to the human food industry. The approach, as written, would be of little practical use in the animal food industry. AFIA is also aware of limited data for many of the parameters used in the seven tentative model criteria. AFIA believes the model criteria are generally not useful for determining high-risk animal foods, and FDA’s Center for Veterinary Medicine should create a specific set of criteria model after its Animal Feed Safety System criteria.
 
Although FSMA mentions animal health in Section 204, AFIA believes with current day industry utilizing modern processing techniques, the development of a list of high-risk animal food products would not be productive and would consume considerable time and resources with little benefit. Either FDA should develop an animal food specific model or the agency should choose to focus on human food where more data are available.
 
Public Notification of a Reportable Food Event
 
Section 211 of FSMA amended the Reportable Food Registry provisions in Section 417 of the Federal Food, Drug and Cosmetic Act to require notification of consumers in “grocery stores” regarding certain reportable foods. Reportable foods are those food, feed, pet food or ingredients with the potential for causing serious adverse health consequences or death in humans or animals.
 
In March, the FDA published an advanced notice of proposed rulemaking seeking feedback on implementing this provision. Under the law, FDA may require a responsible party to submit “consumer-oriented information” regarding a reportable food, except for fruits and vegetables that are raw agricultural commodities. Such consumer-oriented information would include: a description of the article of food; product identification codes sufficient for consumers to identify the reportable food (e.g., UPC, SKU or lot or batch numbers); contact information for the responsible party; and any other information FDA deems necessary to enable consumers to accurately determine whether they possess the reportable food. A standardized one pager would be developed by FDA containing this information that would then be posted by grocery stores (that are part of a chain with more than 15 locations) within 24 hours of the information being posted to the FDA website.
 
In comments to the agency, AFIA stated the belief that congressional intent and the way the advance notice of proposed rulemaking was written did not address specific animal food issues; therefore, animal food should be exempt from this rulemaking. The statutory language does not mention animal food, it addresses notification to “consumers” and requires notifications be published in “grocery stores” only. The law also exempts only the raw agricultural commodities of fruits and vegetables instead of including grains, such as what was done in other parts of FSMA where the law applied to animal food. These items clearly indicate Congress was thinking only of human food products when drafting this provision.
 
Intentional Adulteration of Food
 
AFIA submitted comments on the proposed rule for “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration” on June 30, which requires registered domestic and foreign food facilities to address hazards that may be intentionally introduced by acts of terrorism. Animal food, however, is one of a number of proposed exemptions, because it is not considered to be high risk for intentional adulteration due to its minimized potential impact on human health. The proposed rule is aimed at preventing incidents that would cause massive public health harm, including acts of terrorism. There is a great deal of separation between animal food and the ultimate health of humans that would mitigate the risk of spreading a contaminant through animal food to animals and then on to humans. In the comments, AFIA agreed with FDA’s proposed exemption for animal food because animal food poses a low risk for intentional adulteration. 
 
Sanitary Transportation of Food
 
On July 30, AFIA submitted comments on the proposed rule for “Sanitary Transportation of Human and Animal Food.” The proposed rule would establish requirements for those who transport food (including animal food) to use sanitary transportation practices to ensure the safety of that food. 
 
AFIA urged several recommendations to improve the regulations and make them more practical for the animal food industry. AFIA advocated for additional exemptions to the rule for intra-company transports, products going to farms in dedicated vehicles and short-haul loads. FDA is proposing to exempt shelf-stable products; however, FDA did not provide any examples of how this would apply to animal food. AFIA asked FDA to include examples of shelf-stable animal foods for inclusion in the definition in the regulation so it would be clear how this applied in the industry. 
 
Instead of requiring information on the previous three loads in a container, AFIA encouraged that a carrier should only be required to provide information to the shipper on a single previous load as three previous loads are impractical and unnecessary in animal food. In the proposed rule, FDA is willing to allow electronic records, but proposed the forms must comply with 21 CFR, Part 11 electronic records and signatures rules. The acceptance of electronic records for satisfaction of records requirements is appreciated; however, compliance 21 CFR, Part 11 will be a significant, unnecessary burden to the industry and should not be required. 
 
Economic Impact and Cost/Benefit of the Proposed Rules
 
A number of organizations have expressed serious concerns about the high costs of these proposed rules and minimal benefit. The Mercatus Center of George Mason University, a respected study center that reviews federal rules and policies, has told FDA that the agency’s estimated costs are very low and the maximum benefit is probably about $30 million annually on FDA’s estimated $87 million to $129 million in costs to the industry. Another industry study estimated the industry’s costs to be near $500 million based on surveys of industry segments.  
 
Executive Order 12866 requires agencies to “propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs.” The federal Administrative Procedure Act requires agencies to perform cost and benefit analysis. Mercatus said the agency had neither empirical data nor scientific data to justify the proposed animal food rule. It also said the agency failed to examine alternatives that would lower the costs.  
 
At press time, AFIA is awaiting the second round of proposed rules, which are likely to raise costs higher due to the expected addition of some portions of the proposed rules that the White House Office of Management and Budget removed to lower the estimated costs of the rules.  
 
Although Congress did specify rules were to be promulgated, it also created a provision in Section 418 (m) that allows the agency to “exempt or modify the requirements for compliance under this section with respect to facilities that are solely engaged in the production of food for animals other than man.” AFIA asked OMB to consider promulgating CGMP rules first, performing an analysis to determine the real benefits and promulgate preventive control rules if merited by a retrospective analysis of the CGMP rules costs and benefits.  
 
AFIA FSMA Training Sessions
 
In order to address industry concerns about the lack of experience with process controls and CGMPs, AFIA has begun a series of training sessions with three phases during the next 18 months. Phase I will address the overall FSMA statute, focusing on the preventive controls, basic CGMPs and ways to address hazard analysis. Phase II will address CGMPs more depth and specifics on hazard analysis. Phase III (which will take place after the publication of final rules by FDA) will address preventive controls. There will be several training sites for each phase and many documents will be provided to assist firms in document development. FSMA has many recordkeeping requirements and a two-year recordkeeping requirement.
 
Future
 
With the publication of more rules this summer, AFIA expects to hold other discussion rounds with its members to determine the impact, practicality and enforceability of each rule. AFIA will continue its basic FSMA training programs and develop “qualified individual” training once the Food Safety Preventive Controls Alliance releases the animal food framework for training. Qualified individuals are required at each facility to develop the facility’s animal food safety plan, which is facility-specific. A qualified individual is not required to be an employee of the firm or facility, but it’s clear such individuals will need to be based at larger facilities.  
 
Given the breadth and depth of this law and subsequent rules, AFIA believes a 10-year process is needed to train FDA/state investigators, to bring the industry into full compliance.  
 
For more information on FSMA, contact Richard Sellers, AFIA senior vice president of legislative and regulatory affairs, at (703) 558-3569 or rsellers@afia.org.
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