Regulatory Outlook
3/11/2015
Richard Sellers, senior vice president of legislative and regulatory affairs
Wednesday, March 11, 2015
by: Richard Sellers, senior vice president of legislative and regulatory affairs

Section: Spring 2015




Each year the American Feed Industry Association reviews the major issues of the year to detail what occurred previously and look into our crystal ball for the year to come. As we have learned from the past, most issues don’t change with a new year, as regulatory issues are usually on a continuum. However, there is no disagreement the major issue this year—and last—was the publication of the animal food proposed rules and the expected publication of animal food rules in August 2015, by the U.S. Food and Drug Administration, implementing the Food Safety Modernization Act signed into law in 2011.

Food Safety Modernization Act
 
FSMA has consumed much of AFIA and FDA’s time since it was made a law in 2011. More than 2,000 pages of proposed rules have been published and final rules will be seen in August of this year under a court order resulting from a lawsuit filed by public interest groups against FDA claiming the agency was delaying publication of rules mandated by Congress to be finalized in 2012.  
 
Each facility manufacturing, processing, packing or holding food, feed, pet food or ingredients are required to register with FDA under the Bioterrorism Act unless the facility is a farm. “Farm” for livestock is defined as a feed mill making feed for animals that is consumed by the animals on the land owned by the feed mill’s company. This exemption is usually only for a few poultry operations and cattle feedlots. FDA is examining whether that exemption should continue or not, but that will not likely be part of the final rule, as specific changes were not proposed by FDA.  
 
By registering with FDA, a facility is automatically subject to these new FSMA rules. FSMA did not authorize Current Good Manufacturing Practices rules, but FDA has authority in other laws to develop CGMPs rules and believes these would be good controls in addition to hazard identification and preventive controls (HID/PC) required by FSMA. The CGMPs and HID/PC rules have been published together in the same rulemaking packet.  
 
AFIA reviewed the rules in depth and noted to FDA that compliance with the rules would be very costly (more than $600 million). The rules are mainly geared toward the food industry, are overly prescriptive and are not practical for the U.S. animal food industry, which includes feed and pet food. AFIA also noted the rules should agree with the 40-year-old CGMPs for medicated feed with which large feed mills have good knowledge and excellent compliance.  
 
AFIA commented to FDA that most significant hazards in feed mills can be controlled by CGMPs, thereby not requiring more costly preventive controls. Such an approach could significantly reduce the total costs of the rules. Also, AFIA believes the timelines for compliance are not long enough and AFIA will provide data indicating that more time is needed by the industry to comply.
 
FDA has established the Food Safety Preventive Controls Alliance, which set up the Animal Food Safety Preventive Controls Alliance to develop a framework for training and to develop guidance and example documents. This group is currently operating by developing the documents and structure necessary to compliance of the new rules by FDA-registered facilities. AFIA’s Dr. Henry Turlington is AFIA’s representative to the Alliance.
 
AFIA has conducted trainings about the proposed FSMA animal food rules at 10 different venues and expects two more phases of training to take place, including a series of training events in the spring of this year. The trainings focused on providing detail on the law and rules and assisting firms in developing new compliance programs.  
 
AFIA believes the new final rules will adopt many of the industry’s suggested changes that will be more practical, more feed-industry specific and less costly than what FDA has proposed. After publication, FDA said it will allow a phase-in period for implementation of several years depending on a facility’s parent company’s size.  
 
There were more than 65 member firms involved in reviewing and drafting comments to proposed rules for the following: CGMPs and PCs for animal food, intentional adulteration, safe transportation of food, foreign supplier verification, third-party certification of foreign suppliers, enforcement options, intentional adulteration of food and feed, and high and low risk facilities models. The working groups’ hard work paid off with the groups being named AFIA’s Members’ of the Year for 2014. See page 33 to learn who’s involved.
 
AFIA will continue lobbying its positions on FSMA that include reducing the costs, making the rules less prescriptive and more feed-industry oriented, among other things, during this FDA final rule drafting period. This includes meetings with FDA on implementation periods, with the president’s Office of Management and Budget (which oversees rulemaking for all federal departments and agencies), and speaking with legislators on Capitol Hill.  
 
The final rules will likely have many of AFIA-suggested changes, including more emphasis on CGMPs, thereby significantly reducing the costs to comply.  
 
Veterinary Feed Directive
 
The Veterinary Feed Directive process was codified in 1996 by Congress in the Animal Drug Availability Act. Within a year, the first VFD animal drug was approved. Since that time, the same product has been approved for beef and another animal drug additive has been approved for use in pigs, catfish and salmonids. The use of these compounds is governed by the applicable federal animal drug regulations and the VFD rules. Such use requires the authorization by a licensed veterinarian via the VFD process.  
 
In 2013, FDA proposed that all growth promotion, feed efficiency and milk production claims should be voluntarily removed and therapeutic claims with veterinarian oversight should be utilized. This would encompass 29 drug sponsors, all of which have agreed to the change, with about 15 chemical entities involving 283 claims—a monumental undertaking by the feed industry and FDA. These changes must take affect by drug sponsors before December 2016, according to FDA. 
 
Along with the changes, FDA decided, at the feed industry’s request, to update the VFD rules that govern how the process works. Of particular concern were the administrative burdens placed on the feed industry by an outdated VFD form and system. FDA has provided two draft VFD rule changes and is expected to publish a final rule in April 2015 adopting all of the feed industry’s requested changes.  
 
Discussions with the animal drug and feed industries have taken place on several occasions. There are efforts to create a model VFD form, a timeline for the changes, method for roll-out of the changes and other relevant topics. Of particular concern is what to do about existing products in the marketplace when the new products are approved for each animal drug. What FDA will allow in implementation time of any new rule and new products is the main issue.  
 
FDA and the animal drug and feed industries will provide education campaigns on the newly updated VFD rule after it publishes. The feed industry anticipates doing webinars, guidance documents and meetings to assist with compliance of the new procedures. It will also survey its members close to the time of the drug sponsor changes to determine how much existing Type A medicated articles (drug premixes) are in the marketplace. This will assist in determining whether the industry will request additional implementation time to exhaust supplies of old product and phase-in the new products. For more information on VFD, visit FDA’s website here: www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm.
 
Ingredient Approval Process
 
Since the enactment of the Food and Drug Administration Amendments Act of 2007, FDA has jeopardized the ingredient approval process by noting that this new law requires development of “ingredient definitions and standards.” The term “standards” had not appeared in federal and state law and was not defined. This resulted in FDA stating that most ingredients in the Association of American Feed Control Officials Official Publication needed to be reviewed and published in the Code of Federal Regulations. This presents major problems and new costs for FDA, AAFCO and the industry. As a result of these efforts, FDA has seen an unprecedented number of food additive petitions since firms are not trusting the 35-year old AAFCO informal review process of proposed ingredients. 
 
FDA recently provided AFIA a potential roadmap for meeting the FDAAA’s and FDA’s requirements for listing and publication in the Code of Federal Regulations. FDA recognizes there are about 900 ingredients in AAFCO’s OP and probably 700 need additional information to be prepared to meet the requirements of the particular ingredient being either generally recognized as safe or published as an approved food (feed) additive. FDA has recently provided AFIA with a draft roadmap for comments on how this effort will proceed.  
Work will continue on this effort throughout the year. AFIA expects FDA and AAFCO to reauthorize their memorandum of understanding for another two years until September 2017, providing additional time for FDA to adopt the already approved and AAFCO-listed ingredients in some form via the roadmap process. AFIA will also continue to pursue its goal of recognizing the AAFCO OP by placing it in federal law.  
 
State Issues
 
Every state legislature will hold a session this year and feed laws in several states are under review by either the legislature, department of jurisdiction or industry. AFIA will be involved in the following state feed law reviews:  Illinois, Kansas, Michigan, Minnesota, Nevada, Utah and Wisconsin. Other states will be reviewing their feed rules. AFIA’s goal is for the state to adopt (as close as possible) the AAFCO Model Bill and Regulations without the civil penalty provision the organization recently adopted, which AFIA opposes. [See article on page 10 regarding state efforts]. It will be the busiest state year ever for AFIA made busier by the electronic age.  
 
Association of American Feed Control Officials
 
AAFCO has matured over the last several years with the contracting of the Federation of Animal Science Societies to manage AAFCO’s business affairs. The relationship has resulted in better meetings, agendas at all meetings, better publications and timing and a dramatic and welcomed increase in the overall efficiencies of AAFCO. The organization is continuing reviews of its by-laws, committee structure and events to streamline all efforts.
 
These changes benefit the industry by promoting AAFCO uniformity among their members (states and FDA), having more of their members attending AAFCO’s meetings, interacting better with industry, streamlining the AAFCO meeting and approval process and a general upgrade of the efficiencies of AAFCO efforts. AFIA appreciates all these efforts and our 106-year relationship between our two great organizations.  
 
Genetically Engineered Products and Labels
 
Genetically modified organisms have been in the marketplace since the first planting of GMO soybeans in 1996. The products have provided better crop yields, use fewer pesticides and are generally regarded as safe products by the scientific and medical communities. However, some major efforts are being made to require mandatory labeling of products containing GMOs by state referendum, state legislative efforts or a combination of these.  
 
Recently, efforts have been underway by a large coalition of agriculture organizations to pursue a federal legislation that would preclude a patchwork of state efforts. AFIA supports both the use of safe, proven technology and efforts to mandate some type of national uniformity without interfering into long-standing animal food labeling and policy issues.
 
AFIA is better equipped than ever to tackle these and many other issues with the addition of two more staff members in the last two years. The support of the AFIA Board of Directors and membership to make AFIA the strong organization representing the interests of the total feed industry is greatly appreciated. Our strong program is recognized by AAFCO, FDA, our state affiliates, our ingredient sister organizations and our customer producer organizations. Strong assistance by our member-led committees and working groups continues to provide AFIA with the leadership it needs be the strong organization that it is now and in the future. 
 
AFIA’s legislative and regulatory team is closely monitoring these issues and will issue updates via AFIA FeedGram newsletters during 2015 and email notifications as needed. For more information on FSMA, VFD or other regulatory issues, contact Richard Sellers, AFIA senior vice president of legislative and regulatory affairs, at (703) 558-3569 or rsellers@afia.org.
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