Regulatory - FSMA Update
3/10/2014
Richard Sellers, senior vice president of legislative and regulatory affairs
A Look Ahead for 2014 and a Look Back at 2013
Monday, March 10, 2014
by: Richard Sellers, senior vice president of legislative and regulatory affairs

Section: Spring 2014





FSMA and VFD Will Dominate Feed Regulatory Agenda in 2014 with a Strong Push by AFIA for Fixing the Ingredient Approval System
Food Safety Modernization Act
Even though the Food Safety Modernization Act was signed into law in January 2011, it will continue to have a major impact on the feed industry throughout 2014. The animal food preventive control proposed rules were released in October 2013 with a very short comment period and more than 400 pages to review. Unfortunately, a lawsuit against the U.S. Food and Drug Administration by consumer groups prevailed in federal court, which resulted in a court order that limited the comment periods for all the rules. Final rules must be issued by the end of June 2015, according to the court’s order.
 
A bit of good news came before the end of 2013, when FDA published FSMA required proposed rules for intentional adulteration, which FDA said animal food is not included. It asked for comments on that approach, and the American Feed Industry Association will agree with it. However, the safe food transportation proposed rules, published in early February, have a slightly longer comment period under the court’s order. AFIA most recently submitted comments on the foreign supplier verification programs and third-party certification for foreign supplier. The comment period remains open for the animal food, intentional adulteration and safe food transportation rules. This is quite a load of federal regulations to review and submit comments.
 
Moreover, FDA said it will re-propose or issue certain new proposals on issues in the proposed rules for produce, human and animal food. At time of publication, FDA said it had not decided the scope of the notice. It is likely the agency will propose rules for suppler verification, environmental testing and end product testing—all issues appearing in the test of the preamble to the animal food rules, but not in the rules themselves.
 
In the midst of the FSMA rulemakings, FDA published a proposed rule on the Veterinary Feed Directive, or VFD, process that it had published draft rules for two years earlier. AFIA agreed with the entire draft proposal, but needs to review the rule in light of the new proposal. AFIA has requested a 60-day extension of the comment period in order to finish comments on the FSMA rules.  
AFIA held working group meetings in mid-January that were attended by 35 AFIA members, who discussed the FSMA rules and reached significant consensus on a number of FSMA-related issues. AFIA’s final comments will likely have already been delivered to members for final review and comments when this publication is distributed.
 
The AFIA staff is hopeful that we can capture the major issues and a large number of the minor ones in these comments with the short review time.
 
AFIA has two principal concerns regarding the animal food rule. One concerns whether FDA should separate the rules into feed and pet food, such that it is not only clear to the FDA investigators but pet food microbial controls will not be a burden on feed mills. At press time, the prevailing consensus is that the final rules can be crafted in such a way as to have one set of rules with clear differentiation for each segment by inserting such terms, as “where appropriate” and “if applicable,” so each industry segment can determine what is required to meet the requirements.
 
The other major issue concerns the part of FSMA requiring FDA to define very small businesses (VSBs) and small businesses (SBs). FDA developed three option levels for VSBs based on animal food sales, which are $500,000, $1,000,000 or $2,500,000 in average annual sales. The agency is asking for comments on which level it should use.  Below whatever VSB level FDA establishes, the facility would not be subject to the preventive controls if it either labels its products with name/address or submits a food safety plan to FDA and provides FDA with the data sufficient to determine the firm is a VSB. Such firms would also be provided three years to comply with any final rule. No firm would be exempt from the other proposed rules, which are current good manufacturing practices rules.  
If a firm couldn’t fall under the VSB proposal because it sold more dollar volume than the threshold FDA adopts, then it could be granted two years to comply if it had less than 500 employees at all of a firm’s operations, including non-feed ones.
 
AFIA members are concerned with exempting any facilities from this important rule.FDA said that at the $500,000 threshold, there are only three firms that would be exempt. These are likely small pet food treat manufacturers. The consensus of the AFIA FSMA working group is that no firm should be exempt from these important rules. AFIA may offer FDA a much lower option, such that all firms would be required to comply.
 
Of major concern with the structure of the rules is FDA’s clear hazard analysis and critical control point language that is pervasive in the proposed rules. AFIA will note in its comments that Congress never used the term HACCP in FSMA, and while AFIA holds HACCP training courses for its members, it does not support mandatory HACCP, as a government requirement for one food safety program stifles innovation.
 
AFIA will utilize comments prepared by the Grocery Manufacturers Association to align the association with other major groups expressing the same concerns about FDA’s approach in the rulemaking. The food groups had more time to prepare comments and AFIA agrees with GMA’s approach on a number of issues and concerns.
 
Veterinary Feed Directive
The Veterinary Feed Directive is a provision placed into federal law at the request of AFIA in the 1996 Animal Drug Availability Act to prevent U.S. Food and Drug Administration from distributing the medicated feed distribution system by requiring prescription medicated feed. FDA has determined that more approved animal drug use in medicated feed be under the control of a veterinarian. The VFD process requires a veterinarian to issue VFD orders for certain approved animal drugs to control use.
 
FDA said it wants to move all medically important animal drugs used in feed and drinking water from production claims (e.g. growth promotion, feed efficiency and milk production) to therapeutic claims (e.g. cure, treat, prevent or mitigate disease). It has given drug sponsors three years and a road map via guidance documents. These documents tied with a VFD requirement for these drugs provide a program for future use in medicated feed.
 
AFIA estimates there are some 15 drug compounds with nearly 120 uses that would need changing to meet FDA’s new requirements for “judicious use” of these medically important drugs. FDA claims this would not only protect the drugs but diminish use and assist in reducing antibiotic resistance to drugs used both in agriculture and human medicine. 
AFIA’s concern is with the VFD portion of FDA’s judicious use approach. The expected disruption in the marketplace by moving these drugs to therapeutic use will dramatically change medicated feed dynamics. AFIA sees the need for training veterinarians in the VFD process, working to be able to stock VFD feed at producer-available locations and raising awareness in the producer industries on how this process works.
 
FDAAA and the Ingredient Approval Process
The Food and Drug Administration Amendments Act of 2007 required U.S. Food and Drug Administration to create ingredient standards and definitions for pet food. FDA said they should do it for all animal food, but is unsure where there are “standards,” as the American Association of Feed Control Officials definitions are not considered standards. FDA has signed a memorandum of understanding with AAFCO until September 2015, which makes the AAFCO/FDA informal approval process operational until then. Beyond that timeframe, AFIA members are concerned about the approval process and what to do about investments of time and resources in pursuing new, innovative ingredients.
 
AFIA has worked with FDA to provide a number of options. However, many of the options have run into trouble with the agency’s attorneys. One goal is to have federal law recognize some version of AAFCO’s “Official Publication,” which would be recognized as the legal feed ingredients in the U.S.
 
Last spring, AFIA Board of Directors visited many of their legislators in Congress. Some convinced the legislators to write FDA about this crisis of ingredient approval. Some 35 representatives signed on to one a letter. One representative wrote a separate letter as well as two senators. FDA has responded to the group letter and two other letters. The response has been seen as incomplete and FDA said that the Center for Veterinary Medicine does not know how it will proceed.
 
At time of publication, AFIA is formulating a plan to resolve this issue long term. The AAFCO leadership would like this issue resolved as well.
 
Salmonella in Feed 
In July 2013, U.S. Food and Drug Administration published a final compliance policy guide for Salmonella in feed and withdrew a final rule regarding the same. The gist of the CPG is that FDA moved from a view that all salmonellae were adulterates in feed, to one that states only eight serotypes in five species of feed are adulterates. The CPG also said any salmonellae in pet food (brought into the home) may be considered adulterants in pet food.
 
AFIA is still interested in working with the U.S. Department of Agriculture’s Agricultural Research Service’s Feed and Food Safety Research Unit to conduct a nationwide survey of feed and ingredients to determine if the eight serotypes of FDA’s concern are found in feed. If not, then these hazards are not reasonably foreseeable and thus no preventive controls are needed under FSMA. This likely will take some months to a year to accomplish once the survey begins.
 
AFIA’s legislative and regulatory team is closely monitoring these issues and will issue updates via AFIA “FeedGram” newsletters during 2014 and weekly FSMA updates (distributed on Wednesdays). For more information on FSMA, VFD or other regulatory issues, contact Richard Sellers, AFIA senior vice president of legislative and regulatory affairs, at rsellers@afia.org or (703) 558-3569. 
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