Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane
Rockville MD 20852
RE: Proposed Rule- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Food for Animals; Docket No. FDA-2011-N-0922 and Regulatory Information Number 0910-AG10
Georgia’s food and fiber production and processing is a $76.9 billion industry, and accounted for more than 375,800 Georgia jobs in 2012. In almost two-thirds of Georgia’s counties, agribusiness and directly related industries are the largest or second-largest economic engines. This is a massive, complex farm and agribusiness economic engine and is made up of many diverse interests, including those in the feed and grain sectors. These businesses are essential to providing the affordable, safe and bountiful food supply we enjoy today. Production and processing benefits are foundational to our national security and the American way of life.
It is these feed and grain agribusinesses and associations listed below that write to you today with many serious concerns about the proposed rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Food for Animals.” Our industry knowledge and practical application of the practices outlined will have many negative consequences, both known and unknown, on animal agriculture in Georgia and across the United States.
The undersigned recommend the U.S. Food and Drug Administration (FDA) take a “B.A.S.E” approach to achieve the goals set forth in the Food Safety Modernization Act. “B” stands for Borders, which is a critical area where FDA should be focusing their attention and resources. “A” stands for Audits, recognizing that FDA will need to actively audit the states, as well as foreign suppliers in other countries. FDA will set the Standard, the “S,” by which firms will be audited. Successful implementation of the rules is contingent on Education, representing the “E,” ensuring that all stakeholders know their roles and responsibilities required by the rules. Food and feed safety is a journey, not a destination. This journey allows us the flexibility to implement new knowledge and technology as we constantly continue to achieve food and feed safety.
We strongly urge the FDA to solicit comments on a second, concurrent, public comment period for all of the FSMA proposed rules: preventative controls for human and animal food, produce safety, third-party certification, and foreign supplier verification. All of the proposals are understandably connected because of their subject matter. It is impossible to effectively evaluate and comment on one rule proposal, while being uncertain about the content that will be included in the other final rule proposals.
In order to ensure that foreign and domestic producers compete on a level playing field, it is critical that we have the opportunity to compare the anticipated major revisions to all five rules at the same time. A second draft will better enable all impacted parties to review changes and offer feedback to help FDA ensure successful implementation of the final rule. Successful Food Safety Modernization Act (FSMA) implementation is too important to food safety, and the future of food production, to hastily promulgate the final rule for one component of the FSMA without giving all affected sectors of the agricultural industry and government sufficient opportunity to participate in an open, comprehensive rulemaking process.
Regulation is a reasonable expectation of our modern society. The FDA must understand that a “one size fits all” approach to agricultural regulations is unproductive in light of the variation in production practices and economic realities of modern agricultural production across the United States. The foundational terms “crop”, “exemption”, “farm”, “harvesting”, “processing”, “raw agricultural commodity” and “same ownership” within the current proposal must be revised to reflect the realities of modern agricultural production, to clarify their meaning and their subsequent application in the regulation. Vertically integrated animal production systems need to be carefully considered and subjected to reasonable risk and science based regulations and redefined terms for “farm” and “same ownership” applied to their system. Grain handling operations need to have the terms “processing” and “raw agricultural product” defined in such a manner as to accommodate current grain storage best management practices and industry standards for commerce while maintaining food and feed safety. The FDA has an obligation to provide food and feed regulation with desired outcomes that are measurable, well defined, based on unbiased research data and that do not to place firms in an unnecessary regulatory paralysis.
It is essential that FDA conduct extensive outreach and education with local, state and federal regulatory partners and industry members before the implementation of the proposed rule to ensure the continuing affordable, safe and abundant food supply American’s and families all across the world have become accustomed to from U.S. producers. For all of the reasons mentioned above, we do not support the proposed rule.
Thank you for your consideration of our comments. We appreciate the FDA’s efforts to support public health in the United States.
Georgia Feed & Grain Association
Georgia Agribusiness Council
GAC feed & grain members
Other allied state associations