Dear Mr. Young,
The Renewable Fuels Association (RFA) submitted comments to the September 29, 2013 proposed rule for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (78 Federal Register 64,736). We appreciate that FDA was sensitive to the concerns raised by RFA and other stakeholders, and we are pleased the Agency has proposed a supplemental rule that helps alleviate many of those concerns.
RFA is the leading national trade association for America’s ethanol industry. Founded in 1981, our mission is to drive expanded production and use of American-made ethanol and co-products by raising awareness about the benefits of renewable fuels. The U.S. ethanol sector has become one of the largest contributors to the U.S. feed supply. Roughly one-third of every 56-pound bushel of grain that enters the ethanol process is enhanced and returned to the animal feed market. Two processes are primarily used to make ethanol in the United States: dry milling and wet milling. Both processes utilize only the starch portion of the corn kernel for ethanol production. The remaining protein, fat, fiber and other nutritional components remain available for use as animal feed or other products. While there are a variety of animal feed co-products manufactured at U.S. ethanol facilities, distillers grains are the most common.
COMMENTS ON THE SUPPLEMENTAL PROPOSED RULE
In response to the original animal feed proposed rule, we voiced specific concerns related to the interpretation of the current good manufacturing processes (CGMPs). Our member companies were very concerned that the CGMPs outlined in the proposal were too much like the human food regulations. The revised CGMPs in the supplemental proposed rule appear more applicable to the animal feed industry and appear to provide more flexibility for the wide variety of the animal feed facility processes covered.
The previously proposed requirements for hazard analysis and risk-based preventive controls resembled too closely the Hazard Analysis and Critical Control Point (HACCP) regulations aimed at human food safety, whether a known or reasonably foreseeable hazard was “reasonably likely to occur.” HACCP regulations focus on critical control points to control hazards that are “reasonably likely to occur.” We strongly support the elimination of the terminology “hazard reasonably likely to occur” in the supplemental proposed rule. Removing this ambiguous terminology should help to reduce the potential for misinterpretation and unnecessary application of preventive controls for hazards that are insignificant or extremely unlikely to occur.
The new proposed terminology “significant hazard,” which refers to risks that are identified by comprehensive facility hazard analysis and must be mitigated, provides a much clearer criteria for risk- based decision-making at animal feed facilities. Rather than requiring application of HAACP-like standards in an indiscriminate manner, the supplemental proposal appears to allow facilities to take into account the severity and probability of potential hazards when determining how best to establish and implement appropriate preventive control management components.
However, the RFA is concerned with the provisions of the supplemental proposal establishing product and environmental testing programs, supplier approval programs, and verification programs that were not in the initial proposed rule language. As expressed previously, the facility should be provided the flexibility to determine its own needs and compliance strategy. While we do respect that supplier verification programs can play a role in quality operations, the individual facility can best develop in- house programs for these measures and incorporate these measures into the facility written food safety plan. These programs work best if they are designed based on the specific products and activities of the facility. If applied in a prescriptive and indiscriminate way, these programs can add unnecessary cost burdens and divert resources away from the effective practices that ethanol producers currently use to assure safe, high quality co-products. We request that FDA carefully consider the economic impact of proposed testing, supplier approval, and verification requirements.
Overall, the changes in the supplemental proposed rules improve the clarity of the regulation and its application to ethanol production facilities. However, interpretation of certain provisions of the regulations and how to implement them for compliance is still an ongoing concern for industry stakeholders. Thus, we are asking FDA for additional clarification on the specific items below from the supplemental proposal:
Several provisions raise important questions surrounding the chain of custody and what party may ultimately be responsible for demonstrating compliance with certain elements of the proposed regulation. For example, FDA states, “Proposed § 507.27(b) would require that shipping containers such as totes, drums, and tubs, as well as bulk vehicles, used to distribute animal food be inspected prior to use to ensure the container or vehicle will not contaminate the animal food.” (58,490) It is common practice that ownership of the animal feed is transferred at the facility upon loadout, and bulk trucks carrying the feed are the property of the buyer. We request more clarification on how transfer of custody at the facility affects who is ultimately responsible for demonstrating adherence to the regulation.
Similarly, it is not abundantly clear who would be responsible for environmental monitoring at various points in the supply chain, should those provisions be finalized. That is, ethanol producers cannot control exposure of animal feed to the environment after loadout, transfer of custody, and departure from the facility. One of the examples of environmental monitoring requirements provided by FDA (58,495) includes language specifying that monitoring and hazard assessment would occur “prior to packaging,” which for animal feed like distillers grains implies loadout in bulk vehicles. However, the other examples provided on the same page do not offer this same distinction, so it is unclear how far downstream environmental monitoring is necessary and who has that responsibility. While we assume hazard assessment and monitoring is not the responsibility of the producer once ownership of the animal feed as transferred and the product has left the facility, we request more clarification on the “boundaries” of responsibility for proposed measures like environmental monitoring.
While the supplemental proposal appears to have been written with the intention of making animal feed requirements less like the human food safety regulations, there is remaining concern that FDA inspectors are accustomed to human food facilities and have much less experience with animal feed facilities and processes. This may influence how they inspect animal feed facilities. Because these animal feed regulations are new to the industry as well as the regulatory inspectors, there is a need to develop an understanding between the two parties pertaining to the final regulatory compliance obligations. To this end, RFA is actively participating in the Animal Food Safety Preventive Controls Alliance; and we feel it provides an important forum for developing this mutual understanding of the final rules and to provide guidance documents and training opportunities for qualified individuals. We encourage FDA to continue to provide the resources necessary to ensure the Alliance is active and effective, as the group will play an instrumental role in developing guidance for performing facility hazard analysis, establishing control measures, etc.
Thank you for the opportunity to comment. With over 30 years of successful feeding, ethanol co- products have a long history of being recognized as a safe and highly nutritious animal feed ingredient.
We appreciate FDA’s careful consideration of stakeholder feedback on this issue. If you have questions regarding the contents of this letter, please contact Kelly Davis at email@example.com
Bob Dinneen President & CEO
December 15, 2014
Division of Dockets Management (HFA-305) Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
ATTN: Docket No. FDA–2011–N–0922 RIN 0910–AG10
Re: Comments of the Renewable Fuels Association (RFA); Supplemental Notice of Proposed Rulemaking; Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (79 Fed. Reg. 58,476)