| Comment Record|
Mr. Randall Gordon ||
2001-11-21 14:49:31 |
National Grain and Feed Association |
| Comments for FDA General |
1. General Comments
November 21, 2001
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
Re: Docket No. 01N-0423
The National Grain and Feed Association appreciates the opportunity to submit this statement concerning the Food and Drug Administration’s current animal feeding regulations that are designed to prevent the establishment or spread of bovine spongiform encephalopathy (BSE) in the United States.
Established in 1896, the NGFA is the U.S.-based non-profit trade association that consists of more than 1,000 grain, feed, processing and grain-related firms that operate more than 5,000 facilities and handle more than two-thirds of U.S. grains and oilseeds. More than 300 of the NGFA’s member companies operate feed manufacturing and integrated feeding operations.
At the outset, it is important to emphasize that there has not been a single case of BSE in the United States. This is the case though the U.S. government has maintained a vigilant surveillance program since 1990 – surveillance that was expanded in 1993 to include non-ambulatory cattle (fallen stock) and is viewed as the most extensive of any country in the world with the exception of Europe, where the BSE agent does exist .
Thus, the U.S. government is in the enviable position of implementing safeguards that are prudent in preventing the occurrence of BSE, rather than attempting to control or eradicate it. The NGFA believes that FDA should review its existing regulations from this perspective.
The success in keeping the United States BSE-free has been attributable in no small part to the effective “three-firewall” strategy implemented by government and strongly supported by the NGFA and other industry and animal agriculture organizations:
· The first, and arguably most important, of those firewalls is an intensive program of import controls implemented by USDA, FDA and the U.S. Customs Service that is designed to prevent the importation of animals and animal products from Europe, Japan and other countries where BSE is known or suspected to exist, or where domestic controls are insufficient to protect against the risk of BSE.
· The second firewall consists of the FDA’s rule, which took effect on Aug. 4, 1997, that prohibits the feeding of specified mammalian proteins to ruminant animals and is widely considered to be a model for the world. The NGFA was an active participant in the process that resulted in FDA’s rule, as well as in education and information efforts initiated by the agency and the private sector to acquaint affected industry sectors about the rule’s requirements.
· The third firewall consists of an active, government-based inspection and surveillance program implemented by FDA and State feed control authorities to verify compliance with the FDA rule. This third firewall also includes the U.S. Department of Agriculture’s active surveillance of livestock to detect BSE.
The NGFA commends FDA for initiating this rulemaking to review its current BSE-prevention regulations. As it does so, we believe it is of paramount importance for FDA to continue to base its decision-making on the best available science and prudent risk-assessment based on the facts that are known today. It can be argued that the entire world is looking to FDA as a model agency for prudent, science-based risk assessment for preventing the establishment or amplification of BSE. To deviate from that sound course could undermine the agency’s moral authority to regulate protection of food and feed safety. Were that to occur, we likely would see a hodge-podge of different state laws and regulations emerge to address BSE and other food safety issues, as well as an undermining of consumer confidence.
The NGFA has adopted a BSE-Prevention Policy Statement, which is attached to this statement, pledging its firm commitment to science-based measures to prevent the BSE agent from entering the United States. We recognize that science is not static, and that the agency and the industry have a responsibility to base future decisions on the best available facts that exist. But based upon our understanding of current science related to BSE, the NGFA fully supports FDA’s existing regulations, and does not believe that the current ban on feeding certain mammalian protein to ruminant animals should be expanded beyond the restrictions currently in place. We support the continued use of ruminant-derived protein as a safe, nutritious and wholesome feed ingredient for species for which it is legally approved.
With this groundwork laid, the NGFA wishes to provide specific comments on several of the questions raised by FDA in its October 5, 2001 Federal Register notice. Our statement groups NGFA’s responses to FDA’s questions into three major areas: 1) the scope of the feeding restrictions; 2) enforcement- and compliance-related issues; and 3) operations-related issues.
Scope of Feeding Restrictions
First, several of FDA’s questions relate to the scope of the feeding restrictions contained in its BSE-prevention rule.
The NGFA believes the current FDA rule is adequate to meet the stated objective of preventing the amplification through feed of BSE if the agent ever were to enter the United States. In a related matter, the NGFA is actively discouraging attempts in Congress and the states to legislate additional restrictions that we believe are neither science-based nor necessary. Rather than broadening the rule to achieve other, unspecified, objectives, we believe the first order of business is to achieve as close to 100 percent compliance with the existing rule as possible, particularly among multi-specie feed mills that manufacture ruminant feed and handle prohibited mammalian protein. [Question 2]
The NGFA does not believe the current FDA feeding restrictions should be broadened to include other mammalian proteins unless there is compelling scientific evidence that the ingredient is a vector of the BSE agent. We are aware that the agency has explored whether to broaden the ban on feeding mammalian protein to ruminants to include such ingredients as blood products, gelatin and milk products. It is our understanding that available scientific research in Europe has disproved these wholesome feed ingredients as potential vectors of the BSE agent, and we believe FDA should not expand the ban to encompass these ingredients, particularly given the absence of the BSE agent in the United States. [Question 3]
For the same science-based reasoning, we also do not believe that FDA should revoke or change any or all of the exclusions for certain products allowed in the current rule. [Question 7] Nor should the agency add to the list of mammalian proteins that are restricted from being used in feed for cattle or other ruminants. [Question 8]. While the NGFA has no position concerning FDA’s specific question on whether to broaden the ban to encompass poultry litter and other recycled poultry waste products, it is important to clarify that these products are not typically used in commercial feed operations because onerous safety-testing requirements and transportation costs far outweigh the value of the protein derived from such products. It also is our understanding from animal agriculture groups that use of poultry litter waste as a feed ingredient on the farm is very limited. However, NGFA would ask FDA and states how they propose to conduct inspections and bring enforcement action of any rule banning such usage.
In a series of enforcement- and compliance-related questions, FDA asks whether there are additional enforcement activities needed to provide adequate public health protection and whether there are ways to improve compliance with the existing rule. [Question 1]
The resource-intensive inspections conducted by FDA and the states following the effective date of the final rule in 1997 correctly, in our view, were expansive and designed to reach all identifiable rendering plants and commercial feed manufacturers, as well as a selected sampling of on-farm feeding operations. Those initial inspections served a useful educational, as well as inspectional, function.
But as the agency and states complete this comprehensive initial round of inspections – as well reinspections where warranted by lingering compliance-related issues – the NGFA strongly recommends that FDA and its state partners adopt a more targeted inspection and enforcement effort for the future. The NGFA believes that the central component of such a plan should be a trace-forward approach, in which the movement and use of mammalian protein that is prohibited from use in ruminant feed is tracked from its source to subsequent receivers and handlers. The NGFA recommends that this be accomplished through the development of a statistically valid random inspection program, and that it be augmented and backstopped by states conducting BSE-rule compliance inspections as part of their routine feed mill inspections. We commend the Association of American Feed Control Officials for including this latter component in its newly issued BSE Policy Statement. The NGFA also supports trace-back investigations and inspections if violations are detected among subsequent handlers and users of restricted-use material.
Based upon discussions in joint meetings in which we have participated with other animal agriculture, feed and rendering organizations, we believe there is an emerging consensus that a trace-forward approach makes sense from both a risk-assessment and resource-allocation standpoint for the future. As part of such an approach, the NGFA believes that FDA should prioritize its future inspection and compliance efforts to focus first on facilities that manufacture feed for multiple species – one of which is ruminants – and which receive and handle both prohibited mammalian protein. Surveillance and enforcement also should be focused on direct purchasers of mammalian protein prohibited from use in ruminant feed to ensure that the product is being directed and sold to appropriate channels. Surveillance and enforcement also should be directed at the disposition of salvaged products that may contain mammalian protein prohibited from use in ruminant feed.
Of secondary concern, in our view, should be multi-specie facilities that utilize prohibited mammalian protein but do not manufacture ruminant feed. Of even lower inspection priority should be facilities that do not receive or handle mammalian protein that is prohibited from use in ruminant feed.
The NGFA also believes there is a need for FDA to work with states to develop an overall strategic plan to guide its future BSE-prevention surveillance and inspection efforts. We recommend that a trace-forward/trace-back enforcement strategy – augmented by states making compliance with the BSE-prevention rule a part of their routine feed mill inspections – become the central feature of such a strategy.
We also believe that such a plan should attempt, as much as possible, to enhance coordination and interpretations of inspection results by states and FDA. The recent modifications to FDA’s BSE Inspection Checklist, which improve its clarity, are a positive step and should lead to improved uniformity of the inspection interpretations and results. We are aware that some of the alleged “violations” of the BSE-prevention rule in the initial round of inspections resulted from misinterpretation of the questions posed on the previous inspection checklist form. The NGFA believes that FDA, industry and other interested parties should continue to evaluate the BSE inspection checklist based upon actual field experience, and to make future modifications that may be needed to ensure accurate inspection results.
The NGFA believes that development of such a strategic plan also would encourage states to continue to adopt and enforce FDA’s BSE-prevention regulations, rather than developing alternative rules that may not be science-based and result in unjustified disruptions in the efficiency of the U.S. animal feed and feeding industries. We are very concerned that differing state feed laws and regulatory requirements on BSE – such as those enacted earlier this year in South Dakota – are having unintended and negative consequences, and have the potential to create confusion among the regulated industries as to compliance requirements, as well as additional costs that will be borne by feed manufacturers, feeders and consumers, without providing substantive food or feed safety protections.
FDA also asks whether additional enforcement authorities are needed to enhance compliance with the rule. [Question 14] The NGFA believes that existing authorities at both the federal and state level, including states’ authority to issue stop-sale orders, are strong and effective tools to encourage compliance. A visible surveillance presence by FDA and states, we believe, is more important to continued compliance than additional enforcement authorities.
We also believe that compliance can be improved by continued efforts of industry organizations and companies – in partnership with efforts underway by FDA and states – to provide accurate and timely education and information on the BSE-prevention rule. To this end, the NGFA in 1994 developed a Model Feed Quality Assurance Program for commercial feed mills – a first for the industry – which has been updated frequently to incorporate the latest in best management practices for the industry. As part of that program – as well as in stand-alone pieces – the NGFA has developed and disseminated widely a compliance guide for commercial feed mills concerning the BSE-prevention rule. The NGFA, in partnership with its Affiliated State and Regional Grain and Feed Associations, as well as several state agencies and universities, has conducted 14 Feed Quality Assurance Workshops in all regions of the country to encourage broad implementation of Q/A principles. Last December, we also produced a set of four feed quality assurance videos, which also incorporate compliance information on the FDA BSE-prevention rule and can be used by feed mill managers as a continuing education tool for their employees.
FDA also asks what role, if any, public or private certification programs should play as part of an overall compliance strategy. [Question 15] The NGFA’s BSE-Prevention Policy Statement is outspoken in its strong support for government-based inspections – by FDA and states – leading to full and fair enforcement of the BSE-prevention rule to ensure compliance throughout the supply chain, including by renderers, feed manufacturers, farmers and ranchers, transporters and meat processors. The NGFA believes it is absolutely essential for the feed manufacturing industry to support existing, government-based inspection and compliance efforts. A strong, credible government-based inspection and enforcement program provides the integrity and impartiality that is essential to maintaining consumer confidence.
For the feed manufacturing sector, the NGFA’s policy statement commits our organization to work to facilitate marketplace acceptance of individual company-to-company assurances, including contractual guarantees, company affidavits and other self-certification mechanisms, that may be requested by certain customers and that are responsive to customer needs. The NGFA’s Feed Trade Rules and Arbitration System, as well as the courts, provide a time-honored mechanism for enforcing such assurances. We currently are working directly with the National Cattlemen’s Beef Association on just such an approach. It is our understanding that these feed manufacturer-to-feeder affidavits are meeting the needs of most customers. In this regard, we strongly urge FDA to work with AAFCO to develop a mechanism whereby copies of the BSE Inspection Checklist can be provided to inspected firms after appropriate review to attest to their compliance with the rule to facilitate company efforts provide verification to feeder/customers. We are pleased that this concept is part of AAFCO’s BSE Policy Statement.
The NGFA fully recognizes and appreciates the rendering industry’s decision to voluntarily undertake a third-party inspection and certification program for its segment of the industry. Its decision to do so is understandable, given the fact that renderers represent the “top of the pyramid” in terms of compliance with the BSE-prevention rule; if prohibited mammalian protein produced and shipped from rendering plants is properly labeled and has been produced in accordance with the rule, compliance benefits accrue to each subsequent handler that purchases and utilizes the product.
But there is a fundamental difference in the feasibility and cost-impact of such a third-party certification approach that applies to a relatively finite number of rendering plants and the economies of scale that apply when transposing such an approach to the breadth of the commercial feed manufacturing industry, with its 6,000-plus mills, only a small percentage of which are multi-specie mills still utilizing mammalian material banned from use in ruminant feed.
For these reasons, the NGFA believes strongly that the use of public or private certification programs for the feed manufacturing sector should be an individual company decision, based upon the perceived value of such certification vis-à-vis customer preferences and market demand. We believe in the integrity of our industry to truthfully attest in company self-certifications or affidavit statements as to their use – or non-use – of prohibited mammalian material and their awareness and compliance with the FDA rule.
While we do not oppose FDA providing oversight of the integrity of private certification programs – if requested to do so – we caution the agency to obtain the necessary assurances – and to closely monitor subsequent adherence with such assurances – that its role not be used to imply an endorsement or to create competitive marketplace advantages or disadvantages for companies based upon their voluntary business decision on whether or not to participate. Simply put, the NGFA does not believe a feed manufacturer’s decision on whether or not to participate in such certification approaches should imply that its feed products are any safer or less safe than those that do not.
In a final enforcement/compliance-related question, FDA asks about the availability of accurate, efficient analytical methods for detecting mammalian protein in ruminant feed. [Question 13] As the agency knows, polymerase chain reaction (PCR) tests are being developed that are designed to detect bovine DNA. To our knowledge, however, such tests to this point do not accurately or consistently differentiate between currently allowed mammalian protein – such as blood and blood meal, milk and gelatin products – and prohibited material. Such tests also reportedly are highly sensitive and could lead to false positive results that require subsequent confirmation.
Before using such tests, the NGFA believes strongly that before utilizing such tests, FDA should confirm their effectiveness in accurately and repeatedly differentiating between prohibited and non-prohibited mammalian material – including blood, milk and gelatin products – without resulting in false positives. Further, we believe that the detection capabilities of such tests should be compatible with the existing equipment clean-out and sequencing procedures recognized under the medicated feed current good manufacturing regulations, as referenced in the Preamble to the 1997 BSE-prevention rule, under which minute levels of carryover may be present in finished feed. We also strongly urge the agency to resist circumventing its science- and risk-based approach to assessing the safety of mammalian material for the convenience of utilizing an imperfect analytical test as an inspection or enforcement tool in field.
Finally, FDA asks whether it should require licensing of renderers and feed manufacturers that produce feed or feed ingredients containing mammalian protein. [Question 6] The NGFA does not believe such a requirement is necessary, given FDA’s access to sales documents under its existing rule that allows it to track the disposition of mammalian protein prohibited from use in feed, as we have advocated under the trace-forward approach discussed previously. Licensing or registration also would result in additional paperwork and recordkeeping burdens and costs for both FDA and the regulated industry, and would be resource-intensive for the agency.
A final group of questions posed by FDA concerns operations-related issues on which we would like to provide input:
The NGFA believes strongly that FDA should not amend its current regulations to require dedicated facilities for the production of animal feed containing mammalian protein. [Question 4] The NGFA believes strongly that this decision should be made by individual companies, based upon practicality given the types of feed they manufacture and market preferences from customers and feeders with whom they do business. In this regard, to facilitate compliance and consumer confidence, the NGFA’s BSE-Prevention Policy Statement recommends, as a best-management practice, that feed mills that manufacture ruminant feeds voluntarily discontinue using prohibited mammalian protein unless they have separate and distinct mixing, handling and storage systems to prevent accidental commingling or cross-contamination. It is our understanding that many feed manufacturers have made such a business decision, either because they believed it represented the easiest and most effective way for them to comply with the BSE-prevention rule or because of recommendations from their trade association or requests from insurance carriers and feeder-customers.
Ultimately, though, this is a decision best made by the management of the individual facility. For some feed manufacturers, using dedicated plants or equipment may be impractical given the lines of feed they manufacture (e.g., dairy and pet food) and their use of least-cost formulated rations. For this reason, we believe it would be inadvisable and costly for FDA to mandate such a requirement. But we believe this again points to the wisdom of adopting a trace-forward inspection approach in the future, to ensure that facilities that are utilizing both prohibited and non-prohibited mammalian protein are observing the required equipment clean out and/or sequencing procedures required under the FDA rule.
For many of the same reasons, the NGFA also does not support FDA requiring dedicated transportation of animal feed containing mammalian protein. [Question 5] Doing so would increase delivery costs and present operational challenges to feed manufacturers, rail carriers and truckers in effectively transporting feed and feed ingredients. A case-in-point is the recent change in South Dakota’s statute and regulations, which has resulted in feed companies making duplicate deliveries to wholesale dealers and to farms that previously were efficiently and safely done with one. This creates additional costs and inefficiencies.
To address this matter, the NGFA earlier this year established an Animal Protein Transportation Task Force consisting of representatives from the rendering, soy processing, animal feed manufacturing, and rail, truck and barge industries to develop a set of “best management practices” for transporting animal and plant protein products to foster compliance the aspects of the FDA rule that apply to distributors, including the prohibition on commingling or cross-contaminating ruminant feed or feed ingredients with mammalian proteins that are banned from use in ruminant animals.
A draft set of “best management practices” has been developed and is under review by the task force prior to being sent to pertinent organizations for their review, comments and approval. They include specific provisions for each industry sector, including rail carriers and rail car lessors, truckers, and shippers and receivers of feed and feed ingredients.
The draft “best management practices” identify procedures when using dedicated transportation fleets; customer-assigned equipment; and clean-out procedures if hauling both prohibited and non-prohibited mammalian materials in the same conveyance. They also address loading and receiving procedures applicable to transportation providers, plant and animal protein suppliers, and feed manufacturers. Once finalized early next year, we will be disseminating this set of best management practices widely – including to FDA and states – and encouraging that they be adopted and utilized.
FDA also asks if it should extend its current recordkeeping requirements beyond one year. [Question 10] The NGFA believes the current one-year requirement is well understood and achievable, and is not aware of any justification for lengthening this requirement.
Next, FDA asks if FDA should change its current rule to require labeling of feed containing protein ingredients to identify the specific mammalian species from which the protein was derived. [Question 11] In addition, the agency asks whether to amend the rule’s language pursuant to the BSE caution statement to identify specific ruminant species to which the product is not to be fed. [Question 12]
The NGFA strongly opposes any change to the current labeling requirements. In fact, we believe one of the strengths of the current rule is that its labeling requirements and caution statement are well understood by feed manufacturers and their customers. Rather than providing additional clarity, amending the current labeling requirement or the caution statement would create unnecessary confusion and require an additional “learning curve.” Such a change also would be extremely costly for the feed manufacturing industry because of the resultant labeling changes, with little offsetting benefit.
Concerning the identification of the specific mammalian protein source on the label, the NGFA strongly supports the continued use of the “animal protein products” collective term as recognized by AAFCO.
Collective terms were created by AAFCO after consultation with FDA and the industry in 1969 as a method for describing – in a single term on feed labels – a group of ingredients that perform a similar function, but do not necessarily have equivalent nutritional values. The “animal protein products” collective term – one of seven collective terms currently approved by AAFCO – encompasses 45 different ingredients, including meat and bone meal, poultry byproducts, milk protein, various forms of whey, fish meal and other forms of fish protein, casein and other protein-based ingredients of animal origin.
In 1998, AAFCO, with the strong support of the NGFA, acted to designate individual ingredients found within the “animal protein products” collective term which, if derived from ruminant animals, are prohibited from being used in ruminant feed under FDA’s BSE-prevention regulations. In the AAFCO Official Publication, mammalian materials that are prohibited from use in ruminant feed are designated clearly with an asterisk.
For feed manufacturers, collective terms are extremely useful and cost-effective. They enable feed manufacturers to interchange sources of various ingredients that have a similar function based on least-cost formulations, without having to change the list of individual ingredients preprinted on feed bags, tags and labels. At the same time, feed customers are assured that the feed contains protein sources adequate for the species for which the feed is intended.
The NGFA is unaware of any misuse of the animal protein products collective term that would justify a change in the label to require identification of the specific mammalian protein source. It is the presence or absence of the BSE caution statement that is widely understood by feeders as dictating whether the feed contains or may contain a prohibited mammalian protein. Further, we do not believe eliminating or changing the collective term would improve either the efficiency of BSE inspections or enhance compliance. The NGFA notes that even if use of the animal protein products collective term were disallowed, inspectors still would be expected to review records as part of their BSE inspections to verify the source of the proteins being used in ruminant feeds, regardless of whether the “animal protein products” collective term was used.
Some have cited the desire of a few customers for information on the source of animal protein as being a justification for a change in the labeling requirement. The NGFA notes that it is common practice in the feed industry to provide such information to customers upon request – either orally or in writing. The NGFA believes it is inappropriate for FDA through this rulemaking process to interject itself into such customer-relations issues that are not food- or feed-safety related.
Concerning FDA’s question about changing the caution statement to require the listing of specific ruminant species, in addition to cattle, the NGFA believes this is unnecessary and would result in excessive costs for labeling changes that far outweigh any theoretical benefit. Commercial feeding of sheep, goat, bison, elk and deer is a relatively niche specialty market characterized by feeders who fully understand that they are feeding ruminants.
The NGFA appreciates the opportunity to provide its views on this important matter, and pledges its continued efforts to achieve the mutual objective of keeping the United States free of BSE.
Joseph Garber, Chairman
Feed Industry Committee
National Grain and Feed Association