| Comment Record|
Mr. Richard Sellers ||
2001-11-21 14:37:03 |
American Feed Industry Assocation |
| Comments for FDA General |
1. General Comments
November 8, 2001
Dockets Management Branch
Food & Drug Administration (HFC-
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
RE: Docket 01N-0423 Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed; Public Hearing; Request for Comments
The American Feed Industry Association (AFIA) is the national trade association for feed and pet food manufacturers, ingredient manufacturers and suppliers, equipment manufacturers and other firms which supply goods and services to the feed industry. AFIA’s nearly 700 corporate members manufacture 75% of the nation’s primary, commercial feed. AFIA members are subject to the current regulation (21 CFR § 589.2000) and offers these comments on their behalf.
Regarding the questions raised in the public hearing notice published in the Federal Register on October 5, 2001, AFIA offers the following answers: (Parenthetical references are to the June 5, 1997 Federal Register at 30936-30978)
1. What additional enforcement activities, if any, regarding the present rule are needed to provide adequate public health controls? Are there other suggestions for ways to improve compliance with the rule?
The top enforcement priority of the agency should be education, followed by aggressive action against any firm or individual knowingly feeding prohibited material to ruminants or distributing prohibited material for that use.
The 1997 final rule is basically a labeling and record-keeping rule and compliance in the recordkeeping area has been nearly perfect. AFIA believes there are more anomalies in the inspection report than meet the eye, and actually more compliance due to the subjectivity of the report. We support CVM’s efforts to further clarify the compliance issues and its efforts to reduce the subjectivity in the inspection form.
We strongly believe independent, third party certification programs, such as the Facility Certification Institute’s Restricted Use Protein Certified Facility Program, offer education and inspection capabilities as an adjunct to the FDA/State inspection program. For instance, if a firm claims it does not use restricted use protein products, how does the agency verify this? State/federal agencies may have to rely on trace forward to verify this. FCI’s agents spend over two hours in these facilities insuring the firm is not utilizing these products.
AFIA has been assisting FDA in encouraging the states to perform the initial inspections and met with some resistance by a few states. We are continuing our efforts and encourage FDA to do likewise. Also, to the extent possible, FDA should fund all state inspections for compliance with this rule. State investigators are more familiar with feed mills, usually operate out of home bases, and can perform the inspections more rapidly and efficiently than most FDA investigators.
2. Is the present rule at Sec. 589.2000 adequate to meet its intended objectives? If not, what are its inadequacies? Are there additional objectives that this rule should now address? If so, what are these new objectives?
The feed rule, as part of the three firewalls the government has instituted, is more than adequate to meet the objectives stated in 1997. In fact, two government studies have indicated our risk at near zero. The industry and FDA must strive for 100% compliance and 100% inspections. FDA made a compelling argument to adopt the current restrictions based on sound science and a review of industry practices. AFIA believes that enforcement of the current rule will result in a greater reduction in risk than any or all of the proposed changes raised here.
3. Should the present FDA ban on the use of certain mammalian proteins in ruminant feed be broadened? If so, what should the new parameters of use be? Should the rule be broadened beyond ruminant feed? Beyond mammalian protein?
Neither current science nor the current factual situation supports an expansion of the rule at this time. AFIA believes the rule needs revisiting from time-to-time and applauds the agency’s efforts to do so with the hearing and docket. However, achieving full compliance with the current rule will contribute more to risk management than any specific expansion of the rule. AFIA believes that occasional revisiting of the current rule will serve to strengthen it if new risks are identified or remove restrictions if no longer justified by scientific assessment of risk.
4. Should FDA require dedicated facilities for the production of animal feed containing mammalian protein to decrease as much as possible the possibility of comingling during production?
While AFIA supports dedicated facilities and/or transportation vehicles whenever reasonably feasible, a requirement for them would not preclude all risks. Such a requirement would also cause unwarranted burdens and unnecessarily increase costs for many firms. Therefore, AFIA does not support such a requirement.
On a related note, the agency has evidence of contaminated ingredients entering facilities manufacturing ruminant feed. AFIA believes full compliance with the present rule is needed, and this is dependent on extensive education and appropriate enforcement actions. AFIA acknowledges that commingling incidents have occurred, but that the low level and low incidence of these occurrences are evidence of the industry’s commitment to a BSE-free U.S.
However, AFIA is concerned about the legal standard for carryover and is asking the agency to meet with the industry to discuss the agency’s response to the few commingling incidents that have taken place and detail what were the agency’s concerns about carryover. The standard offered in the preamble to the feed rule for preventing carryover is the one AFIA suggested, and the same one the industry has used for 30 years in good manufacturing practices for medicated feed.
5. Should FDA require dedicated transportation of animal feed containing mammalian protein to decrease as much as possible the possibility of comingling during transport?
The same answer provided in question #4 applies here.
6. In order to improve production practices and increase assurance of compliance with the rule, should FDA require FDA licensing of renderers and other firms/facilities engaged in the production of animal feed containing mammalian protein?
No. This would be a reversal of the agency’s 30-year philosophy for regulating the feed and feed ingredient industries. AFIA strongly believes that licensing would only increase the agency’s and industry’s paperwork burden with little commensurate benefit. Although the question assumes that an improvement in production practices and increase in compliance might occur, in fact, the resources required to maintain such a system could be better spent inspecting facilities using restricted use protein products and providing better overall surveillance of the higher risk categories. AFIA believes FDA can adequately trace lots of restricted use protein products utilizing “trace forward” techniques, which are far less resource intensive than a licensing scheme. How would the agency garner the resources to license on-farm mixers, when, according to one state feed control official, there are 5,000 in one Midwestern state alone? AFIA believes the high costs of a licensing program would rob the agency of inspection resources needed to educate industry and enforce the current rule.
7. Should FDA revoke or change any/all of the current exclusions for certain products allowed in the current rule at Sec. 589.2000(a)(1)?
No. In the preamble to the 1997 feed rule (at 30938), FDA provided adequate scientific justification for the exemptions offered in the rule. AFIA believes those exemptions are still scientifically justified and, in fact, the safety of blood products has been reconfirmed. AFIA strongly supports the current exemptions from the feed rule and urges FDA to monitor the science in this area and consider changes only where there is compelling scientific evidence.
8. Should FDA add to the list of prohibited material in ruminant feed (i.e., add to the definition of ``protein derived from mammalian tissues'') poultry litter and other recycled poultry waste products?
As this is primarily an on-farm practice, AFIA will defer to poultry and beef producers to answer this question.
9. Should FDA remove the exemption for pet foods from labeling with the precautionary statements?
No. In the 1997 feed rule preamble (at 30955), FDA reviewed information submitted by a commenter regarding the concern expressed by consumers when pet food products were labeled with the cautionary statement. FDA concluded that “...the cautionary statement serves no useful purpose on the pet food and feed for nonruminant laboratory animals and has amended the rule by creating [a new section]...to exclude pet food products that are sold or intended for sale at retail to non-food-producing animals and feeds for nonruminant laboratory animals.” Nothing indicates that FDA’s 1997 conclusion is no longer valid. Moreover, it appears that education and enforcement of salvage dealers and producers would be a more cost-effective strategy than changing the label statement.
10. Should FDA extend its present recordkeeping requirements beyond 1 year? If so, how many years?
In the 1997 feed rule preamble (at 30960), FDA adequately justified its change from a two-year record retention to a one-year record retention. FDA stated that the recordkeeping requirement is to help FDA determine compliance with the rule. It further noted that extending the time would have little practical value in determining the source of a TSE in an animal.
Recordkeeping requirements relate principally to documentation of compliance. The 3-5 year latency period between exposure and disease manifestation would require considerably longer recordkeeping requirements if these data were to be of use for investigatory purposes should BSE be identified in the US. The relative value of these saved records, given the overall small probability that BSE will occur in the US and the large number of feed sources used by the average producer, suggest that that cost-effectiveness of additional recordkeeping would be minimal. As such, AFIA does not support the required retention of records beyond 1 year.
11. Should FDA change its rule to require labeling of protein- containing feed to specify what type(s) of mammal was used in the production of the protein, e.g. ``porcine MBM'', ``bovine MBM''.
In the 1997 feed rule, FDA indicated that the Association of American Feed Control Officials might need to amend its definition of “animal protein products” to indicate which ingredients are restricted proteins. This was accomplished by AAFCO in 1997 and published in the 1998 (and subsequent) edition of the AAFCO Official Publication. In that same preamble (at 30955), FDA indicated the collective term did not need changing.
However, some feed control officials have suggested an unnecessary change by removing those ingredients covered in this rule from this collective term or by requiring the use of actual ingredient names of restricted proteins. These officials are claiming that it is difficult to determine if restricted proteins are being used in a feed if a collective term is used on the feed label. AFIA strongly opposes such a move and has stated to AAFCO and FDA officials the reasons for this opposition. Besides the increased labeling costs which would be necessary every time an ingredient within that collective term were changed in a formula, AFIA believes such a requirement would accomplish little, if any, toward the goal of determining compliance with this rule. As indicated in other FDA guidance documents and question/answer documents, the two means of determining if a restricted protein is used in a feed are the label includes the cautionary statement “Do not feed to cattle or other ruminants.” or if the formula lists a restricted protein. If the label lists one or more specific animal protein products, in lieu of the collective term “animal protein products,” then any investigator must still check the formula and batch records to determine if a restricted protein were utilized or not.
12. In order to make the statement clearer, should the required cautionary statement on the label of products that contain protein derived from mammalian tissues and that are intended for use in animal feed be changed to read: ``Do not feed to cattle, sheep, goats, bison, elk, or deer.''?
No. AFIA is unaware of any problems with understanding the nomenclature used in the cautionary statement. In fact, AFIA and others argued that the longer, more defined cautionary statement proposed by FDA was cumbersome and confusing. AFIA believes a more extensive educational campaign may prove more effective in accomplishing the intended protection than expanding the cautionary statement.
13. What new information is available on potential efficient, accurate analytical methods that may be used in detecting mammalian proteins, especially the prohibited mammalian proteins, in feed and what should the sampling parameters of such a program be?
AFIA does not have any new information on these topics. However, AFIA believes there is definitely a need for tests which are both sensitive and specific in order to ensure compliance and investigate apparent violations. No current tests meet these requirements. Further, false positive tests incorrectly increase the public perception that there are violations. Thus, AFIA urges FDA to monitor developments in this area, for purposes of validating test methods under § 589.2000(c)(2)(ii) and for use in the agency’s own sampling and testing activities.
14. Regarding enforcing compliance with the rule, what further authorities, if any, would be desirable in order to enforce the rule adequately (civil monetary penalties?, others?)
AFIA believes the current federal and state statutory penalties for violation of this rule are severe and adequate. Several states have exercised their stop sale authority and may move to condemn feed if serious violations are encountered. AFIA is aware that FDA and various states have cooperated in enforcement actions, thereby saving the resources of FDA.
15. Regarding helping to increase compliance with the rule, what role, if any, should public or private certification programs play?
AFIA established an independent third party, certification program in the non-profit corporation, Facility Certification Institute. This institute has certified over 200 facilities for compliance with this rule. This program acts as an adjunct to the federal/state cooperative inspections. Furthermore, FDA has indicated in its Q and A documents that it would be unlikely to inspect a facility that asserts it is not utilizing any restricted use protein products within the meaning of this rule. FCI not only certifies such facilities, but performs random audits, posts the firms on its website and requires customer notification if certification is revoked. This program insures firms that claim no use of these ingredients do not in fact use them and continue not to use them.
FCI believes FDA and FCI can benefit from a partnership arrangement and, has filed a request for partnership with FDA. Basically, a FCI certified facility would file a notice with the FDA district office in which the plant is located, providing a copy of the certification certificate initially and annually. FDA would develop a Compliance Policy Guide (CPG) that states such certifications would be recognized if third party and independent and would place the firm on a low regulatory inspection priority list for FDA and contracted State inspections for compliance with this rule. Given industry support, public and/or private certification programs can be implemented faster and less expensively than government regulations.
AFIA believes FDA should recognize true independent, third party certification programs, such as FCI and one run by the Animal Protein Producers Industry as valuable tools in further assuring compliance with the rule. The agency should encourage firms to utilize these tools, such as it does with producer quality assurance programs, disseminate information about the programs and enter partnership agreements with third party certification organizations for the mutual benefit of each.
16. Regarding the import of feed, what should the restrictions on such import be (country specific? comparison between domestic and foreign controls?)
Imported feed products and feed ingredients represent a much greater potential risk than imported animals. Current inspection processes are NOT sufficient to preclude the entry of restricted products in all cases as demonstrated in audits performed by USDA with regard to FMD. There is a real need for strengthening the certification for imported products and import controls.
Import of feed and animal protein products should be restricted from those countries with BSE or which are not actively performing surveillance in accordance with the Office of International Epizootics (OIE). USDA has regionalized certain areas like the European Union because of the free flow of commerce among and between countries within the EU, and the announcement that the EU believes considerable commingling occurs in animal
protein products. AFIA supports this concept and believes this is a scientifically sound approach. Of concern to AFIA is the apparent duplication of efforts between APHIS and FDA and that FDA’s import alert in January of this year for animal protein products from the EU was a full month after the APHIS import alert. Coordination of efforts is essential to conserve resources, and swifter action is necessary to have effective control.
AFIA is very concerned about the potential for transshipment of animal protein products from the EU through third countries and misbranding. FDA should not only fortify its port of entry investigations, but also move to take swift action against violators. We do not believe the current minimal investigation level provides sufficient deterrent. AFIA would support an Administration request for more port inspection funding.
Because import controls are the first firewall in the prevention of BSE from gaining entrance to the U.S., AFIA believes this effort should receive the greatest attention and funding.
17. Are there any other additional measures necessary to guard against BSE and vCJD in the United States?
AFIA believes the agency has been diligent in carrying out the responsibilities commensurate with reducing the risk of BSE being established and amplified in the U.S. However, Administration support lagged during the two-year 1999-2000 period as states were unable to secure complete funding for investigations, and numbers of inspections were reduced from the first two years. Only after a series of negative media articles appeared earlier this year, did more funds and resources materialize with a new commitment to finish all of the inspections. This commitment was made in 1997 to finish the inspections within the first two years of the inspection program, but resources appeared to be moved to cover other “hot” agency issues.
This “see saw” commitment to the inspection program is unfortunate and unwarranted for an industry which has cooperated with the agency on an ongoing, constant basis for four years. We need these inspection resources; the American people deserve nothing less than the agency’s full commitment to preventing these devastating diseases from entering the U.S.
AFIA pledges it continuing commitment to a goal of 100% inspections, 100% compliance and assuring the federal/state agencies have the necessary resources to make that happen.
Thank you for the opportunity to submit these comments.
Vice President, Feed Control & Nutrition
American Feed Industry Association
1501 Wilson Blvd., Suite 1100
Arlington, VA 22209