Comments by
R. Dan Sowards, President
Comments to the President's Council and FSIS
on behalf of the Association of Food and Drug Officials

President's Council on Food Safety

The Board of Directors of the Association of Food and Drug Officials (referred to as AFDO in this document) appreciates the opportunity to provide the President’s Council on Food Safety and the United States Department of Agriculture’s Food Safety and Inspection Service with official comments on the Council’s Draft Strategic Plan.

The AFDO Board has reviewed the proposed Strategic Plan and is pleased that the Council has focused on sound science, risk assessment, risk management, and risk communication. AFDO strongly believes that the most effective way to utilize our limited resources to ensure the safety of our nation’s food supply is to focus on risk, utilizing the best science available. In this respect the Draft Strategic Plan appears to be very comprehensive in most respects.

AFDO is also pleased that the Council appears to have tentatively concluded that a national food safety system in the U.S. must involve state and local government participation. AFDO has long advocated a national integrated food safety system for the U.S., with specific roles for federal, state, and local agencies, including interaction among the partners to produce a seamless system. Our comments are therefore constructive in nature and meant to advance this position through the Council’s strategic planning efforts.

Although previous discussions with members of the Council’s Task Force have indicated that the “we” in the vision statement, and the term “National Food Safety System” include state and local partners, the document does not completely define the term, nor is the role of the state and local partners clearly defined. Since the Draft Strategic Plan is a “national” plan for addressing food safety in this country, AFDO believes very strongly that the importance of these roles need to be more clearly verbalized and emphasized.

Also, there are a number of different references to what the “system” is. There are several references to “national food safety system,” and one reference each to “integrated food safety system” and “vertical integration of food safety.” However, we strongly believe that “system” must be defined, and that the definition of “system” should include “federal, state, and local partners” and “regulated industry,” since industry also plays a vital role in research and implementation.

AFDO is concerned that a contradictory message is being given in the Vision and the Overarching Goal. The “vision” includes the statement “...Consumers can be confident that food is safe.” However, the document is full of references to “reduce” and “reducing” foodborne illness. AFDO is therefore concerned that the public will read the “vision” to mean that there is “no risk.” We realize that the vision for the future is that our food can be considered “safe” once we implement all of the components of a new strategic plan. At the same time, the current vision statement could be misconstrued by the public.

The Council will also notice that AFDO has recommended herein a number of additions to the “action plan.” We also believe that more measurable goals, with accountability, should be included, along with a coordinated food policy.

AFDO believes that a good Strategic Plan, which adequately incorporates the roles of State and local programs, can assist the states in assuring that our State programs continue to be funded. A Strategic Plan that does not accomplish this could discourage state legislatures (and city councils) from continuing funding for these vital programs.

The Council will also notice that AFDO also believes the role of surveillance in the overall Strategic Plan needs to be emphasized to a greater degree than that which is currently found in the Draft. Surveillance enables us to collect valuable data, in addition to inspections, to prevent and/or reduce illness, and in some instances identify problem areas.

AFDO also believes that preventive measures in the Draft Strategic Plan need to be strengthened. AFDO has made some specific recommendations in the document which we believe will assist the Council in accomplishing this goal.

AFDO realizes that there is a long-standing difference in the philosophies of food regulation between the U.S. Food and Drug Administration and the USDA’s Food Safety and Inspection Service, and that this has been reflected in their respective relationships with the states and locals. FDA has a long history of contracting and partnering with the states because few of FDA’s laws and regulations are preemptive. FDA’s historical lack of human resources to carry out its mission has required the agency to utilize the human resources and expertise in the states and local agencies in order to fulfill its responsibilities of ensuring food safety.

On the other hand, the principal laws and regulations of FSIS have long been preemptive. Although FSIS has long partnered with those states with meat and poultry inspection programs, the partnerships did not directly involve subordinating its authority and control over federally inspected products, or over amenable state-inspected products which are also required to meet the same standards.

AFDO has worked diligently in the past few years to reduce this dichotomy by advocating additional areas where FSIS and the states can work together in partnership to eliminate duplication and at the same time ensure FSIS and consumers that the level of consumer protection not be lowered but rather increased. AFDO has also worked with the federal agencies to increase cooperation to reduce friction and to identify opportunities for cooperation. These areas have included recalls, inspection of facilities over which both agencies have jurisdiction, the food distribution system, and regulation of shell eggs. We believe that it is ONLY through increased cooperation between the federal agencies, and increased respect for and reliance on the enormous human resources available at the state and local levels, that we can indeed improve food safety in the U.S. and at the same time eliminate duplication, gaps, and inconsistencies.

AFDO also agrees with the concept of federal oversight of state food inspection programs, and state oversight of local food inspection programs. If there is any doubt in the minds of consumers or the federal agencies that the inspections and laboratory analyses conducted by state and local regulatory agencies are not equivalent, we must establish a system which ensure consumer confidence. Therefore, AFDO implores the President’s Council to utilize the work of the National Food Safety System (NFSS) Work Groups, which are actively examining these and many other issues and making concrete recommendations. At least one pilot project (laboratory) has already begun, and AFDO believes that additional pilot projects must begin soon, such as a pilot project using the Roles and Responsibilities model Partnership Agreement which includes a strong federal oversight component. These activities should be reflected in the Plan.

We would also be remiss if we did not mention that the terms “oversight” as we have used this term, and “coordinate” as the Council has used the term, should not be interpreted as synonymous with “control over” or “directing the activities of.” AFDO purposely used the term “integrate” for the past three years in order to emphasize individual “autonomy” with an integration of activities to eliminate duplication and gaps. Respect for all partners should be an integral part of the Strategic Plan.

We bring these particular issues to the Council’s attention because these issues are vitally important for any strategic plan that addresses food safety for the nation. These issues should not be omitted from or only alluded to in the Plan. The issues should be specific action items for implementation of the Plan.

With respect to other general comments, AFDO believes that the term “producers” as used in the Draft should be expanded to include “processors” and “distributors,” both key industry components. Also, the role of industry, with the exception of the development of “best practices” as mentioned in Objective 6, Page 16, is almost totally absent. Industry has much to offer in the form of data and product specific expertise to assist the regulatory agencies in many areas. These should be specifically addressed.

AFDO also believes that, while the document acknowledges a knowledge gap with respect to surveillance data findings, the goal should be to identify food/pathogen “pairs” that should receive the highest priority for monitoring and regulation. Some of this can be accomplished by evaluating the “production to table” environment. Data exists in many locations, and the regulated food industry should be a strong partner here without fear of regulatory action from the release of such data.

Further, one of the largest gaps in our current system is the identification of “who is doing what” and what is being done. The Council needs to recognize that, because of the amount and quality of food safety work being accomplished at the state and local levels, it is imperative that we not only identify tasks each federal agency is performing in order to eliminate gaps and overlaps, but we also need to understand the scope of the work and accomplishments of the states and locals. The Roles and Responsibilities Work Group of the National Food Safety System has produced a document which attempts to address this problem in general terms along with some specifics. Once the Office of Management and Budget has approved the information gathering activities, the assessment tools that the six Work Groups have developed should capture this information for the Council. This is another example of how the work of the NFSS can and should be an integral part of the Strategic Plan.

In the area of “risk assessment”, AFDO has long advocated the institution of “universal HACCP” (hazard analysis and critical control point) at the federal and state levels. While we understand that many large food processors already use HACCP to identify and control food safety hazards, and that federal regulations for certain food commodities mandate the use of HACCP, more than 80 percent of the food processors in the U.S. do not use and are not required to use HACCP. Thus, 80 percent of the food processing industry is not required to conduct a risk assessment. AFDO sees no rationale for continuing to address food safety hazards in a piecemeal fashion. As new commodity-specific food safety hazards are identified, FDA proposes to regulate hazards by mandating HACCP. AFDO believes that HACCP should be mandated for all food processing, so that a company is required to conduct a risk assessment at a bare minimum. If no major risk is found (i.e. no critical control points are identified), then the operational impact on the firm is minimal. On the other hand, if major risks are observed, additional evaluations and changes must be implemented, and most of us would agree that HACCP is the best means currently known to control those risks. AFDO therefore believes that the Council should acknowledge this fact in the Strategic Plan and advocate HACCP across-the-board. After all, the Plan is based upon risk assessment and risk management.

With respect to imports, AFDO would bring to the Council’s attention that “risk assessment” can and should be used in resource utilization and planning, as well as the regulation of imported foods, since 65 percent of our seafood and greater than 25 percent of our fresh produce is imported, two areas of “high priority” based upon the food safety problems encountered with both commodities.


Specific Comments

In the section entitled “Food Safety Regulation Today,” the states are mentioned only in an ancillary fashion. We wish to bring to the Council’s attention the fact that nearly all the states operate under statutes containing language quite similar or in most cases identical to the federal statutes, and that the states conduct the majority of the inspections in the U.S. (including producers, manufacturers, and distributors - not just retail) and do the vast majority of the enforcement actions. For example, one state, through an official Partnership with FDA, identifies violative products and conducts a majority of all of the recalls FDA classifies and announces each year. This same section of the Draft Strategic Plan states that the document “takes into account the strengths that various state food safety systems may bring (emphasis added) to the protection...... .” AFDO strongly believes that the word “may” should be eliminated.

On page 8, paragraph 4 of the January 7th document, the Council should add the term “effective” to “...comprehensive, efficient, consistent and equitable.... .” All of our regulatory programs must be effective in reducing or eliminating food safety hazards.
AFDO also believes that the “Overarching Goal” found on Page 9 should include the term “risk-based” to reaffirm the document’s overall scientific basis.

Goal I - Sound Science and Risk Assessment. One of the objectives within this goal involves the establishment of national risk-based standards to control food safety risks. AFDO believes that the terms “coordinated and unified” should be added to this objective, and that this should be translated into an action item. We would mention that there have been situations where different risk assessments by different federal agencies (e.g. methyl mercury in fish) have resulted in different standards, causing problems among the states as to which standard to use. A coordinated and unified risk assessment methodology among the federal agencies should alleviate this problem.

Bullet 2 under possible action items concerns the development of rapid tests for pathogenic microorganisms and chemical agents in food specimens. AFDO strongly believes that the development of rapid field tests could significantly reduce the need for, collection, and laboratory analysis of food samples from the field, which often show negative results and therefore are of little value compared to the resources expended in the collection efforts.

Bullet 4 concerns the establishment of Centers of Excellence to develop training programs linked to food safety and public health. AFDO has been an advocate of a national training center (note no capitalization) which would provide up-to-date training for federal, state, and local regulatory officials, and perhaps for regulated industry as well. Such a center could be a composite of many different forms of training, not just a physical location.

In the second Action Item under Objective 1, reword the sentence, “Develop, implement, integrate, and update priority risk assessments......”

Under Objective 2, add an action item: “Develop state-of-the-art information systems to improve ease, accuracy, and completeness in gathering and distributing information.”

Under Objective 3, reword the final sentence of the second Action Item to read, “The scope of a unified program should include......drug and biologic residues, and veterinary drug and biologic residues associated with animals that are sources of human food.”


Goal II: Risk Management. AFDO believes that this goal is an area where the coordination and cooperation among federal, state, and local regulatory agencies can provide the greatest impact on the development of a seamless national food safety system. As the Council has pointed out, all three levels of government have a vested interest in the management of risk through regulation, inspection, and enforcement.

One of the objectives and action items listed by the Council involves the development of national standards and the identification of state and local standards and regulations that should be applied within national standards. AFDO could not agree more. A review of all state and local laws and regulations which currently fill gaps in the national system, or which offer an additional level of consumer protection, should be closely examined to determine where such standards can be incorporated into an existing or new national standard or regulation. At the same time AFDO believes that the first objective should be reworded to ensure that the Council is referring to uniform national risk-based standards. Further, the AFDO Board, in lieu of general field preemption of all state standards and rules, supports national standards and regulations, which have gone through notice-and-comment rule making, as being the national standard(s).

On Page 11 under the Risk Management summary section, add a sentence at the end of the section: “This information will be used to adjust strategies, priorities, and resources to fill identified gaps in managing food-related risk.”

On Page 12 under Objective 3, reword the first sentence of the second Action Item to read, “Upgrade the ability at all levels.......to conduct public health surveillance and evaluation of foodborne illness.....”

Also, reword the first sentence of the third Action Item to read, “Expand the capacity and increase the expertise of public health laboratories....”

Reword the first sentence of the sixth Action Item to read, “Upgrade food laboratory standards and build complementary infrastructures at federal, state........”

On Page 13 there is a discussion of what constitutes an “effective” system. The Council uses the term “coordination.” AFDO believes that the Council should add the terms “coordination and integration....”. If a federal agency makes improvements to become more effective, but does not coordinate with other agencies, the value of the improvement is greatly decreased or lost altogether.

Under Objective 3, page 14, AFDO believes industry data (previously mentioned) could be used in the development of a strategy to identify high risk foods. Also, as this Objective relates to disease surveillance, a huge gap in the current system is the lack of a strategy aimed at consumers and the medical community to improve reporting of the currently unreported/under-reported and unconfirmed illnesses, a number which constitutes the majority of foodborne illnesses.

Under Objective 4, add a sentence to the first Action Item to read: “Further refine prioritization of inspectional work using operator performance criteria.”

Reword the second sentence of the third Action Item, “This approach also would help to ensure a level playing field......”

Reword the first sentence of the fourth Action Item to read, “Develop an analytical framework that provides step-by-step guidance for risk-based inspections at all levels....”

Under Objective 5, the Council advises to “...Protect the food supply through consistent training and consistent enforcement....” AFDO is not clear as to whether this refers to regulatory agencies, industry, or both.

Also, reword the first sentence of the first Action Item to be two separate sentences (Page 13): “Maintain and augment, where necessary, trained enforcement and compliance officers. Use these specialized staff in situations that cross inspectional jurisdictions or in situations that rely heavily on investigatory skills such as interviewing and auditing.”

AFDO also recommends rewording the second sentence of the third Action Item to read, “Target compliance inspections toward facilities at critical control points in the farm-to-table continuum that have a history of non-compliance.”

Under Objective 7, add an Action Item to read, “Develop a system to evaluate and record decisions and rationale about the food safety aspects of proposed food production, processing, and delivery innovations.”

Under Objective 8, reword the second sentence of the third Action Item to read, “Develop national protocols for initiating......adequate communication between partnering agencies, with industry and the public during recalls.”

Bullet 2 under Action Items (Federal Register document): The Council advocates the development and promotion of effective techniques and controls based on national standards. AFDO believes the Plan should specifically include an overarching laboratory accreditation to ensure acceptability of analyses from state and local laboratories in particular. There have been several situations in the past few years where a federal agency would not accept state laboratory analyses until confirmed by the federal agency’s own analyses. This additional confirmation significantly delayed national recalls of products already under State recall.

Bullet 6 under Action Items (Federal Register document): The Council addresses the expansion and enhancement of effective surveillance of illness and other health effects resulting from food safety hazards. AFDO believes that the Strategic Plan should also address expansion of the surveillance of the food industry. It is at the industry level where major food safety hazards are identified and can be controlled to reduce the risk of illness.

AFDO is very pleased that in Bullet 8 under Action Items (Federal Register document) the Council recognizes the concept of partnerships with state and local governments by advocating the effective implementation of food safety activities in partnership with the states and locals. Only through equal partnerships can we effectively utilize the vast human resources available to us to improve food safety in the U.S.

Bullet 9 under Action Items (Federal Register document), and on Page 16 under “Objective 6": The Council addresses the promotion of additional voluntary “best practices” ........ to reduce the risk of illness. AFDO certainly agrees that these “best practices” provide a valuable role in food safety. At the same time, we believe the federal agencies need to examine these in the same fashion that the Nutrition Labeling and Education Act requires FDA to examine the “voluntary labeling of fresh fruits and vegetables.” In other words, is the “voluntary” compliance with such practices at a level which assures adequate protection of public health (assuming that the so-called “best practice” does indeed increase public health protection)? If not, then the federal agencies need to consider the establishment of a mandatory regulation. Also, in examining these “best practices,” which by their very nature address an issue not currently addressed by formal regulation, we need to consider the effects on our trading partners, some of whom may require compliance with such practices before permitting the exportation of U.S. products to their countries.

Objective 9: Reword the Objective to read, “Develop an improved system of assuring that foods being exported to the U.S. are produced under a food safety system that achieves a level of science-based protection that is specified by the U.S.” Then, reword the first sentence of the first Action Item to read, “Strengthen assessments of foreign food safety systems.......”

Under Objective 10, substitute for the first action item, the following: “Develop a system to continually monitor and routinely evaluate the effectiveness, value, and efficiency of food safety risk management systems using critical indicators. Use data to identify emerging food safety/food-related public health problems or gaps in risk management services. Adjust strategies, priorities, and resources as warranted to make corrections or improvements to the risk management system.”

And finally, AFDO believes that the Plan should address the need to continually evaluate our risk management systems, based on the new information we obtain on an ongoing basis.

Risk Communication.

AFDO fully supports the use of risk communication as a third part of the Strategic Plan. Without good risk communication, new technologies that are developed to eliminate or reduce food safety hazards (or the risk thereto), may not gain public acceptance. In addition, without public acceptance, industry may be reluctant to utilize these technologies, or at a minimum the technologies will be under-utilized. Specific examples include biotechnology, irradiation, and new food processing techniques. Therefore, a separate Action Item should be added which specifically addresses this issue.

Bullet 3 under Action Items (Federal Register document): The Council advocates the establishment of opportunities for public/private partnerships to promote effective communications about food safety risks. AFDO’s only comment is that now is the time for regulated industry and consumer advocates to work together on this issue. Food safety education (risk communication) will never become a truly effective tool for improving food safety until the consumer is no longer confused by conflicting information and left wondering who is right and who is wrong.

In the summary for the Risk Communication Goal, reword the final sentence in the second paragraph to read, “As research and experience reveal new information....and transmission of foodborne hazards and preventive approaches to eliminate or minimize food-related hazards, food safety agencies........”

Objective 2 under the title of “Risk Communication Goal” summary, the sentence should be reworded to begin, “Develop state-of-the art science-based integrated education and training systems.”

Also, reword the first Action Item to read, “Develop messages with a consistent, focused content and a coordinated delivery system. Provide variety in style, format, media, level of detail and sophistication as needed to effectively deliver the message to a range of target audiences.”

Under Objective 4, reword the first Action Item to read, “Develop and implement a system to evaluate the effectiveness of information campaigns......” Consider including examples of potential evaluation criteria aka the second Action Item.

Also, under the heading “Food Safety: The Nation’s Challenge,” reword the fourth sentence to read, “More consumers demand these foods year round, making safety issues surrounding production, transportation, refrigeration, and international trade increasingly important.”

Legislative Changes

AFDO believes some legislative changes are needed to allow the federal agencies, in partnership with their state and local counterparts, to effectively improve food safety and better utilize human and monetary resources. This is irrespective of any reorganization that may occur at the national level. We have listed a few examples below.


1. The Federal Advisory Committee Act. This Act has become a large obstacle to collaborative discussions and solutions between state and local regulatory agencies and our federal counterparts. It has often been used as the reason why state and local officials have been excluded from certain discussions and decisions which directly impact our food safety programs. Inter-agency collaboration and communication between federal and state agencies, which is a must in order to make the Strategic Plan work, is a clear barrier to “integration, cooperation, and true partnerships.” Consequently, the Act should be amended to permit unfettered communication.

2. The Paperwork Reduction Act. There are many occasions when valuable information, necessary for the efficient and effective operation of our federal food safety agencies, cannot be collected in a timely fashion. Specific surveys of state and local programs, including budgets, manpower, technical expertise, and so forth, will be necessary to adequately implement the Strategic Plan to eliminate inefficiencies, duplication, and gaps. This information would have been quite valuable to the Council in the development of the Plan (“who is doing what, and how often”). The NFSS Work Groups have already developed questionnaires which need to be submitted for information gathering purposes, but this Act requires OMB clearance of each request, thus both hindering and delaying the process.

3. Inclusion of Irradiation as a Food Additive in the Federal Food, Drug, and Cosmetic Act. As we all know, it has taken literally years to obtain product specific approvals for the use of irradiation, including approvals which had to go through two separate federal agencies. Further, the FDA is currently faced with having to go through multiple approvals now, based upon a number of petitions received in the last six months. Food additive status and subsequent rule making should never have been required for irradiation, as it is a process, not a food additive. The Act should be amended to remove irradiation from the definition of food additive.

4. The Dietary Supplement Health and Education Act. Although AFDO understands the rationale used to remove dietary supplements from applicability to the food additive section of the Federal Food, Drug, and Cosmetic Act, some segments of the supplement industry have used this exclusion as carte blanche to market products for which no safety data exists, but are patently unsafe, or are unsafe without specific directions for use including dosage quantities. A mid-course correction is therefore needed to require manufacturers of supplements to provide FDA, on request, with their safety assessments. Although FDA would be excluded from using the level of safety required for food additives in reviewing such information, at least FDA and the public would have some assurance that companies have made bona fide attempts to market safe products. As it currently stands, the public believes that the safety of all such products is indeed assured by FDA, which is not the case!

Conclusions

AFDO believes it has responded to most of the questions asked by the Council with respect to the Draft Strategic Plan goals and objectives. On the issue of “success,” the Plan will only be as successful as the amount of cooperation and resources put into the Plan by the federal agencies, and their relationship with their state and local partners. The Plan must also transcend administrations in order to achieve anything more than transient success. Also, success can only be measured by decreasing the risk of foodborne illness by identification of the hazards and subsequent reduction of the hazards, combined with public understanding and acceptance of technologies that are (and will) make our foods safer. Consumers must also share in food safety by implementing safe practices in the home.

AFDO further believes that the system can be improved only if a total resource assessment (federal, state, and local) is done, followed by a clear vision of what can be accomplished by sharing food safety responsibilities based upon those resources. If the federal agencies put into place a system of oversight of state and local programs, there should be no reason for a federal agency to duplicate the work of their State and local counterparts at processing, wholesale, retail, or transportation levels. If a federal agency believes additional training of State and local investigators is needed, use of scarce federal dollars could be used more effectively by upgrading your state counterparts through training and oversight, rather than duplicating state and local activities at the federal level.

Further, the federal agencies MUST allocate resources (both human and financial) across agency lines if we are to address the most critical issues based upon risk. If one agency has resources enough to address an issue that is of a lesser risk, these resources should be instead freed up to assist in another, more critical area. A first step has been taken by the President in requiring a single budget request. AFDO hopes that Congress will now take the initiative and permit the sharing of these resources across agencies. AFDO notes that it is often the organizational structures that tend to prevent adjustment of resources between agencies to ensure that the most important issues are addressed!

Some consumer advocates have for two years portrayed the work of State and/or local officials as being inconsistent at best, and they are adamant that further erosion of federal oversight of food establishments throughout the continuum should not occur simply in the name of increased utilization of State and local resources. Although AFDO understands that consistency among State and local food safety agencies may leave room for improvement, adequate federal oversight and/or intervention when needed should alleviate these concerns. If a State is not operating a program acceptable to the federal agency, the agency should be obligated to step in to ensure that safe food is provided to the citizens of that state. Further, AFDO does not advocate that federal agencies should turn over the entire inspection process to the states. We do, however, believe that it is senseless to have a federal agency visit establishments which are already inspected three and four times a year by state and local agencies, unless such visits are a part of an official oversight plan included in Contracts and Partnership Agreements with that State.

And finally, with respect to the numerous proposals for organizational changes found in the Plan, AFDO makes the following comments: AFDO does not see a need to address or support any single organizational structure. Instead, we approach this from the standpoint that the best structure is one which adequately coordinates and integrates the activities of all federal, state, and local food safety agencies into a seamless food safety system - one that accepts the states and locals as full partners in the process, and one that eliminates the current overlaps, gaps, and duplication that currently exist. If this can be accomplished without any major structural changes to the current system, then AFDO fully supports these efforts. If, on the other hand, the goals cannot be achieved through current efforts, then we would support a system that could achieve our stated goal. At the same time, we believe that current efforts may well achieve this vision if our previous recommendations are accepted by the Council, adequate funding is provided, and these efforts continue into the foreseeable future.

Lastly, AFDO believes the Council must establish a new coordinating group which would be given the responsibility of determining what kinds of funds and personnel will be necessary to carry out the Strategic Plan, what the time lines should be for implementing the Action Items, who should be responsible for implementation of the specific items, and where the coordination between federal and federal, and federal and state programs is to occur to eliminate the gaps and overlaps that currently exist, including how the Plan is to be implemented. AFDO recommends that such a coordinating group should be composed of a number of different stakeholders, not of the least of which should be your State and local counterparts.

AFDO wishes to thank the President’s Council on Food Safety for the opportunity to provide comments on the Draft Strategic Plan.