Draft Report on FDA Oversight of State Food Firm Inspections
Request for Comments
R. Dan Sowards, President
Comments to the U.S. Inspector General on behalf of the
Association of Food and Drug Officials (AFDO)
Draft Report on FDA Oversight of State Food Firm Inspections
The Association of Food and Drug Officials Board of Directors, hereinafter referred to as AFDO, is pleased to offer comments on the Draft Report on “FDA Oversight of State Food Firm Inspections” (OEI-01-98-00400) recently requested by you and your staff from the Office of Evaluation and Inspections.
AFDO is the 104-year-old principal organization that represents federal, state, and local government regulatory officials and industry associates with food safety responsibilities throughout the U.S. AFDO’s motto is “Uniformity Through Cooperation and Communication,” which we have been fulfilling these many years through the development of model laws, regulations, and guidelines, and by conducting training and education. AFDO strongly supports an adequate oversight role for federal agencies to ensure that State program capacities produce inspections, which are equivalent to federal inspections conducted throughout the U.S.
AFDO realizes that the U.S. Food and Drug Administration (FDA), due to a lack of capacity (current staff are needed to complete their own field assignments), has not been in a position to implement an adequate oversight program to provide assurance to those outside the agency that State inspections are indeed equivalent. Although many states do quality inspections in a much more efficient manner than FDA, this has not been adequately documented. In this respect, AFDO believes that for the most part the Draft Document prepared by the Office of Inspector General’s Office of Evaluation and Inspections is on target.
AFDO agrees that adequate training in auditing and evaluations is necessary for both FDA staff engaged in this activity, as well as State program personnel who must assure both FDA and their own legislatures that inspections are of good quality and equivalent to those conducted by their federal counterparts. AFDO agrees that FDA, the states, and those outside the agencies need such assurances. FDA auditors must be able to demonstrate good audit technique (good judgement and excellent diplomatic skills), as well as program knowledge to be able to perform a fair and accurate evaluation, communicate it well, and convey a sense of confidence in a State’s ability to make any recommended improvements to its food safety system.
AFDO also agrees that any audit inspections conducted by FDA should be joint audits rather than the independent audits that are typically used to “catch” mistakes rather than correcting deficiencies. Joint inspections have worked well in the past, both between FDA and the states, and the states and locals, especially for training purposes. This helps to ensure uniformity. The states welcome any opportunities to document that our inspections are equivalent, as well as opportunities to improve. We wholeheartedly agree that “....State input into developing the guidance document for on-site audits....” should necessarily be a part of the overall plan. AFDO believes that the OIG should utilize the draft documents prepared by the National Food Safety System (NFSS) Roles and Responsibilities Work Group on “oversight” and “uniform standards” as a template for federal oversight of State programs. These documents have been forwarded to the federal agencies involved in the NFSS activities under the President’s Food Safety Initiative.
Although AFDO supports the OIG’s intentions and the overall goals presented in the document, we have a number of concerns.
First, we believe that FDA has not issued contracts and partnerships with states who do not provide quality inspections which are equivalent to those conducted by FDA investigators. Although documentation and oversight may appear sparse, FDA District staff are quite familiar with the personnel and the abilities of the various State programs with which they have contracts and partnerships. Further, many of these same state program personnel are commissioned by FDA and therefore conduct federal inspections - not merely state contract inspections. Consequently, the problem may involve a lack of documentation that the inspections are equivalent, rather than equivalency itself.
Under the current system, FDA receives a large capacity for inspections at a very cheap price by federal standards. For an oversight system to have any significant leverage with the states, there will have to be significant incentives for states to do all of the things the OIG recommends in the Draft Report. Building and maintaining adequate training systems, continuously providing key inspection and performance data, performing and reporting inspections in a standardized way, and making program improvements recommended by FDA as a result of audits may be essential elements for evaluating the adequacy and equivalence of a State program, but these requirements will be neither easy nor cheap for the states. For such an oversight system to be feasible and palatable for the states, the FDA will have to invest in a system that assists states in building a standardized system and rewards them for maintaining and improving their programs within boundaries negotiated with FDA.
FDA pays for contracts, but most of the leveraging involves partnerships, which FDA receives for next to nothing. Without incentives the states may chose not to participate rather than accept additional reporting requirements.
AFDO also does not believe that the OIG can adequately compare State and federal inspections based upon the number of hours per inspection, the classification of inspections, or the number of days spent in training. Although a two hour inspection of a large food processor might be suspect, one might also question the necessity of spending 30 or more hours to conduct the same inspection as does FDA. The efficiency with which many states conduct inspections is unparalleled. Most utilize laptop computers during the inspection, thereby printing the FD-483 form along with other forms (detention, destruction, etc.) before the closing conference with management. The body of the report is often completed at the end of the inspection rather than over several days back in the office from notes taken during the inspection. Copies of labels are scanned and submitted electronically to the office, and the reports are often submitted electronically.
Further, some states require investigators to have the previous inspection report on disk so that the previous inspection report can be updated, rather than duplicating the collection of information that has not changed from one inspection to the next. Therefore, in AFDO’s opinion most State inspections are more than adequate and time should not automatically reflect negatively on the quality of the inspection.
AFDO is also aware that FDA’s reliance on the states to conduct many food inspections has often been due to the fact that, as OIG points out, FDA has for many years utilized its own field staff to conduct drug, device, and biologics inspections. Most FDA personnel hired during the last 15 years are able to chose which area of regulation they wish to specialize in. In some cases this has created a situation where there are few FDAers in some Districts who have expertise in foods. There have always been some FDAers in the Districts who have continued to work in the area of foods, but the numbers have dwindled. AFDO suspects that in certain areas at least some of FDA’s institutional memory (longtime expertise) may have been lost. We mention this because it is important to note that in some instances the states have more expertise in foods than does the FDA District, which would be engaged in oversight and audits. Therefore, depending upon who the FDA auditor is, the joint audits may point out that the federal investigator has less expertise that the State investigator. In order for an oversight mechanism to work, FDA must improve its own capacity for quality food inspections, and this requires dollars from Congress and time for training.
Many State programs pride themselves on not only the quality of their inspections, but also on the breadth of the knowledge of their investigators. As an example, a number of states have ensured throughout the years that their field investigators have an excellent working knowledge of food labeling, including the application of the Nutrition Labeling and Education Act and Dietary Supplement Health and Education Act requirements; whereas, FDA does not expect their own field investigators to have a good working knowledge of these regulations, depending instead on the compliance staff in the Districts to analyze food labels. In fact, FDA investigators are discouraged from listing food labeling violations on the FD-483 unless the investigator is certain of his judgment. Many states would reject inspection reports, which did not include labeling review/violations as deficient or incomplete.
Based upon these and other comments from AFDO Board members, we question whether all FDA Districts are currently in a position to adequately judge the quality and uniformity of State inspections and the capacities of State programs. This is not to say that State programs would not benefit from better FDA oversight. We firmly believe in oversight and the need for such oversight to document for all, including Congress and consumer advocates, that contract and partnership dollars are being well spent. Therefore, this begs the question, “What should such an oversight mechanism look like, and where do we begin?”
AFDO has previously mentioned the need for OIG to utilize the oversight document prepared by the NFSS Roles and Responsibilities Work Group. This is not to say that OIG’s comments do not have merit. Both FDA and State program personnel should have additional training in auditing and program evaluation. Both agencies should conduct more joint inspections, which many years ago used to be the rule, not the exception. At the same time, AFDO cautions that only extremely well trained individuals, who know all of the ins and outs of a particular type of inspection (acidified foods, low acid canned foods, etc.), should attempt to engage in a joint audit inspection where the sole purpose is to “improve” the State program only. We are also not convinced that a single audit inspection of a State investigator every three years will provide much in the way of significant information on the State inspection program. We strongly believe that programmatic oversight is much more important than audit inspections. In other words, OIG’s outline of an adequate audit mechanism should begin with a look at a State’s capacities, laws, regulations, and abilities, rather than the inspections. Further, investigator certification should be a requirement for both FDA and State personnel.
AFDO is also concerned with OIG’s comments on contracts and partnerships with respect to the benefits they provide to both FDA and the states. OIG appears to view these merely as inspections that the states would otherwise conduct under their own laws and regulations. In a vacuum this is true. Nearly all of the states would indeed continue to conduct inspections irrespective of contracts and partnerships. However, the Federal Managers Financial Integrity Act (FMFIA) requires the states to subtract any fees for licenses or permits they collect for their state inspections before determining the costs FDA is to pay for the inspections. In many cases these fees the states collect do not pay the actual costs of the inspections. In fact, some states either have no license fees or the fees are minimal ($25.00 in some cases). Therefore, many states rely on the contracts as a mechanism to recover their full costs of conducting the inspections. Many states do not have enough resources to inspect their entire inventories and therefore rely on the contracts to supplement their travel funds, or purchase computers or equipment related to inspections. Funding of these essentials is quite limited in a number of states.
Further, partnerships are not limited only to inspections. They also include sampling (which in some states would not occur if it were not for the partnership funds from FDA), recalls, recall effectiveness checks, and so forth. The OIG Draft Report also does not address the huge successes of a number of the “other than inspection” partnerships. For example, the recalls conducted by the New York Department of Agriculture and Markets amounted to over 84 percent of all of the food recalls classified by FDA in the New York District (69 of 82 recalls).
The OIG Draft Report also does not mention that two types of FDA contracts/partnerships already have built-in inspection performance standards. These include low acid canned foods/acidified foods and seafood processors. Again, some states conduct these inspections using the FDA commissioning process whereby the inspections are literally FDA inspections and not State inspections. In these instances the State is utilizing federal laws and regulations and federal authority to conduct the inspections, rather than relying on state laws and regulations.
Also, FDA already requires that all inspection data needed to capture the results of State inspections (contracts and partnerships) into the FACTS system is included in the State inspection reports or in summaries. Further, entry of the information into FACTS takes an additional 0.5 to 2.0 hours per inspection. This is time taken away from State and FDA personnel who would otherwise be conducting additional inspections. Consequently, the additional cost of data entry must now be built into the contracts. Although this was a part of the OIG Draft Report (data entry into FACTS), the FACTS system has been utilized for this purpose for less than a year, even by FDA. FACTS was previously utilized only for sample data entry. Also, access to the FACTS system requires security clearance and the purchase of many additional rights to the software, which thus far FDA has not been able to fund. Therefore, data entry often requires both the FDA investigator and the State investigator to sit down side-by-side at the computer in order to get the information entered into the system. To reduce or eliminate this problem, FDA needs to funding to create a system which promotes uniformity in inspection reports and which can be utilized by both FDA and the states to directly input the data electronically, rather than having to expunge the data FDA needs from the State reports. Again, financial and other incentives must be forthcoming to the states to encourage them to take advantage of such a system.
Although OIG is correct in its assessment of the lack of documented oversight of contracts and partnerships with the states, and the need for such oversight, contracts and partnerships are the only current mechanisms (besides “work sharing”) FDA has to capture the inspectional and sampling data from the states. Today’s funding of both federal and State inspection programs dictates that we must leverage our resources in order to ensure that high and medium risk establishments receive adequate inspectional coverage. AFDO has long advocated the use of contracts, partnerships, memoranda of understanding, and work share agreements to assist FDA in the completion of their annual work plans, and to ensure that gaps and duplication in the system are eliminated. With the exception of the addition of adequate oversight of these programs, AFDO does not see a rationale for changing the basic system. The states need resources such as funding for travel, laboratories to analyze samples, training, and equipment; while FDA needs the states to complete inspections and collect samples. No proposed system should require duplication of these activities.
The Draft Report states that variations in State laws and regulations and inspection practices add complications, costs, and frustrations for food firms engaged in multi-state commerce. Although AFDO agrees to a point that some non-uniformity exists, most of the non-uniformity exists among local regulatory jurisdictions and not among State jurisdictions. Contract and partnership inspections have long been one way of ensuring a certain amount of uniformity in both practice and regulation. FDA does not accept inspections that are not conducted utilizing state regulations alone that are not in conformance with the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder. For example, states which conduct seafood HACCP inspections and which have not adopted FDA regulations as State regulations are required to conduct these inspections utilizing their federal commissions rather than under “partnerships” using any non-uniform state regulations. AFDO fully supports uniformity of laws and regulations and has consistently advocated this for many years, including in our official comments to the President’s Council on Food Safety Draft Strategic Plan.
Also with respect to the uniformity issue, AFDO is concerned that the OIG’s Draft Report does not adequately address the issue of how the FDA and the states can use the results of the oversight and audit mechanism to improve uniformity. It is not enough to merely identify problems and non-uniformity, but there must be mechanisms and incentives to directly address and correct the problems. A program must be developed to accomplish this in conjunction with the development and implementation of the oversight and audit process. Considerable thought by both FDA and the states is needed in advance.
AFDO is also concerned with the OIG’s recommendation that consumer groups be one of the judges of the successes and failures of the inspections conducted by states. During the past several years at least one consumer advocate has repeatedly represented that many inspections conducted by the states are “inadequate” and “subject to local politics,” which are generalizations that do not fit all situations. The same group also repeats the fact that FDA inspects firms only once every ten years on average, without acknowledging that the states may be inspecting these facilities twice every year. On the other hand, AFDO believes that consumer advocates should be consulted regarding what elements they consider to be essential to an adequate oversight program that would satisfy their concerns. Further, they should have access to the results of the inspections. We cannot operate in a vacuum and expect consumers to trust in our inspectional results.
AFDO also does not agree with the comment that “...Industry representatives have expressed concern that an even greater reliance on State inspections such as under a nationally integrated regulatory system could magnify the existing complications and costs.” Both the National Food Processors Association and the Grocery Manufacturers of America are on record as supporting AFDO’s vision of a fully integrated food safety system. That system, as visualized by AFDO, includes adequate oversight by FDA. At the same time, industry is also on record in support of contracts and partnerships because these agreements eliminate the need for multiple inspections of their facilities. AFDO believes that an oversight system that includes clear, scientifically sound, practical, and fair expectations regarding performance of the states, coupled with performance incentives, should allay any fears industry may have expressed to OIG! AFDO also encourages industry input into what such a system should entail.
In conclusion, AFDO believes that many of the proposals found in the OIG Draft Report have merit, especially where FDA oversight of both contracts and partnerships is concerned. At the same time such mechanisms should not be overly burdensome to either party. An oversight mechanism should be flexible enough to ensure equivalence of federal and State programs and inspections without diverting too many resources away from essential activities. OIG should advocate for more human resources for FDA so that FDA is indeed in a position to fill any void that might exist if/when a state falls short and cannot meet the equivalency criteria. FDA will also need additional resources to provide the training necessary to keep FDA and State/local investigators at the cutting edge of new technology and regulation. Incentives must be provided to the states to encourage continued participation.
Oversight should be a shared responsibility between FDA and the states. Before any oversight plan is initiated, the states should be consulted and the plan mutually agreed upon. The plan must include mechanisms which allow for flexibility to ensure that the oversight is the least burdensome possible for both agencies when quality inspections, equivalency of programs and inspections, and uniformity can be easily documented. The plan must also recognize that in some cases the quality of State inspections may exceed the quality of FDA inspections, and that audit inspections should address both sides of the issue. Both FDA and State investigators should be certified to conduct the various types of inspections. The oversight tool should also establish procedures that both FDA and State training and auditing personnel should follow. The OIG and FDA should utilize the documents produced by the NFSS Work Groups as a template. Further, we firmly believe that AFDO is the appropriate national organization with which FDA should consult to obtain State input into the development of a proposed oversight and auditing document.
Finally, it is AFDO’s hope that in the near future Congress will supply FDA with ample long-term funding for leveraging with the states. Building State capacities in a more permanent fashion can only improve food safety in the U.S. and will go a long way towards facilitating the oversight process recommended by OIG.
AFDO wishes to thank the Office of the Inspector General for the opportunity to comment on the Draft Report and offer potential solutions from the point of view of the states.
