| AFDO White Paper: FDA Food Inspection Contracts: A Time for Change
In 1972 the U.S. Food and Drug Administration (FDA) began contracting with State food safety programs to conduct "sanitation" inspections of food wholesalers and food manufacturers. Although the contracts have evolved some over the years (especially in the last four years, including the elimination of forms, cover sheets, and the addition of endorsements into the fairly new FACTS system), they have remained relatively unchanged for 31 years.
During the last few years, based upon an FDA-requested audit of the Contracts system by the HHS Office of the Inspector General and the concerns of consumer advocates that State inspections were not up to federal standards, more emphasis has been placed on training and equivalency of these inspections. Further, depending upon the results of a pilot project with Texas and Rhode Island, FDA may soon pay states with Food Inspection Contracts and/or other inspection contracts (Tissue Residue, Medical Device, Drugs) to enter certain required information directly into FDA's FACTS system through what is now called eSAF, or Electronic State Access to FACTS.
Based upon a recent survey of the States, AFDO has determined that the States and locals collectively conduct over 2.4 million inspections of food processors, wholesalers, salvage establishments, retailers, and other food-related endeavors each year. Of these, over 86,000 inspections are of FDA-regulated establishments such as food processors, dairy plants, food wholesalers, and food salvage establishments. However, FDA is only able to capture a small fraction of these inspections through the use of contracts. This year 8,100 inspections are to be conducted under the Food Inspection Contracts, which is less than 10 percent of the total number of State inspections of FDA regulated facilities conducted for the year. For example, in Texas the Manufactured Foods Division conducts about 8,000 inspections each year, of which around 5,500 inspections involve establishments also regulated by the FDA. However, only 550 of these inspections will be "captured" by FDA into the FACTS system as Contract inspections during 2003. FDA anticipates increasing the numbers of Food Contract Inspections to 9,100 in FY '04 and to 10,000 in FY '05 - which is still only 11.6 percent of State inspections of the FDA-regulated industries.
Further, the States and locals investigate 46,000 complaints; conduct almost 3,000 disaster-related investigations; and collect and analyze over 323,000 food samples each year. Currently only a very small percentage of these activities are captured at the federal level.
Given the fact that consumer advocates are gradually accepting the fact that States are conducting quality inspections but also continue to be critical with the numbers of inspections conducted by the FDA, it seems only reasonable that a change in the way we conduct business is needed. This paper examines one possible change, some of the advantages and drawbacks, and what would be required to make the paradigm shift a reality.
THE PROPOSAL.
"A system should be developed, using multi-year (minimum 5 year) contracts, grants or cooperative agreements, that (a) enables FDA to electronically capture most, if not all, of the inspections, sample analyses, embargoes, recalls, and related activities involving FDA-regulated industry currently conducted by the States; and (b) that reduces the impact on the States from duplicative paperwork and/or data entry. Funds should be used to support state programs, not merely to capture individual inspections or samples. Further, the system should ensure that States have electronic access to FDA's inspectional data, as well as work plans to eliminate duplication."
"The system should provide FDA and the states with a vision for what food safety in the 21st Century should look like, should be used for forming a cohesive strategic plan for food safety in the U.S., should be user-friendly and should result in maximum efficiency in the use of federal and state food safety resources. The system should provide for a comprehensive nationwide inspection database accessible to all participants, and should eliminate duplication of inspectional efforts. The system should include an accurate database of all regulated facilities.
Assumptions:
- Every year FDA's Office of Regulatory Affairs (ORA) has to scramble to find enough dollars to fully fund the various contracts with the States. For 31 years the contracts have been let on an annual basis. Millions of dollars are spent each year to capture only a fraction of the inspections conducted by the States.
- FDA does not yet have LINE ITEM BUDGET AUTHORITY FOR STATE GRANTS, COOPERATIVE AGREEMENTS AND/OR CONTRACTS.
- Congress, the Office of Management and Budget, consumer advocates, and others have been and continue to be quite vocal with respect to the lack of numbers of inspections conducted by FDA. They continue to report that "….FDA conducts inspections of an establishment on average once every [10] years…."
- Through the use of audits of State inspections, the advent of ORA-U (FDA's new training mechanism that includes the States), and additional programmatic oversight, FDA is ensuring that State inspections are equivalent (not harmonize) to FDA inspections. Equivalency means "equal in force, amount, or value," as opposed to "harmonize" which means "the same." Inspections should be "equal to" in the evaluation of whether or not food is safe, as opposed to requiring that all inspections be conducted exactly the same. FDA is cognizant that there is a difference between the way states conduct inspections (including laws and regulations) and the way FDA conducts inspections.
- Although FDA has been able to increase the numbers of field investigators with money received for bio-terrorism, FDA may never have the manpower to conduct inspections of all high and medium risk establishments (as defined by FDA) within the U.S. and outside the country, within time frames necessary to ensure food safety. Therefore, recognition and acceptance of State inspections is needed to assure Congress, consumers, and our foreign trading partners that foods produced, warehoused, and transported from all U.S. companies are safe.
- Irrespective of the number of inspections conducted by the FDA, the States will continue to inspect, license, and collect fees from food processing and wholesale establishments within their borders as mandated by their own legislatures. Therefore, instead of duplicating State efforts on an infrequent basis, FDA should support and enhance State regulatory programs to build a stronger national system that would result in a safer national food supply.
- Some states already surpass FDA in such areas as numbers of recalls of violative products, samples collected and analyzed, and complaints investigated, including products in interstate commerce. States for the most part have greater regulatory authority than FDA, including mandatory recalls, detention (embargo) authority, and administrative penalties. This has resulted in a more efficient regulatory process than FDA can achieve, even with the additional authorities granted by recent federal legislation. A national system of capturing this data would provide a much better understanding of where food safety problems exist and permit FDA and state agencies to focus resources, including training and enforcement, toward commodities and facilities presenting the greatest risk.
- In a number of the larger states, FDA must rely on the State to assist with the enforcement of federal requirements because FDA has no field staff in the vicinity of the regulated establishment. FDA often asks States to utilize their embargo authority over violative products FDA investigators encounter. Although new federal legislation may provide FDA with some increase in authority, FDA will continue to rely on the States for assistance in this area.
- Most states have more accurate Official Establishment Inventories than does the FDA because they are in the regulated establishments more often, and because in many instances regulated establishments must license or permit with the State. FDA's new registration authority not withstanding, many smaller establishments that engage in intrastate activities only may not be knowledgeable of this new requirement. FDA will need to continue to rely on the States to provide accurate inventories of establishments in their jurisdictions.
- In the area of dietary supplement regulation, FDA simply does not have the manpower to adequately patrol the industry. FDA is constantly being criticized by Congress, the regulated industry itself, the public, the media, and consumer advocates for not being more active in the regulatory oversight of this large and growing industry. Some States have the manpower, the regulatory authority, and in some cases already have the expertise. A new integrated system would allow FDA to tap this valuable resource, as well as provide additional training and incentives to additional states to enter this regulatory field.
- Since the FDA Food Inspection Contracts are for one year increments, very few states hire staff using Contract funds. Most funds are utilized for travel and/or equipment purchases. The current approach is very short-sighted and may waste resources since there is no continuity from year to year. The current system provides no strategic focus or long-term strategic plan.
- Many States, especially the larger states with more sophisticated food inspection programs, already have computerized systems for data entry. Some states are completely electronic from the inspection to the filing of the reports. Such states will be reluctant to dump their current systems for a "new" integrated system unless sufficient incentives are provided.
WHAT WOULD BE THE POSITIVE RESULTS?
- FDA would have 800 percent more inspections captured in their database than under the current system. FDA would be in a position to advise all parties, including Congress that high and medium risk establishments are receiving equivalent inspections within time frames that can better assure the safety of our food supply.
- FDA would be able to claim that millions of pounds of adulterated, contaminated and misbranded products are being removed from commercial channels, thereby potentially preventing thousands of cases of foodborne illness and injury. FDA could demonstrate the effectiveness of training, intervention strategies, and elimination of duplication to the nation as a whole with this consolidated information.
- FDA would be able to concentrate more resources on adulterated, contaminated, and misbranded imports, including more frequent inspections of foreign processors exporting to the U.S.
- FDA could assure their critics that a new truly "national food safety system" is in place that ensures the U.S. continues to have "the safest food in the world," through the sharing of resources.
- The States would be free of duplicative data entry and inspection reports, and at the same time able to increase inspectional or support staff with the dollars provided through a true partnership with FDA.
- FDA could be assured that all, or most, states have the core capacities within their programs to be equivalent to FDA. Again, equivalency does not mean "harmonization." Refer to Item No. 4 in the "Assumptions" Section.
- The States would have access to FDA inspectional data and work plans, and vice versa, in order to reduce or eliminate duplication and develop a more focused strategic plan to reduce food-borne illness outbreaks.
- Industry would benefit from the elimination of duplicative inspections by more than one regulatory agency and be assured that the inspectional results would agree.
- FDA would greatly benefit from the additional regulatory tools available to the States, such as embargo (detention, stop sale) authority, mandatory recalls (some states), and administrative penalties, as well as a more accurate Official Establishment Inventory (OEI).
- States that lack some of the necessary core capacities for a good regulatory program, such as use of computers for inspections, or lack of manpower, would greatly benefit through a systematic buildup of their programs and resources. This approach could also support stronger food safety programs at the local level.
DRAWBACKS AND HURDLES.
- Considerable "buy-in" from the States, FDA, Congress, and consumer advocates will be required.
- Until FDA has line-item budget authority for grants, partnerships, and/or contracts, this vision is not achievable.
- State legislatures, irrespective of the noble cause or the federal funds available, may not be willing to permit expansion of some state programs, seeing instead an increase in the bureaucracy or the even darker thought of simply more money for their general revenue funds.
- Some State programs never receive the benefits from federal funding as the dollars go into the "general revenue fund" rather than to the programs.
- Some state programs are not heavily geared toward regulatory and are more or less educational in nature. Such states may not agree that FDA's regulatory approach is the best for the industry within their borders.
- Some states would be reticent about taking federal dollars that must be used for programmatic issues (building up core programs or similar) rather than for inspections alone, fearing that the federal/state agreement may lack flexibility and/or result in federal control of their programs.
- States that have their own electronic system for capturing inspectional data may be reluctant to duplicate data entry into FDA's FACTS system, irrespective of the ultimate results of capturing all the inspectional data at the national level.
- Although the technology exists, currently no system exists that would enable all State inspectional data to be entered into one system with a minimum of effort.
- Confidentiality still remains a problem for both the States and our federal counterparts. It is imperative that this issue be overcome to permit local health units, who inspect retail establishments daily, to have access to recall information. It would be imprudent for States to access this information and not be in a position to apprise locals that recalled product is on the retail shelves.
CONCLUSIONS.
Since 1996 the Association of Food and Drug Officials (AFDO) has actively promoted the vision of a fully integrated food safety system for the U.S. We have done this through presentations to national and state associations, comments at national public hearings, to FDA and USDA, and in written comments to various federal requests for comments. We actively worked with our federal counterparts within the structure of the National Food Safety System (NFSS) Project, which during its short life span managed to create a national laboratory data entry system as well as other important food safety innovations. Further, AFDO's motto for more than 100 years has been "uniformity through cooperation and communication."
It is within this vision that AFDO seeks to muster the resources of all the state and local food safety programs, and combine them with the resources of our federal partners to create a new system that will greatly enhance food safety in the U.S. Such a system would accomplish many things, not the least of which would be to significantly improve food safety through long-term strategic planning and elimination of duplication.
As previously stated, the States (and locals) collectively conduct over 2.4 million inspections per year, of which over 86,000 are of facilities that will require registration with the FDA under the new bioterrorism legislation enacted by Congress last summer. The numbers of complaints investigated (66,000), samples collected and analyzed (324,000), food-borne illnesses investigated (8,000), recalls initiated (657), and embargos issued (14,000) by the States literally dwarf the activities of our federal partners. Even so, without an integrated system to capture such information at the national level and ensure uniformity, such information seems to fall on deaf ears at certain levels of our respective governments. Consumer advocates continue to hammer FDA and USDA/FSIS for lack of enforcement. And yet, the States collectively had over 128,000 enforcement activities during 2001, including over 4,000 criminal prosecutions. Consequently, something serious needs to be done to ensure that we use our resources to the utmost in our fight against food-borne illness, food adulteration, and intentional contamination of our food supply.
Through this paper AFDO is attempting to look objectively at the current system utilized by the FDA to "capture" inspections, what a future system might bring in the way of improvements to our current food safety system, the positives and negatives for making a paradigm shift, and the obstacles confronting us. Although this is a cursory examination of the issues, we believe that the numbers speak for themselves and that commitment by Congress, consumer advocates, and our federal counterparts is critical to making the best use of these great resources, and it would be a travesty to do otherwise.
Though the obstacles to a truly integrated food safety system may seem large, such as turf, distrust, lack of an FDA budget line item for partnerships and grants to the states, and short-sightedness, we believe that these obstacles can and must be overcome. Not all States will be willing to give up their current systems of capturing inspectional and sampling data. Consumer advocates may initially balk at the concept that we should not have to rely solely on the federal government to protect the food supply. Our federal counterparts may not initially accept the equality of the States' work in the area of food safety. However, it is to everyone's long-term advantage, especially to the U.S. consumer, that we overcome these obstacles.
Elements of such a system are already in place or are taking shape. FDA has recognized the need for uniformity and equivalency in the inspections for which they are contracting. They have recognized the need to build strong state programs since that is where "the rubber meets the road." FDA has also bought into the concept of national uniformity for laboratory accreditation and laboratory data entry and retrieval (eLEXNET). Systems are now in place to ensure equivalency of inspections through audits and uniform training. All that remains is for the players to agree that something serious needs to be done, agree upon ways to make it happen, and convince Congress that the pennies spent to integrate the system will be worth billions in the long-run by reducing food-borne illness outbreaks, enabling all concerned to put resources where they are most needed, and eliminating duplication.
AFDO therefore implores FDA, USDA, and Congress to obtain and provide for line item budget authority for federal partnerships and grants to the States, along with adequate funding. AFDO implores FDA to work seriously with the States to develop a system for capturing inspectional and inspection-related data at the national level without dual entry, if possible. If a single data entry system cannot be devised, then FDA should provide adequate long-term funding to enable the States to enter the data directly (or indirectly through the Internet) into their (FDA) database(s) without straining State resources from the double entry requirement.
Although this paper focuses on food safety, many states also conduct inspections of drug and device manufacturers, wholesalers, and salvagers. The same concepts applied herein to food safety can also be used to eliminate duplication and improve data collection activities in these and other areas as well, ultimately improving the safety of drugs and medical devices manufactured and distributed in this country.
AFDO also sees this as a great opportunity for our federal counterparts to increase oversight of imports. By increasing and better utilization of the strengths of these core food safety programs at the state and local levels through multi-year grants or partnerships, more federal resources would be freed up to focus on imports, both at the U.S. ports of entry and through increased overseas inspections.
AFDO realizes that the "word is still out" on the effectiveness and ease of data entry for the eSAF Pilots with the States of Texas and Rhode Island. Worries mount among the States regarding the impact of the duplicate data entry on the State programs, required in order for FDA to capture the inspectional data into the FACTS System. FDA has stated that eSAF was developed to eliminate duplicate entry; however, the state system must be capable of collecting data electronically using the same fields that are required by FDA's FACTS system. Regardless, though, AFDO is committed to supporting long-term efforts to ensure that all of the data from State programs is captured at the federal level, duplication eliminated, and joint strategic planning implemented to significantly improve food safety in the U.S.
In conclusion, AFDO believes the time has come to move from yearly food inspection contracts (after 31 years), toward a fully integrated system of food safety in the U.S. This means a commitment by Congress, our federal partners, and our own State programs to find permanent solutions to the duplicate data entry problem, commitment to multi-year contracts, grants and/or partnerships to build up core capacities at the state level, elimination of duplicate inspections, and integration of our resources, inspections, sampling, and other food safety-related activities to achieve truly the safest food supply in the world for our citizens.
This paper was adopted by a vote of the AFDO Board of Directors as an official position Statement on March 24, 2003.
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