NASDA and AFDO Testify Against Senate Committee Regarding S. 3128

  • Speaker: NASDA and AFDO
  • Subject: S. 3128, National Uniformity for Food Act of 2006
  • Venue: Senate Health, Education, Labor and Pensions Committee
  • Date of Speech: July 27, 2007

 

Written Statement
of
The National Association of State Departments of Agriculture (NASDA)
And
The Association of Food and Drug Officials (AFDO)
For the
Senate Health, Education, Labor and Pensions Committee
Regarding
S. 3128, the National Uniformity for Food Act of 2006
Thursday, July 27, 2006
 
 
 
Mr. Chairman and members of the Committee, thank you for the opportunity to provide our views on S. 3128, the National Uniformity for Food Act. NASDA represents the commissioners, secretaries and directors of agriculture in the fifty states and four territories, and we are partners in the Nation’s extensive food safety system. AFDO represents the state and local government food safety officials who perform inspections, investigations, and other food safety regulatory activities. 
 
Our organizations are dedicated to ensuring consumer public health and safety in our food supply. While NASDA and AFDO have a long history of supporting consistency in national regulation of foods, drugs, cosmetics, and consumer products, we are very troubled about the substantial effect that the preemption contained in S. 3128 will have on the complementary state and local food safety programs and authorities that comprise our national food safety system. Today, we would like to broadly outline the critical role state and local partners play in the implementation of food health and safety standards, and explain the reasons why we believe this legislation is flawed and will seriously compromise our ability to carry out these important food safety responsibilities.
 
Roles and Responsibilities of Local, State and Federal Partners in Food Safety
 
Our current food safety regulatory system is the shared responsibility of local, state and federal partners. The Food and Drug Administration (FDA) is responsible for ensuring that domestic and imported food products are safe, sanitary, nutritious, wholesome and properly labeled. The primary statutes governing FDA’s activities are the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Public Health Services Act. The FDA establishes regulatory requirements and guidance for assuring that food is safe and not adulterated. State, local and county public health and agriculture departments play a major role in helping FDA carry out these responsibilities by conducting state inspections of food establishments, laboratory analyses of foods, and by taking enforcement action when violations result in unacceptable risk to the public. FDA works with states to set safety standards for food establishments and commodities, and evaluates the states’ performance in upholding such standards as well as any federal standards that may apply.
 
While FDA has primary authority in the food safety network, there is an entire system of complementary state and local laws working in harmony to protect our national food supply. Because all problems exist locally first, states often act as sentinels for emerging issues and have the ability to rapidly respond, often before such issues rise to the level of national concern, and thus before FDA takes action. 
 
To support FDA ‘s statutory authority, state agencies are primarily responsible for the actual inspections, enforcement, training, and carrying out a wide range of other food safety regulatory activities. For example, FDA contracts with states to monitor medicated animal feeds and to investigate incidents of pesticide or drug residues in foods. Approximately 80 percent of food safety inspections in the United States are completed at the state and local level. In 2002, AFDO conducted a survey of state programs to capture information regarding the volume and importance of work done in the area of food safety. State and local agencies performed more than 2.5 million inspections, conducted almost 90,000 investigations, took more than 128,000 enforcement actions (including more than 4,000 criminal prosecutions, almost 14,000 embargo/seizures, and more than 30,000 stop sales), and analyzed 328,000 food samples.
 
These numbers dwarf the activities of our federal partners and demonstrate a real commitment to food safety at the state and local level. States for the most part have greater regulatory authority than FDA, including mandatory recalls, detention (embargo) authority, and administrative penalties. This highly-integrated system has resulted in a more effective and efficient regulatory process than FDA could achieve alone. We use our resources to the utmost in our efforts against food-borne illness, food adulteration, and intentional contamination of our food supply. This is exactly why states are extremely troubled and concerned about the potential federal preemption under S. 3128. The legislation would radically change the traditional allocation of power/authority between states and the federal government.
 
Scope and Effect of Federal Preemption
 
The stated purpose of S. 3128, the National Uniformity for Food Act of 2006 is “to provide for uniform food safety warning notification requirements.” However the legislation really has two purposes, one explicitly stated and the other cleverly disguised in the phrase, “and for other purposes.” The unstated purpose of the bill is to assert federal preemption over state food safety authority in two critical areas: (1) food adulteration laws; and (2)  food standards (contaminant levels) for adulteration.
 
Section 2 of the bill requires that state food adulteration laws be identical to the Federal Food Drug and Cosmetic Act (FFDCA) in ten specific areas. Specifically, the FFDCA would be amended to read:
 
“Except as provided in subsection (b) [which allows for petitions], no State or political subdivision of a State may directly or indirectly establish under any authority... (6) any requirement for a food described in Section 402(a)(1)...”  [emphasis added].
 
The bill continues to list nine additional paragraphs defining the conditions under which FDA considers food to be adulterated.
 
This requirement for state food adulteration laws to be identical to federal adulteration laws may sound reasonable and even desirable. However, the consequences and impact of this simple requirement are significant.
 
Because the bill specifically preempts (prohibits) states from acting “directly or indirectly” “under any authority” to declare food adulterated, it calls into question the state and local laws that address adulterated foods (or food that “bears or contains any poisonous or deleterious substance which may render it injurious to health.” ). 
 
Because many state laws are NOT identical to federal laws in this area, states will NOT have the authority to determine what constitutes adulterated foods. Where state laws are deemed not to be identical, states will lose enforcement authority over adulterated foods.
 
This preemption greatly alarms us because food adulteration determinations are generally done on a case-by-case basis. FDA’s Model Food Code and other regulatory guidance recommend minimum criteria for adulteration determinations while giving states the necessary flexibility to make decisions and take the appropriate food safety actions/approaches based on local situations. For example, the following incidents demonstrate how states have used adulteration determinations as the basis for enforcement action:
 
·        During the 2003 power outage in the Northeast, food inspectors from the New York Department of Agriculture & Markets investigated over 1,000 food establishments to conduct food safety assessments. Over 400,000 pounds of potentially hazardous foods held under unsafe temperatures for a prolonged duration were destroyed voluntarily by industry and another 19,917 pounds of similar products were placed under seizure and were destroyed.
 
·        Imported gel candies containing the ingredient konjak were associated with the choking deaths of children in Canada, Japan, and the United States. Following the choking death of a young New Jersey girl, a number of states began to embargo the products within domestic markets. The New York Department of Agriculture & Markets alone placed under food seizure 129,731 pounds [over 60 tons] of the products and coordinated 26 food recalls. FDA did not respond to the matter for some eight months, which was well after numerous state programs had removed these potentially dangerous candies from store shelves. When the agency finally acted, FDA considered these products “unfit for food” and therefore “adulterated” under the FFDCA.
 
·        The Michigan Department of Agriculture responded to an incident resulting in the destruction of approximately 500,000 pounds of pickles from a company and 100 acres of farm fields containing cucumbers. The department made the determination that the pickles and cucumbers were adulterated based on the fact that the cucumbers were grown on fields that had been treated with Class 2 bio-solids eight months prior. EPA regulations require 14 months to pass before crops like cucumbers can be harvested from fields treated with bio-solids. To conclude that the pickles were adulterated, the department did not rely on lab testing to determine if fecal microorganisms were present. The determination was made based on the logic that:
 
(1) The EPA site restrictions for managing bio-solids on crop fields are safety-based.
(2) Those standards were not followed so it is likely that soil on the cucumbers contained inactivated bio-solids.
      (3) As such, the cucumbers were deemed adulterated. (The department would have to sample 100% of the crop to rely on testing as a means to assure safety.)
(4)   The adulterated cucumbers were mixed with other cucumbers by the pickle processor. The department adheres to the regulatory guidance: “mixing of adulterated food with good food renders the finished product adulterated regardless of the final concentration of contaminant in the finished food.”
 
 
 
In each of these examples, the states relied on the existing laws or rules—which are similar, but not identical to—corresponding portions of the FFDCA and implementing regulations to take regulatory (enforcement) action. Thus, these actions described above would not be possible if S. 3128 is enacted because the first test a state must have in order to enforce food safety laws is identical adulteration standards. 
 
We believe it is imperative that states retain the right to act quickly to address local and statewide public health concerns because most of these events cannot be anticipated or are not adequately addressed nationally. The preemption embodied in this legislation is broad and sweeping. This goes far beyond requiring uniform food labels. At its core, S. 3128 is about federal preemption of food adulteration policy, standards and enforcement—and this is the crux of our opposition to it. 
 
If members of this committee remember no other message from us about this bill, let it be this one: it is absolutely NOT necessary to require uniform food adulteration laws in order to have uniform food safety warning notification requirements. There is no necessary connection between adulteration and labeling. The goal of our food safety laws is not to ensure that adulterated food is uniformly labeled. It is to ensure that adulterated food is removed from the food supply. 
 
We believe the bill, as currently written, will leave a critical gap in the safety net that protects consumers. It threatens existing state food safety programs and jeopardizes state/federal food safety cooperative programs such as those related to Grade A milk, retail food protection, and shellfish sanitation. We simply disagree with recent legal analyses which claim that state laws and regulations will not be undermined by this legislation. Forty state attorneys general have stated in a March 2006 letter to Congress that “the bill would create a new federal bureaucracy dedicated to evaluating, judging and even invalidating proposed state and local laws, a startling change in state-federal relations in the food safety area.”
 
It is under this legislative provision in the bill that states also lose their authority to take enforcement actions, embargo or destroy contaminated foods using laws that are based upon the Public Health Services Act. This statute provides state authority under a variety of food safety programs, such as Grade-A milk (Pasteurization Milk Orders), shellfish sanitation, retail food activities, and food defense/anti-terrorism programs. The legislative language clearly preempts these authorities.
 
Under these provisions states will certainly be able to continue to inspect food manufacturers, processors, handlers and sellers. States will be able to ensure that the inspected facility is clean, neat and sanitary. However, we will not have the authority to be able to verify or assure the public that the food processed within that establishment actually is safe and unadulterated. This is not only ironic—it doesn’t make sense. How can we conduct food safety inspections, and then not be given the ability to say the product is safe and unadulterated?
 
Petition Process
 
S. 3128 would establish a petition process by which states could request exemption for selected food safety and notification requirements that do not meet the national uniformity requirements under the bill. States may also petition that a national standard determination be made by FDA regarding the specific requirement.
 
We believe the petition process will bog down the FDA because states will not be willing to risk their authority and will thus petition the agency for exemptions and/or national standards. States will have little time to determine the process for petitioning. Further, the conditions under which such petitions will be evaluated are completely unknown because there are no written criteria for this “citizen’s” petition process. Both state and federal governments will become mired in a morass of bureaucracy as FDA develops procedures for such petitions.   
 
The cumbersome petition process through which the proponents argue the FDA could deal with imminent hazards brought to its attention by state or local food safety officials would effectively transform our safety net into a tightrope.
 
The Congressional Budget Office (CBO) analysis of the counterpart House legislation (H.R. 4167) states “based on information from FDA and a review of state requirements most likely to be affected by the bill, CBO assumes that states would submit roughly 200 petitions to FDA early in 2007 and another 40 petitions over the 2008-2011 period.” CBO goes on to state further, “CBO assumes that FDA would not be able to fully comply with the time limits [for acting on petitions] imposed under the bill.”
 
At least 40 states have been advised by their attorney general or other legal counsel that their laws are at risk. States will not be in a position to put their programs at risk, and it is very likely that many will petition the FDA for an exemption. States will have to divert already limited resources to developing such petitions, to navigate a process for which no procedure exists, and under which no criteria for evaluation exist. 
 
In addition, the “imminent hazard” provisions are unwieldy for a crisis situation. While the state may take action, it may only do so in the face of serious adverse health consequences or death. Then it must notify FDA and determine that FDA has not initiated enforcement action. Next, states must submit a petition within 30 days of that action, and it must simultaneously initiate enforcement action of its own. 
 
Localities, such as county and municipal authorities, have no means under which to petition the FDA for a variance. They will turn to the state, which may well lack the resources to provide assistance on their behalf. Programs such as that in the Maricopa County Department of Health, an award winning public health department in Arizona, have no voice in this preemption debate.
 
 
New Expansion of Guidance, Force of Law and Regulatory Standards
 
Finally, it has been repeatedly argued that this bill is solely about food warning labels. It is not. 
 
In addition to preemption of state adulteration laws, NASDA and AFDO are gravely concerned about the provision that confers the power of law upon FDA guidance documents that are purely advisory. This provision was added to the House bill by the Barton amendment and is included in S. 3128. The CBO analysis mentioned above was prepared before the Barton amendment was added and this almost certainly will increase the number of petitions to the FDA.
 
Regulatory standards are quite different in nature from guidance. Regulatory standards are reference numbers that have been vetted through the public rule-making process and published in the Federal Register. Stakeholders are given the opportunity, through public comment, to question and advise FDA on the appropriateness of both the science and the policy. Once adopted, standards are enforceable. 
 
On the other hand, guidance numbers (sometimes called action levels) are not developed with this level of scrutiny or deliberation. They are provided to states and the regulated community for consideration, representing FDA’s thinking at the time, but lack the necessary evaluation for rule-making purposes. However, S. 3128 preempts states from making this determination and the states must conform to the guidance document. Further, federal regulation itself (21 CFR Section 10.115(a)(1) states that guidance documents “do not establish legal enforceable rights or responsibilities. They do not legally bind the public or FDA.” Yet, S. 3128 will require that these documents carry the force of law when applied by states.
 
The impact of this provision is significant and far-reaching in both its scope and consequences. For example, practices outlined in documents such as “Guide to Minimize Food Safety Microbial Hazards for Fresh Fruits and Vegetables” will become mandatory, not just advisory. Under S. 3128, if states wish to address food safety practices at the farm, their growers will have no option but to adhere to the practices in the guidance documents and to those practices alone. Any deviation will require a petition to the FDA and a decision. All the food safety provisions of the Food Code having any bearing on food contamination will become mandatory. States will not have the authority to grant a variance because under S. 3128 this determination can be made only by the FDA.
 
Furthermore, because these documents are written as advisory in nature, they are updated only when critical to the FDA and when resources allow. Because they currently are not binding, the necessity to update them carries no urgency. Consequently, guidance levels may be well outdated and remain “on the books”. Such is the case with e.coli in cheese and cheese products. The FDA’s “Compliance Policy Guide” considers cheeses to be adulterated with e.coli when levels reach more than 10,000 per gram. Several states have, in consultation with FDA, adopted more strict reference numbers of 10 or 100 per gram. These will be preempted, and the public placed at risk of serious illness until states petition for an exemption or a national standard. (It is not clear in the case, which would be the better course, or the most likely to succeed since evaluation criteria do not exist.)   We view this as unacceptable.
 
Conclusions/Proponents’ Arguments
 
Proponents of S. 3128 argue that it will decrease consumers’ confusion by requiring identical food labels and other standards to be set by the FDA. We aren’t aware that consumers are confused. In fact, most consumer groups oppose this legislation.
 
On its face, S. 3128 appears to support consumers and the proponents’ position is that the federal government is the sole agency with the expertise, funding and experience to set food safety standards; to determine appropriate warning language for hazardous foods; and to determine the adequacy of food safety programs across the nation. We disagree.
 
Proponents argue that this law is necessary to tame the deluge of non-uniform state laws, standards and labeling requirements. But they have provided no examples, except for California’s Proposition 65, to illustrate such a compelling need. In fact, proponents argue that only eleven state laws differ, and of those, several have not used the authority granted thereunder. Clearly then, S. 3128 is a bad solution for a problem that does not exist. This hardly seems to justify total preemption.
 
As we stated above, it is absolutely NOT necessary to require uniform food adulteration laws in order to have uniform food safety warning notification requirements.
 
NASDA and AFDO do not oppose uniform product labels. However, preemption of state adulteration laws is NOT required to accomplish this. The Nutrition Education and Labeling Act preempts certain specific components of product labels, and does so WITHOUT requiring “identical” adulteration laws or standards. The same is possible for warning labels.
 
In summary, NASDA and AFDO hope that you will take the time to fully research these issues before taking action on S. 3128 and ask yourself….when it comes to protecting public health, which would YOU rather have, a safety net or a tightrope? Thank you.