Bill patches up tensions between state and FDA for ‘consumers’ best interests’

The public has the right to know.

But does it?

When it comes to food safety, that was the question at the heart of tensions between Washington state and the U.S. Food and Drug Administration.

On one hand, the state’s Public Records Act, which favors disclosure, requires the state and local agencies to make their written records available to the public for inspection and copying, upon request. That is unless the information fits into one of various specific exemptions in the act or otherwise provided in state law.

For example, the state’s Public Records Act provides exemptions from public disclosure for certain information that relates to agriculture and livestock.

On the federal level, the federal Freedom of Information Act provides for the disclosure of information and documents controlled by the U.S. government. But not all information. Some types of information are exempt from disclosure under the federal act. These would include trade secrets, certain commercial and financial information obtained from a person, and geological information and data concerning wells.

The tension between the federal and state entities hinged on cases in which FDA food safety information, collected with assurances that it was protected from disclosure, was shared with Washington state where it was deemed a public record. By sharing the records with the state, the FDA was creating backdoor access to the protected information.

This type of conflict arose last April when some publications, including the Food Safety News obtained federally protected information about pet food through public disclosure request of the Washington State’s Department of Agriculture.

The FDA said the department shouldn’t have released it, citing exemptions the FDA has under the Freedom of Information Act that relate to such issues as trade secrets and confidential trade information. FDA reacted to the department’s disclosure by cutting the department off of  what the FDA refers to as “non-public” information. This came as a blow to the department’s food-safety team since collaboration between the FDA and the department is critically important.

Not only that, the FDA temporarily withheld about 50 percent of its emergency response funding to the department — funding that pays for staff and infrastructure to respond to outbreaks and other emergencies.

Steve Fuller, assistant director of the department’s Food Safety and Consumer Services Division, described the situation as having “a significant negative impact on our ability to do our work and effectively collaborate with FDA.”

For example, the department could no longer participate in national conference calls about outbreaks and recall activities because some federally nonpublic information might be shared on those calls.”

He said that without a doubt, that limits the department’s ability to protect public health. A solution needed to be forged.

Good news from state lawmakers
The department submitted request legislation, HB 1385, to the legislators, and they, in turn, voted unanimously for it, with the governor swiftly following with his signature.

It wasn’t about trying to win but rather to come to an agreement with the FDA that would benefit food safety and therefore consumers.

In short, the bill says that information or records obtained from the department from the FDA that are in agreement with an FDA contract or commissioning agreement (commissioners are those who qualify to obtain FDA information but must hold it confidential) are exempt from public disclosure under the state’s Public Records Act. But that’s only as long as the information or records are also exempt from disclosure under the federal Freedom of Information Act.

The bill lists these examples of information that would be exempt:

• Confidential commercial information;
• Information under the federal deliverative process privilege;
• Information compiled b law enforcement; and
• Information expressly required to be kept confidential by other laws.

A staff comment at the end of the bill points out that “it would seem that it would be in the public’s interest to disclose this kind of information However certain information provided by the FDA is not disclosable under federal law. The Washington State Department of Agriculture is in a position to either abide with the federal disclosure laws, or not receive information from the FDA necessary to ensure food safety.”

In short, “This bill provides the narrowest of exemptions to Washington’s public disclosure laws so that communication can be reopened between the state and the FDA.”

Prime sponsor of the bill, House Deputy Majority Leader Rep. Larry Springer, said it was necessary to pass the bill because “if we didn’t fix this” we wouldn’t get important food-safety information from the FDA.

“This is really important for public health,” he said. “It’s in the consumers’ best interest.”

He gave as an example of what FDA was concerned about. “Let’s say the people in a conference call between the FDA and the department were trying to determine if some chicken was contaminated,” he said. “Under our laws, we would have had to divulge the information.

“You don’t want to create a reaction before the FDA can determine if the problem is real and can start making plans,” he said. “You don’t want to jump the gun.”

And while the bill doesn’t go into effect until July 28, 2019, Fuller said WSDA’s working relationship with FDA has already started to improve.

“Our relationship with the FDA is starting to get better,” he said.

He thinks that resolving issues around “commissioning” people, those who can obtain a free-flow of information from the FDA, will happen soon, “but it could take a few weeks.” And that, in turn, is linked to getting a free flow of information with FDA.

“To their credit, the FDA worked hard to preserve the funding,” he said.

One thing the bill didn’t do was restrict the state from disclosing information that it gathers.

“The public will have access to that,” he said. “It’s important that people see us as transparent. Transparency is an important part of what we do.”

He also pointed out that most people in the state want citizens to have access to information. And while the bill restricts some of it, in the end run, he said, it “actually results in Washington state having more access,” thanks to the agreement on this issue.

“It’s better to have half the conversation than zero,” he said. “The bill lets us get as much information as possible by having more access to information through the FDA. ”

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