Regulatory Focus™ > News Articles > Groups Call on FDA to End Transparency Policy They Say Violates Spirit, Letter of Law

Groups Call on FDA to End Transparency Policy They Say Violates Spirit, Letter of Law

Posted 11 March 2013 | By Alexander Gaffney, RAC

The way in which the US Food and Drug Administration's (FDA) treats some Freedom of Information Act (FOIA) requests-the primary method of extracting non-publicly available information from an agency-has angered more governmental transparency advocates, who say the agency needs to stop its use of a so-called "minor deletion" policy it says is preventing groups from appealing adverse FOIA decisions.


The policy of "minor deletions" is essentially a loophole in the Freedom of Information Act of 1966. Under the law, if an agency outright denies access to a document, the requesting entity is then able to appeal for reconsideration. However, if the agency redacts parts of the document-"minor deletions"-but otherwise makes it available, that same entity is unable to appeal. They are instead allowed to file a second request for "reconsideration."

But what constitutes a "minor deletion?" As it just so happens, it's not a legally-defined term, leaving it up to FDA to determine what's minor.

As public advocacy group Public Citizen wrote last year, FDA's practices have seen everything from the redaction of a single word to entire swaths of pages defined as a "minor deletion"-a practice the group referred to as a "blatant violation of FOIA."

In effect, the policy has made more arduous the streamlined process envisioned by Congress, Public Citizen argued in its petition to have FDA end the policy. And it has another effect as well: The deletions do not represent a legal denial of a FOIA claim, allowing FDA to pad its numbers, Public Citizen wrote.

New Petition

Now the Public Citizen petition is getting some support from a collection of groups, which say the practice "violates both the letter and the spirit of FOIA and casts serious doubt on the accuracy of FOIA performance data that FDA provides to Congress and the public."

The groups-16 in all-are collected under the umbrella of, which bills itself as a transparency organization that strives for improved access to records and other government information.

The groups include Cause of Action, the American Library Association, the Union of Concerned Scientists, the Project on Government Oversight, the Center for Effective Government, the Government Accountability Project and the Society of American Archivists.

"The law simply does not permit the agency to make deletions, minor or otherwise, from documents without giving a requester of his right to appeal an adverse determination in whole or in part," the group argues in its letter.

So, too, is the policy against President Barack Obama's pledge to make government more transparency, the group added, noting that a 2009 directive from Attorney General Eric Holder instructed agencies to remove "unnecessary bureaucratic hurdles."

The group urges FDA to revoke its use of the minor deletion policy, and to revise its staff manuals to inform FDA employees that it is not permitted.

The Public Citizen petition, submitted 19 September 2012, is due for a response from FDA on 19 March 2013 (180 days after submission), though FDA may choose to issue an interim response if it feels it needs more time to address the issues raised in the petition.

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