Data Quality Act: A Formidable Watchdog

As a result of a recent court action, the Data Quality Act is now a formidable watchdog to ensure that the FDA accepts only those reports from the Advisory Committee that are DQA compliant. Read the following from Inside EPA:

Industry Sees Court Rejection Of DOJ Petition Aiding Bid For DQA Review

Proponents of making Data Quality Act (DQA) petitions judicially reviewable claim they received a boost after a federal appeals court rejected the Justice Department’s (DOJ) bid to clarify that a recent ruling did not address the issue, though DQA critics say the DOJ petition reinforces the administration’s position that DQA decisions are not judicially reviewable.

The U.S. Court of Appeals for the District of Columbia Circuit May 10 denied DOJ’s petition in Prime Time Int’l Co. v. Vilsack asking the court to clarify that a ruling in the suit did not address whether the DQA creates judicially enforceable rights. The court previously issued a March 26 ruling dismissing an industry challenge of the U.S. Department of Agriculture’s failure to respond to its DQA petition challenging tobacco tax assessments.

The Center for Regulatory Effectiveness (CRE) — a think tank with links to industry — has previously argued that the DC Circuit’s ruling may open the door to new DQA lawsuits because it finds that DQA guidelines issued by the White House Office of Management & Budget (OMB) are “binding” (Inside EPA, April 30).

But DOJ in an April 30 petition countered that the court’s decision, while accepting a narrower government claim at issue in the suit, “did not reach the broader ground” on judicial review of DQA decisions.

DOJ cited a ruling by the U.S. Court of Appeals for the 4th Circuit in Salt Institute v. Leavitt that finding DQA petitions are not judicially reviewable. “Although this Court’s opinion did not address the Government’s broader argument or the Salt decision, the [CRE] has urged that this Court implicitly rejected the Government’s position on its second argument.” Relevant documents are available on

DOJ asked the court for further clarification on the issue of whether the petitions are reviewable. “In our view, it is clear that this Court did not reach the broader issue of [DQA] enforcement or create an implicit conflict with Salt,” the petition says. “Nonetheless, in an abundance of caution, we respectfully request that the Court amend its opinion to clarify that it did not reach the question whether the [DQA] creates judicially enforceable rights.”

However, the court May 10 issued a one-page response to the April 30 DOJ petition, denying it without comment. A DOJ spokesperson did not respond to a request for comment by press time.

Industry says the May 10 order could bolster a pending Ninth Circuit appeal, Americans for Safe Access (ASA) v. Department of Health & Human Services (HHS). In that case, medical marijuana advocacy group Americans for Safe Access filed a lawsuit against HHS and the Food & Drug Administration arguing that the agencies violated the DQA for failing to rely on sound science in determining that marijuana has no medicinal value.

“The Government is clearly worried that the Prime Time decision could impact the pending ASA appeal, as well it should be,” CRE writes in a May 26 memo describing the potential precedent set in Prime Time. “The D.C. Circuit is often considered to be the most influential Circuit on [Administrative Procedure Act (APA)] issues (certainly more so than the Fourth Circuit), and the Government has little more than the single sentence — which some consider dicta — from the Salt Institute opinion in the Fourth Circuit on which to rely.”

The memo continues, “Although the D.C. Circuit did not explicitly hold that agency action on a [DQA] petition is judicially reviewable under the APA, it went a long way in that direction.”

The group, which has long supported greater use of DQA petitions, says that if the court in ASA “were to accept the D.C. Circuit’s position that the OMB guidelines carry the force of law and are entitled to Chevron-level deference, it would undercut the Government’s reliance on the Salt Institute opinion and leaves it with little more than the argument that the [DQA] does not apply because another statue proves an adequate alternative remedy” — but says this would be “difficult” because there are no alternative proceedings underway and agencies must respond to DQA petitions within defined time frames.

The group argues that any decision in the Ninth Circuit case could trigger a Supreme Court review of the issue. “Even if the Ninth Circuit were to somehow rule against ASA and deny judicial review, it would have a difficult time drafting an opinion that did not arguably create a Circuit split with the D.C. Circuit (and possibly the Fourth Circuit), thereby setting the stage for possible Supreme Court review,” CRE concludes.

CRE says that even if the Ninth Circuit rules in favor of judicial review for the DQA, it could create a split with the Fourth Circuit and possibly set the stage to move to the Supreme Court.

But a source with the Center for Progressive Reform, a think tank focused on environmental and health regulation, says the move by the DOJ makes the administration’s position on judicial review of the DQA “crystal clear.” Further, the source says recent issues like the BP oil spill and tainted peanut butter scandal illustrate the need for better regulation. “It’s time to stop fiddling around the edges with the Data Quality Act,” the source says. — Aaron Lovell

  Editors Note  See the attachment hereto for relevant legal filings.


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