New FDA security rules will bar agency from hiring some foreign nationals


The U.S. Food and Drug Administration (FDA) is moving to adopt a new policy on security background checks that is sowing confusion and alarm among some of its scientists.

The change, described in a “communications plan” shared with the agency’s senior staff in recent weeks, appears to effectively bar the agency from hiring—as employees or contractors—foreign nationals who have not lived in the United States for a total of 3 out of the last 5 years.

FDA says that the new requirement is based on recent revisions to a government-wide security policy, but it appears to be interpreting those rules more strictly than some other agencies.

The change would apply to hires slated to start work after 1 October, and not to existing employees.

Based on past hiring, FDA estimates that the change would affect about 50 people a year—most of them postdoctoral fellows in short-term positions.

Some FDA scientists fear the change will prevent the agency from bringing in foreign talent.

“This is a real sea change in how we function,” says an FDA scientist who requested anonymity.

“We can kind of look around and name people who are now in serious leadership positions in the FDA who would never have gotten in the door under this rule.”

Who gets identity cards?

The change focuses on the rules for receiving standardized government identity cards that enable access to agency facilities, data and computer systems.

Specifically, the agency’s communications plan describes recent “revisions” to a 13-year-old policy known as the Homeland Security Presidential Directive-12 (HSPD-12) that requires secure and reliable forms of identification for all government employees.

To get a so-called Personal Identity Verification (PIV) card, a new hire must go through a background check performed by the U.S. Office of Personnel Management (OPM).

That office has said it can perform a background check only if the candidate has 3 years of U.S. residency.

But federal agencies also have been allowed to hire PIV-ineligible foreign nationals at their discretion, and to issue them alternate ID cards until they meet the 3-year residency requirement. At that point, they can receive an OPM background check for the PIV card.

The new FDA document suggests that this flexibility disappeared with a new HSPD-12 “implementation policy” issued in January by the Department of Health and Human Services (HHS), which includes FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health (NIH).

The revised HHS policy no longer allows FDA to “assume the risk” of hiring PIV-ineligible candidates, according to the FDA document.

It describes a phase-in process in which foreign nationals who start an FDA job in fiscal year 2017 (which ends 30 September) can still get an alternate ID card that provides them “restricted local access” to FDA facilities and certain computer systems.

For employees set to come onboard in 2018, a PIV is required, and “it is strongly suggested that hiring managers inquire of prospective hires how long they have resided in the U.S. prior to extending an offer,” it says.

FDA appears to be staking out tougher standards than required under the government-wide directive or HHS policy.

HHS agencies can still choose to bring on foreign nationals using alternative access cards, a department spokesperson told ScienceInsider.

At NIH, for example, a spokesperson confirmed that the agency plans to allow foreign nationals to join the agency by this route.

An FDA spokesperson acknowledged the discrepancy, but said FDA’s primary responsibility—working with companies to regulate drug and food safety—imposes special requirements. “We differ from the other HHS operating division in that we’re in possession of trade secrets and confidential commercial information and data that’s valued in the billions of dollars,” she said, “so it’s our view that we need to follow both the letter and the intent of the new policy.”


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