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Federal Regulations Advisor Insight and Commentary on U.S. Government Regulatory Affairs

Monday Morning Regulatory Review – 4/22/13

Posted in Judicial Review & Remedies, Regulatory Process

The Office of Management and Budget (OMB) rapidly completed review on a small step in response to President Obama (POTUS)’s agenda on gun violence with an advance notice of proposed rulemaking.  The Department of Labor (DOL) submitted to OMB its response to at least one court decision on the H-2B conundrum and needed to explain the situation to appropriators.  The Office of the Federal Register (OFR) submitted proposed rule that will affect all agencies and may present improvements in the use of external standards in regulations.  The Food and Drug Administration (FDA) announced extension of the massive food safety rules comment period.

Guns, HIPAA & NICS:  OMB completed review in short order of the Department of Health and Human Services (HHS) HIPAA Privacy Rule and the National Instant Criminal Background Check System (NICS) advance notice of proposed rulemaking on April 18, 2013, and HHS appears to have requested expedited publication; the ANPRM is available for public inspection and will be published in the Federal Register on April 23, 2013.  HHS asserts that the ANPRM aims to reduce gun violence through improving the background check system for licensed dealer sale or transfer of firearms under the National Instant Criminal Background Check System (NICS).  Current law prohibits individuals from owning firearms if they have been involuntarily committed to a mental institution, found incompetent to stand trial or not guilty by reason of insanity, or otherwise determined through formal adjudication to have a severe mental health condition.  The ANPRM solicit public comments on whether and to what extent the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule may be a barrier to States’ reporting the identities of individuals subject to these mental health prohibitions to the NICS.  HHS is considering creating an express permission in the HIPAA rules for reporting the relevant information to NICS and ways to mitigate any unintended adverse consequences for individuals seeking needed mental health services that may be caused by creating express regulatory permission to report relevant information to NICS.  This executive action – albeit pre-rule – comes in the wake of POTUS’s defeat on expanding background checks in the Senate, but the issue of uneven reporting of mental health disqualifications has existed for some time.

Wage Methodology:  DOL submitted a new Wage Methodology for the Temporary Non-agricultural Employment H-2B Program interim final rule for OMB review on April 19, 2013, in light of the decision of the United States District Court for the Eastern District of Pennsylvania enjoining DOL’s previous wage methodology rules.  How this rulemaking qualifies as an “interim final rule” will not be known until the rule is released, but it would not qualify as an “emergency” in light of the years of regulatory debate and litigation.  The rule must address also the 11th Circuit decision that DOL has no authority to promulgate H-2B regulations – that authority issue is fundamental to DOL taking any action.  Whether DOL (and the Department of Justice (DOJ)) will simply not acquiesce, or propose a rule that affects all states except the 11th Circuit (Alabama, Florida, and Georgia) or will seek en banc review in the United States Court of Appeals for the 11th Circuit or certiorari from the United States Supreme Court (SCOTUS) is not yet known.

Acting Secretary of Labor Harris, in testimony before House Appropriations last week, admitted that DOL is “caught” between Congress’ bar of the 2011 rule and the District Court injunction against the 2008 rule.  He further noted and DOL is working with the Department of Homeland Security (DHS) and OMB to try to meet an April 22 – today – deadline for a new rule.  The Acting Secretary called the 11th Circuit decision that DOL has no regulatory authority a “very significant wrench” for which he has no solution at present.

Incorporation by Reference:  The National Archives and Records Administration (NARA) – the parent of the OFR – submitted a proposed Incorporation by Reference rule for OMB review on April 19, 2013.  This proposal may follow up on the recent Administrative Conference of the United States (ACUS) recommendations that NARA improve and make more efficient agency use of voluntary consensus standards as regulatory requirements.

Food Safety:  In testimony last week before a Senate appropriations subcommittee, FDA Commissioner Hamburg announced an extension of the comment period on the Food Safety Modernization Act proposed rules – probably an additional 120 days (doubling the comment period) – because of multiple requests for more time to analyze and comment upon the complex rules.  A notice of extension is expected this week.