Regulatory Transactions

From: GovInfoSecurity

Overdue HIPAA Modifications Top the List

By Marianne Kolbasuk McGee

A long-overdue omnibus package that includes HIPAA modifications tops the list of regulations dealing with health data privacy and security issues that are pending for 2013.

Also pending is an accounting of disclosures rule that, in early draft form, called for providing patients, upon request, with reports listing everyone who accessed their electronic health information. Plus, rules for Stage 3 of the HITECH Act electronic health record incentive program, which begins in 2016, are in development.

From: Washington Times

By Tim Devaney

The Obama administration is pushing back  against critics who have accused the president of unleashing a “regulatory  tsunami” against the business community.

In a long-delayed report from the White  House Office of Management and Budget, released just before the long holiday  weekend, a senior administration official, speaking “on background,” said the  list of new regulations for 2013 is actually shorter than it was in 2011 and  2012.

“This 2012 agenda makes clear that there is no ‘regulatory tsunami’ coming  from this administration,” the source said. “It actually includes slightly fewer  economically significant active rulemakings from executive agencies than the  previous two agendas.”

From: Forbes

Jon Entine

Way paved for approval of first genetically modified animal for human consumption; Genetic Literacy Project investigation uncovers Executive Office violations of science integrity guidelines, raising legal, ethical concerns.  

The Food and Drug Administration today released an electronic version of its Environmental Assessment for a genetically modified (GM) salmon developed by AquaBounty Technologies of Massachusetts—effectively giving its preliminary seal of approval on the first transgenic animal to be considered for federal approval.

Editor’s Note:  OMB Watch continues to confuse OIRA carrying out their duties assigned by the President with delay.

From: OMB Watch

Congressional opponents of public protections spent much of 2012 attempting to increase the procedural hurdles to establishing new rules that would implement federal laws and standards.  Efforts to attack the scientific evidence employed by agencies continued.  Both efforts are likely to re-emerge next year.

Legislative Assaults on Regulations Continued throughout 2012

Last year’s end-of-year wrap up described the legislative attacks on specific health, safety, and environmental standards, as well as the regulatory process itself.  Most of these bills were passed by the Republican-controlled House of Representatives but stalled in the Democratically-controlled Senate.

From: Utility Products

EPA’s critics say they see ill omens for President Barack Obama’s second term in Friday’s announcement of significantly tightened air pollution limits on soot from exhaust pipes and smokestacks.

The finished rule that emerged from the agency Friday is mostly as stringent as the one that EPA submitted for White House review in the summer. That’s a turnaround from the experience of the last couple of years, in which White House pressure forced the EPA to postpone a new rule on smog and placed regulations on toxic coal ash into a deep freeze.

From: Thompson Reuters News & Insights

By Wayne D’Angelo, Esq., Kelley Drye & Warren

Before we even finished counting the votes in the 2012 presidential election, political pundits, environmental and energy practitioners and, in some ways, even Wall Street traders, offered their insights on how President Obama would regulate the energy industry in the next four years.  Such an exercise is perilously speculative, particularly when applied emerging segments of the industry, such as hydraulic fracturing and horizontal drilling.   Nonetheless, the general consensus is that the administration will take a heavy hand, that long-shelved initiatives will take on new life and that the hydrocarbon extraction industry should brace for punitive measures.

Editor’s Note:  The author of the opinion article below seems to misunderstand OIRA’s mission which is to carry out the requirements of the Paperwork Reduction Act and other regulatory review tasks assigned by the President, just as OMB has done for eight consecutive administrations, not concern themselves with the opinion of pundits of any political viewpoint.  Assertions to the contrary reflect a lack of understanding of OIRA’s institutional commitment to serving the President.

From: Food Safety News/Opinion

FDA’s Excuses to Court on Food Safety Rule Delays Are Unconvincing

By Thomas McGarity

Editor’s Note:  As CRE has previously explained, cybersecurity and the Data Quality Act will be integral to implementation and enforcement of NHSTA “black box” regulations.

From: The Detroit News

By David Shepardson

From: E&E Publishing/Greenwire

Lawrence Hurley and John McArdle

It’s not often that Chief Justice John Roberts is caught by surprise, but he expressed shock yesterday at how quickly U.S. EPA issued a rule that is likely to have a major impact on how a Supreme Court case is decided.

An exchange between the chief justice and federal government lawyer Malcolm Stewart over the administration’s uncharacteristic speediness in drafting and approving the rule cast a spotlight on the murky world of administrative rulemaking. Critics often say it takes much too long for rules to be approved, except in cases where political officials in the White House step in and speed things up.

Editor’s Note:  The Supreme Court was not amused by the surprise EPA rule.

From: American Forest & Paper Association

WASHINGTON – The White House Office of Information and Regulatory Affairs today cleared the Environmental Protection Agency’s (EPA) final rule to clarify that Clean Water Act “point source” permits are not required for stormwater discharges from logging roads.

The decision comes on the heels of the American Forest & Paper Association (AF&PA) and others asking EPA to wait until the Supreme Court has considered the case being heard on Monday, Dec. 3 that addresses the issues the agency attempts to address in this rulemaking.