Regulatory Transactions

From: Bloomberg

By Mark Drajem

Companies that make biofuels from corn husks, soy and other materials are mounting a last-ditch lobbying campaign to prevent a weakening of the U.S. renewable-fuel mandate, saying a lower requirement would set back an industry that is ready to blossom.

The Environmental Protection Agency, responding to complaints from refiners and fossil-fuel oil producers, has proposed a reduction in the amount of renewable fuels that refiners must blend into gasoline and diesel next year, according to a draft obtained by Bloomberg on Oct. 10.

From: Drinker Biddle & Reath LLP

Article By: Fred Reish, Bruce L. Ashton, Joshua J. Waldbeser

In our last newsletter, we wrote about the DOL’s (Department of Labor’s)  Advance Notice of Proposed Rule Making (ANPRM) concerning the projection of retirement income on ERISA participant benefit statements. Since that article was published, a number of  plan sponsor and service provider organizations have filed their comments with the DOL, and the comment period has now expired.  This article contains a general summary of the comments and our view of the next steps.

Editor’s Note:  Regulatory scholars increasingly study the influence on the federal regulatory process of the regulations promulgated by our major trading partners.

From: RegBlog

Edgar Mkrtchian

A European Commission proposal to regulate electronic cigarettes as pharmaceuticals has run into substantial roadblocks.  On October 8, the European Parliament passed an amendment to the Commission’s proposal.  As amended, the proposal would subject e-cigarettes to the same regulatory regime as normal cigarettes.  In the wake of upheaval, a final vote on the proposal has been delayed to help build a consensus.

From: CSPNet  The Source for Convenience Store and Fuel News

Herzog optimistic after attending Food and Drug Law Institute tobacco regulation conference 

Editor’s Note:  The following article illustrates why proposed information collections need to undergo a thorough review, conducted with appropriate resources, under the Paperwork Reduction Act.

From: Washington Free Beacon

HHS Predicted Obamacare Exchange Sign Up Would Take 28 Minutes

White House approved HHS 28 minute estimate for Obamacare exchange application time in April 

BY: Elizabeth Harrington

The Department of Health and Human Services (HHS) estimated consumers would take an average of 28 minutes to sign up for Obamacare, according to a notice the agency sent to the White House in February.

Editor’s Note: CRE maintains an ongoing interest in international regulatory developments affecting American businesses.

From: RegBlog

Pooja Agarwal

More than 2,600 people reportedly died during clinical trials for new drugs in India between 2005 and 2012.  It is perhaps no surprise that the Indian Supreme Court recently demanded that the government create a strict regulatory plan before the end of the year for clinical trials to ensure the safety of the human subjects who participate in them.

From: MedPageToday

By Crystal Phend, Senior Staff Writer

When the FDA finally issues its proposed regulations on electronic cigarettes, which may be as soon as the end of the month, what will they look like? Probably pretty familiar, experts said.

The first step is likely to be just bringing the nicotine-vapor devices officially under the agency’s tobacco control authority and up to speed with the age, marketing, and packaging restrictions that have long been in place for conventional cigarettes.

Editor’s Note:  Please see RegBlog’s Thee-Part Series on Regulatory Incorporation here.

From: RegBlog

RegBlog is pleased to publish this week’s series facilitating further debate over the practice of federal agencies incorporating private standards into binding government regulations.  Our previous series, Regulating by Reference, chronicled the surprising reality that “some legally binding rules also originate within private organizations – not the government.”

This practice, known as “incorporation by reference,” takes advantage of industry expertise, but also is perceived to come into tension with general principles of open government because the private standards an agency incorporates by reference are not always readily available to the public.  Despite this alleged tension, Congress passed a law in 1996 requiring federal agencies to incorporate private standards by reference whenever appropriate and practical.

From: AINOnline

Slowly but surely, unmanned aircraft systems (UAS) are entering the U.S. National Airspace System (NAS) despite a regulatory regime that was previously considered prohibitive to all but government agencies and research institutions. Unmanned aircraft have flown for the first time commercially in remote Arctic airspace, and companies are considering or have already begun the process of obtaining FAA airworthiness certification of their UAS designs.

Heretofore, the FAA has required that private entities obtain a special airworthiness certificate in the experimental category to operate UASs, a status that prohibits them from being used commercially. Military services and public organizations require a certificate of authorization (COA).

From: Politico

The FDA Friday quietly posted the White House’s redline version of the proposed Foreign Supplier Verification Program and third party auditor accreditation rules to the regulatory docket, offering the first look at what exactly what the Office of Management and Budget changed during the two years it was reviewing these provisions.