December 12, 2017

FDA Network Takes a New Approach to Produce Safety

From: FDA Food Safety Magazine

Source: FDA

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The challenges of successful implementation include regional differences in growing conditions and practices across the country, and that the produce industry has never before had this kind of FDA oversight.

The PSN does two things:

  1. It establishes regionally based policy and regulatory experts throughout the country, making them uniquely suited to address the issues specific to the states they’re supporting.
  2. It also places these experts, from two very different FDA offices, within one team. The network combines the regulatory expertise from the FDA’s Office of Regulatory Affairs (ORA) with the policy and science expertise from the Center for Food Safety and Applied Nutrition (CFSAN).

December 7, 2017

The DHS Form that Wouldn’t Die

From: Center for Immigration Studies

By David North

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All of this shows the power of tradition in the U.S. government. The Paperwork Reduction Act requires periodic reviews of government forms, which is commendable. But this form itself should have been eliminated, so no further reviews would be needed.

What is the form in question? It is the ancient N-300, and it relates to a century or so ago, when aliens often filed a form indicating that they were intending to become citizens, (i.e., first papers) before they got around to actually applying for citizenship (second papers).

November 22, 2017

Trump administration starts push to officially rescind ‘startup visa’ rule

Editor’s Note: See, Should the EB-5 Investor Visa Program Recognize Cyber Workers?

From: San Francisco Chronicle

By Trisha Thadani

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The rule, which is the closest Silicon Valley has come to a visa for entrepreneurs, was approved by the Department of Homeland Security during President Barack Obama’s last few hours in office. But a week before it was set to go into effect in July, the Trump administration delayed it with the intent to rescind it altogether.

November 13, 2017

Administration Acts On Executive Order: Proposed Short-Term Plan Rule Hits OMB

From: Inside Health Policy

The first regulatory action stemming from President Donald Trump’s Oct. 12 executive order asking agencies to reverse Obama-era rules on short-terms plans and promote associated health plans is under review by the Office of Management and Budget (OMB). OMB received the proposed rule on “Short Term Limited Duration Insurance” on Monday (Nov. 6). One source was somewhat surprised to see a proposed, rather than “interim final” rule. . . .

Read Complete Article [paywall]

November 8, 2017

Supplement Industry Has ‘Rare Opportunity’ to Seek Regulatory Reform

Editor’s Note: FDA guidance documents, including new dietary ingredient (NDI) guidance, are subject to the “seek and obtain correction” provisions of the Data Quality Act.

From: Natural Products Insider

by Josh Long

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NDI Guidance

It’s possible OMB’s Office of Information and Regulatory Affairs (OIRA) could review FDA’s draft new dietary ingredient (NDI) guidance, or a proposed final version. As the U.S. Government Accountability Office noted in an April 2015 report, OIRA “reviews some significant guidance documents” before they are issued.

Read Complete Article

November 7, 2017

Trump’s agriculture department reverses course on biotech rules

From: Science Magazine

By Kelly Servick

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USDA’s announcement and its notice in the federal register today provided little detail about the motivation for the reversal. The agency is taking another look at the rules to balance “regulatory requirements [that] foster public confidence” with a “review process that doesn’t restrict innovation,” Secretary of Agriculture Sonny Purdue said in a statement. USDA will now start fresh discussions with stakeholders to consider other approaches, the statement said.

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November 3, 2017

BLM Takes Step To Undo Gas Venting And Flaring Rule

From: Law360

By Michael Phillis

The Bureau of Land Management on Wednesday sent to the White House for review a proposal to rescind or revise an Obama-era regulation aimed at limiting venting and flaring from gas wells on federal lands, which is the final step before it is made public.

The Office of Information and Regulatory Affairs, which is part of the executive branch, posted a brief notice that said it received the BLM’s proposal. . . .

Read Complete Article (paywall)

November 2, 2017

New Dietary Ingredient Guidance: The Waiting Game

Editor’s Note: FDA guidance documents are subject to the Data Quality Act’s requirements and correction procedures.

From: Regulatory Affairs Professional Society

By Jennifer M. Adams, JD, Ashish R. Talati, JD, MS, RAC

This article discusses FDA’s publication of its revised draft of Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry (2016 Draft Guidance) and the implications regarding the lack of finalization in the year following its publication. The authors make suggestions regarding what companies may begin doing prior to and in anticipation of eventual finalization.

November 1, 2017

Gov’t won’t pursue talking car mandate

From: Associated Press

By JOAN LOWY

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The White House declined to comment, but the proposal has been dropped from the White House Office of Management and Budget’s list of regulations actively under consideration and instead has been relegated to its long-term agenda.

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Administration officials indicated their decision was based on several factors, including general wariness of imposing costly mandates on industry, even though most automakers support requiring V2V, industry officials said. President Donald Trump has made reducing government regulations, which he sees as a drain on the economy, a guiding principle of his administration.

October 26, 2017

White House reviewing proposal to kill Obama rule on workers’ tips

From: The Hill

BY LYDIA WHEELER

A Labor Department proposal to kill an Obama-era rule preventing employers from pooling workers’ tips is now under White House review.

The White House Office of Information and Regulatory Affairs (OIRA) received the proposed rule from the Labor Department on Tuesday according to the list of regulations under review.

Read Complete Article