News & Insights

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The Vatican Enters a GMO “Palaver,” Supports Use of Biotechnology

By Marshall L. Matz with Peter Matz, as published by Agri-Pulse “Palaver” is a wonderful word used in Africa to...

NRDC Steps Up Fight Against GRAS Notices

By Mark L. Itzkoff In a recent blog post, we discussed the realignment among some public advocacy groups that resulted...

FDA Released its Proposed Animal Food Rule: What’s in it?

FDA published its proposed animal food rule, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food...

Eight Is Enough: EPA’s Dust and Feathers Discharge Argument Goes Down the Drain

In a decision with broad implications for production agriculture, a West Virginia federal judge concluded that Clean Water Act (CWA)...

Rambo Takes on American Agriculture

“The ecological and economic importance of the Chesapeake Bay is well documented….And yet, nutrient pollution and sedimentation remain a critical...

My Mobile Medical Application Will be Regulated by FDA…What Do I Do Now?

Recently, FDA finalized its guidance on Mobile Medical Applications (MMA), which is available here. The release of this guidance document...

Ken Ackerman’s Latest History: Abraham Lincoln’s Spoiled Son

How hard was it for Robert Todd Lincoln-oldest son of the great president who won the Civil War, ended slavery,...

Citizen Suit Goes Down The Drain in Farm Tile Case

Farm tile drains are not a point-source of pollution under the Clean Water Act, even if the outflows contain contaminated...

Bienvenue Aux Etats-Unis!

With so many of our respected friends and colleagues furloughed, federal agency budgets decimated, or wholly dependent on user fees...

Universities Salute World Food Prize Commitment to Sound Science & Biotechnology

As I mentioned last week, a major coalition of farm, food and anti-hunger organizations joined 30 institutions of higher education...

Building the Relationship

In a time when there is an information vacuum, I would encourage all meat and poultry establishment operators to “build...

Is Livestock Causing Climate Change?

“Livestock matters to climate change. The sector contributes 7.1 gigatonnes (giga=billion) CO2-eq (equivalent) to global anthropogenic GHG emissions – a...

HHS Guidance Expands Scope of Refill Reminders and Reasonable Costs

As we reported recently, the Department of Health and Human Services (HHS) announced its intent to issue guidance regarding prescription...

Major Coalition, including Academia, Commends World Food Prize for Supporting Biotechnology

A very broad coalition of 100 food and agriculture organizations, including 30 research universities and anti-hunger organizations, have sent a...

The Phone Call that Comes Too Late

At least once a month, our USDA or FDA practice group receives that phone call…the phone call that comes from...

It Is “That” Time of Year

No, it is not time to face the Christmas shopping crowds, the kids have their back to school supplies, and...

Livestock & Meat Groups Want COOL Relief Pending WTO Review

On Monday, a group of trade associations representing the spectrum of America’s beef and pork production system issued an urgent...

FDA’s GRAS Review Process for Foods May Be Tested by Litigious Public Interest Group

By Bruce Silverglade and Mark L. Itzkoff As reported in Politico this week, there has been a shake-up of sorts...

MDR Reporting of Foreign Adverse Events — What is Your Obligation?

Under the U.S. Food and Drug Administration’s (FDA) Medical Device Reporting (MDR) Regulation, 21 C.F.R. Part 803, medical device manufacturers...

HITECH First Amendment Challenge Delayed – HHS Promises Guidance and Agrees to Limited Enforcement Delay

The Department of Health and Human Services (HHS) revealed in court filings yesterday that it expects to issue guidance regarding...

Judge Denies Attempt to Stop New COOL Rule

Opponents of USDA’s new mandatory Country-of-Origin-Labeling (mCOOL) rule received a setback this morning. A federal judge denied the mCOOL opponents...

The FTC and Keeping Privacy Promises

In 2012, identity theft was the number one complaint reported to the Consumer Sentinel Network. Protection of private consumer information...

FDA Proposed Reg will be “Game Changer” for Auditing and Certification Organizations

Get ready, set, go! After years of delay, FDA is now on a fast-track to finalize its proposed regulation on...

Canada, Mexico Think U.S. Labeling Requirements are un-COOL

The United States has irked its neighbors with a meat labeling mandate that may have the effect of discriminating against...