Category: Legislation

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FDA Now Accepting Registration Renewals

This morning, the Food and Drug Administration (FDA) announced that as of 12:01AM this morning, the updated food facility registration system is now accepting food facility registration renewals. The renewal period was expected to open on October 1, 2012, however, FDA delayed the registration after receiving numerous requests from the Grocery Manufacturers Association and other trade associations … Continue Reading

Food Security Act Doesn’t Apply to Proceeds

The Food Security Act of 1995 is part of a matryoshka of statutes.   In the center is the general rule of 9-320(a) of the UCC, that a buyer in the ordinary course of business takes free of a security interest created by its seller.  The next doll is the Farm Products Exception, which I wrote about here:  except, … Continue Reading

Are FDA Reinspection Fees An Opportunity?

Fred Degnan, from King & Spalding, led a very insightful presentation on "Responding to Government Investigations and Warning Letters" at the recent ACI food regulatory summit. His presentation led to an interesting discussion about FDA’s close out of investigations. It was generally agreed that the FDA, in essence, is not notifying parties when it has decided to … Continue Reading

FDA’s Right To Photograph In Your Plant

The FDA asserts in its inspection manual its right to photograph in your plant. Yet the FDA does not have statutory authority to photograph. The manual cites the following cases as authority for its right to photograph the inside of a plant: Dow Chem. Co. v. United States, 476 U.S. 227 (1986), and United States … Continue Reading

3 New Ways FDA Will Access Your Records and 5 Things You Can Do About It

The Food Safety Modernization Act ("FSMA") significantly expands the FDA’s ability to access a food company’s records. The expanded authority is found in three places in the statute: FSMA § 101 amends 31 USC § 350c(a) and allows the FDA to obtain records related not only to a product that the FDA believes "will cause … Continue Reading

More on FSMA and Food Safety Risk Avoidance

Thank you to Parker Smith & Feek for inviting me to speak to about FSMA and how it’s changing the status quo. My slide-deck can be viewed here. Following my talk, Marty Bask from Parker Smith & Feek led a very interesting discussion about the pros and cons of product recall and contamination coverage. A link … Continue Reading

Looking for Information and Presentations on FSMA, Recalls and The RFR? Look No Further.

I’ll be speaking at several events over the next two months on the Food Safety Modernization Act (FSMA) and how this comprehensive and far reaching legislation affects the status quo for food companies. Two of these events are free, and all promise to address relevant and critical issues for those involved in the food industry. a. May … Continue Reading

More on the FSMA and the “Tester Amendment”

Earlier this week, I presented a webinar to the American Cheese Society entitled the "Food Safety Modernization Act and Product Liability." A link to the presentation is here. The presentation covered a number of topics and included a discussion of the so-called "Tester Amendment" to FSMA. The "Tester Amendment" in section 103 of FSMA "exempts" … Continue Reading

How Regulatory Changes Affect Litigation Risks

On February 24, 2011, Lee Smith and I presented "How Regulatory Changes Affect Litigation Risks" to the Grocery Manufacturers Association’s food litigation conference. A link to the slide-deck can be found here. We discussed ways that the Reportable Food Registry (RFR) and the Food Safety Modernization Act (FSMA) are affecting litigation now and can be … Continue Reading

Preparing for FSMA Produce Safety Rules: What “Ag-in-the Middle” Needs to Do

Many who track FDA’s implementation of the Food Safety Modernization Act (FSMA) believe that a priority for FDA is Section 105, “Standards for Produce Safety” (FDCA section 419), in particular, the leafy greens regulations. Farms are exempt under FSMA’s produce safety rules if: (A) during the previous 3-year period, the average annual monetary value of … Continue Reading

Why CSPI’s Loyalty Card Suit Has No Merit and Does Not Promote Food Safety

Following the playbook it has followed in the past with sodium and other issues, the Center for Science in the Public Interest (CSPI) has filed yet another complaint of very questionable legal merit to promote a policy agenda. This time CSPI seeks to compel all retailers to use loyalty cards as a recall alert system. … Continue Reading

Proposed Bill Would Eliminate the Corporate and LLC Shield for Many Washington Contracts

Note: This blog entry was  authored by Douglas Batey and originally published on the LLC Law Monitor blog. The Washington legislature is currently considering a bill that would apparently require any contract that calls for the payment of money by an LLC or corporation, to include an extra signature by an authorized representative that would render the … Continue Reading

How the Food Safety Modernization Act Changes the Status Quo

Yesterday (while taking a break from the Sustainable Food Summit in San Francisco), I traveled to Modesto, California to speak to the Manufacturer’s Council of the Central Valley. I spoke about the new Food Safety Modernization Act (FSMA). The focus of my talk was how the FSMA changes the status quo for food businesses. And … Continue Reading

It’s Official: The Food Safety Modernization Act Is Law. What Food Companies Need to Do Right Now

President Obama signed into law today the Food Safety Modernization Act (FSMA). Companies with facilities subject to FDA jurisdiction should  take immediate steps to review and, where necessary, modify SOPs, policies and procedures. For example, given the FDA’s expanded access to business records, companies should set SOPs that anticipate (before a crisis occurs) what records they may … Continue Reading

Green Chemistry Regulations Delayed

Apparently, according to the San Francisco Chronicle, due to opposition from both the industry and environmental and health groups defending green-chemistry regulations, the state of California failed to meet a deadline to approve the new regulations. Earlier in December, environmentalists and health lobbyists had complained that the rules were watered down and accused Gov. Schwarzenegger of … Continue Reading

Food Safety Modernization Act Will Become Law and Some Provisions Effective Immediately

This entry has been corrected to reflect that some of the provisions in the Food Safety Modernization Act, most significantly the preventative controls section, will be phased in over time. Today the House passed and sent to the President for his signature a bill to overhaul the current regulations on food safety, which were established over 70 years … Continue Reading

What Happens if Food Safety Bill Becomes Law (or Doesn’t)?

We’re nearly down to the wire on whether the 111th Congress will send S.510, the food safety bill, to the President for signature into law. I’m told it could happen by the weekend. No matter what happens in Congress, food law is changing and changing faster than it ever has.  The ABA Food Supplements Subcommittee and Products … Continue Reading
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