Category: FSMA

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Safeguarding FSMA’s Protectors: OSHA Issues Interim Whistleblower Reporting Regulations

From labor and employment attorney Alyson Palmer: The U.S. Occupational Safety and Health Administration (OSHA) published an interim final rule on February 13, 2014, creating the process for handling retaliation complaints brought by whistleblowers under Section 402 of the Food Safety Modernization Act (FSMA). Section 402 of FSMA amended the Federal Food, Drug, and Cosmetic … Continue Reading

Settlement Reached for FSMA Final Rule Deadlines

On August 29, 2012, the Center for Food Safety (CFS) and the Center for Environmental Health filed an action against the U.S. Food and Drug Administration (FDA) alleging that the agency had violated the Food Safety Modernization Act (FSMA) and the Administrative Procedure Act (APA) by unlawfully withholding FSMA regulations beyond the required statutory deadlines. … Continue Reading

Food Safety Regulations: Proposed FDA Rule on Sanitary Transportation

The U.S. Food and Drug Administration (FDA) issued its proposed rule on sanitary transportation under the Food Safety Modernization Act (FSMA) that would require certain shippers, receivers, and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation. The proposed “Sanitary Transportation … Continue Reading

Register Today for FDA’s Public Meetings on Two Major FSMA Proposed Rules

Earlier this year, the Food and Drug Administration (FDA) made some progress toward implementing the Food Safety Modernization Act (FSMA) by issuing two new proposed food safety rules. Specifically, the agency published proposed rules to establish standards for (1) growing, harvesting, packing, and holding of produce for human consumption (the “Produce Safety Rule”) and for … Continue Reading

FDA Extends Food Facility Registration Deadline Until January 31

The Food and Drug Administration (FDA) has extended the deadline for food facilities to submit their registration until January 31, 2013. Under the FDA Food Safety Modernization Act (FSMA), domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to renew their facility … Continue Reading

Mark Your Calendars! Biennial Registration of Food Facilities Under FSMA Starts Next Week

Registration of food facilities with the U.S. Food and Drug Administration (FDA) has been a requirement for almost a decade. Since the passage of the Public Health Security and Bioterrorism Preparedness Response Act on June 12, 2002, facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States have been required … Continue Reading

FDA Issues Interim Regulation and Input on Document Inspection Requirements under FSMA

Effective March 1, 2012, the FDA implemented an Interim Final Rule on the “Establishment, Maintenance, and Availability of Records” under the Food Safety Modernization Act, “FSMA”. The FSMA statute among other new provisions, expanded the FDA’s authority to access and demand records from relating to the specific suspect article of food records, to include those relating … Continue Reading

FSMA And Prop 65 At The GMA Conference

Attorneys Lee N. Smith and Melissa A. Jones participated in the GMA 2012 Food Claims and Litigation Conference in Dana Point.  Mr. Smith (his real name) spoke on the effect of the New Food Safety Modernization Act and its potential impact on litigation, and Ms. Jones (her real name) and Mr. Smith also presented an overview of Proposition … Continue Reading

Upcoming Events

On December 8, 2011 I participated in a webinar organized by the Strafford Publication Group. In conjunction with Jonathan Cohen from the Gilbert firm and Joseph Bottiglieri with Bonner Kiernan Trebach & Crociata LLP, we presented Food Safety Claims: Products Liability Issues on the new requirements under the Food Safety Modernization Act. Nicole Hancock of … Continue Reading

Listeria Outbreak/FSMA Produce Regulations

The FDA confirmed this week that Listeria matching the strain that has caused health effects, was found on equipment and fruit at the Jensen Farms packing facility in Colorado.FDA Link..The recall that was announced on September 14 apparently actually began several days earlier and according to press reports included shutting down operations, the harvest and calling … Continue Reading

Product Traceability Pilot Studies

In the wake of recent recalls the progress of implementation of the Food Safety Modernization Act (FSMA) has become more significant. The Pilot Traceability Project was announced as of last week. This project is intended to provide a structure for tracing ingredients back to their source in the event of a recall. Section 204 of … Continue Reading

American Cheese Society Conference

I attended the American Cheese Society conference in Montreal earlier in the month. The conference was attended by cheese producers and suppliers from around the world. At the conference I presented a PowerPoint on Food Safety Modernization Act  (FSMA) .  There were several talks on Food Safety and clearly, the industry is concerned about the new provisions where cheese in … Continue Reading

Moving In-House

As you might have heard, I’m leaving Stoel Rives LLP this month, my professional home for almost 14 years (and parts of three decades). I am honored and humbled to have been asked by The Kellogg Company to join them as their in-house food safety and quality lawyer. My departure from Stoel Rives is bittersweet. … 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

The FDA’s Reportable Food Registry: Four Burning Questions

I authored the following article that appeared in the April 29, 2011 issue of Food Chemical News: As the clock ticks on the FDA’s 24-hour deadline to report to the FDA’s Reportable Food Registry, a food retailer, manufacturer or supplier is forced to make snap decisions that can profoundly impact business and litigation. Once a … Continue Reading

Listen on Demand to April 29, 2011 AON Webinar on the FSMA

A 60-minute webinar broadcast on April 29 on the Food Safety Modernization Act (and a short discussion of implications of the Japanese earthquake, tsunami and resulting nuclear disaster on food safety) is available for replay at this link. The webinar was sponsored by AON. My gratitude to AON for inviting me to participate. As always, I’m interested in your feedback and questions.… 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
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