Elliot represents businesses and trade associations in litigation and regulatory matters, with more than three decades of experience in consumer product safety (CPSC), occupational safety and health (OSHA) and environmental law (EPA).
Consumer Product Safety
Occupational Safety and Health
Occupational Safety and Health
May 28th, 2015
May 12th, 2015
October 25th, 2016
May 15th, 2019
Today, the Washington Post recognized OFW Law for being a leader in U.S. Food and Drug Administration law, and food safety regulatory matters. We are proud of the role we have played in advancing public health through the development of food safety statutes and regulations. As a result of our involvement, we are intimately familiar […]
Washington Post Recognizes OFW Law’s FDA Regulatory Practice Read More »
When FSIS issues a regulation, they are required to do so by issuing a proposal in the Federal Register and seeking public input. The regulations are, in effect, the laws that govern the way an establishment can operate. The regulations for the meat and poultry industry are contained in Title 9 of the Code of
Interpreting FSIS Directives, Notices and Regulatory Documents (Who’s on First…) Read More »
We are pleased to announce that Nathaniel “Nathan” Fretz, Esq., formerly with the House Agriculture Committee staff, will be joining OFW in the practice of law. Fretz, who will join our Government Relations Practice, also served in the U.S. Department of Agriculture’s Food Safety and Inspection Service. Please click the announcement, below, to enlarge it.
Former Minority Counsel to House Ag Committee, Nathan Fretz, Joins OFW Law Read More »
The Food and Drug Administration has announced that it will hold two additional public meetings on its proposed rule “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.” 79 Fed. Reg. 5353 (Jan. 31, 2014). On December 24, 2013, FDA published a proposed rule on food defense. 78 Fed. Reg. 78013. Under the proposed rule,
FDA Announces Two More Public Meetings on its Intentional Adulteration Proposed Rule Read More »
As required by the Food Safety Modernization Act, FDA has published a proposed rule that would require registered food facilities to implement food defense plans to reduce the risk of intentional adulteration. The proposed rule represents FDA’s first attempt to establish regulatory requirements to address intentional adulteration of food. As the preamble states: “We acknowledge
FDA Takes on Intentional Adulteration Read More »
On November 13, 2013, the U.S. Consumer Product Safety Commission (CPSC) issued a proposed interpretive rule concerning corrective action plans for “voluntary” recalls that may impact future voluntary consumer product recalls in two significant ways. First, CPSC proposes to make voluntary recall agreements that companies negotiate with CPSC legally binding. Second, CPSC proposes to permit
CPSC Proposes to Make Voluntary Recalls and Compliance Programs Legally Binding Read More »
A Congressional Research Service (CRS) report from earlier in the month revealed that national net farm income—a key indicator of U.S. farm well-being—is forecast at a record $131 billion in 2013, up 15% from last year, and about $13 billion above 2011’s previous record. In addition to record net farm income, farm wealth is also at record levels.
Today, FDA published a notice in the Federal Register announcing the availability of the Generic Drug User Fee Act (GDUFA) Information Technology (IT) Plan. The plan explains FDA’s approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the GDUFA Performance Goals and Procedures for Fiscal Years 2013
Generic Drug User Fee Act Information Technology Plan Read More »
I am always amazed each Thanksgiving that my friends have questions on “cooking turkey.” I am even more amazed that they ask me questions, because I have a solid reputation for not being able to cook anything! That said, perhaps they ask because I do know how to make certain the turkey makes it safely
A Safe Thanksgiving Read More »
This past Monday (November 18), the FDA Center for Devices and Radiological Health (CDRH) launched a new webpage describing the revamped structure of its Office of Compliance (OC). One of the stated goals of the reorganization is to better align OC’s resources to its mission. While the stated goal in and of itself is fairly
FDA/CDRH Revamps Structure of its Office of Compliance Read More »
Will we get a farm bill or won’t we get a farm bill? No one knows at this point. There are still a number of unanswered questions. The biggest fight is over how much to cut the spending on food stamps. We have 50 million people receiving food stamps now and growing. House Republicans want
Former Secretary Block Comments on Farm Bill Read More »
By Mark L. Itzkoff In a recent blog post, we discussed the realignment among some public advocacy groups that resulted in several researchers moving from the Pew Charitable Trusts (Pew) to the Natural Resources Defense Council (NRDC). At the time, we noted that the review process for food ingredients that are generally recognized as safe (GRAS)
NRDC Steps Up Fight Against GRAS Notices Read More »
“The ecological and economic importance of the Chesapeake Bay is well documented….And yet, nutrient pollution and sedimentation remain a critical concern.” So says Judge Sylvia H. Rambo, U.S. District Court judge in Pennsylvania. Judge Rambo, in a 99-page opinion filed on September 13, 2013, challenged and dismissed the arguments of the American Farm Bureau on
Rambo Takes on American Agriculture Read More »
How hard was it for Robert Todd Lincoln-oldest son of the great president who won the Civil War, ended slavery, and today tops most polls as most admired leader in American history-to make a mark in life as anything except being his father’s son? Pretty darn hard.” OFW Law’s Ken Ackerman takes on The Chosen
Ken Ackerman’s Latest History: Abraham Lincoln’s Spoiled Son Read More »
In a time when there is an information vacuum, I would encourage all meat and poultry establishment operators to “build the relationship” with their FSIS inspection program personnel (IPP). While these individuals have a specific job to perform, verification and enforcement of the regulations, we all have the same goal – the shipment of safe
Building the Relationship Read More »
“Livestock matters to climate change. The sector contributes 7.1 gigatonnes (giga=billion) CO2-eq (equivalent) to global anthropogenic GHG emissions – a contribution that can be readily reduced by up to one-third – placing the sector as an integral part of any solution to climate change.” FAO Report Rome, 2013 Once again, the United Nations Food and
Is Livestock Causing Climate Change? Read More »
No, it is not time to face the Christmas shopping crowds, the kids have their back to school supplies, and we have made our fantasy football selections. So what is it I am supposed to be dreading? Oh yes, final days for government budgets, continuing resolutions, and possible government shutdowns. What does this mean, how
It Is “That” Time of Year Read More »
Under the U.S. Food and Drug Administration’s (FDA) Medical Device Reporting (MDR) Regulation, 21 C.F.R. Part 803, medical device manufacturers must report adverse events involving their devices to FDA when information reasonably suggests that: Their device may have caused or contributed to a death or serious injury; or Their device has malfunctioned, and it or
MDR Reporting of Foreign Adverse Events — What is Your Obligation? Read More »
By Mark L. Itzkoff As someone who has worked with numerous food companies on food additive and GRAS issues for 25 years, I read with interest the August 7, 2013, article, Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe, in JAMA Internal Medicine. The article reports on a
PEW Report’s Mischaracterization of GRAS Process Leads to Questionable Conclusions Read More »
FDA has published a final rule defining the term “gluten-free” for voluntary use in food labeling. Food labels will have to comply with the new regulatory definition starting August 5, 2014, roughly ten years after Congress directed FDA to define “gluten-free” in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). The “gluten-free”
“Gluten-Free” Now Has an Official FDA Definition Read More »
Former Congressman and OFW Law Senior Policy Advisor Charlie Stenholm (D-TX) greets six-time Major League Baseball Gold Glove Award winning catcher Jim Sundberg, who spent 12 years with the Texas Rangers, at the American Meat Institute’s (AMI) Annual Hot Dog Lunch on Capitol Hill. The 2013 Hot Dog Lunch was co-hosted by House Agriculture Committee Chairman Frank
Hot Dogs on the Hill Read More »
The Obama Administration recently announced that it will delay the employer health insurance mandate under the Affordable Care Act (aka “Obamacare”) until 2015. When questioned about the delay, White House Press Secretary Jay Carney said “people who suggest that there’s anything unusual about the delaying of the deadline, implementation of a complex, comprehensive law, are
Will FSMA Court-ordered Deadlines Set a Precedent? Read More »
Based on our experience reviewing a number of noncompliance records, we recommend that when USDA’s Food Safety and Inspection Service (FSIS) documents regulatory noncompliance at your facility, you review it with a “fine tooth comb.” To successfully review a noncompliance record (NR), you must first know your food safety programs and the governing regulations. You
Reviewing Regulatory Noncompliance – It is Good For Your Business Read More »
After two years of not passing a Farm Bill out of the House, it should be obvious to everyone that Farm Bills, as we have known and passed them, are over. This time around, a majority wanted to end direct payments; the Farm Bill did that. Most Members wanted to make producers more dependent on
A Farm Bill by the Boot Straps Read More »
By Casper E. Uldriks The FDA issues Warning Letters to provide firms notice that unless they achieve voluntary correction of the violations noted in the letter, the agency is prepared to initiate an enforcement action without further notice. Enforcement actions may include, for example, the seizure of goods, injunction and/or prosecution. Other administrative actions may be
Dealing With FDA Warning Letters Read More »
On May 23, 2013, the United States Department of Agriculture’s (USDA) Agriculture Marketing Service (AMS) issued a final rule to amend the Country of Origin Labeling (COOL) regulations (which became effective March 16, 2009). The final rule provides consumers more detailed information for muscle cut commodities by requiring that labels specify the production steps of
AMS Issues Final COOL Amendment Read More »
In conjunction with the opening of the G-8 Open Data for Agriculture conference on April 29, USDA Secretary Vilsack announced the newest “Community” on the government’s data access point data.gov: the Food, Agriculture and Rural Community. Coincidentally, April 30 is the 20th anniversary of the release of the World Wide Web’s core standards for free
Data.gov Launches New Ag & Food Community Read More »
By Mark L. Itzkoff On April 11, 2013, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced that it was adding bisphenol A (BPA) to the list of chemicals known to the state to cause reproductive toxicity under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). However, BPA’s time on the list
BPA Removed from Prop 65 List After Brief Appearance Read More »
FDA has announced that it will extend for an additional 120 days the comment periods for two major proposed rules implementing the Food Safety Modernization Act (FSMA): preventive controls for human food (Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food) and produce safety standards (Standards for the Growing, Harvesting,
Yesterday, the U.S. District Court for the Northern District of California issued an order requiring FDA to propose new deadlines for issuance of regulations implementing the Food Safety Modernization Act (FSMA). Center for Food Safety v. Hamburg, 4:12-cv-04529 (N.D. Cal. Apr. 22, 2013). In a lawsuit brought by two consumer groups, the court held that
Court Orders FDA to Set a Timeline for Issuing Regulations Implementing FSMA Read More »
While most people are filling out their brackets for March Madness®, producers of muscle cuts of meat are dealing with a different type of “March Madness.” On March 12, 2013, in response to a World Trade Organization (WTO) ruling that the current U.S. country of origin labeling (COOL) requirements for muscle cut meat discriminate against
New AMS Proposed Rule for COOL Drives Meat Industry Mad Read More »
The 2013 Economic Report of the President, an annual report written by the Chair of the Council of Economic Advisers, was released on Friday, March 15. An important vehicle for presenting the Administration’s domestic and international economic policies, the report provides an overview of the nation’s economic progress. This year, it includes a chapter on agriculture,
The Economic Report of the President on Agriculture Read More »
Click here for the explanatory statement accompanying the agriculture portion of the Senate’s Continuing Resolution (CR), which was released Monday night and includes the Agriculture appropriations bill. It contains language similar to a Conference Report in that it incorporates by reference items from the House and Senate reports, while highlighting certain items. The Senate CR is a
Ag Portion of FY 2013 CR: Explanatory Statement Read More »
