By Dr. Nina Fedoroff, as published in Agri-Pulse USDA and FDA proposals to regulate genetically engineered (GE) plants and animals following the recent update of the regulatory framework are on their websites awaiting public comment by June 19, 2017. The documents on which comments are requested are long, dense and, at times, internally inconsistent. Here’s a detailed […]
Think This is Biotech Regulatory Relief? Not Yet. Read More »
This morning, FDA’s Office of Nutrition and Food Labeling announced that it intends to extend the compliance date for the new Nutrition Facts requirements. FDA’s announcement, which is included on its “Changes to the Nutrition Facts Label” webpage, notes that, after feedback from industry and consumer groups: FDA determined that additional time would provide manufacturers covered
FDA Announces Intent to Extend the Compliance Date for New Nutrition Facts Rules Read More »
This morning I watched the oral arguments before the CPSC in the staff appeal of the ALJ’s decision in the Zen Magnets case. I felt as if I was watching World War One trench warfare in modern dress. And like trench warfare where the combatants refuse to give an inch, insisting on holding their positions,
Fighting the Magnet Wars Read More »
Today’s Federal Register announces a technical amendment to FDA’s regulation of medical devices to align the regulations with the the Food, Drug, and Cosmetic Act (FD&C Act). The 21st Century Cures Act became law on December 13, 2016, and amended the FD&C Act by removing the requirement for local Institutional Review Board (IRB) review for
FDA Implements 21st Century Cures Requirements for Devices Read More »
By former USDA Secretary John R. Block I have two subjects to cover today. One that is very hopeful – Governor Terry Branstad, now Ambassador Terry Branstad, is headed to China. The other issue, which is not very hopeful, has to do with horses. Ambassador Branstad – as Governor of Iowa, he was very close
John Block: Branstad and Horses Read More »
By former USDA Secretary John R. Block Back in March, President Trump gave us a look at his budget plan. Although without much detail, it made clear to us that one of his highest priorities was to downsize the federal government. And, he would do that by cutting spending. He had already said that he
John Block: Budget Read More »
The U.S. Trade Representative (USTR) is seeking “public comments on matters relevant to the modernization of NAFTA in order to inform development of U.S. negotiating positions.” This is an opportunity for anyone impacted by U.S. trade with Canada and Mexico, either positively or negatively, to raise issues that they would like to see addressed in
NAFTA Re-Negotiation Objectives: USTR Requests Public Input Read More »
NYC just announced that its revised calorie labeling rule for food service establishments will take effect on May 22, 2017, and will begin being enforced with notices of violation subject to fines on August 21, 2017. This pre-dates the recently re-delayed effective date for federal menu labeling of May 7, 2018. The NYC rule,
NYC Menu Labeling Law – Enforceable? Read More »
By former USDA Secretary John R. Block “Trump’s Tax Plan Would Spur Growth” – that is the headline in a recent Wall Street Journal paper. First, let me say that President Trump’s tax reform plan is not very specific. I think that is good. The Congress will write the legislation anyway. We all know if
John Block: Two Issues Read More »
By former USDA Secretary John R. Block I am encouraged. I think that we have some pretty strong voices in the Trump Administration speaking out in support of agriculture. Our strongest voice comes from Secretary of Agriculture Sonny Perdue. He said after meeting with 75 Senators “their number-one, two, and three priorities were trade, trade,
John Block: GE Science Read More »
By former USDA Secretary John R. Block It’s only been a week since confirmation, but Agriculture Secretary Sonny Perdue has hit the ground running. He has ordered that schools be given more flexibility in their school lunch programs, more local control. They won’t be forced to reduce the sodium (salt) in the food served. He
John Block: Perdue’s Agenda Read More »
FDA is again extending the compliance date for menu labeling – just days before the regulatory requirements of § 101.11 were to have become effective. On May 4, 2017, the agency will publish an interim final rule that extends the compliance date from May 5, 2017, to May 7, 2018, and that opens a 60-day
The restaurant industry was bracing for FDA’s menu labeling regulation, requiring mandatory calorie disclosure on menus at chains that have 20 or more locations. The final compliance date was coming up next week on May 5, 2017. However, in a last minute change, FDA submitted an interim final rule to the White House Office of
That is one of the most common – and difficult – questions to answer when OFW Law teaches a Food Safety Modernization Act Foreign Supplier Verification Programs (FSMA FSVP) course. Determining the compliance dates is typically more challenging for the affected importers. To make it easier, OFW Law has created flow diagrams and examples to
I’m a FSVP Importer: How Do I Know When I Need To Comply? Read More »
FSMA – The D.C. acronym for the Food Safety Modernization Act. When I am working with clients or speaking with industry, everyone is familiar with FSMA. But they think of FSMA as the Preventive Controls or Produce Safety Rules. Some are also aware of the Sanitary Transportation Rule, but the Foreign Supplier Verification Programs (FSVP)
The Relatively Unknown FSMA Rule – Foreign Supplier Verification Programs Rule Read More »
By former USDA Secretary John R. Block Last week on Saturday, it was Earth Day. I always thought of Earth Day as a celebration of the earth with its natural beauty and, of course, the food and crops it provides to feed everything living – especially mankind. But this year, it became a “March for
John Block: Sound Science Read More »
There has been a great deal of discussion, and in some circles hand-wringing, about President Trump’s regulatory reform initiatives and how they will impact independent agencies like the CPSC. The Office of Information and Regulatory Affairs (OIRA) within OMB is a key player in the debate since OIRA reviews and can influence changes in the
Regulatory Tools Depend on the Craftsmen Who Use Them Read More »
By former USDA Secretary John R. Block I can report that I was on my Illinois farm last week. Weather was beautiful and we planted 360 acres of corn. Then it rained. At least we got started. It is always exciting when you first hit the field with hope and optimism of a good crop.
John Block: How Do We Raise Prices? Read More »
This week, I stopped by the U.S. Department of Agriculture and met with Governor Perdue’s Chief of Staff and Policy Advisor, Brian Klippenstein. It was a short visit but we all agreed that we desperately need to get Sonny Perdue confirmed. All of the ag departments, from trade, forest service, nutrition programs, farm programs, and
John Block: Confirmation Process Read More »
As federal policy rapidly develops under the Trump Administration, much of it reversing or seeking to reverse the Obama legacy, the world of medical privacy (at least that which is on the books for now) remains static – after all, privacy always has been a bipartisan issue. Right? Not so fast . . . Trump
Trump’s New OCR Director and HIPAA Policy Read More »
By former USDA Secretary John R. Block President Trump took his oath of office with a priority list of actions he wanted to take in his first 100 days. It has not been easy. In the first place, I don’t think his team had prepared enough to move quickly on getting his nominees through the
John Block: Slow Process Read More »
Yesterday, FDA published a final rule making some technical amendments to its prior notice of imported food regulations. The prior notice regulations implement section 801(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(m)), which requires that FDA receive prior notice of food imported into the United States. Coordinating the Automated Broker Interface/Automated
Prior Notice of “Grey Market” Food Imports Read More »
By former USDA Secretary John R. Block I was back on the farm in Illinois last week. I’m glad to report that the pigs are healthy and happy, and we are ready to start planting next month. Some farms are not as fortunate. Wild fires have burned more than 1,000 square miles, killing thousands of
John Block: Farm Economy Read More »
By former USDA Secretary John R. Block Before focusing on today’s ag issue, I want to pay tribute to Clayton Yeutter. Clayton passed away Saturday, March 4 – age 86 – having served as U.S. Trade Ambassador and Secretary of Agriculture for Presidents Reagan and Bush. Clayton Yeutter – a good friend and champion for
John Block: Organic Foods Read More »
Egg cartons in the United States are not required by federal regulations to bear labels which identify the living conditions of the hens. Two animal rights non-profit organizations and six individuals sought to change that by filing petitions with four different federal agencies under the apparent strategy of not putting all their eggs in one
Egg Carton Labeling Petitions Fail to Hatch Read More »
By former USDA Secretary John R. Block President Trump’s first major address to a joint session of Congress got a lot of attention. He told us what he is going to do. He reminded us what he has already done. He worked to sell his vision for the country to the Congress and the people.
John Block: Trump Speaks Read More »
By former USDA Secretary John R. Block I have two issues to put forward today. They aren’t related, but we are going to have more discussion about each of them this year. President Trump tells us he will put forth a tax reform plan with tax cuts. Speaker Paul Ryan also is advocating tax legislation,
John Block: Two Issues Read More »
By former USDA Secretary John R. Block The headlines in the papers and on the evening highlights: “White House in Crisis” and “Conflicts Between Trump Appointees.” Yes – for anyone following the new President and Republican Congress’s effort to take control and move forward, it is a wild and crazy show. However, let me say
John Block: Controversy is Good Read More »
U.S. purveyors of foods, food additives, dietary supplements, and cosmetics for export are often asked by foreign customers or foreign governments to supply a “certificate” for products regulated by FDA. Review of a certificate may be required by foreign countries as part of the process to import a product into those countries. A Certificate of
CFSAN Soon Will Issue Certificates of Free Sale for Exports Online Read More »
By former USDA Secretary John R. Block President Trump is aggressively working to relieve the heavy burden of excessive regulations imposed on businesses in recent years. Remember what President Reagan said about regulations: “A government regulation is the nearest thing to eternal life that anyone will ever see on this earth.” I think that we
John Block: Regulations Read More »
Although it took a while, new leadership has finally come to the Consumer Product Safety Commission. After a flurry of last minute activity—and a rejection of the Administration’s direction concerning new regulations—earlier this week, Elliot Kaye was removed as agency chairman. He has announced that he plans to remain as a commissioner. Commissioner Ann Marie
Welcoming New Leadership at the CPSC Read More »
Views expressed in this post are intended as solely those of the author. Nothing is more boring than the Federal notice-and-comment rulemaking process under the Federal Administrative Procedures Act (APA). It is dry, obscure, and complex. Trust me, I teach seminars on it, and even the perkiest student on my most entertaining day needs heroic
Pity the Poor APA: How President Trump has Crippled Federal Rulemaking in Ten Short Days Read More »
The opening days of a new year are, to some, an apropos time to look back and reflect on the year that is now “one for the books.” Unable to resist the urge to do so ourselves, we have compiled our “Top-5” list for medical device regulation in 2016. Device Modification Guidance It has been
Medical Device “Top 5” for 2016 Read More »
By former USDA Secretary John R. Block I want to focus on trade today. From agriculture’s perspective, it is extremely important. 25% of ag income comes from products sold to other countries. Production from 1 out of every 3 acres is exported. Agriculture has a positive trade balance of more than $30 billion. As positive
By former USDA Secretary John R. Block The news of the day is that Donald Trump is President. His critics are in shock. I say – “get over it.” He has tapped Governor Sonny Perdue for Secretary of Agriculture. Perdue grew up on a Georgia farm and has a veterinarian’s degree. Gary Baise, who pulled
John Block: Perdue as Ag Secretary Read More »
