FDA's New Produce Safety Rules: Somewhat Less Than Meets the Eye
When I teach my environmental law and food safety law students how to go about ascertaining the meaning of implementing regulations, I tell them to start with the sections of the regulations devoted to definitions and exemptions. Quite frequently the most hard-fought controversies during the rulemaking process through which the agency promulgated the regulations were over the definitions and exemptions.
That certainly seems to be true in the case of the long-awaited Food and Drug Administration’s (FDA) proposed “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” which the Obama Administration, with much fanfare, issued on January 4. According to FDA’s analysis of the economic impact of the proposal, almost 80 percent of the country’s produce growers will not have to meet the standards because they are not covered in the definitions or are otherwise exempt.
The proposed rule, which was required by the landmark Food Safety Modernization Act of 2010, would for the first time establish legally enforceable standards for produce farmers. The standards set out requirements for sanitizing tools and equipment, for ensuring that agricultural water is safe and sanitary, for using animal-based fertilizers (e.g., compost) on food crops, for …
The saga of the missing FDA food safety regulations continues with a new government filing in a lawsuit challenging FDA’s failure to promulgate regulations implementing three critical programs that Congress established in the Food Safety Modernization Act of 2011.
As I noted in a previous posting, the three sets of regulations are currently bottled up in the White House Office of Information and Regulatory Affairs (OIRA), where they have gathered dust for a year.
Well before the statutory deadlines, FDA sent OIRA proposed regulations requiring most food processors and manufacturers to come up with hazard analysis at critical control point (HACCP) programs, requiring growers to comply with “science-based” minimum sanitation standards, and for importers to verify that their products were produced under conditions that complied with FDA food safety requirements. But the deadlines came and went while OIRA sat on the regulations to avoid criticism from …
One of the crowning legislative achievements of the Obama Administration’s first term was the enactment of the Food Safety Modernization Act.
Like any safety statute, however, the new law will have no practical bite until the implementing rules are issued. In this case, that’s until the Food and Drug Administration (FDA) promulgates regulations fleshing out the obligations of growers, producers and importers of food. Unfortunately, after almost two years, the regulations for the three most critical programs enacted by the new law have been written, but have not yet been promulgated.
On Thanksgiving Day, one set of implementing regulations will have been bottled up at the White House’s Office of Information and Regulatory Affairs (OIRA) for exactly one year. Two other critical sets of regulations will pass the one-year milestone between Thanksgiving and December 9.
Signed by President Obama in January 2011, the new …
In the week before Christmas last year, 14-year-old Anais Fournier went to Valley Mall in Hagerstown, Maryland with some friends. While there she purchased and consumed a 24-ounce can of an energy drink manufactured by the Monster Beverage Corporation. She returned to the mall the next day and consumed another Monster energy drink. Later that evening, while she was watching a movie at home with her boyfriend, she went into cardiac arrest. She died four days later on the day before Christmas Eve. An autopsy concluded that she had died of “cardiac arrhythmia due to caffeine toxicity.”
Thanks to the efforts of her mother to get to the bottom of the matter, Anais’s untimely death may stimulate new efforts to regulate sports drinks and other potentially dangerous dietary supplements and to hold companies accountable in courts of law for their irresponsible marketing strategies.
Anais’s mother …
A host of concerned groups and individuals wrote to Secretary of Agriculture Tom Vilsack today urging him to withdraw proposed changes to poultry inspection rules until food safety and worker safety concerns are addressed. The letter was signed by a range of food safety and worker safety groups and individual signers, including CPR Member Scholars Martha McCluskey, Thomas McGarity, Sidney Shapiro, and Rena Steinzor.
The letter explains the food safety and worker safety issues at stake, and takes USDA to task for its rushed approach:
The Food Safety and Inspection Service (FSIS) developed the proposal with limited public input. The agency did not adequately consult with its inspection advisory committee, nor did the agency hold public meetings to solicit the views of the public. Previous agency proposals that sought to substantially change parts of the federal inspection program have been debated and discussed in public forums so …
Yesterday, the U.S. Food and Drug Administration (FDA) announced that it would amend an existing food additive regulation to prohibit the use of Bisphenol A (BPA) in “infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups).” BPA, a chemical commonly added to polycarbonate resins (a fancy word for plastics), continues to raise concerns over its low-dose, endocrine-disrupting health effects. Despite these health and safety concerns, the FDA’s decision to ban BPA in these limited items responds to a petition from the American Chemistry Council (ACC), which cites abandonment as the reason for the regulation amendment—not safety.
The good news about FDA’s BPA ban: FDA finally took an affirmative step toward protecting some of the public from BPA. The bad news: the step is a meager one …
Cross-posted from Georgetown Law Faculty Blog.
When an agency defends over three decades of inaction on an important problem by saying that acting would take too long, one hopes a judge reviewing the agency's inaction will see through the pretense. This is exactly what happened this week, when a federal magistrate judge in New York ruled that the U.S. Food and Drug Administration had acted arbitrarily in citing time and resource constraints in declining to limit the use of antibiotics in animal feed.
Some 80 percent of the antibiotics used in the United States are given to animals destined to become part of our food supply. Most of these drugs are given not to sick but to healthy animals; they are used not to treat disease but to promote animal growth or to prevent bacterial infections from occurring. Both of these purposes are tied to …
CPR Member Scholar Noah Sachs and I submitted comments yesterday to FDA regarding the American Chemistry Council’s (ACC) petition to the agency on BPA. In September, the ACC petitioned FDA to remove approval for the use of BPA in “infant feeding bottles and certain spill-proof cups” (Rena Steinzor and I explained at the time the story behind the seemingly counter-intuitive move).
In our comments this week, we advocate for FDA to utilize its full rulemaking authority and take broader regulatory action to protect the public against BPA. Specifically, we propose:
- Issuing new regulations encompassing the ACC’s Petition and Rep. Edward Markey’s March 16, 2012 Petitions concerning abandoned uses;
- Banning a much broader range of BPA uses without reference to age limits or target consumers; and
- Mandating labeling of BPA in all food contact materials.
As we explain in the comments, convincing scientific evidence supports …
One of the many ways that the slow and agonizing contraction of the newspaper industry is felt is in the depth of coverage that papers provide their readers. It’s a matter of simple math, really. As newsrooms shrink, reporters are stretched ever thinner. So a newspaper that 15 years ago had separate reporters covering elementary and secondary education is now likely to have just one covering both. Similarly, newspapers have fewer reporters dedicated to the environmental beat, let alone beats covering regulatory issues — topics at the heart of the Center for Progressive Reform’s work. The result is that many reporters don’t have time to take on stories they might once have covered, and if they do, they sometimes have a steeper learning curve and too little time to really dig in. That’s a recipe for simplistic coverage, which is just a nice way …
Last Friday, the FDA denied the Natural Resources Defense Council’s (NRDC) citizen petition requesting that the agency ban Bisphenol A (BPA) as an approved food additive and food contact substance. The agency took nearly three years to issue this decision, and did so only under a court’s order. The FDA’s denial of the petition was disappointing, because the existing science on BPA is strong enough to warrant restrictions on its use. The announcement was an unsurprising continuation of the federal government’s “wait and see” approach to BPA regulation.
FDA spokesman Douglas Karas said that “this announcement is not a final safety determination and the FDA continues to support research examining the safety of BPA.” There is no question that continued risk assessment and scientific study of BPA should be part of the FDA’s action plan for addressing the health and safety concerns …
