WLF Briefing to Examine Office of Management and Budget’s Role in Regulators’ Use of Science

PodiumPic1Science and Federal Regulation: Is the Office of Management and Budget an Effective Gatekeeper?

WLF Media Briefing, Tuesday, May 19, 10:00-11:00 a.m. EDT

Location: 2009 Massachusetts Avenue, NW (WLF headquarters)—RSVP to glammi@wlf.org or click HERE for free registration to view program live online

Speakers:

Two Cheers for the Tenth Circuit’s Temporary Stay of the CPSC’s New Magnet Safety Standard

zen magnetsOn April 1—no joke—the Consumer Product Safety Commission’s troubling new standard for magnet sets was slated to go into effect.  However, thanks to the efforts of the sole remaining distributor of Small Rare Earth Magnets (SREMs) in the United States, Zen Magnets LLC, consumer freedom won a last-minute reprieve.

As companies wishing to challenge final rules of federal agencies may typically do, Zen Magnets filed a stay of enforcement directly in the U.S. Court of Appeals covering its home state, Colorado in this case.  In rapid response to Zen Magnets LLC’s motion for a stay, the Tenth Circuit issued a same-day order to temporarily “stay the enforcement and effect of the Safety Standard for Magnet Sets promulgated by respondent Consumer Product Safety Commission on October 3, 2014, which goes into effect on April 1, 2015.”  In addition, the Court ordered CPSC to file a brief in response on or before today (April 14) “to assist the court in its review of the motion.”

Under the Federal Rules of Appellate Procedure, the Court had to consider four factors in issuing the motion to stay: likelihood of success on the merits; threat of irreparable harm; absence of harm to the government; and risk of harm to the public interest.  Just because the Tenth Circuit has issued the stay does not mean that it has decided the motion to stay enforcement will succeed.  Still, if the Court were convinced that the arguments Zen Magnets has presented in opposition to the Magnet Safety Standard were frivolous or had little chance to prevail, it is unlikely the Court would have issued even a temporary stay.  Since the appeals court’s review marks the first time any entity outside the agency’s purview has had an opportunity to check CPSC’s work, it is encouraging to see the Tenth Circuit forcing the agency to explain its unprecedented actions here. Continue reading

Federal Regulators’ Disregard for Sound Science Displayed in Four Agencies’ Actions

4th CircuitHow federal regulators use—and abuse—science in the regulatory process has a profound impact on regulated businesses and consumers who purchase their products and services.  In addition to the financial impact, every time that an agency forces science and the scientific process to serve its ideological or political agendas, rather than be guided by the neutral data, the public becomes less trusting of government pronouncements based on science. Below are some troubling recent examples of regulatory junk science. The first example demonstrates that protections against junk science do exist in the courtroom. The subsequent three examples reflect the lack of similar protections in the rulemaking and adjudication contexts.

Fourth and Sixth Circuits Slap-down EEOC. For the second time in less than a year, a federal appellate court has rebuked the Equal Employment Opportunity Commission (EEOC) for its use of junk science in accusing an employer of discrimination for conducting criminal background checks in its hiring process. EEOC’s litigation crusade against criminal background checks has faltered since its outset, with federal district court judges in Ohio and Maryland separately dismissing Title VII claims in 2013. Last April, just 20 days after hearing oral argument, the U.S. Court of Appeals for the Sixth Circuit affirmed the Ohio trial judge’s decision in EEOC v. Kaplan. The court found the EEOC’s statistical proof of disparate impact—compiled and presented by expert witness Kevin Murphy, an industrial psychologist—unreliable and “based on a homemade methodology” not generally accepted in the scientific community. A WLF Legal Opinion Letter and a WLF Legal Pulse post, both published last spring, offer more detail on the ruling. Continue reading

One Major Positive, But Still Many Negatives, for Asbestos Defendants in 2014

NewportWhen assessing liability risk, businesses, insurers, and others impacted by America’s free-wheeling civil justice system often ask, “What’s the next asbestos?” Regrettably for defendants still wrapped up in what the Supreme Court once called “the elephantine mass” of asbestos litigation, asbestos is still the next asbestos. In 2014, asbestos defendants continued to struggle against the tide of unfavorable judicial rulings, though one positive development this year did offer a great deal of hope to besieged businesses.

A January 9 ruling by U.S. Bankruptcy Court Judge George Hodges found a “startling pattern of misrepresentation” and withholding of exposure evidence in a ten-case sampling from asbestos actions consolidated in his court as In re Garlock Sealing Technologies, LLC, et al. Judge Hodges ordered full discovery in those cases to determine whether allegedly injured plaintiffs had exaggerated the value of their claims and failed to disclose claims they had made to asbestos bankruptcy trusts. A Fall 2014 WLF Conversations With paper, featuring former Attorney General Dick Thornburgh and former Delaware state court judge Peggy Abelman, addressed the larger concerns with such withholding of bankruptcy claims information. A January 21 Featured Expert Column on the WLF Legal Pulse also discussed In re Garlock in detail. Continue reading

White House Boosts Fictional “Food Addiction” Concept to School Kids

BSFriesAs we’ve discussed numerous times here, some nutrition nanny activists, regulators, and plaintiffs’ lawyers have embraced and promoted the concept that food can be “addictive.” The term grabs people’s attention, conjuring up disturbing mental images of helplessness and withdrawal. It’s no wonder, then, that the notion of “food addiction” is often invoked in the context of greater government regulation, taxes, and advertising restrictions designed to redirect our dietary choices.

On September 26, the concept received its highest profile reference yet, from First Lady Michelle Obama, during an interview broadcast to millions of students on the in-school “Channel One News.” When asked about the criticism the federal government’s new school lunch rules have faced, the First Lady responded:

It’s natural. Change is hard. And the thing about highly processed, sugary, salty foods is that you get addicted to it. I don’t want to just settle because it’s hard. I don’t want to give up because it’s expensive. I don’t want that to be the excuse.

The interview appears to have been very carefully scripted, so her mention of “addiction” was hardly spontaneous or casual, nor was her referencing it in the context of “highly processed, sugary, salty foods.” Federal government regulation is taking direct aim at those demonized products and their ingredients.

For instance, the Department of Agriculture has proposed banning the sale of certain foods in public schools that don’t meet “Smart Snacks” guidelines, as well as banning advertising of those products in schools. Also, as part of its update of the Nutrition Facts label affixed to all packaged foods, the Food and Drug Administration (FDA) is proposing a new “added sugars” item. FDA is pursuing this mandate even though the agency acknowledges that no chemical difference exists between naturally occurring and added sugars in food. The “added sugars” mandate would also expose federal regulators to constitutional challenges under the First and Fourth Amendments, as leading food regulation attorneys Richard Frank and Bruce Silverglade argue in a September 26 WLF Legal Backgrounder.

The First Lady’s reference to “food addiction” was ill-advised, especially considering the age and maturity level of her captive audience on Channel One News. The concept of addiction has been significantly dumbed down and politicized over the past few decades to the point where it has almost lost any objective meaning. Reputable scientists have questioned not only the methodology behind “food addiction” studies, but also the researchers’ motivation.

The “Let’s Move” effort led by the First Lady advances the indisputably worthy goal of a healthier America, but that goal cannot be met by fomenting faulty food addiction concerns. Such a concept creates a serious moral hazard—people struggling to lose weight may throw up their hands because they believe addiction to (insert high-calorie product) has taken hold. Talk of addiction, and the choice-restrictive public policies it fuels, also diverts attention and resources from actual solutions to obesity in America.

Also published by Forbes.com at WLF’s contributor page

Washington Post Parrots Activists’ Skewed Spin of FDA’s “GRAS” Process

The ScreamJust below the fold in the print and digital versions of this morning’s Washington Post blares the headline “Food additives on the rise as FDA scrutiny wanes.” The story dutifully advances the perspective of professional activists that the Food and Drug Administration’s (FDA) “generally recognized as safe” (GRAS) process for food additives is perilously broken. Food nanny organizations such as Center for Science in the Public Interest and the Natural Resources Defense Council have ramped up their attacks on GRAS over the past several years, assisted by a 2010 Government Accountability Office (GAO) report calling for changes to the process.

As explained in a Washington Legal Foundation Legal Backgrounder by Hyman, Phelps & McNamara attorneys Roberto Carvajal and Nisha Shah, the GRAS process dates back to 1958, when Congress determined that certain uses of substances in foods that were generally recognized as safe need not go through formal FDA approval. For nearly four decades, FDA applied that exception very narrowly, but the Clinton-era agency leadership altered that interpretation in 1997. They concluded that narrow application of the GRAS exception deeply strained agency resources and chilled food industry innovation. The agency’s new approach permitted food processors to self-report new uses of certain substances and provide FDA with the science supporting the GRAS conclusion. In response to the critical 2010 GAO report, the agency acknowledged that while the GRAS process could be improved, “FDA believes that the GRAS concept has continuing utility as a practical tool for distinguishing between substances and new uses of substances that merit a full pre-market safety evaluation by FDA and those that do not.”

FDA’s resolve on the GRAS process seems to be weakening, however. The Post article features a troubling front-page quote from FDA’s Deputy Commissioner Michael Taylor: “We simply do not have the information to vouch for the safety of many of these chemicals.” He goes on to proclaim later in the article, “We aren’t saying we have a public health crisis.” But of course Deputy Commissioner Taylor understands that when FDA uses the term “public health crisis,” even when denying the existence of one, it sounds alarm bells. FDA’s latest statements could be setting the stage for regulatory action against such common, widely-used ingredients as caffeine and sodium, which the agency has long considered GRAS.

For those who might be interested in learning more about the GRAS process from a far different perspective than the Washington Post provided today, watch WLF’s free July 10 Web Seminar, The Future of FDA’s “GRAS” Designation in an Era of Increased Scrutiny. The Powerpoint presentation utilized by our speakers, Keller and Heckman LLP’s Melvin Drozen and Evangelia Pelonis, is available here.

FDA Advisory Committee Not Rife with Conflicts of Interest? — “Please!” Quips Federal Judge

FDAIn order to achieve results that it believes are vital to public health, the Food and Drug Administration (FDA) has demonstrated time and again that it’s not afraid to trample laws and constitutional rights along the way. Occasionally, judges reintroduce FDA to the Rule of Law. We applaud one such recent rebuke by Judge Richard Leon, whose July 21 Lorillard v. FDA decision reminded FDA that it cannot stack a science advisory panel with members who will tell the agency what it wants to hear.

FDA tobacco control. After the U.S. Supreme Court rejected the agency’s attempt to seize regulatory oversight of tobacco products in 2000 (FDA v. Brown & Williamson), Congress granted FDA the authority it coveted in 2010. Banning or severely restricting the use of menthol in cigarettes has long been a goal of FDA’s friends in the anti-tobacco movement. FDA created a science advisory panel, the Tobacco Products Scientific Advisory Committee (TPSAC) to study menthol. The TPSAC concluded in 2011 that menthol had a negative effect on public health. Two companies filed suit in Febuary 2011, charging that FDA violated federal law by appointing members to the TPSAC who had clear conflicts of interest. The plaintiffs asked the court to strike the TPSAC’s report from the regulatory record.

Judge Leon’s opinion. The TPSAC members in question had ongoing contracts to testify as expert witnesses for plaintiffs in suits against tobacco companies. They also served as consultants to manufacturers of tobacco cessation products. FDA didn’t feel such relationships conflicted with their duties on the TPSAC. Judge Leon was quite flabbergasted by FDA’s decision. “Please!” he exclaimed, adding, “This conclusion defies common sense.” With regard to the members’ work with plaintiffs’ lawyers, Judge Leon explained that they had a financial incentive not to make any recommendations that would compromise the lawsuits in which they would testify. On the product consulting work, the judge noted that any FDA regulation of menthol would likely inspire more smokers to quit, potentially with the assistance of cessation products. Thus the TPSAC members also had a financial incentive to offer advice that would encourage a ban or restrictions on menthol. Judge Leon concluded that such blatant disregard for obvious conflicts violated federal law, and he enjoined FDA from utilizing the report in its assessment of menthol. Continue reading