March 26, 2015 2:23 PM
Dan Nosowitz in Modern Farmer offers some insights on the recent class action lawsuit filed against California winemakers. The plaintiffs found that some inexpensive wines contained arsenic at levels exceeding the federal drinking water standard for this substance. Nosowitz rightly points out that the standard is for water, not wine and “people don’t, or shouldn’t, drink as much wine as water.”
Well, let’s not go that far… kidding of course! Moderation is surely a good idea when it comes to alcohol consumption. Yet even if you drank as much wine as you do water, there’s still no reason to be alarmed about arsenic. The levels in wine are still too low to have any significant adverse impacts, and ironically, such small amounts might even have health benefits.
Arsenic is an element that naturally occurs in the earth’s crust, so traces of arsenic inevitably appear in food and water. Certainly, high levels of arsenic are not healthy and concentrated exposures can be immediately deadly. But the trace levels found in water and food are rarely an issue. Problems have emerged primarily in developing nations like Bangladesh where poor people drink from untreated water sources with arsenic levels that range in the hundreds of parts per billion (ppb), and sometimes more than 1,000 ppb.
It’s worth noting that the levels allegedly found in wine are reportedly just five times greater (or 500 percent higher as noted in the press) than the federal drinking water standard of 10 ppb. So, some number of samples—we don’t know how many—tested by the plaintiffs in this case had some level of arsenic near the 50 ppb level. But did you know that until 2006, that was the allowable level in drinking water in the United States and it had been for decades?
The U.S. Environmental Protection Agency (EPA) changed the standard to 10 ppb in 2001 with full compliance not required until 2006. The 10 ppb standard for arsenic in drinking water is excessively overcautious. When EPA proposed it, it was very controversial because the cost to small drinking water systems was substantial and the benefits highly questionable. EPA’s Science Advisory Board highlighted lots of problems with EPA’s science and maintained that the change could actually undermine public health. The SAB explained that the costs might cause some small communities to disconnect their water systems, forcing people to use untreated well water, but EPA finalized the rule anyway.
If you look at the history, you can see that EPA did not change the standard for safety reasons; they did it for political ones. You may remember, environmental activists attacked the Bush administration for taking time to reconsider changing the standard, which the Clinton administration rushed out during the final hours of the Clinton presidency. Green groups made it sound like the Bush administration was adding arsenic to the water supply. And this bad press made a rational and scientific debate impossible.
March 19, 2015 1:57 PM
James Mills of the National Institute of Child Health and Human Development lamented in an article in the New England Journal of Medicine back in 1993: “‘If you torture your data long enough, they will tell you whatever you want to hear’ has become a popular observation in our office. In plain English, this means that study data, if manipulated in enough different ways can prove whatever the investigator wants to prove.”
Government regulators will resort to such data torture to justify an activist regulatory agendas if they can’t do it with good data and sound science. One approach includes selective use of data—excluding years or datasets that might change the conclusions of a risk assessment. The Consumer Product Safety Commission’s recent Chronic Hazard Advisory Panel (CHAP) report on the chemical class known as phthalates offers one new example of excluding inconvenient data.
In short, the CHAP report is being used to justify a proposed rule that would essentially ban the use of certain chemicals for toys that children might mouth or chew. These chemicals make plastics soft and pliable, suited for such things as a plastic version of a “rubber duckie.” For background on this issue, see my other blog posts here and here.
In addition, in the absence of any compelling body of data that any individual phthalate is the cause of human health effects, the panel relied on the possibility that the cumulative effects of phthalates as a class pose risks. Accordingly, they needed data on human exposure from all sources.
The panel developed a “cumulative risk assessment” that they maintained justified regulations. But pharmacologist Christopher J. Borgert, Ph.D., observes in a review of the CHAP report that the panel’s cumulative risk assessment: “failed to recognize obvious inconsistencies with human experience and clinical evidence”; “overstates the accuracy of its cumulative risk methods and conclusions”; and “appears to have grossly overestimated chemical potencies.” In other words, the panel failed to properly apply the available data and research.
To make matters worse, they used old and irrelevant data for their human exposure assessments even though more accurate and recent data was available. Former and current CPSC commissioners have noted that had the panel used the most recent data, their risk assessment would have produced the opposite result. This issue raises the prospect that the panel members were intentionally “selective” in their use of data because they desired to generate a particular conclusion, as appears to be the case with their selection of studies that they also reviewed.
March 18, 2015 2:00 PM
Many “stakeholders” have complained about the process through which the Consumer Product Safety Commission (CPSC) developed its proposed rule related to a class of chemicals called phthalates—and rightly so. In particular, the agency’s failure to allow public comment and open peer review of its Chronic Hazard Advisory Panel report (CHAP report) underscore the fact that bureaucrats want to avoid scrutiny that might hold them accountable for rash and unscientific decisions.
Designed to make plastics soft and pliable, these chemicals have many valuable uses for making a wide range of products from blood bags, to rain boots and swimming pool liners as well as children’s toys, which are the subject of this regulation. Safely used for decades, activists and regulators are poised to essentially throw away these valuable technologies based largely on junk science.
While this rule only affects toys that children might place in their mouths or chew, it sets a terrible precedent. I already detailed how this rule might harm consumers in a blog post last week. Now let’s look at the so-called “science” behind it.
The justification for the proposed regulations are found within the CHAP report, which is a review and risk assessment that the agency released in July 2014. A key problem stems from the fact that the CHAP report relies on a selective review of limited studies that offer scant evidence that individual phthalates or cumulative exposure pose any significant risk to humans at current exposure levels.
Most of the CHAP-report-identified “evidence” that these chemicals pose health risks comes from lab tests that over-dose rodents to trigger health effects. Such tests are not particularly relevant to humans that better metabolize the substance and who are exposed to traces that are multitudes lower.
The human research highlighted in the CHAP report is not particularly compelling either. Many of these human studies are noted to be “small,” which limits their value for drawing any conclusions. And many of them report associations between potential health effects in babies whose mothers’ phthalate exposure levels were measured in single “spot” urine samples during pregnancy. Given that humans metabolize phthalates relatively quickly, one time spot measurements may be misleading about actual exposures, raising important questions about the utility of such studies.
March 13, 2015 8:58 AM
On Monday, the Consumer Product Safety Commission will close the comment period for a proposed rule related to chemicals used to make soft and pliable plastics. While they claim to do this in the name of children’s health, it’s not clear that the rule will do more good than harm.
The process and the “scientific” review that brings us to this proposed rule has been controversial, to say the least. I detail some of those issues in comments that I will submit on Monday and will post some of that here on Monday as well.
Unfortunately, not enough attention has focused on the fact that the agency-commissioned study—referred to as the Chronic Hazard Advisory Panel (CHAP) report—failed to fully consider the potential implications of substitute products that will replace those they ban.
Before initiating a rulemaking that may remove chemical technologies from the marketplace that have been safely used for decades, CPSC should consider whether replacement products pose greater risks. The CHAP allegedly addresses replacement products by reviewing data on the potential environmental health effects of other chemical substitutes. But the CHAP did not address whether or not the substitutes that might actually win a place in the market would affect product performance in ways that help or harm public health and safety.
The rule should ensure net safety, considering all factors. It is incumbent that regulators don’t inadvertently increase risks with short-sighted decisions. Based on the CHAP, we lack reasonable assurance that regulatory action will increase net safety and, in fact, such actions might accidentally introduce new hazards and even greater public health and safety risks.
February 19, 2015 6:54 AM
Many people associate professional licensing with consumer safety. For example, we wouldn’t want any schlub doing surgery. But where occupational licensing laws may have started out with the goal of protecting consumers, they have now become a means by which certain professionals restrict competition. States require licenses for hundreds of occupations including perilous professions like florist, funeral director, hair braider, and fortune teller.
The case of the “Caveman” blogger who was bullied by the North Carolina Board of Dietetics/Nutrition for providing nutritional advice without a license illustrates how licensing threatens not just our economic freedom, but our other basic freedoms. Luckily for blogger Steve Cooksey, his right to express his opinion and give advice to fellow dieters won out over the need to protect licensed dieticians from competition.
As the Institute for Justice, which has been fighting on Cooksey behalf, wrote yesterday:
In December 2011, Steve Cooksey started an advice column on his blog to answer reader questions about his struggle with Type II diabetes. Cooksey had lost 78 pounds, freed himself of drugs and doctors, and normalized his blood sugar after adopting a low-carb “Paleo” diet, modeled on the diet of our Stone Age ancestors. He wanted to use his blog to share his experience with others.
However, in January 2012, the North Carolina Board of Dietetics/Nutrition informed Cooksey that he could not give readers personalized advice on diet, whether for free or for compensation, because doing so constituted the unlicensed practice of dietetics. The board deemed Cooksey’s advice the unlicensed practice of nutritional counseling, sent him a 19-page print-up of his website indicating in red pen what he was and was not allowed to say, and threatened him with legal action if he did not comply.
February 12, 2015 1:34 PM
Thomas Jefferson once said, “If people let the government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as are the souls of those who live under tyranny.” On this issue, TJ seems to have hit the nail on the head.
Since Uncle Sam started telling us what to eat, Americans have steadily grown less healthy in many ways. In the 1970s, we were told to eat less meat and more grains. We listened, but it did little to curtail the oncoming obesity “epidemic” (some claim government recommendations may have actually caused this epidemic). And for decades, we have been told to restrict our consumption of cholesterol in order to reduce our risk of cardiovascular disease. That is, until now. The new dietary guidelines will no longer recommend restrictions on cholesterol consumption. This is a great first step, but the best advice is to stop listening to government nutritional advice.
For many people, this will seem like an abrupt about-face after 50 years of lectures about cholesterol. But for those in the medical research field, the shift is long overdue. During the last decade, it has become increasingly clear that there is no real evidence linking dietary cholesterol and blood serum cholesterol (which is used as a stand-in for CVD risk). While many physicians are still wedded to the idea that their patients at risk for cardiovascular disease should limit their egg consumption, it sounds like the Dietary Guidelines Advisory Committee—a joint effort of HHS and USDA—has finally come to grips with the evidence. Unfortunately, the real lesson remains unlearned: the U.S. government shouldn’t be the authority on what is or isn’t a healthy diet.
The DGAC, which consists of “nationally recognized experts,” meets every five years to review medical literature and hash out recommendations for what a healthy diet should look like. Their report to the secretaries ultimately becomes the official Dietary Guidelines for Americans, which is used by policy makers as a guideline in federally administered nutritional programs and assistance. Unfortunately, it sounds like they will still cling to their increasingly suspect beliefs about saturated fat.
February 5, 2015 10:41 AM
A recent article in Wine Industry Insight titled “Micro-Agglomerates: 350 Million Illegal Corks Per Year?” reports: “Agglomerated cork manufacturers and importers are facing scrutiny from two major federal agencies over health concerns about the plastic used to bind bits of cork glued together. The concern is that chemicals in the binding plastic can leach into wine.”
But a closer look at the issue indicates that these agencies are not focused on the corks, there’s nothing illegal about them, and safety concerns are unwarranted.
The two agencies allegedly interested in the issue are the U.S. Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). The chemical in question, toluene diisocyanate or TDI, Wine Industry Insight notes, is “listed as a potential carcinogen” with the International Agency for Research on Cancer (IARC) and the National Toxicology Program (NTP).
This sounds scary, but there are many reasons why no one should be alarmed about the closures or the chemical involved. But before going into that, we should be clear as to what the agencies are doing in regard to the corks.
According to an EPA press release, the agency has proposed a rule that would require manufactures to notify the agency if a consumer product they are making will contain more than 0.1 percent of TDI by weight. The EPA does not mention scrutiny of corks that may contain TDI. It’s very possible that these corks don’t contain that much TDI and would not even be subject to this proposed rule.
Nor is the FDA really scrutinizing the issue. Instead, the agency received letter from an outside party asking questions about related FDA law. Wine Industry Insight has posted a link to a letter from the FDA responding to that party, but the name of the party asking questions is either blanked out or never included. But Wine Industry Insight points out that it was an association that represents competitors of agglomerated cork producers—a synthetic cork association—who filed the petition. It notes:
“Competition is fierce for the low-end market which is why a synthetic cork association blew the TDI whistle on agglomerates in a letter to the FDA.”
Obviously, competitors have an interest in making this an issue, but FDA isn’t taking the bait. FDA has authority to regulate “food additives” that might pose a threat to public health and that includes chemicals that might migrate from packaging into food. In its cryptic, bureaucratically written letter, FDA is basically indicating that they have data showing there is no detectable migration of TDI into the wine for the closures currently on the market. Otherwise, they’d be regulating now, but they’re not.
So much for “federal scrutiny.” There really isn’t much because there’s no good reason for it.
February 5, 2015 7:59 AM
“Say goodbye to your favorite sprinkled doughnuts,” warned Clayton Morris, guest host on Fox & Friends. “The [FDA] is now regulating Americans intake of trans fat…the amount needed to make something as small as a sprinkle on your doughnut may be banned.” Morris is referring to the decision announced by the Food and Drug Administration in 2013 to reclassify partially hydrogenated oils—revoking its status as “generally recognized as safe” and creating a de facto ban on the artificial trans fat found in the oils. Fox’s overwrought presentation of the issue led many observers to ridicule the segment as well as opposition to the FDA action. The ribbing is warranted; discussion on both sides of the debate has overwhelmingly relied on emotional arguments and hyperbole. As a result, most people aren’t talking about the real threat this FDA action poses.
“Only Vladimir Putin would deny American children—and adults that need to rethink their dietary life choices—their God-given right to ingest sugar in whatever form they deem fit,” Elliot Hannon at Slate joked. “Your doughnuts are safe from Obama’s grasp” wrote Steve Benen at MSNBC. And Cenk Uygur dedicated almost seven minutes of his show, The Young Turks, to myth-busting/ridiculing the Fox segment. Uygur’s response included all of the primary arguments made by those who support an FDA trans fat ban and demonstrated how useless the Fox & Friends-style argument is.
Uygur takes all of the points made by Morris and shows why it is actually an argument for why trans fat ought to be banned. So what that Americans have almost completely eliminated trans fat from their diets already? “It was the FDA effort to eliminate trans fat in the first place that almost solved the problem and now they’re trying to solve it completely,” he asserts. Almost completely isn’t good enough; according to Uygur and the FDA, trans fat consumption is still responsible for a certain number of deaths so it is completely appropriate for the FDA to act to stop these preventable deaths. “Heart attacks, that’s what the right wing calls freedom,” he jokes. He is similarly unmoved by the argument that most food companies have voluntarily removed trans fat from their products. In fact, he points to this as a refutation of the idea that sprinkles or any other food will be taken off the market if trans fat is reclassified. “Nobody is banning any of these foods. It’s a total lie,” he says.
Uygur is right. Well, at least partially. FDA action in 2003 requiring manufacturers to list trans fat on nutritional labels did contribute to a reduction in consumption. Of course, it was also pressure from public health advocates and consumers’ demand for healthier products that resulted in the drop: from 4.6 grams a day in 2003 to around 1 gram a day in 2012. It’s worth noting, however, that the public health advocates crying out against trans fat now were the same ones who promoted the use of trans fat by vilifying saturated fat in the 1980s. Uygur is also right that the FDA isn’t banning any particular food: not doughnuts, sprinkles, pie crust; they’ll all survive a “trans fat ban.” They may need to be reformulated, may taste different, and be more susceptible to spoilage, but most products, if not all, will remain on shelves in some form or another.
Uygur also right when he argues that almost eliminating trans fat from our diet isn’t an argument against a complete ban. For instance, claiming that Americans consume next to zero arsenic isn’t going convince many people that we should let food companies put arsenic in our food. But this is the part of the discussion missing from both sides: trans fat isn’t arsenic and it’s not a poison: it’s a food. As with any other food or beverage, if you consume it in great enough quantities, there will be negative consequences. But trans fat isn’t “harmful”; it is unhealthful, potentially. So, the question is: when is it okay for the FDA to make decisions about what foods or ingredients can or can’t be part of a healthful diet. And is that something we want the FDA deciding at all?
November 24, 2014 9:58 AM
As the Ontario provincial government in Canada considers policies that may force farmers to stop using, or drastically reduce use of, a class of pesticides called neonicotinoids, a new study shows why such policies are unlikely to do any good. Supposedly, limiting use of these pesticides will improve honeybee hive health, but such regulations will simply make it harder for farmers to produce an affordable food supply.
The study, which relies on data from actual field conditions, confirms that farmers can protect their crops using these chemicals without harming honeybee hives. Published in PeerJ, it assessed the impact of neonicotinoid-treated canola crops on hives that foraged among these crops in 2012. The researchers found no adverse impacts and very low exposure to the chemicals. The authors report:
Overall, colonies were vigorous during and after the exposure period, and we found no effects of exposure to clothianidin seed-treated canola on any endpoint measures. Bees foraged heavily on the test fields during peak bloom and residue analysis indicated that honey bees were exposed to low levels (0.5–2 ppb) of clothianidin in pollen. Low levels of clothianidin were detected in a few pollen samples collected toward the end of the bloom from control hives, illustrating the difficulty of conducting a perfectly controlled field study with free-ranging honey bees in agricultural landscapes. Overwintering success did not differ significantly between treatment and control hives, and was similar to overwintering colony loss rates reported for the winter of 2012–2013 for beekeepers in Ontario and Canada. Our results suggest that exposure to canola grown from seed treated with clothianidin poses low risk to honey bees.
Despite all the media hype about how these chemicals harm honeybees, these findings are not surprising. Research condemning these chemicals has tended to focus on lab studies that overdose bees to see if pesticides affect hive health. But those studies have little relevance to real-life exposure to these chemicals in the field. The U.S. Agricultural Research Service’s Kim Kaplan explains that such studies have “relied on large, unrealistic doses and gave bees no other choice for pollen, and therefore did not reflect risk to honey bees under real world conditions.”
October 31, 2014 2:18 PM
“‘If you torture your data long enough, they will tell you whatever you want to hear.’ Dr. James Mills noted in a 1993 New England Journal of Medicine article. “In plain English, this means that study data, if manipulated in enough different ways can prove whatever the investigator wants to prove.”
Indeed, such “data torturing” is responsible for a recent junk science study that claims drinking soda will age your cells, which makes it as dangerous as smoking. But these findings reflect clever manipulation of data—and nothing more.
Regarding the soda study, columnist Daniel Engber points out in Slate: “The newly published paper delivers a mishmash of suspect stats and overbroad conclusions, marshaled to advance a theory that’s both unsupported by the data and somewhat at odds with existing research in the field.” Engber goes on to detail how these researchers worked and reworked the data to get their desired result.
Unfortunately, such data mining is all too common. In many cases, researchers don’t even have to work that hard. Rather than using a truly random sample, their “data mining” may simply involve excluding certain participants as “outliers” or pulling out select data subsets from a larger database. In that case, the sample may reflect the researcher’s bias instead of constituting a truly random sample.
For example, many studies on the chemical bisphenol A (BPA) rely on data mined from the National Health and Nutrition Examination Survey (NHANES), a Centers for Disease Control and Prevention (CDC) program that assesses national health trends. CDC collects health data from a different group of volunteers every year via physical exams and interviews. In addition to recording the volunteers’ health ailments, the data also include measurements of BPA in urine and blood. NHANS is a treasure trove for researches who want to cherry pick subsets of data to produce spurious correlations that they can market as meaningful findings.