Wake up and smell the coffee!

Much of my day revolves around drinking coffee. My relationship with the beverage is not one of dependence (like it is for many), but of reverence.  Coffee emits the only aroma I can detect five rooms away, as I am quite sense-of-smell-challenged. Whether I am at my desk, a deposition or meeting with a client, it focuses me, and in times of stress, it relaxes me.  While it propels me forward in the morning, I can drop off to sleep like a well-fed infant regardless of how much caffeine I have theretofore consumed. After 40 years of imbibing, the stimulating substance seems to understand me and will do whatever I need it to do.

Many avoid caffeinated coffee because of bygone reports of adverse health effects. Recent research reported in Harvard Women’s Health Watch reveals that a “few cups a day” is safe and may even be beneficial. Studies show that the risk for Type 2 diabetes is lower among regular coffee drinkers than among those who don’t drink it. Coffee may also reduce the risks that one will develop gallstones, colon cancer, liver damage (in people at high risk for liver disease), and Parkinson’s Disease, and it seems to improve cognitive function.  The popular drink has also been shown to enhance endurance during tough physical activity. For those who drink coffee to stay alert (particular if one is fighting sleep deprivation), the new research suggests it is better to spread consumption over the course of the day.  For instance, if you usually drink 16 ounces in the morning, you should try consuming a 2-3 ounce serving every hour or so.  Apparently, moderation is the key.  I suppose that leaves me out.

Thinking ABOUT the Box

Scientists have reignited a debate over the class of chemicals known as bipoly- and perfluoro-alkyls.  “PFASs,” as they are commonly called, are used in thousands of products, such as electronics, footwear, sleeping bags, tents, protective fire gear, fire extinguisher foams, and pizza boxes.  On Friday, May 1, 2015, a top federal health official and 200 health experts (toxicologists and epidemiologists among them), voiced new concerns about their toxic nature because the substances linger in the human body for years after exposure and increase the risks of kidney cancer, thyroid disease and other health problems.  DuPont banned the use of one type of PFAS in its Teflon products years ago (and other companies followed), but the present controversy concerns whether enough research has been conducted with regard to the replacements.

Linda S. Birnbaum, the head of the national toxicology program for the Department of Health and Human Services, wrote a commentary for Environmental Health Perspectives, positing that “The question is: should these chemicals continue to be used in consumer products in the meantime, given their persistence in the environment? Research is needed to find safe alternatives for all current uses of PFASs.” The American Chemistry Council, however, maintains that tests, reviewed by the Environmental Protection Agency, concluded that these alternatives were safer than the chemicals they were replacing.  DuPont rejected the concerns, its head of risk management stating, “We don’t dismiss the right of folks to debate this…we just believe based on the 10-year history of extensive studies done on the alternatives, that the regulatory agencies have done their job of determining that these things are safe for their intended uses.”  Another environmental scientist, Dr. Paul Brooks, warns, “When you have something that is a first cousin or brother-in-law to a chemical that we are certain is carcinogenic, you have to somehow prove that it is safe before you use it — that it is not injurious,” he said. “You just have to be cautious.”

The class of chemicals is known for its durability and water-resistant properties.  Cardboard pizza boxes treated with the chemicals, for example, stay sturdy even when grease seeps into them.  The fluoro-technology industry is estimated to have reached $19.7 billion in sales in 2013.

“It’s likely they’re going to have some health effects, it just may take us a while to figure out what it is,” said Thomas F. Webster, a professor of environmental health at Boston University’s school of public health who was an author of a paper seeking more scrutiny of PFASs. “It might take five or 10 years to really do the research.”

You’ll Scream, All Right.

On April 20, 2015, Blue Bell Creameries voluntarily recalled all of its products including ice cream, frozen yogurt, sherbet and frozen snacks.  The company did so after sampling of chocolate chip cookie dough ice cream produced on March 17, 2015 and March 27, 2015 was found to contain listeria monocytogenes.  The bacteria causes listeriosis, an infection that is life-threatening, particularly to pregnant women and their newborns, adults 65 and older and people with weakened immune systems.  The Center for Disease Control in Atlanta has recommended that consumers not eat any Blue Bell brand products and that institutions and retailers not serve or sell them.  As of April 21, 2015, ten cases of listeriosis (including three deaths), have been identified in four states (Arizona, Kansas, Oklahoma and Texas), an outbreak believed to be related to the recalled products.

“One Package of Flu Medication…Unleaded, Please.”

On April 16, 2015, the Suffolk County Commissioner of Health Services, Dr. James Tomarken, warned parents that a powdered product marketed to treat influenza, fever, sneezing and nasal discharge in infants and children may contain excessive levels of lead. The product, Bo Ying Compound, is manufactured by Eu Yan Sang (Hong Kong) Ltd., is labeled in Chinese and English, and is marketed in retail outlets and online. “Parents and caregivers should not use Bo Ying Compound, Commissioner Tomarken said, “due to the potential risk of lead poisoning.” “Those caregivers who have the product in their homes should discard it, and those who may have already given Bo Ying Compound to their children should consult a health care provider for evaluations and possible blood lead testing,” the Commissioner stated. The warning was apparently prompted by the Maryland Department of Health and Mental Hygiene having found elevated lead levels in samples taken from two stores in the state. In 2014, the New York City Department of Health and Mental Hygiene received a report of lead poisoning in an 18-month-old child who was given Bo Ying Compound. The New York City Department of Health and Mental Hygiene analyzed samples of this product collected in New York City and also found elevated levels in the product.

The CDC has stated that “no safe blood lead level in children has been identified.” It estimates that approximately one-half million U.S. children between the ages of 1 and 5 have blood lead levels above 5 micrograms per deciliter (µg/dL), the reference point at which the agency recommends that public health actions be initiated. Exposure to lead has long been believed to cause serious damage to the central nervous system, the kidneys and the immune system. In children (whose brains and nervous systems are developing), chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems.

The Tsk-Tsk-Tsk Story of TSCA

The Toxic Substances Control Act (“TSCA”), regulates the dissemination of existing and new chemicals. Its three goals have always been to: 1) “assess and regulate new commercial chemicals before their entrance into the market”; 2) “regulate chemicals which were already existing in 1976 that posed an unreasonable risk to health or to the environment”; and 3) regulate the distribution and use of these chemicals. It prohibits the manufacture or importation of chemicals that are not on the TSCA Inventory of “existing” chemicals (or those subject to one of many exemptions). Producers must submit pre-manufacturing notification (“PMN’S”) to the EPA at least 90 days prior to creating or importing new chemicals for commercial purposes. The federal agency reviews the PMN’S and if it finds an “unreasonable risk to human health or the environment,” it may limit or ban production of the new substance.

When TSCA was passed in 1976, it “grandfathered in” some 60,000 substances that were already in use, making them exempt from review. The law makes it very difficult for the EPA to deem a substance “dangerous” and regulate it as such: in fact, of the 84,000 chemicals now registered for use in the United States, only 200 have been tested and the EPA has only banned five as “dangerous.” As a result of the federal government’s inaction in this area, individual states have banned certain chemicals, creating a regulatory quagmire in which manufacturers have to comply with different standards in different territories.

The law has faced considerable criticism and calls for reform from manufacturers and environmental advocates alike. In 2009, chemical producers called for the law to be “modernized” into a more centralized regulation…to avoid inconsistencies and ambiguities and to avoid the stifling of innovation and job creation. At the same time, environmental groups and state agencies have argued for tighter controls and labeling. In response to public concerns, manufacturers started to incorporate “screening mechanism(s) to diminish and/or prevent the marketing of products containing chemical substances that could potentially adversely affect human health and the environment.” Additionally, the demand for sustainable products has forced the market, to some degree, to adopt more green chemistry. Since 2003, 18 states have passed 71 laws regarding chemicals, and the state of California, in particular, implemented the Green Chemistry Initiative (“CGCI”) in an effort to increase innovation and reduce or eliminate hazardous substances to human health and the environment.

Clearly, technological advancement and invention of new chemicals is ahead of TSCA regulation in the United States. In 2013, two Senators proposed the Chemical Safety Improvement Act (“CSIA”), as TSCA’s first major bipartisan overhaul. The CSIA would have established a new safety standard of “no unreasonable risk of harm to human health or the environment will result from exposure to a chemical substance” under “intended conditions of use.” The standard was consistent with TSCA, balancing the potential risks and benefits. If it had passed, the new law would have required the EPA to: 1) use an evaluative framework for decision-making that employs the “best available science” and “science-based criteria;” 2) propose a screening process and selection criteria to identify substances as either “high” or “low” priority for safety assessment and determination; 3) conduct a safety assessment for each high priority substance; 4) determine whether the chemical meets the safety standard under intended conditions of use; 5) eliminate the long regulatory process to obtain information from companies regarding their chemicals; 6) grant the EPA additional flexibility to take action on unsafe chemicals; and 7) require the EPA to declare chemicals “likely to be safe” before they can come to market. The law has yet to be passed. And so the tragic story of TSCA continues.

Time to Round Up “Roundup”?

The International Agency for Research on Cancer (a research arm of the World Health Organization), reported this past week that glyphosate, the main ingredient in Monsanto’s Roundup, is a “probable carcinogen.”  Specifically, the finding links the product to non-Hodgkin’s lymphoma and lung cancer.  And while it was not the first time that that connection has been made, it is “one of the strongest indictments of glyphosate”, says the international director for the Organic Consumers Association.  Monsanto responded with a written statement that “all labeled uses of glyphosate are safe for human health and supported by one of the most extensive worldwide human health databases ever compiled on an agricultural product.”  The manufacturer issued an “urgent request for the WHO to meet with the global glyphosate taskforces and other regulatory agencies to account for the scientific studies used in their analysis and, equally as important, to account for those scientific studies that were disregarded.”

The U.S. Department of Agriculture does not test food for glyphosate residues.  While the EPA raised the allowable  limits of glyphosate residues on fruits and vegetables in 2013, the agency is scheduled to review the chemical this year.  Most genetically modified crops, such as corn and soybeans, are modified to survive applications of Roundup, the most widely used herbicide in the world.  “The widespread adoption of genetically modified agricultural products has led to an explosion in the use of glyphosate,” says Ken Cook, president of the Environmental Group, which promotes labeling of all such products.  “Consumers have the right to know how their food is grown,” says Cook, “and whether their food dollars are driving up the use of a probable carcinogen.”

2,4-D or not 2,4-D: A Question is Answered

The Environmental Protection Agency decided not to order the widely-used herbicide, 2, 4-D, off the market.  In so doing, the EPA denied the Natural Resources Defense Council’s petition to revoke the chemical’s approval.  The EPA determined that the environmental group had not adequately shown that 2, 4-D is harmful under the conditions in which it is used.  “At best, N.R.D.C. is asking E.P.A. to take a revised look at the toxicity of 2, 4-D,” the E.P.A. stated, “yet the ground for tolerance revocation is a lack of safety.”

First authorized for use in the late 1940s, 2, 4-D was one of two ingredients in “Agent Orange”, an herbicide used during the Vietnam War to defoliate trees.  The other component, 2, 4, 5-T, was found to produce 2, 3, 7, 8-TCDD, the most toxic form of dioxin, as a by-product, and the US Department of Agriculture halted its use on food crops (except rice), in 1970, and the EPA terminated all remaining uses in the US in 1985.  Because of the TCDD contaminant, Agent Orange has been blamed for a number of serious illnesses in exposed individuals and their off-spring.  Agent Orange had a much higher level of TCDD than commercially-utilized 2, 4, 5-T, and it was sprayed in concentrations that were 50 times greater than those normally used on US agriculture.

At present, 2, 4-D is one of the most commonly used weed killers in the world.  It is an ingredient in many home lawn-care products and it is used by countless farmers.  Use is expected to grow substantially in the coming years because the primary manufacturer is seeking federal approval to sell corn seeds that are genetically-engineered to be resistant to 2, 4-D.  Farmers planting that corn would be able to spray 2, 4-D on their fields to kill weeds without hurting the crop.