Supreme Court Puts Clean Power Plan on Hold, but Clean Agriculture Can Move Forward

Posted on February 12, 2016 by Peter Lehner

The Supreme Court's unexplained stay of the clean power plan was "one of the most environmentally harmful judicial actions of all time," writes Michael Gerrard of Columbia Law School in a recent, excellent blog. Rather than venting outrage, Gerrard quickly moves on to explain that the Clean Power Plan isn’t the only way to cut carbon pollution.

Ramping up efforts like fuel efficiency standards for cars and trucks, and building efficiency standards, he notes, will also help reduce carbon pollution. Gerrard mentions a couple of points about agriculture, but often, this sector is overlooked when it comes to climate solutions. It’s worth taking a closer look at some of the opportunities to reduce climate pollution from our food system.

Food waste is the second largest component of most landfills. As it rots, it releases methane, a potent greenhouse gas. A recent report by the UN Conference on Trade and Development estimates that 2 percent to 4 percent of all manmade climate pollution arises simply from food rotting in landfills.

Keeping food waste out of landfills can help reduce methane pollution. Massachusetts, California, Connecticut, Rhode Island, Vermont, and some cities have enacted laws to manage organic waste disposal in landfills. The idea is to create incentives to reduce food waste and divert it to other purposes, such as animal feed or composting. Instead of being thrown away and becoming a source of pollution, this “waste” can be put to good use. Landfill gas collection systems can be further incentivized. And the nascent effort to reduce food waste from businesses and households can be significantly ramped up.

Another major source of greenhouse gases is the over application of fertilizer. Excess nitrogen fertilizer causes two big problems. The first is water pollution. Nitrogen that isn’t taken up by crops runs off farms and enters larger waterways, where it stimulates the growth of algae and creates “dead zones” deprived of oxygen. The second, and less frequently discussed issue, is the volatilization of nitrogen into nitrous oxide, a greenhouse gas about 300 times more potent than CO2.  The IPCC estimates that 12 percent of all non-CO2 greenhouse gas emissions come from synthetic fertilizer application.  

A number of techniques can reduce these emissions while also providing a cost benefit to farmers. Farm policies could encourage practices like cover cropping, which reduces the need for fertilizer by making soils more rich and fertile. Crop rotations can do the same, yet current crop insurance programs actually discourage the use of these practices. Precision application technologies for fertilizers are getting ever better, but their uptake on farms is slow.

Manure from animals, and the "enteric emissions" from cattle (more commonly thought of as belching) are two more significant sources of climate pollution. Enteric fermentation alone may account for as much as 40 percent of all non-CO2 greenhouse gas emissions, according to the IPCC. Changes in diet might help with these emissions, but this is an area that needs more research.

Some of the emissions from manure can be captured if manure lagoons were covered and better managed. As it stands, these pits are only slightly regulated and are major sources of water pollution sources as well as odor nuisances. An even better practice is to raise cows on rotating pastures, where their waste can enhance soils and help store carbon. And, of course, if Americans did shift to a diet lower in red meat, as per the recommendation of the Dietary Guidelines Advisory Committee, we could further reduce climate pollution from cattle.

Agriculture is one of our nation's most important economic sectors, and is especially vulnerable to the extreme weather impacts of climate change. Its product -- food -- is critical not only for our economy, but is an integral and uniquely personal part of our everyday lives. When we think about how to address climate change, it makes sense to think about food and agriculture. The food we choose to produce, and how we produce it, use it, and dispose of it, all have an impact on climate pollution—and therefore have the potential to become climate solutions. 

After 15 Years, EPA Finally Moves to Ban Brain-Damaging Pesticide Chlorpyrifos

Posted on December 4, 2015 by Peter Lehner

Nearly 15 years have passed since the EPA effectively banned the residential use of the pesticide chlorpyrifos (often marketed under the name Dursban), which causes brain damage in children. Kids were exposed at home when they played on pesticide-treated rugs, or hugged pets wearing flea collars containing chlorpyrifos. Yet the agency’s decision left farmworkers and children in rural areas unprotected, as chlorpyrifos was still allowed in agriculture (often marketed under the name Lorsban). This organophosphate pesticide was, and still is, one of the most widely used in agriculture.

Last month, after a decision by the 9th Circuit Court of Appeals that called the EPA's delay "egregious," the EPA at last proposed to ban most agricultural uses of this toxic pesticide.  If the ban on food use applications is finalized -- and it will surely be fought by the agricultural industry-- it will be a major victory for public health and farm communities.

Back in 2007, Earthjustice (which under full disclosure is my employer) began legal action to protect children, farmworkers, and rural communities from chlorpyrifos. Despite the clear evidence of harm, more than five million pounds of toxic chlorpyrifos were still being sprayed every year on soybeans, fruit and nut orchards, and other crops, putting hundreds of thousands of people at risk of exposure. Farmworkers who handled chlorpyrifos, even with safety gear, had been poisoned. (The new farmworker protection standards, which required more vigilant training and monitoring, among other things, should reduce such harms.)  Their children risked exposure at home, as chemicals can linger on clothing. Not only farmworker communities, but anyone living downwind of farms could be exposed when the wind carried the toxic spray into their neighborhoods. Community monitoring even found chlorpyrifos in schoolyards. 

The EPA was failing to protect children from pesticide drift; nor did the agency recognize the growing body of peer-reviewed, published research that found children exposed to the pesticide in the womb had serious brain impairments, including lower IQs and attention deficit disorder.

Over the next nine years, the EPA repeatedly missed deadlines to respond to the petition, and it relied on a questionable exposure model created by Dow, the manufacturer of the pesticide. (In 1995, Dow was fined $732,000 by the EPA for concealing more than 200 reports of poisoning related to chlorpyrifos.)

Only in response to multiple lawsuits, and a court decision that set a mandatory deadline for response, did the EPA at last take action. The public comment process and the finalization of the rule still remain, but at least the process has started. This is a great step forward. Moreover, the EPA is also reviewing all organophosphate pesticides, which are used in the United States and worldwide on a wide variety of crops from corn to cotton to nuts. The decision on chlorpyrifos should set a strong example. 

Is Our Diet Healthy if it Threatens the Planet? Environmental Sustainability and the Dietary Guidelines for Americans

Posted on October 8, 2015 by Lisa Heinzerling

This week, the Obama administration passed up an opportunity to promote environmental sustainability by incorporating sustainability into the Dietary Guidelines for Americans. The Secretaries of the Departments of Agriculture and Health and Human Services, Tom Vilsack and Sylvia Burwell, announced in a blog post that they would not follow the recommendation of their scientific advisory committee by incorporating environmental sustainability into the dietary guidelines. Their decision is unfortunate, and reflects a crabbed understanding of their authority under the law.

Experts on food systems have long drawn a connection between a healthy environment and food security. The representatives of the 185 countries present at the first-ever World Food Summit in 1996, for example, observed the links between food insecurity and environmental problems such as the loss of biodiversity, desertification, overfishing, degradation of land, forests, water, and watersheds, and ecological changes brought on by global warming. A substantial impetus behind the contemporary food movement is the conviction that our food system, and the security of the food supply it creates, is only as stable as the environment from which it comes. Even the Pope is onto the intimate connection between food security and the environment: the 2015 papal encyclical on the environment and poverty, Laudato Si', emphasizes the importance of a healthy environment to a secure food system. As Wendell Berry, the great agrarian and essayist, has put it, "What is good for the water is good for the ground, what is good for the ground is good for the plants, what is good for the plants is good for animals, what is good for animals is good for people, what is good for people is good for the air, what is good for the air is good for the water. And vice versa."

Federal agencies in the United States have increasingly been urged to recognize the relationship between a healthy environment and secure food. A recent entry in this field is the 2015 recommendation from a scientific advisory committee to the Department of Agriculture (USDA) and the Department of Health and Human Services (HHS), urging that these agencies revise the Dietary Guidelines for Americans to take into account the environmental consequences of industrial agriculture and their implications for future food security. 

The Dietary Guidelines for Americans are, as USDA and HHS have described them, "intended to be used in developing educational materials and aiding policymakers in designing and carrying out nutrition-related programs, including Federal nutrition assistance and education programs," and they "also serve as the basis for nutrition messages and consumer materials developed by nutrition educators and health professionals for the general public and specific audiences, such as children." Previous iterations of the Dietary Guidelines for Americans have contained recommendations on intake of fat, sodium, alcoholic beverages, physical activity, and more. The influence of the Guidelines on food assistance programs and educational initiatives has long made them a focal point for political and scientific controversy.

The statutory basis for the Dietary Guidelines for Americans is the National Nutrition Monitoring and Related Research Act of 1990. The Nutrition Monitoring Act requires the Secretaries of Agriculture and Health and Human Services to "publish a report entitled 'Dietary Guidelines for Americans'" every five years. This report is to contain "nutritional and dietary information and guidelines for the general public." The information and guidelines must be "be based on the preponderance of the scientific and medical knowledge which is current at the time the report is prepared." 

Information and guidelines concerning the environmental sustainability of our present diet are assuredly "dietary information and guidelines for the general public." The exhaustive report prepared by the scientific advisory committee, reflecting current evidence on the link between dietary choices and environmental sustainability, certainly reflects "the preponderance of the scientific … knowledge which is current" at this time. The secretaries of USDA and HHS would have been well within their range of legal discretion in deciding that environmental sustainability – no less than advice on alcohol consumption or physical activity – should be considered in developing food assistance packages and educational programming for Americans. Indeed, given the huge contribution of agriculture to climate change, incorporating environmental sustainability into the dietary guidelines could well have become an important feature of the Obama administration's legacy on climate change – if the secretaries of USDA and HHS had had the vision and will to make it so.

THE TIMES THEY ARE A CHANGING FOR CALIFORNIA’S PROPOSITION 65

Posted on September 9, 2015 by Robert Falk

California’s “Proposition 65” warning requirements have long been a major concern for businesses that want their products offered for sale in the State’s large marketplace.  Businesses whose products contain even a detectable amount of any one of more than 900 chemicals often face enforcement lawsuits brought by for-profit plaintiffs unless their products contain a “clear and reasonable” Proposition 65 warning.  Short of eliminating the chemical entirely, the only way for businesses to immunize themselves from such claims has been for companies to label or display their products with a generic warning based on language set forth in the original Proposition 65 regulations.  It usually states: “WARNING:  This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.” 

Three new developments threaten to make Proposition 65 less predictable and more difficult. 

1)      New Proposition 65 Warning Regulations Proposed for Adoption:  Earlier this year, the California Office of Environmental Health Hazard Assessment (“OEHHA”) formally proposed an extensive set of new rules concerning the requirements for Proposition 65 warnings to be deemed “clear and reasonable.”  While Proposition 65’s current regulations allow for compliance with its warning requirements through the type of generic, one sentence statement appearing above, the proposed regulations will, among other things, require:

a.       use of a yellow triangle pictogram containing an exclamation point;

b.      a more unequivocal warning statement indicating that the product “can expose” a user to chemicals known to the State to cause cancer and birth defects or other reproductive harm;

c.       listing particular chemicals if they are among a group of twelve which are the most frequent targets of Proposition 65 litigation;

d.      adding a URL to all warnings linking a public website that OEHHA will operate to provide information supplementing the warning for those so interested (see below); and

e.       presentation of the warning in languages in addition to English if the product label otherwise uses languages other than English.

The proposed new Proposition 65 warning regulations specify alternative and additional requirements for certain types of products, including for food, restaurants, and several products or facilities that have previously been the subject of enforcement litigation.  They also adopt revised and more onerous requirements for warnings for “environmental exposures,” such as for air emissions that arise from the operation of facilities or equipment within the State.  As proposed, businesses will have two years from the adoption of a final rule to transition their warnings to meet the requirements of the new regulation, after which they can face enforcement actions and citizen’s suits for products in the California market that still bear the old (or no) warnings.

2)      New Proposition 65 Website-Related Requirements Proposed for Adoption:  Although not contemplated by the voters when they approved Proposition 65 over twenty-five years ago, OEHHA is also proposing that it operate a website to provide information to the public to supplement and explain the basis for the Proposition 65 warnings given by businesses.  Information to be provided on this website may include the routes or pathways by which exposure to a chemical from a product may occur, OEHHA’s quantification of the level of exposure to a chemical presented by a product, and other information that may be of interest to plaintiffs as well as to sensitive consumers and other members of the public. 

Significantly, in addition to its potential public education function, the proposed website regulations also empower OEHHA to require that manufacturers, importers, and distributors of products bearing a Proposition 65 warning provide the agency with information if so requested.  Such information may include the identities of the chemicals in the product for which a warning is being given, the location or components of a product in which such chemicals are present, the concentration of those chemicals, and “any other information the lead agency deems necessary.”  While trade secret protection may be asserted in some circumstances, the requirement to provide information to OEHHA will be enforceable by public prosecutors, including the California Attorney General and District Attorneys.  

3)      Potential Changes Relative to Proposition 65’s “Safe Harbor” Levels for Chemicals Listed for Reproductive Effects:   Lead has been the focus of the vast majority of all Proposition 65 enforcement actions to date and resulted in hundreds, if not thousands, of settlements with national and international implications over the past two decades.  Cases have included those concerning trace levels of lead in ceramic tableware, water faucets, candy, mini-blinds, toys, and a wide array of other consumer products and foods.  However, in 2013, a trial concerning lead in 100% fruit juices, packaged fruits, and baby foods resulted in a highly significant Proposition 65 defense verdict based on a judge’s finding that the trace levels of lead exposure presented by each of these products was less that the State’s published “safe harbor” warning threshold for lead of 0.5 “micrograms/day.”  A California Court of Appeal decision published earlier this year sustained, among other things, the trial court’s finding that it was permissible for defendants’ experts to construct a daily average level of exposure based on real world data concerning the frequency of the consumption of the products at issue over a fourteen day time period.   Environmental Law Foundation v. Beech-Nut Corporation, et al., 325 Cal.App.4th 307 (2015). 

In anticipation of this type of appellate decision, earlier this year, one of the most historically active Proposition 65 plaintiff’s groups, the Mateel Environmental Justice Foundation, filed a lawsuit seeking a writ of mandate and declaratory relief challenging the 0.5 microgram/day “safe harbor” for lead.  Mateel contends that California’s published threshold for lead was not set consistently with Proposition 65’s 1,000-fold safety factor requirement for reproductive toxicants.  It therefore argues that this longstanding Proposition 65 safe harbor threshold should be declared illegal and inoperative despite it having been published more than 25 years ago and relied on for thousands of settlements and warning decisions.  Mateel further argues in its case that OEHHA should be ordered to promptly establish a dramatically more stringent safe harbor level for lead based on updated science concerning trace level exposures to lead.  It also seeks to have OEHHA ordered to adopt a rule precluding the averaging of exposure across multiple days in relation to the lead safe harbor level.  A second prominent citizen’s group, the Center for Environmental Health, which also focuses on Proposition 65 enforcement, submitted an administrative petition to OEHHA in early July seeking relief parallel to that sought by Mateel, regardless of the outcome of the lawsuit. 

OEHHA has just announced that, in response to this petition, it will soon initiate a rulemaking to update the existing Proposition 65 safe harbor for lead and several related Proposition 65 regulations.  The proposals include several major changes in the way the extent of exposure is calculated and how Proposition 65’s regulatory exemption for “naturally occurring” exemption for foods is determined.  OEHHA’s new proposals essentially seek to nullify the important Beech-Nut precedents and will likely make it even more difficult for businesses to defend Proposition 65 claims about lead and the nearly 300 other chemicals listed for reproductive effects, especially those that may be present as trace contaminants in food products.  OEHHA’s proposals include the following four elements:

A.      Revised Safe Harbor for Lead and Other Chemicals.  OEHHA proposes to repeal the current safe harbor level for lead (the Maximum Allowable Dose Level or MADL).  In its place, OEHHA proposes multiple levels that depend on the frequency of exposure, from exposure once per day to once every 116 or more days.  OEHHA asserts that the once-per-day figure should be reduced from 0.5 to 0.2 micrograms/day and that the existing 0.5 microgram/day level should instead apply only to exposures that occur no more than once every third day.  For exposures that would occur only once every 6 to 9 days, the lead safe harbor figure would rise to 1.0 microgram/day and to higher amounts as exposure intervals become more infrequent.  Plaintiffs’ groups contend that the lead safe harbor should be an order of magnitude lower at 0.03 micrograms per single day and do not want any alternative levels based on frequency of exposure over time.  Despite its proposal for lead, as to all other chemicals listed for reproductive effects OEHHA proposes to eliminate any consideration of the frequency of exposure when safe harbor levels are applied. 

B.      Naturally Occurring Allowances for Lead and Arsenic in Some Foods.  OEHHA also proposes to adopt specific naturally occurring allowances for lead and arsenic (but not other chemicals such as cadmium) in some specific types of food ingredients/products.  The allowances for arsenic are 60 ppb and 130 ppb for white and brown rice respectively.  For lead, they are 8.8 ppb for raw leafy vegetables and 6.2 ppb for raw non-leafy vegetables, fruit, meat, seafood, eggs, and fresh milk.  The agency bases its proposal on data regarding background levels of lead in soil in California as well as rates of uptake by relevant plants. 

C.      Averaging of Product Samples.  OEHHA further proposes to expressly prohibit averaging lead or other contaminant levels across different lots of a food product in the final form it will be purchased by a consumer.  It would instead require that the level of a contaminant in a lot of food be determined by “representative sampling” from within a particular lot.  OEHHA also would define a “lot” on a production basis, apparently by reference to date or production codes, which could significantly increase the amount of testing required.  Testing on this scale may be infeasible for most businesses.

D.      Average Rate of Exposure.  Finally, OEHHA proposes to dictate that, as to any Proposition 65-listed chemical (lead or otherwise), the “average rate of exposure” must always be calculated based on the arithmetic mean and not a geometric mean or some other measure of the central tendency of a data set.  OEHHA’s proposal flies directly in the face of the scientific testimony that prevailed in Beech-Nut and the prior position of the California Attorney General’s office on this issue.

OEHHA has scheduled public hearings to further discuss its new proposals on October 14 and 19, 2015.  It is also inviting written public comment on the lead safe harbor issue until October 28, 2015, and on the averaging issues until November 2, 2015.

Time to Clean Up Our Dirty Food System

Posted on December 19, 2014 by Peter Lehner

For decades, environmental lawyers focused on cleaning up the air and water. We made tremendous progress. Today, in most of the country, our air is safer to breathe and our waters more fit for drinking and recreation than at the dawn of the environmental movement. 

But while our air and water got cleaner, our food system got dirtier during that same time period. Vast numbers of chemicals started to be used in the production and processing of food, with little thought given to the long-term impacts on human health and the environment. 

Safeguards have failed to keep pace with the introduction of new chemicals, and the powerful industries behind these products put tremendous pressure on federal agencies to limit health protections, putting our health and our environment at risk. 

Here are three ways to start cleaning up our dirty food system:

1. Close the Giant Food Additive Loophole

Hundreds, if not a thousand or more, chemical food additives used in processed and packaged foods that make up the majority of the American diet are never publicly revealed, much less reviewed for safety by the FDA. A recent report from NRDC explored this loophole in food safety law, known as GRAS, or “generally recognized as safe,” which allows chemical manufacturers to decide for themselves if their product is safe. In many cases, the FDA isn’t even notified when chemical additives enter our food supply.

Some additives which manufacturers claimed to be “generally recognized as safe” have been linked to fetal leukemia, testicular degeneration, and other adverse effects in human cell or animal tests. NRDC found these additives listed as ingredients in at least 20 food products.

The FDA can and should move now to end the conflict of interest in this system; and when the agency does review a manufacturer’s safety claims, their concerns should be made available to the public. Ultimately, Congress needs to close the GRAS loophole and reform outdated food safety law. 

2. Stop Risky Herbicide Used on Corn and Soy

The EPA recently approved the herbicide Enlist Duo, which is toxic to many plants, but not to a new strain of genetically modified corn and soy. Enlist Duo is likely to become the replacement for the weed-killer popularly known as Roundup, which became one of the most widely used herbicides in the nation after Monsanto developed genetically modified corn engineered to resist it. According to Monsanto, Roundup and its family of glyphosate-based herbicides are registered for use in more than 130 countries.   

But after 20 years of heavy use, Roundup is no longer effective against certain weeds, which have evolved a resistance to it.  The industry’s solution is to escalate: develop a new strain of GMO crops that can withstand a new, more potent herbicide.  

Enlist Duo is a combination of glyphosate, the active ingredient in Roundup, and another herbicide, 2,4-D. The EPA signed off on Enlist Duo despite ample evidence of the harm caused by 2,4-D, and without taking into account the last two decades of research on glyphosate. 

In recent years, glyphosate has emerged as a major contributor to the alarming decline of monarch butterflies, as it has decimated milkweeds across the Midwest, the only plant on which a monarch will lay its eggs. (Milkweeds have not evolved any resistance to glyphosate.) Emerging evidence suggests glyphosate may pose a threat to human health, with possible links to kidney disease, pre-term deliveries, attention deficit hyperactivity disorder, birth defects, and miscarriages. 

2,4-D has been associated with decreased fertility, higher rates of birth defects, and other signs of endocrine disruption. It’s been found in drinking water and can drift in the air over great distances, increasing the likelihood of human exposure far from the fields where it’s sprayed. 

The approval of Enlist Duo will expand both the geographic area and the length of the season during which 2,4-D would be used, potentially increasing the risk of exposure to 20 million children and women of childbearing age here in the U. S.

NRDC is suing the EPA for its approval of Enlist Duo.  

3. Stop Antibiotic Abuse in Livestock Industry

Eighty percent of the antibiotics sold in this country are for use in livestock and poultry, not for humans. And these antibiotics are largely used on animals that aren’t sick. 

To keep antibiotics effective, we need to change the way we raise animals for their meat. NRDC has been spearheading a campaign to raise awareness of antibiotic abuse in the livestock industry and pressing the FDA to take action. Recently, a number of major food companies have announced that they have or will transition away from antibiotics, including Perdue Farms, Chik-Fil-A, Panera Bread, Chipotle and others. 

These moves are encouraging and welcome but still voluntary, and not yet backed up by any increased transparency into antibiotic practices. And Foster Farms, the biggest chicken producer in the West, whose product was linked to a widespread Salmonella outbreak in 2013 and 2014, has yet to announce any changes in its antibiotics practices. 

Meanwhile, the latest FDA statistics show that antibiotic sales to the livestock industry continue to rise. Real change will come when we have truly effective safeguards—not the voluntary measures offered by the FDA, and not the similarly weak proposal recently (and commendably) vetoed by Governor Jerry Brown of California. 

Governor Brown has called stakeholders back to the table to find a more effective way for the industry to change its risky practices. It’s possible that California could lead the way forward on antibiotic stewardship. 

New FDA Fish Consumption Advisories: Is the Proof in the Eating?

Posted on July 17, 2014 by Gregory Bibler

            On June 10, FDA issued draft updated advice on fish consumption. 

            The announced purpose of the new advice is to redress a health problem largely attributable to the old advice:  “For years many women have limited or avoided eating fish during pregnancy or feeding fish to their young children,” FDA stated.  Prominently featured in the old advice, which is still in effect, were warnings that methyl mercury may harm an unborn baby or young child’s developing nervous system, and that nearly all fish and shellfish contain traces of methyl mercury.  Women, and their doctors, became so concerned about the potential for trace amounts of methyl mercury in fish to cause harm that they avoided fish entirely.

            Acting on the misperception that all fish and all risk should be avoided caused more harm than good.  “[P]rimary research studies with pregnant women have consistently found that the nutritional value of fish is important during growth and development before birth,” FDA now says, “even though nearly all fish contain at least traces of mercury.”  Rather than trumpeting the dangers of methyl mercury in fish and shellfish, therefore, the new advice affirmatively promotes fish consumption (including shellfish).

            There is no indication in the advice that the data on methyl mercury have changed.  Both the old and new advisory, in fact, target the same four “bad” fish to be avoided:  shark, tilefish, swordfish, and king mackerel.  What has changed is a realization that, absent appropriately worded warnings, the public inevitably will conclude that there is no level of acceptable risk.

            The essential premise of FDA’s new advice, in short, is that it is not possible to eliminate all risk without unacceptable cost.  Implicit in FDA’s justification, in fact, is the realization that warning the public that trace levels of chemicals may cause harm, without making clear either the relative magnitude of the risk or the countervailing benefits that may be sacrificed in eliminating such risk, may itself cause harm.  This is not a new lesson.  Unfortunately, it is an historical lesson that we appear doomed to repeat.

Arsenic and Apple Juice: Are We Now Safe?

Posted on July 30, 2013 by Michael Rodburg

Earlier this month the FDA proposed an “action level” of 10 ppb for inorganic arsenic in apple juice (down from 23 ppb), bringing it to the same level as EPA’s drinking water MCL. One may view this action as the culmination of a campaign of sorts initiated by a 2011 Consumer Reports article whose cause was taken up by Dr. Oz. Yet, the FDA has been monitoring arsenic levels for many years and has never viewed the data as any cause for concern.  Should we now believe that the FDA has made us completely safe by adopting a drinking water standard for juice?  In a practical sense, yes, but in EPA-Superfund speak, not really; and that is the point of this post.

The poisonous propensities of arsenic have been the stuff of history and literature for centuries; the Poison of Kings and the King of Poisons. Remember elderberry wine from Arsenic and Old Lace? But, arsenic is, after all, not only naturally occurring but rather ubiquitous.  The human race has managed to live with some level of arsenic for a few millennia now without evident consequence.  Indeed, because of naturally occurring arsenic in groundwater in the western United States, the MCL is actually set “considering cost, benefits and the ability of public water systems to detect and remove contaminants using suitable treatment technologies.” If, in contrast, one turns to the gold-standard of “safe,” the one in a million excess cancer risk level, the drinking water standard required is .02 ppb;  that’s right folks, 500 times lower than the current MCL and FDA’s proposed new juice level.


What does it mean?  I think it points out that the ultra-conservatism of the “10 to the minus six” environmental risk standard leads to absurd results and hugely unnecessary costs.  I still recall with a smile a quite notorious Superfund site (which shall remain nameless to protect a client) that had literally dozens and dozens of polysyllabic chemicals at high levels in soils, groundwater and waste disposal units throughout several hundred acres.  In the baseline risk assessment, the only risk to exceed the 10-6 level was that from naturally occurring arsenic in the soil!

The more we know about the genetic basis and causes of cancer, the more we realize how poorly both our animal models and in vitro experiments perform in predicting cancerous effects.  (See E. Topol, The Creative Destruction of Medicine (Basic Books 2011) for a good discussion of the limitations and frustrations of our current methods and models for finding cancer fighting drugs.)  While we are a long way from tossing EPA’s current approach to carcinogenic risk, we should perhaps take into account far more than we do now the inherent limits of our understanding and incorporate more the practical necessity for “cost, benefits and the ability” to “remove contaminants using suitable treatment technologies.” And yes, my grandchildren will continue to drink their apple juice.

Three Cheers for the FDA!!!

Posted on April 5, 2013 by Robert Falk

In the wake of salmonella, e-coli, and listeria outbreaks in the nation’s food supply, and driven by fears concerning contaminants like melanine and lead being imported in foods from developing countries like China, the U.S. Food and Drug Administration’s (“FDA’s”) food safety assurance programs have fallen under much criticism in recent years.  In a rare instance of bipartisan consensus in this day and age, in 2010, Congress overwhelmingly passed and, on January 4, 2011, President Obama signed, Public Law 111-353, the Food Safety Modernization Act (“FSMA”).  FSMA, in turn, required FDA to provide the first comprehensive update to its food safety programs in decades. 

On January 16, 2013, almost a year behind the schedule set by Congress, FDA published two significant draft rules and accompanying preambles to implement FSMA’s upgraded food safety system requirements (78 Fed. Reg. 3504 ; 78 Fed. Reg. 3646).  In these two significant rulemakings, FDA essentially proposes to:  (1) add to an updated set of its longstanding “good manufacturing practices (“GMP”) requirements (found in 21 C.F.R. Part 110), a mandate that all food processors implement hazard analysis and critical point of control (“HACCP”) programs, and (2) to require growers of food commodities that will not be subject to extensive processing to implement programs of good agricultural practices (“GAPs”).

Kudos to the FDA for proposing such a sensible approach to addressing Congress’s goal of ensuring enhanced food safety in America.  Rather than making requirements more prescriptive, FDA instead has essentially proposed to require food processors not already subject to HACCP requirements to conduct these disciplined analysis of food safety hazards “reasonably likely to occur” and then have the results of that risk-based analysis drive the processors to further identify, implement, and track the additional compliance measures necessary to address the potentially significant hazard presented.  In the GAP context, FDA has taken the additional step of itself analyzing the food safety hazards that are “reasonably likely to occur” in fresh produce and concluded (subject to public comment) that microbiological risks are the hazards at the farm level warranting the imposition of GAP requirements under the law for the first time (rather than merely as recommendations as has been the case until now).

Politicians, regulators, and environmental lawyers and activists too often dismiss or merely give lip service to risk-based analysis and regulation, but, at least here, FDA proposes to meaningfully embrace and apply the approach so as to allow food safety management and control resources to be best allocated to protecting the public’s health and safety.  Hat’s off to the FDA!!!

French Government Requires Annual Reporting of Nanoparticles

Posted on March 12, 2013 by Leslie Carothers

Over a year ago, I commented on the continuing discovery of new commercial uses for nanomaterials—particles at the scale of one billionth of a meter—and the continuing delay in developing better means of governmental oversight to manage any health and environmental risks.  Since then, several new steps in regulatory oversight have been taken, most notably in Europe. 

Here in the United States, EPA has employed the significant new use rule or SNUR under Section 5 of the Toxic Substances Control Act with respect to a number of nanomaterials undergoing premanufacture (PMN) review, its most recent pronouncement being the proposed application of SNURs to 14 carbon nanotube materials as published in the February 25, 2013 Federal Register.  78 Fed. Reg. 12684-12701.  Such SNURs can impose restrictions and conditions on the production, import, and use of a pmn chemical containing nanomaterials.  These requirements generally address worker protection and may also limit production unless releases to water are prevented or further testing of health or environmental impacts is performed.  See, e.g. the December 28, 2011 proposed rule establishing SNURs for seven nanomaterials.  76 Fed.Reg. 81447-81462.     

European regulators have traditionally been less reluctant to request chemical information or regulate chemical constituents than their U.S. counterparts.  The European Union’s REACH law governing chemicals, both new and in use, illustrates the EU’s willingness to impose significant information reporting.  The EU is also more inclined to require broader disclosure of information to the public in the form of product labeling, and the European Commission has set labeling requirements for the use of nanomaterials in food.  The new rule, effective in 2014, adds a definition for “engineered nanomaterials” at Article 2(t), and Article 18.3 requires that all ingredients in the form of engineered nanomaterials be clearly indicated with the word “nano” in brackets after the ingredient name.  Paragraph 25 of the rule’s preamble also notes the possibility that nanomaterial content will result in a “novel food” under the current rule generally known for its coverage of genetically modified organisms.  (Revision of the novel food rule has been delayed by an interesting dispute over whether food from the offspring of cloned animals should be categorized as “novel.”  Further delay is likely while EU regulators grapple with exotic equine ingredients.)

France has taken another step in the regulation of nanomaterials by adopting the first mandatory reporting scheme beginning in January 2013, with the initial annual report due May 1.  The French decree (Decree No. 2012-232) requires manufacturers, importers, distributors, and research and development laboratories using quantities of 100 grams or more to submit an annual declaration identifying the quantity and use of substances with “nanoparticle status” under the EC’s definition set forth in the REACH (Registration, Evaluation, Authorization and Restriction of Chemical Substances) regulations.  Companies exporting to France presumably will have to provide the information so that importers can comply with the new requirement.

Implementation of the French reporting program may well provide valuable information to U.S. regulators on whether and how a reporting rule can strengthen governmental oversight without unduly burdening commercial introduction of new and potentially beneficial materials.

TSCA Reform: The Battle Continues

Posted on February 7, 2013 by Lynn L. Bergeson

For Toxic Substances Control Act (TSCA) aficionados, a new federal legislative session holds the promise of long overdue legislative reform.  Among the oldest environmental laws, it is also the most neglected.  While hope springs eternal, the odds are against reform any time soon.  A deeply divided Congress makes any environmental measure contentious.  Pile on other Congressional priorities, including immigration reform, gun safety, and climate change, and we have the makings of more Congressional inaction and gridlock.

It is against this backdrop that we await introduction of Senator David Vitter’s (R-LA) TSCA reform bill, expected this month.  As the new ranking Republican on the Senate Environment and Public Works Committee, Senator Vitter’s much-awaited bill marks the first Republican alternative to Senator Frank Lautenberg’s (D-NJ) long-standing TSCA reform measure, the Safe Chemicals Act.

Among many contentious issues is the TSCA safety standard.  Senator Lautenberg’s bill contains a “reasonable certainty of no harm” standard to replace the current “unreasonable risk” standard.  This language is found in the 1996 Food Quality Protection Act and defines the applicable standard for pesticide exposures in food.  A key area of controversy is whether such a standard for food safety is appropriate for chemical exposures, or otherwise represents a “zero risk” standard that likely would inspire epic regulatory costs for questionable improvements in true risk reduction.  In the void left by Congressional inaction, state measures are gaining ground.  The California Safer Consumer Products Regulations are expected to be issued in final form sometime this year.  This game-changing approach to assessing the safety of chemicals in consumer products by requiring chemical “alternative” assessments may well become the default safety standard in the absence of federal legislation.

2013 will be a watershed year for domestic chemical management initiatives.  Even if federal inaction continues, a California initiative, like so many others in the past, may prevail and take domestic chemical product safety to places and levels Congress declines to go.

FDA Still Dragging Its Feet on Antibiotics in Animal Feed

Posted on November 13, 2012 by Peter Lehner

Eighty percent of all the antibiotics sold in the United States are given to farm animals – not humans. Most of these animals aren't even sick. It's standard practice on factory farms, as a substitute for better management practices, to routinely dose healthy pigs, cows, and chickens with antibiotics that are vital for treating human disease.  As a result of this non-therapeutic antibiotic use, these farms have become breeding grounds for superbugs--dangerous germs that can't be knocked out with the usual medicines. And that puts human health at risk.

The Natural Resources Defense Council, where I serve as Executive Director, has been at the forefront of this issue.  In response to an NRDC initiated lawsuit, twice this year a federal court ordered the FDA to take action. In March, the court required the FDA to withdraw approval for the use of penicillin and tetracyclines in animal feed, unless drug manufacturers can prove this practice is not a public health risk. In June, the court directed the FDA to reconsider its denial of two citizen petitions on antibiotic use in livestock, saying “The adoption of voluntary measures does not excuse the Agency from its duty to review the Citizen Petitions on their merits.”

Superbugs can travel off farms and contaminate the surrounding air and water, as well as our food supply, which puts people at risk of acquiring serious and even life-threatening infections. In 2010, almost 52 percent of retail chicken breasts tested by the FDA were contaminated with antibiotic-resistant E. coli. Drug-resistant bacteria have been detected in air and drinking water near industrial hog farms in three states. Drug-resistant infections caused by antibiotic-resistant bacteria, including those generated by factory farms, have been estimated to cost Americans up to $35 billion every year.

The FDA has known for more than 30 years that antibiotic abuse on factory farms poses a risk to human health. In its March decision, the court determined that the FDA formally found back in 1977 that penicillin and tetracyclines had not been shown to be safe. In its June decision, concerning other antibiotics, the court pointed out that “the Agency has all but made a finding that the subtherapeutic use of antibiotics in food-producing animals has not been shown to be safe.” Nonetheless, the use of penicillin, tetracyclines, and other medically important antibiotics in livestock quadrupled between 1970 and 2009. The agency has not stopped the practice of routinely feeding antibiotics to healthy livestock, relying instead on "voluntary guidance" to address the issue.

The FDA has appealed the March and June  decisions and remains focused on the failed strategy of allowing industry to use antibiotics as it chooses instead of standing up to protect public health. NRDC is fighting FDA’s appeals. Under an FOIA request, the FDA will begin releasing public health risk assessment documents on antibiotics to us. NRDC is also working with leading scientific organizations to keep public pressure on the FDA. Health groups from the CDC to the American Medical Association have spoken out against antibiotic abuse on industrial farms. Hundreds of thousands of citizens, including chefs, medical professionals, and progressive food companies, have called on the FDA to do its job and protect the health of our families.

It's time for the FDA to follow the law and do its job. The agency needs to curb antibiotic abuse on factory farms and protect antibiotics for those who need them most--sick people.

Federalism can be Messy -- BPA and Product Regulation in the States

Posted on September 27, 2012 by Kenneth Gray

Depending on how you count, advocates have led over 25 state legislatures or regulators to consider or adopt bans on certain uses of Bisphenol A (BPA), the recently publicized monomer that is (or was) present as a residual at low levels in some plastic products.  Recently, the U.S. Food and Drug Administration (FDA) accepted a petition from the American Chemistry Council banning use of BPA in baby bottles and sippy cups, because the use had been abandoned by manufacturers. 

For many, FDA’s scientific review of BPA studies and thoughtful analysis on the merits of regulation was too slow, and to those who conclude “I don’t want exposure to any substances of concern” use-by-use regulation did not (and will never) provide comfort.  What started as a concern in baby bottles and sippy cups, and was the subject of numerous state bans several years ago -- before the FDA acted this summer to acknowledge the abandonment of BPA in those bottle and sippy cups -- is more recently the subject of additional state proposals for bans from lids of food cans and containers.  Some ask: “Can you please ban it from any product that may reach my children?”

Because it is difficult to get the federal machine to act quickly, why not seek an audience in your state capital?  It is easier to file legislation in many states than in Congress, easier to get exercised citizens to the state capital, easier to involve local media looking for a controversy, and cheaper for citizens to play at the state level than in Washington.  However, state toxicologists and regulators often don’t have the resources of the FDA, they are often not as well equipped (and certainly not as experienced) in making the necessary risk evaluations and product regulations.  And putting environmental police in the grocery aisles seems to squander limited state environmental resources.  As Maine DEP Commissioner Patricia Aho recently put it: “We’re environmental regulators.  You’re asking us to be the FDA in some regards here.”

Even assuming states are equipped to address those issues, how can national manufacturers (or national or regional retailers) deal with state-by-state regulation of different products using the same materials?  Not very well!  And how are consumers to understand why chemicals in a product present acceptable risks in one state, but unacceptable risks in another?  They don’t.  Why is state-by-state regulation of chemicals in products in the national interest when FDA has jurisdiction?  Maybe it isn’t. 

Congressman Markey has petitioned the FDA for a federal ban on coatings in infant formula packages (arguing abandonment), and the federal agency has sought comment.  But that petition was made after extensive state efforts against use in baby bottles and sippy cups.  The FDA will consider the matter, so it may be some time before the FDA acts.  In the interim, states are still being encouraged to adopt their own bans on certain uses of BPA.

FDA is even more broadly considering BPA safety and its uses under FDA jurisdiction, but in the meantime, keep your eye on your local legislature if you want to watch a messy process that is frustrating for everyone.

MANDATORY LABELING OF FOODS PRODUCED USING GENETIC ENGINEERING IS ON THE HORIZON

Posted on May 29, 2012 by Robert Uram

Labeling of food produced using genetic engineering is on the horizon either as a result of a petition that is pending before the Food and Drug Administration or as a result of a ballot initiative in California.  Labeling of genetically engineered food appears to have widespread popular support.

The presence of foods produced with the assistance of genetically modified organisms, or GMOs, is widespread in the United States, especially for crops like corn and soybeans.  The most common genetic modification to date is an introduced trait to make a plant resistant to a specific herbicide, allowing farmers to use the herbicide without killing the crop.  Today, most of the crops produced using GMOs can used without having to comply with any significant regulatory requirements. 

Concern over use of genetically modified organisms covers a broad range of issues, including increased use of pesticides, the presence of genetically engineered foods in products that are not intended to be produced with such methodologies, and health concerns that may arise from consuming genetically engineered foods.  One way to address those concerns is to ensure that consumers know which products are produced using genetic modification so that those with concerns can avoid them.  However, unlike many other developed countries, the United States has no laws requiring labeling of food produced with genetically modified organisms.

Recently, more than one million individuals, more than 500 partner organizations representing the healthcare community, consumer advocates, farmers, concerned parents, environmentalists, food and farming organizations, businesses, and 55 members of Congress joined in support of a petition to the Food and Drug Administration for mandatory labeling of genetically engineered foods.  The petition, among other things, calls for the FDA to issue regulations requiring labeling of all foods produced using genetic engineering.

In addition to the FDA petition, an initiative has been filed in California seeking to require the labeling of genetically modified foods in California. On May 2, 2012, more than 970,000 signatures were filed supporting a referendum to impose a California right-to-know requirement for GMOs.  The California law is known as the California Right-To-Know Genetically Engineered Food Act.  If adopted by the voters this November, commencing on July 1, 2014, retail sale of food offered in California would be banned if it is or may have been entirely or partially produced with genetic engineering, unless the production method is disclosed in clear and conspicuous words.  The labeling requirements would not apply to foods which inadvertently contain genetically engineered food products and has other limited exceptions.

These labeling requirements, if adopted, will give consumers a greater opportunity to decide whether or a not to purchase genetically engineered food and may have a far reaching effect on the markets for genetically engineered food.