The Ongoing Legacy of Rachel Carson’s Silent Spring

Posted on October 3, 2012 by Drew Ernst

2012 marks the 50th anniversary of Silent Spring, one of the first books to point out the environmental dangers associated with pursuing technological and scientific advances without fully understanding their possible negative side effects. Silent Spring was a revolutionary environmental exposé published in 1962 by an unassuming author, Rachel Carson.  Her book inspired a powerful social movement that continues to impact environmental law and American society today.

A scientist and ecologist, Carson was a former editor of U.S. Fish and Wildlife Service publications and a feature writer for the Baltimore Sun who eventually dedicated herself to writing books that taught people about the fragile beauty of Earth’s ecosystem. Silent Spring was written in the wake of post-war lethargy, new affluence and during a time when Americans were confident science had all the answers.  Disturbed by the proliferate use of synthetic chemical pesticides after WWII, Carson challenged this practice and sounded a loud warning about the use of chemical pesticides, a reminder of the responsibility of science and the limits of technological progress.

Critics called Carson an alarmist, and Silent Spring was met with intense rebuttals from the scientific establishment and some major industries.  Regardless, Carson was steadfast in her resolve to show the need for new environmental policies and regulations necessary to protect human health and the environment.

Silent Spring is proof of the power of public opinion, and despite scientific skeptics, the book sparked a major environmental revolution.  Carson’s exhaustive environmental calculations in Silent Spring brought to light the fact that people were subjecting themselves to slow poisoning by the misuse of chemical pesticides and toxic pollutants that take more than 15 years to break down. In addition, she exposed the fact that these chemicals could cause irreparable liver and nervous system damage, cancer and reproductive issues. 

Carson’s testimony before Congress in 1963 later served as the catalyst for the ban on the domestic production of DDT and sparked a grassroots movement demanding better environmental protection and increased regulation, resulting in the formation of the U.S. Environmental Protection Agency (EPA).

Sadly Carson was not able to enjoy the fruits of her labor. She died after a long battle with breast cancer in 1964, just 18 months after her testimony before Congress.  However, many celebrate the impact of her work on April 22 each year on Earth Day.

So after 50 years, how much has changed?  Today, there is federal regulation of  everything from coastal development to farming practices. Environmental protection includes policies concerning natural resources, human health, economic growth, energy, transportation, agriculture, industry and international trade and all parts of society.   Many would say there is over regulation today.  In many cases, I agree.  However as Rachel Carson showed us, there is a need for some regulation, if just to protect us from ourselves.

Water Quality Trends in the Northwest (Fish Consumption Rates)

Posted on July 9, 2012 by Kevin Beaton

The criterion to protect human health found in state water quality standards under the Clean Water Act are getting more stringent in the Northwest.  This is occurring because people in the Northwest supposedly eat more fish from Northwest waters than other parts of the country.  The esoteric standard setting process to protect people from toxic pollutants in surface waters is premised upon numerous risk based assumptions which include the amount of surface water an average person consumes combined with the amount of fish consumed from such waters.  The more water and fish people consume the more stringent the criteria becomes.  EPA establishes national defaults for states to use in their human health standard setting process for both water ingestion and fish consumption rates (“FCR”).  The national recommended FCR is 17.5 g/day.  A detailed description of the standard setting process can be found in EPA’s Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (2000).

Until recently, use of the EPA default FCR was acceptable in the Northwest.  However the state of Oregon recently adopted (and EPA approved in 2011) a FCR ten times higher than the national default.  The principal driver behind Oregon’s change was a FCR study funded by EPA in the 1990’s that evaluated the FCR of members of a number of Northwest Tribes in Oregon, Washington and Idaho.  See A Fish Consumption Survey of the Umatilla, Nez Perce, Yakima, and Warm Springs Tribes of the Columbia River Basin (CRITFC 1994). The CRITFC study showed that Tribal members consumed much higher rates of fish.

In May 2012, EPA disapproved Idaho’s human health criteria in Idaho’s water quality standards which were based on EPA’s national recommended default FCR.  EPA disapproved Idaho’s standard because the state did not “consider” the CRITFC study.  (Idaho believes it did consider the CRITFC study.)  EPA also questioned whether Idaho’s standards were protective of Oregon’s downstream standards.  Idaho now has 90 days to respond to EPA’s disapproval.  Meanwhile the state of Washington is in the process of reevaluating its human health standards and FCRs. Whether this trend moves into other states or other EPA regions remains to be seen.

One might legitimately ask whether this issue is nothing more than an academic exercise amongst toxicologists and risk assessors.  Ultimately the answer to that question is found in the Clean Water Act itself.  Roughly calculated, increasing the FCR ten times equates into the criteria for many toxic pollutants becoming ten times more stringent.  Under the Clean Water Act NPDES Permit limits must be established to meet these new criteria.  Under the new standards adopted by Oregon some of the toxic pollutants that are likely to present particularly challenging compliance issues for permittees will include mercury, PCBs and arsenic, as the presence of these pollutants are somewhat pervasive in Northwest waters.  In most instances, requiring permittees to implement costly pollution controls to attempt to achieve the new criteria at the end of the pipe will have minimal affect on achieving the new stringent standards in the receiving waters.  In light of EPA’s recent disapproval of Idaho’s standards, the state must now decide if it needs to amend its criteria or conduct its own fish survey statewide.  Untested legal issues are raised by EPA’s disapproval like whether a state must establish a state-wide FCR based on a very small percentage of the population or because a downstream state (Oregon) has decided to adopt more stringent criteria.  Like many increasingly complex issues under the Clean Water Act, these issues may have to be settled in federal court.

Finally! OSHA Revises Hazard Communication Standard

Posted on April 11, 2012 by Earl Phillips

OSHA recently announced its final rule final rule revising the Hazard Communication Standard (HCS). Originally promulgated in 1983, the HCS is based on workers' "right to know" about the hazards they face in the workplace. The intent of the revised HCS is to clarify the information provided to workers, based on an employee's "right to understand" workplace hazards. Click to view OSHA's press release, "US Department of Labor's OSHA revises Hazard Communication Standard: Regulation protects workers from dangerous chemicals, helps American businesses compete worldwide."

The revised HCS reflects the United Nations' Globally Harmonized System of Classification and Labeling of Chemicals (GHCS), which was negotiated by a variety of stakeholders around the world. Because American workers may use chemicals made abroad (and workers abroad may use US-produced chemicals), a consistent labeling standard around the world will enhance worker safety by making labels easier for everyone to understand.

The revised HCS makes three primary changes from the current standard:

Hazard Classification
Chemical producers and importers still bear the responsibility for classifying hazards presented by chemicals. The revised HCS provides detailed criteria for classifying the type and severity of hazard presented. The intent of the new information on hazard class and severity category is to efficiently provide guidance on the appropriate response to exposure.

Chemical Labels
The new rule requires a standardized label design that includes the use of pictograms, shown on the Hazard Communication Standard Pictogram Quick Card, which depict the type of hazard presented. Labels are also required to include a "signal word" ("danger" for more severe hazards and "warning" for less severe hazards) and a precautionary statement suggesting safety measures. A sample Hazard Communication Standard Label is available on the OSHA website. 

Safety Data Sheets
OSHA will now require a standardized 16-section format for Safety Data Sheets (SDSs), formerly known as Material Safety Data Sheets or MSDSs. This is expected to enhance ease of use, especially in an emergency, by ensuring that key information (for example, spill response procedures) can be quickly found within the document. The new SDS format is shown on the OSHA website. 

EFFECTIVE DATE
Chemical producers and importers are required to implement the revised label and SDS formats in 2015. As the GHSC labels are phased in around the world, American workers may start to receive labels and SDSs in the new format before the labeling rule goes into effect in the US. Therefore, to ensure that employees understand the new labels, OSHA requires US employers to train employees on the new label elements and SDS format by December 1, 2013.

REFORMING EPA’S HUMAN HEALTH RISK ASSESSMENTS

Posted on March 14, 2012 by Angus Macbeth

Risk assessments carried out under EPA’s IRIS program have been the subject of critical notice in recent months. The human health risk assessments which EPA performs across a range of programs merit attention, given their broad impacts in practical contexts; for instance, they form the basis for Superfund cleanups and RCRA corrective actions. But because they constitute guidance, they are not subject to judicial review at the time they are published and have not received much scrutiny by lawyers. Here are four aspects of how EPA typically conducts human health risk assessments that deserve attention and reform:

1. Publication Bias. In conducting a human health risk assessment, EPA starts by conducting a literature search  and assembling the scientific papers that report a chemical’s effects or lack of effects on humans and relevant animal species. This appears to be a fair way to review the scientific understanding of the chemical’s possible effects on humans and animals, but it fails to take account of publication bias. This well known phenomenon favors publication of studies finding “positive” results – an association between the chemical and a biological effect – over those that do not. In risk assessments, the determination of a dose below which there is no observable effect is very important. Reviewing the published literature can be highly misleading on that central issue. See, e.g., Sena et al., “Publication Bias in Reports of Animal Stroke Studies Leads to Major Overstatement of Efficacy,”  PLos Biol 8(3) e1000344 (2010) (“published results of interventions in animal models of stroke overstate their efficacy by around one third.”). EPA needs to capture the results of research showing, at given doses, that a chemical has no effect on human or animal biological systems. A start in that direction would be to require researchers who receive government support to report such results.

2. Multiple Comparisons. A researcher on, say, the neurodevelopmental effect of a chemical on children or rats can have the treated subjects perform 20 different tests; at a 95% confidence level, the researcher finds one association which is written up and published without reporting on other tests that did not show an association. Having made 20 comparisons at the 95% confidence level, at least one association is likely to be spurious – the result of random chance. But if one does not know how many tests or comparisons were made, there is no basis for making a fair judgment as to the strength or value to give to the reported positive result. There is no requirement in law or custom that directs researchers to report the number of comparisons they made, and publication bias discourages the ambitious academic from reporting a large number of comparisons which would result in sober analysts putting lesser weight on the positive results reported. EPA needs to know how many comparisons a researcher made and what the results were. This could be achieved in large measure by requiring that government-supported researchers report such data; in addition, EPA could simply ask the researchers to provide this information before it relied on the published results in a weight-of-the-evidence review.

3. Meta analysis. In a weight of the evidence review, replication of results has great weight in persuading the reviewer that the results are sound; conversely, failure to replicate results detracts markedly from the weight that a study will be given. Being able to tell whether results are replicated or not replicated depends on having common metrics used in the studies; e.g., administering the same dose under the same conditions at the same age. This is very rarely done, thereby erecting barriers to accurate determination of the weight that should be given to experimental results. See, e.g., Goodman et al, “Using Systematic Reviews and Meta-Analyses to Support Regulatory Decision Making for Neurotoxicants: Lessons Learned from a Case Study of PCBs,” 118 Env. Health Perspectives 728 (2010). Again the federal agencies that support research financially should require that experiments be conducted and reported with sufficient common metrics to allow effective meta-analysis. Of course, this would not preclude measuring and reporting whatever else the authors chose.

4. Review of data relied on in critical studies. EPA typically relies on one or a few “critical studies” in performing its analysis and reaching conclusions as to the risks to human health that are presented by a chemical. EPA reviews the printed reports found in the peer reviewed journals carefully, but it very rarely asks to see the underlying data. To a lawyer, this seems perverse – a bias against examining the actual data that is said to support the Agency’s conclusion. With no falsification, there are a number of ways to present data that will affect such data’s ultimate implications. Statistical treatment is the most obvious example. Human health risk assessments are of major importance to the public health and frequently result in many millions of dollars of expenditure by companies guarding against the risks that EPA identifies. It is clearly important to make these judgments as accurate as possible. In these circumstances, at least for the critical studies, the Agency should routinely ask that the data underlying the printed article should be produced; it should then examine the data and the reported results should only be relied on where they are fully supported by the data.

Dealing with these four issues should contribute significantly to producing human health risk assessments that would command the respect of the knowledgeable public.