Report Exposes the Flaws in EPA’s Pesticide Approval Process

Washington, DC–(ENEWSPF)–March 28, 2013.  A scathing new report by the Natural Resources Defense Council (NRDC) sheds much needed light on the flaws in the Environmental Protection Agency’s (EPA) pesticide approval process, noting that in terms of the agency’s ability to offer transparency and rigorously test these inherently toxic chemicals, “the public’s trust is misplaced.” The recent lawsuit brought about by a coalition of beekeepers, consumer, and environmental groups, including Beyond Pesticides, emphasizes the harm resulting from EPA’s abuse of the statutory “conditional registration” program. Through this program, EPA has allowed the wide and growing use of the systemic neonicotinoid pesticides that are  linked to the dramatic decline in honey bee health and viability of honey bee colonies.

A startling number of pesticides, nearly 65% of the more than 16,000 pesticides now on the market, were first approved by the process of “conditional registration,” a loophole in which EPA allows new pesticides on the market without the full range of legally mandated toxicity tests. NRDC accuses EPA of misusing the conditional registration process, and their assertions are by no means unfounded. The report cites EPA’s own 2004-2010 internal analysis that ultimately determined the agency had misused the provision “98 percent of the time.”

Environmental_Protection_Agency_logoBeyond the agency’s scurrilous use of the conditional registration provision, NRDC makes the important point that, “EPA’s database is seriously disorganized.” The agency has no tracking system in place to keep a record of the data it has requested as part of the conditional registration process. EPA doesn’t follow up on receiving that data, and when the agency does receive the data there is no notice to the public providing an interpretation of the new information. In fact, EPA provides no public comment period before the agency decides whether to fully register a conditional pesticide.

NRDC explains, “The lack of both tracking and public engagement makes it impossible to know: 1) if the requested studies were submitted in a timely manner; 2) whether the submitted studies were reliably conducted; 3) if the EPA’s conclusions concerning safety were well-founded; and 4) if the EPA should have altered its regulatory decision for any of those pesticides.”

Two conditionally registered pesticides of significant concern to Beyond Pesticides were emphasized by NRDC’s report: nanosilver and clothianidin.(a neonicotinoid pesticide).

Nanosilver, silver nanoparticles, consists of many silver atoms or ions clustered together to form a particle 1-100nm in size. Due to their small size, these nanoparticles are able to invade bacteria and other microorganisms and kill them. Silver nanoparticles (or nanosilver) are now widely impregnated into a wide range of consumer products, including textiles such as socks, sportswear, underwear and bedding, vacuums, washing machines, toys, sunscreens, and a host of others. However, the long-term impacts of this new technology to human health and the environment are still unknown. There are concerns about the material’s ability to travel through the human body and damage brain, liver, stomach, testes and other organs, as well as pass from mother to fetus, notes NRDC. Beyond Pesticides has recently documented the ability of silver nanoparticles to disrupt ecosystems, and harm earthworms by suppressing their immune system.

Beyond Pesticides also covered NRDC’s current lawsuit against EPA’s conditional registration of the antimicrobial pesticide HeiQ AGS-20, produced by the Swiss Company HeiQ Materials Ag and applied to a diverse range of textiles, including clothes, blankets, and pillowcases in efforts to suppress odor and bacterial growth. This material never went through the full range of required tests, even though EPA affirmed that nanosilver is different than silver, and cannot apply under the registration of conventional silver antimicrobials. Despite knowing that people would be in direct contact with this untested material, EPA allowed its conditional registration under the guise that its use would be in the public benefit. The agency explained that it would reduce the overall burden of conventional silver in the environment due to its smaller size. Evidently this was not a well thought out claim, as NRDC notes, “…nanosilver is not only replacing conventional silver uses, but also being sold for new and expanded markets, resulting in the release of far more nanosilver and toxic silver ions into sewage and water treatment systems, and ultimately into rivers, streams, and other receiving waters.”

And what if the necessary tests show that nanosilver is more harmful than conventional silver? Manufactures are not required to disclose whether nanomaterials are in their products. Without a defined labeling system that enables consumers to make an informed choice on purchasing products containing these untested materials, large numbers of people may fall victim to EPA’s failed regulatory system.

Large numbers of honey bees already have. In fact, 2013 may be the year that Colony Collapse Disorder (CCD) impacts our food supply, as many commercial beekeepers are reporting that they will not have the colonies necessary to pollinate California’s almond trees. In 2003, EPA granted conditional registration to clothianidin without a field study that is considered core and essential to the issuance of the continued registration.

beeEPA stated in 2003, “The possibility of toxic chronic exposure to nontarget pollinators through the translocation of clothianidin residues in nectar and pollen has prompted EFED to require field testing (141-5) that can help in evaluating this uncertainty. In order to fully evaluate the possibility of this long term toxic effect, a complete worker bee life cycle study must be conducted . . .”

The registrant, Bayer, conducted these studies and submitted them to EPA in 2007. At first the agency accepted the corporation’s study, which concluded that their chemical had no effect on bees, but upon further review in 2010 changed its position and indicated that the study was deficient, and could only be used as supplemental data. To illustrate, Bayer’s study was so lacking that EPA could not even conduct a statistical analysis of the results, as the company failed to provide the agency with the necessary raw data. EPA indicated that another field study would be required in order to fully register the chemical – this after the pesticide had been in use for 7 years.

But in 2010 EPA gave clothianidin fully registered status. Bayer’s study was deficient and only supplementary, an adequate study had not yet been provided, but clothianidin received full registration. There is no indication to this date that the necessary study has been provided; however, independent scientific studies showing the harmful effects of clothianidin on honey bee colonies show clearly that this chemical is a cause of major bee kills and significant contributor to the devastating, ongoing mortality of bees known as CCD.

NRDC recommends that EPA corrects its flawed practice of conditional registration. The study proposes: “1) Review all previously conditionally registered pesticides and bring them into compliance with the law and with the recommendations of this report; 2) Immediately cancel pesticide registrations with overdue studies or those that are out of compliance for any other reason; 3) Properly document conditional registration actions; 3) Properly document conditional registration actions; 4) Establish a process where the public can comment on new data received to support a conditional registration; 5) Place all submitted data into a publicly accessible, updated database; 6) Use the conditional registration process only in the limited and rare circumstances described by Congress.” (Read the details of the recommendations here.)

Beyond Pesticides endorses the above recommendations, but advocates an approach that relies less on risk assessments in the registration of pesticides. Risk assessments determine “acceptable harm” that considers as ”acceptable” uses that result in the death of  1 in 1 million people. Additionally, EPA’s risk assessment fails to look at chemical mixtures, synergistic effects, certain health endpoints (such as endocrine disruption), disproportionate effects to vulnerable population groups, and regular noncompliance with product label directions. These deficiencies contribute to its severe limitations in defining real world poisoning.

An enlightened policy approach to proposed or continued toxic chemical use, in an age where the adverse effects have been widely and increasingly documented, is to first ask whether there is a less toxic way of achieving the toxic chemical’s intended purpose. Simply, “Is there another practice that would make the substance unnecessary?” This approach does not preclude and should demand the prohibition of high hazard chemical use, those chemicals that are simply too dangerous.

The alternatives assessment approach differs most dramatically from a risk assessment-based policy in rejecting uses and exposures deemed acceptable under risk assessment calculations, but unnecessary because of the availability of safer alternatives. For example, in agriculture, where data shows clear links to pesticide use and cancer, it would no longer be possible to use hazardous pesticides, as it is with risk assessment-based policy, when there are clearly effective organic systems with competitive yields that, in fact, outperform chemical-intensive agriculture in drought years. Cost comparisons must take into account externalities such as water pollution and water utility expenses, associated with chemical-intensive farming. The same is true for home and garden pesticide use and defined integrated pest management systems with prescribed practices and only specific substances as a last resort.

An improved process for conditionally registering pesticides is not enough. Regulatory restrictions must be tied to an alternatives assessment that moves chemicals off the market or prohibits their marketing as safer approaches and technologies emerge.

All unattributed positions and opinions in this piece are those of Beyond Pesticides.

Sources: NRDC, http://www.beyondpesticides.org