More on this event Regulation of Crop Protection Chemicals in the US was held on April 8th-9th in Washington, DC, US. More details are available at: www.informa-ls.com/usacrop. There will be further coverage in future issues of Agrow. > Not a subscriber? Subscribe > Get a free trial

The assessment of pesticide risks to endangered species presents a "challenge to the workload" of the US EPA and there is "still a lot to do" for the Agency to meet its obligations under the Endangered Species Act (ESA).  These remarks were made by the assistant administrator of the EPA's Office of Prevention, Pesticides and Toxic Substances, Jim Gulliford, at the inaugural CropLife America/Informa conference on US crop protection chemical regulation in Washington, DC, this month.

Mr Gulliford's wrap-up of the first day of the meeting echoed the views of several earlier speakers from government and industry about achieving ESA compliance. In opening the conference, EPA Office of Pesticide Programs (OPP) director Debbie Edwards described endangered species assessments as the OPP's "biggest challenge".  She reiterated the OPP's commitment to conduct these assessments through the registration review programme that got underway last year.  The OPP is committed to assessing 70 active ingredients a year through that programme, which represents "a huge challenge", Ms Edwards said.  She emphasised the need for a "transparent process" and for trust between the EPA and the wildlife services to achieve a common goal.

Industry representatives expressed concern that individual lawsuit-driven endangered species assessments could impact on the EPA's ability to focus on national determinations through an orderly process.  Prior to the April 8th conference, the EPA was dealing with six lawsuits involving 193 ais and 41 endangered species. Another lawsuit was filed on the eve of the meeting (see this issue, p xx).  Carrying out endangered species assessments to court-imposed deadlines consumes significant EPA resources and is a distraction from making national determinations, asserted Bayer CropScience's senior principle scientist, Dr Tilghman Hall, who is technical chair of the industry's FIFRA Endangered Species Task Force (FESTF).

Conference welcome: Jay Vroom, President and CEO, CropLifeAmerica		Over 150 people attend the launch of Regulation of Crop Protection Chemicals in the US
Opening remarks by Debbie Edwards, Director Office of Pesticides Programs, US Environmental Protection Agency (EPA)		Q&A session on Joint Reviews: Panel moderator Isi Siddiqui, VP, Science and Regulatory Affairs, CropLifeAmerica, panellist Paula Paul, DuPont, and Lois Rossi, US EPA
Photos: Ryan Thomas

The lawsuits have arisen because of the well-documented failure of the EPA and the wildlife services to conduct consultations on endangered species assessments as required by the ESA.  The Fish and Wildlife Service (FWS) and the National Marine Fisheries Service drew up streamlined EPA consultation procedures in 2004 but these "counterpart rules" were judged to be illegal in 2006 (Agrow No 503, p 9).  Without such rules, there is no clear policy on how consultations will be carried out and the Agency remains vulnerable to more lawsuits, Dr Hall pointed out.  A "path forward" must be developed, she urged.

How endangered species assessments will be carried out through the registration review programme remains to be seen.  A pilot programme has been initiated with FMC's herbicide, clomazone, which was one of the first ais to enter registration review (Agrow No 513, p 10). The process, which is "still being shaped", allows a "relatively short time" for "extremely complex" national assessments, said Bernalyn McGaughey, president of Compliance Services International and FESTF project manager. She urged registrants to take a proactive stance, backed by "strong" documentation.  The FESTF's multi-jurisdictional database of species characteristics and locations could be useful for focusing on areas of potential concern, Ms McGaughey added.

If the EPA concludes that a pesticide may affect an endangered species, it will consult with the wildlife services to obtain a "biological opinion" that would be used in risk mitigation.  A "clear and timely" process for these consultations is needed, but none yet exists, Ms McGaughey pointed out.  What happens to affected uses while the consultation process is undertaken is also unclear.  While the sequence of mitigation actions is uncertain, the instrument of action has generally been identified as the county bulletin.  Issuing such a bulletin involves the input of many stakeholders.  A federal decision is therefore subject to influence by many local factors, Ms McGaughey noted.

The industry hopes that registration reviews and wildlife service consultations will follow parallel paths. However, there are concerns over the different risk assessment standards of the ESA and the FIFRA and differences in procedures and philosophies between the EPA and the wildlife services.  There are also worries over potential disparities in timing.  The first registration review dockets indicate that decisions should be reached within two to seven years, whereas previous consultations between the EPA and the wildlife services have spanned up to ten years, Ms McGaughey pointed out.

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The EPA concedes that it "does not have a great record" on completing endangered species assessments. However, it has been spurred into action by a series of lawsuits.  Dr Donald Brady, the acting director of the OPP's environmental fate and effects division outlined some of the court-imposed workload on the Agency.  It must examine 7-10 ais every three months for the next 18 months to determine possible effects on California red-legged frogs.  The EPA agreed to examine 66 pesticides over a three-year schedule under a 2006 legal settlement with the Center for Biological Diversity (Agrow No 507, p 13).

Dr Brady acknowledged that the court-imposed emphasis on particular species in certain localities reduces the Agency's ability to conduct nationwide assessments.  He is keen to move beyond the litigation and embark on much broader consultations on endangered species.  Dr Brady sees the predictable work schedule of registration reviews as being the most efficient way for the EPA to meet ESA requirements.  However, it remains a "daunting challenge".

Several speakers alluded to the different approaches taken by the EPA and the wildlife services, particularly regarding the EPA's focus on federal action and the services' more localised approach.  Differences in opinions between the two branches of government have been documented in various lawsuits.  One area of contention highlighted by Rick Sayers of the FWS is the EPA's extrapolation of sub-lethal effects to many species from the limited set of species that pesticides are tested on. This is a "difficult issue" for the FWS, he pointed out. In a move reminiscent of the counterpart rule process, Mr Sayers raised the prospect of developing regulations that could be acceptable to both sides.  However, he conceded that this could take several years to accomplish.

One of the differences between the FIFRA and the ESA is that the FIFRA allows the EPA to request more data in support of a registration, while the ESA requires the use of the "best available data".  The EPA can therefore issue a data call-in during a registration review, but it cannot request more data once wildlife service consultations start, explained Steven Quarles of the law firm, Crowell & Moring.  There has been considerable legal argument over what constitutes best available data. These could range from studies submitted by registrants to academic research papers.  Mr Sayers raised the concern that the EPA would not consider foreign-language research, thereby excluding certain French language Canadian studies.

Opening session on "Pesticide Risk Assessment for Endangered Species"		The networking reception
The Informa team still smiling at the end of day one (nothing to do with the wine!)		The next photo — it could be you!
Photos: Ryan Thomas

Several speakers remarked about the immense scale of the task at hand, noting that there are over 1,300 listed endangered species potentially affected by hundreds of pesticide uses.  Very few counties in the US have no endangered species or no agricultural land, Dr Hall noted.  Dr Dwayne Moore of Intrinsik Environmental Sciences suggested that the scope of national assessments could be narrowed by the use of simple filtering procedures, thereby making assessments more manageable. He cited a case study in which mammals might be exposed to a rodenticide in a bait station.  By factoring in body size, dietary preferences and geographical distribution, the number of potentially affected species could be reduced from 60 to 13, he pointed out.

CWA permits

Another contentious area with marked similarities to the endangered species issue is whether pesticides applied to water require a permit under the Clean Water Act (CWA). The government again drew up rules in the face of numerous lawsuits centring on disparities between the FIFRA and another statute, only for the rules to be challenged in court. The main difference is that the rules were challenged by industry and environmentalists alike. Oral arguments in the litigation are due to be heard at the end of this month.

The industry welcomed the 2006 ruling confirming the EPA's long-standing policy that the legal application of a pesticide to water does not need a National Pollutant Discharge Elimination System (NPDES) permit.  However, CropLife America and others were disappointed that the action was too narrow in scope and subsequently filed a legal challenge (Agrow No 510, p 12).  The industry endorses the EPA's interpretation of the CWA where pesticides are applied in accordance with the FIFRA. However, it contends that a FIFRA violating application of a pesticide does not transform it into a pollutant requiring a NPDES permit, said Kirsten Nathanson of Crowell & Moring.

This amounts to a "limited challenge", whereas environmentalist groups have contested the fundamental basis of the EPA rule, Ms Nathanson stressed.  In a legal move dubbed the "Chevron two-step", the environmentalists claim that the CWA is "unambiguous" in its intent to cover pesticides.  They argue that any foreign substance applied to water is a pollutant and that all pesticides should therefore be regarded as pollutants.  Moreover, even if the CWA were ambiguous in this regard, the EPA "deserves no deference".  Compliance with the FIFRA should not be relevant to determining compliance with the CWA, they argue.

The Western Environmental Law Center filed its lawsuit against the EPA rules in the Oregon District Court. Industry groups filed legal challenges in 11 of the 12 federal courts.  The jurisdiction of the case has yet to be determined.  It is likely to be several months before a decision on the case is reached.  In the meantime, the EPA rules remain in effect, Ms Nathanson pointed out.

Agrow World Crop Protection News is a worldwide business-to-business news service for the crop protect and production industries, published by Informa Healthcare, part of the Informa Group. The newsletter has been running for more than 22 years and has over 10,000 readers in agrochemical companies and related businesses around the world. For more information, see www.agrow.com   and www.agrowawards.com

Informa Life Sciences lead the marketing in providing quality, expert-led conferences, delivering the expert knowledge our clients need to excel in their professional roles and guaranteeing a competitive advantage for their organisations. Our Agrochemicals conference portfolio includes Registration of Agrochemicals in Europe, AgChem Forum and Crop Protection: Generics, Patents and Parallel Trade Summit. For further information on our events and to find out more about us, visit www.informa-ls.com or email naomi.gill@informa.com

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