Inside U.S. Trade - 07/25/2014
Under Industry Pressure In TTIP, EU Weighs Shift On Pesticides Regulation
Posted: July 24, 2014
The European Commission is weighing whether to propose changing EU legislation governing the use of pesticides in a way that could make it easier for companies to market products containing substances that affect human hormones, which is a key demand by the crop protection industries on both sides of the Atlantic in U.S.-EU trade talks.
The commission is poised to initiate a public consultation -- expected in early September -- that will ask stakeholders to weigh in on several different options for how the EU's pesticide law could be modified as part of a larger effort to revamp EU rules on hormone-affecting substances called "endocrine disruptors."
One of the options proposed by the commission in a June 17 "roadmap" is to shift from the current EU approach of banning the use of all endocrine disruptors in pesticides toward a model that could allow them to be used as long as certain steps are taken to mitigate the risk.
This risk assessment-based model is favored by the U.S. and EU pesticide industries and is the approach employed under the U.S. Environmental Protection Agency's "Endocrine Disruptor Screening Program." Such a model seeks to evaluate both whether a hazard exists and if it can be mitigated by limiting exposure, in order to allow the marketing of an otherwise dangerous product.
But an EU official acknowledged that altering the pesticide law along these lines would require legislative action, meaning that any such changes would be months away at the earliest and entail a tough debate between the commission, EU member states and the European Parliament.
Environmental and public safety advocates have reacted with alarm to the roadmap, warning that the commission appears to be on track to water down critical safeguards. Industry lobbyists, meanwhile, argue that the roadmap overall appears skewed toward maintaining what they claim is a non-scientific and overly restrictive regulatory framework.
Getting the EU to move to a risk-assessment based model was a key recommendation made by CropLife America (CLA) and the European Crop Protection Association (ECPA) in a March 10 joint submission to U.S. and EU negotiators for the Transatlantic Trade and Investment Partnership (TTIP) (Inside U.S. Trade, April 18). They urged the EU to make this change through the TTIP in order to avoid causing potential disruptions to trade in the future.
The June 17 roadmap is part of an effort by the commission to revamp the way endocrine disruptors areregulated in the EU by establishing the criteria for what constitutes an endocrine disruptor and by clarifying the regulatory consequences if a substance meets those criteria.
The European Commission currently does not have working criteria for what constitutes an endocrine disruptor, which has hobbled the effectiveness of existing EU law, sources on both sides of the debate say.
In addition, separate EU laws regulating different sectors impose different regulatory consequences on endocrine disruptors, which all sides acknowledge gives rise to inconsistency. For instance, endocrine disruptors are treated differently in EU laws governing pesticides, industrial chemicals, cosmetics and so-called biocides -- a category of products including fungicides and herbicides.
But how this should be addressed is hotly contested. The topic is controversial even between the European Commission's Directorate-General for Environment (DG ENV) and Directorate-General for Health & Consumers (DG SANCO), who have joint jurisdiction over the issue, according to EU sources.
Environmental and public health advocates have called for criteria that capture substances that are known or potential endocrine disruptors, regardless of whether or not they demonstrate an immediate adverse effect; they also generally want existing laws to be left unchanged despite the inconsistencies between laws governing pesticides, biocides and cosmetics, for example. Some sources characterized DG ENV as leaning in favor of this approach.
But industry groups argue such an approach could potentially engulf a wide range of substances currently on the market and stifle innovation, without any benefit for consumer safety; they are urging the commission to narrowly tailor any restrictions based on whether a substance shows a clear adverse effect, and to determine whether limiting exposure can allow such a substance to continue to be used safely across all sectors.
Sources characterized DG SANCO, which regulates cosmetics and industrial chemicals, as falling more on this side of the debate and working actively to put its stamp on the language being used in the consultation process, which is being co-led by the two directorates general.
One EU official said an internal consultation between DG ENV, DG SANCO and other directorates with purview over the file -- including DG Trade -- is expected to be finalized by Sept. 5, following the August holidays. This official expected that the consultation would be launched the following week.
Pesticides are regulated in the EU by what is known as the Plant Protection Products Regulation (PPPR).The legislation, brought into force in 2011, includes provisions banning substances having "endocrine disrupting properties which may cause adverse effects" and directed the commission to identify criteria by the end of 2013.
The PPPR takes a hazard-based approach to endocrine disruptors, meaning that if a substance meets the criteria laid out, it is not allowed onto the market regardless of whether mitigating steps can be taken to limit exposure. This model is criticized as excessively restrictive and unscientific by the U.S. and EU pesticide industries, which prefer the risk-assessment based approach used in the United States.
The roadmap lays out three options for how the EU can move forward: make no change; introduce "further elements of risk assessment into sectorial legislation" like the PPPR; or introduce further socioeconomic considerations, including "risk-benefit" analysis.
The latter option refers to the idea that a substance could be approved even if it is detrimental to human health or safety in the event that those costs are outweighed by the broader socioeconomic gains. That could be the case, for instance, in the event of a pest infestation that threatened the food supply.
Clare Thorp, senior director for human health policy at CropLife America, said the European Commission's roadmap moves in a positive direction from a scientific perspective because it appears to indicate willingness to introduce some elements of risk assessment into the process. She added, however, that it remains "far from clear how the commission would implement this approach and whether it would really enable compounds which are not endocrine disruptors (with an adverse effect) to remain on the market."
"The EU is doing things that move in a much better direction, but it is ultimately trying to tweak a really problematic piece of legislation," she said, referring to the PPPR. "As the science has advanced, it is increasingly clear that implementing a hazard based approach to regulating certain pesticides is neither scientifically valid nor more protective of human health."
But Angeliki Lysimachou, a scientist at the Brussels office of the global Pesticide Action Network (PAN), argued in an interview that moving away from the hazard approach is problematic because endocrine disruptors have been shown to produce latent adverse effects that would be not immediately apparent through a standard risk assessment.
Lysimachou also noted that risk assessments do not typically factor in how a substance might affect a person during critical developmental phases, which is when she said exposure to endocrine disrupting chemicals is potentially most harmful. In a statement on PAN's website reacting to the publication of the roadmap, she said "tiny exposures at the wrong moment in life may induce dramatic consequences: adverse sex organs development, impaired cognition, cancer, diabetes, obesity, etc."Inside U.S. Trade - 07/25/2014, Vol. 32, No. 30