What is in the new –2009- legislation? (Annex II: criteria Art. 4.2 and 4.3: requirements ) Article 4 Approval criteria for active substances 1.An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3.
No harmful effects on health (Requirement, Art.4.3.b) 3.A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements: (b)it shall have no immediate or delayed harmful effect on human health, including for vulnerable groups, or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available; or on groundwater;
No unacceptable effects on the environment (Requirement, Art.4.3.e) (e)it shall have no unacceptable effects on the environment, having particular regard to the following considerations where the scientific methods accepted by the Authority to assess such effects are available: (i)its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, groundwater, air and soil taking into account locations distant from its use following long-range environmental transportation; (ii)its impact on non-target species, including on the ongoing behaviour of those species; (iii)its impact on biodiversity and the ecosystem;
And –of course- derogations on criteria CMR (Art. 4.7) 7.By way of derogation from paragraph 1, where on the basis of documented evidence included in the application an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods, such active substance may be approved for a time limited period necessary to control that serious danger but not exceeding five years even if it does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. This derogation shall not apply to active substances which are or have to be classified in accordance with Directive 67/548/EEC, as carcinogenic category 1, carcinogenic category 2 without a threshold, or toxic for reproduction category 1. Members States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control that serious danger to plant health in their territory. At the same time, they shall elaborate a phasing out plan on how to control the serious danger by other means, including non-chemical methods, and shall forthwith transmit it to the Commission.
Now what about ED criteria? (Annex II, 3.6.5). 3.6.5.An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not considered to have endocrine disrupting properties that may cause adverse effect in humans, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, i.e. the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005. Within four years from the entry into force of this Regulation, the Commission shall present to the Committee referred to in Article 79 (1) a draft of the measures concerning specific scientific criteria for the determination of endocrine disrupting properties to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4). Pending the adoption of these criteria, substances, that are or have to be classified, in accordance with the provisions of Directive 67/548/EEC, as carcinogen category 3 and toxic for reproduction category 3, shall be considered to have endocrine disrupting properties. In addition, substances, such as those that are or have to be classified, in accordance with the provisions of Directive 67/548/EEC, as toxic for reproduction category 3 and which have toxic effects on the endocrine organs, may be considered to have such endocrine disrupting properties.
Crucial: Commission to come up with criteria for ED properties in four years time DG Environment leading, and put 1 fte on it DG Env. wants to create one system for pesticides and chemicals in general (REACH) DG Env. will come up with a programme in July 2009 for this 4 years Many questions: what definition, what pilots, what testing batteries, what end-points, etc. Industry lobbying heavily
What can expect from such a programme? Discussion on the definition Discussion on the testing battery (OECD) Pilots in EU-countries Discussion on criteria (or risk management) Not a start of regulation
Weighbridge's definition: consequently and adverse "An endocrine disrupter is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub) populations. Pesticides Regulation: …….may cause adverse effects REACH: Article 57(f) of REACH requires that for the chemicals with ED properties to be subject to authorisation there must be scientific evidence of probably serious effects to human health or the environment. From REACH point of view delete adverse?
Threshold or no threshold? NGOs: No threshold because: Hormonally active substances act in concert with natural hormones Baseline exposure of citizens Cumulative effects Low doses & windows of exposure Late occurrence of adverse effects
Testing battery Do we want to propose a testing battery at all? NGO general considerations on testing batteries: Need to minimise animal testing where possible Need to cover all endocrine end-points Need to try to ensure sensitive species are covered Need to take account of new insights in toxicology Need for independent laboratories to ensure results are un-biased Need to involve academic scientists actively publishing on endocrine disruption
Theo Colborn: no confidence in present system Theo Colborn, author of Our Stolen Future and founder and president of TEDX has called for a radical change of the testing battery, doing tests at very low doses, checking all organs and tissues and systems that make up the endocrine system. She has further highlighted that expert scientists, working at the cutting edge of research into endocrine disruption should be given the opportunity and wherewithal to design a couple of comprehensive multi-organ assays to detect the most sensitive alterations in embryonic and fetal development and function, and that the various tissues from such a test should be sent to known experts in that field.
How to deal with industry biased research Examples on Bisphenol-A, on tobacco and soft drinks Double check in independent laboratories Let industry pay but government perform studies in government laboratories Theo Colborn proposal? Other ideas?
Testing battery, adapt the US system? US battery published: Tier-1, ED screening testing on properties and possibly adverse effects. · Amphibian metamorphosis · Androgen receptor binding · Aromatase · Estrogen receptor binding (alpha and beta) · Thyroid receptor binding · The most sensitive in vitro hormone-sensitive cells tests · Testing levels of neuropeptides (pituitary gland) · Pancreas test · Fish screen · Hersberger · Male pubertal · Female pubertal · Steroidogenese sliced-testes · Steroidogenese Cell-based H295R · Uterotrophic · 15-day intact Adult Male rat assay Tier-2, ED multi-generation adverse effect testing. · Amphibian 2-generation Avian 2-generation Fish lifecycle Invertebrate (Mysid) lifecycle Mammalian 2-generation (updated to include all ED-endpoints using peer-reviewed academic literature) In utero through lactation
Conditions for testing (NGO) - All endocrine systems shall be considered - Low-dose testing will be performed in all testing assays, and concentrations steps will be an order of magnitude every time (starting from zero and then up) - Prenatal testing of the chemicals will be necessary; in general timing is essential (see internet website TEDX, and the critical window of development) - All organs, tissues and systems that make up the specific endocrine system will be considered as an endpoint of effects - Brain functioning (and developmental effects on the brain) have to be considered as part of the hormone system and seen in connection with the regulation of hypothalamic peptides; concentration analysis of these neuropeptides could be used as an assay for developmental effects (Tait et al., EHP, 117:112, 2009) - For testing the most sensitive animals will be taken (no Sprague-Dawley rat fi.) and several strains of animals in every assay - Feed for test animals will have to be low on phyto-oestrogens. - A panel of independent academic scientists (no industry affiliation) actively publishing on endocrine disruption shall be consulted to select the best and most sensitive test battery; the panel shall review the test battery every 3 years) - Academic peer-reviewed research shall always be collected and taken as a basis for further evaluation
Decision taking (Criteria) Any biochemical alterations during key development stages above background may lead to serious, but subtle pathology later in life or in subsequent generations Industry: properties not enough, full proof of adverse effects necessary, including mechanism of action. Big battle field once it comes to decisions
Can we develop an NGO action strategy? Pilots done by BBA, PSD and Denmark (Should we be involved?) BKH-study useful or not? (Campaign for regulation or ignore?) Ongoing approval of pesticides. (Choose a few campaign targets?) List of ED-chemicals of REACH. (?) Testing battery (Involvement in OECD discussion?, Sept. Copenh.) More ideas?