Are you aware of which substances are classified as endocrine disrupting chemicals (EDC)? Do you carry out any operations involving EDC?
These are the types of questions that are being considered by many companies in light of significant consumer, government and industry concern for EDC. In order to further delve into this topic, several companies and organizations attended an Enhesa webinar on EDC on the 27 January or 2 February 2010. What this webinar addressed was that regardless of the controversial nature of the scientific research, countries are still proposing and adopting measures that regulate how certain priority EDC are used. The focus was on Canada, which is especially relevant because it has been particularly systematic and comprehensive in promoting measures to regulate the use of key EDC. However, for the purposes of comparison, a consideration of how the US and the EU are dealing with these substances was also discussed. North American and the European Union have taken the upper hand globally in attempting to classify, assess and regulate potentially harmful EDC.
The Organisation for Economic Co-operation and Development (OECD) it has adopted the following working definition for an EDC and a potential EDC as agreed upon by an OECD Workshop hosted by the European Union and World Health Organization in Weybridge, UK in December 1996:
“An endocrine disrupting chemical (EDC) is an exogenous substance that causes adverse health effects in an intact organism, or its progeny, consequent to changes in endocrine function.”
“A potential endocrine disrupting chemical (EDC) is a substance that possesses properties that might be expected to lead to endocrine disruption in an intact organism.”
While a clear definition has been developed and accepted on the international level, it is less clear which substances can actually be classified to fit into this definition. Various jurisdictions and organisations have been attempting to identify those chemicals which are endocrine disrupting. One of the earliest examples of a substances being classified as an endocrine disrupter in humans with direct restrictive regulation resulting is diethylstilbestrol (DES), a synthetic oestrogen prescribed in the 1950s and 1960s to five million pregnant women for the prevention of spontaneous abortion. It was found that some of the children who had been exposed in the uterus had developmental abnormalities, and that some of the girls developed an unusual form of vaginal cancer when they reached puberty. As a consequence, DES was banned in the 1970s.
Since that time, there have been many attempts to develop a concrete listing of EDC. The main difficulty with this task is the lack of scientific consensus. However, upon examination of the various lists generated from a range of countries and organizations, there is widespread agreement on some of the most common EDC. Most persistent organic pesticides (POPs) and similar organic contaminants like PCBs (polychlorinated biphenyls), and dioxins are considered to be endocrine disrupting. Natural and synthetic hormones like estrogen and estradiol are also included on most lists. Pesticides, plasticizers, surfactants and other industrial chemicals such as phthalates, bisphenol A, carbon tetrachloride, nonylphenol, and the food antioxidant butylated hydroxyanisole (BHA) are some of the most relevant EDC under current attention. In addition, metals such as arsenic, lead, cadmium, and mercury are contended to have endocrine disrupting properties.
Concerns over the potential impacts of substances that disrupt endocrine function led to the Canadian Environmental Protection Act, 1999 (CEPA) making research on “hormone disrupting substances” a Ministerial duty for both Environment Canada and Health Canada. This legal authority resulted in piecemeal research projects and initiatives to gather more information on EDC. However, in December 2006, the Prime Minister, along with the Ministers of the Environment and Health, unveiled Canada’s new Chemicals Management Plan. The plan began by taking immediate action to regulate chemicals that are harmful to human health or the environment. A key element in the Chemicals Management Plan is the collection of information on the properties and uses of the approximately 200 chemical substances identified through the categorization process as high priorities for action. This information is being used to make decisions regarding the best approach to protect Canadians and their environment from risks these substances might pose. Several known endocrine disruptors are included in these batches of substancesand have been made subject to the Chemicals Management Plan.
For chemical substances that have been found toxic after scientific examination, or for those strongly suspected of being dangerous, steps are taken to control their use, as well as to prevent, reduce or eliminate their release into the environment. This is known as risk management. CEPA defines “toxic” substances as those that enter or may enter the environment at levels or conditions that: have or may have a harmful effect on the environment; are or could be dangerous to the environment that life depends on; or are or could be dangerous to human life or health. Before the government can regulate these substances, they have to be added to the List of Toxic Substances (Schedule 1 of CEPA). Potential EDC already on Schedule 1 include dichlorodiphenyltrichloroethane (DDT), bis(2-ethylhexyl) phthalate, lead, mercury, PBDEs, polychlorinated dibenzodioxins, polychlorinated dibenzofurans, polycyclic aromatic hydrocarbons and polychlorinated biphenyl (PCBs). Many of the EDC on Schedule 1 are already being addressed by proposed or adopted risk management tools.
One key example is bisphenol A. Bisphenol A is used primarily as a formulant in the manufacture of polycarbonate plastic and epoxy resins. Polycarbonates have wide application in consumer products (e.g. repeat-use polycarbonate containers), in medical devices, glazing applications, film and the electronics industry, while epoxy resins are used in protective coatings, structural composites, electrical laminates and as adhesives and sealants. The classification and assessment process of the Chemicals Management Plan established that bisphenol A meets the criteria to be designated as CEPA-toxic and should be added to the List of Toxic Substances.
As a result, a risk management approach that was published in October 2008 proposes that several measures should be implemented. These include: banning the importation, sale and advertising of polycarbonate baby bottles made with bisphenol A monomer; developing stringent migration targets for bisphenol A in infant formula cans; establishing stringent migration targets for bisphenol A in canned foods in general; and imposing regulations to minimize the risks from releases of bisphenol A into the environment. In addition, it was proposed to adopt a precautionary approach for bisphenol A in food packaging for products intended for newborns and infants and will be adopting the As Low As Reasonably Achievable (ALARA) principle to minimize exposure of these vulnerable populations to bisphenol A.
The first risk management measure regarding polycarbonate baby bottles made with bisphenol A monomer was officially proposed on 27 June 2009 in the Order Amending Schedule I to the Hazardous Products Act (bisphenol A). If adopted, the Order would add polycarbonate baby bottles that contain 4,4- isopropylidenediphenol (bisphenol A) to Schedule I. This addition would prohibit the advertisement, sale and importation of polycarbonate plastic baby bottles that contain bisphenol A in order to reduce newborn and infant exposure to this substance.
Until recently, the United States has not been particularly active in the classification, assessment or regulation of EDC. Legislation in 1996 resulted in the creation of the Endocrine Disruptor Screening Program (EDSP). While the EDSP has finally developed a list of priority EDC to assess, it is only considering certain pesticides, which will be subjected to further assessment and potentially new measures. There has been no indication as to what extent the EDSP will expand this list. In September 2009, however, the Environmental Protection Agency (EPA) announced that it will enhance chemical management under existing laws. By enhancing its Chemical Management Program, the EPA will develop chemical action plans for key substances, including EDC, by reviewing available hazard, exposure and use information. Based on these reviews, the EPA may also require labelling, restriction or even ban certain chemicals.
As a result of this initiation, the EPA published four action plans in December 2009 for phthalates, long-chain perfluorinated chemicals (PFCs), PBDEs in products and short-chain chlorinated paraffins. For PBDEs, as an example, the action plan indicates that the EPA intends to initiate rulemaking in the Fall of 2010 to add commercial PDBE mixtures and/or the congeners they contain to the Concern List under the Toxic Substances Control Act section 5(b)(4) as chemicals that present or may present an unreasonable risk of injury to health or the environment. The intention is to continue to publish one action plan every four months after the first four. An action plan toBisphenol A is currently in development as one of the next plans to be published.
The European Union has also begun taking strides of its own to better classify, assess, and regulate EDC. In 1999, the European Commission adopted a strategy that was in line with the precautionary principle COM(1999)706. This strategy, known as the ‘Community strategy for endocrine disrupters;’ set out the actions that would be undertaken to address the potential environment and health impacts of endocrine disruption. The first step of this strategy was to create a list of priority substance which would be considered as “suspected endocrine disrupters.” From a total of 564 chemicals that had been suggested by various organisations or in published papers or reports as being suspected EDC, 66 substances showed evidence of endocrine disrupting activity. Bisphenol A, PCBs, phthalates are included on this list.
Despite the fact that these substances have been classified as key EDC and are being subject to further assessment, the 1999 strategy has been surpassed by Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH), as adopted on 1 June 2007. Currently, the most relevant part of REACH for the purposes of implementing measures for EDC is the authorization component. In order to deal with chemicals of high concern, REACH foresees a special permission system. Substances of very high concern (SVHC) are those that can cause cancer, mutations or problems with reproduction (CMRs), or that accumulate in human bodies and the environment (i.e. persistent, bioaccumulative and toxic or very persistent and very bioaccumulative), as well as other chemicals which are of ‘equivalent concern.’ These will be put on the Candidate List. Chemicals can only be nominated to the Candidate List by the action of an EU Member State government, or by the instruction of the European Commission to the European Chemicals Agency.
These substances will have to obtain authorisation which is specific to a particular use or application. Also, within this group of substances, some will be subject to stricter conditions in order to obtain an authorisation by decision of the European Commission. For example, the persistent and bioaccumulative chemicals can only get an authorisation if the socio-economic benefits outweigh the risks of use, and if there are no safer alternatives. If an authorization has not been obtained, the substance is effectively banned from that specific use or application. Three phthalates, DBP, BBP and DEHP, were placed on the first publication of the Candidate List in December 2008, and their priority ranking for the authorisation procedure is currently the subject of a public consultation. From 1 June 2011, substances in products which are on the candidate list (subject to certain criteria) will need to be reported to the European Chemicals Agency.
When considering the business impacts resulting from the development of legislation regarding EDC, one needs to first consider that these substances are in a unique position. Scientific assessment of many of these substances has not resulted in conclusive evidence that EDC should be a priority. There is a lack of consistent classification while classification and assessment methods are being created or amended to account for new research. Despite the scientific uncertainty, measures are still being implemented to significantly restrict their use in products operations. On one side, consumer concern is acting as a market force driving industry to take the initiative and make adjustments in products and operations. On the other hand, several governments, such as Canada, are favouring the use of the precautionary principle in developing specific measures. In this regard, such jurisdictions are discounting the lack of certainty and implementing new restrictive measures in light of the potential for these substances to be endocrine disrupting.
As a result of the development of new restrictions or requirements regarding EDC, a company could expect a potential administrative burden or financial burden. The administrative burden results from such requirements as reporting under the Canadian Chemicals Management Plan or obtaining authorisation under REACH in the European Union. The potential financial burden is much broader. Any required alteration or cessation of operations involving EDC will cause a company to incur financial loses. These requirements could include changes in raw material selection to avoid and reduce EDC, in production process to minimise releases of EDC, in design specifications to avoid and reduce the presence of EDC in products being sold and the conditions for purchase of components and parts that contain EDC. These measures could also result in a provision to necessitate wastewater treatment to avoid or reduce discharges or to implement measures to address worker exposure to EDC.
In this regard, what can you do to avoid incurring an administrative or financial burden for any operations involving EDC? In the first instance, it should be a priority to review the substances with high concern of endocrine disruption and assess if any of these are used in operations or products. It would be advantageous to record information on, or develop, a management plan for any of the activities involving these substances (i.e. regarding use of EDC in production of manufactured items or release of EDC in wastewater discharges). Identifying products at risk and attempting to find alternatives to the use of EDC as far as possible would also be a key step in preparing for the implementation of any new stringent legislation being adopted. Bottom line, affected companies should not wait for government action to begin implementing measures to restrict or eliminate use of EDC. Invoking the idea of the precautionary principle is the way forward for dealing with EDC.