Proposed policy orientations for ANSES in 2013 The purpose of this - - PDF document

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Doc CA 12/3.03 BOARD OF ADMINISTRATORS MEETING OF 27 SEPTEMBER 2012 Point 2 of the Agenda

Proposed policy orientations for ANSES in 2013

The purpose of this document is to present an initial review of the actions undertaken in 2012 and the Agency’s major policy orientations for 2013. These will be expressed as:

• a work programme for 2013 covering all of the Agency’s activities
• a proposed budget for 2013

which will be submitted to the Board of Administrators for approval before the end of the year, in line with the new budgetary restraints incumbent on the Agency for the following three years, along with the ‘goals and performance’ contract that must also be finalised by the end of 2012.

• 1. Initial conclusions concerning the actions undertaken by ANSES over the last

12 months There has been a very high level of activity at the Agency over the last 12 months. Here are a few examples. 1.1 Opinions following formal requests We received 350 formal requests between 1 July 2011 and 30 June 2012, compared with 299 over the previous 12 months, an increase of 17%. To illustrate the variety of subjects dealt with since the start of 2012, we might mention the following:

• Publication of the results of the French national study of PCB concentrations in

consumers of freshwater fish, carried out by ANSES and InVS at the request of the DGS, which enabled ANSES to determine maximum frequencies of consumption with no long-term risk to humans from fish with high levels of PCB bioaccumulation.

• A re-assessment of the risks related to antiparasitic collars for pets, for some of

which marketing authorisation was subsequently withdrawn.

• A risk assessment on talc in the workplace, a study carried out following several

reports of the use in the workplace of a coating produced from talc and suspected of containing asbestos fibres.

• An expert appraisal of brush fires taking into account pollution of the air and soil,

the toxicity of wood smoke and the exposure and health effects related to air pollution for the population as a whole and for professional fire-fighters in particular.

• An expert appraisal for the selection of pollutants to be taken into account in health

risk assessments for impact studies concerning road infrastructures and the associated health effects.

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• An expert appraisal on the possible impact of growth factors in milk on the risk of

developing cancer.

• A study to identify the exotic diseases whose introduction in France would

present the highest risk to animal health with recommendations on the most appropriate methods for combating and monitoring these pathogens.

• An opinion by the Agency on ways of defining endocrine disruptors as part of a

review of European strategy and Community regulations on plant protection products and biocides. This was carried out according to a cross-cutting approach with input from the Regulated Products Department (DPR) and the Risk Assessment Department (DER), with a view to proposing a single, scientific definition of the notion of endocrine disruption, while also making recommendations

• n the best way to apply it more specifically in the framework of European

regulations on plant protection products.

• A call for reports of any adverse effects related to the consumption of energy

drinks, following reports received as part of the nutritional vigilance scheme and in parallel with the study on the consumption of these drinks carried out by the Agency.

• A progress report on the risks and nutritional benefits of intense sweeteners

when consumed by pregnant women.

• A report on the result of a public consultation on substitutes for Bisphenol A.
• Opinions on the consequences to be drawn from recent scientific publications on

the sublethal effects of neonicotinoids and the effects when combined with pathogens on bee health. The Opinions recommended reinforcing European regulations on approval of plant protection products. The work was carried out according to a cross-cutting approach with input from the DPR and the DER, in

• rder to take an overall view of the issue of bee health.
• A risk assessment concerning exposure by the respiratory and mucocutaneous

routes via the reuse of treated wastewater for the irrigation of crops or green spaces.

• Completion of several urgent opinions on sensitive issues (perchlorate, ethylene
• xide, nitrosamine, etc.).
• Updating the online CIQUAL table giving the nutritional composition of foods.
• Making available a tool for ranking animal diseases, at the request of the DGAL,
• ne of the measures resulting from the national consultation on the health sector.
• A study carried out by IRSTEA at ANSES’s request, listing the personal

protective clothing and equipment used by farm workers, with a view to setting up performance tests in the second half of 2012. The goal is to be able to make recommendations, as a result of our internal request, on changes to be made to current regulations. The increased number of requests received, combined with the reinforcement of the rules applied to the collective expert assessment process itself and the reduction in resources, has led to an increase in the number of requests currently underway, which has risen from 181 at the end of June 2011 to 232 at the end of June 2012. The Agency has taken steps for deadlines to be monitored closely to ensure that this backlog of formal requests is dealt with as efficiently as possible: we have a

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French Agency for Food, Environmental and Occupational Health & Safety 27-31, Avenue du Général Leclerc, F94701 Maisons-Alfort Cedex -Telephone: + 33 (0)1 49 77 13 50 - www.anses.fr

contractual obligation to meet 90% of our deadlines and are currently meeting 89.5%. Some of these late deliveries include extremely complex dossiers involving the prior collection of specific data, especially in cases of Research and Development Agreements (CRDs), which can involve very long delays. There are proposals for these deadlines to be monitored systematically by the ministerial liaison committee, in the knowledge that the Agency does its utmost to adapt its schedules to take account of emergencies and mandatory deadlines, which can occasionally affect its longer-term work programme. 1.2 Regulated products 1.2.1 Update on the situation concerning biocides We have two types of activity:

• the assessment of active substances requiring decisions at European level but for

which the assessment is entrusted to a national agency. This task, begun in 2004, is close to completion: out of 73 dossiers entrusted to the Agency since the start of the European process, 14 have been rejected as inadmissible and 17 draft Competent Authority Reports (CARs) had been completed by 31 December 2011. In the first half

• f 2012, six dossiers were submitted, leaving a further 36, of which 30 should be

dealt with by the end of 2012 and in 2013. All these dossiers must be completed by the end of 2014.

• the assessment of biocidal products which require marketing authorisation at

national level. Manufacturers file applications once the active substance concerned has received authorisation at European level. The number of applications is increasing, and in the years to come this second activity will make up the majority of ANSES’s workload concerning biocides. A total of 74 Opinions on these products under the terms of Directive 98/8/EC have been issued since the start of 2012. In 2012, 18 initial applications for MAs will have been processed, compared with eight in

• 2011. This activity is expected to increase in the years to come. The Agency is

currently working with the ministries, partly to adjust the fees in line with the costs

• ccasioned by these assessment studies, and partly to adapt the procedures before

the new provisions of Regulation 528/2012/EC come into force. Furthermore, 213 Opinions have been issued on applications in the context of national regulations during the transitional period, concerning certain biocidal products for which an MA is required before an active substance can be listed at European level. 1.2.2 Activities concerning plant protection products During the first half of 2012, we received 1173 dossiers for plant protection products (922 of which were covered by a tax) compared with 982 in the first half of 2011, an increase of 19.5%, whereas the first half of 2011 had also seen a high level of activity. This increase in the number of applications is largely the result of the new European regulation coming into force, which divides Europe up into three geographic zones. ANSES, which is in the South Zone, is strongly placed and attracts numerous applications. Therefore this trend should also continue in the second half of 2012. The increase in the number of applications especially concerns applications for marketing authorisation or their re-examination (an increase of 101 dossiers), whose processing imposes a considerable workload. In response to this increase, we boosted our teams at the start of the year with a full time equivalent of 10 (over the course of the entire year), as a result of internal redeployment made possible by a systematic search for economy and efficiency. This extra staff enabled

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us to produce 820 Opinions in the first half of 2012, compared with 777 in the first six months

• f 2011, an improvement of 5.5%. However, even this increase in numbers was insufficient

to deal with the flow of incoming dossiers, with the backlog growing by more than 350 in the same period. 1.2.3 Activities concerning the REACH Regulation Once 3400 chemicals had been registered in the European database in December 2010 and the first Community Rolling Action Plan (CoRAP) for priority substances had been prepared in 2011, assessments commenced in 2012. ANSES was given three substances to assess (carbon tetrachloride, 1,3-diphenylguanidine and octocrylene) in 2012 and, together with the Dutch Institute for Public Health and the Environment (RIVM), began the assessment of formaldehyde, listed for 2013. At the start of 2012, as part of a Best Risk Management Option (Best-RMO) analysis, ANSES proposed to undertake a REACH restriction procedure for two substances already prohibited in France (gamma-butyrolactone and 1,4-butanediol) in order to extend the ban throughout Europe. Regarding Bisphenol A (BPA), ANSES also proposed, again as a Best-RMO analysis, to undertake a restriction procedure concerning the non-food uses that could potentially lead to the exposure of vulnerable population groups. Discussions are under way at European level to determine whether these proposals offer the best options for future regulations. The Agency has also developed a proposal for the classification and labelling of BPA as a Category 1B reproductive toxicant, which will be sent to the European Chemicals Agency in September 2012. 1.3 Veterinary medicinal products The French Agency for Veterinary Medicinal Products (ANMV) has two main activities:

• Assessing veterinary medicinal products: the number of dossiers processed at

European level continues to grow. In the first half of 2012, the ANMV participated in the assessment of 85 dossiers (compared with 76 in the first half of 2011). At national level, the number is down and only five dossiers have been examined since the beginning of 2012.

• Post-MA surveillance of veterinary medicinal products, involving the recording and

investigation of 697 serious cases arising from pharmacovigilance activities in the first half of the year, 145 analyses for quality controls of veterinary medicinal products sold in France and 33 inspections of establishments dealing in veterinary pharmaceuticals. The first half of 2012 saw a reassessment of the risks related to external anti-parasitics which led to the withdrawal or suspension of 76 MAs. The ANMV also oversaw the withdrawal of all batches of these drugs.

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1.4 Activities of the laboratories The following events in 2012 are of particular interest:

• The new animal health epidemiological surveillance platform, based at the

ANSES facility in Maisons-Alfort grouping together all parties involved in these issues, mobilised its full potential for a rapid and efficient response on several topics

• f public interest, such as the emergence of the Schmallenberg virus, the re-

emergence of bovine tuberculosis, and bee colony collapse.

• The inauguration of the Plant Health Laboratory (LSV) in Angers, after the

premises were extended to host the virology and GMO analysis activities, with a meeting organised by the Laboratory for all the NRLs of the European Union, attended by the representatives of the French authorities and the European Commission.

• A new OIE international reference mandate awarded to the Maisons-Alfort

Laboratory for Animal Health concerning epizootic haemorrhagic disease.

• Validation by the European Commission of the surveillance programme proposed

by our laboratory in Sophia-Antipolis, which has now become a European Reference Laboratory, concerning the characterisation of bee mortality and its

• causes. The plan will involve 17 countries of the European Union, including France,

which will have 6 pilot départements.

• Completion of a scientific assessment of the work of the laboratories, in July,

regarding research and reference, by committees of outside experts. The results will be examined together with the Scientific Board and the ministries concerned before the end of 2012. The question will be how best to exploit these findings, especially how to make best use of our assets to further increase the efficacy of our work as regards our priority missions. 1.5 Other activities carried out in the first half of 2012 To round off this brief summary of our activity over the last few months, we should also point out:

• The renewal of a large number of expert committees (CES) in the course of the

year (five in the field of regulated products, three in the field of food, chemical and biological risks, and two in animal health and nutrition) and the creation of several permanent expert workgroups associated with a specific CES (animal welfare, biotechnology, nutritional vigilance, etc.).

• An external audit of the National Research Programme for Environmental and

Occupational Health (PNREST) completed in April 2012 and presented to the Scientific Board.

• The launch of a new Call for Projects as a part of PNREST: more than 200 letters
• f intent were received, half of which were preselected by the scientific committee

responsible for this Call for Projects and will undergo an in-depth assessment before final selection in the autumn of 2012.

• The establishment of an Expert Committee on biological risks related to plant
• health. An initial Opinion resulting from this work was published in July, and

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concerned a new bacterium, Xylella fastidiosa, which could affect broad categories

• f very important crops in France (especially Prunus seedlings).
• The organisation of major scientific events for the purpose of disseminating as

widely as possible current scientific knowledge, especially including the scientific conferences devoted to exposure indicators on 30 May 2012, the conference that brought together the European organisations funding research in the field of environmental health as a part of the ERA-ENVHEALTH project in Paris on 13 and 14 June, and ANSES’s active participation in the international conference on Prenatal Programming and Toxicity (PPTox III) organised in Paris on 14 to 16 May 2012.

• Signature of cooperation agreements with our main national partners such as

InVS and ITSAP (scientific technical institute for bees and pollination), and the upcoming signature of agreements with INERIS, INRS, INRA and ANSM1.

• Pursuit of our strategy for international cooperation, with an agreement signed

with the NIOSH, our US counterpart in occupational health, and the launch of a European project, to be coordinated by ANSES, on the harmonisation of methodologies used in Total Diet Studies, in order to make it easier to compare the levels of exposure of European consumers to chemical and microbiological contaminants.

• Finalisation of the ANSES multiyear real-estate strategy programme (SPSI)

which has now been submitted to the government property agency, France- Domaine, and which will soon be submitted to the Board of Administrators for approval.

• Signature of the leasing agreement for the construction of the Agency’s

headquarters, which should enable all of the teams at Maisons-Alfort to be sited together before the end of 2014.

• Deployment of a new website for the Agency, which should be on line before the

end of 2012.

• Setting up the Laboratories Planning Committee, which brings together the

General Directorate, the Scientific Affairs Department for Laboratories, and the directors and scientific coordinators as concerns the laboratories’ spheres of competence.

• 2. The background for 2013

Next year, 2013, will be the third year running of budgetary restrictions for ANSES, with another sharp drop planned for the next three-year period of 2013-2015 for the Agency’s

• laboratories. This situation obliges us to make much clearer choices in our priorities than
• before. Savings in 2011 and 2012 were made possible partly by eliminating certain

positions after the merger between AFSSA and AFSSET, but also by seeking all possible reductions in operating expenditure, while nonetheless preserving the maximum number of

• skills. The limits of this approach have now been reached, especially as the budgetary

restraints on ANSES seem likely to remain in place for the foreseeable future. These restrictions must be clearly taken into account when drawing up the future goals and performance contract for the period 2012-2015, which has to be presented to the Board of

1 INERIS - French National Institute for Industrial Environment and Risks

INRS - French National Research and Safety Institute for the Prevention of Occupational Accidents and Illnesses INRA - French National Institute for Agronomic Research ANSM : French National Agency of Medicine and Health Products Safety

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Administrators for final validation before the end of the year. The policy orientations proposed for 2013 will also need to be adapted in light of the resources actually available, when drawing up the work programme to be finalised jointly with the ministries and other stakeholders, especially in the framework of the thematic steering committees scheduled to meet in October. The following elements will need to be taken into account in any decision:

• All our efforts to make savings and increase efficiency with our support

services must be pursued with determination, whether in the short, medium or long terms: the action plan proposed in response to the inspection and audit reports (see the separate item on the Agenda for the Board Meeting) contains a series of measures concerning the support services, purchases and laboratory management which will contribute to the desired optimisation process, reducing the need to cut back on the resources for the missions themselves.

• It is essential that the respective budgets are balanced in each major area of

intervention bearing in mind both the changes in funding from the different ministries for 2013, and also the outlook through to 2015 in the framework of the future three- year funding period of 2013-2015.

• Careful consideration must be given to what is feasible regarding possible

decisions concerning refocusing our activities, and their potential impact on the workforce, especially concerning the possibility of redeploying personnel.

• Within the laboratories, the greatest attention must be paid to maintaining a

balance between reference and research activities by putting to good use the findings of the collective assessment carried out in July 2012; the reduction in resources will inevitably lead to the curtailment of some of the Agency’s traditional activities for the sake of focusing more closely on the government’s priorities in terms of public health regarding food safety and also veterinary medicines and plant protection products. While pursuing this goal, we must not lose sight of the need to preserve the rapid-response capability of the Agency’s laboratories. Regarding the growing gap between the number of requests received from the ministries and our financial resources for responding to them, we also need to examine ways of raising extra revenue to complement the grants from the ministries, while ensuring that their sources do not in any way compromise the Agency’s independence. Other background elements for the coming year worthy of note include the follow-up to the environmental conference of 14 and 15 September 2012 and preparation for a response to the National Environment and Health Action Plan (PNSE), which concludes at the end of 2013. The year will also see the implementation of the new legal and regulatory framework for the ethical standards applying to expert appraisal, and for the avoidance of conflicts

• f interest, which will mean adapting the requirements of our in-house Rules of Procedure

and our Code of Ethics, with the help of the Agency’s Committee for Ethical Standards and Prevention of Conflicts of Interest. The Agency will meanwhile continue to make every effort to promote its expert appraisal activities.

• 3. Principal policy orientations for our distinct areas of expertise for 2013

The annexes contain proposals for policy orientations for 2013 concerning each of the Agency’s five spheres of competence:

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• Food safety
• Environmental health
• Occupational health
• Animal health and welfare
• Plant health and protection.

These will be discussed during meetings of the thematic steering committee to the Board of administrators, planned for October 2012. After an arbitrage phase they will then be formulated into a work programme, made up of project sheets for each of the Agency’s major entities, to be submitted to the Board of Administrators before the end of the year. Furthermore, the Agency is engaged in an examination of future prospects, under the guidance of the Scientific Board, with a view to clarifying the medium-term scientific priorities, depending on the corresponding health & safety issues. In addition to the various topics for the work programme, listed in the annexes, it should be noted that in 2013 we will be accentuating the transversal approach implemented at ANSES since its creation, especially as regards:

• the issue of endocrine disruptors, concerns about their effects at low doses and

exposure by the oral, respiratory and dermal routes on the development of certain multifactorial chronic pathologies (diabetes, obesity, reproductive disorders, cancers, etc.).

• the question of pesticides, with a complementary and coherent consideration of

regulatory aspects (examining applications for MAs); of health risk assessments for farm workers (work is currently under way resulting from a formal internal request, with an Opinion expected by the end of 2013) and exposed population groups (a review of maximum residue limits, a follow-up to TDS 2); and of the results of monitoring impact indicators by the Observatory for Pesticide Residues.

• the complex issue of the combined exposure to multiple sources of hazards,

concerning the risks to consumers and the follow-up to the Pericles study, or the mystery of the multifactorial origin of bee mortality (current formal internal request). In 2013 the permanent Working Group set up to investigate the impact of electromagnetic fields should issue its first report, and the new WGs on nanomaterials, animal welfare, bee health and nutritional vigilance will be getting well under way. There will also be an increase in activities to assess biocidal products and macro-organisms, for which it will be necessary to find new sources of funding if the required expenditure is to be covered

• adequately. The Agency’s laboratories will consult with the other National Reference

Laboratories, to consider, with all the accredited laboratories in their networks, ways of improving the efficiency and reliability of official analyses. Lastly, in 2013 the Agency will identify the actions to be taken following the PNREST audit.

• 4. Other priorities for 2013

Most of the other actions planned for 2013 and the years to follow are described in the draft action plan submitted to the Board of Administrators, written primarily in response to the various recommendations made in the reports on the recent inspection and audit of

• ANSES. Particular highlights of 2013 will be:

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• Our application for ISO 9001 certification for our activities, based on the NF X 50-

110 requirements for expert appraisal activities;

• Setting up a skills and know-how catalogue for all Agency personnel;
• Setting up an audit and evaluation unit, to reinforce current internal control

arrangements;

• Creating a Purchasing Directorate and an Invoicing Department;
• Continuing our strategy for cooperation at European and international level,

with a view to benefiting from any work and data already available and avoiding unnecessary duplication;

• Multiplying cross-disciplinary contacts between the units of laboratories

contributing to studies of the same pathogen or contaminant in different matrices;

• Ensuring maximum use of the Agency’s new website and its different associated

sites, in a strategy of making access as easy as possible to all of the Agency’s information and data in its various spheres of competence;

• Setting up a sustainable development policy, in particular involving a

considerable reduction in the use of paper for publications, taking necessary action according to the results of the greenhouse emissions assessments currently under way, and implementing an action plan at Maisons-Alfort with a view to grouping the teams together on the site of the veterinary school.