Epinano, health monitoring of workers exposed to nanos

Epinano, epidemiological monitoring system for workers potentially exposed to nanomaterials

By AVICENN Team – Last Added September 2022

Objectives

The Epinano monitoring system was launched at the beginning of 2014 in order to constitute and then monitor a cohort of workers producing or handling nanomaterials for the purpose of epidemiological monitoring. More specifically, it is:

• carry out general monitoring of the possible medium and long-term health effects of occupational exposure to nanomaterials
• to allow the setting up of studies and following the best practices exploring specific research hypotheses.

A pioneering and singular device

The EpiNano device is unique on two counts:

• firstly because it is the only occupational health monitoring system dedicated exclusively to nanomaterials (other systems exist in France, such as the SUMER survey, the Occupational Disease Surveillance Program (MCP) or the regional occupational and environmental pathology consultations (CRPPE), the national network for vigilance and prevention of occupational pathologies (RNV3P), … but they are broader)
• on the other hand because no other country has (to date) implemented such epidemiological monitoring measures linked to occupational exposure to nanos.

EpiNano is thus the first device of such a scale to be implemented¹A “Nanoparticles Survey” had indeed been set up in 2011-2012 by the CISME but its scope was very limited. See “Spotting employees potentially exposed to nanoparticles”, Jacquet F in Occupational Health References, INRS, No. 132, December 2012, p. 33-38. Other countries and institutions abroad have recommended setting up monitoring of exposed workers, so the EpiNano device could have other "little brothers" soon? The use of EpiNano tools for the harmonization at European level of methods for monitoring workers exposed to nanomaterials has been the subject of discussions since 2013²Source: Epidemiological surveillance of workers potentially exposed to nanomaterials intentionally produced in France: EpiNano device, Archives of Occupational and Environmental DiseasesDecember 2013, without knowing what stage they are at today.

From its origins to its launch in 2014

As early as 2006, a report by the Committee for Prevention and Precaution (CPP:) pointed out that “epidemiological studies on exposed populations, particularly in the workplace, must be undertaken”³See Nanotechnologies, nanoparticles: what dangers? what risks?, Prevention and Precaution Committee (CPP), Ministry of Ecology, May 2006.

A working group comprising epidemiologists, toxicologists, occupational physicians, physico-chemists and stakeholders in the prevention system⁴Working group for the implementation of epidemiological monitoring of workers exposed to nanomaterials et "Health risks of nanotechnology" actor's notebook for the national public debate on nanotechnology 2009-2010, IReSP was assembled by the Institute for Public Health Research (IReSP) from 2007, to analyze this question.

In 2008, Afsset (now ANSES) had in turn written that with a view to the “carrying out specific epidemiological studies on potentially exposed workers, it is essential to implement a system for listing personnel working in contact with nanomaterials and monitoring working conditions« ⁵See Nanomaterials, Safety at work, Afsset, May 2008.

In response to a request from the Ministries of Health and Labor, the National Institute for Health Surveillance (lnVS, which in 2016 became Public Health France) had carried out a feasibility study of epidemiological monitoring of workers and researchers exposed to nanomaterials, published in 2011⁶See Elements of feasibility for an epidemiological surveillance system for workers exposed to intentionally produced nanomaterials, National Institute for Health Surveillance (InVS), March 2011. Two parts had been proposed: on the one hand, a prospective cohort study, on the other hand, repeated cross-sectional surveys.

The EpiNano monitoring device protocol has since been deployed by Public Health France (which has taken over the INVS missions since 2016).
It entered its operational phase at the beginning of 2014, after being submitted in early 2013 to the Advisory Committee on the processing of information in health research (CCTIRS) and to the CNIL which both gave him a favorable opinion.

Management and partners

Public Health France is responsible for steering the system.

Other partners are associated:

• theANSES, which manages the mandatory declarations of nanomaterials in r-nano in France
• the Directorate General for Labor (DGT) of the Ministry of Labor with which an agreement was signed in 2014, the medical labor inspectorate in the regions (via the DREETS) whose mission is to help make the system known to companies
• theINRS, CEA,INERIS, with regard to the assessment of exposure to nanomaterials and the metrology of aerosols at workstations.

A three-step protocol

The protocol was designed to be pragmatic and scalable. For its launch, EpiNano was spread over three stages:

• 1) the inclusion of companies working in the field of manufactured nanomaterials (by questionnaire sent to companies – identified in particular on the basis of the register r-nano)
• 2) within companies, identification of workstations potentially exposed to nanomaterials and semi-quantitative characterization of exposure (by observation visit to the company)
• 3) the inclusion of employees assigned or intervening in these positions (via a questionnaire sent to employees) and their general follow-up in a prospective cohort, via a questionnaire every three years.

Workers identified as potentially exposed are included in a register to form a prospective cohort with epidemiological monitoring.
Health follow-up is oriented towards monitoring respiratory and cardiovascular effects, but retains a general nature.
The cohort should also be used for studies and following the best practices exploring specific research hypotheses.

A program initially centered on carbon nanotubes and nano-titanium dioxide…

Initially EpiNano was limited to two families of nanomaterials: titanium dioxide nanoparticles and carbon nanotubes, in the form of powders. Their risks are indeed beginning to be well documented.⁷See our sheets:
- Risks associated with carbon nanotubes,veillenanos.fr
- Risks associated with nano titanium dioxide,veillenanos.fr and are often close to those of asbestos.
It was planned from the start that EpiNano could then be extended to other nanomaterials.

In 2014, the data reported in r-nano relating to carbon nanotubes and nano-titanium dioxide have been communicated to the INVS for this Epinano project.

… then extended to silica nanoparticles and carbon black

The program would have been extended to silica nanoparticles since January 2016⁸(information obtained in March 2017, during the ANSES nano dialogue committee) and carbon black⁹(when ?).

This list may still be subject to change depending on the national industrial and scientific context.

The main steps today

• 1) Agreement of the establishment in conjunction with the occupational physician.
• 2) Identification of the exhibitor stations by the competent persons of the establishment and transmission of the industrial hygiene data (HI) necessary to Public Health France.
• 3) Transmission by the establishment of the list of workers eligible for inclusion in EpiNano, in a secure manner and after informing the workers.
• 4) Public Health France sends a letter to the worker's home including an inclusion questionnaire, a refusal form and an information notice.
• 5) Analysis by Public Health France of worker data collected by questionnaire. They will be supplemented by health and cause of death data available from the National System.
  health data (SNDS) in particular. The career history will be reconstituted by extracting data from the CNAV.

Difficulties in implementation

Use of register data declared in the register r-nano proves to be very difficult: the data are fragmented, their analysis is complicated and the identification of the sites where the declared nanomaterials are handled was not easy when the project was launched.
In addition, very few companies have agreed to open their doors and those that do do not necessarily go through with the process.

– from 2014 to 2016

Mi-2016¹⁰See Guseva Canu I et al. (InVS), Epidemiological surveillance system for workers potentially exposed to manufactured nanomaterials in France, EpiNano: assessment after two years of operation, 34th National Congress of Occupational Medicine and Health, Archives of Occupational and Environmental Diseases, 77(3): 521-522, Jun 2016, 156 companies had been contacted, of which only 22 companies had agreed to join the system and had been visited by the EpiNano team from InVS; of the 149 workstations using nano-objects and observed by the team, around half were classified as potentially exposing. This work made it possible to identify 158 people eligible for EpiNano, a third of whom have already joined the system by completing the inclusion questionnaire.
Beginning of October 2016¹¹Figures provided by Kathleen Chami (Santé Publique France / InVS) during the Nanomaterials Day J3P in Nancy on October 13, 2016, the number of companies volunteering had increased to 29, of which 27 were visited, with 153 positions observed and 155 eligible workers; Only 63 had agreed to be part of the follow-up with a double questionnaire (active and passive) for cross-referencing with other databases (SNIIRAM, PMSI, CepiDC).

The occupational physician was associated with the project in 11 companies, by participating in the project presentation meeting and/or the visit. In four companies, the doctor led the project as a resource person. Some doctors declined their participation due to lack of time and/or the non-priority nature of nanos compared to other professional risks.

In 2016 and 2017, new procedures were developed with the Medical Labor Inspectorate to facilitate the identification of companies producing or using nanomaterials and to improve the identification of exhibitor workstations. From now on, the occupational doctor and his team are at the center of this health monitoring system, with a role of promoter of the cohort, with the management of the company, with the support of the occupational physician inspectors and Public Health France¹²See EpiNano: national device for
Epidemiological surveillance of workers exposed to manufactured nanomaterials – The central role of the occupational physician, Renaudie N et al., Occupational Health References, No. 152, December 2017.
The first version of the individual inclusion self-questionnaire had 27 pages on its own! It now has 15, encouraging a better response rate from workers.

– from 2017 to 2020

Communication efforts have been made and communication tools (leaflet, poster, slide show) have been designed, in conjunction with the DGT's medical labor inspectorate. A promotion plan was carried out in 2017¹³See EpiNano gets a makeover, Renaudie N et al., Archives of Occupational and Environmental Diseases, 79(4), 574, September 2018.

In December 2017, Public Health France launched call for applications for the constitution of a Scientific Council for the EpiNano device.

A progress report after 3 years of operation (2017-2020) has been initiated with the aim of taking stock of the state of recruitment of establishments and workers, and, on the other hand, to identify areas improvement in order to optimize recruitment procedures.

The number of participating establishments in 2021 remains quite modest (< 20) and less than 400 workers are registered in the device. This compromises the power of the device to respond in particular to its objective of forward-looking monitoring, while large tonnages of products are used, produced and imported each year in France.

In an article published at the end of 2021¹⁴See " Watch without knowing“, Jean-Noël Jouzel and Jérôme Pélisse, Journal of Anthropology of KnowledgeDecember 2021 in the Journal of Anthropology of Knowledge, two sociologists attached to the Center for the Sociology of Organizations (CNRS, Sciences Po), shed the spotlight on a hitherto poorly understood area to explain the difficulties encountered in the implementation of EpiNano: institutional and organizational tensions and the dynamics of competition between Public Health France (pursuing research objectives as a priority) and the Medical Labor Inspectorate of the General Directorate of Labor (DGT), more focused on the monitoring of occupational risks, carried out in the field by regional doctors labor inspectors (Mirt).

– from 2021 to 2022

Questioned by AVICENN, Public Health France indicated at the end of November that in view of the low number of participating establishments and registered workers, it had been decided to have a pilot survey carried out by the company Ipsos within the framework of a public contract. to ensure the recruitment of establishments and the monitoring of the data collection process (Santé publique France remaining the sole recipient of the data and the survey methodology remaining otherwise unchanged). The results are expected in 2022.

The High Council for Public Health (HCSP), in its assessment of PNSE 1, 2 and 3 published in 2022¹⁵See Overall assessment of National Health-Environment Plans (2004-2019), HCSP, March 2022 also lists the reluctance of companies to register in EpiNano:

• « A potential fear from the point of view of companies to see their criminal liability committed if the device shows a link between exposure and health effects.
• The lack of time and means to complete the questionnaire on exhibitions.
• Sometimes ill will: even though the occupational physician is voluntary, he is it happened that the HSE referent was opposed to the study, which blocked its deployment.
• Another difficulty is related to R-Nano. SpF is one of a limited number of actors that can access registry data. At this stage, a service provider selected to ensure recruitment and monitoring cannot access information on the name of the establishment, even though this data is not confidential. It is not possible to transmit the list of companies to contact« 

How to contribute to its success?

All companies working in the field of production, transformation or use of nanomaterials in France are invited to contact the project manager: Kathleen Chami of Public Health France.

When will there be an automatic connection between r-nano and Epinano?

In the absence of new "volunteer" recruits, AVICENN pleads for making the registration of companies in EpiNano automatic as soon as they complete a declaration r-nano for the nanomaterials concerned (carbon nanotubes, titanium dioxide nanoparticles, silica nanoparticles and/or carbon black at this stage).

The High Council for Public Health (HCSP) also recommends “removal [of] difficulties” faced by EpiNano via “texts, and a decree or a circular”¹⁶See above.

Due to the low number of volunteer companies, delays due to problems of governance and implementation of the project, the smooth running of the program has been undermined, at least temporarily. The challenge today is therefore not only to keep the cohortists but to integrate a greater number of them so that this system can achieve its objectives.

To be continued ...