44th international medichem congress 2016 · 44th international medichem congress 2016 31 aug – 2...

44th International MEDICHEM Congress 2016

31 Aug – 2 Sept, 2016

Basel // Switzerland

Welcome

We heartly wel-come you to the 44th MEDICHEM congress here in Basel. The venue stands in the

great tradition of MEDICHEM where presentation and discussion allow for intellectual exchange and learning from each other. Under the title “Risk Assessments at the Workplace: Con-cepts for Emerging Issues”, we will hear and be able to discuss about topics from

psycho-social factors at work, setting OELs, neurotoxicity issues, remediation work of polluted sites and also results of research and case reports.

We trust this congress is an asset in your personal continued education and networking among peers.

Also, we hope that you will be able to enjoy Basel and the many attractions it offers.

With best regards

Murray Coombs, MDPresident MEDICHEM

Martin Kuster, MD MOHChair organizing committee

Dear Colleagues, Dear members of MEDICHEM

2 | 44th MEDICHEM CONGRESS 2016

General Information

REGISTRATION OFFICE

Organizers Switzerland Ltd. Obere Egg 2CH-4312 Magden

Phone: +41 61 836 98 78Email: [email protected]: www.organizers.ch

Opening hours of the conference secretariat / Info desk:Thursday, September 1, 2016 from 07:30 – 17:00 Friday, September 2, 2016 from 07:30 – 17:00

BADGE (NAME TAG)

You will receive your badge (name tag) upon your arrival at the conference secretariat / Info desk. On-site registration is also possible.

CERTIFICATE OF ATTENDANCE

You will receive a personal certificate of attendance after the conference by email to the email address indicated during your registration.

INTERNET

Wireless LAN is available within the whole conference venue.

ACCOMMODATION

Hotel Bildungszentrum 21Missionsstrasse 21CH-4055 Basel

Phone: +41 61 260 21 21Email: [email protected]

Arrival by public transportation from Basel SBB: Bus No 30 to stop “Spalentor”.

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44th MEDICHEM CONGRESS 2016 | 3

Social Programme

Sept 1, 2016 from 20:00

Our conference dinner lo-cation impresses with its industrial charm. Within the old Sulzer Burck-hardt machinery hall the WERK 8 team will serve international cuisine.

Arrival from the conference venue:

From Allschwilerplatz tram no 14 (direction Pratteln) to stop “Heuwaage”, then change to tram no 16 (direction Bruderholz) to

stop “Tellplatz”. Continue via “Bruder holzstrasse” and turn left into “Dornacherstrasse”.

WERK 8Gundeldinger FeldDornacherstrasse 192CH-4053 Basel

Guided tour across the Novartis Campus with apéro riche

Novartis CampusWednesday, August 31, 2016From 18:00 to 21:00

Arrival by public trans-portation: From Basel SBB tram no 1 (direction Dreirosenbrücke) to stop “Novartis Campus”.

CONFERENCE DINNER

PRE-CONFERENCE RECEPTION

Programme // September 1

08:30 Opening of MeetingWelcome address by the president of MEDICHEMDr. W. Murray CoombsHealth Director, The Dow Chemical Company // South-Africa

Welcome address by Science Industries SwitzerlandDr. Beat Moser, CEOScience-Industries // Switzerland

Welcome address by the City of BaselThe Honorable Dr. Lukas EngelbergerRegierungsrat // City of Basel


Morning, Sept 1, 2016 Chairpersons of the session:Dr. Andreas FlückigerChief Occupational Health Officer, Roche // Basel / Switzerland

Dr. Maren Beth-HübnerPast Secretary General MEDICHEM, Competence Center of Hazardous Substances and Biological Agents at Work, BG RCI (German Social Accident Insurance Institution for the Raw Materials and Chemical Industry) // Heidelberg / Germany


SESSION: SETTING THE LIMIT: INFLUENCE OR RECENT DEVELOPMENTS ON WORKPLACE HEALTH RISK ASSESSMENTS09:15 The role of expert judge ment

and conceptual approaches in setting OELs by the German MAK Commission Prof. Dr. Andrea HartwigProfessor at the Karlsruhe Institute of Technology (KIT), Karlsruhe, Germany, Chair of Food Chemistry and Toxicology

09:50 Occupational Exposure Limits and REACH: Similarities and Differences of DNELs with OEL setting done e.g. by MAK Dr. Gisela StroppChairperson of the subcommittee on “Hazard Risk Assessment” of the German Advisory Committee on Hazardous Substances (AGS-UAIII); Head, Product Stewardship Industrial Chemicals & Operations // Wuppertal / Germany

10:25 BREAK

10:40 OELs for Carcinogens with Thresholds: What is new in Switzerland?Dr. Michael KollerSecretary of the Swiss MAK-Kommission / Swiss Accident Insurance Fund (SUVA) // Lucerne / Switzerland

11:05 OELs and Sensation: Irritation or Odor as basis for an OEL; do’s and don’ts Dr. rer. nat. Kirsten SuckerInstitute for Prevention and Occupational Medicine of the German Social Accident Insurance, Institute of Ruhr University Bochum (IPA) // Bochum / Germany

11:40 How can Occupational Toxicology support Quality: OEL and Permitted Daily Exposure of Pharmaceuticals Dr. Ester Lovsin-Barle, ERTHead Center of Excellence Health Hazard Assessment; Novartis NBS // Basel / Switzerland

12:15 LUNCH


Afternoon, Sept 1, 2016Chairpersons of sessions A/B:PD Dr. med. DrPH Georg BauerHead, Department Public & Organizational Health, Institute for Epidemiology, Biostatistics and Prevention, University of Zurich // Zurich / Switzerland

Dr. Martin RieggerOccupational physician BASF Switzerland // Kaisten / Switzerland


SESSION A: PSYCHO SOCIAL FACTORS AT WORK: RISKS AND POTENTIAL INTERVENTIONS14:00 Risk Assessment and Work-

Life-Balance – two of a pair? Dr. Miriam RexrothDepartment of Occupational Psychology, BG RCI (German Social Accident Insurance Institution for the Raw Materials and Chemical Industry) // Heidelberg / Germany

14:35 Addressing psychosocial factors at work: practical approaches PD Dr. med. DrPH Georg BauerHead, Department Public & Organizational Health, Institute for Epidemiology, Biostatistics and Prevention, University of Zurich // Zurich / Switzerland

15:10 Introduction of the stress outpatient center – a practical example for Viennese public servantsAssoc. Prof. Priv. Doz. Dr. Lukas PezawasUniv. Clinic for psychiatry & psycho-therapy and private practice; Medical Faculty of the University of Vienna // Vienna / Austria

15:45 BREAK16:00 Health and Sustainability

Tee L. Guidotti, MD, MPH, FRCPC, FFOM, FCBOM, DABT, QEPConsultant in Health, Safety, Environment, and Sustainability Occupational+Environmental Health and Medicine

SESSION B: REGULATORY UPDATE16:35 The interval of the

occupational physicals is longer than a year: change of regulation in Switzerland Dr. Claudia PletscherPresident Swiss MAK Commission and Chief Medical Officer Occupational Medicine, Swiss Accident Insurance Fund (SUVA) // Luzern / Switzerland

17:10 End Day 1: Announcements17:15 MEDICHEM General Assembly20:00 Conference Dinner:

Werk 8Dornacherstrasse 192CH-4053 Basel


Morning, Sept 2, 2016Chairpersons of session A:Prof. Dr. David VernezDirector, Institute universitaire romand de Santé ou Travail // Lausanne / Switzerland


SESSION A: FOCUS NEUROTOXICITY08:30 Manganese: Integrating Neurotoxicology and

Epidemiology in Evaluating Human Health Effects Dr. Ken MundtPrincipal and Health Sciences Global Practice Area Leader and Director of Applied Epidemiology at Ramboll Environment and Health // Amherst, MA / USA

09:05 Neurotoxicity tests: How to interpret data PD Dr. Florianne Tschudi-MonnetGroup Leader of Research on Neuroinflammation, Department Physiology, University of Lausanne // Lausanne / Switzerland

09:40 Integration of Neurotoxicity data for handling pesticides Dr. Clive CampbellChief Medical Officer Syngenta // Basel / Switzerland

10:00 BREAK


Morning, Sept 2, 2016Chairpersons of session B:Dr. Claudia PletscherPresident Swiss MAK-Komission and Chief Medical Officer Occupational Medicine, Swiss Accident Insurance Fund (SUVA) // Lucerne / Switzerland

Dr. Martin KusterHead Corporate Health&Biosafety, Novartis Business Services // Basel / Switzerland

SESSION B: SUSTAINABILITY: REMEDIATION OF POLLUTED CHEMICAL SITES: LESSONS LEARNT10:15 Remediation of mixed waste landfill sites

in the Basel industrial regionDr. Richard HürzelerChief Remediation Officer, Roche // Basel / Switzerland

10:50 Remediation of a small site. Lessons Learnt company perspective – Le Letten, France Dr. Hans-Jürg ReinhartRemediation Manager BASF Schweiz AG // Basel / Switzerland

11:25 Remediation of a large site: Lessons Learnt from a regulators perspective-Bonfol, JuraJean ParratIndustrial Hygienist at the Republic and Canton of Jura // Delémont / Switzerland

12:00 LUNCH




SESSION: OPEN PRESENTATIONS13:15 VISION ZERO – The New

Global Prevention Strategy of the International Social Security Association Volker NeumannBG RCI (Berufsgenossenschaft Rohstoffe und chemische Industrie; German Social Accident Insurance Institution for the Raw Materials and Chemical Industry)

13:35 The Internal and External Dose Relationship Analysis in Occupational Lead Exposure Group Prof. Dr. Fang Jin-BinVice Dean Occupational Health Center, Shanghai Institute of Occupational Disease for the Chemical Industry

13:55 Health Effects of Cobalt and Its Compounds on Humans Dr. Liu Wu-zhongAssociate Chief Physician, Shanghai Institute of Occupational Disease for the Chemical Industry

14:15 Monitoring results of drug product exposure during reconstitution of powder for oral solution Dipl. Ing Cordula MeierMAS Work and Health Occupational Hygienist, F. Hoffmann-La Roche Ltd. // Basel / Switzerland

14:35 Break15:00 OVERUSE INJURIES:

Occupational and/or Genetic Hazard? Marilize Burger, PhDDivision of Exercise Science & Sports Medicine, Department of Human Biology, University of Cape Town // Cape Town / South Africa

Afternoon, Sept 2, 2016Open PresentationsChairpersons of session:Dr. Dirk PallapiesInstitute for Prevention and Occupational Medicine of the German Social Accident Insurance, Institute of Ruhr University Bochum (IPA) // Bochum / Germany

PD Dr. Robert WinkerHead Center Health and Prevetion, Sanatorium HERA // Vienna / Austria


15:20 Diphoterine®, an amphoteric, polyvalent, hypertonic eye / skin chemical splash decontamination solution: 14 years updated data Alan H. Hall, MDToxicology Consulting and Medical Translating Services, Azle and Spring-town, Texas; Colorado School of Public Health, University of Colorado-Denver // Denver, Colorado / USA

15:40 Recurrent Laryngeal Nerve Neuropathy Secondary to Occupational Lead Poisoning Wenceslao A. Kiat Jr. MD, DPSCOT, FPSCOTHead, Comprehensive Occupational Health and Environmental Safety Service, St. Luke’s Medical Center // Quezon City / Philippines

16:00 Light and ultrastructural observations in neonatal experimental animals’ organs after “in vivo” exposure to heavy metals during gestation Professor Elpida-Niki Emmanouil-Nikoloussi, DDS PhD, MD PhDProfessor of Histology-Embryology, School of MedicineEuropean University of Cyprus

16:20 Closing of MeetingPresident MEDICHEM: Dr. Murray Coombs

17:00 End of meeting



Abstracts

Sept 1, 2016; 09:15The role of expert judgement and conceptual approaches in setting OELs by the German MAK CommissionProf. Dr. Andrea HartwigChair of Food Chemistry and Toxicology;

Karlsruhe Institute of Technology (KIT)

// Karlsruhe / Germany

MAK and BAT values are established by the “Permanent Senate Commis-sion for the Investigation of Health Hazards of Chemical Compounds in the Work Area” (MAK Commission). The proposed values are based on available scientific data with respect to epidemiological findings, occupational medical reports, toxicological properties as well as mechanistic data concern-ing the mode of action. Furthermore, occupationally relevant substances are evaluated with respect to carcinogenic, germ cell mutagenic and sensitizing properties as well as percutaneous absorption and potential reproductive toxicity and classified accordingly. Within these evaluations, conceptional work is of increasing importance, for example when evaluating carcinogenic subtances in the low dose range. Other examples for conceptional work are the evaluation of granular biopersistent dust, of fibers, of metals and their compounds and of nanomaterials, discussed in specialized

expert working groups within the MAK commission. Consideration will be also given to the analytical surveillance of MAK and BAT values, accompanied by the development of methods for analysis in air and biological materials. Exposure limits, notations and classifications are published anually in the List of MAK and BAT values and in detailed scientific documentations via open access in “The MAK Collection for Occupational Health and Safety” available also in an English translation http://onlinelibrary.wiley.com/book/10.1002/3527600418

September 1, 2016; 09:50Occupational Exposure Limits and REACH: Similarities and Differences of DNELs with OEL setting done e.g. by MAKDr. Gisela StroppHead, Product Stewardship Industrial

Chemicals & Operations at Bayer Pharma

AG, Wuppertal / Germany; Chairperson of the

subcommittee on “Hazard Risk Assessment” of

the German Advisory Committee on Hazardous

Substances (AGS-UAIII)

There is some overlap, but the primary purpose of OELs and DNELs is different: whereas an Occupational Exposure Limit (OEL) is intended to specifically regulate the exposure at the workplace a Derived No Effect Level (DNEL) under REACH serve as benchmarks for the selection


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of risk management measures. DNELs shall be established reflecting the likely routes, duration and frequency of exposures. The final risk characterisation consists of a comparison of human ex-posures with the DNELs. When DNELs are achieved the risks to humans are considered to be adequately controlled. For the occupational setting, inhalation is a major route of potential exposure, and therefore typically DNELs have to be derived at least for the inhalation route.

Occupational exposure limits (OELs) are available for a number of chemicals, e.g. from the EU Scientific Committee for Occupational Exposure Limits (SCOEL), from the German MAK Commission and e.g. German Committee on Hazardous Substances (AGS). All the committees have published their methodology how to derive an OEL and the methodology to derive a DNEL is defined in a respec-tive ECHA Technical Guidance Docu-ment. Similarities and differences of the DNEL and OEL setting will be pre-sented, and background information for derivation of DNELs will be given.

September 1, 2016; 10:40OELs for Carcinogens with Thresholds: What is new in Switzerland?Dr. med, Dr. rer nat Michael KollerSecretary of the Swiss MAK Commission

(Suissepro); Swiss Accident Insurance Fund

(SUVA) // Lucerne / Switzerland

Carcinogens act either in a genotoxic or non-genotoxic way. Genotoxic carcino-gens interact physically with DNA to damage or change its structure resulting in a mutation. Such a mutation may be the first step (initiation) of carcinogen-esis. We often find no threshold concen-tration for the carcinogenic effect.Non-genotoxic carcinogens are involved in mechanisms such as inflammation, immunosuppression, ROS, receptor activation or epigenetics. These mecha-nisms lead to altered signal transduction or modified gene expression and are mainly found in the second step (promo-tion) of carcinogenesis. In this case, a threshold concentration often can be found.In Switzerland, there were no different notifications of occupational carcino-gens with and without thresholds – all substances were treated as carcinogens without threshold. However, in occupa-tional medicine it would be important to distinguish between carcinogens without and with thresholds, because in case of a lacking threshold even smallest


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concentrations of the substance may (theoretically) lead to cancer. Therefore in 2016, a new notification for carcinogens with thresholds was introduced, similar to SCOEL or DFG. In Switzerland, official notifications and exposure limits for the working place are set by SUVA.

September 1, 2016; 11:05OELs and Sensation: Irritation or Odor as basis for an OEL; do’s and don’tsDr. rer nat Kirsten SuckerHead Exposure Laboratory

Institute for Prevention and Occupational

Medicine of the German Social Accident

Insurance (IPA) Institute of the Ruhr-University

// Bochum / Germany

About 40 % of the occupational exposure limit values (OELs) in Germany are based on the avoidance of sensory irritation. Effects at the eyes and the upper respiratory tract are the endpoints for the establishment of health-based exposure limits. These so-called sensory irritation effects are related to the interaction of volatile chemicals with receptors of the nervous system (e.g. trigeminal nerve endings) and a downstream cascade of reflexes

and defense mechanism such as watery eyes or coughing. It is assumed that high or prolonged exposure can lead to neurogenic inflammation and subse-quently tissue damage.Due to the DGUV funded research, methods and procedures were devel-oped in order to be now able to evaluate and avoid health effects of acute irritant exposure at the workplace. Controlled human exposure studies such as those carried out in the laboratories of the IPA and IfADo, are now considered as the “gold standard” in the irritant research.Based on a scientific analysis of sub-stances known to be sensory irritants with appropriate human and animal data a recommendation for the derivation of occupational exposure limits consider-ing the interspecies extrapolation was published.Unpleasant and annoying odors are not important for setting limit values at the workplace, as long as the annoy-ance is not unreasonable. Currently it is discussed whether odor effects should be considered for the risk assessment of indoor air pollutants, for example, at office workplaces.


Abstracts

September 1, 2016; 11:40How can Occupational Toxicology support Quality: OEL and Permitted Daily Exposure of PharmaceuticalsDr. Ester Lovsin-BarleERT

On November 20th, 2014, the European Medicines Agency (EMA) finalized the “Guideline on setting health based ex-posure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”. This guideline was written to support Chapters 3 and 5 of the EU GMP guideline, which were recently revised to promote a science and risk-based approach to assessment of cross contamination risk, and refer to a “toxicological evaluation” for establishing threshold values for risk identification. The guideline outlines an approach for review and evaluation of pharmacological and toxi-cological data to derive health based limits. These Permitted Daily Exposure (PDE) limits can be applied to evaluate cross con-tamination risks during manufacturing. We will be presenting different methods for calculation of limits used in cross-contami-nation risk assessment and compare them with the occupational exposure limits (OEL). Each of the available methods will be presented with their pros and cons and compare them with the OELs and assess possible correlations.

Keywords: PDE, OEL, pharmaceuticals, manufacturing

September 1, 2016; 14:00Risk Assessment and Work-Life- Balance – two of a pair?Dr. Miriam RexrothDepartment of Occupational Psychology

BG RCI (German Social Accident Insurance

Institution for the Raw Materials and Chemical

Industry) // Heidelberg / Germany

Work-Life-Balance (WLB) has been a popular keyword for quite some time. Nevertheless new research results, that underline the impact of WLB on wellbe-ing, add even more importance to the topic. So far attempts to foster WLB are mostly only individual centered. Organisations offer several possibilities that should support employees to cre-ate a better balance between their life domains. However, structural prevention orientated approaches are often neglect-ed. Organisations often use WLB as an attractive offer for employee recruitment and retention, as it is repeatedly shown that WLB is an important decision factor in choosing an employer. From these observations the impression can arise that WLB lies in the sole responsibility of the employees and is only something “nice to have” for companies. However, the Joint German Occupa-tional Safety and Health Strategy defines


causes of strain in the workplace and includes blurred boundaries between life domains as one possible cause. A missing segmentation of life domains can have a negative impact on WLB and lead to impaired wellbeing. Therefore it seems plausible that organizations are in fact somewhat responsible for creating conditions that allow a balanc-ing of the life domains. Our presentation addresses the controversy between legal requirements for organisations and individual responsibilities for their private life.

September 1, 2016; 14:35Addressing psychosocial factors at work: practical approachesPD Dr. Georg BauerHead, Division Public & Organizational Health,

Institute for Epidemiology, Biostatistics and

Prevention, University of Zurich

// Zurich / Switzerland

Psychosocial factors are highly relevant for occupational health – also in the chemical industry. An imbalance of job demands such as time pressure or unclear roles and of job resources such as decision latitude and social support at work lead to work-related stress. There is consistent evidence that work stress

is related to most non-communicable disease including mental health, car-diovascular disease, muscular-skeletal disorders – but also is related to higher exposures, accidents and social con-flicts.Companies can address psychosocial factors at work on several levels:

a. Individual approaches: e. g. offer-ing courses for stress management, job crafting or recovery crafting. Although these approaches can be effective, they currently are not systematically offered by companies. Here, emerging new apps will facilitate the broader usage in the future.

b. Organisational approaches: e.g. company-wide surveys of the key job demands and job resources as a basis for targeted improvement of working conditions on the company level. As such a “psychosocial risk assessment” is legally required in several European countries and as related, validated instru-ments exist, this approach should find a wider distribution.

c. Team approaches: team leaders and their teams have best knowledge about key psychosocial working conditions and how to improve them on the team level. Practical tools for team health develop-ment are currently emerging.

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September 1, 2016; 15:10Introduction of the stress outpatient center – a practical example for Viennese public servantsAssoc.Prof. Priv.Doz. Dr. Lukas PezawasDep. Psychiatry and Psychotherapy, Medical

Faculty of the University of Vienna; Health and

Prevention Center, Hera // Vienna / Austria

The outpatient clinic for stress-related disorders at the Health and Prevention Center, Sanatorium Hera, has recently been founded to address the challenges that arise from a substantial increase of stress-related psychiatric disorders in the field of occupational medicine.Patients are being treated by a multi-disciplinary team of medical specialists, psychologists and other health care professionals with a variety of phar-macological and non-pharmacological treatments including mindfulness-based stress reduction (MBSR), hypnotherapy, motion/sports therapy and short-time psychotherapy/coaching. Apart from its clinical duties, the team of the outpa-tient clinic for stress-related disorders is highly committed to research investigat-ing the molecular signature of such a patient group.Additional to its clinical structure and important patient characteristics, we will present results of a preliminary analysis of several potential biomarker candidates that have been evaluated in

a rather large sample of patients and healthy controls, which might subserve as potential biomarkers or predictors of stress-related psychiatric disorders in the future.

September 1, 2016; 16:00Health and Sustainability Tee L. Guidotti, MD, MPH, FRCPC, FFOM, FCBOM, DABT, QEPOccupational + Environmental

Health & Medicine

The relationship between sustainability (as sustainable development) and health has been assumed but has it been rarely rigorously examined. Sustain-able development does not automati-cally lead to health gains but can be a strategy to reduce health disparities and enhance as well as protect health. Health is important to sustainability, as well, as a sustainable future requires individual health security and high levels of population health. Sustainability has moved from fad and catch-phrase to social and corporate reality, open-ing important opportunities for health gains. Thinking about sustainability must go beyond the “source-effect model”, causation analysis, and risk assessment, which apply mostly to pollution and embrace other conceptual models. The concept and emphasis of sustainability is transformative because it changes a

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negative (the presence of a threat and the imperative of preventing bad things from happening) into a positive (a better and more secure life) while maintaining essential functions, similar to the change in emphasis on public health to health promotion. Sustainability as a policy also represents a “path of least resistance” to achieving health and social goals with less conflict and fewer issue-specific stumbling blocks. For the chemical in-dustry, the advent of “green chemistry” has opened opportunities for enhancing utility and value as well as reducing risk and furthering social and environmental goals.

September 1, 2016; 16:35The interval of the occupational physicals is longer than a year: change of regulation in SwitzerlandDr. Claudia PletscherMember Swiss MAK-Commission and Chief

Medical Officer Occupational Medicine, Swiss

Accident Insurance Fund (SUVA)

// Lucerne / Switzerland

Suva the Swiss National Accident Insur-ance Fund is an organization under pub-lic law that is responsible for prevention of occupational diseases and accidents in Switzerland.

Medical surveillance programs can be mandatory for employees working in high-risk workplaces in the chemical and pharmaceutical industry. If a workplace must be considered high-risk for occupa-tional disease is decided by a physician of the Suva department of occupational medicine. The extent of the medical screening programs is risk-based. The exam is not a general health checkup but a targeted evaluation of parameters that may as-sociated with occupational exposures or diseases.In Switzerland high standards of techni-cal and organization measures are gener-ally established. The results of the Suva medical surveillance programs indicate that much more of the detected patholo-gies are non-work related. This led to a reevaluation of the medical surveillance programs offered by Suva in 2015. Main changes were made in the evaluation of workers in the chemical and pharma-ceutical production as well as workers potentially exposed to ionizing radiation.The main changes and the new strate-gies of medical surveillance are present-ed in this overview.

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September 2, 2016; 08:30Manganese: Integrating Neuro-toxicology and Epidemiology in Evaluating Human Health EffectsProf. Dr. Kenneth MundtEnvironment and Health; Ramboll Environ, Inc.

// Amherst, Massachusetts, 01002 / USA

Humans are surrounded by hazard-ous chemicals. With few exceptions, however, exposures occur at extremely low concentrations, and health impacts are not seen. Manganese (Mn) is an ex-ample where low concentrations are es-sential to health, but high concentrations are neurotoxic, leading to a debilitating disease called “manganism.” The adult RDI for Mn – poorly absorbed in the gut – is 2 – 5 mg, and is a cofac-tor for vital enzymes critical to multiple metabolic processes. Dietary deficiency is rare, and leads to glucose metabolic disorders, skeletal abnormalities and impaired sexual function. Higher exposures via inhalation occur in Mn mining and refining, steel production and welding. Lower exposures may be seen in some glass, ceramics, coat-ings, textiles, pesticides and cosmetics production processes. Mn also is used in gasoline additives, and some medical applications. Very high Mn exposure (2.6 – 22 mg/m3) leads to dysfunction of the basal ganglia and Parkinson-like symptoms, with

subtler impairments suggested at lower levels. Several complex mechanisms for Mn homeostasis in the nervous system suggest tolerance to moderate exposures. What actually happens at low concentrations (i.e., below 2.6 mg/m3), however, remains unclear, and will require fuller integration of exposure sci-ence with toxicology, mechanistic evalu-ations and epidemiology – including the use of sensitive biomarkers of exposure and effect – to elucidate these complex dose-response relationships.

September 2, 2016; 09:05Neurotoxicity tests: How to interpret dataPD Dr. Florianne Tschudin MonnetGroup Leader of Research on Neurotoxicology/

Neuroinflammation; Department Physiology,

University of Lausanne // Lausanne / Switzerland

There are few epidemiological studies suggesting an association between exposure to environmental toxicants and neurodegenerative diseases. However, several mechanisms are known to be involved in the pathophysiology of neu-rodegenerative diseases. In vitro models are well suited for studying mecha-nisms of toxicity. We use a 3D culture system prepared from fetal rat brain cells, comprising all types of brain cells (neurons, astrocytes, oligodendrocytes and microglial cells) to study toxicant-in-

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duced neuroinflammation, a mechanism of toxicity known to be involved in the neurodegenerative process. Using the herbicide paraquat as model compound, we showed that a repeated treatment during early brain development (i.e. synaptogenesis, myelination) triggered a neuroinflammatory response expressing the neurodegenerative phenotype, even after a treatment arrest allowing partial recovery of paraquat-induced adverse ef-fects on neurons. These results suggest that long-term neuroinflammation may be a link between early environmental-induced adverse effects and late onset of neurodegenerative diseases.Based on these investigations of mechanisms of toxicity, risk assessment is evolving from testing exclusively toxicant-induced apical adverse effects towards a mechanistic-driven approach with the concept of Adverse Outcome Pathway (AOP), developed by OECD in 2012. An AOP is a structured repre-sentation of biological events leading to adverse effects and relevant to risk assessment.

September 2, 2016; 9:40Integration of Neurotoxicity data for handling pesticidesDr. Clive CampbellChief Medical Officer Syngenta

// Basel / Switzerland

It is said that neurotoxicology has emerged from the integration of toxicol-ogy, pharmacology, psychopharmacology and experimental psychology. It involves study of changes in the function and / or structure of the nervous system as a result of chemical exposure, and inter-pretation of the consequences of such changes.The nervous system is complex with different cell types and anatomy, as well as differing synaptic function and neuro-transmitters. I will try to give an overview of the methodology for neurotoxicology stud-ies, over the past few decades, including recognition of the increasing importance of behavioral studies. In addition I will attempt to cover the interpretation of the studies (using examples from our industry), and finally I will illustrate how such studies are used in regulatory and occupational health risk assessments.

Abstracts


September 2, 2016; 10:15Remediation of mixed waste landfill sites in the Basel industrial regionDr. Richard HürzelerChief Remediation Officer, F. Hoffmann-La Roche

Inc. (Roche) // Basel / Switzerland

The Basel region comprises territory in 3 countries (Germany, France, Switzerland) and used to be one of the heaviest in-dustrialized areas within central Europe. Among others the chemical industry started manufacturing within the Basel region as early as the second half of the 19th century.Chemical, pharmaceutical and other in-dustrial operations and the processing of associated wastes left their traces over time. While at the beginning the River Rhine received wastes from manufactur-ing plants this practice was abandoned in the early 1950s. Left with no other options, i.e. waste incineration technol-ogy was not yet developed; hazardous wastes from chemical manufacturing were deposited, together with municipal rubbish, in a variety of local dump sites (e.g. ravines or gravel pits). Thus they were called ‘mixed waste landfills’, ver-sus ‘pure’ hazardous waste landfills.While country specific contaminated site legislation came into effect, notably in Germany (1998) and Switzerland (1998), France introduced a generic legislation regarding pollution management in

2000. In 2001 the chemical and phar-maceutical companies in Basel joined forces and founded the association “IG DRB1)“ (Interest Group relating to landfill safety in the Basel region).IG DRB adopted the issue holistically, conducted a thorough review of inter-nal and external sources and identified 12 disposal sites, 4 in each country, where its members or their predecessor companies had been involved. A col-laboration was established with relevant stakeholders such as authorities, munici-palities, residents and other stakehold-ers at locations in all 3 countries, with the country-specific legal framework having been an additional implication in the process of evaluating risks and measures at the individual sites.The individual historical landfills encoun-tered and each investigation / remedia-tion project the IG DRB kicked-off were unique, according to the presence / distribution of contaminants, the pre-dominant (hydro-)geology as well as its location and foreseeable reuse. Typical contaminants met at these landfills were e.g. Petroleum hydrocarbons (fuel, oil etc.), (halogenated) organic solvents (e.g. Tetra- and Trichloroethene), Pol-yaromatic Hydrocarbons, substituted Benzenes, heavy metals and inorganic salts (e.g. ammonia).Also, the IG DRB committed itself financially to guarantee a fast problem

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resolution. In some cases the IG DRB engagement led to the development of novel approaches or an improvement of solutions such as the application of com-prehensive environmental risk analysis for landfill sites, communication con-cepts, analytical methods (e.g. optimized screening methods) as well as techni-cal / organizational measures for labour safety, hygiene and personnel protection in remediation projects.In 2009, 8 years after its foundation, the IG DRB was replaced by individual pro-ject teams at the remaining landfills.Today, of the 12 initial landfills, 4 have been investigated and/or remediated and are left with no remaining risks. At 2 sites remediation is on-going, while 5 sites are being monitored and at 1 site remediation is pending after the authori-ties’ decision.Thus the chemical / pharmaceutical enter-prises in the Basel region have purpose-fully resolved the initial issue.

1) Founding members of the IG DRB were Ciba

Specialty Chemicals Inc. (today BASF Schweiz

AG), Novartis International Inc., F. Hoffmann-

La-Roche Inc., Syngenta Crop Protection AG,

Clariant (Schweiz) AG, Rohner Inc. and SF-Chem

Inc. (today CABB AG)

September 2, 2016; 10:50Remediation of a small site. Lessons Learnt company perspective – Le Letten, FranceDr. Hans-Jürg ReinhartRemediation Manager BASF Schweiz AG

// Basel / Switzerland

The former landfill “Le Letten” in France close to Basel was operated between 1957 and 1960. On area of 7,500 m2 chemical waste together with con-struction debris were landfilled down a hillside in a forested area. Of 40,000 t of waste 10 % were typical chemical production waste as filter aids, distilla-tion bottoms, disposed failed production batches and packaging materials.The landfill was investigated in several steps between 2000 and 2007. In 2008 IG DRB decided to remediate “Le Letten” by excavating all waste materials. IG DRB1) worked with a general planner, a general contractor and a safety coordinator as prescribed by the French regulations.

Remediation projects follow several steps:- Deforestation- Installation of project infrastructure

and machinery- Temporary cover to protect the

environment- The actual excavation with loading of

material into transport containers

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- Transport and waste treatment in specialized facilities

- Decommissioning of infrastructure- Refilling of remaining pit and

landscaping- Reforestation

The project comes with a series of safety measures:- Rainwater has to be collected on site

and can be discharged after chemical analysis only

- Groundwater is protected and its level decreased by a series of pumping wells up- and downstream of the site. The pumped water has to be cleaned with active carbon filter installations

- A temporary housing protects the environment. A ventilation system evacuates and filters mobilized chemicals but keeps also an under pressure in the “black zone” to prevent an air flow to the outside.

- Personal Protection Equipment has to be chosen carefully according to the chemical fingerprint.

- A black and white zone with lock systems has to be installed an trained

- In this project we used breathing masks with active carbon filters for short stays in the black zone.

- For longer stays a breathing system based on compressed air supply lines in the black area were used.

- Training is key also with external services

- All these safety measures are surveyed with an analytical monitoring program for air and water including on line measurements

- Personnel entering the black zone follow regular medical check-ups including biomonitoring.

- Machinery in the black zone is equipped with an independent compressed air. Rescue equipment cares for safety if the machinery needs to be left unexpectedly.

- Regular safety audits and discussions with external consultants are extremely helpful

- For Transportation we used special containers equipped with pressure compensation through active carbon filters

The excavated waste was sent special water treatment plan. The exact treat-ment facility is chosen after a chemical analysis of a waste lot. Strict limit values have to be respected based on permits for the different facilities.Remediation projects have always a political aspect and have to be accompa-nied by a professional and very transpar-ent communication strategy.Today the former landfill “Le Letten” has been remediated. A very small monitor-ing program is still in place to monitor the natural attenuation of chemical traces still in groundwater.

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September 2, 2016; 11:25Remediation of a large site: Lessons Learnt from a regulators perspective – Bonfol, JuraJean ParratIndustrial Hygienist at the Republic and Canton

of Jura // Delémont / Switzerland

The Swiss ordinance on the remedia-tion of polluted sites entered in force on 1998. Based on this regulation, the Government of the Republic and Canton of Jura signed an agreement with the representative of Swiss chemical firms for the definitive remediation of a contaminated site in Bonfol (JU-CH) containing approximately 114,000 tons of chemical waste. Opening such a site for a total remediation cannot be considered as a trivial job identical to the work practices in the chemical industry. Applying the same workers protection principles and prevention practices as in a current chemical production could lead to a lack in the workers health’s protec-tion and unexpected (or unrecognized) problems. Opening a site for a remedia-tion conduces to direct exposition risks related to the presence of free volatiles and non-volatiles toxic substances. Unlike in the chemical production, substances and products present during the work are often not exactly known, but only suspected (historical investiga-tion are often insufficient, superficial or

incomplete) when not simply ignored, especially in the case of chemical waste produced by chemical production and possibly containing active substances, byproducts or intermediate. The choice of the remediation technique should not only be considered in an environmental perspective but must also to appeal to occupational health (OH) specialists who will be included in a multidisciplinary decision process. During remediation works, applying usual practices of work-ers health prevention could, in certain cases, conduce to failure in the objec-tives of health protection (e.g. using cur-rent TLV and BEI for multiple exposure, applying current accidental risk analysis without taking into account multiple chronic risks, limitating the action on the single prevention of recognized oc-cupational diseases without taking into account the necessary prevention of the work related diseases, using prevention practices of the chemical industry for workers that are often coming from the field of construction or engineering, etc.).Usual practices of the OH specialists have to be widely enlarged beyond their usual daily professional activities. Spe-cific problems have to be recognized and controlled by implementing principles, techniques and assessments programs that are usually not systematically ap-plied in a current chemical production or by engineering or construction activities.

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September 2, 2016; 13:15Vision Zero – the new global prevention strategy of the International Social Security AssociationVolker Neumann, MS

340 million accidents at work happen worldwide every year, only counting those leading to more than four days absence. 360,000 end fatal. Two mil-lion people more die every year due to work-related diseases. To sum this up: around 2.4 million people die every year because of work conditions.In 2014, the International Social Secu-rity Association (ISSA) decided on an important step to meet this unaccepta-ble situation: Its 13 Prevention Sections jointly adapted the Vision Zero Preven-tion Strategy. This ambitious approach aims at a working world in which nobody is killed at work nor suffers injuries or illnesses that are so severe that they result the lifelong impairment of health.

Along with this, the ISSA is promoting “Seven Golden Rules” to systematically improve occupational and health at the enterprise level and published as the “VISION ZERO-Guideline”. These serve as highly practical checklists basing on the experience of 700 industry managers as well as 300 prevention experts, extracted and streamlined for easy application where they are needed.The Seven Golden Rules were born in mining, designed as a reaction to a sec-tor standing out in accident frequency and severity across the world. While many successful mining corporations prove that safe operations are pos-sible despite of the latent risks, their knowledge and experience has led to the Seven Golden Rules, now made available to all sectors by the ISSA, also to the chemical industry. The presenta-tion will give examples of successful enterprises.

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OPEN PRESENTATIONS


September 2, 2016; 13:35The Internal and External Dose Relationship Analysis in Occupational Lead Exposure Group Prof. Dr. Fang Jin-BinShanghai Institute of Occupational

Disease for Chemical Industry

[Objective] To analyze the internal and external dose relationship in occupa-tional lead exposure population. [Methods] 92 workers from the work-place with high lead smoke concen-tration in air were chosen, the lead in urine and blood of them were tested. [Results] Blood lead levels in male lead exposure workers increased with age. Lead levels in blood and urine increased gradually as the extension of working age (p<0.01). The correlation coefficient of external dose and blood lead level in male workers was 0.335 (p=0.003); the correlation coefficient of external dose and urine lead level in male workers was 0.353 (p=0.002). There was a certain cor-relation between lead levels in urine and blood; the correlation coefficient of blood lead level and urine lead level in male workers was 0.886 (p<0.01), in female workers, the value was 0.795 (p<0.01).

[Conclusion] Through the analysis and comparison of the internal and external dose relationship in lead exposure work-ers, a certain correlation was revealed between external dose and lead levels in urine and blood, and between blood lead level and urine lead level.

September 2, 2016: 13:55Health Effects of Cobalt and its Compounds on HumansDr. Wu Liu-ZhongShanghai Institute of Occupational

Disease for Chemical Industry

Cobalt is an essential trace metal ele-ment which is widely used in industrial production. Cobalt plays an important physiological role in human body. However, excessive intake of cobalt can cause a variety of toxic effects on the body. This presentation reviews the physiologi-cal function as well as the health hazards of cobalt and its compounds, in order to raise the awareness on those exposed to cobalt, and to provide direction for further research on the health effects of cobalt.

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September 2, 2016; 14:15Monitoring results of drug product exposure during reconstitution of powder for oral solutionDipl. Ing. Cordula MeierMAS Work and Health, F. Hoffmann-La Roche AG

In this monitoring study the risk of drug substance exposure during reconstitu-tion of powder for oral solution was determined. The exposure was also estimated for incidents which may hap-pen during this reconstitution process. The study was performed with Nap-roxen Sodium as a surrogate instead of the active ingredients of the two most critical Roche products. The dustiness of the non-micronized Naproxen used in test series D is comparable with the dustiness of the 2 products. The results of the studies show clearly that the

exposure during an incident-free recon-stitution is far below the respective limit values. An unacceptable health risk for the persons involved in reconstitution is not present. Additionally, the exposures during some of the potential incidents (tipping over of the bottle, dropping the bottle onto the table from a height of 10 cm) are so low that they can be ac-cepted as long as they do not occur with a very high frequency. In summary: the procedure of reconstitution of powder for oral solution for the two most critical Roche products is safe for the persons involved, even if sporadic incidents occur. Additional protection measures, for example respiratory protection (e.g. filtering face piece masks) or ventila-tion systems (e.g. laminar flow) are not needed when reconstituting the two Roche products.

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September 2, 2016; 15:00Overuse injuries: Occupational and/or genetic Hazard?Marilize Burger PhDDivision of Exercise Science & Sports Medicine,

Department of Human Biology, University of

Cape Town // Cape Town / South Africa

Overuse, whether as a result of partici-pation in sport or occupational activity, is seen as a common cause of various different musculoskeletal soft tissue injuries even though the exact aetiology of these injuries is still unclear. A genetic involvement in the injury aetiology has been proposed. Genetic polymorphisms within several genes encoding struc-tural or regulatory components of the collagen fibril, the basic structural unit of tendons, have previously been associ-ated with lower limb tendon injuries in sport. These and other polymorphisms, highlighting a pathway-based effect from overuse to injury, have now also been shown to be associated with altered risk of common occupational, upper limb, overuse injuries, specifically carpal tun-nel syndrome. This research highlights the role of genetics as a non-modifiable risk factor in upper limb, overuse injuries and this knowledge could potentially be used in the future to reduce risk by alter-ing modifiable risk factors.

September 2, 2016; 15:20Diphoterine®, an amphoteric, polyvalent, hypertonic eye / skin chemical splash decontamination solution: 14 years updated dataAlan Hall, MDToxicology Consulting and Medical Translating

Services, Azle and Springtown, Texas Colorado

School of Public Health, University of Colorado-

Denver // Denver, Colorado / USA

2 – 10 % of all burns are chemical.1 Re-views of safety and efficacy of Diphoter-ine® solution were published in the early 2000s2,3. Since then, in vitro, ex vivo, in vivo and clinical studies support this so-lutions as safe and superior to tap water, normal saline, or buffered solutions.It has 6 binding sites for nearly all chemi-cal substances and is innocuous, not absorbed, non-sensitizing, and superior to water flushing.3-–5 Where Diphoterine is available, chemical splash injury sever-ity is reduced.Ocular chemical applications in animals16 have shown superior efficacy as com-pared to alternative buffered eyewash solutions. In rat studies of concentrated hydrochloric acid dermal exposure17,18 it was more efficacious than normal saline; pain and inflammation were significantly reduced. Industry clinical studies3,7, 8 in comparison with water or buffered solutions have shown lack of sequelae, decreased need

Abstracts


for secondary care, and lesser or absent lost worktime.Delayed utilization has stopped further chemical injury and extracted a portion of already penetrated chemical. Further treatment can thus be done in optimal conditions.When corneal or skin pH is returned to the physiological range (5.5 – 9.0), pain is decreased, re-epithelization time ameliorated, and risk of complications lessened.14,15

Note: references available from presenter

September 2, 2016; 15:40Recurrent Laryngeal Nerve Neuropathy Secondary to Occupational Lead PoisoningDr. Wenceslao A. Kiat Jr.St. Luke’s Medical Center

// Quezon City / Phillippines

Occupational lead exposure constitutes another large group of person at risk. Lack of personal protective equipments and ignorance regarding the deleterious effects of this heavy metal continues to be the major factors that predispose them to its toxic effects. Chronic lead poisoning has toxic effects on multiple

organ systems, particularly the hemato-logic and neurologic systems of all ages. However, recurrent laryngeal nerve involvement is commonly seen in horses but not in humans. We report a case of a 29-year-old male, a metal grinder for about a year and a half. He sought consult because of voice stuttering, in-comprehensibility, feeling of choking and swelling of the right arm noticed within six months in his job. Consult with a neurologist and cardiologist was done and ruled out any primary neurologic or cardiovascular problem. EMG-NCV showed evidenced of nerve entrapment consistent with carpal tunnel syndrome. Blood lead level was 29 ug/dl. A direct nasopharyngolaryngoscopy revealed generalized weakness of the oropharyn-geal area with weakness of velopharyn-geal function. There is also weakness on abduction of left vocal cord compared with the right. Chelation was done using Dimercaptosuccinic acid (DMSA). A repeat blood lead analysis 2 weeks after treatment showed 2 ug/dL. There was also a significant change in his voice and resolution of other symptoms. This report showed that lead poisoning could manifest as voice problem and should be considered as a differential diagnosis.

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September 2, 2016; 16:00Light and Ultrastructural Observations in Neonatal Experimental Animals‘ Organs After “In Vivo” Exposure to Heavy Metals During GestationElpida-Niki Emmanouil-Nikoloussi MD PhD DDS PhD Embryologist-Teratologist; Professor of

Histology-Embryology & Anthropology;

School of Medicine.European University Cyprus

// Nicosia / Cyprus

INTRODUCTION Human environmental exposure to a variety of heavy metals is unavoidable. For instance, millions of people have ac-cess only to arsenic-contaminated water, whereas industrial pollution, naturally occurring high concentrations of heavy metals, and smoking, are all sources of heavy metal intake. Moreover, placenta barrier partial permeability raises questions concerning exposure to heavy metals dur-ing development. Among the several toxic side effects that Heavy Metals can induce to mammalian organism a well-recognized neurotoxic effect, liver and lung toxicity and infertility are discussed. The aim of this presentation is to present and discuss results of our previous research experience based on our collective experimental data and concerning the effects of gestational exposure to heavy metals at neonatal brain and lungs after “in vivo” administration of heavy metals during gestation.

MATERIALS AND METHODS At all our studies, female Balb/c mice, used for them, were kept in standard laboratory conditions. Mice were mated overnight in colony cages for conception and females found positive for vaginal plugs presence were considered as be-ing at 0 gestational day. Pregnant mice were randomized to individual cages. Three groups 20 mice each, one for each substance administration, Cadmium, Lead and Arsenic, were composed. Heavy metals were daily orally admin-istered from gestational day 5 until delivery. Lead (II) acetate 3-hydrate, was given daily in a dose of 1,1 mg/kg b.w. per pregnant animal dissolved in 10 ml of drinking water. This quantity was fully consumed. Arsenic (III) oxide was given as a 3 ppm aquatic solution, provided ad libitum. Cadmium chloride-1-hydrate in a dose of 10 mg/kg of body weight was administered daily per pregnant animal from gestational day 5th until delivery. The individual dose for each animal was daily dissolved in 10 ml of drinking water, quantity that was fully consumed.Food was provided ad libitum to all study groups. A 20 mice control group was also composed. After delivery, neonates were counted and weighted per cage. Immediately after delivery, neonates were euthanized with ether; stillborn neonatal ani-mals were also included in the study.

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Neonates were micro dissected under Stereomicroscope. Their organs were separated and removed; fixed in 10 % neutral formalin and processed for Light Microscopically observations and in 3 % glutaraldehyde and processed for Trans-mission Electron Microscopy – TEM examination.

RESULTS BRAIN and SPINAL CORD: In all treated study groups, nerve fiber shrinkage and separation from myelin was observed in the myelinated nerve fibers; that lead to empty spaces creation and cyst forma-tion. Localized demyelination and nerve axon degeneration was also observed. Furthermore, nerve fibers presented deformations, while in some areas they were totally destroyed. Those obser-vations were attributed to nerve fibril and nerve tubules dysfunction caused by heavy metals exposure and were more intense at the lead-intake group. Apart from that, in localized areas, small granules were observed on the myelin of some myelinated nerve fibers of lead-intake group, attributed to lead accumu-lations.

LUNGS: Small electron-dense granules were observed in various locations, including the endothelium and the inter-cellular alveolar spaces. They were also localized into spaces between the basal lamina and the endothelial cells, as well as inside lung macrophages lysosomes. These granules were attributed to cad-mium accumulations and their diameter was measured 0,1 – 0,2 μm approxi-mately. The distribution of granules was uneven. Apart from that, the endothe-lium presented discontinuity in certain positions, indicating basal membrane damage. Some apoptotic cells were also observed, fact considered abnormal for such a neonatal age. Furthermore, many epithelial cells had morphological aberra-tions, such as disruption of intercellular junctions. Finally, malformed nuclei and perinuclear edema of epithelial cells were also present.

CONCLUSION Environmental exposure to lead, cad-mium and arsenic during embryonic / fe-tal development can cause pathological changes to neonatal brain, spinal cord and lung tissues, with possible impact on normal brain and lung activity and functionality.

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Venue

Birmann

sgasse

Ahornstrasse

Allschwilerstrasse

City Center

Oberwilertstrasse

Leimenstrasse

Steinenring

Bahnhof / Central Station

Steinengraben

Aeschengraben

Neuba

dstras

se

Schützenmattpark

Weiherweg

Spalenring

Binnngerstrasse

Rhine River

Birsigviadukt

Heuwaage-Viadukt

Elisabe

thenstrasse

ViaduktstrasseNauenstrasse

OekolampadManaged by Hotel Bildungszentrum 21Schönenbuchstrasse 9CH-4055 Basel

ARRIVAL BY PUBLIC TRANSPORTATION FROM BASEL SBB

Tram no 1 (Direction Dreirosenbrücke) to stop “Birmannsgasse”. From there it is a three-minute walk along “Ahornstrasse” to “Allschwilerplatz”. The Oekolampad building is on your right hand side.

ARRIVAL BY CAR

The closest parking is “Ahornhof”, Birmanns-gasse 9, Basel. The conference venue is a three-minute walk away.

44th international medichem congress 2016 · 44th international medichem congress 2016 31 aug – 2...

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