Advancing the 3Rs in regulatory toxicology - Carcinogenicity testing: Scope for harmonisation and advancing the 3Rs in regulated sectors of the European Union.
Different government agencies operating in the European Union regulate different types of chemical products but all require testing for carcinogenicity to support applications for product marketing and commercialisation. A conference was held in Brussels in 2013 where representatives of the pharmaceutical, animal health, chemical and plant protection industries, together with representatives of regulatory agencies, universities and other stakeholders, met under the auspices of The European Partnership for Alternative Approaches to Animal Testing (EPAA) to discuss the varying requirements for carcinogenicity testing, and how these studies might be refined to improve hazard evaluation and risk assessment while implementing principles of the 3Rs (replacement, refinement and reduction in animal studies). While there are some similarities, the regulatory approaches in pharmaceutical, animal health, chemical and plant protection sectors have varying degrees of flexibility in requirements for carcinogenicity testing, to an extent reflecting concerns over the magnitude and duration of human exposure, either directly as in therapeutic exposure to pharmaceuticals, or indirectly through the ingestion of residues of veterinary drugs or plant protection chemicals. The article discusses these differences and other considerations for modified carcinogenicity testing paradigms on the basis of scientific and 3Rs approaches.
CEFIC, Brussels, Belgium.
Erwin
E
Annys
Dow AgroSciences, Abingdon, UK.
Richard
R
Billington
IFAH-Europe, Brussels, Belgium.
Rick
R
Clayton
Bayer Pharma AG, Wuppertal, Germany.
Klaus-Dieter
KD
Bremm
Bristol Myers Squibb, Princeton, NJ, USA.
Michael
M
Graziano
Evita Services, Craigavon, Northern Ireland, UK.
Jo
J
McKelvie
European Partnership for Alternatives to Animal Testing (EPAA), Brussels, Belgium.
Ian
I
Ragan
University of Tübingen, Tübingen, Germany.
Michael
M
Schwarz
Medicines Evaluation Board, Utrecht, The Netherlands.
Jan Willem
JW
van der Laan
Environmental Protection Agency, Research Triangle Park, NC, USA.
Charles
C
Wood
Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.
Mattias
M
Öberg
RIVM, Bilthoven, The Netherlands.
Piet
P
Wester
TSGE Consulting Ltd Knaresborough, UK. Electronic address: Kevin.Woodward@TSGEurope.com.
Kevin N
KN
Woodward
D000818:Animals; D015197:Carcinogenicity Tests; D002273:Carcinogens / Q000008:administration & dosage / Q000032:analysis / Q000633:toxicity*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005060:Europe; D005062:European Union; D033161:Government Regulation; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000032:analysis; D018570:Risk Assessment
D002273:Carcinogens; D004364:Pharmaceutical Preparations
Carcinogenicity; Chemicals; Genotoxicity; Pharmaceuticals; Plant protection; Reduction; Refinement; Replacement; Transgenic; Veterinary drugs