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A risk-based classification scheme for genetically modified foods. II: Graded testing.

This paper presents a graded approach to the testing of crop-derived genetically modified (GM) foods based on concern levels in a proposed risk-based classification scheme (RBCS) and currently available testing methods. A graded approach offers the potential for more efficient use of testing resources by focusing less on lower concern GM foods, and more on higher concern foods. In this proposed approach to graded testing, products that are classified as Level I would have met baseline testing requirements that are comparable to what is widely applied to premarket assessment of GM foods at present. In most cases, Level I products would require no further testing, or very limited confirmatory analyses. For products classified as Level II or higher, additional testing would be required, depending on the type of the substance, prior dietary history, estimated exposure level, prior knowledge of toxicity of the substance, and the nature of the concern related to unintended changes in the modified food. Level III testing applies only to the assessment of toxic and antinutritional effects from intended changes and is tailored to the nature of the substance in question. Since appropriate test methods are not currently available for all effects of concern, future research to strengthen the testing of GM foods is discussed.

Authors

  • Chao, Eunice, Chao E, McLaughlin Centre for Population Health Risk Assessment, Institute of Population Health, University of Ottawa, 1 Stewart Street, Ottawa, Ont., Canada K1N 6N5. echao@uottawa.ca

  • Krewski, Daniel, Krewski D,

YEAR OF PUBLICATION: 2008
SOURCE: Regul Toxicol Pharmacol. 2008 Dec;52(3):223-34. doi: 10.1016/j.yrtph.2008.08.002. Epub 2008 Aug 15.
JOURNAL TITLE ABBREVIATION: Regul Toxicol Pharmacol
JOURNAL TITLE: Regulatory toxicology and pharmacology : RTP
ISSN: 1096-0295 (Electronic) 0273-2300 (Linking)
VOLUME: 52
ISSUE: 3
PAGES: 223-34
PLACE OF PUBLICATION: Netherlands
ABSTRACT:
This paper presents a graded approach to the testing of crop-derived genetically modified (GM) foods based on concern levels in a proposed risk-based classification scheme (RBCS) and currently available testing methods. A graded approach offers the potential for more efficient use of testing resources by focusing less on lower concern GM foods, and more on higher concern foods. In this proposed approach to graded testing, products that are classified as Level I would have met baseline testing requirements that are comparable to what is widely applied to premarket assessment of GM foods at present. In most cases, Level I products would require no further testing, or very limited confirmatory analyses. For products classified as Level II or higher, additional testing would be required, depending on the type of the substance, prior dietary history, estimated exposure level, prior knowledge of toxicity of the substance, and the nature of the concern related to unintended changes in the modified food. Level III testing applies only to the assessment of toxic and antinutritional effects from intended changes and is tailored to the nature of the substance in question. Since appropriate test methods are not currently available for all effects of concern, future research to strengthen the testing of GM foods is discussed.
LANGUAGE: eng
DATE OF PUBLICATION: 2008 Dec
DATE OF ELECTRONIC PUBLICATION: 20080815
DATE COMPLETED: 20090227
DATE REVISED: 20081125
MESH DATE: 2009/02/28 09:00
EDAT: 2008/09/05 09:00
STATUS: MEDLINE
PUBLICATION STATUS: ppublish
LOCATION IDENTIFIER: 10.1016/j.yrtph.2008.08.002 [doi]
OWNER: NLM

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Daniel Krewski

Chief Risk Scientist

Dr. Daniel Krewski is Chief Risk Scientist and co-founder of Risk Sciences International (RSI), a firm established in 2006 to bring evidence-based, multidisciplinary expertise to the challenge of understanding, managing, and communicating risk. As RSI’s inaugural CEO and long-time scientific...
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