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Improving Regulatory Decisions through Targeted Research: A Case Study Concerning Amino Acids

Published online by Cambridge University Press:  20 January 2017

Michael D. Rogers  and
Miro Smriga
Michael D. Rogers
Affiliation:
International Council on Amino Acid Science (ICAAS)
Miro Smriga
Affiliation:
ICAAS and Ajinomoto USA
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Abstract

This paper argues that the EU regulatory practice in the food area may be unnecessarily applying the Precautionary Principle by focussing on upper intake limits for naturally occurring nutrients, while not controlling the quality of the ingredients used in commercial products even though precedents of public health issues arising from adulterated ingredients do exist. Risk governance depends heavily on expert evidence and the case of amino acid supplements is used to document an industry-supported effort to strengthen the science database and thus enhance the regulatory process: Thus ensuring that amino acid use in the EU is safely and proportionately regulated. Scientific work conducted in the last decade by the not-for-profit association, the International Council on Amino Acid Science (ICAAS) is used as a simple case study highlighting the role of proactive clinical research in an era characterized by precaution in risk management, and by the escalating costs of scientific research, and the growing influence of the internet.

Type
Symposium on the European Parliament’s Role in Risk Governance
Information
European Journal of Risk Regulation , Volume 3 , Issue 2 , June 2012 , pp. 161 - 168
Copyright
Copyright © Cambridge University Press 2012

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References

1 Gray, George, Rogers, Michael D. and Wiener, Jonathan B., “Beef, Hormones, and Mad Cows”, in Wiener, Jonathan B., Rogers, Michael D., Hammitt, James K. and Sand, Peter H. (eds.), The Reality of Precaution – Comparing Risk Regulation in the United States and Europe, (Washington, D.C.: RFF Press/Earthscan, 2011)Google Scholar.

2 Ibid.

3 Rogers, Michael D., “Risk management and the record of the precautionary principle in EU case law”, 14 Journal of Risk Research (2011), pp. 467–484 CrossRefGoogle Scholar.

4 See for example Zander, Joakim, The Application of the Precautionary Principle in Practice (Cambridge: Cambridge University Press, 2010), at p. 134/135 and 150 CrossRefGoogle Scholar.

5 Specter, Michael, Denialism: How irrational thinking hinders scientific progress, harms the planet and threatens our lives (London: Duckworth Overlook, 2010)Google Scholar.

6 Reniers, Genserik, Geelen, Hanne, Goris, Emilie and Audenaert, Amaryllis, “REACH implementation costs in the Belgian food industry: A semi-qualitative study”, 7 Journal of Business Chemistry (2010), pp. 81–88 Google Scholar.

7 John D. Bernal, “Lessons of the war for science”, 10 Reports on Progress in Physics (1944), pp. 418–436.

8 The references to “on top” and “on tap” in this quotation relate to one of Winston Churchill's dictums namely that “Scientists should be on tap not on top”.

9 Further information is available on the ICAAS website, available on the Internet at <http://www.icaas-org.com/> (last accessed on 13 April 2012).

10 See the Consolidated Version of the Treaty on the Functioning of the European Union, Official Journal 2008 (115/47) in particular Articles 34 and 36, Article 114 and Article 191.2

11 See for example Wu, Guoyao, “Functional amino acids in growth, reproduction and health” , 1(1) Advances in Nutritrion (2010), pp. 31–37 CrossRefGoogle Scholar; and Miro\Smriga, and Torii, Kunio, “Dietary Management of Stress Using Amino Acids Supplements”, in Yehuda, Schlomo and Mostofsky, David I (eds.), Nutrients, Stress and Medical Disorders (New York, NY: Humana Press, 2010), pp. 325–340 Google Scholar.

12 Breen, Leigh and Phillips, Stuart M., “Skeletal muscle protein metabolism in the elderly: Interventions to counteract the ‘anabolic resistance’ of ageing”, 8 Nutrition and Metabolism (2011), pp. 1–11 CrossRefGoogle ScholarPubMed; Kim, Jeong Su, Wilson, Jacob M. and Lee, Sang-Rok, “Dietary implications on mechanisms of sarcopenia roles of protein, amino acids and antioxidants”, 21(1) The Journal of Nutritional Biochemistry (2010), pp. 1–13 CrossRefGoogle ScholarPubMed; Leenders, Marika and van Loon, Luc JC, “Leucine as a pharmaconutrient to prevent and treat sarcopenia and type 2 diabetes”, 69(11) Nutrition Reviews (2011), pp. 675–689 CrossRefGoogle ScholarPubMed.

13 Hanekamp, Jap C., “The precautionary principle: a critique in the context of the EU Food Supplements Directive”, 2 Environmental Liability (2006), pp. 1–9 Google Scholar.

14 Tsubuku, Shoji, Hatayama, Kazuhisa, Katsumata, Toyohisa, et al., “Thirteen-week oral toxicity study of branched-chain amino acids in rats”, 23(2) Int. J. Toxicol. (2004), pp. 119–126 CrossRefGoogle ScholarPubMed; Tsubuku, Shoji, Mochizuki, Masahiro, Mawatari, Kazunori, et al., “Thirteen-week oral toxicity study of L-lysine hydrochloride in rats”, 23(2) Int. J. Toxicol. (2004), pp. 113118Google Scholar; Tsubuku, Shoji, Hatayama, Kazuhisa, Mawatari, Kazunori, et al., “Thirteen-week oral toxicity study of Lglutamine in rats”, 23(2) Int. J. Toxicol. (2004), pp. 107–112 CrossRefGoogle Scholar; Tsubuku, Shoji, Hatayama, Kazuhisa, Mawatari, Kazunori, et al., “Thirteenweek oral toxicity study of L-arginine in rats”, 23(2) Int. J. Toxicol. (2004), pp. 101–105 CrossRefGoogle ScholarPubMed.

15 Thomson, Jasmine S., Ali, Ajmol and Rowlands, David S., “Leucineprotein supplemented recovery feeding enhances subsequent cycling performance in well-trained men”, 36(2) Appl. Physiol. Nutr. Metab. (2011), pp. 24253CrossRefGoogle ScholarPubMed.

16 Kato H, Imamura W, Kanamoto R. “Identification of effective biomarkers for the toxicity of leucine in rats”, J. Nutr. (2012) (forthcoming).

17 Rajavel Elango, Karen Chapman, Maroukh Rafii, et al., “Determination of the tolerable upper intake level of leucine in young men”, Am. J. Clin. Nutr. (2012) (forthcoming).

18 Ibid.

19 European Commission, 2000, “Communication from the European Commission on the Precautionary Principle”, COM (2000)1, Brussels, 01.02.2000, available on the Internet at <http://ec.europa.eu/dgs/health_consumer/library/pub/pub07_en.pdf> (last accessed on 13 April 2012).

20 Ibid.

21 WHO, “Protein and amino acid requirements in human nutrition. Report of a Joint WHO/FAO/UNU Expert Consultation”, WHO Technical Report Series, No. 935 (2007).

22 Pellett, Peter L. and Ghosh, Shibani, “Lysine fortification: past, present, and future”, 25(2) Food Nutr. Bull. (2004), pp. 107–113 CrossRefGoogle ScholarPubMed.

23 See for example: Smriga, Miro, Ghosh, Shibani, Mouneimne, Yousseff, et al., “Lysine fortification reduces anxiety and lessens stress in family members in economically weak communities in Northwest Syria”, 101(22) Proc. Natl. Acad. Sci. U S A. (2004), pp. 8285–8288;CrossRefGoogle ScholarPubMed Ghosh, Shibani, Smriga, Miro, Vuvor, Frederick, et al., “Effect of lysine supplementation on health and morbidity in subjects belonging to poor peri-urban households in Accra, Ghana”, 92(4) Am. J. Clin. Nutr. (2010), pp. 928–939 CrossRefGoogle Scholar; Ghosh, Shibani, Pellett, Peter L., et al. “Impact of lysine-fortified wheat flour on morbidity and immunologic variables among members of rural families in northwest Syria”, 29(3) Food Nutr. Bull. (2008), pp. 163–171 CrossRefGoogle ScholarPubMed.

24 Williamson, B. L, Benson, L. M, Tomlinson, A. J, et al., “On-line HPLC-tandem mass spectrometry analysis of contaminants of Ltryptophan associated with the onset of the eosinophilia-myalgia syndrome”, 92(2) Toxicol. Lett. (1997), pp. 139–148 CrossRefGoogle Scholar; Simat, Thomas J., Kleeberg, Kim Karen, Müller, Burkhardt, et al. “Synthesis, formation, and occurrence of contaminants in biotechnologically manufactured L-tryptophan”, 467 Adv. Exp. Med. Biol. (1999), pp. 469–480 CrossRefGoogle ScholarPubMed; Martínez-Cabot, Anna and Messeguer, Angel, “Generation of quinoneimine intermediates in the bioactivation of 3-(Nphenylamino) alanine (PAA) by human liver microsomes: a potential link between eosinophilia-myalgia syndrome and toxic oil syndrome”, 20(10) Chem. Res. Toxicol. (2007), pp. 1556–1562 CrossRefGoogle Scholar.

25 Ibid.

26 European Commission, 2001, “European Governance – A White Paper”, COM (2001), Brussels, 25.07.2001, available on the Internet at <http://eur-lex.europa.eu/LexUriServ/site/en/com/2001/com2001_0428en01.pdf> (last accessed on 13 April 2012)

27 European Commission, 2001, Governance Working Group 1b Report “Democratising Expertise and Establishing Scientific Reference Systems”, Brussels, 02.07.2001, available on the Internet at <http://ec.europa.eu/governance/areas/group2/report_en.pdf> (last accessed on 13 April 2012).

28 European Commission, 2002, “Communication from the Commission on the Collection and use of Expertise by the Commission: Principles and Guidelines – Improving the knowledge base for better policies”, COM (2002) Brussels, 11.12.2002, available on the Internet at <http://ec.europa.eu/governance/docs/comm_expertise_en.pdf> (last accessed on 13 April 2012).

29 European Commission, 2010, “Smart Regulation in the European Union”, COM(2010) 543, Brussels, 8.10.2010, available on the Internet at <http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2010:0543:FIN:EN:PDF> (last accessed on 13 April 2011).

30 John D. Bernal, Lessons of the war for science, supra note 7.