1

..risk regimes vary substantially across policy domains in a way that the generalist tone of risk society type
analysis obscures and cannot explain (Hood et al, 2001: 171). Discuss with reference to TWO examples of
your own choosing
The risk society thesis embodies a revolutionary framework in its attempt to depict the evolution of
contemporary societies as colonized by risk in modernity. The metamorphosis of societal fabric is driven by
risk as a mobilizing force for collective action, concurrently collapsing the former social, political and regulatory
regimes in the face of imminent existential uncertainty. Nevertheless, the notion of risk society is subject to a
broad range of censure, with critics such as Elliott contesting the overemphasis of the phenomena and
relevance of risk
1
. In a similar vein, Turner questions the core assumption of the role of risk in modernity
2
,
whilst Hood et al dismiss the idea of risk society altogether, asserting instead the synthesis of varied risk
regimes in conjuring modern risk governance across various domains
3
. This essay will expose the inherent
contradiction within the theory as viewed through the cultural paradigm and proceed to examine contrasting
regulatory culture within the US and the EU in the context of nanotechnology and beef hormone health risk
regulation, arguing that notwithstanding the ambiguity and inherent contradictions of the theory as an
analytical tool, its essence can nevertheless be used to delineate the emergence of regulatory trends, with
divergent practices attributed to differing cultural perceptions and hence conceptions of risk within the
regulatory space.
For Beck, the notion of risk society is embodied in the image of society colonized by risk, whereby risk
acts as an organizing principle for regulatory action
4
. In his deliberations over the core attributes of risk
society, Beck postulates the definition of risk as rooted in a systematic way of dealing with hazards and
insecurities in confronting the negative externalities posed by modernisation
5
. Adopting a pragmatist stance,

1
Elliott, A., Becks Sociology of Risk: A critical Assessment, Sociology, (36:2), pages 299-300.

2
Turner, B.S., Part V: Modernity: From Regulation to Risk, Orientalism, Postmodernism & Globalism, (London,
Taylor&Francis: 2003), pages 180-181.

3
Hood, C., Rothstein, H., Baldwin, R., Chapter 10: From Risk Society to Variety in Risk Regulation Regimes, The
Government of Risk, (Oxford University Press, Oxford: 2001), page 171.

4
Beck, U., Chapter 1: on the Logic of wealth distribution and risk distribution, Risk Society: Towards a New
Modernity, (London, Sage: 1992), pages 34-35.

5
Beck, U., Chapter 1: on the Logic of wealth distribution and risk distribution, Risk Society: Towards a New
Modernity, (London, Sage: 1992), page 21.

2

he acknowledges the essence of risk as complex social and natural phenomenon, manifesting both
objectively and subjectively. Risks are open to social definition and construction
6
, concurrently possessing
the ability to materialize
7
. Contrary to the claims advanced by Alexander and Smith, who assert an
inconspicuous role played by cultural theory in risk society hypothesis
8
, Beck emphasizes the importance of
cultural factors in shaping the orienting dispositions of the actors within the regulatory space
9
.
Following Wildavsky and Dake, different cultural stances presume different risk perceptions and enable
individuals to define the external environment and hence their relationship to it, implying selective treatment of
risks and consequent preference for contrasting policy outcomes. Individualists are risk seeking, perceiving
risks as an opportunity, hence endorsing minimal regulation, whilst egalitarians are risk averse, preferring a
precautionary stance
10
. Hence, in contrast to egalitarians, risk may not serve as a stimulus to anticipative
action for individualists. Such cultural risk discrimination precludes the formation of risk society, since it
implies pluralistic nature of regulatory regimes, with an unsystematic treatment of risks as contingent on
cultural risk perceptions. Hence, the core characteristic of Becks risk society, whereby the preoccupation with
debating, preventing and managing risks
11
constitutes the regulatory policy setting, is effectively negated, as
risk colonization may not occur in certain regulatory areas, whilst explicitly manifesting itself in others,
depending on cultural stance. Notwithstanding, in his later works, Beck attempted to incorporate cultural
theory explicitly by discussing the implications of different risk cultures in the context of conflict
12
. However, his

6
Beck, U., Chapter 1: on the Logic of wealth distribution and risk distribution, Risk Society: Towards a New
Modernity, (London, Sage: 1992), page 23.

7
Flynn, R.,Social Constructionism in Analysing Health Risks, Beyond the risk Society: Critical Reflections on Risk and
Human Security, Mythen, G., Walklate, S., (McGrawhill, Berskhire: 2006), page 86.

8
Alexander, J.C., Smith., Social Science and Salvation: Risk Society as a Mythical Discourse, Zeitschrift fr Soziologie,
(25:4), page 256.

9
Beck, U., Risk Society Revisited: Theory, Politics and Research Programmes, The Risk Society and Beyond: Critical
Issues for Social Theory, (London, Sage: 2000), page 219.

10
Wildavsky, A., Dake, K., Theories of Risk Perception: Who fears what and why?, Journal of the American Academy of
Arts and Sciences, 119 (4), pages 43-44.

11
Beck, U., Living in the World Risk Society, A Hobhouse Memorial Public Lecture given on Wednesday 15 February
2006 at the London School of Economics, Economy and Society Volume 35(3), page 332.

12
Beck, U., Clash of Risk Culures or: Overlapping of the State of Normalcy and the State of Exception, World at Risk,
(Cambridge, Polity: 2009), page 73.

3

deliberations could not account for the stark differences in regulatory approaches in the context of the risk
society thesis, as the subsequent analysis demonstrates.
Following Guehlstorf, the understanding of the regulatory regime is best construed by adopting a
reflexive stance towards analyzing regulatory phenomena within the cultural framework
13
, as it enables the
recognition of the complex and often bilateral relationship between content and context in shaping the
contours of the regulatory regime. Reflexivity in turn implies the autopoeitic nature of the actors within the
regulatory space. Autopoesis aids in the understanding of the cultural paradigm due to the endogenous nature
of culture
14
in specifying the internal configuration of the actors involved and consequent conflicts that result
from different cultural stances, as will be demonstrated by the case of the health risk regulation in the US and
EU. When construed in this manner, cultural theory enables a broader understanding of the institutional
dynamics pertinent to a particular regulatory regime.
Surveying the regulatory landscape renders two contrasting regulatory cultures of the United States and
Europe. Although such generalisations are crude, they serve as useful guides in explaining policy stances
across a variety of issues. United States regulatory culture can be conceived as based on resilience, thus
resisting precaution, in contrast to its European counterparts whereby precautionary principle represents the
basis for regulatory action and policy15. In deconstructing the cultural dimensions of the two regimes, Lofstedt
and Vogel note the evolution of Europe into largely an egalitarian state, characterized by popular participation,
distrust towards industry and greater transparency in its regulatory stance. By contrast, the United States
evolved into a culture increasingly favouring industry and emphasizing on self regulation16, thus signifying an
individualist stance. At this point, it is worthwhile to depict the broad contours of the cultural contexts within
which the two regimes are situated. Meidinger notes five main sources of regulatory culture: the general

13
Guehlstorf, N.P., Hallstrom, L.K., The role of culture in risk regulations: a comparative case study of genetically
modified corn in the United States of America and European Union, Environmental Science and Policy (8), pages 327-
328.

14
Wildavsky, A., Choosing Preferences by Constructing Institutions: A cultural theory of preference formation;, The
American Political Science Review , pages 4-5.

15
EU, Communication on Precautionary Principle,
http://ec.europa.eu/dgs/health_consumer/library/pub/pub07_en.pdf (retrieved 21st April 2014), page 3.

16
Lofstedt, R.E., Vogel, D., The changing character of regulation: a comparison of Europe and the United States, Risk
Analysis 21(3), pages 400-401.

4

culture, social culture, law, regulatory tradition as well as work and posits that general culture will reflect the
cultural stance of the regulator17. Vogel notes that the European policy of precaution has arguably been the
result of two major changes: civic culture, as demonstrated by the widespread support for stringent health
standards and greater expectations of the government playing an active role in protecting public health. Risk
aversion has been exacerbated further by a range of prominent regulatory failures thus undermining public
confidence18. By contrast, the US favours innovation as a part of general culture and supports a flexible
regulatory system19. It is against these preferences that the regulatory regimes for the health risks are
formed.
For Beck, the realm of nanotechnology represents a typical manifestation of risk society. Fraught with
scientific uncertainty, controversy over the perceived health risks and hence appropriate policy stance
characerise the realm of nanotechnology regulation, resulting in contrasting regulatory approaches. Forrest
recognized as early as 1989 that the development of nanotechnologywill seriously challenge the ability of
our regulatory systems to respond quickly and maintain the critical balance between dangers and benefits20.
Two decades later little consensus has been reached on the appropriate risk management and governance
framework. However, it is questionable whether debates over the regulatory divergence or convergence21 are
appropriate at this instance due to the relatively nascent state of the nanotechnology phenomenon.
Both the EU and the US stance with respect to the nanotechnology health risk can be disaggregated
further to explain why no significant changes in legislation addressing potential risks have occurred. Studies
have demonstrated that the public attitudes towards nanotechnology are mostly ambivalent both in the US
and the EU, with the majority admitting that they are unsure of the distribution of risks and benefits associated

17
Meidinger, E., Regulatory Culture: A theoretical outline, Law&Policy, 9(4), pages 369-375.

18
Voogel, D., The New Politics of Risk Regulation in Europe, Centre for Risk Analysis and Regulation London School of
Economics, http://eprints.lse.ac.uk/35984/1/Disspaper3.pdf (retrieved 25th April 2014), pages 7-15.

19
Echols, Food Safety Regulation in the European Union Food Safety and the WTO: The Interplay of Culture, Science
and Technology and the United States: Different Cultures, Different Laws, Columbia Journal of International Law 200,
page 529.

20
Forrest, D., Regulating Nanotechnology Development, (Foresight Institute, Palo Alto: 1989), page 1.

21
Falkner, R., Jaspers, N., Regulating Nanotechnologies: Risk, Uncertainty and the Global Governance Gap, Global
Environmental Politics, 12(1), page 42.

5

with nanotechnology22 and hence the realm of nanotechnology is not particularly salient. This is largely
attributable to role of media, demonstrated by Friedman and Egolf, as nanotechnology health risks did not
dominate media coverage23. This is consistent with the current state of the regulation in the United States
and the EU, whereby significant gaps in the regulation remain and no nanospecific legislation was adopted.
However, it also appears that both regions were selective in responding to public concerns with respect to
nanotechnology, whenever they arose. A prominent case has arisen with respect to the legal petition filed by
interest groups against FDA, calling for issuance of nanospecific legislation24. To date, however, no such
legislation was enacted, although as per above guidelines are being increasingly extended to incorporate
nanotechnological applications, which may point to a future trend in enacting sector specific legislation.
Arguably, industrial lobbying has proved quite successful in the US, with the main lobbying group,
Nanobusiness Alliance successfully lobbying the National Nanotechnology Initiative Amendment (2009) which
focuses on promotion and commercialization of nanotechnology25. This would be consistent with the FDAs
free market ideology and focus on promoting guidance and legislation aimed at fostering economic growth.
Finally, Europe has been relatively resistant to lobbying pressures, as exemplified by the labeling controversy,
whereby the EU adhered to the precautionary principles by upholding mandatory labeling26. The above is
consistent with the notion of regulators as autopoeitic systems, striving to stabilize themselves against their
environment, but reacting only to the disturbances which are compatible with their cultural frame. As Hood
notes, in the environment of low political salience of the subject, changes in regulation are less likely to occur.
Autopoietically, the regulator will not be receiving cultural perturbances from the outside environment so as to
trigger a response and stabilize itself against the change that occurred in the environment and hence the
regulatory system and setting will continue reproducing themselves unchanged. Consequently, the success

22
Satterfield, T., Kandikar, M., Beaudrie, C., Conti, J., Harthorn, B., Anticipating the perceived risk of nanotechnologies,
Nature Nanotechnology, (4), page 754.

23
Friedman, S., Egolf, B., Nanotechnology Risks and the Media, IEEE Technology and Society Magazine (2005), page 10.

24
International Centre for Technology Assessment,Re FMDS Docket No. FDA 2006-P-0213-003),
http://www.icta.org/doc/Andrew%20Kimbrell-FDA-2006-P-0213-Citizen%20Petition.pdf, (retrieved 21
st
April 2014).

25
Reuters, Nanotechnology Business Leaders to convene in Washington D.C for 8
th
Annual Nanobusiness Alliance
Public Poicy Tour, March 17-19, 2009, http://www.reuters.com/article/2009/02/25/idUS226488+25-Feb-
2009+BW20090225, (retrieved 21
st
April 2014)

26
Corporate Euro Observatory, Food Lobby fights labeling of nano ingredients,
http://corporateeurope.org/agribusiness/2014/03/food-lobby-fights-labelling-nano-ingredients, (retrieved April 25
th

2014).

6

of lobbying groups above depended on the extent to which their relevance was perceived by the regulator
through its own cultural worldview.
Deconstructing the risk regime in the US renders a picture of an ad hoc and piecemeal regulation. The
regulatory oversight of nanotechnology health risks has a decentralized and pluralistic nature, with regulatory
power shared between Food and Drug Administration (FDA) and Environmental Protection Agency (EPA)27.
In particular, the case of FDA demonstrates lack of systematic risk management framework in
comprehensively managing the regulation of nanotechnology. As per the Federal Food, Drug and Cosmetic
Act, pre-market regulatory tools appear in very few pertinent products, with cosmetic ingredients almost
escaping regulatory oversight, due to essential safety demonstration and product registration bearing a
voluntary status28. Instead, FDA recommends consultation as a part of its approach to reduce the risk of
unintended harm resulting from such products29, hence emphasizing on self-regulation. However, it still
displays allegiance to technical assessments, with effects of nanotechnology evaluated in the context of the
specific product30, hence demonstrating only a partial commitment to risk based regulatory oversight.
Information gathering efforts are ad hoc as evident from FDAs reliance on consultation, public domain
information and voluntary reporting as means of post-market product monitoring31. Notwithstanding, recent
efforts have steered a more risk informed approach in selected areas, as exemplified by the case of the FDAs
own Center for Drug Evaluation and Research devising a specialized risk management framework in the
context of medical nanotechnology32. Recent Food and Drug Administration Safety and Innovation Act

27
Falkner, R., Jaspers, N., Regulating Nanotechnologies: Risk, Uncertainty and the Global Governance Gap, Global
Environmental Politics, 12(1), page 43.

28
Taylor, M., Regulating the products of Nanotechnology: Does FDA have the tools it needs?, The Wilson Center,
http://www.wilsoncenter.org/publication/regulating-the-products-nanotechnology-does-fda-have-the-tools-it-needs-0,
(retrieved April 21
st
2014, page 26).

29
FDA, Approach to Regulating Nanotechnology,
http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm301114.htm, (retrieved 21
st
April2014).

30
FDA, FDA, Approach to Regulating Nanotechnology,
http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm301114.htm, (retrieved 21
st
April2014).

31
FDA, Approach to Regulating Nanotechnology,
http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm301114.htm, (retrieved 21
st
April2014).

32
FDA, As nanotechnology is being used to develop new drugs, FDA is working to ensure quality, safety and
effectiveness, http://blogs.fda.gov/fdavoice/index.php/tag/cders-nanotechnology-risk-assessment-working-group-
nano-group/, (retrieved 21
st
April 2014).

7

mandates specific information gathering efforts to expand the knowledge on the impact of nanotechnology on
biological systems33. In addition, a recent plethora of guidance, such as Draft Guidance for Industry:
Consideration whether an FDA regulated Product Involves the Application of Nanotechnology and Draft
Guidance for Industry: Safety of Nanomaterials in Cosmetic Products34, albeit non binding in nature, exhibit
the nascence of FDAs critical deliberation of potential risks posed by nanotechnology in various contexts,
perhaps resulting in a change of regulatory stance in the future. At present, however, the regulation occurs
largely on a case by case basis under the aegis of Federal Food, Drug and Cosmetics Act and attempts to
develop a specialized nanotechnology risk management approach have so far been partial and superficial in
their nature, partly due to limited nature and scope of regulatory science research, as per the preliminary
review of FDAs current research programs35. Hence, despite FDAs claims of a neutral attitude towards
nanotechnology36, the evidence suggests that it regards it as benign until proven otherwise.
By contrast, EPA applies a more comprehensive risk based approach, involving detailed risk
assessments to determine the potential impact of nanomaterials to inform risk management decisions, future
risk assessments and policy impact37. Following FDA, it did not adopt nanospecific legislation, instead
seeking to accommodate its current regulatory powers to nanotechnology, but in contrast to FDA, its activities
extended to development of nanomaterial specific rules under its Toxic Substances Control Act (TSCA) and
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Examination of the rules under TSCA renders a
different approach to that of FDA. In particular, EPA sought to limit the releases and uses of nanomaterials
under the Premanufacture Notifications provision and novel nanomaterials are vigorously assessed based on

33
FDA, Food and Drug Administration Safety and Innovation Act,
http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/R42680_02042013.pdf, page 24.

34
FDA, Science and Research: Nanotechnology,
http://www.fda.gov/scienceresearch/specialtopics/nanotechnology/default.htm (retrieved 21
st
April 2014).

35
FDA, Current Nanotechnology Programs at FDA,
http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm309672.htm, (retrieved 21
st
April 2014).

36
FDA, FDAs approach to regulating Nanotechnology Products,
http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm301114.htm, (retrieved 21
st
April 2014).

37
Environmental Protection Agency, Nanotechnology and Nanomaterials Research, http://www.epa.gov/nanoscience/
and EPA, Nanomaterials: Research to Support Comprehensive Environmental Assessments for Nanomaterials,
http://cfpub.epa.gov/ncea/CFM/nceaQFind.cfm?keyword=Nanomaterials, (retrieved April 21
st
2014).

8

manufacturer information, under its gatekeeping New Chemicals Program38. Regulatory review specific to the
nanomaterials also extends through Significant New Use Rule (SNUR), although EPAs assessment is based
largely on a voluntary Nanoscale Materials Stewardship Program (NMSP), whereby significant gaps in the
health and safety data remain39, implying that certain nanomaterials are not captured by regulatory review.
Notwithstanding, EPA mandates specific testing for certain untested nanomaterials under TSCA testing rule
and information gathering rule40 to aid in its efforts to expand regulatory knowledge. TSCA endows EPA with
considerable variety of enforcement actions, ranging from petitions to criminal and specific enforcement,
thereby being responsive41. However, TSCA has the potential of not capturing certain nanomaterials, as only
new substances require a pre-manufacture notice, which effectively implies that nanomaterials derived from
existing substances may not be subjected to regulation42, thus partially negating the usefulness of SNUR
provision. By contrast, EPAs nanomaterial regulation of pesticides under FIFRA is still at a nascent stage,
with pre market registration and information provision being the primary regulatory tool, to enable EPA to
conduct a statutorily mandated risk assessment43. Notwithstanding, EPA is considering adoption of a
nanotechnology specific rule, as a result of its information gathering effort to determine the nature of the
nanotechnolgies in pesticides44.
European Union stance on nanotechnology regulation is characterized by the adherence to the policy
objectives based on the precautionary principle45. The regulatory review carried out in 2008 confirmed the
adequacy of the current EU legislative framework to deal with the potential risks posed by nanotechnology,

38
EPA, New Chemicals, http://www.epa.gov/oppt/newchems/index.htm, (retrieved 21
st
April 2014).

39
EPA, Nanoscale Materials Stewardship Program, http://www.epa.gov/oppt/nano/stewardship.htm, (retrieved 21
st

April 2014).

40
EPA, Control of Nanoscale Materials, http://www.epa.gov/oppt/nano/index.html#snur (retrieved 21
st
April 2014).

41
OBrian, F.P., An overview of the law of Nanotechnology, in Nanotechnology Challenge: Creating Legal Institutions
for Uncertain Risks, David A. Dana, (New York, Cambridge Univesity Press:2012), page 365.

42
Marchant, G., Sylvester, D., Abbott, K., Nanotechnology regulation: the US Approach, New Frontiers in Regulation,
page 194.

43
EPA, Regulating Pesticides that use Nanotechnology,
http://www.epa.gov/pesticides/regulating/nanotechnology.html#policy. (retrieved 21
st
April 2014).

44
EPA, Regulating Pesticides that use Nanotechnology-New Policy for Nanotechnology in Pesticides,
http://www.epa.gov/pesticides/regulating/nanotechnology.html#policy. (retrieved 21
st
April 2014).

45
Gispert, I., Overview of Nanomedicines Regulation in the European Union, in Delafuente, J., Grazu., J.,
Nanobiotechnology: Inorganic Nanoparticles, (Amsterdam, Elsevier: 2012), page 500.

9

concurrently recognizing the need for continuous monitoring and improvement on the basis of best available
information to ensure highest standards of public safety46. In 2011, EC rendered a formal definition to the
nanomaterials, hence marking its commitment to precautionary principle in setting it apart from conventional
substances. The regulatory architecture is pluralistic in nature with responsibilities for regulation in various
sectors, but for the purpose of this essay, activities of the EU Chemicals Agency and European Food Safety
Authority are evaluated. EU Chemicals Agency enforces the provisions of REACH and CLP, which are
underpinned by the precautionary principle47, requiring manufacturers to submit a detailed safety dossier,
with ECHA reserving the right to request any information for evaluation purposes and whenever an existing
chemical is modified, registration dossier needs to be updated to reflect that information. Risk assessment
maybe extended to carrying out additional tests to cover all potential risks. Moreover, in 2012 ECHA endorsed
guidance on information fulfillment requirements and specific advice on exposure assessment and hazard risk
assessment of nanomaterials, as prescribed in REACH Implementation Guidance Projects on
Nanomaterials48. However, it is doubtful whether REACH can adequately address the risks posed by
nanotechnology, as due to its non specificity and thresholds triggering action, the risks posed by
nanotechnology may not be adequately captured49. CLP EPAs Certification, Labeling and Packaging
notification programme does not possess any provisions for nanomaterials at present. European Food
Standards Agency follows the EUs code for integrated, safe and responsible approach, by providing
practical guidance on specialized risk assessment for nanotechnology, under the aegis of the EC50. Of
particular relevance is the recent amendment of the Regulations concerning food labeling to include labels for

46
EU, Communication from the Commission to the European Parliament, the council and the European economic and
social committee-regulatory aspects of nanomaterials,
http://ec.europa.eu/nanotechnology/pdf/comm_2008_0366_en.pdf, page 3.

47
EC, Regulatory Aspects of Nanomaterials, http://ec.europa.eu/nanotechnology/pdf/comm_2008_0366_en.pdf,
page 4.

48
ECHA, Updated Guidance on Information Requirements and Chemical Safety Assessment for Nanomaterials,
http://echa.europa.eu/web/guest/view-article/-/journal_content/3df5b7b9-a36d-4e74-811b-3aeee23366f8, retrieved
30
th
April 2014.

49
Lee, R., Stokes, E., Analysis Twenty First Century Novel Regulating Nanotechnologies, Journal of Environmental Law,
21(3), pages 474-475.

50
EFSA, Endorsed Public Consultation, http://www.efsa.europa.eu/en/consultations/call/scaf110114.pdf, page 1,
(retrieved 30
th
April 2014).

10

the nanomaterials present in an effort to empower consumers51. The principle legislative tool is the Novel
Foods legislation, which remained largely unchanged with respect to nanomaterials since its inception in
1997, requires a pre-market assessment and a subsequent EU authorization. However, just like REACH, it is
questionable whether it can adequately address the risks associated with nanotechnology, as pointed out by
Gergely, Bowman and Chaudhry, due to potential that certain nanomaterials may not be defined as a novel
food and hence safety evaluation may not be carried out52. The overall stance of the European Union is
therefore characterized as egalitarian, due to relative risk aversion associated with novel technologies and an
attempted balanced approach to regulation.
The deconstruction of the two regimes above is inconsistent with the proposition of risk society. Although
both regimes possess at least a partial commitment to risk based approaches, the EU regime arguably
possesses more elements of the anticipative type regulatory solutions, such as regulatory discretion to order
greater testing to cover potential risks, as favoured by the risk society thesis. By contrast, the US regulatory
style differs markedly in its reliance on self regulation and as exemplified by the case of FDA. Risk as a
stimulus to action has therefore manifested itself to a greater degree in European regime rather than the US.
Nevertheless, significant deficiencies in current legislation and practices exist which is incompatible with the
notion of anticipative solutions advocated by Beck. However, both the EU53 and US54 recognize the need
for continuous monitoring of the associated risks and subsequent assessment whether further intervention is
required in the form of adaptation or addition to the existing regulations, implying that the regulatory regimes
in question are in a state of constant dynamic flux with respect to their policy stances and hence regulatory
commitment to a certain approaches is likely to be valid only at a certain point in time.
An alternative manifestation of risk society arguably occurs In the realm of beef hormone regulation.
Although the conflict between the US and EU over the potential health risks posed by the hormones can be

51
EU, Commission Delegated Regulation, http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:343:0026:0028:EN:PDF, page 1, (retrieved 30
th
April 2014).

52
Gergely, A., Bowman, D., Chaudhry, Q., Small Ingredients in Big Picture: Regulatory Perspectives on Nanotechnolgies
in Foods and Food Contact Materials, Nanotechnologies in Food, page 155.

53
European Union, (Nanotechnology-EU Legislation),
http://ec.europa.eu/health/nanotechnology/legislation/index_en.htm, (retrieved April 17
th
2014).

54
Marburger, J.H., Connaughton, J.L., Principles for Nanotechnology Environmental, Health, and Safety Oversight,
page 2, http://pananocenter.org/Docs/pdf/NanoEHSPrinciplesMemo.pdf (retrieved April 17th 2014).

11

interpreted as the manifestation of risk society, deeper examination renders regimes exhibiting possess polar
opposite risk perceptions and hence risk regimes for the same type of risk.
Growth hormone regulation in the US occurs through tight cooperation between USDA and FDA,
mandated by the memorandum of understanding to better coordinate regulatory process. USDA has the
primary responsibility for setting the Maximum Residue Level of the hormone55. FSIS monitors labeling of
products, as mandated under the Meat Inspections Act (MIA)56. MIA also endows FSIS with the power to
inspect meat products to determine misuse of the hormones57. In addition, FSIS runs a national residue
program as a part of compliance with MIA and provision of information to public58. FSIS also possesses
considerable detention and seizure powers to mitigate the risk to public health pertinent to Directive 8410.159.
However, product recalls can be voluntary under FSIS Directive 8080.1 and FSIS has the obligation to assist
the pertinent firm with product recalls60. USDA has recently established a food safety risk assessment
committee further signaling commitment to risk based regulation61. Furthermore, it is one of FSISs core
priority areas to develop methods for hormone and hormone like compounds to monitor adverse hormones in
meat and address pertinent health risks62. The responsibility for the medical aspect of the hormone
production is FDA, which grants authorization for animal medicines, following a review of the New Animal

55
Schmidt, R., Rodrick, G., Food Safety Handbook, (Wiley, New Jersey: 2003),
http://muhammadsubchi.files.wordpress.com/2010/04/food-safety-handbook.pdf, (retrieved April 17th 2014).

56
FSIS, Meat Inspections Act-Meat Inspection, http://www.gpo.gov/fdsys/pkg/USCODE-2011-title21/pdf/USCODE-
2011-title21-chap12.pdf, page 470, (retrieved April 17th 2014).

57
FSIS,Inspection and Grading of Meat and Poultry: What are the Differences?
http://www.fsis.usda.gov/wps/wcm/connect/5d43763f-a9aa-459b-94e0-
cdf9e3543923/Inspection_and_Grading_What_Are_the_Differences.pdf?MOD=AJPERES, (retrieved April 17th 2014).

58
FSIS, National Residue Program for Cattle, http://www.usda.gov/oig/webdocs/24601-08-KC.pdf, page 1,( retrieved
April 17th 2014).

59
FSIS, FSIS Directive, Detention and Seizure, http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/8410.1Rev3.pdf,
page 1, ( retrieved April 17th 2014).

60
FSIS, FSIS Directive: Recall of Meat and Poultry Products, http://www.fsis.usda.gov/wps/wcm/connect/77a99dc3-
9784-4a1f-b694-ecf4eea455a6/8080.1.pdf?MOD=AJPERES, page 1, ( retrieved April 17th 2014).


61
FSIS, http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safety-fact-
sheets/production-and-inspection/risk-analysis/risk-analysis.

62
FSIS, Develop a screen for the detection of hormones and hormone like compounds,
http://www.fsis.usda.gov/wps/portal/fsis/topics/science/food-safety-research-priorities/food-safety-research-
studies#13, (retrieved 25
th
April 2014).

12

Drug Application (NADA) by a multidisciplinary personnel. FDA possesses the powers to establish necessary
standards for human consumption in the form of Acceptable Daily Intake and monitors residue as a part of its
enforcement programme. FDA also runs a database for the purposes of post market monitoring and
information gathering effort63. Under the aegis of Federal Food, Drug and Cosmetic Act, FDA has developed
two strategies to conduct comprehensive monitoring of all aspects of distribution of drugs, which includes
sample analysis as well as evaluation through factory inspections and sample collection64. Its enforcement
powers are extensive, ranging from notices to mandatory product recalls and criminal prosecutions65. The
regulation in the European Union stands in marked contrast to its US counterpart. Contrary to the FDAs
process for regulating the Acceptable Daily Intake, the assessments executed by the EU pointed to there
being no Acceptable Daily Intake for the hormones approved for consumption in the US66. The provision is
upheld by the Food Safety Authority, which explicitly adopted a risk based approach to meat inspections, by
prioritizing pertinent hazards and revising former methods to better suit enhanced risk identification and
management when advising the relevant European bodies and member states67. EFSA, however, is not
responsible for the enforcement of the pertinent legislation, acting only as an independent risk assessor, with
the enforcement powers exercised by the European Parliament, the Council of the European Union European
Commission and individual member states 68. The Council of the European Union engages in extensive
information gathering procedures, which include National Residue Monitoring Plans as a way to monitor non-

63
FDA, Safety and Health,
http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055369.htm, (retrieved 25
th
April
2014).

64
FDA, Compliance Program Guidance Manual,
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/UCM11
3398.pdf, (retrieved 25
th
April 2014).

65
FDA, Compliance and Enforcement Information,
http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm254426.htm#regulatorycompliance,
(retrieved 25
th
April 2014).

66
EC, Hormones in Meat-Introduction,
http://ec.europa.eu/food/food/chemicalsafety/contaminants/hormones/index_en.htm. (retrieved 25
th
April 2014).

67
EFAS, Meat Inspection, http://www.efsa.europa.eu/en/topics/topic/meatinspection.htm, (retrieved 25
th
April
2014)..

68
EFSA,
http://www.efsa.europa.eu/cs/Satellite?c=AskEFSA_FAQ&childpagename=EFSA%2FLayout&cid=1211902418498&p=12
11902350382&packedargs=locale%3DEN&pagename=Wrapper%2FCommon, (retrieved 25
th
April 2014).

13

compliance in the individual states69. The Councils Directive 96/23/EC establishes sampling rules and
requires Member States to devise a monitoring plan for the food residues, whilst directive 85/358/EC
establishes specific rules concerning monitoring and detection of hormonal substances.
The outline of the health risk regulation as per above would seem consistent with the notion of risk
society. In both regions, the commitment to risk based approaches is evident and successfully informs the
pertinent policies and practices when ensuring integrity of human health. Although a move to an explicitly risk
based approach in the EU is a relatively recent phenomenon, risk society thesis seems to accurately depict
the trends in regulation, with the idea and perception of potential health risk resulting from cattle hormones
becoming the central component of both regimes. Nevertheless, the pertinent policy stances of the EU and
US remain divergent on the matter, due to opposite outcomes of the respective risk assessment. However, it
remains unclear whether the risk perceptions resulting from risk assessments, or vice versa have lead to the
eventual policy outcomes. In the EU, the Scientific Committee on Veterinary Measures relating to Public
Health (SCVPH), an in house expert group, was responsible for conducting the initial risk assessment in light
of the US-EU trade dispute70, a role that was subsequently adopted by the EFSA71. To date, the EU
advocates the validity of its initial findings, even when considering the recent scientific data. Contrary to Renn,
who claims that the language of science is universal in the scientific circles72, studies by Lynn demonstrated
that scientists risk perceptions are affected by their cultural backgrounds, which is consistent with Schrader-
Frechettes assertion of expert opinion bias. Hence, studies conducted in the climate of precaution might have
contributed to the outcome of the risk assessment by the EU scientists. The reverse is also true of the WTO
Panel on EC Measures Concerning Meat and Meat Products (Hormones), as WTOs principle mandate is to
endorse trade, implying an individualist cultural type. However, the issue is further complicated when
addressing the specifics of the regime content and context in each region. In general, the European regime
content largely reflects the popular attitudes towards beef hormones. Studies have shown that the EU public

69
European Commission, Residues Control, http://ec.europa.eu/food/food/chemicalsafety/residues/control_en.htm ,
(retrieved 25
th
April 2014).

70
EC, Food Contaminants-Hormones,
http://ec.europa.eu/food/food/chemicalsafety/contaminants/hormones/index_en.htm, (retrieved 25
th
April 2014).

71
EFSA, Opinion of the Scientific Panel on contaminants in the food chain (CONTAM) related to hormone residues in
bovine meat and meat products, http://www.efsa.europa.eu/en/efsajournal/pub/510.htm, (retrieved 25
th
April 2014).

72
Lofstedt, R.E., Vogel, D., The changing character of regulation: a comparison of Europe and the United States, Risk
Analysis 21(3), pages 400-401.

14

is sufficiently aware of the health issues and as demonstrated by Tonsor, Schroeder, Fox and Biere, prefers
hormone-free products73, which is consistent with the overall precautionary policy stance of the EU. On the
other hand, US consumers preferences are relatively unstable when compared to their EU counterparts. As
shown by Lusk, Roosen and Fox, US public explicitly recognises the potential health hazards associated with
beef hormones, but ranked the preoccupation with the pertinent health risks as below other risks74, hence
being consistent with the individualist regulatory policy. Media salience has arguably contributed to European
attitudes, with Verbeke, Vaene and Guiot75 demonstrating an increased concern with the beef hormones in
Belgium, which in turn negatively affected consumer behaviour. The European ban itself has generated
significant controversy due to being labeled as protectionist by its US counterparts. However, evidence
suggests that negative sentiments towards the hormones were generated by intense lobbying from consumer
interest groups76 before the import ban came into force, hence marking a longstanding tradition of the
precautionary principle within the EU.
Upon a perfunctory view, the two risk regimes render support for Becks theory. The discourse of risk,
as constructed by a particular cultural stance, runs through both the nanotechnology and beef hormone
regulation in both the US and the EU. The policies seem saturated with the language of risk, and although the
commitment to risk based approaches varies, policies do appear to be based on an attempt to address
potential risks arising from novel technologies by employing risk management techniques and pursuing
extensive enforcement strategies. Nevertheless, examining the case of nanotechnology regulation in detail
renders a mixed conclusion. Although there is clear trend indicating an increasing commitment to risk based
approaches as evidenced by gradual considerations of industry specific legislation to address pertinent
potential risks in a more efficient manner, at present it cannot be said that the regime is compatible with the
risk regulation framework favoured by Beck, namely precaution. Beck defines the modern societies whereby

73
Tonsor, G., Schroeder, T., Fox, J.A., Biere, A., European Preferences for Beef Steak Attitudes, Journal of Agricultural
and Resource Economics, 30(2), page 372.

74
Lusk, J., Roosen, J., Fox, J., Demand for Beef from Cattle Administered Growth Hormones or Fed Genetically
Modified Corn: A Comparison of Consumers in France, Germany, the United Kingdom, and the United States, American
Journal of Agricultural Economics, 85(1), page

75
Verbeke W
1
, Viaene J, Guiot O., Health communication and consumer behavior on meat in Belgium: from BSE until
dioxin, journal of Health Communication, 4(4), page 351.

76
Deveraux, C., Lawrence, R., Watkins, M., The United States, Europe and Trade in Hormone Treated Beef, (Institute
for International Economics, Washington: 2006), page 39.
15

the ability to anticipate and endure dangers, to deal with them biographically and politically acquires
importance77. Arguably, the risk governance of beef hormones in both EU and the US adhere comparatively
better to Becks precautionary characteristic of risk society. However, the present gaps in the legislative
frameworks of both the US and the EU preclude such an approach due to their potential inability to address
risks pertinent specifically to nanotechnology. The current risk regulatory framework instead results in certain
products essentially escaping regulatory oversight. Moreover, cultural stances play a prominent role in
determining the selection of policies hence rendering the risk regulation regimes uneven, as exemplified by
the case of the EU and the US in the context of beef hormone regulation. Culturally saturated risk discourse
within the respective cultural frameworks resulted in a complex interaction between risk regime content and
context, reinforcing and amplifying cultural beliefs of both regulators and regulatees, due to the autopoeitic
nature of regulatory systems. Moreover, the autopoeitic nature of such systems instead results in the
reinforcement of the existing conflict and entrenching of further conflicts over the appropriate policy stance,
since neither of the rival regulatory stances are capable of perceiving each others relevance, due to cultural
filtering taking place in their interactions with the external environment, hence precluding effective
communication and policy harmonization. Finally, examining regional risk regimes in isolation renders Becks
theory invalid. Both in the case of EU and US, the individual regulators, whilst broadly adhering to their
cultural stance, handle different risks with different risk regimes. As discussed above, the risk regime
associated with nanotechnology is comparatively lighter due the legislative gaps, whilst the risk regime
pertinent to beef hormones is arguably more comprehensive in its coverage.
In line with Hood, Becks risk society thesis is therefore a generalization of regulatory practices
pertaining to risk. While risk discourse appeared to have colonized the regulatory discourse, in practice the
policy stances often appear to be divergent both in principle and in practice. In addition, as demonstrated in
the cases of nanotechnology and beef hormone regulation, cultural stances effectively shape the varying risk
regimes for which Becks theory cannot accommodate, as it favours an egalitarian or precautionary stance,
thus being incapable of recognizing individualist approaches to handling of risk. However, it can be used to
monitor the emerging regulatory trends. A move towards sector specific nanotechnology legislation and
specialized risk based strategies to identify and manage specific risks, is driven by lack of understanding and
knowledge of the externalities associated with nanotechnologies. Such a stance would be consistent with risk


77
Beck, U., Chapter 1: Living on the Volcano of Civilization, Risk Society: Towards a New Modernity, (London, Sage:
1992), page 76.
16

extending its influence on regulatory policy and hence would be consistent with Becks thesis. The notion of
risk society should therefore be used carefully in reference to risk regimes as any generalization can render
misleading impressions.



























17

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