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Protecting Public and Planet: Environmental and Health Regulation in the United States and the European Union. Mitchell P. Smith The University of Oklahoma. Environmental and Health Regulation. chemicals. Environmental and Health Regulation. autos recycling.

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Protecting Public and Planet: Environmental and Health Regulation in the United States and the European Union

Mitchell P. Smith

The University of Oklahoma

Environmental and Health Regulation


Environmental and Health Regulation

autos recycling

Environmental and Health Regulation

health claims

The United States:Environmental and Health Regulation in the 21st century

Rigor of Regulation


The European Union:Environmental and Health Regulation in the 21st century

Rigor of Regulation


The U.S. and the EUDiverging Trajectories

Rigor of Regulation




Diverging U.S. and EU Trajectories


Explaining Diverging U.S. and EU Trajectories


Europe: Precaution and Cultural Aversion to Risk

  • BSE (“mad cow” disease)

  • dioxin in beverages, poultry, eggs (1999)

  • preference for “traditional” foods (no GMOs)

Evidence Against Cultural Argument:The U.S.

  • high level of precaution displayed in past regulatory policy (health claims on food labels)

  • policy toward tobacco consumption

  • restrictions on blood donations from people exposed to BSE beef

  • regulation of nitrogen oxides from diesel vehicles

Explaining Diverging U.S. and EU Trajectories

State-Market balance?

State-Market Balance ArgumentAmerican liberal capitalism vs. state-centered European dirigisme

  • Political economy of US =>

    regulatory structures give primacy to free competition

  • Europe’s coordinated capitalism =>

    constrains market exchange in favor of public goods

State-Market Balance ExplanationArguments Against

  • European market has favored intensification of market competition

  • EU concern with regulatory burden on industry (regulatory impact assessment)

  • Policy discourse over regulation in EU closely resembles that in the U.S.

Court Decisions?

  • U.S. courts =>

    high evidentiary standards (on FDA, e.g.)

    free commercial speech

  • ECJ =>

    follows this pattern

    free commercial speech, proportionality

Industry Lobbying?

Industry Lobbying?power of industry lobby in U.S.

  • organizational resources

  • access to policy making

Industry Lobbying?power of industry lobby in U.S. . .


relatively greater access of environmental interest associations in the EU

Industry Lobbying?No

  • U.S.=> court decisions have trumped lobbying

  • EU => rising industry access

Rising Industry Access in the EU

  • increased legislative powers of EP =>

    more industry resources invested in lobbying

  • access via Internal Market Committee (2004; 6th EP) and political groups

  • Competitiveness Council (2002)

What then?

If not cultural attitudes toward risk, national political economies, court decisions, or industry lobbying?

Rigor of Regulation




Institutions and Regulatory Tradeoffs

The Regulatory Dilemma in the US:

competitiveness regulatory objectives


The EU’s Regulatory Trilemma:

The Regulatory Dilemma in the U.S.

Outcomes include:

  • Voluntary regulation (TRI)

  • Regulatory “preemption”

    competitiveness regulatory objectives

The EU’s Regulatory Trilemma

EU Regulation:

  • Harmonizes standards

  • Intensifies cross-border exchange

  • Fosters interest articulation at EU level

Implications of Court Decisions

  • In U.S., court decisions constrain federal regulatory ambitions

  • In the EU, court decisions define areas where single market regulation is incomplete

Illustrating the Argument: health claims

Case demonstrates:

(1) history of precaution in U.S.

(2) contrasting role of court decisions

(3) rising industry lobby in EU

US Regulatory Regime

  • 1906-mid 1980s: health claims as implied drug claims (hence no claims)

  • In 1990 industry lobbying leads to Nutrition Labeling and Education Act (effective 1993 and largely a response to diffuse actions by states)

  • No preemption by states

  • “significant scientific agreement” standard

  • 1993: only 7 claims permitted; 5 more by 2001

US Regulatory Regime

Landmark 1999 court case: Pearson v. Shalala

  • Proportionality

  • Free commercial speech

  • Note parallel to ECJ rulings in early 2000s (which similarly struck down national laws regulating health claims on the grounds that they were excessively restrictive and disproportionate to the objectives sought).

US Regulatory Regime

post-Pearson v. Shalala

FDA endeavors to sustain

its regulatory approach to health claims

on foods

US Regulatory Regime

Subsequent court cases in 2000s (e.g., Whitaker v Thompson I, 2002):

  • FDA too restrictive

  • Has FDA considered all available evidence?

  • Why not a disclaimer?

  • “qualified claims” based on “credible scientific evidence” or “some scientific evidence”

  • Welter of claims (first approved claim July 2003:

    unsaturated fats in tree nuts => reduced risk of heart disease)

  • Yet FDA continues to exercise enforcement discretion

US Regulatory Regime

By 2010, following Alliance for Natural Health vSebelius:

  • Burden on FDA

  • Minimally restrictive disclaimers

  • Show disclaimer would confuse consumers

US Regulatory Regime

Distinction between rules for dietary supplements and rules for foods breaks down


US Regulatory Regime:The Result

EU Regulatory Regime

Wide variation through 1990s:

  • Austria highly restrictive

  • Voluntary codes in Sweden and UK

  • Case by case approach in Germany and France

EU Regulatory Regime

ECJ decisions in early 2000s:

  • 1975 Austrian LMG (2003)

  • DouweEgberts (2004)

  • Parallel to U.S. decisions: proportionality

  • Similar impact on national regulatory regime

EU Regulatory Regime

However, institutional dynamics differ from US:

  • Business sector wants legal certainty (as in U.S.)

  • European Commission: barrier to free movement of foodstuffs

  • DG SANCO: barrier to high level of consumer & public health protection

  • National health ministers want to reclaim regulatory control

EU Regulatory Regime: The Result

2003 Commission proposal:

  • Disease reduction claims subject to EFSA approval

  • Nutrition profiles

EU Regulatory Regime: The Result

  • Industry lobbying: impact on innovation and competitiveness

  • EP cuts nutrition profiles in first reading

  • National health ministers restore nutrition profiles

  • Regulation on Nutrition and Health Claims on Foods enters into force January 2007

European Parliament Second Reading Debate

  • ”. . . the tenacious lobby of food and particularly the drinks industry has not been as effective this time around;” could the EP second reading vote be attributed to the fact that "Members are simply embarrassed . . . that for once, the Council was more progressive than Parliament?”

    -- Dutch MEP Kartika Tamara Liotard, European United Left

  • ”. . . we have nothing to gain from European law being drafted at the International Sweets and Biscuits Fair in Cologne.”

    -- FrédériqueRies, French Liberal Democrat MEP

EU Regulatory Regime: The Result

Industry lobbying continues:

  • More than 44,000 proposed claims submitted to Commission and forwarded to EFSA by Jan. 1, 2008

  • EP seeks to remove nutrition profiles in 2010

  • Committee passes this amendment; tie vote (309-309) in plenary

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