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

and the European Union

Mitchell P. SmithThe University of Oklahoma

Environmental and Health Regulation chemicals

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

Time

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

Rigor of Regulation

Time

The U.S. and the EUDiverging Trajectories

Rigor of Regulation

Time

U.S.

EU

Diverging U.S. and EU Trajectories

WHY?

Explaining Diverging U.S. and EU Trajectories

Culture?

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 competitionEurope’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 speechECJ => 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. . .

and

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 lobbyingaccess via Internal Market Committee (2004;

6th EP) and political groupsCompetitiveness Council (2002)

What then?

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

Rigor of Regulation

Time

U.S.

EU

Institutions and Regulatory Tradeoffs

The Regulatory Dilemma in the US:

competitiveness regulatory objectives

vs.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 standardsIntensifies cross-border exchangeFosters 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” standard1993: only 7 claims permitted; 5 more by 2001

US Regulatory Regime

Landmark 1999 court case: Pearson v. ShalalaProportionalityFree commercial speechNote 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 restrictiveHas 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 v Sebelius:

Burden on FDAMinimally restrictive disclaimersShow 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 restrictiveVoluntary codes in Sweden and UKCase by case approach in Germany and France

EU Regulatory Regime

ECJ decisions in early 2000s:1975 Austrian LMG (2003)Douwe Egberts (2004)Parallel to U.S. decisions: proportionalitySimilar impact on national regulatory regime

EU Regulatory RegimeHowever, institutional dynamics differ from US:Business sector wants legal certainty (as in U.S.)European Commission: barrier to free

movement of foodstuffsDG SANCO: barrier to high level of consumer &

public health protectionNational health ministers want to reclaim

regulatory control

EU Regulatory Regime: The Result2003 Commission proposal:Disease reduction claims subject to EFSA

approvalNutrition profiles

EU Regulatory Regime: The ResultIndustry lobbying: impact on innovation and

competitivenessEP cuts nutrition profiles in first readingNational health ministers restore nutrition

profilesRegulation 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.” -- Frédérique Ries, French Liberal Democrat MEP

EU Regulatory Regime: The ResultIndustry 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 2010Committee passes this amendment; tie vote

(309-309) in plenary