Why is the EU pesticide MRL of ≤0.01 ppm challengeable under the WTO-SPS Agreement?

″In the era of globalization, tradeoffs reached in domestic risk regulatory processes are also likely to be subject to international scrutiny…. governments are asked to defend their risk regulatory measures under the Sanitary and Phytosanitary Agreement of the WTO″

-Jacqueline Peel in Risk Regulation under the WTO-SPS Agreement

First things first

Determining the pesticide MRLs is governed by the legal framework established by the Members of the WTO - SPS Agreement. Determining the pesticide MRL is not an unfeterred right in the hands of the individual Member governments of the WTO.

What is Maximum Residue Limit (MRL)?

Pesticide residues are traces of pesticides in or on the agricultural commodities at the time of harvest.

The MRL is the highest level of pesticide residue that is legally tolerated in an agricultural commodity when traded. The agricultural commodity may be food, grains, oil seeds, fruits and vegetables, milk, meat etc. There are also MRLs for veterinary drugs in meat, fish, prawns, etc. But it is out of the purview of this article that concerns only with pesticide MRLs.

The pesticide MRL is not a toxicological safety standard, but only a trading standard. Since the pesticide MRLs can have direct or indirect effect on the international trade, they are governed by the WTO.

Pesticide MRLs and the WTO

The Agreement on the Application of Sanitary and Phytosanitary Measures (the ″SPS Agreement″) in force from 1st Jan 1995 is a part of the multilateral treaty that established the World Trade Organization (WTO). The SPS Agreement sets out the basic, binding and multilaterally agreed rules for the sanitary and phytosanitary measures (SPS measures) to protect human or animal life or health within the territory of the member country from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs. (Ref: 1.b of Annex A to the SPS Agreement).

The Annex A to the SPS Agreement refers to pesticide residues as ″contaminants″. The Codex defines ″contaminant″ as any substance not intentionally added to food, and which is present in such food as a result of the production, processing, packaging, etc., or as a result of environmental contamination.

Basic rules in the SPS Agreement

While determining the pesticide MRLs, the WTO Member countries should minimize the negative trade effects. The preamble to the SPS Agreement requires the WTO Members to ensure that ″SPS measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members where the same conditions prevail or a disguised restriction on international trade″.

The SPS Agreement encourages the WTO Members to use international standards and to recognize other countries compliance procedures as equivalent to their own, if the same level of protection is achieved.

The WTO Members are permitted under Article 3.3 to maintain pesticide MRLs which are higher than the international norms (such as the one set by Codex Alimentarius Commission) but such measures must be based upon risk assessment described in Article 5 of the SPS Agreement.

About the risk assessment valid under the SPS Agreement

When it comes to food-borne risks, the risk assessment requires the evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs.  Note, the risk to be assessed is from the presence of the contaminant (i.e., pesticide residue) and not from the pesticide per se.

In the dispute EC – Hormones (1998) the USA and Canada challenged the blanket ban imposed by the European Communities (EC) on imports of beef from hormone-treated cattle, for food safety reasons. The EC claimed that the hormones were carcinogenic.

In this case the Panels stated that "a risk assessment carried out in accordance with the SPS Agreement should (i) identify the adverse effects on human health (if any) arising from the presence of the hormones at issue when used as growth promoters in meat or meat products, and (ii) if any such adverse effects exist, evaluate the potential or probability of occurrence of these effects″. Note the words carefully. The risk to be assessed is the one arising from the presence of the hormone in the meat and not the hormone.  Holding that that the carcinogenic potential from the presence of hormones in the imported meat required to be established, the Panels set aside the ban imposed by the EC.

Applying this Panels’ decision to pesticide residues, the risk to be assessed is not the one arising from the pesticide active ingredient, but the risk, if any, arising from the trace levels of pesticides (contaminants) present in the agricultural commodities traded. Theoretical uncertainty is not the kind of risk to be assessed under Article 5.1 of the SPS Agreement as held by the Appellate Body in the EC-Hormone case.

″It is essential to bear in mind that the risk that is to be evaluated in a risk assessment under Article 5.1 is not only risk ascertainable in a science laboratory operating under strictly controlled conditions, but also the risk in human societies as they actually exist,″ observed the Appellate Body in the EC-Hormone case.

All these must be followed while determining the pesticide MRLs.

About the contentious EU pesticide MRL of ≤0.01 ppm

In the EU, the use of pesticides and MRLs are governed by the EC Regulation 396/2005 and 1107/2009. These regulations support hazard-based assessment to food safety and not the risk based assessment required by the SPS Agreement. The hazard assessment and risk assessment are poles apart.

Hazard: Hazard refers to the innate property of a substance capable of causing harm. Examples include fire, ice, electricity, alcohol, chemicals, UV radiation etc.,

Risk:  Risk is the likelihood of harm occurring from hazardous substances.

Risk-based approaches are widely used around the world for evaluation of pesticide residues (contaminants) present in food. The Codex follows risk based approach.

The EU maintains uniform tolerance/MRL of 0.01 ppm for all pesticides that are not registered/allowed for use in the EU countries. This ″one size fits all″ approach is inconsistent with the requirements given in the SPS Agreement.

In the EU, MRLs are set for more than 1300 pesticides covering 378 food products. Out of this, a default MRL of 0.01 ppm (0.01 mg/kg) applies to as many as 690 pesticides (Source: EFSA). In other words, for over 50% of the pesticide MRLs in the EU have ≤0.01 ppm as the default MRL. These are not provisional MRLs.

0.01 mg/kg = 1gm for every 100 tons of an agricultural commodity.

At this trace level (1 gm in 100 tons), a pesticide residue would not be biologically, toxicologically, and environmentally relevant. It only acts as the most potent non-tariff trade barrier on agricultural imports into the EU especially from the developing countries.

The 0.01 ppm MRL is the Limit of Detection (LOD) during laboratory analysis.  LOD is the smallest amount or concentration of a substance that can be detected (using Gas Chromatography) but not necessarily determined as an exact value. The EU import tolerance MRL of ≤0.01 ppm is as good as zero tolerance.  

This zero tolerance is not supported by risk assessment from the presence of ≤0.01 ppm of residues in food commodities. Remember, this kind of risk assessment is a sine quo non as held by WTO-Appellate Body in the EC-Hormones dispute.

In a response to the SPS Committee the EU had in fact admitted that their pesticide MRL of ≤0.01 ppm is not based on a risk evaluation.

″given the concerns identified by EFSA, it is not possible to determine MRLs based on a risk assessment and therefore all MRLs must be lowered to the limit of determination″.

-EU statement before SPS Committee, G/SPS/GEN/1847 (21st Oct 2020)

It is apparent that the EU import tolerance of ≤0.01 ppm MRL is maintained without risk assessment, without sufficient scientific evidence and applied in a manner which would constitute a disguised restriction on international trade. As this SPS measure fails to conform to the relevant provisions of SPS Agreement, it should be held not in accordance with the obligations of the WTO Members under the provisions of the GATT 1994, Article XX(b).

Under the emergency use approvals, the EU permits dual MRLs- a higher one for domestic producers under derogation and another- lower one- for imported products. This violates the core principles of ″Non-Discrimination″ and ″National Treatment″ of the WTO Parallelly, it also violates Article 2.3 of the SPS Agreement (arbitrary and unjustifiable discrimination between members).

The EU import tolerance pesticide MRL of ≤0.01 ppm is inconsistent with Article 1.1, 2.1, 2.2, 2.4, 3.1, 3.2, 3.3, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 10.1 of the SPS Agreement and Article XX(b) of the GATT 1994.

Rejection of exported consignments by the EU  applying the hazard based MRL of ≤0.01 ppm produces serious consequences on agricultural production, price and farmers outside the EU countries.

It’s time for non-EU countries to challenge the hazard based MRL of ≤0.01 ppm before the WTO availing the dispute settlement understanding (DSU). Raising specific trade concerns (STCs) before the SPS Committee alone won’t solve the problem.