Codex MLs for Lead in Wine

The Codex methodology for revising lead maximum limits is flawed for age-restricted products

By: Justin Schwegel

This is an abridged version of an article that will be published in the University of Arkansas Law School’s Journal of Food Law and Policy. When the full citation is available this post will be updated.

In 2017 the Codex Alimentarius Committee on Contaminants in Food’s (CCCF) electronic working group (EWG) to revise the maximum levels (MLs) for lead proposed to revise the maximum level (ML) for lead in wine from .2 parts per million (ppm) to .05 ppm.
The EWG based this proposal on the “ALARA” principle, which aims to adopt standards for dangerous contaminants at a level that is “as low as reasonably achievable.” This same principle is applied when establishing MLs for low-value products largely consumed by children who are most vulnerable to exposure to lead. Another EWG is currently charged with prioritizing commodities for new lead MLs in the General Standard for Contaminants and Toxins in Food and Feed. Some commodities under consideration include high value products not consumed by children like cognac and Scotch. Adopting MLs for cognac based on the same methodology that is applied to grape juice could lead to perverse results and unnecessary waste of valuable products.

Codex’s Relevance to International Trade

The World Trade Organization’s (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) was adopted to help ensure that the greater trade liberalization negotiated by WTO members was not undermined by unnecessary SPS measures. An SPS measure is any measure aimed at protecting human, animal, or plant life or health from disease, or unsafe food and feed. Such measures could function as nontariff barriers to trade in agricultural products.

To help ensure that WTO Members do not resort to unjustified SPS measures for the sake of protectionism, such measures are subjected to the disciplines outlined in the SPS Agreement, namely they must be based on a scientific assessment of risk or the relevant international standard. With respect to food safety the relevant international standard setting body is the Codex Alimentarius. The Codex Committee on Contaminants in Food is the committee responsible for establishing MLs for contaminants such as lead in food and beverages.

Because many developing country WTO Members lack the capacity to conduct risk assessments of their own they defer to Codex for food safety standards. This is often done directly through regulations that formally defer to Codex or mirror Codex standards. The SPS Agreement states that any SPS Measure adopted by a WTO Member that conforms to international standards shall be presumed to be GATT consistent. Because of this safe harbor, many developing countries either defer to Codex when there is no domestic standard (e.g. Morocco for veterinary drug residues), or allow imports that comply with international standards notwithstanding a more restrictive domestic standard (e.g. South Africa for pesticide residues). Because of the deference given to Codex standards, their importance to international trade cannot be overstated. The potential for a negative economic impact of overly restrictive Codex standards is a real concern for many producers.

The Concern over Lead

Lead exposure is disproportionately harmful to children. The Codex Alimentarius Committee on Contaminants in Food’s (CCCF) Electronic Working Group (EWG) to revise the MLs for lead was formed in 2012 at the sixth session of Codex Alimentarius Committee on Contaminants in Food. This followed the 2011 Joint FAO/WHO Expert Committee on Food Additives’ (JECFA) 73rd meeting. The JECFA meeting report cited concerns over lead exposure and noted that it was impossible to establish a tolerable weekly intake for lead that would be health protective. Essentially, JECFA found that no level of lead exposure is safe. JECFA noted, “[b]ecause of the neurodevelopmental effects, fetuses, infants and children are the subgroups that are most sensitive to lead.”

The greatest concern for lead exposure in adults is an associated risk of increased systolic blood pressure, though JECFA noted that this concern was not as significant as the concern for the neurodevelopment impact of children. JECFA also noted the potential negative impact on the neurodevelopment of children, including lower IQ scores, is associated with lower lead concentrations than the other effects and the evidence is greater for neurodevelopmental effects than other effects.

JECFA concluded that, in populations with prolonged dietary exposures “measures should be taken to identify major contributing sources and foods and…to identify methods of reducing dietary exposure that are commensurate with the level of risk reduction [emphasis added].” The methodology used by the EWG for proposing draft MLs may not clearly reflect JECFA’s recommendation. The EWG has:

“no specific rule to identify the appropriate cut-off value, but in general, [its] approach has been to recommend reductions in MLs when the percentage of excluded samples was less than 5 percent.”

There is a clear distinction between the competent risk assessors, the joint FAO/WHO expert bodies, and the competent risk managers, the Codex Alimentarius Commission and its subsidiary bodies. However, it is also clear that Codex has the dual mandate of ensuring both consumer protection and fair practices in food trade. This dual mandate requires balancing economic concerns and food safety concerns. Indeed, the concept that contaminants in food should be as low as reasonably achievable is itself a balancing testrequiring an assessment of the economic cost and the public health benefit of further reducing MLs. It is unclear how a methodology that focuses only on the percentage of trade potentially disrupted without an assessment of dietary exposure for the most vulnerable populations, or the relative economic cost, can ensure that steps taken are commensurate with the level of risk reduction as a result of reduced dietary exposure.

Many of the commodities reviewed by the committee in its nascence reflect a focus on infants and young children, including fruit juices, milk, and infant formula. The concerns regarding dietary exposure to children and fetuses (those most vulnerable to low levels of lead exposure) are not the same for age-restricted products such as alcohol as they are with other food products.

The high unit value of alcoholic beverages versus fruit juices and responsible alcohol consumption guidance provided by national health authorities further support a lower tolerance for trade disruption for alcoholic beverages than for other processed fruit products. However, the recent ML of .05 ppm for grape juice is the same as the proposed level for wine despite the vastly different consumer profile for both products, though the grape juice ML was recently revised to .04 ppm.

With respect to a similar contamination concern, methyl mercury levels in fish, the U.S. and Japanese Codex delegations have consistently opposed maximum limits that would impact international trade flows. They have instead favored consumption guidance that consuming fish of certain species can negatively harm infants, children, and pregnant women. While the risk profiles of methyl mercury and lead are not identical, infants and children are legally prohibited from consuming alcohol in most countries and strong dietary guidance against consuming alcohol already exists for pregnant women. The same guidance warnings that the FDA suggests for the most at-risk populations for methyl mercury in fish are already superseded in alcohol, and as a result those most vulnerable to lead exposure consume a disproportionately small amount of alcohol.

The EWG’s opinion is that following the same methodology for wine as for other products is consistent with the ALARA (as low as reasonably achievable) principle. In this case, the percentage of wine in the sample that would fail to meet the hypothetical ML is 3.4%, which would impact an estimated 2.25 billion euros of global wine production. Establishing a percentage cutoff for economic impact irrespective of the public health risk due to dietary exposure is a simple heuristic to implement. But it isn’t ALARA.

In 2015 the European Union adopted an ML of .2 ppm (the current Codex ML) for wine vintages dating 2001 to 2015, and .15 ppm for wines produced in 2016 or later. This is the same level the OIV has established, though the OIV’s transition year is 2007 rather than 2015. Chile, Brazil, Georgia, and Argentina have also adopted an ML of .15. Where countries have adopted limits, these tend to be forward looking limits to avoid ex post facto regulation of a class of products with a long shelf life. Given these considerations, reducing the ML from .2 ppm to .15 ppm rather than .05 ppm would be better policy.