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SAFEGUARDS | Food NO. 030/16

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Petition (PP: 4E8282 and 4F8261) requested amendment of regulation 40 C 180.361FR to establish tolerances for residues of pendimethalin and its metabolite in various crops, milk, meat, liver, and meat byproducts except liver. It came into force on December 20, 2015. Objections and requests for hearing must be received on or before February 19, 2016.

Pendimethalin [N-(1-ethylpropyl)-3, 4-dimethyl-2,6-dinitrobenzenamine] is a herbicide in a subgroup of pesticides used to control weeds in crops such as cotton, wheat, soybean and various vegetables. It is easily absorbed by soil and the hydrosphere, and thereby transferred to the food supply chain. Under tropical field conditions, its half-life in soil is 60 days. Improper application, including its overuse on food commodities, can lead to high levels of residues reaching the food supply chain. Consumption of these residues can then adversely affect human health.

In the US, safe levels for this pesticide in relation to its intended use, are established as tolerances and approved by US Environmental Protection Agency (EPA). Other countries set maximum residue limits (MRLs) and these are considered legal within their jurisdiction. No harm to consumers must be proven, at these tolerances, from the aggregate data from field study under Good Agricultural Practices (GAP), consumer exposure, and toxicology. In accordance with EPA data, pendimethalin has been classified as a possible human carcinogen (Group C) based on an increase in thyroid tumors in rats given a high dose. However, there is no indication that pendimethalin causes neurotoxicity. Further studies reveal that aggregate exposure in the general population, including infants and children, does not present a risk of harm.

In making the tolerance decision, the EPA seeks to harmonize US tolerances with the international standards, particularly Codex. Unfortunately, Codex does not have MRLs for pendimethalin, therefore, the US has established its own tolerances. Recently, data from 40C 180.361FR [1] supporting the petition have been revised. Additional tolerances of pendimethalin and its metabolites are required to address some specific foods and crops, the details are shown in Table 1. Analysis of the residue, using gas chromatography with electron capture detector (GC/ECD), is an adequate enforcement method, as requested by the Chief of the Analytical Chemistry Branch, Environmental Science Center.

Table 1. Tolerances of Pendimethalin and its metabolites in crops, milk, and meat products

Commodity Parts per million
Bushberry subgroup 13-07B 0.1
Caneberry subgroup 13-07A 0.1
Grass, forage, fodder, and hay crop group 17, forage 1,000
Grass, forage, fodder, and hay crop group 17, hay 2,000
Nut, tree, group 14-12 0.1
Cattle, goat, horse, and sheep: fat 0.3
Cattle, goat, horse, and sheep: meat 0.1
Cattle, goat, horse, and sheep: liver 1.5
Cattle, goat, horse, and sheep: meat byproduct except liver 3.0
Milk 0.04

What do the changes mean?

This updates has the potential to affect agricultural producers, food manufacturers, and pesticide manufacturers. The residue of pendimethalin and its metabolites in or on the products destined for the US must exceed the US EPA tolerances, or be identified in products for which tolerances have not been established. For support in complying with this food safety regulation, food producers should seek professional advice.

SGS is committed to keeping you informed of regulation news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical tests, audits, certifications, inspections, and technical support. We continually invest in our testing, capability, and state-of-the art technology to help you reduce risk, improve food safety and quality. For more information, please visit our website: www.foodsafety.sgs.com.

For enquiries, please contact:

Amornpun Dajsiripun
Global Competence Support Centre Food Specialist
t: +66 2683 0541 ext 2423

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