On 20 Mar 2015, the International Agency of Research on Cancer (IARC) announced the carcinogenicity classification of five pesticides:

• tetrachlorvinphos

• parathion

• malathion

• diazinon

• glyphosate

The Brazilian National Agency of Sanitary Surveillance (ANVISA) consequently clarified the regulatory status of each of the 5 active ingredients in Brazil with a particular focus on current and future regulation of glyphosate.

The Carcinogenic Pesticides

Tetrachlorvinphos

The insecticide has been classified by the IARC as possible carcinogen to humans and has already been banned in the United States and EU. No tetrachlorvinphos based product was registered in Brazil but the active ingredient is still used in veterinary products, including flea collars for pets.

Parathion

Parathion has been also classified as possible carcinogen to human. The active ingredient comes in two forms in pesticides: methyl parathion and ethyl parathion. Ethyl parathion is registered in Brazil. Methyl parathion has already been banned in most countries since 1980s. A ban on ethyl parathion was proposed during the Directorial Broad session of ANVISA however the re-evaluation procedure was suspended by a court ruling before the implementation of the reassessment.

Malathion

Malathion has been classified as probable carcinogen to humans. It is used in agriculture and public health for insect control and continues to be produced in substantial quantities throughout the world. The use of the insecticide was under authorization in the US and EU.

Diazinon

Diazinon has been also classified as probable carcinogen to human. The insecticide has been banned in EU, but the registration is still authorized in the US under certain application restrictions. In Brazil, the pesticide is used in agriculture and public health, as well as veterinary products.

Glyphosate

Glyphosate is the most produced and utilized herbicide in the world. The classification by the IARC as a “probable carcinogen” is challenging it’s increasing use on GM crops in Brazil. The country has made a Resolution from the Board of Collegiate (RDC) in 2008, which determined the toxicological revaluation of the technical and formulation products of glyphosate and other pesticides was necessary. The review finally requested the necessity to establish the ADI by registrants and control the impurities present in the technical material and other potential adverse toxicological effects.

Revaluation Priority

Further re-evaluation on glyphosate and other active ingredients were also proposed by the resolution. ANVISA has entered into an agreement with the Oswaldo Cruz Foundation under which they will draw up technical notes for each active ingredient. The technical note will be reviewed by the ANVISA before public release. According to the analysis of the technical note, the re-evaluation on glyphosate was necessary but the conclusion of the evaluation was that glyphosate was not considered of similar priority to other active ingredients. The Foundation indicated that only that the evidence of mutagenicity, carcinogenicity and endocrine disrupting would support the need for further research. Otherwise the re-evaluation would be “insufficient”.

Given the recent classification of glyphosate by IARC, ANVISA will immediately resume the revaluation on glyphosate in compliance with Decree No. 4074, which stipulated that

 “to promote the re-evaluation of the registration of pesticides, their components and related occurrence when new clues risks that argue against the use of registered products or when the country is alerted accordingly, by international organizations responsible for health, food or environment, of which Brazil is an integral member or agreements signed.”

Considering the classification of diazinon and malathion by IARC as probable carcinogens, ANVISA will wait for the official release of the IARC monographs to determine the priority order of the pesticides that require reassessment

Back ground information

According to Brazilian Law No. 7,802, of July 11, 1989 and Decree No. 4074 of January 4, 2002, pesticide with carcinogenic properties should be prohibited. The utilization of IARC’s criteria is further supported by the Ordinance SNVS No. 03 of 16 January 1992.

However the detailed information on the classification was in an article published in the journal Lancet in March of this year. ANVISA is awaiting the monograph of each active ingredient to determine whether the adopted study method and the result would be applicable to the evaluation on pesticide.

A toxicological re-evaluation generally follows the following administration procedures:

• Initiation of revaluation on active ingredient goes through the Board of Collegiate (RDC);

• Announcement of toxicological studies on the active ingredient for the revaluation;

• analysis of the data and published scientific studies;

• partnership with technical and scientifically recognized institution in toxicology area without conflict of interest;

• publish the technical note for public consultation;

• consolidation of public consultation contributions;

• discussion of the findings and suggestions of referrals by the revaluation committee composed by the MAPA(Ministry of Agriculture, Livestock and Supply) and IBAMA(Brazilian Institute of Environment and Renewable Natural Resources);

• development of conclusive technical notes and publication of the revaluation decision by the (RDC);