Source: PRESS RELEASE, 2/3/14 Editor's Note: Statment by Bayer CropScience follows
In January 2014 the Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) in the Netherlands decided to withdraw the authorization for certain Imidacloprid uses. Bayer CropScience comments as follows:
Gaucho use in sugar beet and fodder beet; Gaucho™ Tuinbouw use in cabbage
Ctgb has decided to withdraw the registrations of Gaucho (Imidacloprid WS 70) for use in sugar beet and fodder beet, and of Gaucho Tuinbouw (Imidacloprid WS 70) in cabbage as of 31 January 2014. The period of grace for the use of existing stocks of Gaucho Tuinbouw in cabbages is until 1 May and until 1 July for Gaucho in sugar beet and fodder beet. These deadlines still allow for treatment of the concerned crops in the upcoming growing season 2014. The uses of Gaucho Tuinbouw in lettuce and endive remain authorized.
In Bayer CropScience’s opinion, its seed treatment products Gaucho and Gaucho Tuinbouw are safe for birds, when used responsibly and properly, according to label instructions. The basis for Ctgb’s decision regarding beets and cabbages are new bird risk assessments, which are not based on new data but on new assumptions concerning exposure. For beets the allegedly identified risk involves exposure of birds to beet pills mistaken for grit, and for cabbages it concerns exposure via the uptake of seedlings.
Bayer CropScience considers the conducted risk assessments to be highly conservative and therefore unrealistic. An example for the highly conservative assumptions in the risk assessment is the underlying exposure value for cabbage which was taken to be a consumption of 228 grams of cabbage per bird within a short period of time.
Admire™ field applications
Ctgb decided to withdraw several field applications of Admire (Imidacloprid WG 70) in ornamental crops (spray applications in ornamentals, tree nursery, flower bulbs, perennials) as of 31 January 2014. The period of grace for use of existing stock is until 1 May 2014. Admire fields of uses such as dipping of bulbs of ornamentals (e.g. lily), and all greenhouse uses remain authorized.
This decision to withdraw Admire uses was triggered by a recently published study by Roessink et al. 1. The results of this study caused the authority to lower the endpoint relevant for the aquatic risk assessment. While the Roessink study was carried out under laboratory conditions, Bayer CropScience conducted an additional semi field study carried out under more realistic agricultural conditions. The protocol had been discussed with Ctgb and the study was carried out with Roessink as independent study director. The new data clearly demonstrates that there are no unacceptable long term effects on the sensitive aquatic organism tested under field conditions.
Based on available data, Bayer CropScience is convinced that changing the endpoint for imidacloprid on aquatic organisms is not justified.
Bayer CropScience is willing to continue to work together with the Dutch board for the Authorisation of Plant Protection Products (Ctgb) to handle the complex issue of appropriate and realistic risk assessments of imidacloprid.
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Dear Stakeholders,
Bayer CropScience would like to advise you of a public announcement being made in the next few days by the Dutch Board for the Authorization of Plant Protection Products and Biocides (Ctgb) regarding their re-evaluation of imidacloprid-based crop protection products and resulting regulatory action.
As part of a registration re-evaluation, the Ctgb conducted new ecological exposure assessments. These assessments included new exposure assumptions, and one new laboratory toxicity study in mayflies (a higher tier study for mayflies using more realistic field conditions, and showing no increase in toxicity, was not included in the assessment). The resulting risk assessment showed levels of concern for birds and aquatic organisms for specific uses and products. Ctgb has recommended cancellation, rather than mitigation, for the following product uses:
Gaucho™ Tuinbouw (Imidacloprid WS 70): uses in cabbages will not be authorized, however, uses in lettuce and endive will be authorized.
Gaucho™ (Imidacloprid WS 70): uses in sugar and fodder beet will not be permitted;
Admire™ (Imidacloprid WG 70): field uses in ornamentals (foliar applications) will not be authorized; however, other label uses will be authorized.
These regulatory decisions only apply to the Netherlands.
Bayer CropScience stands by the environmental and human safety of our imidacloprid products when used responsibly and properly, in accordance with label instructions. In addition, Bayer has submitted comprehensive studies and information to Ctgb, as well as other global regulatory agencies, that specifically address the potential exposure and risk to birds and aquatic organisms. This data fully supports our view that the proper use of these products does not represent an unreasonable risk, and that they continue to be a valuable agricultural pest management tool to growers.
Bayer will continue to work with the Dutch Authorities to address their concerns. In the interim, we are providing for your information a brief overview of the Dutch Authority decision and Bayer’s position as outlined in this email in case you receive questions from interested parties. Please feel free to contact me if you have any further questions regarding this issue.
Freundliche Grüße / Best regards,
Dana Sargent
VP, NA Regulatory Affairs
Bayer CropScience LLP
2 T.W. Alexander Drive
Research Triangle Park
Tel: +1 919 549 5323
Mobile: +1 919 949 0695
Fax: +1 919 549 2514
E-mail: dana.sargent@bayer.com<mailto:dana.sargent@bayer.com
Web: http://www.bayercropscience.com<http://www.bayercropscience.com/
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