Hundred and Twenty-third Session
Rome, 28 October - 2 November 2002
REVISION OF THE TEXT OF THE INTERNATIONAL CODE OF CONDUCT ON THE DISTRIBUTION AND USE OF PESTICIDES
Additional Comments Received in Reply to Note Verbale
G/AGP-22Rev. 2 of 17 July 2002
United States of America
I note that a Technical Consulation meeting held in May this year to discuss the dissension over paragraph 6.1.7 and it sub paragraphs 220.127.116.11 and 18.104.22.168 reached a consensus on the test for the Revised Version of the Code. Australia attended this meeting and the draft incorporating the proposed text of the new paragraphs 6.1.7 and 6.1.8 accurately reflects the consensus of the meeting on this issue.
I would like to bring to you attention that Australia officials have been approached by the Australian agricultural and veterinary chemical industry regarding its concerns over this proposed text. Industry has indicated that it would prefer a return to the language of the 1990 version of the Code. Should the issue be raised at the FAO Council meeting later this year, Australia would support a consensus proposal to retain the 1990 text on this issue should the May 2002 revised text be deemed as unacceptable.
A) The Code should be, by its nature, an instrument approved by all involved in order to sustainably develop a better use of these chemical substances that are so relevant to world agricultural production.
B) Paragraph 6.1.7 makes reference to Article 39.3 of the WTO agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) to which our country adheres.
C) In the consideration of Paragraph 6.1.8, taking into account the concept indicated in TRIPS, which refers to the topic that data should not be protected when it is necessary to protect the public, the proposal in this paragraph addresses human health and environmental safety, leaving out animal health, therefore clarification is required. What is the aim of paragraph 6.1.8 .... human health and environmental safety? Another element which requires clarification is what is the interpretation of “appropriate information,” a term quoted in this paragraph, since information exists in the registration process which cannot be disseminated or is of a confidential nature.
I have the pleasure to communicate that this Ministry gives its agreement to the document on the International Code of Conduct on the Distribution and Use of Pesticides held in Rome last 27-29 August.
I am advised that our Ministry of Agriculture and Fisheries received a copy of the Revised Version of the International Code of Conduct on the Distribution and Use of Pesticides and was requested to provide final comments related to paragraph 6.1.7 thereof.
I am instructed to inform you that the Ministry of Agriculture and Fisheries has no objections to the changes indicated in the document.
The Permanent Representation of Mexico submits to the Organization the final comments of its Government in relation to the revised text of this international instrument:
Mexico is in agreement with the content of paragraph 6.1.7;
while it proposes that paragraph 6.1.8 be read as follows:
“provide public access to the appropriate information related to human health and environmental safety in emergency cases.”
New Zealand is grateful for the work done by FAO in preparing this second revised draft. We recognise that reaching consensus on this complex issue is very difficult.
New Zealand would like to record that our preferred version of the draft Code of Conduct on the Distribution and Use of Pesticides is that presented to the FAO Conference in November 2001.
That said in order to facilitate your work and help reach agreement on the newly revised text you have presented, my authorities have asked me to communicate New Zealand’s ability to accept the newly Revised Version of the International Code of Conduct on the Distribution and Use of Pesticides text, as outlined in your 17 July 2002 Communication.
In accordance with your request concerning the preparation of a final revised text of the Code for submission to 123 Session of the FAO Council, the Ministry of Agriculture of the Slovak Republic provided interministerial comment process together with the concerned expert departments and institutions.
The result of the above-mentioned process was an acceptance of the outcome of the Technical Consultation and approval of the revised version of the FAO International Code of Conduct on the Distribution and Use of Pesticides.
I am pleased to communicate that Uruguay has no observations to make on the revised version of the Code of Conduct, which we hope will be approved at the next FAO Council.
UNITED STATES OF AMERICA
The United States is aware that the FAO International Code of Conduct on the Distribution and Use of Pesticides has served as a valuable model for pesticide regulation and management since its inception, particularly for those countries which lacked their own national programs. Its success and longevity could be attributed to, in part, its reliance upon a cooperative partnership among all relevant sectors: governments, industry and public interest organizations. Over the past decade, national regulatory programs have advanced and incorporated new concepts and policies, such as a greater reliance on safer pest control measures, and have adjusted to reflect advancements in scientific capacity. The Code needed to reflect these developments.
At the last Conference, consensus was reached on all of the revisions specific to pesticide regulation and management, but unfortunately, consensus was not possible on a section related to data protections, and specifically related to the World Trade Organization’s agreement on Trade-Related Aspects of Intellectual Property Rights, known as TRIPs. The US is aware that CropLife International, the primary association of pesticide manufacturers, has informed the FAO that it will not support the Code as written. Since the industry is an important partner in the implementation of the voluntary Code, the US is concerned that without their commitment, the Code’s viability is threatened. Further, because the US considers it is appropriate to include a specific section on data protection in a general, comprehensive Code on pesticide regulation and management, we wanted to provide the Council and its members with additional background information on the US approach.
Since 1970, the US Environmental Protection Agency (EPA) has constructed a rigorous pesticide regulatory program built on comprehensive data requirements, thorough scientific assessments and data reviews that evaluate a wide range of health and environmental risks. We consider an EPA risk assessment to present a detailed and state-of-the-science profile of a pesticide. However, such a thorough risk assessment is not possible without access to scientific data on a pesticide’s potential for health or environmental risks. As is common to all regulatory programs around the world, most of the data upon which EPA bases its reviews is provided by pesticide producing industry. The success of the regulatory program can be attributed, in part, to the fact that industry has confidence that when data is submitted for review, it will be protected from unfair commercial use – such protections are granted as a matter of law and regulation. While ensuring data protections, the US has also adopted laws and procedures which facilitate appropriate public access to health and environmental data, promoting transparency in decision making. In so doing, it provides the public with the opportunity to confirm that decisions on health and environmental safety are based on sound science.
There are many nuances to the current debate about data protection in the Code and its treatment under the TRIPs. The USG does not propose to explore these very complicated and technical options at the moment, but will be prepared to do so at the Council meeting if appropriate. The USG believes that a voluntary code should be flexible enough to help countries develop national measures for data protection appropriate in the context of pesticide regulatory programs, which do not conflict with international obligations they may have in other fora.
The USG is interested in understanding other governments’ views on value of the Code; whether the Code has been useful in working toward the highest standard for health and environmental protections, and whether a voluntary Code can be sustained without a committed partnership among all those who have responsibilities for producing, regulating, and using pesticides. The US is seeking a dialogue about the possibilities and importance of reaching a constructive compromise.