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US leads way on global reviews
Apr. 23, 2008
The US agrochemical industry and regulators acknowledge the many advantages of international reviews of new active ingredients, but both concede that challenges remain in fulfilling the OECD’s 2004 vision of routine work-sharing.
Speaking at the CropLife America/Informa conference this month, Paula Paul of DuPont’s regulatory affairs team said that making a single dossier submission to several global regulatory agencies was “useful but stressful”. Several ais have undergone joint reviews between the US EPA and other agencies, but DuPont’s insecticide, chlorantraniliprole (Rynaxypyr), is regarded as the first to undergo “global registration”, noted Lois Rossi, director of the EPA Office of Pesticide Programs’ (OPP) registration branch.
Ms Paul and Ms Rossi listed the same familiar advantages of global reviews: shared regulatory expertise and consistent decision-making; removal of trade barriers through harmonised maximum residue limits (MRLs); simultaneous product introductions in different markets; and predictable registration timeframes. Ms Paul stressed that the speed and predictability of registrations were of great importance to the industry. However, she cautioned that the speed being given to the relatively small number of ais going through shared reviews might not continue as the process becomes more routine. Ms Paul expressed concern that regulatory systems could become “overburdened”, particularly where smaller countries with fewer resources were involved.
If global reviews do run into resource problems, Ms Paul suggested that the key focus might need to be on toxicology and residue data, with MRL harmonisation being the main goal of the process. She queried whether all data requirements need to be harmonised. The process could allow harmonisation of “core studies”, while others might meet country-specific requirements. Ms Paul questioned where country reviews fitted into the process, noting that they were sometimes driven by “country-specific legislation rather than science”.
The industry wants the global review process to be transparent to all OECD member countries and registrants. Ms Paul raised questions about what submissions and the decision-making process should look like. She also queried whether there was a need for a process to resolve “scientific disagreements” among regulators or between them and a registrant. Consideration needs to be given to the infrastructure for managing the global review process as it becomes more routine, Ms Paul suggested. Ms Rossi acknowledged that regulators discuss forthcoming submissions at fringe meetings around OECD sessions, but Ms Paul did not consider such an approach to be sustainable.
The OECD’s 2004 vision statement called for the generation of a single global submission of data (dossier) and review of those data (monograph) to be routine by 2014. The EPA has accepted three applications under the OECD dossier format to date, Ms Rossi pointed out. Earlier concerns that shared reviews by different regulatory agencies would result in the “lowest common denominator” prevailing have not been borne out. There have been “lively discussions” over the selection of toxicological end-points, but regulators have become more easily convinced to accept another’s views, Ms Rossi said.
All major companies have joined in the global review process, Ms Rossi pointed out. The process begins with pre-submission consultations between the prospective registrant and participating countries. The company then submits an electronic dossier to all of the countries simultaneously for them to screen the data and conduct a completeness check. The data for a specific discipline (such as toxicology) are reviewed by the agreed primary reviewer and posted for comments by secondary reviewers. The participating countries conduct independent risk assessments, exchange results and agree on a harmonised regulatory determination. The generation of a single monograph is a “big challenge” to the EPA as it does not issue decision documents like other regulatory authorities, Ms Rossi noted.
Trilateral reviews by the US, Canadian and Australian authorities have been conducted for Bayer CropScience’s herbicide, pyrasulfotole, and Dow AgroSciences’ herbicide, pyroxsulam. The EPA granted the first registration for pyrasulfotole in 2007, while the Canadian authorities were the first of the three to approve pyroxsulam this year.
There are five global reviews under way: DuPont’s chlorantraniliprole (Australia, Canada, EU, New Zealand and US); Bayer’s insecticide, spirotetramat (Canada, EU and US); Bayer’s herbicide, thiencarbazone-methyl and cyprosulfamide safener (Canada, EU and US); BASF/ Nihon Nohyaku’s insecticide, metaflumizone (Australia, Canada, EU and US); and BASF’s herbicide, saflufenacil (Australia, Canada and US). A further 12 conventional pesticides are due to be submitted for global reviews in 2008-2010 along with four biopesticides and one antimicrobial, Ms Rossi indicated. The 12 conventional pesticides will undergo at least trilateral reviews with one possibly having a global residue programme, she said.
Ms Rossi and Ms Paul pointed to wider participation in the global review process in future. Ms Rossi indicated that the Japanese authorities were interested in getting involved in the peer review process, while Ms Paul urged all OECD members to participate. She also wants the scheme to be extended beyond the OECD to countries such as India, China and Brazil. Other future developments touted by both speakers include label expansions, particularly for minor crops, at a global level.
A further consequence of global reviews could be greater harmonisation of MRLs. The work-sharing experiences of NAFTA and OECD working groups are being taken to the Codex Alimentarius Commission, the OPP’s deputy director, Anne Lindsay, pointed out. The goal is to introduce MRLs to Codex before national approvals have been granted so that Codex and national MRLs can be harmonised, Ms Lindsay said.
Grower groups consider MRL harmonisation to be one of the most important issues in international trade, noted Mathew Lantz of the market access consultancy, Bryant Christie. He acknowledged the importance of Codex MRLs, as many countries defer to Codex if they do not have national MRLs. Recent improvements in the Codex process mean that MRLs can be achieved in less than two years, he pointed out. Cindy Baker, president of the Gowan company, Exigent, noted that MRL harmonisation was improving for new products, but remained a “big issue” for older products. She called for greater acceptance of Codex MRLs, noting that they are prohibited by some countries.
Source: Agrow
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