In March 2013, ICAMA (Institute for the Control of Agrochemicals, Ministry of Agricultural) established a new division called the Pesticide Registration Review Office. The newly formed office has been tasked with reassessing registered pesticide products currently circulating in the marketplace. In this article we provide an explanation delivered by Mr. Zong Fulin, Division Director of the newly formed office in which he explains the rationale for the establishment of this office and the necessity for reassessment of registered pesticides.

China implemented pesticide registration in 1982, however since implementation post market supervision of registered products has been grossly inadequate and poorly equipped to guarantee the safe use of pesticides and minimize the negative environmental and social impact associated with their use. Indeed in the past the only major regulatory hurdle for pesticide products has been the renewal of pesticide registration. In reality this checkpoint has been little more than a formality with successful renewal usually a foregone conclusion. Indeed the only real impetus for revoking registration has been when serious adverse effects or events force the governments to institute a regulatory ban, comparable to closing the stable door after the horse has bolted.

Regulation and enforcement within this industry has ranged from inefficient to corrupt to extremely criminal. The industry has been plagued by practices such as the sale of “registration status", the indefinite extension of registration both of which have continued to hamper implementation of effective and safe regulations. From a purely economic standpoint, not mentioning the social and ethical issues, the consequences of this archaic system has negatively affected the development of the Chinese pesticide industry since its inception. The system has severely hampered domestic R&D and resulted in an industry flooded by inferior quality “me-too” (generic) products. In the short term this paradigm has paid huge economic dividends. However the long term impact is now finally being appreciated reflected in China’s dismal environmental problems and an industry in disarray, poorly poised to meet the demands of increased global regulations and technological trends prioritizing safer substitutes and biocides.

Currently a total of 646 active ingredients have been registered with the ICAMA (including 64 temporary registrations): 194 insecticides, 173 fungicides, 169 herbicides, 49 PGRs, 46 household pesticides, 11 rodenticides and 4 fumigants. These 646 active ingredients have been registered in 29631 products comprising 3333 registrations for TCs (technical/technical material) and 26298 registrations for formulated products. 27784 products have gained full registration encompassing 25732 registration designated for crop protection uses and 2052 designated as household pesticides. 1348 products have been approved for temporary registration comprised of 1012 product designated for crop protection usage and 336 designated for use as household pesticides. 499 products have been registration for repacking. Under ICAMA’s new regulatory system repacking registrations will be cancelled.

As of December 31 2012, 2370 companies registered their products with ICAMA. This figure comprises 2264 domestic companies and 106 overseas companies. 731 of these registrants are capable of basic production of active ingredients while the remaining 1639 are solely focused on processing formulated products. Competition between these companies is fierce as there is considerable overlap in their target markets, to highlight this fact consider the following figures. Glyphosate is the most frequently registered technical material with 130 registrants. Chlorpyrifos and Imidacloprid are distant second and cumulatively represent over 50 registrants of technical material. Approximately 90 other important active ingredients have been registered by 10 to 49 TC manufacturers. These substances include acetaniprid, acetochlor and paraquat. Abamectin has the highest proportion of registrations with a total of 573 companies having registered formulated products of this insecticide. Beta-cypermethrin-formulated products were also registered by over 100 companies. Formulated products of an additional 189 active ingredients have been registered by 10 to 99 discrete formulating companies.

Every year, China produces over 3 million tons of pesticide and exports 1.6 million tons to overseas markets, while only 0.5 million ton of pesticides produced are for domestic consumption. The vast majority of imports involve 300 active ingredients. Many of these substances were registered decades ago when assessment criteria, testing technologies and regulatory awareness were lacking. In light of the China’s environmental problems a registration model developed in the 1980’s is to say the least ill-equipped to deal with the volume of registrations and over three decades worth of technological advancements.

Issues such as pest resistance, bioaccumulation and ecotoxicity have far greater significance than in the early development of China’s pesticide industry and necessitate amendment of the current legislative and regulatory framework to integrate advancements in these fields into the registration system. Other important issues that need addressing are where current registration status conflicts with overlapping regulatory frameworks. To fully explain this phenomenon we can take the example of China’s newest pesticide MRL standard, the “Maximum Residue Limits for Pesticide in Foods (GB2763-2012)” which contains 2293 limits of 322 active ingredients in 10 categories of food commodities. Residue data for some types of formulated products used in applications for specific crops is often insufficient. In such a situation renewal of pesticide registration may inadvertently lead to a situation where MRL standards are violated. There are data gaps of 44 active ingredients, including 11 insecticides, 17 fungicides, 14 herbicides and 2 PGRs.

Under the "Regulation for the Administration on Pesticide", if a registered pesticide causes major negative impact to agriculture, forestry, public health and the ecosystem after it is successfully registered, competent authorities for agricultural administration under the State Council may issue a restriction or withdraw pesticide registration. The draft proposal of China's new pesticide regulation also requires greater post-registration supervision on safety and efficacy of pesticides.

As previously mentioned there is in fact some precedent for pesticide restrictions and bans in China. China has conducted piecemeal reevaluation of pesticides and taken actions on specific highly toxic pesticide, however these lessons were usually learned the hard way only after serious environmental impact. From 1983 to 2011, China banned has banned various kinds of highly toxic pesticide such as HCH, DDT, nitrofen, etc. The Institute also conducted risk assessment on carbosulfan, pyrethroids, BT, imidacloprid and abamect. In the next three years, the office will choose 10 to 20 active ingredients annually for reassessment. These targets will be reassessed under criteria such as safety, efficacy and economic impact. Chemicals that fall short on any one of these criteria may have their registration status revoked and have bans or restrictions imposed on their manufacture or trade. Other chemicals subject to older registration requirements will be reassessed from a current regulatory perspective whereby current data requirements must be adhered too.

Products that pass reassessment will be issued new registration certificates while those failing reassessment will not be granted registration and will no longer be marketable. Mr. Zong expressed his confidence in the technical competence of the newly formed office and promised that the reassessment will be based on standardized risk evaluation procedures. To ensure that political intervention in no way hinders the productivity or efficiency of the newly formed office, the office will be largely autonomous in its work responsibilities and internally select both the leading group and the working group tasked with registration review. The former will be responsible for determination of candidate active ingredients highlighted for prioritized assessment and also formulation of a working plan. The latter will be responsible for compilation and implementation of this working plan as well as providing technical support if necessary. Experts from scientific institution and academia will also be consulted during the review process. Expert teams will be divided into 5 distinct areas and review pesticides from 5 different aspects, including: a chemical review team, efficacy & resistance review team, dietary risk assessment team, environmental impact assessment team and a sustainability & economic review team.

Several high priority pesticides will be given precedence in this assessment. They include: acephate, triazophos, chlorpyrifos, endosulfan, dicofol, glyphosate, 2,4-D butylate, validamycin, hexaflumuron and atrazine.