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Registration Delays Expected as China Launches Pesticide Regime

Oct. 24, 2017, 10:45 AM

DuPont and other companies that want to manufacture or import pesticides in China are bracing for delays after the country launched a new testing and registration regime.

Recently amended pesticide regulations require that chemistry and toxicology tests on new pesticides be completed at laboratories in China or labs approved by the Ministry of Agriculture abroad. But manufacturers say the new policy is still vague on the data that must be submitted to win the country’s approval, which could cause delays in getting their products registered.

“We understand it still needs some time to have full clarity especially on implementation,” a DuPont spokeswoman told Bloomberg Environment in an email.

Manufacturers say they are confused about how to proceed under the regulations in regards to testing and a variety of registration issues.

“Meanwhile, we are attending regularly frequent communication sessions with related government authorities to understand the updates, so that we can ensure we are in well prepared for the changes,” the spokeswoman said.

BASF declined to comment on the new requirements, and Bayer and Syngenta did not respond to requests for comment.

China is the world’s top producer of wheat and rice and leads the globe in its use of pesticides, according to the Food and Agriculture Organization of the United Nations. The country has become increasingly concerned with land and water resources contaminated by overuse of pesticides and fertilizers in recent years, with more than 19 percent of arable land affected by heavy metal and chemical residue above allowable standards

Clarifications Still Needed

China’s pesticide regulations were updated in the Agriculture Ministry’s Order No. 3, which went into effect Aug. 1, but observers said disparities still exist between that directive and the subsequent Proclamation No. 2569, which details the data companies must submit with registration applications.

“Many clarifications are needed for industry to be in compliance with the new regulations,” Brian Xu, a toxicologist with Bergeson & Campbell, a Washington-based law firm focusing on industrial and agricultural chemical regulation, told Bloomberg Environment. “The new regulations fundamentally change the review and approval processes of pesticide registration.”

The regulations are still unclear about many requirements, such as whether supplemental data can be submitted in languages other than Chinese. The list of approved testing facilities also includes no laboratories in the U.S.

“Basically, [the regulations] are a new approach, shifting away from looking at data and moving toward risk assessment approaches,” Jose Carvalho, head of global business development and regulatory policy for agricultural dossiers at Dr. Knoell Consult GmbH, told Bloomberg Environment. “There are still some open questions regarding the testing guidelines for data generation, to fulfill the published data requirements.”

Pesticide Overuse a Concern

Not only is pesticide overuse a major environmental issue in China, but pesticide poisoning is a problem across rural areas either through accidental exposure—particularly in adolescents—or sometimes as a means for committing suicide.

Debate has intensified in recent weeks in China about the use of pesticides after more than 100 goats died after eating rotting green onions containing residue from a banned pesticide that had been on sale to the public at a produce wholesale facility before going bad.

Many smaller pesticide manufacturers in China have been affected by recent sweeping environmental inspections across the country, leading to temporary and indefinite production shutdowns at some facilities, Carvalho said.

This in turn has led to price increases for active ingredients that smaller manufacturers often supplied at a lower price point.

“The intention seems to be the creation of a critical mass in China to have companies with the size to go global,” Carvalho said. “The biggest concern of Chinese consumers is environmental protection related to air quality and food safety. So this is where the government is trying to give some answers and is acting, like with the policy of zero growth of pesticide production.”

The ministry announced Oct. 10 that it is creating a special pesticide administration to focus on pesticide management but provided few other details.

To contact the reporter on this story: Michael Standaert in Shenzhen, China, at correspondents@bna.com

To contact the editor responsible for this story: Rachael Daigle at rdaigle@bna.com