Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By J. Brian Xu, M.D., Ph.D., DABT®

On June 1, 2017, in the People’s Republic of China (China), the newly revised Regulation on Pesticide Administration (RPA) became effective.  The newly revised RPA was approved during the 164th executive meeting of the State Council of China on February 8, 2017, and published as Decree Number 677 of the State Council of China (China Decree 677) on April 1, 2017.  It requires the Ministry of Agriculture (MOA) to formulate relevant rules and measures for its implementation.

The first set of five implementation rules was initially released for public comment on March 17, 2017, and made final on June 21, 2017.  The five implementation rules include:   Pesticide Registration Management Measures (MOA Order No. 3, 2017), Measures for the Management of Pesticide Production License (MOA Order No. 4, 2017), Measures for the Administration of Pesticide Business License (MOA Order No. 5, 2017), Measures for the Management of Tests Used for Pesticide Registration (MOA Order No. 6, 2017), and Measures for the Administration of Pesticide Labels and Manuals (MOA Order No. 7, 2017).  They will become effective on August 1, 2017.

On June 30, 2017, the MOA released the second set of six implementation rules for public comment under the new RPA, which include Data Requirements on Pesticide Registration (Draft); List of Pesticides with Restricted Uses (Draft);  Measures for the Management of QR Code Pesticide Label (Draft); Review Rules of Pesticide Production License (Draft); Review Rules of the Test Institutes that Conduct Tests Used for Pesticide Registration (Draft); and Quality Management Practices of Tests Used for Pesticide Registration (Draft).  The comment period will end on July 30, 2017, but an implementation date was not provided.

Commentary

The MOA Order No. 3, 2017 requires that chemistry and toxicology tests should be completed in Chinese laboratories approved by the MOA or overseas laboratories that have a mutual recognition agreement with the relevant Chinese Authority, and that the tests for efficacy, residue, environment, and others that are closely related to environmental conditions and Chinese specific species shall be conducted in China.  Since China is not a member country of the Organization for Economic Cooperation and Development’s (OECD) Mutual Acceptance of Data (MAD) system, this requirement could reject all test reports from overseas for pesticide registration in China.

The requirements that literature or data in a foreign language shall be translated to Chinese are moved from the Pesticide Registration Management Measures (Draft) to the new Data Requirements on Pesticide Registration (Draft), but it is still not clear if whole articles/reports or only summaries should be translated into Chinese.  In addition, the new Data Requirements on Pesticide Registration (Draft) would add a new category of registration, “Pesticides for Overseas Uses Only.”  The registration of “Pesticides for Overseas Uses Only” requires only chemistry and toxicology data for the products at issue; the data that must be submitted include information on the production process, component analysis, quality specifications and analytical methods, acute “six-pack,” Acceptable Daily Intake (ADI), Acute Reference Dose (ARfD), and other safety and toxicology information.  The new draft rules would not require any efficacy, residue, or environment tests for registration of “Pesticides for Overseas Uses Only.”  The timeline for the second set of six implementation rules under the new RPA is not provided.  Considering it took only three months for the first set of five implementation measures to proceed from drafts for public comments to final versions that will become effective about one and half a months later (August 1, 2017), it is expected that the second set of six implementation rules will become effective by the end of the year.

The new RPA and its implementation rules significantly change registrations for pesticides in China.  Temporary pesticide registration is no longer an option, and pesticide registration now requires a full set of data, including two-year stability data in the initial submission, and requires that many of the tests must be conducted in China.  With these new requirements, the new pesticide registration process may extend the time for manufacturers to bring products to the Chinese market.  Because of many ambiguities in the new RPA and its implementation rules, many questions and uncertainties regarding the process for pesticide registration under the new RPA remain.


 

By J. Brian Xu, M.D., Ph.D., DABT®

On June 1, 2017, in the People’s Republic of China (China), a newly revised Regulation on Pesticide Administration (RPA) became effective.  The newly revised RPA was approved during the 164th executive meeting of the State Council of China on February 8, 2017 and published as Decree Number 677 of the State Council of China (in Chinese only) (China Decree 677) on April 1, 2017.

The first version of the RPA became effective on May 8, 1997, and was revised on November 29, 2001, by China Decree 326.  China Decree 677 makes significant changes to the current version of RPA (China Decree 326), and requires the Ministry of Agriculture (MOA) to formulate relevant rules and measures for its implementation.  The revised RPA includes eight chapters:  General Provisions; Pesticide Registration; Production of Pesticides; Distribution of Pesticides; Uses of Pesticides; Supervision and Management; Legal Liability; and Supplementary Provisions.

On March 17, 2017, the MOA released five implementation measures for public comments (in Chinese only) but did not provide an implementation date.  The measures include:  Pesticide Registration Management Measures (Draft); Measures for the Management of Pesticide Production License (Draft); Measures for the Administration of Pesticide Business License (Draft); Measures for the Administration of Pesticide Labels and Manuals (Draft); and Measures for the Management of Tests Used for Pesticide Registration (Draft).

The new RPA is intended to:  streamline the administration process; implement licensing systems for pesticide production and distribution; promote the reduction of pesticide uses and enhance the management of highly toxic pesticides; clarify the responsibilities of manufacturers, sponsors of the contracted manufacturers, and distributors for the safety, efficacy, and quality of pesticides; establish pesticide recall and pesticide waste recycling systems; and prevent and punish the adulteration of pesticides.  The new RPA also revises the registration process and labeling requirements of pesticides, removes temporary pesticide registration, includes increased fines and blacklisting, and requires that manufacturers and distributors/retailers of pesticides establish a tracking system and maintain the required records for at least two years.

Commentary

The new RPA significantly changed registrations for pesticides in China.  Temporary pesticide registration is no longer an option.  There were two registration review committees:  the Temporary Pesticide Registration Review Committee that held a review meeting every two months; and the Full Pesticide Registration Review Committee that held a review meeting every six months, before the new RPA became effective.  The two committees are being replaced by the National Pesticide Registration Review Committee, but no frequency of review meetings was provided.  It is expected that the National Pesticide Registration Review Committee will meet less frequently than once every two months, which may result in a longer timeline for review and approval.  Without temporary pesticide registrations, a full set of data will be required with every pesticide registration, including two-year stability data in the initial submission.  Therefore, the new pesticide registration process may extend the time for manufacturers to bring products to the Chinese market.

The new RPA requires the foreign registration of active ingredients; possibly new formulations will obtain the registration in another country before registering it in China.

In addition, the Pesticide Registration Management Measures (Draft) requires that chemistry and toxicology tests should be completed in laboratories approved by the MOA or overseas laboratories maintaining mutual recognition agreements with the Chinese Government and complying with Good Laboratory Practices (GLP), and that efficacy, residue, and environment tests shall be conducted in China.  Since China is not a member country of the Organization for Economic Cooperation and Development’s (OECD) Mutual Acceptance of Data (MAD) system, this proposed requirement could reject all test reports from overseas for pesticide registration in China.  It also requires that literature or data in a foreign language shall be translated to Chinese, but is not clear if the whole article/reports or only the summary should be translated into Chinese.  The timeline for new data requirements on pesticide registration under the new RPA is not provided.  Many questions for pesticide registration under the new RPA remain.


 

By Lisa M. Campbell and Margaret R. Graham

On March 20, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a notice that it was delaying the effective date of five regulations, including the final rule on the certification of pesticide applicators.  The effective date for this final rule is now May 22, 2017 (original effective date was March 6, 2017).  In the notice, EPA states that it is “taking this action to give recently arrived Agency officials the opportunity to learn more about these regulations and to decide whether they would like to conduct a substantive review of any of these regulations.”  The new effective date of May 22, 2017, could be delayed further if EPA officials decide to conduct a substantive review.  More information on the pesticide applicator certification rule is available in our memorandum Final EPA Rule Requires Stronger Standards for Applying Riskiest Pesticides.


 

By Lisa M. Campbell and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) has scheduled a final rule to be published on on January 26, 2017, which will temporarily delay the effective date of certain regulations until March 21, 2017.  This final rule is being issued in accordance with the Presidential directive entitled “Regulatory Freeze Pending Review” issued January 20, 2017.  Among the 30 regulations that meet those criteria is the final rule Pesticides; Certification of Pesticide Applicators, which revises EPA’s regulations concerning the certification of applicators of restricted use pesticides which was scheduled to be effective as of March 6, 2017.  The final rule states that it “may consider delaying the effective dates … beyond March 21, 2017,” but in that event, “the Agency would propose any later effective date for public comment.”  More information on this final rule is available in our memorandum Final EPA Rule Requires Stronger Standards for Applying Riskiest Pesticides.