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 Lisa M. Campbell and Lisa R. Burchi

On May 11, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Compliance (OC) and Office of Pesticide Programs (OPP) issued a memorandum to its regional Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Division Directors and Branch Chiefs to establish a joint position of OC and OPP “for how regions should respond to requests for EPA-issued Certificates of Establishment (COEs) and Certificates of Origin (COOs).”

OC and OPP state that the need for a joint position is based on recent requests by exporters to have EPA certify that a specific facility is a registered pesticide producing establishment, or certify that a particular pesticide product was produced at a specific establishment.  These certificates are used by exporters to submit to foreign governments that require “‘EPA documentation’ prior to allowing registered and unregistered pesticide products into their jurisdictions.”

Under the new national approach, EPA regional offices are to stop issuing COEs or COOs.  In the memorandum, OC and OPP state the following three factors in support of this approach:

  • EPA does not believe that FIFRA provides the statutory authority for issuing either a COE or a COO;
  • EPA does not believe that regions have the information necessary to certify the origin of an exported pesticide, registered or unregistered, arriving at a foreign destination; and
  • EPA believes that COE letters, particularly for unregistered pesticides, may be misleading to foreign governments.

Discussion

Under this approach whereby EPA regions will cease the previously routine practice of issuing COEs and COOs, companies may encounter difficulties or business disruptions with some foreign governments that have traditionally required COEs and COOs.  OC and OPP state that they are “working on making FIFRA Section 7 establishment registration information (that which is not confidential business information) available on OC’s website,” which EPA states could be relied upon in lieu of COEs.  As for COOs, OC and OPP suggest that registrants:  (1) “should be directed to the exporters for the COO, which can then be certified by a State or local chamber of commerce”; or (2) could seek commercial third-party service providers to handle COO processing for an exporter. 

EPA states that the new joint position has no effect on Gold Seal Letters issued by OPP that provide the registration status of a registered pesticide product.  Gold Seal Letters will still be issued upon request to the appropriate registered division within OPP.

Registrants are concerned about this new approach, however, and it is likely that debate on it will continue.


 

By Lisa M. Campbell and Lisa R. Burchi

In an April 22 memorandum, the Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) announced its intent to begin preliminary research to assess the EPA’s inspections of, and enforcement against, illegal pesticide imports.

OIG states that its objective with this project is to “determine whether the EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) import inspection program is effectively deterring, identifying and confiscating illegal pesticide imports, to protect human health and the environment.”  OIG’s efforts will include determining whether EPA is effectively identifying pesticide imports for inspection and sampling, as well as whether EPA is taking appropriate enforcement action against noncompliant imports.

OIG notes that this project is included in its fiscal year 2016 Annual Plan.  The Annual Plan notes a project commencement date of June 2016 and describes its efforts as follows:

  • The EPA’s enforcement program addresses the illegal importation of unregistered or otherwise noncompliant pesticide products into the United States. This project could result in reduced risks to human health and the environment due to Federal Insecticide, Fungicide and Rodenticide Act imports noncompliance, while assuring effective deterrence through inspections and enforcement actions. We will seek to determine whether the Federal Insecticide, Fungicide and Rodenticide Act Import Inspection program effectively deters or identifies and confiscates illegal pesticide imports to protect human health and the environment.

OIG’s review of EPA’s activities in this area should come as no surprise considering that the EPA Office of Enforcement and Compliance Assurance (OECA) has identified import border compliance as one of its three FIFRA focus areas for the past several years.  For example, OECA’s FY 2016-2017 National Program Manager Guidance (NPMG), which sets forth OECA’s priority-setting strategies, has made EPA Regions aware of EPA’s strong interest in import compliance.  The NPMG suggests that the Regional office efforts in this regard include monitoring import compliance through inspections; focusing on “high-risk” unregistered pesticides and importers with a history of noncompliance or significant importation activities from countries frequently associated with noncompliant shipments; and overseeing the transition of manual review of Notices of Arrival (NOA) to the Automated Commercial Environment in the International Trade Data System (ACE/ITDS).  Indeed, there is a noticeable uptick in EPA Regional office review of NOAs and OECA enforcement of noncompliant pesticide imports. 

Companies that import pesticides should carefully review their import policies and how they prepare their NOAs to ensure they do not invite EPA scrutiny and potential enforcement action.  


 

By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi


On March 2, 2015, European Union (EU) Ministers approved a Directive previously approved by the European Parliament with regard to genetically modified organisms (GMO). EU Directive 2010/0208, entitled Directive of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory, will allow individual Member States to determine whether they will allow, ban, or otherwise restrict the cultivation of GMOs, even in cases where the EU has authorized use of a GMO following the European Food Safety Authority’s (EFSA) assessment of the risks to health and the environment.

Specifically, the Directive provides: “a Member State may adopt measures restricting or prohibiting the cultivation in all or part of its territory of a GMO, or of a group of GMOs defined by crop or trait, once authorised in accordance with Part C of this Directive or with Regulation (EC) No 1829/2003, provided that such measures are in conformity with Union law, reasoned, proportional and non-discriminatory and, in addition, are based on compelling grounds.” The grounds stated include those related to:

* Environmental policy objectives;
* Town and country planning;
* Land use;
* Socio-economic impacts;
* Avoidance of GMO presence in other products without prejudice to Article 26a;
* Agricultural policy objectives; and
* Public policy.

A Member State also can seek to have all or part of its territory excluded from the geographical scope during the authorization procedure for a GMO.

The passage of this Directive is the culmination of years of negotiations between EU Member States that have disagreed over the cultivation of GMOs in their territories. The new rules, which will allow EU countries to opt-out from otherwise approved EU GMOs, are sure to be controversial as Member States, industry, farmers, and the public work out details related to the potentially non-scientific grounds that a particular Member State relies upon in restricting or banning use of a GMO, and as Member States develop measures that allowed GMOs must take to avoid “possible cross-border contamination.”

The legislation will enter into force following its publication in the Official Journal of the EU, which is expected in Spring 2015.

As various members of the EU continue to oppose production of GMO crops, these policies will remain trade irritants to the U.S. and other countries where GMO crops have been widely adopted. This comes as trade negotiations are ongoing and the EU allowance of trade barriers based on the “precautionary principle” remains a major point of disagreement between the EU and the U.S. (with its reliance on “science-based risk assessment policies”). This latest development, which further allows EU Member States to reject GMO crops under various criteria, will not make resolving any current or future trade disagreements any easier.

 


 

REMINDER

Border Security: EPA's Increased FIFRA Import Enforcement Initiative
March 12, 2015
2:00 p.m. - 3:00 p.m. (EDT)
Register online


Bergeson & Campbell, P.C. (B&C®) is pleased to host a complimentary webinar on recent compliance and enforcement issues regarding the importation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The U.S. Environmental Protection Agency's (EPA) 2014 revisions to its Notice of Arrival (NOA) form (EPA Form 3540-1), coupled with EPA's increasing scrutiny of pesticide imports, indicate that this is an issue of growing interest to EPA and could result in a rise of enforcement cases or, at a minimum, business disruption for shipments that are refused entry.
This webinar will highlight recent developments and suggest steps importers should take to ensure compliance and avoid potential enforcement. There will be 45 minutes of presentation, followed by a 15 minute Q&A period.
Topics will include:
*  Requirements for importation of registered and unregistered pesticides
* Revised NOA "recommendations" and "optional" sections -- what they really mean
* EPA's recent enforcement priority on pesticide importations and examples of EPA and U.S. Customs detentions of imported pesticides
* Industry perspective and steps to avoid non-compliance

Speakers:
* Eileen B. Salathé Gernhard, Lead Counsel, Regulatory and EH&S at Dow AgroSciences, LLC
* Lisa M. Campbell, Partner, B&C
* Lisa R. Burchi, Of Counsel, B&C
* Jon Jacobs, a 25-year veteran of EPA's Office of Enforcement and Compliance Assurance, now in private practice with Jacobs Stotsky PLLC


For questions regarding this webinar, please contact .(JavaScript must be enabled to view this email address).
 


 

March 12, 2015
2:00 p.m. - 3:00 p.m. (EST)

Bergeson & Campbell, P.C. (B&C®) is pleased to host a complimentary webinar on recent compliance and enforcement issues regarding the importation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The U.S. Environmental Protection Agency's (EPA) 2014 revisions to its Notice of Arrival (NOA) form (EPA Form 3540-1), coupled with EPA's increasing scrutiny of pesticide imports, indicate that this is an issue of growing interest to EPA and could result in a rise of enforcement cases or, at a minimum, business disruption for shipments that are refused entry.

Speakers who will be highlighting recent developments and steps for importers to take to ensure compliance and avoid potential enforcement include: Eileen B. Salathé Gernhard, Lead Counsel -- Regulatory and EH&S at Dow AgroSciences, LLC, B&C's Lisa M. Campbell and Lisa R. Burchi, and attorney Jon Jacobs, a 25-year veteran of EPA's Office of Enforcement and Compliance Assurance, now in private practice at Jacobs Stotsky PLLC. There will be 45 minutes of presentation followed by a 15 minute Q&A period.

Please save the date -- registration details will follow.


 

By Lisa M. Campbell

On December 19, 2014, the U.S. Environmental Protection Agency (EPA) announced it is preparing in final the regulations on pesticide export labeling. The new proposed rule corrects the inadvertent removal of a provision that occurred in the January 2013 revisions to these regulations. EPA is restoring the provision that allows information required under the regulations to be placed on collateral labeling (such as bulletins, leaflets, circulars, brochures, data sheets, or flyers) attached to a shipping container of pesticide products rather than on the immediate package of each individual product in the shipment.

Producers of pesticide products and devices intended solely for export will meet EPA’s labeling requirements by attaching a label to the immediate product container, or by providing collateral labeling that is either attached to the immediate product being exported or that accompanies the shipping container of the product being exported at all times when it is shipped or held for shipment in the United States. Collateral labeling will ensure the availability of the required labeling information, while allowing pesticide products and devices that are intended solely for export to be labeled for use in and consistent with the applicable requirements of the importing country.

On January 18, 2013, EPA revised its export label regulations (40 C.F.R. Part 168 Subpart D) concerning the labeling of pesticide products and devices intended solely for export. The revisions were effective on March 19, 2013, with a compliance date of January 21, 2014. Industry stakeholders subsequently expressed concern to EPA that certain provisions no longer appeared in this Subpart, and the inability of registrants to use the labeling method allowed in the previous regulations could create trade barriers and increase costs. EPA agreed and on April 30, 2014, issued a direct final rule to replace the provision that was inadvertently removed. Since EPA received written adverse comment on the direct final rule, EPA withdrew that direct final rule, and issued a new proposed rule to seek public comment on the changes. EPA is now preparing the revisions in final to its export labeling regulations to replace the provision that was inadvertently removed.

The final revisions are available at www.regulations.gov, docket number EPA-HQ-OPP-2009-0607. Additional information on EPA requirements for importers and exporters is available at www2.epa.gov/importing-exporting.