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 Lisa M. Campbell and Lisa R. Burchi

On November 21, 2018, in Court of Justice of the European Union (EU), the Fourth Chamber of the General Court (General Court/Fourth Chamber) issued a judgment in the appeal case T-545/11 RENV that denied all three pleas on appeal and prevented applicants Stichting Greenpeace Nederland and Pesticide Action Network Europe (Applicants) from receiving certain documents containing confidential information relating to the first authorization of the placing of glyphosate on the market as an active substance, specifically the complete list of all tests submitted by the operators seeking the inclusion of glyphosate in Annex I to Directive 91/414.

The judgment provides a detailed history of the case, beginning in 2010, when Applicants requested access to the documents in question.  In this initial case, the Secretary General of the Commission agreed with the Federal Republic of Germany’s decision to refuse access to the documents (contested decision) on the basis that disclosure in Article 4(2) of Regulation No. 1049/2001 would undermine protection of the commercial interests of a natural or legal person.  In upholding Germany’s decision, the Secretary General found that there was “no evidence of an overriding public interest in disclosure” within the meaning of Article 4(2) of Regulation No. 1049/2001, and also that the information “did not relate to emissions into the environment” within the meaning of Article 6(1) of Regulation No. 1367/2006 concerning public disclosure of information on the environmental effects of glyphosate.  As such, “protection of the interests of the manufacturers of that substance had to prevail.” 

The Applicants brought an action for annulment of the contested decision to the Registry of the General Court.  After one of the documents at issue (a draft assessment report issued by Germany prior to the initial inclusion of glyphosate in Annex I to Directive 91/414) was produced to the court (but still not released to the Applicants), the General Court ruled to annul the contested decision.  The Commission appealed this annulment, stating that the General Court erred in its interpretation of the term “information [which] relates to emissions into the environment.”  The Court of Justice was persuaded by this argument, set aside the initial judgment, and referred the case back to the General Court.  The case was then assigned to the Fourth Chamber.  The dispute was limited to the part of the document at issue that “contains information on the degree of purity of the active substance, the ‘identity’ and quantities of all the impurities present in the technical material, the analytical profile of the batches, and the exact composition of the product developed.”

The Applicants put forward three pleas in law in support of their action.  The pleas, and the basis for the General Court/Fourth Chamber’s rejections of those pleas, are as follows:

  1. Failure to Take Account of the Scope of Article 4(5) of Regulation No. 1049/2001:  Article 4(5) of Regulation No. 1049/2001 provides that a Member State may request an institution not to disclose a document originating from that State without its prior agreement.  Applicants submitted that Article 4(5) of Regulation No. 1049/2001 does not constitute a right of veto for a Member State and that the Commission may not rely on the Member State’s opinion regarding the application of an exception provided for by Article 4(2) of that Regulation.  The General Court/Fourth Chamber stated that “the argument put forward cannot succeed, since Article 4(5) of Regulation No 1049/2001 is not the basis on which the Commission refused access to that document.  Consequently, the first plea in law must be rejected.”  Instead, Article 4(2) was the basis for Germany’s decision, and the Commission verified that Germany’s reasons for that decision were “prima facie, well founded.”
  2. Overriding Public Interest In Disclosing Information Relating to Emissions Into the Environment:  Applicants maintained that the exception to the right of access designed to protect the commercial interests of a natural or legal person must be waived, because of an overriding public interest in disclosure of the information requested, which relates to emissions into the environment.  Specifically, Applicants argued that information related to the identity and quantity of impurities present in glyphosate and related test information must be disclosed so that it could be determined “which toxic elements are emitted into the environment and are liable to remain there for some time.”  With regard to the concept of “information relating to emissions into the environment,” the General Court/Fourth Chamber rejected arguments that the provision must be interpreted restrictively to mean only direct or indirect release of substances from installations.  The General Court/Fourth Chamber also found, however, that the concept cannot be interpreted in a way that would “deprive of any practical effect the possibility” that a Member State could refuse to disclose environmental information or “jeopardise the balance which the EU legislature intended to maintain between the objective of transparency and the protection of [commercial] interests.”  In rejecting the second plea, the General Court/Fourth Chamber states:
  • Since the use, the conditions of use and the composition of a plant protection product authorised by a Member State on its territory may be very different from those of products evaluated at EU level during the approval of the active substance, it must be held that the information in the document at issue does not relate to emissions whose release into the environment is foreseeable and has, at the very most, a link to emissions into the environment. Accordingly, such information is excluded from the concept of “information relating to emissions into the environment,” in accordance with paragraph 78 of the judgement on appeal.

  1. Alleged Infringement of Article 4(2) of Regulation No. 1049/2001 and Article 4 of the Aarhus Convention: Applicants argued that the contested decision is not in accordance with Article 4(2) of Regulation No. 1049/2001 and Article 4 of the Aarhus Convention, on the ground that the Commission did not evaluate the actual risk of damage to the commercial interests invoked.  The General Court/Fourth Chamber stated that it must be held “that the Commission correctly weighed up the relevant interests, having set out precisely and specifically the way in which the commercial interests of producers of glyphosate or plant protection products containing it would be jeopardised by the disclosure of the document at issue.”

After rejecting all three pleas, the General Court/Fourth Chamber held that the action must be dismissed in its entirety, and ordered Applicants to pay the costs relating to the various proceedings.

Commentary

This case has been monitored closely because of the potential implications for companies that have submitted data or other information claimed as confidential that could be disclosed based on “overriding public interest.”  The American Chemistry Council (ACC), CropLife America, CropLife International (CLI), the European Chemical Industry Council (Cefic), the European Crop Care Association (ECCA), the Association européenne pour la protection des cultures (ECPA) and the National Association of Manufacturers (NAM) all intervened in support of the form of the order sought by the Commission.  The decision, and, in particular, the limitations placed on the scope of what is to be considered “information on emissions into the environment” provides helpful guidance and ensures that the exceptions provided for disclosure do not swallow the general rules under which institutions must refuse access to documents.

More information on glyphosate issues is available on our blog.


 

By Lisa M. Campbell and Heather F. Collins, M.S.

On November 19, 2018, the U.S. Environmental Protection Agency (EPA) announced that the U.S.-Canada Regulatory Cooperation Council (RCC) Stakeholder Forum will take place on December 4, 2018, from 12:00 p.m. to 5:15 p.m. (EST) and on December 5, 2018, from 9:00 a.m. to 5:00 p.m. (EST) at the Washington Convention Center, 801 Mt. Vernon Place, in Washington, D.C.  The RCC brings together senior regulatory officials, industry, and other members of the public from both sides of the U.S.-Canada border to promote economic growth, innovation, competitiveness, and job creation through the elimination of unnecessary regulatory differences between the U.S. and Canada.  Canadian and U.S. regulators will provide progress reports on existing regulatory cooperation efforts and solicit public input on new opportunities for regulatory cooperation. 

During the forum, EPA’s Office of Pesticide Programs (OPP) and Canada’s Pest Management Regulatory Agency (PMRA) will lead a breakout session that will include updates on the successes of the 2016 work plan and cooperation between the two agencies pertaining to pesticide registration.  The U.S. and Canadian agencies are working together to:

  • Collaborate on a bilateral pesticide re-evaluation for three neonicotinoid pesticides (i.e., imidacloprid, thiamethoxam, and clothianidin) employing a new pollinator risk assessment framework;
  • Develop best practices for coordinated work planning for the re-evaluation of registered pesticides;
  • Develop new and/or alternative approaches to testing and assessment, including reducing the need for animal testing wherever possible;
  • Align pesticide residue trial requirements by prospectively determining the number of residue field trials required for joint registrations; and
  • Jointly develop information technology solutions that facilitate the submission of applications to either regulatory authority.

Additionally, both offices hope to hear feedback from stakeholders to help inform a new three-year pesticide programs work plan for 2019-2021.  

Specific times for this and other breakout sessions, as well as more detail, will be made available online.  The Stakeholder Forum is open to the public, with advance registration.  Space is limited and registrations will be accepted on a first-come-first-served basis.  Registration is available online.


 

By Lisa M. Campbell and Lisa R. Burchi

On November 7, 2018, the U.S. Environmental Protection Agency (EPA) announced that it was ordering Pool Water Products Inc. to stop selling an improperly registered pesticide, ALL CLEAR 3” Jumbo Chlorinating Tablets.  The announcement states that even though the ALL CLEAR 3” Jumbo Chlorinating Tablets product was registered with EPA, Pool Water Products was selling and distributing an unregistered version of the product made in China that has not been evaluated by EPA.

EPA’s action, which it states applies to nationwide distribution, transport and sales of the product, follows a statewide stop-sale order issued earlier this month by the Arizona Department of Agriculture when state inspectors discovered the unregistered pesticide, which is used to disinfect pools, during an August 30 inspection of the company’s Phoenix warehouse.

This case exemplifies the need for companies to understand Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration and amendment requirements, and the importance that a product’s label, formula, and manufacturing process match exactly with the information submitted to EPA and upon which EPA relied in approving the registration.  Many composition and processing changes require an amendment to be approved by EPA; failure to do so could result in an enforcement action such as this one. 

More information on pesticide registration issues is available on our blog.


 

By James V. Aidala and Margaret R. Graham

On September 28, 2018, the U.S. Environmental Protection Agency (EPA) announced it was accepting public nominations of scientific experts to be considered for ad hoc participation on the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) through membership on the Food Quality Protection Act (FQPA) Science Review Board (SRB).  83 Fed. Reg. 49091.  EPA states that “all nominees will be considered for ad hoc participation providing independent scientific advice to the EPA on health and safety issues related to pesticides”  and requests that any individuals nominated have expertise in one or more of the following areas:  biochemistry; chemistry; epidemiology; human health risk assessment; pathology; physiologically based pharmacokinetic (PBPK) modeling; aquatic modeling; pharmacology; ecological risk assessment; environmental exposure and fate; environmental toxicology; occupational, consumer, and general exposure assessment; toxicology; dose response modeling; environmental engineering; statistics; water quality monitoring; hydrologist; Geographic Information Systems (GIS) specialist; computational toxicology; entomology; veterinary entomology; medical entomology, insect ecology, allergenicity, research veterinarian; inhalation toxicology; volatile organics; endocrinology, alternative testing methods, high throughput testing approaches, adverse outcome pathways, cross species extrapolation, and systematic review.  The Designated Federal Officer’s to whom nominations should be provided is listed in the Federal Register notice.  Nominations are due by November 13, 2018

Commentary

FPQA added this SRB to the previous authorization for the SAP to recognize the expanding universe of scientific questions which often underlie issues surrounding pesticide registration.  The FQPA amendment simply adds that “60 scientists who shall be available to the SAP” without specifying any particular disciplines or skills which might be useful to assist with the deliberations and review by the SAP.  This was intended to continually allow EPA to adapt to changing or evolving scientific questions without constantly tinkering with the membership of the SAP itself.  At the same time, it allows these ad hoc members to be recognized for their contributions and to be compensated in the same manner as SAP members.  


 

By Lisa M. Campbell and Heather F. Collins, M.S.

On March 22, 2018, the U.S. Environmental Protection Agency (EPA) released the Pesticide Registration Notice (PR Notice) 2018-1 issued by the Office of Pesticide Programs (OPP) entitled “Determination of Minor Use under Federal Insecticide, Fungicide, and Rodenticide Act Section 2(ll)” (PR Notice 2018-1).  Notice of Availability issued on March 21, 2018.  83 Fed. Reg. 12385.  The PR Notice states that it “describes the revised approach to interpreting economic minor use based on the concept of the registration of a pesticide as an investment.”  It “revises the method and criteria used by EPA for evaluating ‘sufficient economic incentive’ under FIFRA section 2(ll)(2),’” and it “also clarifies that minor use under FIFRA section 2(ll)(1) is based on acreage reported in the [U.S. Department of Agriculture (USDA)] Census of Agriculture.”

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(ll)(1) defines a minor use of a pesticide as a use on a crop grown on 300,000 acres or less in the United States.  Section 2(ll)(2) of FIFRA defines a minor use of a pesticide as one that lacks sufficient economic incentive to seek or maintain a registration but has private or social value.

PR Notice 2018-1:

  • Clarifies that the USDA’s most recent Census of Agriculture, conducted every five years by the USDA’s National Agricultural Statistics Service (NASS), is the appropriate source for data on acreage or crops grown in the U.S. to establish a minor use under the acreage definition in FIFRA 2(ll)(1);
  • Revises and provides guidance to registrants concerning the method used by EPA for evaluating “sufficient economic incentive” under FIFRA Section 2(ll)(2);  and
  • Explains how qualitative information may be used to inform the quantitative analysis and interpret the results.

Previously, EPA’s interpretation of economic minor use in Section 2(ll)(2) was based on PR Notice 97-2.  EPA states PR Notice 2018-1 supersedes PR Notice 97-2.  EPA states that through PR Notice 2018-1, EPA “seeks to identify and encourage the registration of pesticides for minor uses to protect communities from harmful pests.”  EPA states in PR Notice 2018-1 that “the existing methods for identifying an economic minor use in PRN 97-2 do not consider all relevant factors which could affect the incentives of a registrant to apply to register a minor use,” and that “use of the approach in PRN 97-2 to identify economic minor uses could prevent applicants from registering pesticides that would be beneficial to users and growers, thus limiting the availability of pesticides for certain use sites.”  For this reason, “EPA revised the method to determine an economic minor use.”

PR Notice 2018-1 is significant because it can be applied to conventional pesticides, biopesticides, and antimicrobial pesticides to determine whether they meet the definition of minor use.  The criteria in PR Notice 97-2 only applied to conventional pesticides.

EPA states the rationale for revising the PR Notice to consist of the following:

  • EPA has decided to revise the policy on determining minor use.
  • First, PRN 97-2 is outdated regarding the crops that would not meet the acreage definition of a minor use under FIFRA section 2(ll)(1).  PRN 97-2 contained a fixed list of crops that were grown on more than 300,000 acres in 1997, but cropping patterns change over time and the list of crops provided in PRN 97-2 is no longer accurate.
  • Second, the method in PRN 97-2 does not accurately reflect economic incentive to register pesticides.  Gross revenue is not an appropriate measure for estimating returns on an investment; since it does not account for production and distribution costs, it overstates the returns to the investment.  However, revenue from a single year understates the time period when a firm would receive a return on an investment. Finally, gross revenue at full market potential does not account for the difference in timing between costs of registration and future returns.  Costs are likely to be incurred at the beginning of registration, whereas revenues will occur over multiple, future years.
  • Third, PRN 97-2 applies only to registration actions on conventional pesticides.  The notice specifically states that it does not apply to registrations of biopesticides and antimicrobials (e.g., disinfectants).  The method described in this PRN may be used to evaluate the registration incentive for all types of products registered by each of OPP's registering divisions.

Additionally of note, EPA states in PR Notice 2018-1 that seeking minor use designation is not required as part of the pesticide registration process.  It is an optional designation that an applicant can seek to obtain certain incentives associated with minor uses, such as:

  • Extension of exclusive use of data under FIFRA Section 3(c)(1)(F)(ii); and
  • Qualifying for an exemption from the fee or waiver of a portion of the registration service fee for an application for minor uses of a pesticide under FIFRA Section 33(b)(7)(D).

More information on other PR Notices is available on our blog under key phrase Pesticide Registration Notice.

 


 

By Lisa M. Campbell and Lisa R. Burchi

On February 14, 2018, the U.S. Environmental Protection Agency (EPA) and Amazon Services LLC (Amazon) entered into a Consent Agreement and Final Order (CAFO) whereby Amazon agreed to pay $1,215,700 in civil penalties for approximately four thousand alleged violations under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the distribution of unregistered pesticide products.  Amazon neither admitted nor denied the specific factual allegations, which included: 

  • Between January 1, 2013, and November 1, 2015, Amazon distributed, held for distribution, held for shipment, or shipped two unregistered pesticide products called “3pcs Cockroach Cockroaches Bugs Ants Roach Kills Chalk”; and “Miraculous Insecticide Chalk” on multiple occasions in the United States. 
  • Between January 1, 2013, and March 1, 2016, Amazon distributed, held for distribution, held for shipment, or shipped three unregistered pesticide products called “HUA Highly Effective Cockroach Killer Bait Powder”; “R.B.T.Z. Safe Highly Effective Roach Killer Bait Powder Indoor”; “HUA Highly Effective Fly Killing Bait Powder”; and “Ars Mat 60 pcs. Refil for ARS Electric Mosquito Killer Convenient, Clean & Smokeless” on multiple occasions in the United States. 

Amazon also agreed to implement a supplemental environmental project (SEP) consisting of the development, deployment, and operation of a publicly available eLearning course, downloadable educational materials, and test on FIFRA requirements and associated regulations (eLearning Project).  Although no monetary amount was specified for the implementation of the SEP, the eLearning Project will be a significant undertaking, as the materials will be available in three languages (English, Spanish, and Chinese) and Amazon will require all of its Amazon.com sellers to complete the eLeaming course and pass an associated test prior to allowing such Amazon.com sellers to sell products identified as pesticides.  The only circumstance when this requirement will not apply to Amazon.com sellers is when a seller can “demonstrate that the seller's existing compliance program is sufficient to ensure products sold via Amazon.com comply with FIFRA.”

More information on FIFRA enforcement issues is available on our blog under key word enforcement.  


 

By Lisa R. Burchi and Lisa M. Campbell

On January 3, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-01:  Expanding Use of Pesticide Products Under Reevaluation.  Under Notice 2018-01, effective immediately, DPR will not act upon an Application for Pesticide Registration or an Application to Amend a Pesticide Product if it determines the registration or acceptance would potentially “expand use” of an active ingredient or pesticide product currently under reevaluation until the conclusion of the reevaluation.  

DPR states that it commences a reevaluation of an existing registered pesticide when it finds, based on an investigation of all reported episodes and information received, that a significant adverse impact to human health or the environment has occurred or is likely to occur.  DPR states that the policy set forth in Notice 2018-1 is needed for pesticides under reevaluation because until DPR reviews existing data for substances under reevaluation, determines whether additional data to satisfy reevaluation data requirements must be submitted, and then receives and assesses additional data applicable to the reevaluation that can mitigate the concern that prompted the initiation of the reevaluation, DPR “is not in a position to determine that an expanded use will not cause a ‘significant adverse environmental impact,’ as required under its certified regulatory program (3 CCR section 6254).”  Once the reevaluation process is completed, DPR states that it will then be in a position, in light of its reevaluation determination, to consider applications for product registration or amendment.

Scope of Notice 2018-1

DPR is currently reevaluating certain pesticide products containing the following active ingredients:

  • Chloropicrin;
  • Copper-based antifouling paints (copper oxide, copper hydroxide, and cuprous thiocyanate);
  • Cyfluthrin;
  • Diazinon; and
  • Nitroguanidine neonicotinoids (imidacloprid, thiamethoxam, clothianidin, and dinotefuran).

This notice applies to new pesticide products that include these active ingredients, including supplemental distributor registrations (subregistrations) and amendments to currently registered pesticide products, when “expanding use” of the active ingredient relevant to the concern that prompted the reevaluation.  

Specifically, DPR states in Notice 2018-1 that it interprets the following types of actions, related to a new or amended product containing the active ingredient under reevaluation, as examples of “expanding use”:

  • A proposed new pesticide product, including any Special Local Needs registration or Experimental Use Permit, with a label bearing uses or exposure scenarios relevant to the concern that prompted the reevaluation. This includes any product label that is identical or substantially similar to a currently registered product in California.
  • Amendment of a currently registered product to add or modify uses or exposure scenarios relevant to the concern that prompted the reevaluation, even if such use is already on other currently registered pesticide products in California. Examples of such changes include:
    • New or modified uses (e.g., new crops, pests, or use sites);
    • New or modified use patterns (e.g., adding aerial, aquatic, soil applications, or outdoor use);
    • Significant formulation changes (unless prompted by the reevaluation);
    • Increased application rates or total use amount allowed (e.g., acreage or frequency of application); and
    • Other label additions or changes that may increase pesticide exposure in a manner that is relevant to the basis for the reevaluation.

This notice does not preclude expanded use of a product if the expansion is not consistent with uses or exposure scenarios relevant to the concern that prompted the reevaluation.  As an example, DPR states that an application containing an active ingredient that is under reevaluation over concerns regarding exposure to wildlife would not be precluded under this notice as an expanded use is if the product is labeled solely for indoor use, with no potential wildlife exposure.

DPR also acknowledges that a pest management or public health need could arise during a reevaluation that would support the issuance of an Emergency Exemption request under Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  In those cases, with regard to the potential applicability of Notice 2018-1, DPR states that it “will assess the request by relying on currently available information and risk mitigation strategies.”

Discussion

DPR’s reevaluation process can take years to complete, so not only are pending affected submissions for products containing the active ingredients at issue effectively frozen, but future submissions for active ingredients newly entering the reevaluation process could be halted potentially for lengthy periods of time, despite the fact that DPR may ultimately determine that any identified “expanded uses” do not cause a significant adverse environmental impact.  It is an initiative that many in industry are monitoring closely.

More information on other California DPR-related issues is available on our blog under key phrase California DPR.


 

By Lisa M. Campbell, Heather F. Collins, M.S., and Margaret R. Graham

On October 5, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice of extension of the comment period for the draft guidance Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendment issued on September 6, 2017.  Comments now must be received by EPA on or before December 5, 2017.  The notice states that it will “allow stakeholders additional time to submit comments on the proposed guidance.”  Eleven comments were filed in the docket, most of which expressed significant concern with changes EPA is proposing, in addition to requesting an extension to the previous deadline which was set to end on October 6, 2017.

EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.”  A full summary of the changes in the draft guidance is available in our blog item "EPA Releases Draft Guidance for Pesticide Registrants on Notifications, Non-notifications, and Minor Formulation Amendments."

Some of the more substantive comments noted the following issues:

  • Several commenters stated objections to the provisions in the draft PR Notice that would eliminate the ability of registrants of formulated products to use notification to add or change sources of either registered technical active ingredients or inert ingredients.  Concerns expressed with this proposed change included the effect it would have on the ability of registrants to respond quickly to market changes and conditions, including the availability and price of technical and inert ingredients needed for formulations.
  • One commenter had concerns with regard to the proposed changes to the inert ingredient disclosure statement, as EPA is “considering whether the notification method or the non-notification method is an appropriate avenue for industry requested inert disclosure based upon third-party vendor requirements.”  The commenter stated that it “believes there is an approach that satisfies third-party vendors while minimizing the burden on the Agency’s resources,” and “a significant delay to this issue could have third-party vendor impacts.” 
  • Commenters also expressed disappointment with EPA’s notification delivery, stating that EPA “provided very little notice to Stakeholders of this major change in its policies regarding notification” and “as a result, many potentially affected registrants may overlook this change and fail to file comments on it.”

More information on this draft notice and other pesticide registration notice issues is available on our blog under key phrase Pesticide Registration Notice.


 

By J. Brian Xu, M.D., Ph.D., DABT®

On September 29, 2017, the Ministry of Agriculture of China (MOA) issued the final revisions to Data Requirements on Pesticide Registration (MOA Proclamation No. 2569).  The revisions will become effective on November 1, 2017, under the new Regulation on Pesticide Administration (RPA) and Pesticide Registration Management Measures (MOA Order No. 3, 2017).  The draft revisions to Data Requirements on Pesticide Registration were initially released for public comment on June 30, 2017.  The new Data Requirements include 10 chapters and 14 annexes and a category of pesticides for specialty minor crops has been added.  More information on China’s new pesticide regulations is available in our blog under key word China.

Commentary

MOA Order No. 3, 2017 requires chemistry and toxicology tests to be completed in laboratories located in China approved by the MOA or overseas laboratories that have a mutual recognition agreement with the relevant Chinese Authority.  The new Data Requirements on Pesticide Registration do not provide any additional information about the acceptance of data generated in overseas laboratories.

It remains unclear whether, for example, for literature or data prepared in a foreign language, entire study reports/articles, or only summaries, must be translated into Chinese.  In addition, the final revision of Data Requirements on Pesticide Registration deletes the category of “Pesticides for Overseas Uses Only” that was set forth in the draft revision of Data Requirements on Pesticide Registration.

The new RPA, MOA Order No. 3, 2017, and the Data Requirements on Pesticide Registration significantly change the registration requirements and the registration process for pesticides in China.  These new requirements, and the many ambiguities they contain, will likely extend the time for obtaining registrations and impose additional challenges on manufacturers to overcome, particularly foreign manufacturers who wish to bring pesticide products to the Chinese market.


 

By Margaret R. Graham

On September 22, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register (82 Fed. Reg. 44406) announcing the availability of two final Pesticide Registration Notices (PRN):

  1. PRN 2017-1:  Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling, which updates PRN 2001-5 and provides guidance for registrants to follow when developing resistance management information to include on their pesticide labels.  It addresses “end-use herbicide, fungicide/bactericide, or insecticide/acaricide products that are intended mainly for agricultural and certain non-crop land areas under commercial or government-sponsored pest management,” and applies in particular to “all field use agricultural pesticide products, as well as pesticides which are labeled for greenhouse production, sod farms, ornamental crops, aquatic vegetation, rights-of way, and pest management along roadways.”
  2. PRN 2017-2:  Guidance for Herbicide Resistance Management Labeling, Education, Training, and Stewardship, which “communicates the agency's approach to address herbicide-resistant weeds.”  It is “germane to end-use herbicide products used in agriculture, including commercial turf and sod farms, ornamental production in the open.”  It also applies to “non-agricultural use sites such as golf courses, aquatic vegetation, rights-of-way and vegetation management along roadways.”

These final PRNs reflect consideration of public comments submitted on the draft PRNs.  Also available in the dockets are EPA’s responses to comments on the draft PRNs:  Response to Comments on PRN 2017-1; and Response to Comments on PRN 2017-2.  EPA states that “PRNs are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration-related decisions, and to provide guidance to pesticide registrants and OPP personnel.”

More information on PRNs is available on our blog under key phrase pesticide registration notice


 
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