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.
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By Lisa M. CampbellTimothy D. Backstrom, and Lisa R. Burchi

On July 1, 2016, the U.S. Environmental Protection Agency (EPA) issued in the Federal Register an interim final rule adjusting penalty amounts for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) violations by more than three times the current level, in some cases.  The rule also adjusts the level of statutory civil monetary penalty amounts for the other statutes that EPA administers.  EPA issued this interim final rule pursuant to 2015 amendments to the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 (DCIA) (collectively the 2015 Act).  The 2015 Act sets forth new requirements for agencies to:  (1) adjust the level of statutory civil penalties with an initial “catch-up” adjustment through an interim final rulemaking; and (2) beginning January 15, 2017, make subsequent annual adjustments for inflation.

EPA states that the purpose of the 2015 Act is to “provide a mechanism to address these issues by translating originally enacted statutory civil penalty amounts to today’s dollars and rounding statutory civil penalties to the nearest dollar,” and “[o]nce Federal agencies issue the 2016 one-time catchup rule, each statutory civil penalty amount will be adjusted every year to reflect the inflation that has thereafter accrued.” 

EPA sets forth a five step procedure to determine the cost-of-living or inflation adjustment to statutory civil penalties.  Through this interim final rule, EPA amends 40 C.F.R. Part 19 of EPA’s regulations, Adjustment of Civil Monetary Penalties for Inflation, to include:

  1. The operative statutory civil penalty levels, as adjusted for inflation, for violations occurring on or before November 2, 2015, and for violations occurring after November 2, 2015, where penalties are assessed before August 1, 2016; and
  2. The operative statutory civil penalty levels, as adjusted for inflation, where penalties are assessed on or after August 1, 2016, for violations that occurred after November 2, 2015.

Table 2 to 40 C.F.R. Section 19.4 sets forth the specific statutory civil penalty provisions of statutes administered by EPA, with the original statutory civil penalty levels, as enacted, with the last column of which displaying the operative statutory civil penalty levels where penalties are assessed on or after August 1, 2016, for violations that occurred after November 2, 2015.  Specific changes to FIFRA penalties in Table 2 are as follows:

  • U.S. Code citation:  7 U.S.C. 136(a)(1); Environmental Statute:  FIFRA; ​Statutory civil penalties, as enacted:  $5,000; Statutory civil penalties for violations that occurred after November 2, 2015, and assessed on or after August 1, 2016:  $18,750; and
  • U.S. Code citation:  7 U.S.C. 136(a)(2)*; Environmental Statute:  FIFRA; ​Statutory civil penalties, as enacted:  $1,000/500/1,000; Statutory civil penalties for violations that occurred after November 2, 2015, and assessed on or after August 1, 2016:  $2,750/$1,772/$2,750.

* Note that 7 U.S.C. 136(a)(2) contains three separate maximum civil penalty provisions.  The first mention of $1,000 and the $500 statutory maximum civil penalty amount were originally enacted in 1978 (Pub. L. No. 95-396) and the second mention of $1,000 was enacted in 1972 (Pub. L. No. 92-516).

Commentary

Despite the large increase in some of the civil penalty amounts, EPA has determined, pursuant to Administrative Procedure Act (APA) Section 553(b)(3)(B), that it “would be impracticable and unnecessary to delay publication of this rule pending opportunity for notice and comment.” According to EPA, notice and comment are not necessary “because the 2015 Act does not allow agencies to alter the rule based on public comment.”  This rationale presumes that EPA has correctly determined the size of the initial “catch-up” penalty adjustment mandated by the 2015 Act.  Despite EPA’s APA finding, EPA would likely be obligated to consider any comment arguing that EPA did not determine the size of this initial adjustment correctly.  Future annual adjustments should be much smaller and, thus, presumably not as likely to be as controversial.


 
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By Lisa M. Campbell and Timothy D. Backstrom
 
On July 5, 2016, a three judge panel of the U.S. Court of Appeals for the Ninth Circuit issued a brief opinion denying a petition for review of a U.S. Environmental Protection Agency (EPA) order in which EPA declined to “immediately adopt interim prohibitions on the use of toxic drift-prone pesticides … near homes, schools, parks, and daycare centers or wherever children congregate.”  Petitioners Pesticide Action Network North America (PANNA), United Farm Workers, and Pineros y Campesinos Unidos del Noroeste (PANNA, et al.) filed an administrative petition in 2009 asking EPA to conduct pesticide-specific drift assessments and to impose interim buffer zones to protect children from pesticide drift.
 
The Circuit Court agreed with EPA’s contention that the petitioners do not have jurisdiction to review the reregistration and tolerance determinations previously made by EPA pursuant to the Food Quality Protection Act (FQPA), because such challenges are now time barred.  EPA agreed with the petitioners that it should consider potential risks from spray drift as part of the registration review under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  The petitioners argued that EPA had thereby acknowledged legal error when it previously reregistered food-use pesticides, but EPA has vigorously contested that premise.  In 2014, EPA issued a proposal describing the methodology for assessing risk from pesticide drift that EPA will use prospectively in making registration review decisions.
 
The petitioners requested that EPA adopt interim relief by imposing uniform buffer zones for all pesticides that are registered for application by ground sprayers, broadcast, or aerial application, and that may cause certain human health effects.  EPA rejected this request for across-the-board buffer zones as unscientific and inefficient and likely to result in a misallocation of EPA resources.  The Circuit Court concluded that “substantial evidence” supports EPA’s decision to deny this interim relief, stating that “[t]he record suggests that the risk of exposure to pesticide draft depends on a number of factors, including pesticide toxicity, the method of application, the size of pesticide droplets, and weather conditions,” and “adequately supports EPA’s conclusion that the imposition of uniform buffer zones is not the most ‘scientifically appropriate’ method for mitigating the risk of exposure to pesticide drift.”


Commentary


The Circuit Court has clearly recognized that uniform buffer zones like those sought by the petitioners would not be “scientifically appropriate.”  While this decision is both welcome by industry and constructive, the evaluation of potential exposure and risk from pesticide drift during the registration review process for individual pesticides will likely remain controversial.

More information on EPA’s spray drift policy is available in our memorandum Spray Drift and Volatilization: Issues to Navigate Carefully as EPA Develops Registration Review Decisions.


 
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By Lisa M. Campbell and Timothy D. Backstrom

On June 29, 2016, the U.S. Environmental Protection Agency (EPA) submitted a status report in the Ninth Circuit Court of Appeals case concerning a petition by Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) to revoke the tolerances and cancel the registrations for chlorpyrifos.  The Court of Appeals issued an order on December 10, 2015, requiring EPA to take final action concerning the PANNA and NRDC petition no later than December 30, 2016.  To comply with an earlier order, EPA issued a proposed rule to revoke the tolerances for chlorpyrifos before it could complete a refined drinking water assessment or propose a new “point of departure” for chlorpyrifos based on biomonitoring data from an epidemiological study. 

EPA’s status report states that it has made “significant progress” towards meeting the December 30, 2016, deadline, but “extraordinary circumstances exist that make it impracticable for the Agency to meet the Court’s deadline.”  Based on these extraordinary circumstances, EPA has requested a six-month extension for final action on the petition. 

EPA notes that a proposed new point of departure was presented to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP), but was not favorably received.  At the same time, EPA states that the SAP “raised concerns about the approach EPA adopted in the Proposed Rule, namely that the continued use of acetylcholinesterase inhibition as the point of departure may not be sufficiently health protective.”  EPA infers that the SAP may be disposed to recommend a “hybrid approach,” but the written SAP report will not be issued until the end of July, 2016.

EPA states that it had planned to seek public comment on its refined drinking water assessment and new point of departure for chlorpyrifos immediately after the SAP meeting.  EPA now believes that it would be best to obtain the final SAP report before deciding how to establish a point of departure.  Accordingly, EPA proposes to seek comment on its refined drinking water analysis and analysis of the epidemiological data by early Fall 2016, and to take final action on the PANNA and NRDC petition by June 30, 2017.

Commentary

EPA expects that the refined drinking water assessment for chlorpyrifos will allow “tailored risk mitigation” that could eliminate one basis for the proposed revocation of chlorpyrifos tolerances.  In contrast, EPA’s concerns about the potential neurodevelopmental effects of chlorpyrifos may not be as readily addressed by risk mitigation.  If EPA decides either to retain the Food Quality Protection Act (FQPA) 10X safety factor for chlorpyrifos based on purported neurodevelopmental effects observed in epidemiological studies, or to adopt some “hybrid” risk assessment methodology for neurodevelopmental effects in response to the SAP recommendations, debate on the merits of doing so will likely be strong.  The status report does not appear to suggest that EPA is currently considering revisiting its general views on the chlorpyrifos epidemiological data; if EPA is not doing so, considerable continued debate on this issue is also likely.


 
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By Lynn L. Bergeson, Lisa M. Campbell, and Lisa R. Burchi

On June 29, 2016, the U.S. District Court for the Northern District of California (Court) issued an opinion dismissing the complaint and denying the motion for summary judgment of the Center for Environmental Health, Beyond Pesticides, and Physicians for Social Responsibility (CEH, et al.), and granting the U.S. Environmental Protection Agency’s (EPA) motion for summary judgment. 

Background

This case stems from a petition filed in 2006 requesting EPA to initiate a rulemaking to require the labeling of 371 inert ingredients in pesticides.  EPA issued an Advance Notice of Proposed Rulemaking (ANPR) in 2009, but did not proceed further with a rulemaking.  CEH, et al. filed a second lawsuit in March 2014, alleging that EPA’s failure to complete the rulemaking process started by the ANPR violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Administrative Procedure Act (APA).  In May 2014, EPA responded by amending its response to the 2006 petition to explain that it had decided to pursue an approach different from requiring mandatory disclosure on the pesticide label of a hazardous inert ingredient.  EPA announced that it would instead pursue a “‘combination of regulatory and focused non-regulatory actions that do not rely on rulemaking’ including potentially:  (1) removing over ninety chemicals from the list of inert ingredients approved for pesticide use; (2) evaluating the effect of the 371 inert ingredients on food crops; (3) directing pesticide registrants to modify their registrations by replacing hazardous inert ingredients with less hazardous ones; and (4) seeking to expand the existing voluntary disclosure program.”  The Court granted EPA’s motion for judgment on the pleadings in the March 2014 lawsuit, “finding that there was no further relief that [the Court] could offer to plaintiffs and that the action was moot.”

CEH, et al.’s complaint in the case at issue challenges EPA’s May 2014 denial of its rulemaking petition, alleging that under FIFRA and APA, EPA’s decision to deny the rulemaking petition was “arbitrary, capricious, and contrary to [FIFRA].”  CEH, et al. requested the court to “set aside the denial and to remand the decision to the EPA to consider ‘the evidence weighing in favor of disclosure of inert pesticide ingredients.’”  Background on the complaint is available in our blog item NGOs File Suit Regarding Inert Ingredients’ Disclosure.

In support of its ruling to grant EPA’s motion for summary judgment, the court stated:  “EPA is not mandated to require disclosure of the inert ingredients at issue,” since “[p]laintiffs have provided no persuasive evidence that EPA’s decision to forego rulemaking is inconsistent with the ANPR.”  The Court noted, for example, that EPA’s regulation governing disclosure of inert ingredients, 40 C.F.R. § 156.10(g)(7), states that “[t]he Administrator may require the name of any inert ingredient(s) to be listed in the ingredient statement if he determines that such ingredient(s) may pose a hazard to man or the environment”; this allows EPA to require applicants to list hazardous inert ingredients, but “does not mandate it.”  In addition, the Court found that EPA’s decision “that a series of non-rule actions would achieve a greater reduction in the risks from the use of pesticides and could be implemented in a timelier manner,” was not arbitrary or capricious, even if it “conceivably offers a less effective remedy than what plaintiffs sought.”

Discussion

The decision supports EPA’s discretionary authority to determine how to best manage and address any inert ingredients that may cause unreasonable adverse effects on the environment.  EPA has set forth several actions that it is taking or intends to take in lieu of mandatory label disclosure of inert ingredients.  For example, on October 22, 2014, EPA proposed to remove 72 chemical substances from the current listing of inert ingredients approved for use in pesticide products because the inert ingredients are no longer used in any registered pesticide product.  Registrants of any pesticides containing a potentially hazardous inert ingredient should monitor how EPA’s regulatory and focused non-regulatory actions affect such substances.  


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

On June 7, 2016, the U.S. Environmental Protection Agency (EPA) announced that it was making two draft Pesticide Registration Notices (PR Notices) available for public comment:  (1) PR Notice 2016-X:  Draft Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling; and (2) PR Notice 2016-XX:  Draft Guidance for Herbicide Resistance Management Labeling, Education, Training, and Stewardship.  In its news release, EPA states that it has started a “more widespread effort aimed at combating and slowing the development of pesticide resistance,” in an effort to “address the growing issue of resistance and preserve the useful life of pesticides.”

Draft PR Notice 2016-X

Draft PR Notice 2016-X, which revises and updates PR Notice 2001-5, applies to all conventional agricultural pesticides (i.e., herbicides, fungicides, bactericides, insecticides and acaricides).  The focus of the updates in PR Notice 2016-X is on pesticide labels and improving information about how pesticide users can minimize and manage pest resistance.  

Specifically, EPA is proposing that specific resistance-management statements be included with the Directions for Use section under the heading “Resistance Management Recommendations.”  EPA states that the proposed labeling statements “focus on the mitigation of pest resistance and should be used where applicable based on the availability of other pesticides and production practices specific to that crop.”  As one example, EPA recommends the following general resistance management labeling statements for insecticide/acaricide products containing only a single active ingredient or multiple active ingredients that are from the same Mode of Action (MOA) group:

  • For resistance management, (name of product) contains a Group (mode of action group number) insecticide (or acaricide). Any (insect/mite) population may contain individuals naturally resistant to (name of product) and other Group (mode of action group number) insecticides/acaricides. The resistant individuals may dominate the insect/mite population if this group of insecticides/acaricides are used repeatedly in the same fields.

Since the recommended resistance-management statements depend on an active ingredient’s MOA, PR Notice 2016-X also addresses MOA grouping and identification symbols for agricultural uses of herbicides, fungicides/bactericides, and insecticides/acaricides.  The pesticide groupings are provided by the Weed Science Society of America (WSSA), the Herbicide Resistance Action Committee (HRAC), the Fungicide Resistance Action Committee (FRAC) and the Insecticide Resistance Action Committee (IRAC).  The MOA groups, and the identifier numbers and/or letters (i.e., symbols or codes) for herbicides, fungicides/bactericides and insecticides/acaricides may be accessed through the websites of the different Resistance Action Committees.  For example, for insecticides, IRAC uses a combination of numbers and letters to identify various MOA groups.  EPA recommends that the IRAC MOA identifier codes be used for designating insecticide MOA grouping information on labels for pesticides containing insecticides.  The IRAC MOA list and identifier codes can be found online.

While current PR Notice 2001-5 contains similar guidance in terms of MOA groupings and general pesticide-resistance statements, the Draft PR Notice 2016-X provides:  (1) additional guidance, and recommended format, for resistance management statements or information to place on labels; (2) includes references to external technical resources for guidance on resistance management (e.g., professional scientific societies, resistance action committees for different types of pesticides); and (3) updates the instructions on how to submit changes to existing labels to enhance resistance management language.  In addition, while PR Notice 2001-5 states that “implementation of this program is purely voluntary by the pesticide industry,” the language in Draft PR Notice 2016-X is arguably stronger, with EPA “encouraging” registrants to add the appropriate resistance-management statements through notification, amendment, or as part of an application for a new product.

Draft PR Notice 2016-XX

Draft PR Notice 2016-XX, which only applies to herbicides, is intended to provide guidance on labeling, education, training, and stewardship for herbicides undergoing registration review or registration (i.e., new herbicide actives, new uses proposed for use on herbicide-resistant crops, or other case-specific registration actions).  EPA states it is focusing on the holistic guidance for herbicides first because:

  1. Herbicides are the most widely used agricultural chemicals;
  2. No new herbicide mechanism of action has been developed in the last 30 years; and
  3. Herbicide-resistant weeds are rapidly increasing.  In the future, the Agency plans to evaluate other types of pesticides (e.g., fungicides, bactericides, insecticides, and acaricides) to determine whether and what guidance may be appropriate for these types of pesticides.

Under guidance described in PR Notice 2016-XX, EPA proposes to divide 28 herbicide Mechanisms of Actions into three categories of concern (low, moderate, high) based on the risk of developing herbicide-resistant weeds.  Appendix I to PR Notice 2016-XX provides three tables with herbicide Mechanisms of Actions of “Low Concern,” “Moderate Concern,” and “High Concern” for herbicide resistance.  EPA states its intent to make these tables available on its website, noting that the tables would need to be “checked periodically to determine if there are changes to the groupings or level of concern categories.”  Appendix II to PR Notice 2016-XX sets forth the following eleven elements that are focused on labeling, education, training, and stewardship strategies:

  • Element 1.  List Mechanism of Action Group Number on label.
  • Element 2.  List seasonal and annual maximum number of applications and amounts.
  • Element 3.  Provide Resistance Management language from PR Notice 2016-X, and/or Best Management Practices language from WSSA and HRAC, and/or HRAC proposed guidelines for herbicide labels. Note that Best Management Practices (BMP) should be appropriate to crop and production system.
  • Element 4.  Instruction to user to scout before and after application.
  • Element 5.  Provide definition of Likely Resistance.
  • Element 6.  Instruction to user to report lack of performance to registrant or their representative.
  • Element 7.  List confirmed resistant weeds in a separate table and list recommended rates for these weeds with the table.
  • Element 8.  Registrant report new cases of likely and confirmed resistance to EPA and users yearly. This is in addition to any adverse effects reporting.
  • Element 9.  Provide growers with:
  1. Resistance Management Plan;
  2. Remedial Action Plan (to control resistant weeds this season or next season);
  3. Educational materials on resistance management; and
  4. Plans should be locally developed and easily modified. EPA recommends that registrants work with Extension, Consultants, Crop Groups, HRAC, and the U.S. Department of Agricultute (USDA).
  • Element 10.  For combination products with multiple Mechanisms of Action, list which herbicide is controlling which weed (a three-way mixture may only have one effective Mechanism of Action for some problem weeds).  List minimum recommended rate if resistance is suspected.
  • Element 11.  Any additional specific requirements (e.g., mandatory crop rotation, unique agronomic aspects, additional training, time limited registration, etc.).

Elements 1 through 4 are proposed for Mechanisms of Actions of Low Concern, elements 1 through 8 are proposed for Mechanisms of Actions of Moderate Concern, and elements 1 through 11 are proposed for Mechanisms of Actions of High Concern.

The PR Notices are available on www.regulations.gov under Docket Numbers EPA-HQ-OPP-2016-0242 for PR Notice 2016-X; and EPA-HQ-OPP-2016-0226 for PR Notice 2016-XX.  Comments are due by August 2, 2016

With regard to PR Notice 2016-XX, EPA states that while comments are welcome on all aspects of this Notice, EPA is especially interested in comments on the following: (1) the approach, elements and categorization used to address herbicide resistance; (2) limiting the application of these measures during registration review to new herbicide active ingredients, new uses of herbicides proposed for use on herbicide-resistant crops, and other case-specific registration actions; (3) other effective measures to inform the stakeholder community of the occurrence of likely resistance; and (4) other useful strategies that, when implemented, would slow the development of herbicide resistance and prolong the useful life of herbicides.

More information on pesticide resistance management is available on EPA’s website.

Commentary

Avoiding the onset of resistance to any pesticide product is a widely shared goal of users and registrants of the pesticide to maintain the effectiveness and profitability of the product.  There is controversy, however, when EPA suggests specific instructions to the user community, since pesticide applications are site and situation specific, making general “one size fits all” approaches, even “flexible” ones, suspect among much of the user community.  When the instructions involve label requirements, which are enforceable, concerns about flexibility and the need to adapt to local conditions increase.

Resistance management has been a stated goal of EPA for some time; here EPA seems to argue it is of the utmost importance to preserve useful pest control tools since it is better to have more “tools in the toolbox.”  Yet, when EPA seeks to restrict a product or class of products and users and registrants cite the need for that product for resistance management, few benefits seem to be associated with resistance management in such cases.  Overall, there is also suspicion that EPA’s concerns regarding herbicide resistance masks a political response to critics of the widespread adoption of herbicide-resistant genetically engineered crops -- since the high value of resistance management gains little value when EPA attempts to restrict other products.  An example is EPA’s approach to organophosphate insecticides, where EPA is currently seeking to eliminate many uses that otherwise are viewed as important for insecticide resistance management.

Having EPA attempt to address resistance management via label instructions will be controversial, notwithstanding broad consensus that avoiding resistance is a shared goal.  So, the likely debate will focus less on the goal, and more on the means of achieving the goal, as this issue moves forward.


 
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By Lisa M. Campbell and Sheryl L. Dolan

On June 2, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) and Health Canada’s Pest Management Regulatory Agency (PMRA) released harmonized product chemistry templates for use by registrants when submitting pesticide registration packages

These templates were developed by EPA and PMRA under the United States -- Canada Regulatory Cooperation Council (RCC) workplan.  EPA stated that the templates are based on the Organization for Economic Cooperation and Development’s (OECD) Harmonized Templates for Reporting Chemical Test Summaries’ format, “but have been streamlined to address a single product/application and will facilitate the review of product chemistry data for global and joint registrations, as well as other actions.”  EPA and PMRA are encouraging applicants to begin using these templates to organize and summarize the product chemistry data for each product and/or registration package that is submitted to EPA and PMRA.

More information on these templates is available in the RCC’s Work Planning Format document.  


 
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By Lisa M. Campbell and Lisa R. Burchi

On May 10, 2016, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) issued guidelines on highly hazardous pesticides (HHP) (Guidelines) as part of the International Code of Conduct on Pesticide Management (Code of Conduct).  HHPs are defined in the Guidelines as “pesticides that are acknowledged to present particularly high levels of acute or chronic hazards to health or environment according to internationally accepted classification systems such as WHO or GHS or their listing in relevant binding international agreements or conventions.  In addition, pesticides that appear to cause severe or irreversible harm to health or the environment under conditions of use in a country may be considered to be and treated as highly hazardous.”  The Guidelines state that they are “intended to help national or regional pesticide regulators with limited resources to design a process to address HHPs that follows the three steps of identification, assessment and mitigation,” and they aim “to underscore the importance of adequate pesticide legislation, and risk and needs assessment as part of the registration process.”

Background

In 2006, the FAO Council endorsed FAO participation in the Strategic Approach to International Chemicals Management (SAICM) and noted that the International Code of Conduct on the Distribution and Use of Pesticides was to be considered an important element of the SAICM process.  The Council “suggested that the activities of FAO could include pesticide risk reduction, including the progressive banning of Highly Hazardous Pesticides (HHPs).”  The Joint FAO/WHO Meeting on Pesticide Management (JMPM) developed the criteria that defines HHPs when the Code of Conduct was revised in 2013.

In 2015, SAICM’s International Conference on Chemicals Management adopted a resolution recognizing “HHPs as an issue of concern and called for concerted action to address HHPs, with emphasis on promoting agro-ecologically based alternatives and strengthening national regulatory capacity to conduct risk assessment and risk management.”

2016 HHP Guidelines

The Guidelines include information on:

Identification of HHPs:  The Guidelines set forth the following eight criteria for identifying HHPs (i.e., HHPs should be defined as having one or more of the following characteristics):

  • Criterion 1: Pesticide formulations that meet the criteria of classes Ia or Ib of the WHO Recommended Classification of Pesticides by Hazard;
  • Criterion 2: Pesticide active ingredients and their formulations that meet the criteria of carcinogenicity Categories 1A and 1B of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS);
  • Criterion 3: Pesticide active ingredients and their formulations that meet the criteria of mutagenicity Categories 1A and 1B of the GHS;  
  • Criterion 4: Pesticide active ingredients and their formulations that meet the criteria of reproductive toxicity Categories 1A and 1B of the GHS; 
  • Criterion 5: Pesticide active ingredients listed by the Stockholm Convention in its Annexes A and B, and those meeting all the criteria in paragraph 1 of Annex D of the Convention;
  • Criterion 6: Pesticide active ingredients and formulations listed by the Rotterdam Convention in its Annex III;
  • Criterion 7: Pesticides listed under the Montreal Protocol; or
  • Criterion 8: Pesticide active ingredients and formulations that have shown a high incidence of severe or irreversible adverse effects on human health or the environment.

Assessment: The Guidelines set forth guidance to assess the risks to human health and the environment under the conditions of use, as well as the needs for the products.  FAO developed a Pesticide Registration Toolkit (Toolkit) to assists registrars in the evaluation for authorization of pesticides and review of registered pesticides. The Guidelines state:

  • The Toolkit can best be considered as a web-based registration handbook intended for day-to-day use by pesticide registrars.  It supports and facilitates informed decision-making by registrars, but is not an automated system that suggests decisions for registrars.
  • Registrars can use the Toolkit to support several of their regular tasks. With respect to highly hazardous pesticides (HHPs), the Toolkit can be used as an aid to implement the three steps described in these guidelines:  Identification, Assessment and Mitigation.

Mitigation:  The Guidelines provide options for mitigating risks of HHPs currently in use, and for possible new HHPs.  Specifically, the Guidelines state the “main lines for risk mitigation are ending, restricting or changing formulations or uses.  Selection of the most appropriate option will vary from case to case and depend on risk levels and needs, but also on policies and adequacy of institutional infrastructure for pesticide management.”

Planning:  The Guidelines set forth steps for designing an action plan to address HHPs.  FAO and WHO note the importance of effective communication and involvement with stakeholders in the pesticide supply chain (e.g., growers, food retailers, consumers) in developing an action plan.

Prevention:  The Guidelines discuss elements to prevent future problems with HHPs, particularly possible revision of the registration system, strengthened enforcement, extensive training, and the installation of surveillance systems.

Discussion

Concerns have been raised previously regarding any potential for efforts by WHO and FAO to eliminate HHPs to be based purely on hazard without consideration of risk.  The Guidelines include discussions related to the steps to “assess the risks that [HHP] products are posing to human health and the environment under the conditions of use in that country and to review the needs for these products, taking into consideration available alternatives.”  Whether this provision sufficiently addresses past concerns should be examined.

Companies will need to review the Guidelines, and the Toolkit, to determine how their products would be identified, assessed, prioritized, and managed under the Guidelines and Toolkit.  While some elements of the Guidelines are relatively straight-forward, others may be more subjective and thus much more controversial, such as, for example, the HHP criteria that a pesticide active ingredient or formulation has “shown a high incidence of severe or irreversible adverse effects on human health or the environment.”  In addition, the Toolkit is under development, meaning that several modules are not completed and that webpages may not yet be completed.  It, thus, will be important to continue to monitor how the Guidelines and Toolkit are developed and applied. 

 


 
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By Lisa M. Campbell, Lisa R. Burchi, and Timothy D. Backstrom

On Wednesday, June 1, 2016, Administrative Law Judge (ALJ) Susan L. Biro issued an Initial Decision in the matter of Bayer CropScience LP and Nichino America, Inc. (BCS/NAI), U.S. Environmental Protection Agency (EPA) Docket No. FIFRA-HQ-2016-0001.

This decision was issued following BCS/NAI’s request for a hearing to contest EPA’s Notice of Intent to Cancel Pesticide Registrations (NOIC).  BCS/NAI challenged EPA’s position that a conditional registration term in the relevant registrations required BCS/NAI to cancel voluntarily their flubendiamide registrations within one week of notification by EPA that the currently registered flubendiamide products will result in unreasonable adverse effects on the environment, and EPA’s issuance of a NOIC for all BCS/NAI flubendiamide products as a result of BCS/NAI’s decision declining EPA’s request to cancel voluntarily all flubendiamide registrations.

In an earlier order, Biro denied BCS/NAI’s Motion for Accelerated Decision and ruled that as a matter of law EPA was authorized to cancel the conditional registrations under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(e) and did not need to provide BCS/NAI the full Section 6(b) cancellation process.  More information regarding that decision is available in our blog item EPA ALJ Denies Bayer’s Motion for Accelerated Decision.

Without the ability to review the bases underlying EPA’s determination that the continued registration of flubendiamide does not meet the Registration Standard under Section 6(b), the only two issues for consideration under Section 6(e) were: (1) whether BCS/NAI “initiated and pursued appropriate action to comply” with the voluntary cancellation provision of their conditional flubendiamide registration; and (2) whether EPA’s existing stocks determination was consistent with FIFRA.

With regard to the first issue, the ALJ found that new arguments offered by BSC/NAI were not timely raised, and even if they had been, the ALJ was “not persuaded by the merits of these objections.”  Specifically, in response to the objection that BCS/NAI’s voluntary cancellation condition was excused because “EPA was required to engage in open, measured scientific dialogue before demanding cancellation” but did not do so, the ALJ found instead that “while it is clear from the record that Petitioners were not in agreement with EPA as to the toxicity end-points chosen or the Agency’s ultimate determination, they clearly were aware of them, and the rationale behind them, and had an opportunity to respond to EPA and engage in dialogue with Agency officials about these issues.”  The ALJ concluded that BCS/NAI was not excused from the voluntary cancellation provision that was a condition of BSC/NAI’s registrations and did not submit a voluntary cancellation request, thus triggering the Section 6(e) cancellation proceedings.

With regard to the second issue concerning existing stocks, BCS/NAI had challenged EPA’s determination that the use of the flubendiamide technical registration product or the further distribution and sales of the end-use products would be prohibited, but use of the end-use products by end-users would be allowed.  BCS/NAI argued that FIFRA is a risk-based statute and the facts supported an existing stocks policy that allows for sale, distribution, and use of the limited existing stocks available at the time of cancellation.  The ALJ found, however, that EPA’s decision was consistent with FIFRA since FIFRA grants EPA the discretion to allow the continued sale and use of a cancelled pesticide but does not require that EPA make any “determination” that continued use and sale is consistent with FIFRA’s purposes.

Commentary

BCS/NAI have indicated they will appeal the matter to the Environmental Appeals Board.  A key issue in this forthcoming appeal will be whether EPA had discretion to adopt a condition of registration so restrictive in nature that it deprived BCS/NAI of any meaningful right to contest EPA’s subsequent scientific determinations.  Most conditional registrations do not include a comparable condition, but it is common for EPA to issue conditional registrations under FIFRA Section 3(c)(7) that remain in effect only for a limited period during the pendency of data development.

This case illustrates the difficulty that a registrant may encounter subsequently contesting any condition that it has nominally accepted.  Applicants should be wary and should carefully scrutinize any conditions that EPA may propose.  It may be worthwhile in some instances to consider contesting a particularly onerous condition.  FIFRA Section 3(c)(6) affords every applicant the right to contest a decision by EPA to deny an application for a less restrictive registration.


 
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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.


 
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By Lisa M. Campbell and Timothy D. Backstrom

On May 11, 2016, the U.S. Court of Appeals for the Ninth Circuit issued an unpublished memorandum decision in an environmental justice case, Garcia v. McCarthy, Case No. 14-15494, that many have been watching closely.  The Ninth Circuit affirmed a decision by the U.S. District Court dismissing the Plaintiffs’ Complaint for lack of subject matter jurisdiction.  The District Court case involved an effort by the original complainants (parents of Latino school children) to obtain judicial review of a decision by the U.S. Environmental Protection Agency (EPA), to enter into a voluntary compliance agreement with the California Department of Pesticide Regulation (CDPR).  The original administrative complaint filed in 1999 alleged that CDPR “authorized the use of methyl bromide and other pesticides in a fashion that had a disproportionately harmful effect on Latino school children in violation of Title VI.”  Although EPA made an initial finding of a prima facie violation of Title VI, Plaintiffs asserted that EPA did not inform the complainants of the status of their complaint while the matter was being investigated and did not allow them to participate in settlement negotiations.

In challenging EPA’s settlement with CDPR, Petitioners alleged that EPA acted arbitrarily and capriciously by limiting its investigation to methyl bromide exposure between 1995 and 2001, and by failing to allow for Plaintiffs’ participation in settlement negotiations.  The Ninth Circuit followed the Supreme Court enforcement discretion case Heckler v. Cheney, 470 U.S. 821 (1985), finding that EPA’s decision to settle the matter was also committed to EPA discretion by law.  The Ninth Circuit stated:

  • [Petitioners’ allegations] are entirely untethered to any statutory provision or regulation implementing Title VI.  None of the statutes or regulations cited by plaintiffs provide a meaningful standard for defining the limits of EPA’s discretion in investigating a complaint, and none require EPA to permit plaintiffs to participate in EPA’s settlement negotiations. EPA’s plenary authority to either accept, reject, or refer a complaint to another federal agency, 40 C.F.R. § 7.120(d)(1)(i), must necessarily include the lesser power to determine the scope of the investigation in the event the complaint is accepted.

Commentary

EPA’s original decision finding a prima facie violation of Title VI by CDPR was surprising and concerning to many.  The current challenge to EPA’s decision to resolve the complaint through a voluntary settlement with CDPR raised additional environmental justice concerns.  Some industry observers were concerned about the possibility that the Ninth Circuit might view EPA’s decision to exclude the complainants from settlement discussions with disfavor.  The decision by the Ninth Circuit to affirm the District Court’s dismissal means that EPA will retain substantial discretion to negotiate appropriate settlements, even though it determines a Title VI complaint is meritorious.


 
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By Lisa M. Campbell and James V. Aidala

On May 9, 2016, Jack Housenger, Director of the U.S. Environmental Protection Agency’s Office of Pesticide Programs (OPP), announced the selection of Anna Lowit for the Senior Science Advisor Position in OPP’s Immediate Office. 

Lowit has been a toxicologist in OPP’s Health Effects Division since 1998. Housenger’s announcement of Lowit’s selection notes that she has “provided expert technical advice and guidance to senior management on issues related to toxicity testing, human risk assessment, and science policy issues,” and that she “provided substantial input to enhance science quality and ensured that scientifically accepted procedures and consistent criteria were applied, so that OPP’s risk assessments were recognized as reflecting the state-of-the-science.”

In light of the many current and expected issues involving fundamental science policy issues -- such as the application of the Food Quality Protection Act (FQPA) 10X safety factor, endocrine effects tests and their meaning, utilization of information from epidemiological studies, regulatory application of constantly evolving cancer assessment methodologies, and the appropriate approach to evaluating products of synthetic biology -- the Senior Science Advisor position is among the most important positions on the organization chart of OPP.


 
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By Lisa M. Campbell, Sheryl L. Dolan, and Margaret R. Graham
 

On May 3, 2016, the U.S. Environmental Protection Agency (EPA) issued a final rule that amends current pesticide tolerance crop grouping (Crop Group) regulations.  Crop groupings allow petitioners to request a tolerance for multiple related commodities based on research data for one or more representative crops.  This final rule is the fourth amendment in a series of planned Crop Group updates begun in December 2007 through collaboration by the U.S. Department of Agriculture’s (USDA) Interregional Research Project Number 4 (IR-4) and the International Crop Groupings Consulting Committee (ICGCC).

This final rule specifically creates five new Crop Groups, three new and two revised commodity definitions, and revises the regulations on the interaction of Crop Group tolerances with processed food, meat, milk, and egg tolerances.  The changes include:

  • Crop Group 22: Stalk, Stem and Leaf Petiole Group:  EPA is adding this new Crop Group.
  • Crop Group 23: Tropical and Subtropical Fruit, Edible Peel Group.  EPA is adding this new Crop Group.
  • Crop Group 24: Tropical and Subtropical Fruit, Inedible Peel Group.  EPA is adding this new Crop Group.  EPA has revised several of the subgroup titles from the proposed rule.
  • Crop Group 4-16: Leafy Vegetable Group:  EPA is expanding and restructuring this existing Crop Group by both adding and removing commodities.  EPA has revised the Crop Group’s name, which was “Crop Group 4: Leafy Vegetables (Except Brassica Vegetables)” in the proposed rule.
  • Crop Group 5-16: Head and Stem Brassica Vegetable Group:  EPA is revising this existing Crop Group’s name, which was “Crop Group 5: Brassica (Cole) Leafy Vegetables” in the proposed rule and has removed commodities and restructured this Crop Group.

EPA states that these revisions will “promote greater use of crop groupings for tolerance-setting purposes,” and “expand the number of crops that can have tolerances established and thus allow minor use growers a wider choice of pest control tools, including lower-risk pesticides, to be used on minor crops” both domestically and in countries that import food to the United States. 

EPA’s three prior amendments expanded existing Crop Groups, established new Crop Groups and subgroups, and revised representative crops.  These revisions included new oilseeds and edible fungi (mushrooms) Crop Groups and expansions of existing stone fruit and tree nut Crop Groups.

EPA’s website provides more information on crop groupings and minor uses


 
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By Lisa M. Campbell and Lisa R. Burchi

On April 25, 2016, the U.S. Environmental Protection Agency’s (EPA) Administrative Law Judge (ALJ) Susan L. Biro issued an order denying Petitioners Bayer CropScience LP and Nichino America, Inc.’s (BCS/NAI or Petitioners) motion for accelerated decision and deciding that the abbreviated Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(e) cancellation hearing, rather than the full Section 6(b) process, was appropriate (Order).  This decision is significant and, if it stands, could have far-reaching impact on easing EPA’s potential ability to cancel conditionally registered pesticide products. 

Background information regarding Bayer’s decision to challenge EPA’s position that a conditional registration term in the relevant registrations required BCS/NAI to cancel voluntarily their flubendiamide registrations within one week of notification by EPA that the currently registered flubendiamide products will result in unreasonable adverse effects on the environment, and EPA’s notice of intent to cancel all BCS/NAI flubendiamide products as a result of BCS/NAI’s decision declining EPA’s request to cancel voluntarily all flubendiamide registrations, is available in our blog items:  Bayer Announces That It Will Not Submit Voluntary Cancellation Requests for Flubendiamide and EPA Issues Notice to Cancel Flubendiamide Registrations

BCS/NAI’s Motion for Accelerated Decision (Motion) requested that the ALJ “issue an accelerated decision finding that EPA’s forced ‘voluntary’ cancellation provision is unlawful, denying the proposed cancellation of the registrations under [FIFRA] § 6(e), and requiring EPA to follow the process required under § 6(b) if it wishes to cancel the flubendiamide registrations for failure to meet the FIFRA registration standard.”  Petitioners argued that the more abbreviated procedure under FIFRA Section 6(e) was the wrong procedure to apply for a cancellation procedure, and that it is unlawful for EPA to “bypass cancellation process and due process rights guaranteed by statute and to shield its cancellation decision from review and challenge by Bayer, Nichino, and all other affected stakeholders.”  Petitioners further argued that case law supported its position, since “[i]n the only other FIFRA cancellation proceeding to have been conducted in at least two decades, EPA drew a sharp distinction between FIFRA§§ 6(b) and 6(e) and confirmed that when EPA makes a cancellation decision based on a Registration Standard determination, the proper process is for EPA to proceed with cancellation under § 6(b).”

EPA’s opposition to the Motion argued in part that when Petitioners agreed to cancel voluntarily their flubendiamide registrations within one week of notification by EPA that the currently registered flubendiamide products will result in unreasonable adverse effects on the environment, Petitioners “waived or reduced their due process rights from a fuller FIFRA section 6(b) hearing to the more limited FIFRA sections 6(e) and 6(f) rights to get their products to market quicker.”  EPA further argued that in seeking other relief, Petitioners are “in effect, asking this Tribunal to rewrite the terms and conditions of their registrations,” which would exceed its authority.

In its Order, the ALJ concludes that FIFRA’s “text, structure, and legislative history and federal court opinions allow for this Section 6(e) proceeding.” The ALJ states that “Petitioners have cited nothing in the statute or legislative history to suggest that EPA is obliged to use the pre-existing general registration cancellation process under FIFRA Section 6(b) for cancelling general registrations, to cancel conditional registrations.”  The ALJ further notes:  “The few cases that Petitioners cite to support their claim that EPA is required to go through a Section 6(b) proceeding to cancel pesticide registrations are all clearly distinguishable from the facts of this case because they involve general registrations, not conditional registrations.”  Instead, the ALJ compared a “conditional registration” to a learner’s permit not entitled to Section 6(b) cancellation proceedings, while unconditional registrations are “entitled to an extended process because EPA previously determined their use, on an indefinite basis, would not cause unreasonable adverse effects on the environment.”

  • [A] “conditional registration” is not equivalent to a full registration; it is a stop-gap status that gives the registrant time to gather data to prove it is entitled to general registration. This situation is analogous to obtaining a learner’s permit to obtain the requisite skill to demonstrate competence on the practical driving skills test in order to obtain a driver’s license. As such, conditional registrations are not entitled to the same lengthy procedures for cancellation under Section 6(b).

The ALJ further dismissed Petitioners’ argument that the “forced” voluntary cancellation condition in their conditional registrations is unlawful, finding instead that Petitioners had options and “made a business decision, likely for excellent economic reasons, and accepted the conditions and put their products on the market under conditional registrations.”  In addition, the ALJ found that “the record in this case indicates that Petitioners played an active part in drafting the conditions in the [Preliminary Acceptance Letter] PAL containing the voluntary cancellation provisions and were well aware of their significance.”  The Order states:

  • As such, this Tribunal sees no reason to allow Petitioners out of the 2008 legal agreement they knowingly made for a “fast death” cancellation arrangement. This is especially true because Petitioners only sought to challenge the voluntary cancellation arrangement as “unlawful” seven years after entering into it and only when EPA sought to trigger the cancellation and make Petitioners live up to their end of the bargain. In the interim, Petitioners financially benefited from the conditional registration, which allowed them to sell their products while pursuing data to remove the “uncertainty” as to their adverse effects on the environment.

Commentary

If the case proceeds under the FIFRA Section 6(e) hearing process, the only issues to be determined will be limited to “whether the registrant has initiated and pursued appropriate action to comply with the condition,” and the EPA determination concerning disposition of existing stocks.  This means that BCS/NAI’s significant issues as to whether EPA’s determination that the continued registration of flubendiamide does not meet the Registration Standard cannot be reviewed since, as BCS/NAI discuss in their motion, that the ALJ under a Section 6(e) hearing process cannot conduct “an independent scientific review to gauge the strength of EPA’s scientific conclusions in support of its proposed cancellation.”

Many in industry agree with BSC/NAI’s argument in their Motion that EPA’s decision to proceed in this way has shown “an apparent unwillingness to subject its positions to peer review and public scrutiny in compliance with FIFRA.”  It is unclear how many other conditional registrations have conditional registration provisions that would require voluntary cancellation in the manner that the one at issue in this proceeding does.  Even if that provision is not a typical provision, the potential implications for abbreviated cancellation proceedings for other conditional registrations are significant and should be carefully considered by registrants with regard to both their existing and future registrations.  A condition of registration could result in a de facto waiver of rights otherwise afforded to challenge a cancellation determination that is not supported by the science and/or not consistent with the FIFRA Registration Standard.  This may be easier said than done, as many in the registrant community find there is often not much “voluntary” about accepting an EPA proposed condition of registration.


 
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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.  


 
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By Lisa M. Campbell and Lisa R. Burchi

In response to the increasing concerns regarding emerging viral pathogens that are not on U.S. Environmental Protection Agency (EPA)-registered disinfectant labels, EPA announced on April 7, 2016, that it was updating its Guidance regarding emerging viral pathogens.  Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is authorized to evaluate the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health.  Many believe that the process under which registrants can identify “effective disinfectant products for use against emerging pathogens,” and the process for EPA to “permit registrants to make limited claims of their product’s efficacy against such pathogens,” have not been clear and efficient.  EPA notes, for example, that “[emerging] pathogens are often unavailable commercially, and standard methods for laboratory testing may not have been developed,” such that it “can be difficult to assess the efficacy of EPA-registered disinfectants against such pathogens in a timely manner and to add these viruses to existing product registrations.”

EPA hopes that its Guidance will “expedite the process for registrants to provide useful information to the public” regarding products that may be effective against emerging viral pathogens associated with certain human or animal disease outbreaks.

EPA’s new draft Guidance document, Draft Guidance to Registrants:  Process for Making Claims Against Emerging Viral Pathogens Not on EPA-Registered Disinfectant Labels, describes “a voluntary two-stage process to enable the use of certain EPA-registered disinfectant products against these emerging viral pathogens, uses not previously identified on the product label”:

  • First Stage:  This stage may be performed prior to any outbreak. EPA summarizes the first stage as follows:  “registrants with an eligible disinfectant product may submit a request, via label amendment, to add a designated statement to the master label and additional terms to the product registration.  If the product meets the eligibility criteria suggested in this Guidance, [EPA] generally will approve the amendment.  Approval of the amendment would include additional terms and conditions of registration regarding how the designated statement may be published and communicated.”
  • Second Stage:  This stage would occur only during a human or animal disease outbreak caused by an emerging virus.  EPA summarizes this stage as follows:  “In this stage, registrants of products with the previously mentioned label amendment and terms of registration would be allowed to use the designated statement in off-label communications intended to inform the user community/public that the disinfectant product(s) may be used against the specific emerging viral pathogen.  These off-label statements can inform the public about the utility of these products against the emerging pathogen in the most expeditious manner and can be more easily removed once the outbreak has ended than statements on a label.”

Comments related to clarity of this Guidance will be accepted until May 6, 2016.  For more information, please see our memorandum EPA Announces Updated Guidance for Antimicrobial Pesticide Products Intended to Combat Emerging Pathogens.


 
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