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, 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


 

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.


 

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.


 

By Lisa M. Campbell and Timothy D. Backstrom

On March 28, 2016, a three-judge panel in the U.S. Court of Appeals for the Ninth Circuit, Case Nos. 15-71207, et al. (consolidated) issued an order denying the Petitioners’ March 10, 2016, motion asking the court to adjudicate their challenges to the Environmental Protection Agency’s (EPA) registration of the pesticide Enlist Duo during remand of the registration decision to EPA, as well as their alternative request that the court stay issuance of its mandate and retain jurisdiction pursuant to the original petition for review.  The brief three-sentence order did not offer any explanation as to why the court denied the relief requested by the Petitioners.

The Petitioners’ March 10, 2016, motion stated that it is “appropriate to adjudicate those arguments now, because Enlist Duo remains on the market during the limited remand, causing petitioners continued harm.”  In support of their motion, Petitioners argued that the purpose of the remand was to address the “narrow question” of “synergistic effects of Enlist Duo’s two main ingredients on non-target plants,” and that an ultimate decision by EPA on this narrow issue “may have no bearing on the arguments petitioners have already briefed in this Court.”  Petitioners also argued that the registrant and intervenor Dow AgroSciences LLC (DowAgro) has “reneged on its promise to the Court not to sell Enlist Duo” during the remand.

EPA and DowAgro both filed responses on March 21, 2016, opposing the Petitioners’ motion.  EPA’s response to the motion stated that the court’s order remanding the matter to EPA was general in scope, and “EPA may properly choose to revisit the issues raised in Petitioners’ briefs while it also considers the new information provided by Dow regarding the synergistic effects of Enlist Duo’s two active ingredients.”  Thus, if the court were to consider the Petitioners’ claims during remand, “the Court would be advising EPA as to the outcome of its remand work, which is contrary to the Court’s function.”  EPA also opposed the request to stay the mandate and retain jurisdiction “because Petitioners will have ample opportunity to challenge any new agency action that EPA issues after concluding its remand work.”

DowAgro’s response stated that “[t]his Court’s order did not limit the scope of the remand, so the agency is free to alter, amend, or supersede the existing registration.”  DowAgro also argued that adjudicating petitioners’ claims during remand would lead to improper “piecemeal review” because “petitioners’ challenges to the original registration may be substantially altered or mooted entirely.”  With respect to the Petitioners’ allegation that DowAgro “reneged” on a promise not to sell Enlist Duo during the remand, DowAgro stated that this offer was only for “the interim period while this Court was considering the remand motion, not the indefinite period the matter was on remand to the agency.”

More information regarding the court’s original remand order is available in our blog item Ninth Circuit Denies EPA Motion for Vacatur, Grants EPA Motion for Remand.

Commentary

It would have been, in the view of many, surprising for the court to agree to adjudicate Petitioners’ claims concerning the registration decision for Enlist Duo during the period that decision is remanded to EPA for further action.  Similarly, it is not surprising to many that the court declined to retain jurisdiction, since the remand to EPA will not operate to constrain the ability of the Petitioners to raise the same claims in the event that EPA decides to issue a new registration for Enlist Duo following remand.

It is not clear at this juncture whether EPA will be inclined to reconsider its views concerning any of the Petitioners’ claims during the remand process.  Petitioners likely will, however, have another opportunity to seek review concerning their claims, assuming they participate in the administrative process during remand, and EPA does not alter its original decision in a manner that moots those claims.


 

By Lisa M. Campbell, James V. Aidala, and Carla N. Hutton

On March 25, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) sent a memorandum to Jim Jones, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), announcing that it plans to begin preliminary research to assess EPA’s management and oversight of resistance issues related to herbicide tolerant genetically engineered (GE) crops.  OIG states that its review will include the Office of Pesticide Programs (OPP), as well as other applicable headquarters and regional offices.  OIG’s objectives are to determine:

  1. What processes and practices, including alternatives, EPA has provided to delay herbicide resistance;
  2. What steps EPA has taken to determine and validate the accurate risk to human health and the environment for approved pesticides to be used to combat herbicide resistant weeds; and
  3. Whether EPA independently collects and assesses data on, and mitigates actual occurrences of, herbicide resistance in the field.

OIG states that the anticipated benefit of the project “is a greater understanding of herbicide resistance[,] which will lead to an enhancement of EPA’s herbicide resistance management and oversight.”

Commentary

Pesticide resistance is not a new issue and is one that EPA has affirmatively addressed when granting registrations for new products, GE or not, for some time.  In fact, that newer chemistries often have a more niche mode of action to reduce potential toxicity concerns has led some observers to speculate that greater resistance is one potential trade-off for the development of less toxic materials.

This “investigation” may appear to some to be a response to concerns raised by critics of GE crops generally and to a recent EPA decision to approve Enlist Duo herbicide, a new formulation of 2,4,D- and glyphosate designed to address the problem of weed resistance to glyphosate-tolerant crops.  Glyphosate tolerant crops were first approved some years ago, and their use was so broadly and readily adopted that issues have arisen with regard to potential resistance to some weed species.  EPA is currently expected to approve another GE strain, Dicamba-tolerant crops, to control glyphosate tolerant weeds.

To critics of GE crops, using more herbicides to control problems caused by what they claim is overuse of another herbicide is evidence of a troubling “pesticide treadmill,” which they believe should not have been allowed to occur in the first place.  Rebutting this criticism, others assert that resistance is a problem for all pesticides, not only genetically modified ones, and that with sufficient controls, resistance can be delayed, if not avoided.  Registrants point out that it is very much in their self-interest to take steps to avoid resistance to their products -- once that occurs, the market viability of the product is significantly reduced.


 

By Lisa M. Campbell and Margaret R. Graham

On March 17, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP), announced in an open letter to stakeholders, that it has developed new tools to “enhance the quality of its risk assessments and risk management decisions and better ensure protection of human health and the environment from pesticide use.”  These tools have been developed as part of EPA’s efforts to implement OPP’s Strategic Vision for Adopting 21st Century Science Methodologies (Strategic Vision) initiative.  As part of this initiative, OPP released two guidance documents:

  1. Final Guidance:  Process for Establishing & Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies.  OPP states that this guidance will “expand the use of alternative methods for acute toxicity testing” and “describes a transparent, stepwise process for evaluating and implementing alternative testing methods (not using live animals) for acute oral, dermal and inhalation toxicity, along with skin and eye irritation and skin sensitization.”  
  2. Draft Guidance:  Retrospective Analysis & Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations. OPP states that this draft guidance “to waive all acute lethality dermal studies for formulated pesticide products” was developed through an analysis “across numerous classes representing conventional pesticides, antimicrobials, and biopesticides [that] examined the utility of the acute dermal toxicity study for formulations in pesticide labelling for end-use products.”  

Comments on the draft guidance for waiving acute dermal toxicity tests are due May 16, 2016.  The National Research Council’s 2007 report, Toxicity Testing in the 21st Century:  A Vision and a Strategy, instigated OPP’s Strategic Vision initiative.  EPA states that these guidance documents are significant steps in the report’s implementation and intended to reduced animal testing. 


 

By Lisa M. Campbell and Timothy D. Backstrom

On March 8, 2016, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register stating that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will hold a three-day meeting scheduled for April 19-21, 2016, from 9:00 a.m. to 5:00 p.m. (EDT) to consider and review Chlorpyrifos:  Analysis of Biomonitoring Data.  The meeting will be held at EPA’s Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, Virginia 22202.  The meeting will be webcast.  More information will be posted online.

The notice states that written comments are encouraged through April 5, 2016, and that requests for oral comments are encouraged to be submitted by April 12, 2016, but that both may be submitted until the date of the meeting.  Nominations of candidates to serve as ad hoc members of FIFRA SAP for the meeting are requested on or before March 23, 2016.

In this meeting, EPA states that it will solicit comment from FIFRA SAP on the evaluation of biomonitoring data using the physiologically-based pharmacokinetic (PBPK) model, proposed points of departure and extrapolation/uncertainty factors, and examples of a proposed approach to use the PBPK model to simulate internal doses of chlorpyrifos from current exposure patterns from drinking water, food, and worker exposure.  The FIFRA SAP has been reviewing the human health effects of chlorpyrifos since 2008.  The notice states that “at this point in time, the Agency’s analysis of biomonitoring data from the cord blood collected as part of the Columbia University epidemiology studies has progressed to a point where peer review would be useful” and that “[s]pecifically, the Agency has done additional characterization of the pharmacokinetic profile of simulated exposures from oral and dermal exposures using the PBPK model.”

The notice states that in 2008 and 2012, the FIFRA SAP “cautioned EPA against using the biomonitoring data from epidemiology studies … to directly derive points of departure due to uncertainties associated with a lack of knowledge about timing of indoor chlorpyrifos applications and a single measure of exposure (cord blood).”  The 2012 FIFRA SAP recommended that EPA use the PBPK model to further characterize the dose estimates in the epidemiology studies.

The notice states that EPA would have preferred to complete its analysis of the available biomonitoring prior to commencing rulemaking, but that the timing for the proposal was directed by the U.S. Court of Appeals for the Ninth Circuit, which ordered EPA to respond to an administrative petition to revoke all chlorpyrifos tolerances by October 31, 2015.

More information on the Ninth Circuit case is available in our blog item Circuit Court Grants Writ of Mandamus Requiring EPA to Act on Petition to Ban Chlorpyrifos.

Commentary

EPA’s decision to utilize biomonitoring data that was collected as part of the Columbia University epidemiology studies for chlorpyrifos to derive proposed points of departure for risk assessment purposes will be highly controversial.  If EPA proceeds to use biomonitoring data from epidemiological studies to derive points of departure for risk assessment purposes, the implications for all pesticide product risk assessments could be significant.  Whether EPA can defensibly do so from both a scientific and legal standpoint is a subject that will likely be debated strongly.  All pesticide registrants should monitor these developments closely.  


 

By Lisa M. Campbell and Timothy D. Backstrom

On February 29, 2016, the U.S. Environmental Protection Agency (EPA) released a prepublication copy of a notice of intent to cancel all Bayer CropScience, LP and Nichino America, Inc. (BCS/NAI) flubendiamide products.  The affected products are:

  • EPA Reg. No. 264-1025 -- BELT SC Insecticide;
  • EPA Reg. No. 71711-26 -- FLUBENDIAMIDE Technical;
  • EPA Reg. No. 71711-32 -- VETICA Insecticide; and
  • EPA Reg. No. 71711-33 -- TOURISMO Insecticide.

The cancellation notice was issued by EPA, pursuant to Section 6(e) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and announces EPA’s intent to cancel the registration of these four products based on the registrants’ failure to comply with a required condition of their registrations.  Under this condition, which EPA alleges was agreed to by the registrants, each flunbendiamide registrant is required to submit a voluntary cancellation request if EPA finds that the product causes unreasonable adverse effects on the environment.

EPA made such a finding of unreasonable adverse effects in a decision memorandum issued on January 29, 2016, but BCS/NAI has rejected EPA’s request to submit a voluntary cancellation.  More information on BCS/NAI’s refusal to submit a request for voluntary cancellation is available in our blog item Bayer Announces That It Will Not Submit Voluntary Cancellation Requests for Flubendiamide.

EPA’s finding of unreasonable adverse effects is based on the purported risk to aquatic invertebrates associated with flubendiamide.  More information on EPA’s rationale, including the decision memorandum, is available on EPA’s website.  After the cancellation notice is published, each registrant will have 30 days to request a hearing concerning the notice.  FIFRA Section 6(e) provides that the only matters that may be considered in the resulting hearing are whether the registrants have complied with the condition in question and whether EPA’s determination on existing stocks is consistent with FIFRA.  In contrast, the registrants have stated that EPA is required to provide an adjudicatory hearing concerning the substantive basis for EPA’s determination that the products in question cause unreasonable adverse effects on the environment.

Commentary

The dispute between BCS/NAI and EPA concerning cancellation of the conditional registrations for flubendiamide products will be carefully watched by the pesticide industry.  The critical issue is whether EPA can effectively circumvent the adjudicatory hearing that would otherwise be available on the substance of EPA’s determination concerning risks and benefits by imposing a condition that requires affected registrants to accept EPA’s determination.  EPA will argue that the registrants accepted the condition in question when the registrations for flubendiamide were first issued.  The registrants will argue that EPA may not use such a condition to constrain hearing rights because this contravenes the intent of FIFRA.


 

By Lisa M. Campbell and Timothy D. Backstrom

On February 10, 2016, the U.S. Environmental Protection Agency (EPA) announced it was initiating an external peer review of the updated draft protocol for testing the antimicrobial efficacy of copper-containing surface products.  The products in question are hard surface copper-containing surface products such as door handles, light switch panels, and bed rails, which are utilized for their antimicrobial characteristics.  EPA states that “the testing described in this draft protocol is designed to support registration of copper-containing surface products (such as door knobs or other items that are not intended for food contact) that bear sanitizer claims.”  Numerous changes have been made to the draft, including changes to the test microbes, culture preparation, quality control process, and product characterization.  Following completion of the review, EPA states that it will evaluate the findings and revise the draft as appropriate prior to posting the final protocol.

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA evaluates the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health.  EPA indicates that antimicrobial efficacy testing of copper-containing surface products poses challenges because of the prolonged product life span, the likelihood that cleaning and disinfecting agents would be used on the surfaces, and the wide variation in potential product forms and use patterns.  EPA states the following regarding the protocols and how they will affect the test results:

  • This protocol is designed to address these issues by including a product characterization component that challenges the product’s physical durability and chemical stability when used as proposed;
  • The efficacy assessment component of the protocol involves evaluation of the performance of two product manufacturing lots against two pathogenic microorganisms -- Staphylococcus aureus and Pseudomonas aeruginosa; and
  • The efficacy test results, in combination with the product durability/stability component, will be used to determine the sanitizing activity of the copper-containing surface.

More information is available on EPA’s Antimicrobial Pesticide Registration website.  Information regarding other antimicrobial pesticide issues is available in our blog items EPA Posts Revised Antimicrobial Pesticides Use Site Index and EPA Releases Guidance Document:  Antimicrobial Pesticides Use Site Index.

Commentary

Products that are intended to have pesticidal efficacy over a protracted period require testing that differs materially from those pesticides that are only effective for a transient period and, thus, must be used repeatedly.  Some believe copper-containing surfaces have great promise as antimicrobial sanitizers, particularly in health care environments where limiting patient exposure to potential pathogens has become a critical institutional concern.  EPA’s enhanced test protocols are intended to address questions EPA and others have raised concerning the continued efficacy of a copper-containing surface over a prolonged life span, and the potential impact of cleaning and disinfecting agents.


 

By Susan M. Kirsch

On January 26, 2016, the U.S. Environmental Protection Agency (EPA) published its draft National Pollutant Discharge Elimination System (NPDES) General Permit for Discharges from the Application of Pesticides in the Federal Register, which applies to discharges of pesticides to waters of the United States.  EPA is requesting comments on the draft permit by March 11, 2016.  This draft 2016 pesticide general permit (PGP) is largely an updated version of the 2011 PGP, which will expire on October 31, 2016.  EPA’s permit would apply to Maine, New Hampshire, New Mexico, Idaho, and the District of Columbia; Puerto Rico and certain other territories; as well as Indian lands and federal facilities in other states that are covered by state-developed PGPs.  Separately, 46 states must update their existing permits, and some states have already begun this process or have already reissued permits within the last year.

The draft 2016 PGP retains coverage of the previous pesticide use patterns (mosquito/flying insect; weed and algae; animal pest; and forest canopy), and leaves unchanged the reliance on technology-based effluent limitations (TBELs) to satisfy permit requirements, which require proper maintenance and calibration of equipment along with visual inspections to minimize discharges and meet water quality standards and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) label requirements.  The draft 2016 PGP also retains the distinctions in compliance requirements of “For-hire Applicators” and “Decision Makers,” and includes the same requirements for recordkeeping and reporting of adverse incidents.  The draft permit now mandates electronic reporting, which will make Notice of Intent (NOI) and Annual Report submissions public on EPA’s e-reporting website.  The draft permit retains the “joint and several liability” provision that would extend potential legal risks to all parties involved in decision-making and application of pesticides.  In spite of the lack of new or altered provisions, there are some aspects of the draft 2016 PGP that could signal an EPA policy change going forward, and could potentially appear in the final version of the permit.  These areas include:

  • Absence of a definition for “Waters of the U.S.,” which could create confusion as to the scope of jurisdiction;
  • An ongoing Endangered Species Act (ESA) consultation, which could expand the list of requirements included in the final permit;
  • Request for comments on whether water quality-based effluent limitations (WQBELs), such as water quality monitoring and fish tissue testing (i.e., laboratory studies), should be included in the final permit;
  • Request for comments on whether additional information should be included in NOI submissions, including whether the treatment area includes a source water for public drinking water supplies;  and
  • An expanded discussion of required compliance with all other applicable state and federal laws, including FIFRA storage and handling requirements, which could be perceived to attach Clean Water Act liability to a PGP permittee’s violations of FIFRA and other laws.

EPA’s webpage for pesticide NPDES permitting includes links to the draft permit, fact sheet, and Federal Register docket.


 
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