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

By Lisa M. Campbell and Margaret R. Graham

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


 

By Lynn L. Bergeson and Carla N. Hutton

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update).  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the Update to the Coordinated Framework offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.”  Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.”  To help product developers and the public understand what the regulatory pathway for products might look like, the 2017 Update presents information about agency roles and responsibilities in several forms, including:

  • Graphics that illustrate agency-specific overviews of regulatory roles;
  • Case studies that demonstrate how a product developer might navigate the regulatory framework; and
  • A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.

In its blog item, “Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System,” the Obama Administration acknowledges that while the 2017 Update represents “remarkable progress by the EPA, FDA, and USDA to modernize the regulatory system for biotechnology products, much work remains.”  EPA, FDA, and USDA will consider the comments submitted in response to the proposed 2017 Update and information gathered during the three public engagement sessions hosted by EPA, FDA, and USDA to inform ongoing and future agency activities.  In addition, the agencies commissioned an independent study by the National Academy of Sciences (NAS) on future biotechnology products.  When completed, the agencies will consider the study’s findings, as well as the comments.  More information on the Update to the Coordinated Framework will be available in our forthcoming memorandum, which will be available on our website under the key phrase biobased products, biotechnology


 

By Lynn L. Bergeson, Oscar Hernandez, Ph.D., Lara A. Hall, MS, RQAP-GLP, and Margaret R. Graham

On December 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice regarding the availability of final test guidelines, OCSPP Series 850 Group A -- Ecological Effects, part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA).  The notice states that these test guidelines “serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions,” and they “provide guidance for conducting the test, and are also used by EPA, the public, and companies that submit data to EPA.”  The test guidelines will be accessible through EPA Docket ID Numbers EPA-HQ-OPPT-2009-0150 through EPAHQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576 on www.regulations.gov.

The changes to test guidelines are varied.  Some of the changes include:

  • Simple cosmetic changes, e.g., presentation of test conditions, test validity criteria, and equations for calculating response measurements;
  • Housekeeping changes, e.g., the addition of final versions of draft guidelines that had not been prepared in final yet;
  • The addition of a limit test option to several acute invertebrate toxicity tests;
  • Changes from “cut off” dosages in existing guidelines to limit concentrations and a change in the limit concentration for industrial chemicals from “1,000 milligrams/liter (mg/L)” to “100 mg/L” for acute toxicity tests and “10 mg/L” for chronic tests; and
  • Changes to terminology, e.g., to clarify 10-day versus acute exposures for sediment-dwelling invertebrate toxicity tests and saltwater versus marine conditions.

The addition of a limit test option aligns well with the new TSCA mandate to reduce vertebrate testing as a matter of federal policy.  EPA notes that certain guidelines were not issued in final, but remain available for reference as draft guidelines.  In that certain ecological effects guidelines relate to guidelines already developed for the Endocrine Disruptor Screening Program (EDSP), EPA notes that it will consider test design elements from the relevant EDSP guidelines in the development of OSCPP 850 series guidelines.


 

By Margaret R. Graham

On November 29, 2016, the U.S. Environmental Protection Agency (EPA) announced the issuance of its new guidance for testing pesticides designed to reduce animal testing for acute dermal toxicity for pesticides, Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations & Supporting Retrospective Analysis, in final.  This guidance was issued as part of the Office of Pesticide Programs’ (OPP) Strategic Vision for implementing the 2007 National Research Council’s report on Toxicity Testing in the 21st Century.

OPP states that it “receives about 200-300 dermal formulation toxicity tests annually, each of which generally use 10 animals per test,” and “[w]e expect this waiver guidance to save 2,500 or more laboratory animals every year.”  Further, as described in OPP Director Jack Housenger’s March 17, 2016, letter to stakeholders, “[t]his new policy represents significant progress toward EPA’s goal of significantly reducing the use of animals in acute effects testing.”

More information on OPP’s Strategic Direction for Adopting 21st Century Science Methodologies is available on EPA’s website and in our blog item EPA’s OPP Releases Guidance Documents Related to Strategic Vision for Adopting 21st Century Science Methodologies.


 

By Susan M. Kirsch

On November 1, 2016, the U.S. Environmental Protection Agency (EPA) published its Final National Pollutant Discharge Elimination System (NPDES) Pesticide General Permit for Point Source Discharges from the Application of Pesticides in the Federal Register, which regulates discharges to waters of the United States from the application of biological pesticides and chemical pesticides that leave a residue. 81 Fed. Reg. 75816.  The 2016 NPDES Pesticide General Permit (PGP) replaces the 2011 PGP, which expired on October 31, 2016.  The PGP applies to the following geographic areas where EPA serves as the NPDES permitting authority:

  • The States of: Massachusetts, New Hampshire, New Mexico, and Idaho;
  • District of Columbia;
  • All U.S. territories except the U.S. Virgin Islands;
  • Federal facilities in Delaware, Vermont, Colorado, and Washington;
  • Discharges in Texas that are not under the authority of the Texas Commission on Environmental Quality, including activities associated with oil and gas exploration (see Appendix A of the Final 2016 PGP for further description); and
  • All areas of Indian Country that are not covered by an EPA-approved permitting program (see Appendix A for Indian Country covered within each EPA Region). 

Similar to the 2011 PGP, the 2016 PGP contains additional permit conditions and modifications that some states and tribes added through the Clean Water Act (CWA) Section 401 certification process and/or the Coastal Zone Management Act process.  Part 9 of the 2016 PGP provides a detailed breakdown of any additional requirements.  Forty-six states have delegated authority to administer state versions of the PGP.  The majority of states recently revised and reissued their respective state PGPs for another five-year permit cycle.

The 2016 PGP applies to the same pesticide use patterns covered by the 2011 PGP, which are:

  • Mosquito and Other Flying Insect Pest Control -- control of public health/nuisance and other flying insect pests (including mosquitoes and black flies) that develop or are present during a portion of their life cycle in or above standing or flowing water.  
  • Weed and Algae Pest Control -- control of weeds, algae, and pathogens that are pests in water and at water’s edge, including ditches and/or canals.
  • Animal Pest Control -- control of animal pests, including fish, lampreys, insets, mollusks, and pathogens, in water and at water’s edge.
  • Forest Canopy Pest Control -- application of a pesticide to a forest canopy to control the population of a pest species (e.g., insect or pathogen) where, to target the pests effectively, a portion of the pesticide unavoidably will be applied over and deposited to water.

The 2016 PGP requirements are nearly identical to those in the 2011 PGP, with the exception of the following two updates included in the 2016 PGP:

  • Electronic reporting (Part 7.8) -- All reporting under the 2016 PGP (i.e., Notice of Intent (NOI), Annual Report, and Notice of Terminations (NOT) submissions) must be submitted via EPA’s eNOI system to be consistent with EPA’s Electronic Reporting Rule.  EPA will make these reports publicly available through a searchable index tool -- eNOI search.  More information on electronic reporting, and access to the Central Data Exchange for NOI, Annual Report, and NOT submissions is available here.
  • Updated definition of the National Marine Fisheries Service (NMFS) Listed Resources of Concern -- Following consultation between EPA and NMFS, as required under Section 7 of the Endangered Species Act (ESA), EPA expanded the Listed Resources of Concern to include additional species not included in the 2011 PGP definition.  Under Part 1.1.2.4, pesticide discharges that overlap with NMFS Listed Resources of Concern trigger additional NOI requirements to certify that the discharges and discharge-related activities are not likely to adversely affect federally listed “endangered” or “threatened” species, or federally-designated “critical habitat.”  Permittees may consult EPA’s PGP NMFS Listed Resources of Concern -- Interactive Mapping Tool to determine whether a discharge activity will overlap with these Resources of Concern.  Appendix I provides endangered species instructions for affected permittees.  EPA states in the corresponding Fact Sheet for the 2016 PGP that it continues to estimate that less than two percent of the total number of Operators in the PGP coverage areas will need to meet additional permit requirements in order to meet ESA-related provisions.

The 2016 PGP permit conditions went into effect on October 31, 2016, and the PGP will expire in five years on October 31, 2021.  2016 PGP coverage is automatic through January 12, 2017, without the submission of an NOI, but pesticide Operators (i.e., pesticide applicators) must comply with all 2016 PGP conditions as of October 31, 2016.  For any discharges commencing on or before January 12, 2017, that will continue after this date, a decision-maker must submit an NOI no later than January 2, 2017, to ensure PGP coverage, and for any discharges subsequent to January 12, 2017, an NOI submission is required no later than 10 days before the first discharge.  Table 1-1 at Part 1.2.3 outlines which decision-makers must submit NOIs based on the particular pesticide use pattern, location (i.e., if discharging to a designated Outstanding National Resource Water), and acreage thresholds.  Table 1-2 at Part 1.2.3 provides applicable NOI submission deadlines, including grace periods for NOI filing for discharges in response to a Declared Pest Emergency.

EPA’s webpage for pesticide NPDES permitting includes links to the final 2016 PGP, a related fact sheet, the permitting decision tool, and information on eNOI and ESA procedures.  

Commentary

Although the 2016 PGP largely mirrors the 2011 version of the permit, it will be important for decision-makers to familiarize themselves with the new electronic reporting requirements (Part 7.8).  EPA’s eNOI system is publicly searchable and could subject PGP permit holders to additional scrutiny by citizens and advocacy groups concerned about potential environmental and public health implications of pesticide applications in their areas.  Decision-makers should consult EPA’s PGP NMFS Listed Resources of Concern -- Interactive Mapping Tool and the Alternative PGP Sources of Information for NMFS Listed Resources of Concern to determine where discharges may overlap with these areas and trigger additional permit conditions.


 

By Lisa M. Campbell, Lisa R. Burchi, and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) has recently announced the availability of two proposed test methods and associated testing guidance for evaluating antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa and Staphylococcus aureus, for comments.  EPA states that registrants of antimicrobial products with public health claims are “required to submit efficacy data to EPA in support of the product’s registration” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  EPA is soliciting comments on the clarity of the standard operating procedures and the regulatory guidance.  The two test methods are:

The Draft Guidance to Assess the Efficacy of Antimicrobial Pesticide Products Intended to Control Public Health Biofilms on Hard, Non-Porous Surfaces describes biofilms and their public health significance; the two test procedures for developing efficacy data supporting biofilm claims; products that may be eligible for biofilm claims; test criteria; data submission procedures for efficacy data; and labeling guidance.

The draft guidance states that the term biofilm “is reserved for claims against biofilm that contain specific bacteria that are directly or indirectly infectious or pathogenic to humans,” and “biofilm claims are considered to be public health claims for which the agency must review and approve appropriate efficacy data.”  EPA states: “Examples of use sites that may be supported by the biofilm test methodologies herein, and found acceptable, include restrooms, shower stalls, sink basins or drains (excluding the drain pipe) and nearby hard, non-porous surfaces of walls, countertops, and instrument trays in patient care areas of hospitals.  In contrast, claims against non-public health slimicides must also be supported by appropriate efficacy data, however, submission of the data is only required when requested by the EPA.” 

The Draft Guidance also sets forth examples of acceptable label claims against public health biofilms and acceptable non-public health claims.  The examples of acceptable label claims against public health biofilms are:

  1. Kills 99.9999% of bacteria* in biofilm on a hard, non-porous surface;
  2. Kills a minimum of 99.9999% of bacteria* in biofilm;
  3. Reduces at least 99.9999% of bacteria* growing in biofilm;
  4. Formulated to kill 99.9999% of bacteria* in biofilm;
  5. Other related claims:
  • Kills biofilm bacteria*; and
  • Penetrates biofilm, killing the bacteria* living there.

*[List of bacteria “tested as a biofilm”; at a minimum, Pseudomonas aeruginosa and Staphylococcus aureus].

Examples of acceptable non-public health claims supported by appropriate efficacy data include:

  • Slimicide;
  • Cleans away microorganism slime/grunge;
  • Maintains control of slime; and
  • Controls slime-forming microorganisms.

Comments will be accepted until December 5, 2016.


 

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

On September 19, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report, EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of Hospital-Level Disinfectants, the result of OIG’s review of EPA’s Antimicrobial Testing Program (ATP) to “determine whether the program ensures the efficacy of EPA-registered hospital sterilants, disinfectants, and tuberculocides (“hospital-level disinfectants”); and to evaluate options for improving the ATP.”  OIG found that the ATP “does not assure that hospital-level disinfectant products continue to be effective after they are registered,”  specifically that:

  • Once the EPA tests a product and it passes, it is listed as Agency Confirmed Efficacy on the agency’s website and is typically not tested again; the long-term efficacy of the product cannot be assured.
  • EPA relies on manufacturers to voluntarily submit product samples for testing. In the last three years, out of the approximately 300 registered hospital disinfectant products that have not been tested, manufacturers submitted only 12 samples to EPA for ATP efficacy testing.

Importantly, however, OIG concludes: “Although the program as currently designed and conducted does not assure that most hospital disinfectant products continue to be effective, at this point it is redundant and unnecessary to make adjustments, since the EPA is concurrently having the products re-registered.”

OIG makes two major recommendations:

  1. EPA should suspend administering the current Antimicrobial Testing Program until completion of the one-time re-registration process.
  2. EPA should develop a risk-based antimicrobial testing strategy to assure the effectiveness of public health pesticides used in hospital settings once products are in the marketplace. At a minimum, OIG states, the strategy should:
  • Include a framework for periodic testing to assure products continue to be effective after registration.
  • Define a program scope that is flexible and responsive to current and relevant public health risks.
  • Identify risk factors for selecting products to test.
  • Identify the method to be used for obtaining samples for testing.
  • Designate a date to commence risk-based post-registration testing.

In its response, EPA agreed with OIG’s recommendations, and stated it will develop a plan to coordinate and implement the discontinuation of the present-day program, with the closure of the ATP program to take place by November 2017.  EPA also stated that by December 2018 it plans to develop a risk-based strategy to assure the effectiveness of public health pesticides used in hospital settings once products are in the marketplace.  

Registrants of the affected products should monitor closely the development of EPA’s plans both to discontinue the program and to establish this new risk-based strategy for assuring product efficacy.


 

By Lisa M. Campbell, Lisa R. Burchi, and Margaret R. Graham

On September 16, 2016, the U.S. Environmental Protection Agency (EPA) announced it settled an enforcement matter with Syngenta Crop Protection, LLC (Syngenta or Respondent) via a Consent Agreement and Final Order (CAFO) concerning EPA’s allegations that Syngenta violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and EPA’s Pesticide Container and Containment Rule (PCCR).  The investigation took place over three years, starting in August 2012 and concluding in January 2015.  The multi-regional investigation which took place over three years, from August 2012 to January 2015, was conducted by EPA Regions 4, 5, 7, and 8, and found violations in six states:  Ohio, Colorado, Iowa, Kansas, Michigan and Missouri.

The CAFO listed the alleged violations in three parts:

  1. Failure to have repackaging agreements and failure to maintain records concerning the repackaging agreements:  In the CAFO, EPA states that it identified numerous and separate occasions when Respondent distributed or sold approximately 19 registered pesticides to approximately 222 refillers “prior to having written repackaging agreements in place with such refillers,” “and/or failed to maintain records of the repackaging agreements with the refillers.”  The requirements for such agreements and record keeping are set forth at 40 C.F.R. §§ 165.67(b)(3), 165.67(d), and 165.67(h).
  2. Distribution and sale of misbranded pesticides:  In the CAFO, EPA states that at least seven inspections conducted at different facilities that were refillers of Respondent’s pesticides found pesticides affixed with outdated labels, as well as sales of such products with outdated labels.  EPA states that Syngenta was the registrant of all the products at issue and had provided the refillers with the outdated labels for repackaging the pesticide products in refillable containers or bulk tanks on at least 19 separate occasions.
  3. Failure to maintain data submitted for pesticide registration:  In the CAFO, EPA states it conducted an inspection at two laboratories to review compliance with Good Laboratory Practice requirements, and to audit the data for studies submitted by Respondent to EPA to support one of its pesticide registrations.  In both cases, Respondent informed EPA that it did not maintain records or raw data associated with the studies and the laboratories confirmed they did not maintain the records at their facilities.

Syngenta neither admits nor denies these allegations, but has agreed to pay a civil penalty of $766,508, as well as to complete an environmental compliance promotion Supplemental Environmental Project (SEP) within four years at a cost of not less than $436,990.  Specifically, the SEP will involve a four-year educational awareness training and campaign to educate the regulated community on FIFRA regulatory compliance requirements pertaining to the PCCR.  The training will focus on the requirements relevant to bulk pesticide containers, containment, labels, storage, transportation, delivery, clean-out, repackaging agreements, and recordkeeping.  The training is intended to increase awareness across a broad array of businesses that handle pesticides, including registrants, refillers, retailers, commercial applicators, and custom blenders of pesticides.

Discussion

EPA states that the settlement sends “a strong message to pesticide companies to maintain compliance with all federal environmental laws.”  Indeed, the breadth of EPA’s investigation and the ultimate size of the penalty signify EPA’s focus on pesticide violations and, particularly, misbranded pesticides.  EPA in recent years has focused on labeling violations between registrant and supplemental distributor labels and the issues in this case have some similarities, particularly the need for written contacts between registrants and refillers or supplemental distributors, and also the need to ensure that current pesticide labels are provided before repackaging and relabeling take place. 

More information concerning supplemental distributors and repackaging is available in our blog item Registrants Penalized for Actions of Third-Party Pesticide Distributor, our memorandum EPA’s Enforcement Efforts Regarding FIFRA Supplemental Distribution and How to Avoid Noncompliance and in the materials from our webinar EPA's Supplemental Distribution:  Enforcement Actions Are Buzzing:  How to Avoid Getting Stung.


 

By Lisa R. Burchi and Margaret R. Graham

On September 2, 2016, the U.S. Environmental Protection Agency (EPA) issued guidance to registrants on the process for making claims against emerging viral pathogens not on EPA-registered disinfectant labels (Guidance).  A draft of this guidance was issued in April 2016 and comments were sought at that time.  More information concerning the draft guidance is available in our blog item EPA Combats Emerging Pathogens Through Updating Guidance for Antimicrobial Pesticide Products.

The current Guidance document, which EPA states “provides general guidance to registrants that can be used to identify effective disinfectant products for use against emerging viral pathogens and to permit registrants to make limited claims of their product’s efficacy against such pathogens,” includes changes incorporated following EPA’s review of the three public comments received in response to that draft.  

The Guidance retains the voluntary two-stage process, but amends the first stage as indicated:

  • In the first stage, which may be performed prior to any outbreak, registrants with an eligible disinfectant product may submit a request, via label amendment or during the registration of a new product, to control a specific emerging viral pathogen 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.

In its response to comments document, EPA responded to several comments, including:

  • Changes were made to EPA’s mandated non-label statements to remove certain language that could be considered redundant.
  • EPA is developing a coordinated process with the Centers for Disease Control and Prevention for the purpose of providing a more standardized and consistent approach to emerging viral pathogen outbreaks.  Once this process is established, the agency expects to consult with the U.S. Department of Agriculture to develop a similar approach.
  • The Guidance document allows for the addition of emerging pathogen claim language to the master label during the new product registration process if the product is eligible.  Additional language has been added to multiple locations in the Guidance document to clarify that the process is appropriate for new product registrations.
  • EPA “may consider allowing use of additional modes of claim communication under future versions of this Guidance document, however, hangtags and other promotional materials are not authorized at this time.  Because the statements authorized under this Guidance are pesticidal claims that do not meet the FIFRA registration criteria, it is essential that these off-label claims are not made outside of an emerging pathogen outbreak as described in the Guidance. Accordingly, the Guidance limits these off-label claims primarily to communications outlets that are wholly within the registrant’s control (800 numbers, social media and websites) from which the off-label claims can be immediately removed. Hangtags and other promotional materials directed towards general consumers are largely out of the registrant’s control once the products enter the chain of commerce, and may persist long after the period during which the off-label claims are authorized.”

EPA also notes that this Guidance document “provides general guidance to EPA, pesticide registrants, applicants for pesticide registrations, and the public.  This guidance is not binding on EPA or any outside parties, and EPA may depart from the guidance where circumstances warrant and without prior notice.”


 

by James V. Aidala

The threat of the Zika Virus grows every day, and the need for clear information is especially pressing if you are pregnant.  How do you prevent getting infected with the Zika Virus, and what insect repellents are best?  The first question is easy to answer:  public health experts agree that women who are pregnant or who might be pregnant should use insect repellents.  The answer to the second question is not so simple.

I am a former senior official at the U.S. Environmental Protection Agency (EPA), and familiar with how the U.S. evaluates and approves pesticides, which include insect repellents.  It is not easy for the average consumer to know what works and what does not work.  Unfortunately, EPA policies have made this question much more complicated, having made important distinctions between some “natural”-type repellents and other products available in the marketplace.

Years ago, EPA de-regulated a number of natural, non-toxic materials from being subject to the registration requirements of the federal pesticide law (the Federal Insecticide, Fungicide, and Rodenticide Act).  This made sense at the time since garlic, pepper, rotten eggs, vinegar, and other common chemicals are sometimes used as pesticides.  Before de-regulation, these products were also subject to the same requirements as synthetic chemical pesticides with long unpronounceable names (e.g., diethyltoluamide, better known as DEET) which EPA requires to have volumes of efficacy and safety test data.  Being natural does not mean a substance is non-toxic; some natural ingredients are fully evaluated and widely used.  But in the interest of efficient use of resources EPA issued a list of products that could be sold as pesticides, but would not be subject to EPA data requirements and review (EPA calls them “minimum risk pesticides”).

This list of pesticides which are not subject to EPA evaluation, and which are not required to have data which proves they are effective, includes a number of botanical ingredients, such as oil of citronella, geranium, rosemary, peppermint, and many others.  Many of these products can be used as pesticides -- some may work better than others -- and many work for the intended use (example:  rotten eggs, or as EPA refers to them -- “putrescent whole egg solids” -- are used as a deer repellent).

Many of these ingredients have been marketed as “natural” insect repellents, and labeled as “safe” or “non-toxic” using words that will not appear on products where EPA reviews and approves the instructions on the product label.

Here is the bureaucratic distinction which matters greatly to EPA, but will not be understood by consumers:

  • If the repellant label includes “public health claims” -- that it repels mosquitoes that may cause a disease (like Zika Virus or West Nile Virus) -- then the product has to have data showing that it works;
  • If the product just says “repels mosquitoes,” it is not required to have data that shows it is effective, and may very well be ineffective.

Few, if any, humans outside of EPA label experts realize this important distinction:  if there is no health claim on the label, then it is, in effect, a situation of “buyer beware.” 

What remains:  EPA’s deregulation of these products means it is legal to sell products which do not work, as long as the ingredients appear on the EPA minimum risk pesticides list.

Consumer Reports (CR) recently reported in May of this year on studies conducted on repellents.  Their results:

  • Using a “natural” mosquito repellent, with active ingredients such as citronella or clove, lemongrass, or rosemary oils, might seem like a good idea, especially if you’re pregnant or planning to be.
  • But five of the six plant-based repellents we tested…lasted one hour or less against Aedes mosquitoes, the kind that can spread Zika.

Not all repellents with the same ingredient are equally effective, and they found that some formulations of the chemical repellents also do not work for very long in their tests.  Some botanical pesticides are effective and have the public health claims on the label (example:  lemon eucalyptus, a botanical ingredient not on the exempt product list, and CR testing did find it to be effective).

To reduce confusion about what works, EPA for years has struggled to correct the situation by trying to impose changes to the requirements for insect repellents.

Unfortunately, to end the confusion about the difference between “repels mosquitoes” and “repels mosquitoes that can cause the Zika Virus,” EPA has to conduct a rulemaking which requires a long and bureaucratic process to complete.  The good news is that EPA is working on such a solution.  The bad news is that they have been working on it for almost ten years and they still have more work to do.  There are details and petitions and proposals and reasons why it has taken so long, but it is the kind of story that gives bureaucracy a bad name.

With the onset and fears about the Zika Virus, however, EPA should make the needed changes immediately to ensure that consumers are not misled into using products which are not proven effective in repelling mosquitoes. 

From a consumer’s point of view, it really is that simple.  Legally, it is more complicated.  In the meantime, EPA should be loud and clear in its communication about the distinction, even if they cannot take immediate action to reduce the confusion.


 
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