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, Lisa R. Burchi and James V. Aidala

On September 28, 2015, the U.S. Environmental Protection Agency (EPA) announced revisions to its worker protection standard.  EPA states that these revisions are intended to “enhance the protections provided to agricultural workers, pesticide handlers, and other persons under the Worker Protection Standard (WPS) by strengthening elements of the existing regulation, such as training, notification, pesticide safety and hazard communication information, use of personal protective equipment, and the providing of supplies for routine washing and emergency decontamination.”

Among the changes to the WPS are the following:

  • Training:  The final rule retains proposed content expansions that have been the subject of considerable discussion and concern (e.g., provisions that EPA intends to reduce take-home exposure) and the requirement for employers to ensure that workers and handlers receive pesticide safety training every year (increased from existing rules that require training every five years).  EPA has eliminated the proposed training “grace period,” that would have allowed employers to delay providing full pesticide safety training to workers under certain circumstances. 
  • Notification:  The final rule retains the proposed requirements for employers to:  (1) post warning signs around treated areas in outdoor production when the product used has a restricted-entry interval (REI) greater than 48 hours; and (2) provide to workers performing early-entry tasks (i.e., entering a treated area when an REI is in effect), information about the pesticide used in the area where they will work, the specific task(s) to be performed, the personal protective equipment (PPE) required by the labeling, and the amount of time the worker may remain in the treated area.  EPA has not promulgated the proposed requirement for employers to keep a record of the information provided to workers performing early-entry tasks.
  • Hazard Communication:  The final rule requires employers to post pesticide application information and a safety data sheet (SDS) for each pesticide used on the establishment at a central location on the establishment (the “central display”).  This is a departure from the proposal to eliminate the existing requirement for a central display of pesticide application-specific information.  The final rule also requires the employer to maintain and make available to workers and handlers, their designated representatives, and treating medical personnel upon request, the pesticide application-specific information and the SDSs for pesticides used on the establishment for two years.  EPA has eliminated the proposed requirement for the employer to maintain copies of the labeling for each product used on the establishment for two years.
  • Requirements During Pesticide Applications:  The final rule requires an “application exclusion zone,” that is, the area immediately surrounding the application equipment, from which workers and other persons must be excluded.  An application exclusion zone of 100 feet horizontally from the application equipment in all directions applies when the pesticide is applied by any of the following methods:  (1) aerially; (2) air blast application; (3) as a spray using a spray quality (droplet spectrum) of smaller than medium (volume median diameter of less than 294 microns); or (4) as a fumigant, smoke, mist, or fog.  An application exclusion zone of 25 feet horizontally from the application equipment in all directions applies when the pesticide is sprayed from a height of greater than 12 inches from the planting medium using a spray quality (droplet spectrum) of medium or larger (volume median diameter of 294 microns or greater).  This “application exclusion zone” differs from the proposed “entry-restricted areas,” that would have extended a specified distance around the entire treated area during application based on the application equipment used.  The final rule requires handlers to suspend application, rather than cease application, if they are aware of any person in the application exclusion zone other than a properly trained and equipped handler involved in the application.
  • Minimum Age:  The final rule increases the minimum age for handlers and workers performing early-entry tasks from a proposed 16 years old to at least 18 years old.  EPA states it increased the minimum age from 16 to 18 based on “comments received and an evaluation of existing literature related to adolescents’ development of maturity and judgment.”  EPA provides an exemption from minimum age requirements for adolescents working on an establishment owned by an immediate family member.  The final rule does not require the employer to record workers’ or handlers’ birthdates as part of the training record, but does require the employer to verify they meet the minimum age requirements.
  • PPE:  The final rule cross-references certain Occupational Safety and Health Administration (OSHA) requirements for respirator use for which employers will be required to comply.  In response to comments, the final rule expands the respirators subject to fit testing beyond the proposal to include filtering facepiece respirators.  The final rule maintains the existing exception from the handler PPE requirements when using a closed system to transfer or load pesticides, and adopts a general performance standard for closed systems, which differs from the specific design standards based on California’s existing standard for closed systems discussed in the proposal.

EPA received a significant number of comments on the proposed rule, which has generated significant controversy.  While it appears that EPA has modified the final WPS in certain respects in response to concerns raised, there remain many provisions that are controversial and will require significant work, with significant costs, by agricultural and handler employees to meet. 

Controversy regarding these new requirements is longstanding.  At its most simple form, critics of increasing the stringency of the current regulations ask why significant changes were needed after twenty years of greater protection offered by the existing regulatory requirements.  In addition, over the intervening years, for a variety of reasons, many (not all) of the most hazardous pesticides have been removed from the market or otherwise are used less.  More complex concerns address potential jurisdictional overreaches and the paltry record supporting what some view as expansive and expensive regulatory requirements.  Others, not surprisingly, cite the number of reported (and unreported) incidents as proof for the need nonetheless to improve the extent and effectiveness of the current regulations.  What EPA has issued here as the final revisions to the regulations attempts to balance these views. 

Some believe that, in similar situations, where industry and activist groups criticize an action, albeit for very different reasons, the EPA action at issue must have struck the correct balance of disparate views.  This breezy measure of success in an important health protection program such as this rule addresses by definition is not likely to satisfy either perspective, and complaints about the new requirements can be expected to continue, especially about the economic impact of the new requirements for some, and for others, how the occupational risks of pesticides remain too high and deserve even greater restrictions. 

Outside the boundaries of the worker protection regulations, some of the underlying logic and regulation of the updated requirements indicate that EPA, at least under the current Administration, will continue its emphasis on the broader goals of environmental justice and protecting “children” from the hazards of pesticide exposure.  (For example, among the most controversial elements of the changes is the prohibition on certain activities for those under the age of 18, while beforehand the cutoff age was 16; this seems partly a result of EPA’s attempt to make its policy of prohibiting testing of pesticides on children consistent with its policy of who might be exposed in occupational settings.)

The final rule will become effective 60 days after it is published in the Federal Register, but agricultural employers and handler employers will not be required to comply with most of the new requirements in the final rule until 14 months after the effective date.

For more information, please see Bergeson & Campbell, P.C.’s (B&C®) memorandum Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2015 and James V. Aidala Comments on EPA’s Worker Protection Standards.  More information is also available on EPA’s Worker Protection Standard webpage.


 

By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

In an opinion issued on August 10, 2015, the U.S. Court of Appeals for the Ninth Circuit granted a writ of mandamus requested by Pesticide Action Network North America and the Natural Resources Defense Council (Petitioners) to require that the U.S. Environmental Protection Agency (EPA) act in response to a 2007 administrative petition to cancel the registrations of all pesticides containing chlorpyrifos.  A writ of mandamus to compel administrative action is an extraordinary remedy and is generally reserved for instances of egregious delay.  The same court had previously declined to grant mandamus to the same Petitioners in 2013, but has now concluded that mandamus is the only way to end a “cycle of incomplete responses, missed deadlines, and unreasonable delay.”

After the Petitioners commenced the current case, EPA issued a preliminary decision indicating that it intended to deny the petition to cancel chlorpyrifos, and told the court that it would take final action after reviewing public comments by the summer of 2015.  In a status report subsequently filed in response to a June 10, 2015, order by the court, EPA changed course and stated that unresolved concerns about the risk associated with chlorpyrifos levels in some drinking water might warrant a rulemaking to revoke all existing chlorpyrifos tolerances.  EPA stated that it intended to commence such a rulemaking in April, 2016, unless the registrants of chlorpyrifos products agree to make labeling changes to mitigate the risk from residues in drinking water.  The Petitioners were not satisfied with this amorphous response by EPA, and the court has now agreed.

The writ of mandamus directs EPA to issue a proposed or final rule to revoke chlorpyrifos tolerances, or a full and final response to the administrative petition to cancel chlorpyrifos, no later than October 31, 2015.  If EPA elects to issue a proposed revocation rule, EPA must inform the court by October 31, 2015, of the timeline for finalizing the proposed rule.  Meeting this specific directive from the court will be very challenging.  EPA must determine quickly whether the registrants of chlorpyrifos products will agree to label changes that EPA considers sufficient to mitigate drinking water risks.  Such label changes could hypothetically obviate the need for a tolerance revocation rule and provide a basis for a final decision by EPA to deny the petition to ban chlorpyrifos.  Otherwise, EPA will need to substantially accelerate its stated timetable for issuing a proposed rule to revoke chlorpyrifos tolerances.

In brief, this commitment by EPA will accelerate discussions with the registrant and user groups in an attempt to resolve the issues identified in EPA’s assessment.  It appears that this will compress a process which has typically taken many months into a much tighter time frame, to comply with the court’s order.  That obviously was among the goals of the plaintiffs in the case; it remains to be seen how doing so will affect the EPA’s ability to evaluate the risks and benefits of the pesticide as fully as it typically has done in the past. 


 

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

On June 24, 2015, in the United States District Court for the Northern District of California, the Center for Environmental Health, Beyond Pesticides, and Physicians for Social Responsibility (Plaintiffs) sued the U.S. Environmental Protection Agency (EPA) and its Administrator Gina McCarthy regarding a 2014 decision by EPA not to proceed with a rulemaking to require disclosure of hazardous inert ingredients on pesticide product labels under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  This decision was characterized by EPA as a denial of a petition previously filed by the Plaintiffs. 

Specifically, Plaintiffs and others previously petitioned EPA in 2006 to require label disclosure of some 370 substances used as inert ingredients in pesticide products that Plaintiffs claim are known to be hazardous to human health and the environment.  In 2009, EPA decided to partially grant the 2006 petition and issued an advance notice of proposed rulemaking to require disclosure of hazardous inert ingredients on pesticide labels.  When EPA did not pursue the rulemaking, the Plaintiffs filed a suit on March 5, 2014, alleging unreasonable delay.  On May 22, 2014, EPA issued a letter explaining that EPA had decided not to proceed with a proposed rule and stating that “this amended response constitutes a denial of the [2006] petitions.”

In the May 22, 2014, letter, EPA cited some legal arguments by registrants in opposition to the proposed rule, including a contention that inert ingredients are entitled to confidential treatment as a class, and that EPA cannot compel disclosure of inert ingredients based solely on hazard without considering exposure.  In the letter, EPA stated that it has concluded that it “can achieve greater reduction in the risks from use of pesticides containing potentially hazardous inert ingredients through a series of non-rule actions designed to reduce the presence of hazardous inert ingredients in specific pesticide products.”  EPA also set forth its plan to prioritize pesticide inert ingredients for increased scrutiny, as well as a list of voluntary and regulatory actions that could be used, as appropriate, to address potential risks from inert ingredients.

In the Complaint, Plaintiffs request that the court:  (1) declare that EPA’s May 22, 2014, decision violates FIFRA and is arbitrary, capricious, and runs counter to the evidence in the record; (2) remand the case to EPA with instructions to consider the evidence weighing in favor of disclosure of inert pesticide ingredients, including the abundance of documentation regarding toxicity and potential risks of exposure to inert pesticide ingredients; (3) retain jurisdiction over this matter until such time as EPA complies with its duties to control unreasonable risk as set forth under FIFRA, including the risks posed by hazardous inert ingredients, and completes its rulemaking to increase disclosure of inert ingredients contained in pesticide products; and (4) award Plaintiffs their costs of litigation.

 


 

By Lisa M. Campbell and James V. Aidala

The U.S. Environmental Protection Agency’s (EPA) Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide Products published in the Federal Register on May 29, 2015, seeks comment on a proposal to adopt mandatory pesticide label restrictions to protect managed bees under contract pollination services from foliar application of pesticides that are acutely toxic to bees on a contact exposure basis, unless the application is made in accordance with a government-declared public health response. These label restrictions would prohibit applications of pesticide products that EPA has identified as acutely toxic to bees, during bloom when bees are known to be present under contract.

As part of this mitigation proposal, the 48-hour notification exception for crops under contracted pollination services during bloom for all neonicotinoid product labels would be removed. These restrictions are intended to reduce the likelihood of acute exposure and mortality to managed bees under contract. EPA is not proposing at this time to require new language for pesticide labels for managed bees not under contract pollination services. This does not, however, alter EPA’s previous actions intended to impose more specific restrictions on neonicotinoid pesticides through label language addressing potential risks to bees not under contract for pollination services.

EPA is also seeking comment on a proposal to rely on efforts made by states and tribes to reduce pesticide exposures for application sites not under contracted services, through development of locally-based measures, specifically through managed pollinator protection plans. These plans would include local and customizable mitigation measures to address certain scenarios that can result in exposure to pollinators. EPA intends to monitor the success of these plans in deciding whether further label restrictions are warranted.

EPA states that if it receives evidence during the public comment period, and/or through outreach at stakeholder meetings, that the contract provisions that are the subject of the proposed rule commonly considered effective and mutually agreed upon stakeholder practices (i.e., beekeeper-to-grower) indicating that the application of acutely toxic pesticides is not of risk concern for bees under contract, then EPA will consider this information in determining whether this scenario needs the mitigation indicated in the proposed language.

EPA states that the proposed actions are consistent with the Presidential Memorandum issued in June 2014 to reduce the effect of factors that have been associated with pollinator declines in general, as well as the mandate to engage state and tribal partners in the development of pollinator protection plans. Comments on the proposal are due by June 29, 2015.

Commentary

The main elements of EPA’s pesticide regulatory strategies and policies were only a small part of the response to the President last week on a National Strategy for pollinators, but now that EPA has issued this proposal, attention will turn to what EPA is more precisely planning to do with regard to proposing and implementing new restrictions on pesticides generally and/or neonicotinoid products in particular.

As expected, the focus of the proposal is on new restrictions for acutely toxic pesticide applications (defined in the notice as “pesticides with an acutely lethal dose to 50% of the bees tested of less than 11 micrograms per bee”), where the pesticide application site is also where there are contracted pollination services. Essentially, foliar application of pesticides acutely toxic to bees are prohibited where there are bee colonies present pursuant to a contract to provide pollination services. EPA’s proposal (at Appendix A) includes a long list of pesticides (over 75) that meet the acute toxicity criteria that will be subject to the new restrictions. This list includes many more pesticides than just the neonicotinoid products.

In addition, for managed bees not under contracted services, or for other “unmanaged” bees, EPA’s reliance on state “Managed Pollinator Protection Plans” (MP3s) is consistent with public statements that EPA officials and line staff have made in recent months, so there appears to be few surprises in the proposal at first glance. Some states already have plans; many are under development. EPA has worked closely with state pesticide regulatory officials on development of state plans, and signaled that it expects state plans to incorporate three core ideas: public participation in developing the plan; some kind of notification scheme to alert beekeepers of insecticide applications; and a way to evaluate whether the state plan is effective in reducing insecticide exposure to bees.

Even so, what may generate the most public comment about EPA’s proposal is what it does NOT do; for example: 

  • The proposal does not impose a ban on neonicotinoid pesticides as some advocacy groups have sought; 
  • The proposal does not require EPA approval of state management plans (MP3s); 
  • The proposal does suggest options for registrants to seek product-specific exemptions to what is mandated; in other words, it again seeks to impose EPA regulatory actions “by letter” using a “one size fits all” approach; and 
  • The proposal does not offer significantly new restrictions regarding pollinators generally, but maintains a focus on contracted honeybees and commercial pollination services.

As the proposal has just been issued, stakeholders will now review the content to look for “the devil in the details” -- and develop comments to submit during the 30-day comment period EPA offers. (It would not be surprising if the comment period on such a high profile proposal is extended.)

More information concerning the Presidential Memorandum and the national strategy are available in Bergeson & Campbell, P.C.’s (B&C®) blog post on Pollinator Health Task Force Issues National Strategy to Promote the Health of Honey Bees and Other Pollinators.


 

By Lisa M. Campbell and Lisa R. Burchi

On April 20, 2015, the U.S. Environmental Protection Agency (EPA) announced it had reached settlements with three major pesticide registrants, for the actions of a third-party pesticide distributor, Harrell’s LLC (Harrell’s), a Florida-based lawn and turf care business that was distributing the registrants’ respective products.  EPA alleged that Harrell’s sold improperly labeled products that contained the pesticides dithiopyr, chlorantra-niliprole, and imidacloprid.

Without admitting liability, each registrant agreed to pay a penalty with one agreeing, in addition to completing a supplemental environmental project (SEP), to create a $231,000 educational website for the pesticide industry that will feature information on complying with federal pesticide laws.

A 2012 EPA investigation found more than 350 instances of Harrell’s products having been sold without proper pesticide labels -- in some cases, labels were either illegible or were not on the products at all.  The products at issue were registered and were sold and distributed by Harrell’s under supplemental distributor relationships.  In late 2013, Harrell’s agreed to pay a $1,736,560 civil penalty to EPA, one of the largest ever for a pesticide case.  

Under EPA regulations, supplemental distributors like Harrell’s are agents of the registrants, and those registrants are thus responsible and liable for the actions of their supplemental distributors.  In its recent National Enforcement Program Managers Guidance (NPMG), EPA’s Office of Enforcement and Compliance Assurance identifies Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) supplemental distribution as a mandatory “focus area.”  Specifically, EPA states:

Although required to be consistent with the labels of the basic registered products, distributor product labels frequently deviate substantially from the EPA accepted labels.  Such unapproved product labeling can lead to misuse and misapplication as well as pose significant risks to the users who rely on product labels to inform them about proper and safe pesticide use.  Due to the potential risk associated with the use of improperly labeled pesticides, it is important that the EPA aggressively pursue compliance for supplemental registrations. 

Bergeson & Campbell, P.C. (B&C®) recently issued a memorandum discussing the enforcement actions, the regulatory requirements for supplemental distribution, and what issues companies should address to help avoid such an enforcement action. That memorandum, “EPA’s Enforcement Efforts Regarding FIFRA Supplemental Distribution and How to Avoid Noncompliance,” is available online.

B&C also presented a webinar, “EPA's Supplemental Distribution Enforcement Actions Are Buzzing: How to Avoid Getting Stung,” on July 23, 2014, highlighting the most important steps that both registrants and supplemental distributors can take to ensure compliance and avoid being stung in the current heightened enforcement environment.  A recap of the webinar is available online.


 

By Lisa M. Campbell and James V. Aidala

 

On April 9, 2015, the California Department of Pesticide Regulation (DPR) held the first of a planned series of workshops intended to help DPR develop “regulation concepts” for possible notifications prior to field fumigations.  The presentations and video from that workshop are now available on DPR’s website.

 

DPR’s presentation at the workshop focused on the background that it believes supports the consideration of a notification requirement, and on current methyl bromide notification regulations and fumigant labeling requirements that it believes potentially could be used as a foundation to assist in the development of a rulemaking concept for soil-applied field fumigants. 

 

In addition, DPR considered whether the concept can be reconciled with the current label requirements as emergency preparedness and response requirements, or maintained as a separate “right-to-know” requirement.  DPR recommended expanding notification to all field fumigations, including applications of chloropicrin, 1,3-dichloropropene, methyl bromide, or pesticides that generate methyl isothiocyanate.

 

This potential regulatory development is of significant interest to pesticide registrants in general.  The application of a right-to-know model to pesticide applications, pursuant to which growers and applicators would have to notify those in a defined proximity to the planned pesticide application, would have far-reaching ramifications.  DPR’s further development of this potential regulation should be monitored closely.

 

Of note are similar notification schemes reportedly under consideration by the U.S. Environmental Protection Agency (EPA) as part of its pollinator protection proposals.  EPA staff has spoken of how one essential component of any pollinator protection program will be some kind of notification scheme for beekeepers, or at least commercial beekeepers, who have hives in the vicinity of the use area for certain pesticides.  As that issue evolves, it will invite comparison with EPA’s position on other requirements for mandatory notification, where generally EPA has not supported blanket federal requirements for notification of nearby pesticide applications.  This development in the pollinator area could lead to reconsideration at the federal level regarding broader advance notification requirements for specified pesticide applications. 


 

By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.


On April 15, 2015, the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS), the National Oceanic and Atmospheric Administration National Marine Fisheries Service (NMFS), and the U.S. Department of Agriculture (USDA) held a one-day workshop regarding assessing risks to endangered and threatened species from pesticides. This workshop was intended to provide a forum for stakeholders to offer scientific and technical feedback on the ongoing agency efforts to develop draft Biological Evaluations (BE) for three pilot chemicals (chlorpyrifos, diazinon, and malathion) in response to the National Academy of Sciences’ (NAS) report “Assessing Risks to Endangered and Threatened Species from Pesticides.” The workshop was the fourth interagency workshop on this issue, and follows previously-held public meetings in November and December 2013, April 2014, and October 2014, and was held as part of the enhancement of the stakeholder engagement process finalized in March 2013. A copy of the Fourth ESA Stakeholder Workshop agenda is available online. The Interagency presentations are also available online.

This workshop presentations and discussion appeared to demonstrate progress among the agencies in coordinating their work to address the issues that have been the subject of this and prior workshops. The presentation content exhibited a better understanding of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) evaluation process by the Services, and the presentations themselves allowed for more interaction between the presenters and participants; some of the question and answer sessions (conducted after each segment) included detailed exchanges of information among the participants.

To the dismay of some registrants and observers, however, as the various evaluation models were described, and an avian case study presented, the direction of the joint analyses seemed to be moving towards the marriage of very conservative EPA assessment models and assumptions with the Services’ desire to avoid any potential impacts on individual members of a protected species and any habitat. Should this direction not change, the Endangered Species Act pilot assessments could be very conservative and indicate what many may believe is an unwarranted need for significant changes in some current pesticide labels. Simply put, from a registrant perspective, the good news is that the agencies are cooperating and working better together; the bad news is that both EPA and the Services appear to be planning to use very conservative models and assumptions, which could result in proposals for severe restrictions on some current use patterns.

 


 

By Lisa M. Campbell

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

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

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

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


 
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