By Lynn L. Bergeson and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) recently announced, in two separate notices, that it is initiating a process to revise (1) certain requirements in the Agricultural Worker Protection Standard (WPS) (82 Fed. Reg. 60576 (Dec. 21. 2017)); and (2) to revise the minimum age requirements in the Certification of Pesticide Applicators (C&T) rule.  82 Fed. Reg. 60195 (Dec. 19. 2017).

For the WPS rulemaking, the provisions at issue were identified as part of the public comments received in response to Executive Order (EO) 13777, Enforcing the Regulatory Reform Agenda.  Three provisions in particular were the subject of public comment, and later consideration by the EPA’s Office of Pesticide Programs (OPP) Pesticide Program Dialogue Committee (PPDC) at its November 2, 2017, meeting.  The three provisions are:  minimum age (the 2015 WPS specifies a minimum age of 18 years, with an exemption for owners of agricultural establishments and their immediate family members); designated representative (the 2015 WPS requires employers to provide pesticide application information and safety data sheets to a designated representative of a worker or handler under specified circumstances); and application exclusion zones (AEZ) (the 2015 WPS requires the establishment of AEZs with respect to outdoor production on farms, nurseries, and forests to reduce the number of incidents where workers or others are exposed to pesticides during agricultural pesticide applications). 

EPA also announced that the compliance dates in the revised WPS remain in effect and that EPA has no intent to extend them.  This means that most provisions in the revised WPS went into effect on January 2, 2017, and compliance with two additional requirements will begin on January 2, 2018.  The two requirements include compliance with the display of pesticide safety information, and pesticide handlers must temporarily suspend applications if workers or others enter in the application zone during pesticide applications.  The only requirements in the revised WPS that will not be in effect as of January 2, 2018, are the requirements that the worker and handler pesticide safety training material cover the expanded content at 40 C.F.R. §§ 170.401(c)(3) and 170.501(c)(3).  The 2015 revised WPS provided that compliance with the expanded pesticide safety content in these sections was not required until 180 days after EPA publishes in the Federal Register a notice of availability of certain training materials.  While there are training materials available that meet the expanded content requirement, EPA has not yet published such a Federal Register and apparently does not intend to do so until after the rulemaking announced on December 21 has concluded.

For the C&T rule, EPA expects to “publish a Notice of Proposed Rulemaking to solicit public input on proposed revisions to the rule by the end of FY2018,” and it has no plans to change the implementation dates in the January 4, 2017, final rule.  The C&T notice states that “EPA has determined that further consideration of the rule’s minimum age requirements is warranted through the rulemaking process” after it considered comments received pursuant to EO 13777, revisiting the record, and reviewing the applicable statutory. 

More information on WPS issues is available on our blog under key phrase Worker Protection Standard. 

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

On July 20, 2017, the Trump Administration released its 2017 Unified Regulatory Agenda.  The U.S. Environmental Protection Agency’s (EPA) Agency Rule List included several pesticide rulemakings in the proposed rule stage, as well as the Certification of Pesticide Applicators rulemaking that is in the final rule stage.  The five items in the proposed rule stage are:

1. RIN 2015-AA00:  Revision of Procedural Rules for Hearings on Cancellations, Suspensions, Changes in Classifications, and Denials of Pesticide Registrations.  The agenda states that this proposed rulemaking is a “revision of the Rules of Practice governing the conduct of licensing adjudications under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).”   The issuance of the proposed rule is scheduled for January 2018.
2. RIN 2070-AK00:  Pesticides; Technical Amendments to Data Requirements.  The agenda states that to satisfy one of the commitments in a settlement agreement reached with the American Chemistry Council (Docket ID Number EPA-HQ-OPP-2008-0110-0139), EPA is proposing a correction pertaining to the 200 parts per billion (ppb) level described in 40 C.F.R. Section 158.2230(d) that was originally used by the U.S. Food and Drug Administration with respect to the “concentration of residues in or on food for tiering of data requirements for indirect food use biocides.”  Through this rulemaking, the agenda states that EPA intends to “clarify that the 200 ppb level is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food.”   The issuance of the proposed rule is scheduled for July 2017.
3. RIN 2070-AK06:  Pesticides; Procedural Rule Amendment; Requirement for Certain Pesticide Actions to Publish Notices in the Federal Register.  In the agenda, EPA states that as the as the Federal Register is “no longer the most cost effective or efficient way for providing notice or sharing information with the public,” it is considering changing the way that it provides notice on or shares information with the public -- specifically, by no longer publishing certain information in the Federal Register, but instead providing the same information on a consolidated website which the agenda states “will be more accessible to the public and other interested parties, as well as a more cost effective and efficient mechanism for providing timely updates.”  The agenda lists the following kinds of notification it is considering making this change regarding: (1) reregistration of a pesticide product with a new active ingredient or new use; (2) announcing approvals of specific, quarantine and public health exemptions; and (3) Summaries of certain state registrations.  For Registration Review, the agenda state that EPA “intends to announce availability of the documents that are currently announced in the Federal Register on the EPA's Registration Review Website.”  For notices of availability announced in the Federal Register, the agenda states that “EPA intends to direct the public to a case-specific docket on Regulations.gov to view pertinent registration review documents and provide comment.”  The issuance of the proposed rule is scheduled for April 2018.
4. RIN 2070-AK40:  Extension of Compliance Date(s); Agricultural Worker Protection Standard.  As reported in our memoranda summarizing the Worker Protection Standard (WPS) final rule, EPA Publishes Worker Protection Standard Final Rule, the WPS final rule was issued on November 2, 2015, but has not yet been made effective.  More information on the delay of its effective date is available in our blog item EPA to Delay Agricultural WPS Indefinitely; Cites Issues with Guidance and Training.  This proposed rulemaking will adjust the compliance date.  The issuance of the proposed rule is scheduled for July 2017 and the issuance of the final rule is scheduled for November 2017.
5. RIN 2080-AA13:  Updates to 40 C.F.R. § 26 Subpart K to reflect recent changes to 40 C.F.R. Subpart A (The Common Rule).  As reported in our blog item Federal Agencies Announce Revision to Modernize Federal Policy for the Protection of Human Subjects, on January 19, 2017, EPA, together with a host of other federal agencies, released a final rule to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991, and is now codified in 40 C.F.R. § 26, Subpart A.  These revisions, scheduled to become effective on January 19, 2018, will create a conflict within some of the EPA-specific subparts, in particular, Subpart K of 40 C.F.R. 26 (Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intention Exposure of Non-Pregnant, Non-Nursing Adults) which regulates third party pesticide research.  The agenda states that this proposed rulemaking is “intended to resolve proposed rulemaking discrepancies created by the recent revision to Subpart A, and will not alter the fundamental protections for human subjects, including vulnerable populations.”  The issuance of the proposed rule is scheduled for January 2018.

The two items in the final rule stage are:

1. RIN 2070-AJ20:  Pesticides; Certification of Pesticide Applicators.  As reported in our memoranda summarizing the Certification of Pesticide Applicators’ final rule, Final EPA Rule Requires Stronger Standards for Applying Riskiest Pesticides, the final rule was issued on January 4, 2017.  More information on the delay of its effective date is available in our blog item EPA Delays Effective Date of Certification of Pesticide Applicators Final Rule.  On June 2, 2017, a Federal Register publication was issued that delayed the effective date until May 22, 2018.
2. RIN 2070-AK13:  Procedural Rule to Remove Obsolete Information.  The agenda states that this final rule will remove information from EPA’s existing pesticide regulations that is now out of date or obsolete and will “provide clearer and more reliable information to those seeking to register a pesticide product.”  The agenda further states that as rulemaking is intended to be a non-substantive, procedural rulemaking “since the EPA does not intend to make any substantive changes to the existing requirements,” EPA is considering issuing this as a final rule and not going through the notice and comment period.  The issuance of the final rule is scheduled for January 2018.

Commentary

Much of the work noted emphasizes potential procedural efficiencies and clarifications.  The potential move to more announcements on the websites and away from the Federal Register is, at least in part, likely intended as a cost-saving measure.  It is also a change that will be closely watched.  For example, in recent years, EPA has seen registrations challenged based on assertions of an alleged lack of appropriate notice concerning the receipt or processing of registration applications, and these past challenges will likely influence any new procedures that EPA may adopt. 

Of more interest is the new Administration’s call for suggestions of what rules or policies should be changed as part of a broader push for economic growth and less regulatory costs, which may result in more substantive regulatory changes and some likely controversial decisions about what rules or programs will be modified or eliminated -- but that exercise is not part of this announcement.  The delay in the compliance date for the WPS regulation is more substantive, but changes that may be proposed have not yet been announced.

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

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

Background

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

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

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

Discussion

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

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By Lisa M. Campbell and Lisa R. Burchi

In a November 2, 2015, Federal Register notice, the U.S. Environmental Protection Agency (EPA)  issued the final rule revising the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Worker Protection Standard (WPS).  EPA previously announced these revisions on September 28, 2015, and stated that it would issue the final rule in the Federal Register within 60 days. 

The following are important dates:

• January 4, 2016:  The date when the final WPS rule is effective.
• January 4, 2017:  The date by which agricultural employers and handler employers will be required to comply with all of the new requirements set forth in the final rule except for the ones listed below.
• January 4, 2018 (Or 180 Days After An EPA Announcement That Training Materials Are Available, Whichever Is Later):  The date by which agricultural employers and handler employers will be required to comply with certain new requirements for the content of pesticide safety training for workers and handlers and pesticide safety information display (to be codified at 40 C.F.R. § 170.311(a)(3), 40 C.F.R. § 170.401(c)(3), and 40 C.F.R. § 170.501(c)(3)).  EPA states it delayed implementation of the final rule regarding certain training and display materials to provide agricultural employers and handler employers time for such materials to be updated, printed, and distributed as well as to allow time for existing trainers to familiarize themselves with those new materials.
• January 4, 2018:  The date by which agricultural employers and handler employers will be required to comply with the requirement that the handler performing an application must immediately suspend a pesticide application if any worker or other person, other than an appropriately trained and equipped handler involved in the application, is in the application exclusion zone described in § 170.405(a)(1) or the area specified in column B of the Table in § 170.405(b)(4) (to be codified at 40 C.F.R. 170.505(b)). 

EPA also states that it is “committed to a robust outreach, communications and training effort to communicate the new rule requirements to affected WPS stakeholders.”  EPA has stated its intent to do the following to facilitate implementation:

• Issue plain language “how to comply” fact sheets and guidance materials.
• Develop compliance assistance materials that are targeted to specific agricultural sectors and rule requirements, such as respirator requirements or the WPS exemptions and exceptions.
• Develop and disseminate new worker and handler training materials, conduct outreach to potentially affected parties, and provide assistance and resources to States and Tribes for WPS implementation.
• Hold Pesticide Regulatory Education Program courses for State and Tribal pesticide program staff that will focus on WPS implementation, and Pesticide Inspector Residential Training courses for State and Tribal pesticide inspectors that will focus on WPS inspection requirements.

The details of the WPS final rule are discussed in Bergeson & Campbell, P.C.’s (B&C^®) blog entry EPA Announces Revisions to Its Worker Protection Standard.

For more information, please see B&C’s 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.

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

On August 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a proposal to revise the Certification of Pesticide Applicators rule.  EPA is proposing stricter standards for people certified to use “restricted use” pesticides (certified applicators).  Restricted use pesticides are not available for purchase by the general public, require special handling, and may only be applied by a certified applicator or someone working under the direct supervision of a certified applicator.

The proposed stricter standards include:

• Certified applicators must be at least 18 years old;
• Those working under the supervision of certified applicators would now need training on using pesticides safely and protecting their families from take-home pesticide exposure;
• Certifications would have to be renewed every 3 years;
• Additional specialized licensing for certain methods of application that can pose greater risks if not conducted properly, such as fumigation and aerial application; and
• Updates to the requirements for States, Tribes, and Federal agencies that administer their own certification programs to incorporate the strengthened standards. 

Currently, the majority of certification programs have no renewal requirements.  Thus, this requirement will put additional burdens on States and Tribes administering certification programs to not only strengthen their standards under this new proposal but to incorporate a time-keeping process to ensure applicators’ renewals are kept up to date, and sufficient certification programs are available for re-certifying purposes.  In addition, for some certification programs, the specialized licensing programs will need to be developed, tested, and instituted.

EPA’s proposal to update certification and training requirements comes along with the parallel effort to revise the worker protection standards (WPS), where a final rule updating those requirements are expected sometime in September.  Like the revised WPS, revising the training requirements has been on EPA’s agenda for many years, and this part of the updated requirements for worker protection is expected to be less controversial than some of the changes to the WPS.  In particular, since EPA has emphasized the protection of children as part of its pesticide regulatory program, making the minimum age 18 for pesticide applicators is part of that agenda.

EPA encourages public comment on the proposed improvements.  Comments on the proposal are due November 23, 2015.

More information about certification for pesticide applicators is available here.

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

On August 11, 2015, the U.S. Court of Appeals for the Ninth Circuit denied a motion for a stay pending review filed on December 18, 2014, by the Natural Resources Defense Council (NRDC), as well as a subsequent stay motion filed on February 6, 2015, by the Center for Food Safety and other petitioners (Case Nos. 14-73353 and 14-73359, consolidated).  Both motions requested that the court stay an October 15, 2014, decision by the U.S. Environmental Protection Agency (EPA) to register Enlist Duo herbicide (a combination of glyphosate and 2,4,-D) for use on corn and soybeans in six Midwestern states.

NRDC and CFS, et al. (Petitioners), filed these stay motions in a case consolidating petitions for review challenging EPA’s decision to register Enlist Duo.  The registrant of Enlist Duo (Dow AgroSciences) has intervened in the consolidated case.  The Petitioners argue that EPA failed to consider the impacts of increased glyphosate use on monarch butterflies, and did not fully assess the potential human health effects from 2,4-D.  In response, both EPA and Dow AgroSciences argue that approval of Enlist Duo will not lead to increased use of glyphosate, and that EPA fully considered all of the human health effects of 2,4-D before granting the registration.

The motions for a stay filed by the Petitioners were effectively motions for preliminary injunctive relief, an extraordinary remedy requiring that those seeking such relief show that they are likely to succeed on the merits, that there is likely to be irreparable harm, that the balance of equities tips sharply in their favor, and that an injunction is in the public interest.  In denying the stay motions, the court cited Winter v. NRDC, 555 U.S. 7 (2008).  In the Winter case, the Supreme Court held that irreparable injury must be likely and that a mere possibility of irreparable injury will not suffice in awarding injunctive relief.  Although the court did not opine further on its rationale for denying the Petitioners’ stay motions, it may be inferred that the court determined that the Petitioners had not satisfied the rigorous prerequisites for injunctive relief.

While this decision avoids an immediate disruption in the marketing of pesticides, the potential for disruption to the registration remains until the court challenge has been resolved.  As Enlist is a new product designed for use with crops genetically modified to be resistant to glyphosate and 2,4,-D, any disruption now would be especially impactful to the registrant and customers of the product.  Further, it could also have a chilling effect on efforts to introduce similar new or pending products if growers perceive too great a risk of uncertainty for this or similar pesticides.

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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.

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By Lisa M. Campbell and Timothy D. Backstrom

In a March 9, 2015, decision in Perez v. Mortgage Bankers Ass'n., the U.S. Supreme Court unanimously held that an interpretative rule issued by an administrative agency does not require notice and opportunity for comment, even if the interpretative rule construes a substantive (or "legislative") rule previously issued by the agency and even if the interpretative rule alters a prior interpretation of the same rule. In the Perez decision, the Court explicitly overruled Paralyzed Veterans of America v. D.C. Arena, L.P., a 1997 decision by the U.S. Court of Appeals for the D.C. Circuit that held that notice and comment is required whenever an agency issues an interpretative rule altering a prior interpretation of a legislative rule, based on the premise that adopting a new interpretation of a rule is tantamount to an amendment of the underlying rule.

Pursuant to Administrative Procedure Act (APA) Section 553(b)(A), notice and comment rulemaking procedures do not apply to "interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice." In Perez, the Supreme Court concluded that "[t]he text of the APA answers the question presented." Finding the APA exemption for interpretative rules to be "categorical," the Court held that "it is fatal to the rule announced in Paralyzed Veterans." Since an agency can adopt an initial interpretative rule without notice and comment, it is "also not required to use those procedures when it amends or repeals that interpretive rule." The actual legal effect of this new ruling is likely to be limited in scope, because the Paralyzed Veterans decision only required an agency to use notice and comment procedures in those instances where the agency was both interpreting an underlying substantive regulation and revising or contradicting a prior interpretation of that regulation.

Although the APA does not define "interpretative rules," the general consensus is that such rules only are intended to announce how the agency intends to construe a particular statute or regulation. Interpretative rules are not supposed to have any independent force of law. While an agency must generally follow its own interpretation of a statute or regulation unless and until it has been revised, no party outside of the agency is required to conform to that same interpretation. This contrasts to a legislative rule, which binds parties other than the agency as well, and which can only be lawfully adopted after providing notice and opportunity for comment. A "statement of policy" has even less formality than an interpretative rule, because even the agency that issued a policy statement is free to deviate from that policy without formally withdrawing or revising it.

While the Supreme Court was unanimous in setting aside the Paralyzed Veterans precedent, the Court did not clearly resolve the question of how much judicial deference should be afforded to such agency interpretations. It can be argued that an interpretation adopted by an agency without notice and comment should be afforded a lesser degree of judicial deference, but there has been a general trend in recent years toward affording judicial deference to agency interpretations in situations where an underlying statute or regulation is ambiguous. In three concurring opinions, several conservative members of the Court (Scalia, Thomas, and Alito) signaled that they are willing to revisit the 1945 Supreme Court decision in Bowles v. Seminole Rock & Sand Co., a case holding that reviewing courts should generally defer to the agency's interpretation when construing an ambiguous regulation. Scalia's concurring opinion goes even further, indicating that he would like to revisit the general rule announced in the seminal 1984 precedent Chevron v. NRDC, which affords substantial judicial deference to an administrative agency in construing ambiguous statutory provisions. Unlike an administrative agency's interpretation of an ambiguous regulation, however, ambiguous statutory provisions will typically be construed in the context of promulgation of a substantive or legislative rule, and this type of exercise means that the agency's statutory construction can only be adopted after notice and comment.

On balance, it is possible that the Perez decision could encourage administrative agencies to issue new interpretative rules or even policy statements in lieu of using more elaborate notice and comment rulemaking procedures. Such an approach could be particularly tempting where an agency anticipates that a reviewing court is likely to give deference to its interpretation. After all, the principle that the public is not bound by an interpretative rule or policy statement will provide little solace if regulated parties must effectively presume that the agency's announced construction is correct.

This risk is mitigated somewhat by language in the majority opinion that makes it clear that a newly adopted agency interpretation may require greater substantive justification and be entitled to less judicial deference when it conflicts with a prior interpretation. Moreover, it is possible that the Perez decision could ultimately undermine Seminole Rock, a case that has encouraged reviewing courts to give administrative agencies a high degree of discretion when interpreting ambiguous provisions in their own rules. After all, when the agency is free to resolve clearly such ambiguities through amendments adopted through notice and comment rulemaking, there may be less justification for resolving the same ambiguities through non-binding interpretations.

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