By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson

On February 25, 2022, the U.S. Environmental Protection Agency (EPA) announced it has issued a response denying the objections filed against its final rule revoking all chlorpyrifos tolerances (Response). EPA issued the August 18, 2021, final rule in response to the Ninth Circuit Court’s Order directing EPA to issue a final rule in response to Pesticide Action Network North America and Natural Resources Defense Council’s 2007 petition, which requested EPA to revoke all chlorpyrifos tolerances.

After issuing the August 2021 final rule, and consistent with the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA provided an opportunity for any interested party to file an objection to any aspect of the final rule and request a hearing on those objections. Several objections were filed, with concerns ranging from the scope of the revocation of tolerances, the economic and environmental impacts of the revocation, and the implementation timeframe. EPA stated that after careful consideration, it denied all objections, hearing requests, and requests to stay the final rule filed during the period for submitting responses to the final rule.

In addition to its Response, EPA issued letters to the registrants of chlorpyrifos products with food uses confirming revocation of the tolerances and providing options for cancellation and label amendments. In particular, these options include the ability for registrants to submit registration amendments to remove food uses from product labels or submit a voluntary cancellation for products where all uses are subject to the tolerance revocation. For registrations not voluntarily cancelled, EPA stated it intends to issue a Notice of Intent to Cancel under the Federal Insecticide, Fungicide, and Rodenticide Act to cancel registered food uses of chlorpyrifos associated with the revoked tolerances. A copy of its Response and the accompanying order in the chlorpyrifos final rule docket is available at EPA-HQ-OPP-2021-0523.

EPA states that this action will be incorporated into the ongoing registration review of chlorpyrifos and it will continue to review the comments submitted on the chlorpyrifos Proposed Interim Decision, draft Revised Human Health Risk Assessment, and draft Ecological Risk Assessment. These documents are available in the chlorpyrifos registration review docket at EPA-HQ-OPP-2008-0850. After considering public comments, EPA will proceed with registration review for the remaining non-food uses.

Additional information on chlorpyrifos is available on our blog and on EPA’s website.

Commentary

It is not surprising that EPA denied all objections to its tolerance revocation decision. Since the earlier decision in 2009 to revoke the tolerances for the insecticide carbofuran, EPA, along with advocates of greater restrictions on pesticide exposures, have found a pathway for terminating pesticide uses while avoiding the significant procedural requirements of FIFRA’s cancellation provisions. The elaborate legal niceties of either approach will likely not quiet those grower groups and others who challenged EPA’s decision in this case.

Of note, in its lengthy Response (51 pages in the Federal Register, 87 Fed. Reg. 11222 (Feb. 28, 2022)), EPA again admits that some uses of chlorpyrifos on certain crops in certain areas are “high benefit” uses that can meet the required safety standards even when using EPA’s most conservative assumptions. Those eleven crop uses were among the many additional uses of the insecticide, and here EPA is explaining its case that as part of its decision, all of the uses on the current label are to be assessed together. At the point in time when EPA most recently assessed chlorpyrifos uses (the 2020 registration review Pesticide Interim Decision), some uses may have been able to meet the standard, but as explained in this notice: “In the final rule, EPA assessed aggregate exposure based on all currently registered uses of chlorpyrifos as required by the FFDCA and consistent with its guidance.”

This will likely be of little satisfaction to growers who produce those crops identified by EPA as meeting the standard.

To affected growers, the revocation of tolerances for the identified crop uses that nonetheless could meet the standard, along with the long-winded denial of objections citing the fine points of the legal procedures, amount -- to them -- as what Justice Scalia once described as “pure applesauce.” (Ironically, according to EPA’s 2020 assessment, applesauce sourced from New York and Michigan apples would have met the required standards according to EPA’s 2020 risk assessment.) Those groups may decide to continue the legal back-and-forth process for further review of the original decision and now the objection denials.

But the larger question for all registrants and pesticide users, not just chlorpyrifos, is what longer term issues are raised by EPA’s approach.

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By Heather F. Collins, M.S. and Barbara A. Christianson

On January 10, 2022, the U.S. Environmental Protection Agency (EPA) announced it is opening a 60-day comment period requesting public comments on the sixth proposed rule in an ongoing series of revisions to the pesticide crop grouping regulations.

EPA states it is proposing revisions to its pesticide tolerance crop grouping regulations, which allow the establishment of tolerances for multiple related crops based on data from a representative set of crops. EPA proposes to amend the following crop groups:

• Crop Group 6: Legume Vegetables;
• Crop Group 7: Foliage of Legume Vegetables;
• Crop Group 15: Cereal Grains; and
• Crop Group 16: Forage, Fodder, and Straw of Cereal Grains.

The proposed rule includes changes to the terminology in the names of Crop Groups 6, 7, and 16 and the addition of commodities and modifications that increase efficiencies in assessing the risks of pesticides used on crops grown in and outside of the United States. The crop groups will now include certain minor or specialty crops, many of which have become more popular since the crop groups were first established.

EPA sets the maximum amount of a pesticide allowed to remain in or on a food (tolerances) as part of the process of regulating pesticides that may leave residues in food. Crop groups are established when residue data for certain representative crops are used to establish pesticide tolerances for a group of crops that are botanically or taxonomically related. Representative crops of a crop group or subgroup are those crops whose residue data can be used to establish a tolerance for the entire group or subgroup.

According to EPA, these revisions will:

• Enhance EPA’s ability to conduct food safety evaluations for tolerance-setting purposes;
• Promote global harmonization of food safety standards;
• Reduce regulatory burden; and
• Ensure food safety for agricultural goods.

Comments on the proposed rule are due on or before March 11, 2022, in docket EPA-HQ-OPP-2006-0766 at www.regulations.gov.

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By James V. Aidala and Lisa R. Burchi

On November 18, 2021, the United Farm Workers and several other non-governmental organizations (NGO) filed a petition with the U.S. Environmental Protection Agency (EPA) to revoke all food tolerances and cancel registrations for organophosphate (OP) pesticides (Petition). The Petition was filed pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. Section 346a(d), the Administrative Procedure Act (APA), 5 U.S.C. Section 551, and the First Amendment Constitutional Right to Petition.

The Petition seeks final EPA actions to revoke tolerances and cancel registrations for 15 OPs by the registration review deadline of October 1, 2022.

The Petition also states that EPA must take the following actions:

• Update EPA’s human health risk assessments (HHRA) for OP pesticides to use a regulatory endpoint that the Petition claims will protect children from learning disabilities and other neurodevelopmental harm.
• Complete Endangered Species Act (ESA) consultations and ensure its registrations comply with the ESA;
• Conduct endocrine disruptor screening of all pesticides.
• Complete a cumulative risk assessment for all the OPs to address their cumulative acute poisoning and neurodevelopmental effects.

The Petition focuses on 15 OPs that are currently going through registration review:

• Acephate (EPA-HQ-OPP-2008-0915);
• Bensulide (EPA-HQ-OPP-2008-0022);
• Chlorethoxyfos (EPA-HQ-OPP-2008-0843);
• Chlorpyrifos-methyl (EPA-HQ-OPP-2010-0119);
• Diazinon (EPA-HQ-OPP-2008-0351);
• Dichlorvos (EPA-HQ-OPP-2009-0209);
• Dicrotophos (EPA-HQ-OPP-2008-0440);
• Dimethoate (EPA-HQ-OPP-2009-0059);
• Ethoprop (EPA-HQ-OPP-2008-0560);
• Malathion (EPA-HQ-OPP-2009-0317);
• Naled (EPA-HQ-OPP-2009-0053);
• Phorate (EPA-HQ-OPP-2007-0674);
• Phosmet (EPA-HQ-OPP-2009-0316);
• Terbufos (EPA-HQ-OPP-2008-0119); and
• Tribufos (EPA-HQ-OPP-2008-0883).

Commentary

Now that EPA is in receipt of the Petition, it must determine that it has received a “complete” petition to revoke a tolerance based on criteria set forth in EPA’s regulations (40. C.F.R. § 180.7). If EPA determines the Petition is complete, it will publish in the Federal Register within 30 days a notice of filing for the Petition, which must include the informative summary of the Petition submitted by the petitioner. FFDCA Section 408(d)(3). A public comment period follows.

Generally, the Petition is an important signaling document that the petitioners use to outline how EPA should approach the 2022 registration review deadline for these OP products. It signals that unless EPA completes all elements of a registration review, including a complete ESA assessment and an endocrine disruptor review -- which may be impossible for EPA to complete -- then EPA should act now to revoke OP tolerances in light of arguments contained in the Petition. It stresses the environmental justice commitments announced by the Biden Administration, arguing that evidence is clear, in their view, of the need to take immediate action to end OP use across virtually all of the members of the class. It seems to anticipate that even if EPA rolls out registration reviews of the individual OP pesticides before the deadline, there will likely be comment and debate about the specific analyses and evaluation of each member of the category. This would additionally delay the completion of any revised cumulative risk assessment for the OPs.

From the view of the petitioners, not only will EPA miss the 2022 deadline, but they also argue the evidence is sufficient now for EPA to take action to revoke tolerances for these compounds based on evidence already before EPA. Other stakeholders and EPA’s eventual analyses will dispute such conclusions, but completing registration review (as defined in the Petition) will likely be impossible to complete before next October. As a result, the Petition here suggests the template these advocacy groups will use to challenge continued registration of OP products past the 2022 deadline.

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By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson

On August 18, 2021, the U.S. Environmental Protection Agency (EPA) announced that it will stop the use of the pesticide chlorpyrifos on all food. In the pre-publication of the Federal Register notice released on August 19, 2021, EPA revoked all “tolerances” for chlorpyrifos, which establish an amount of a pesticide that is allowed on food. In addition, EPA states that it will issue a Notice of Intent to Cancel under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to cancel registered food uses of chlorpyrifos associated with the revoked tolerances. EPA has stated the cancellation order will follow in approximately six months after the tolerance revocations.

EPA’s announcement responds to the Ninth Circuit’s order, issued on April 29, 2021, that vacated EPA orders issued in 2017 and 2019 denying a 2007 petition filed by Pesticide Action Network North America and Natural Resources Defense Council. That petition requested that EPA revoke all chlorpyrifos tolerances, or the maximum allowed residue levels in food, because those tolerances were not safe, in part due to the potential for neurodevelopmental effects in children. The 2017 and 2019 orders denying the 2007 petition were challenged in the Ninth Circuit by a coalition of farmworker, health, environmental, and other groups.

In its order, the Ninth Circuit found that “...EPA had abdicated its statutory duty under the Federal Food, Drug and Cosmetic Act (FFDCA) ...” to “conclude, to the statutorily required standard of reasonable certainty, that the present tolerances caused no harm.” After vacating the 2017 and 2019 orders, the court remanded the matter to EPA with instructions to: “(1) grant the 2007 Petition; (2) issue a final regulation within 60 days following issuance of the mandate that either (a) revokes all chlorpyrifos tolerances or (b) modifies chlorpyrifos tolerances and simultaneously certifies that, with the tolerances so modified, the EPA ‘has determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information,’ including for ‘infants and children’; and (3) modify or cancel related FIFRA registrations for food use in a timely fashion consistent with the requirements of 21 U.S.C. § 346a(a)(1).”

In its announcement, EPA states that it has determined that the current aggregate exposures from the use of chlorpyrifos do not meet the legally required safety standard that there is a reasonable certainty that no harm will result from such exposures. Chlorpyrifos is an organophosphate insecticide used for a large variety of agricultural uses and has been continually reviewed with regard to potential adverse effects, including possible neurological effects in children, which has been the subject of considerable controversy for many years. EPA’s announcement notes that a number of other countries, including the European Union and Canada, and some states, including California, Hawaii, New York, Maryland, and Oregon, have taken similar action to restrict the use of this pesticide on food.

EPA states its action also will be incorporated into the ongoing registration review for chlorpyrifos. EPA is continuing to review the comments submitted on the chlorpyrifos proposed interim decision, draft revised human health risk assessment, and draft ecological risk assessment. These documents are available in the chlorpyrifos registration review docket EPA-HQ-OPP-2008-0850 at www.regulations.gov and a discussion of these issues is available on our blog here.

After considering public comments, EPA will proceed with its registration review of the remaining non-food uses of chlorpyrifos by issuing the interim decision, which may consider additional measures to reduce human health and ecological risks.

Commentary

Separate from any issues of science, evidence, or interpretation, the FFDCA’s channels of trade provision is designed to address what happens if EPA cancels a pesticide product for not meeting Food Quality Protection Act (FQPA) standards and then revokes the tolerance. EPA’s initial description of its decision was unclear on this important point regarding the status of food already in the channels of trade that may contain chlorpyrifos residues.

EPA statements at an August 18, 2021, phone briefing with agricultural stakeholders appeared to present a position that the tolerance revocations would be in effect immediately upon publication in the Federal Register. This implied that there may be an immediate revocation of the tolerances before any parallel action to cancel the associated pesticide registrations. The pre-publication version of the notice clarified that the revocation of chlorpyrifos tolerances would not become effective until six months after the publication of the notice in the Federal Register.  As of August 24, 2021, the notice has not been published in the Federal Register.

This revocation delay of six months aligns with the statement also made by EPA to cancel the registration of chlorpyrifos food use products six months after the revocation notice. EPA may face questions from some of the groups that have been advocating for this type of EPA action concerning why, if these tolerances need to be revoked, the use of the pesticide will continue in effect for the remainder of this growing season. Ed Messina, Office Director of the Office of Pesticide Programs, made a glancing reference to this at the phone conference when he stated EPA and the U.S. Food and Drug Administration (FDA) are “having discussions.” 

According to EPA, use of chlorpyrifos has been in decline due to restrictions at the state level and reduced production. EPA also notes that some alternatives have been registered in recent years for most crops, other chemistries and insect growth regulators are available for certain target pests, and that EPA is committed to reviewing replacements for and alternatives to chlorpyrifos. Some growers, however, are using registered chlorpyrifos products on food crops and hoped to be able to continue certain uses. 

EPA states in the pre-publication notice that some uses in certain areas appear to be able to meet the FQPA standard as evaluated in its 2016 and 2020 risk assessment documents, even if including the full 10x FQPA “extra” safety factor (these assessments are the reference documents EPA cites in its revocation notice). EPA further states that the Ninth Circuit’s order did not provide EPA with time to consider further changes to the use patterns or label restrictions to align with such changes hinted at in the revocation notice, and so EPA is issuing the revocation decision now. This begs the question of whether EPA might consider some continued uses in the future, although even considering any “new” tolerance would be very controversial.

In addition, none of the current actions affect (for now) the tolerances for stored grains using the sister chemical (chlorpyrifos-methyl) with a similar toxicological profile. There also are non-food use applications of chlorpyrifos, for example, mosquito control application of chlorpyrifos sprayed over a large area, that are not affected by the tolerance revocation.

This mix of messages may not be easy to explain to users and the consuming public. 

Issues regarding the timing of the revocations and continued uses are also likely to present challenges for FDA. For example, there are various blended commodities (e.g., animal feed grain, possibly co-mingling harvests from different times) where FDA may be unable to determine what part of any enforcement sample came from a particular date of use.

The orderly transition for treated commodities was designed to avoid public and grower confusion that characterized the episodes of StarLink corn chaos in 2000 or the Cheerios contamination incident in 1994 involving a reported over 100 million boxes of cereal that were eventually destroyed. EPA cites international trade obligations as another reason for the coordinated actions effective in six months to notify foreign trading partners with a “reasonable interval” for adjusting to a changed regulatory situation.

Additional information on chlorpyrifos is available on our blog.

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By Jason E. Johnston

On November 6, 2020, the U.S. Environmental Protection Agency (EPA) published a final rule in the Federal Register that makes several changes to “Crop Group 19:  Herbs and Spices Group.”  85 Fed. Reg. 70976.  The original proposed rule, which was published on August 27, 2019 (84 Fed. Reg. 44804), was created in response to a petition developed by the International Crop Grouping Consulting Committee (ICGCC) workgroup that was submitted by the Interregional Research Project Number 4 (IR-4).  EPA received comments from eight entities and revised the original proposed rule in response to those comments.

The major components of the new rule are a revision of the commodity definition for marjoram; the addition of three new commodity definitions for basil, edible flowers, and mint; and replacement of the existing “Crop Group 19:  Herbs and Spices Group” with two new expanded crop groups, “Crop Group 25:  Herb Group” and “Crop Group 26:  Spice Group.”  Recognizing that the existing combined Crop Group 19 Herbs and Spices Group limited the establishment of crop group tolerances, EPA created the two new separate crop groups to benefit herb and spice growers.  EPA states that the anticipated economic benefit of the new crop groups is estimated to be a cost savings of $51.8 million annually.

The crop groups in the final rule include even more commodities than those listed in the proposal.  Crop Group 25 includes 418 herb commodities directly and 25 indirectly through the modification of the definition of edible flowers in 40 C.F.R. Section 180.1. Crop Group 26 includes 205 spice commodities.  The final rule specifies all commodities in the new crop groups and the subgroups therein (i.e., 25A and 25B for fresh herbs and dried herbs) and provides updated representative commodities for each crop group and subgroup.  The effective date of the final rule is January 5, 2021.

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By Jason E. Johnston

On August 27, 2019, the U.S. Environmental Protection Agency (EPA) published a proposed rule in the Federal Register that makes several changes to the current “Crop Group 19:  Herbs and Spices Group.”  This latest proposal, which is the fifth in a series of crop group amendments, was created in response to a petition developed by the International Crop Group Consulting Committee (ICGCC) workgroup that was submitted by the Interregional Research Project Number 4 (IR-4).  The goals of the crop group amendment program include reducing regulatory burden, coordination with international definitions, and removing barriers to trade.  The major components of this proposal are revision of the commodity definition for marjoram; addition of three new commodity definitions for basil, edible flowers, and mint; and replacement of the existing “Crop Group 19:  Herbs and Spices Group” with two new crop groups, “Crop Group 25:  Herb Group” and “Crop Group 26:  Spice Group.”  Recognizing that the existing combined Crop Group 19 Herb and Spice Group has limited the establishment of crop group tolerances, EPA has proposed creating the two new separate crop groups to benefit herb and spice growers.  The new crop groups are quite large, containing 317 herb commodities in Crop Group 25 and 166 spice commodities in Crop Group 26.  The proposal specifies all commodities in the new crop groups (and the subgroups therein, i.e., 25A and 25B for fresh herbs and dried herbs) and provides updated representative commodities for each crop group and subgroup.

The Federal Register notice requests that comments on the proposal be submitted on or before October 28, 2019.  The public can submit comments at www.regulations.gov in Docket Number EPA-HQ-OPP-2006-0766.

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By Lisa M. Campbell and Timothy D. Backstrom

On August 7, 2019, the League of United Latin American Citizens, Pesticide Action Network North America, Natural Resources Defense Council, and other petitioners (Petitioners) filed a new petition in the Ninth Circuit Court of Appeals seeking judicial review of United States Environmental Protection Agency (EPA) orders denying their request that EPA revoke all tolerances and cancel all registrations for chlorpyrifos.  On August 8, 2019, New York, California, Hawaii, Maryland, Vermont, Washington, Massachusetts, and the District of Columbia (States) also filed a new petition for judicial review concerning the refusal of EPA to ban chlorpyrifos.  The Petitioners and the States seek judicial review of the July 18, 2019, final order by EPA dismissing all objections to the initial decision by EPA to retain tolerances and registrations for chlorpyrifos, and of EPA’s March 29, 2017, order that initially denied a 2007 petition to revoke all tolerances and cancel all registrations for chlorpyrifos.

The Petitioners and the States also seek consolidation of their newly filed petitions for judicial review with currently pending chlorpyrifos litigation in LULAC, et al. v. Wheeler, et al.  As part of rehearing in the LULAC case, the Ninth Circuit vacated a prior decision that ordered EPA to cancel chlorpyrifos registrations, and instead issued a writ of mandamus requiring EPA to respond to objections to the 2017 denial order within 90 days.  EPA then issued the July 18, 2019, order denying all objections, along with a motion on July 19, 2019, to dismiss the LULAC case as moot.  EPA seeks dismissal of LULAC because it contends that the 2017 initial order was never itself reviewable, and EPA has now done everything that the writ of mandamus required. The Petitioners oppose the motion to dismiss because it would require the Court to take a position on a jurisdictional issue which they contend was not decided during rehearing.  The Petitioners and the States also argue that dismissal would be unnecessary and inefficient, requiring the challenging parties to reconstitute the record for review compiled in LULAC.

Petitioners also note that the Ninth Circuit retained jurisdiction when it issued mandamus in LULAC, and they request that their combined challenge to the EPA decision to retain the existing tolerances and registrations for chlorpyrifos be heard by the Court en banc as well.

Commentary

The latest petitions for judicial review of EPA’s 2019 decision to retain all tolerances and registrations for chlorpyrifos pending registration review were anticipated by all parties, and all parties agree that the procedural requisites for a judicial determination concerning the legality of EPA’s final decision to deny the 2007 administrative petition have now been satisfied.  The Petitioners and the States will likely argue that prior scientific determinations by EPA, including EPA analysis of epidemiology studies that purport to establish a link between exposure to chlorpyrifos and adverse neurodevelopmental effects in children, require that EPA proceed to revoke all tolerances and cancel all registrations for chlorpyrifos, while EPA will likely argue that difficult scientific issues concerning chlorpyrifos remain unresolved and should be addressed by EPA as part of the pending registration review for chlorpyrifos.

In addition to the dispute about combining the new petitions for review with the LULAC case, an interesting element of the latest filing by the Petitioners is that they attempt to bootstrap en banc review of the 2019 order in which EPA finally denied the administrative petition to revoke tolerances and cancel registrations for chlorpyrifos.  En banc review for an initial hearing (as opposed to en banc rehearing in a previously decided case) is allowed by the applicable appellate rules, but such review is disfavored and would be highly unusual.  Petitioners argue that it is warranted here because the en banc panel in the rehearing in the LULAC case reserved jurisdiction.  Given the motion by EPA to dismiss the LULAC case as moot, it can be presumed that EPA is likely to oppose this vicarious argument for en banc judicial review.   EPA can argue that the only reason the en banc panel retained jurisdiction was to assure that EPA would timely comply with the writ of mandamus that required EPA to rule on the objections within 90 days.

For further information on the long history of litigation concerning the petition to ban chlorpyrifos, please review our prior blog entries.

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

On July 18, 2019, the U.S. Environmental Protection Agency (EPA) issued a pre-publication version of a Federal Register notice announcing a final order denying the Pesticide Action Network North America’s (PANNA) and the Natural Resources Defense Council’s (NRDC) 2007 Petition requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos (Order).  This Order constitutes final Agency action denying all of the Petitioners’ objections to EPA’s previous refusal to revoke the tolerances for chlorpyrifos.  This Order also constitutes final administrative action concerning all parts of the 2007 Petition that were not previously addressed by EPA.  Given the previous extensive chlorpyrifos litigation, this latest action by EPA will likely lead to further litigation challenging EPA’s decision to allow continued use of chlorpyrifos under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA).

Background

The FIFRA registrations and related tolerances for chlorpyrifos have a complicated regulatory and legal history, as discussed in previous blogs available here.

EPA’s new Order denies objections made by PANNA and NRDC under the FFDCA to EPA’s March 29, 2017, order denying the request by PANNA and NRDC that EPA revoke all tolerances for chlorpyrifos and cancel all chlorpyrifos product registrations.  In the Order, EPA begins by summarizing its prior responses to the 2007 Petition, in which EPA denied each of ten claims raised in support of the Petitioners’ request that EPA revoke all chlorpyrifos tolerances and cancel all chlorpyrifos registrations.  The ten claims are:

1. EPA has ignored genetic evidence of vulnerable populations.
2. EPA has delayed a decision regarding endocrine disrupting effects.
3. EPA has ignored data regarding cancer risks.
4. EPA’s 2006 cumulative risk assessment (CRA) for the organophosphates misrepresented risks and failed to apply the Food Quality Protection Act (FQPA) 10X safety factor.
5. EPA over-relied on registrant data.
6. EPA has failed to address properly the exporting hazard in foreign countries from chlorpyrifos.
7. EPA has failed to incorporate quantitatively data demonstrating long-lasting effects from early life exposure to chlorpyrifos in children.
8. EPA has disregarded data demonstrating that there is no evidence of a safe level of exposure during pre-birth and early life stages.
9. EPA has failed to cite or incorporate quantitatively studies and clinical reports suggesting potential adverse effects below 10 percent cholinesterase inhibition.
10. EPA has failed to incorporate inhalation routes of exposure.

EPA’s Order next focuses on the June 2017 objections to the March 29, 2017, Denial Order that were filed by several public interest groups and states.  The three main objections, and EPA’s response, are as follows:

• Claims Regarding the Legal Standard for Reviewing Petitions to Revoke:  Objectors assert that EPA’s Denial Order applied the wrong legal standard.  Objectors assert that neither “scientific uncertainty” nor the October 2022 deadline for registration review under FIFRA Section 3(g), nor the widespread agricultural use of chlorpyrifos, provide a basis for denying petitions to revoke. Objectors claim that EPA has unlawfully left chlorpyrifos tolerances in place without making the safety finding required by the FFDCA.

• EPA Response:  In its Order, EPA denies the objections related to Petitioners’ claims regarding neurodevelopmental toxicity, stating that the objections and the underlying Petition are not supported by valid, complete, and reliable evidence sufficient to meet the Petitioners’ burden under the FFDCA, as set forth in EPA’s implementing regulations.  Specifically, EPA states that Objectors have not met their regulatory burden to provide “reasonable grounds” for revocation, including an assertion of facts to justify the modification or revocation of the tolerance (40 C.F.R. § 180.32(b)) or the initial evidentiary burden for persons seeking revocation to come forward with sufficient evidence to show that pesticide tolerances to be modified or revoked are not safe.  After summarizing its review of available epidemiologic data, including feedback from the 2012 and 2016 FIFRA Scientific Advisory Panel (SAP) meetings, EPA states that “the epidemiologic studies are central to the Petitioner’s claims regarding neurodevelopmental effects, yet the Petitioners and Objectors rely only on summaries in publications to present their case. Petitioners have not presented the raw data from the epidemiology studies for consideration of their claims.” EPA “concludes that the information yet presented by Petitioners is not sufficiently valid, complete, and reliable to support abandoning the use of AChE inhibition as the critical effect for regulatory purposes under the FFDCA section 408” and also that Petitioners have “failed to meet their initial burden of providing sufficiently valid, complete, and reliable evidence that neurodevelopmental effects may be occurring at levels below EPA’s current regulatory standard and no information submitted with the objections addresses this shortcoming of the Petition.”

• Objections Asserting that EPA Has Found Chlorpyrifos to Be Unsafe: Objectors assert that EPA has previously found that chlorpyrifos tolerances are unsafe and has not disavowed those findings. Specifically, they claim that EPA has found that chlorpyrifos results in unsafe drinking water exposures and results in adverse neurodevelopmental effects to children and that EPA must therefore revoke the tolerances.

• EPA Response:  EPA denies making any regulatory findings that chlorpyrifos tolerances are not safe, stating that its statements in its 2015 proposed tolerance revocation was not a final action.  EPA states: “Proposed rules are just that -- proposals; they do not bind federal agencies. Indeed, EPA made clear it was issuing the proposal because of the court order, without having resolved many of the issues critical to EPA’s FFDCA determination and without having fully considered comments previously submitted to the Agency.”  Regarding those objections related to drinking water, EPA states that since the Petition did not identify drinking water exposure as a basis for seeking tolerance revocation, the Objectors cannot now raise that concern as a basis for challenging EPA’s denial of the Petition. EPA also states: “The mere fact that EPA is considering the potential impact of chlorpyrifos exposures in drinking water in the Agency’s FIFRA section 3(g) registration review does not somehow provide Petitioners and Objectors with a vehicle for introducing that topic in the objections process on the Petition denial.”  EPA instead will continue its FIFRA Section 3(g) registration review and complete its evaluation of drinking water exposures to chlorpyrifos, and address these issues in its upcoming registration review decision.

• Objections Asserting that the Denial Order Failed to Respond to Significant Concerns Raised in Comments:  Objectors argue that EPA’s Denial Order committed a procedural error by failing to address significant concerns raised in the comments on EPA’s 2014 risk assessment and 2015 proposed revocation that EPA’s assessment fails to protect children. In particular, the Objectors focus on concerns raised in comments asserting that (1) EPA’s use of 10 percemt cholinesterase as a regulatory standard is not protective for effects to children’s developing brains; (2) EPA has not properly accounted for effects from inhalation of chlorpyrifos from spray drift and volatilization; and (3) EPA inappropriately used the Corteva physiologically based pharmacokinetic (PBPK) model to reduce inter- and intra-species safety factors because the model is ethically and scientifically deficient.

• EPA Response:  EPA denies the objections claiming procedural error, stating it “has no obligation to respond to rulemaking comments in denying the Petition or responding to objections, both of which are adjudicatory actions that are not part of the rulemaking process.  EPA also restated its prior response to the Petition that the “objections fail to meet burden of presenting evidence sufficiently valid, complete and reliable to demonstrate that chlorpyrifos results in neurodevelopmental effects that render its tolerances not safe.”  EPA further “believes it is lawful and appropriate for it to consider federally enforceable chlorpyrifos product labeling restrictions in assessing the extent of bystander risk from spray drift under both the FFDCA and FIFRA.”

Commentary

This latest EPA assessment appears to be more finely crafted than the earlier March 2017 response to the tolerance revocation Petition.  EPA explains that it does not consider the epidemiology studies cited by the Petitioners to be persuasive sufficiently to change EPA’s fundamental approach to assessing chlorpyrifos risks.  EPA notes that its current risk assessment utilizes the default 10X safety factor for infants and children specified by the FQPA, so any argument that it has not utilized this safety factor is moot.  At the same time, EPA maintains that the epidemiology studies do not justify changing EPA’s point of departure for risk assessment, which remains the threshold for 10 percent acetylcholinesterase (AChE) inhibition.  EPA states that there are significant problems with using the epidemiology studies for risk assessment, including lack of access to the underlying data, the absence of any known mechanism for neurodevelopmental effects below the threshold for AChE inhibition, and a lack of scientific consensus on a method for choosing an alternate point of departure based on the epidemiology studies.  This interpretation of the epidemiology studies for chlorpyrifos will remain controversial and these studies will continue to be cited by those who seek to eliminate chlorpyrifos use.

EPA has also taken a position that the burden is on the Petitioners to support a petition to revoke tolerances with reliable data.  What is less clear is “how much” evidence EPA considers sufficient to meet the threshold for tolerance revocation.  Meanwhile, EPA will defer its assessment of possible neurodevelopmental effects of chlorpyrifos below the threshold for AChE inhibition pending completion of the registration review for chlorpyrifos.  The deadline for EPA to complete registration review is October 1, 2022, although EPA states that it intends to expedite this process and to issue a proposed registration review decision by October 2020.

EPA also has included in its decision an intriguing discussion of some new animal studies for chlorpyrifos that purport to show low-level neurodevelopmental effects from chlorpyrifos.  The California Department of Pesticide Regulation relied substantially on these new studies when it designated chlorpyrifos as a Toxic Air Contaminant.  If these new chlorpyrifos studies are deemed credible, they could supplant efforts to use the chlorpyrifos epidemiology data in risk assessments and allow EPA to establish a new point of departure for chlorpyrifos that is not based on AChE inhibition.  Rather than disregarding these new data, which were not submitted in support of the tolerance revocation Petition, EPA says affirmatively that it intends to review them in the pending registration review.

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By Lisa M. Campbell and Timothy D. Backstrom

On August 9, 2018, the majority of a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an opinion in the latest chlorpyrifos case (League of United Latin American Citizens (LULAC) v. Wheeler, No. 17-71636) granting the petition for review of a 2017 order by the U.S. Environmental Protection Agency (EPA) that denied an administrative petition to revoke the tolerances for chlorpyrifos; vacating the 2017 order; and remanding the matter back to EPA with explicit directions to EPA to “revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days.”  A separate dissent stated that the court should have dismissed the case for lack of jurisdiction.  Please see our blog item “EPA Denies Petition to Ban Chlorpyrifos” for more information on EPA’s denial of the petition in 2017.

EPA argued in its brief that the court lacks jurisdiction to review the 2017 order denying the petition to revoke the tolerances for chlorpyrifos because Section 408(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to rule on administrative objections to its denial of the petition to revoke the tolerances for chlorpyrifos before judicial review is available under FFDCA Section 408(h)(1).The majority opinion rejected this argument, stating that FFDCA Section 408(h)(1) “does not ‘clearly state’ that obtaining a section (g)(2)(C) order in response to administrative objections is a jurisdictional requirement.” Rather than a jurisdictional limitation, the majority construed the objections process in FFDCA as a non-jurisdictional “claims-processing rule.”In contrast, the dissenting judge agreed with EPA’s argument that the court lacks jurisdiction to review this matter until after EPA responds to the objections to the 2017 order.

After concluding that the objections process is not jurisdictional in character, the majority next considered whether the petitioners should nonetheless be required to exhaust their administrative remedies by waiting until EPA responds to their objections before obtaining judicial review.Although FFDCA Section 408(g)(2)(C) requires EPA to rule on the objections “as soon as practicable,” EPA had taken no action for 13 months after the objections were filed.The majority concluded that the exhaustion requirement should be waived “in light of the strong individual interests against requiring exhaustion and weak institutional interests in favor of it.”

EPA did not specifically address the substantive merits of the 2017 order in its brief, and the majority found that EPA has consequently “forfeited any merits-based argument.”The 2017 order was issued in the context of an administrative record in which EPA has repeatedly determined that the FFDCA standard for maintenance of chlorpyrifos tolerances (“a reasonable certainty that no harm will result from aggregate exposure to the pesticide”) could not be met because of the risk of neurodevelopmental effects. The standard for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) incorporates this same FFDCA standard. Although the 2017 order stated that “the science addressing neurodevelopmental effects is unresolved,” it did nothing to alter these prior EPA determinations. The majority noted that EPA’s assertion that “significant uncertainty” remains regarding the health effects of chlorpyrifos being directly at odds with the “reasonably certainty” standard and “therefore mandates revoking the tolerance under [FFDCA Section 408(b)(2)(A)(i)].” The majority concluded that the possibility that future evidence may contradict EPA’s current determinations cannot justify continued inaction, and that the failure of EPA to proceed with the revocation of the tolerances and the cancellation of the registrations for chlorpyrifos “has now placed the agency in direct contravention of the FFDCA and FIFRA.”

Commentary

The court’s direct instruction requiring EPA to proceed promptly with revocation of all tolerances and cancellations of all registrations for chlorpyrifos represents an unusually aggressive judicial intervention in the administrative process.Nevertheless, this outcome must be viewed in the context of an eleven year history beginning with an administrative petition that requested the same relief, followed by a writ of mandamus in 2015 from the same court requiring EPA to make a prompt decision on the petition.Although substantial controversy remains concerning the correct interpretation of epidemiology studies with chlorpyrifos, it appears that the court believes that EPA has not taken any action that would support a change in EPA’s prior conclusion that these studies constitute evidence of potential neurodevelopmental effects in children at chlorpyrifos exposure levels below the threshold for acetylcholinesterase (AChE) inhibition. Had EPA’s 2017 denial of the administrative petition been accompanied by an amended risk assessment for chlorpyrifos which articulated a changed conclusion, the court may have been less likely to substitute its judgment for that of EPA.The court seemed to find that because the scientific assessments in the current administrative record could not support the “reasonable certainty” standard in the FFDCA, the conclusion it reached on the merits was unavoidable.

Please see our blog item “Oral Argument Held in Case Challenging EPA’s Denial of Petition to Revoke Chlorpyrifos Tolerances” for information on the oral argument that took place on July 9, 2018, and the briefing in this case.  Further information on the case proceedings is available on our blog under key word chlorpyrifos.

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By Timothy D. Backstrom

On July 9, 2018, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) held oral argument in League of United Latin American Citizens (LULAC) v. Pruitt, a case brought to challenge the decision by the U.S. Environmental Protection Agency (EPA) to deny a 2007 petition by Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC).  The 2007 petition requested that EPA revoke all chlorpyrifos tolerances granted under the Federal Food, Drug, and Cosmetic Act (FFDCA) and all chlorpyrifos registrations granted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  After a series of delays and court decisions concerning EPA action on the 2007 petition, the Ninth Circuit issued a writ of mandamus in In re PANNA v. EPA requiring that EPA take action to grant or to deny the petition no later than March 31, 2017.   Although EPA proposed in November 2015 to partially grant the 2007 petition and to revoke all chlorpyrifos tolerances based on concerns about neurodevelopmental effects in children, EPA ultimately decided to deny the entire PANNA and NRDC tolerance revocation petition in a decision dated March 29, 2017.  More information on EPA’s March 29, 2017, decision is available in our blog item “EPA Denies Petition to Ban Chlorpyrifos.”

After the March 29, 2017 denial decision, the Ninth Circuit denied a motion for further mandamus relief in the PANNA case.  The court stated that, once EPA denies a tolerance revocation petition under FFDCA, “[f]iling objections and awaiting their resolution by the EPA Administrator is a prerequisite to obtaining judicial review of EPA’s final response to the petition.”  The petitioners in the current LULAC case filed administrative objections to EPA’s denial decision on June 5, 2017, but, on the same date, they also brought a new action seeking immediate judicial review.  Five States and the District of Columbia subsequently intervened in the new case.  EPA filed a motion to dismiss the LULAC case for lack of jurisdiction on August 21, 2017, but the court denied that motion, without prejudice to EPA renewing its jurisdictional arguments during briefing on the merits.

Background to Tolerance Petition Decision

EPA’s risk assessments concerning the potential neurodevelopmental effects of chlorpyrifos have been the subject of scientific controversy for a number of years.  In decisions that were the subject of significant criticism and controversy, EPA scientists construed the associations reported in certain epidemiological studies of exposure to chlorpyrifos as evidence that chlorpyrifos may cause neurodevelopmental effects in children at exposure levels that are less than the threshold for induction of acetylcholinesterase inhibition.  In November, 2016, EPA issued an updated risk assessment for chlorpyrifos and all organophosphate (OP) pesticides based on the same epidemiology studies, which included a determination that EPA would retain the default 10X safety factor established by the Food Quality Protection Act (FQPA) for chlorpyrifos and for all OP pesticides.  Pesticide industry representatives have raised concerns about the design and conduct of the chlorpyrifos epidemiology studies, the scientific plausibility of the proposed association of neurodevelopmental effects with low level chlorpyrifos exposure, and the rationale for extending the FQPA determination to OP pesticides other than chlorpyrifos.

Prior to the change in administration in 2017, it appeared that EPA would proceed with its 2015 proposal to revoke chlorpyrifos tolerances based on the 2016 updated risk assessment.  Instead, on March 29, 2017, EPA decided to deny the 2007 petition and to defer its ultimate scientific decision concerning the neurodevelopmental effects of chlorpyrifos until after EPA completes the currently pending registration review process for chlorpyrifos.

Briefs in the LULAC Case

In their briefs, the petitioners and the intervenors in the LULAC case have objected to further delay in EPA’s scientific decision concerning the neurodevelopmental risks presented by chlorpyrifos, as well as to the procedures specified by FFDCA that would require that they await resolution of their objections before seeking judicial review.  From their perspective, EPA has already determined repeatedly that continued chlorpyrifos exposure is unsafe for infants and children, and EPA is therefore required to proceed with immediate revocation of all chlorpyrifos tolerances.

In their briefs, the petitioners and the intervenors argued that the procedures required by FFDCA are not jurisdictional, and that the court therefore has discretion to waive exhaustion of these procedures.  They also argued that exhaustion should be waived in this instance because allowing EPA time to rule on their objections would ultimately be futile, and because further delay would perpetuate EPA’s purported disregard of the FFDCA safety standard.  Further, they argued that, if immediate review is not available under FFDCA, it should be available under FIFRA because EPA also denied a request to cancel the FIFRA registrations for chlorpyrifos.  Finally, the petitioners requested during briefing that the court issue “a writ of mandamus directing EPA to decide LULAC’s objections within 60 days.”

In its brief, EPA argued that the petitioners lack any jurisdiction to bring the current case because the detailed procedures specified in the FFDCA are jurisdictional in nature, and exhaustion of these procedures therefore cannot be waived by a reviewing court.  EPA also argued that, even if the court could waive the exhaustion requirement, the petitioners have raised the same issues in their objections as they raised in their briefs, and there is no basis for the court to presume that allowing EPA to address these issues would be futile.  Moreover, EPA argued that FFDCA Section 346a(h)(5) expressly precludes separate judicial review under FIFRA of EPA’s decision concerning the 2007 petition.  Finally, EPA contended in its brief that the petitioners’ request for a writ of mandamus must be denied because the petitioners did not follow the procedure for making such a request in Federal Rule of Appellate Procedure 21(a).

Commentary

During the oral arguments on July 9, 2018, two of the three judges on the Ninth Circuit panel reportedly expressed frustration concerning the prospect for years of further delay before EPA makes its ultimate decision concerning chlorpyrifos.  Although it is not clear how the court would overcome the formidable jurisdictional barriers to immediate judicial review, it appears that some sort of judicial decision or order compelling EPA to take more immediate action on chlorpyrifos is a possibility. More information regarding these proceedings is available on our blog under key word chlorpyrifos.

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