Posted on June 25, 2018 by editorBy Timothy D. Backstrom and Lisa M. Campbell
On June 19, 2018, 16 federal agencies, including the U.S. Environmental Protection Agency (EPA), issued a final rule delaying until January 21, 2019, the general compliance date for 2017 revisions to the policy governing studies with human subjects that are sponsored or utilized for regulatory purposes by the federal government (83 Fed. Reg. 28497). These revisions to the human testing policy were adopted on January 19, 2017, in a final rule (82 Fed. Reg. 7149) that amended and expanded the “Common Rule” governing human testing originally promulgated in 1991. The 2017 revisions to the human testing policy were originally scheduled to take effect on January 19, 2018, but the agencies published an interim final rule on January 22, 2018, that delayed the effective date for the new policy until July 19, 2018. Thereafter, on April 20, 2018, the same 16 agencies published a proposed rule (83 Fed. Reg. 17595) to delay the general compliance date for an additional six-month period, and to allow regulated entities to implement certain burden-reducing provisions during this interim period.
The rule delaying the effective date of the 2017 revisions for an additional six months takes effect on July 19, 2018. In the period between July 19, 2018, and January 21, 2019, regulated entities must continue to comply with the requirements of the human testing policy as it was in effect prior to the 2017 revisions. Notwithstanding this general rule, affected institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions. Those three provisions are:
- The revised definition of “research,” which deems certain activities not to be research covered by the Common Rule;
- The elimination of the requirement for annual continuing review with respect to certain categories of research; and
- The elimination of the requirement that institutional review boards (IRB) review grant applications or other funding proposals related to the research.
The principal purposes of the additional delay in implementation of the 2017 revisions to the human testing Common Rule are to allow more time for affected institutions to prepare for compliance and for the federal agencies that have adopted the new policy to issue further guidance. The final rule states that the agencies do not expect that any additional delay in the implementation of the policy will be needed.
More information on the federal policy for the protection of human subjects is available in our blog under key phrases human subjects and common rule.
Posted on June 15, 2018 by editorBy Timothy D. Backstrom and Lisa M. Campbell
On June 14, 2018, the U.S. Environmental Protection Agency (EPA) announced that it will soon publish in the Federal Register a Notice of Availability (NOA) stating that worker safety training materials, including the expanded subject matter required by the 2015 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Worker Protection Standard (WPS) for agricultural workers and pesticide handlers, are available for use. The prepublication version of the NOA is available on EPA’s website. The NOA confirms that the publication “triggers the WPS requirement that training programs must include all of the topics specified in the 2015 revisions to the WPS.” Because the 2015 WPS rule is already in effect, employers must provide expanded training addressing these topics within 180 days of publication. The expanded training materials that are the subject of the NOA were developed through a cooperative agreement with the Pesticide Education Resources Collaborative (PERC), and are available on PERC’s website.
EPA previously issued a Federal Register notice on December 21, 2017, stating that it “expects to publish a Notice of Proposed Rulemaking in FY 2018 to solicit public input on proposed revisions to the WPS requirements for minimum age, designated representative, and application exclusion zone.” In this 2017 notice, EPA stated that it did not expect to issue the NOA for training materials addressing the 2015 WPS rule until after completing a rulemaking concerning these proposed revisions. This deferral of the NOA would have significantly delayed the expanded training for handlers and agricultural workers contemplated by the 2015 rule. In the NOA, EPA states that it is still reconsidering the same three requirements, and that “if those requirements are changed through a final rulemaking, training materials may need to be amended to reflect such changes.”
On May 30, 2018, two complaints were filed against EPA in the United States District Court for the Southern District of New York challenging EPA’s decision to defer publication of the NOA. More information on these lawsuits is available in our blog item "Lawsuits Filed in Federal District Court Regarding WPS Training Delay." Because publication of the new NOA will afford the plaintiffs in these cases all of the substantive relief they were seeking, it appears that these actions will now be moot other than any request for attorney’s fees and costs incurred by the plaintiffs.
More information on WPS issues is available on our blog under key words Worker Protection Standard, delay, guidance, and training.
Posted on June 06, 2018 by editorBy Timothy D. Backstrom
On May 30, 2018, two complaints were filed against the U.S. Environmental Protection Agency (EPA) in the United States District Court for the Southern District of New York. Both of these suits concern a decision by EPA to defer publication of a notice of availability (NOA) of training materials prepared pursuant to the Agricultural Worker Protection Standard (WPS), 40 C.F.R. Part 170. The WPS was originally promulgated in 1974, substantially amended in 1992, and then revised again in 2015. Although the 2015 revisions to the WPS are currently in effect, employers are not required to adopt new training programs for agricultural workers and handlers until 180 days after EPA publishes the NOA announcing the availability of the new training materials in the Federal Register.
On December 21, 2017, EPA issued a Federal Register notice indicating that it “expects to publish a Notice of Proposed Rulemaking in FY 2018 to solicit public input on proposed revisions to the WPS requirements for minimum age, designated representative, and application exclusion zones.” In this 2017 notice, EPA acknowledged that the WPS provisions it will propose to revise are already in effect and that training materials consistent with the 2015 rule have already been prepared, but stated that EPA does not expect to issue the NOA for these new training materials until after it completes a rulemaking concerning the proposed revisions to the 2015 WPS rule. The plaintiffs in both of the new district court cases are challenging the decision of EPA to defer issuance of the NOA, which has delayed the timetable for expanded training for agricultural workers and handlers contemplated by the 2015 WPS rule.
The first of two complaints was filed by Rural & Migrant Ministry, et al. (RAM) v. EPA, Case No. 1:18-cv-04743. RAM’s complaint includes four causes of action based on EPA’s failure to issue the NOA. RAM alleges that this failure is “arbitrary and capricious,” constitutes “agency action unlawfully withheld and unreasonably delayed,” and violates the publication requirements of the Administrative Procedure Act (APA) and the Federal Register Act. RAM requests a declaratory judgment that EPA has violated the APA and the Federal Register Act, and injunctive relief to require immediate publication of the NOA.
The second complaint was filed by the States of New York, California, and Maryland, New York v. Pruitt, Case No. 1:18-cv-04739. These State plaintiffs also contend that EPA’s failure to publish the NOA is “arbitrary and capricious,” and constitutes “action unlawfully withheld or unreasonably delayed.” Like RAM, the State plaintiffs seek a declaratory judgment and an injunction requiring that EPA immediately publish the NOA for the expanded training materials. EPA will presumably seek consolidation of the two cases, which both challenge the same EPA actions and seek comparable relief.
The principal question presented by these two WPS cases is whether EPA can lawfully defer full implementation of the expanded training required by the 2015 WPS while it undertakes and completes a new rulemaking to revise certain provisions of the same rule. Although EPA acknowledges that it has prepared the written materials needed to effectuate the expanded training required by the 2015 WPS, EPA will likely argue that it is both more efficient and less confusing for employers and workers to use the existing training materials until after EPA has finished revising the WPS. In contrast, the plaintiffs in these two cases will argue that the 2015 WPS is already in effect, and that the protection for workers associated with the expanded training required by this rule has been improperly delayed by EPA without any prior notice and comment rulemaking.
The decision by EPA to defer full implementation of the 2015 WPS while EPA considers potential revisions to the WPS may be deemed analogous in some respects to other EPA actions that delayed the effective date for a rule expanding requirements for certified applicators who apply restricted use pesticides (RUP). In a decision issued by the U.S. District Court for the Northern District of California on March 21, 2018, the court vacated several EPA actions that had delayed the effective date for the RUP rule, holding that EPA was required to provide notice and opportunity for comment before taking such actions and that EPA lacked “good cause” for acting without notice and comment. See Order Granting Plaintiffs’ Motion for Summary Judgment, Pineros Y Campesinos Unidoa Del Noroeste v. Pruitt, Case No. 17-cv-03434-JSW.
The current cases may be distinguished from the actions EPA took to defer the effective date for the RUP rule because EPA has declined to take affirmative action to effectuate certain requirements in the 2015 WPS, rather than deferring the effective date for any of the requirements in that rule. It remains to be seen whether the district court will consider this procedural distinction to warrant a different outcome.
More information on WPS issues is available on our blog under key words Worker Protection Standard, delay, guidance, and training.
Posted on May 23, 2017 by Lynn L. BergesonBy Lynn L. Bergeson and Margaret R. Graham
In a May 11, 2017, letter from U.S. Environmental Protection Agency (EPA) Acting Assistant Administrator Wendy Cleland-Hamnett to the CEO of the National Association of State Departments of Agriculture (NASDA) posted by Bloomberg’s BNA Daily Environment Report, Cleland-Hamnett states that it is appropriate to grant NASDA’s request to delay implementation of all revised provisions to the agricultural Worker Protection Standard (WPS) “until the necessary guidance and training have been completed which would allow state lead pesticide agencies to successfully implement the rule changes.” EPA has not yet issued any formal delay notifications.
The May 11, 2017, letter was sent in response to a February 17, 2017, letter from NASDA (February 21, 2017, per the NASDA website) that requested EPA to extend the WPS “until at least January 2, 2018, or until adequate enforcement guidance, educational materials, and training resources have been completed and the state lead agencies have the tools, time, and resources necessary to effectively implement the rule changes and assist the regulated community with compliance activities.” This letter was not submitted in the WPS docket in response to a request for comment, but pursuant to a NASDA membership decision. NASDA states in the letter that the new WPS regulations require “significant additional staff time to provide sufficient outreach to workers, handlers, applicators, agricultural employers, trainers and other stakeholders,” and that “the enhanced compliance and record keeping requirements require a robust delivery and understanding of educational resources and training materials to assist [state lead agencies] and the regulated community in understanding, complying, and enforcing the new requirements.”
The WPS final rule including updates and revisions to the existing worker protection regulations for pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) became effective on January 1, 2016, and on January 4, 2017, agricultural employers and handler employers were required to comply with all of the new requirements set forth in the final rule – with the exception of two requirements that would be implemented not before January 2018. More information on the final rule is available in our blog item EPA Publishes Worker Protection Standard Final Rule.
|
