This rule establishes how EPA will consider the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information. EPA shall give greater consideration to studies where the underlying dose-response data are available in a manner sufficient for independent validation.
This rule was proposed on April 30, 2018. The comment period for the proposed rule was open from April 30, 2018, to August 16, 2018. A public hearing for the proposed rule was held on July 17, 2018, in Washington, DC.
On March 3, 2020, EPA announced a supplemental notice of proposed rulemaking (SNPRM) that provided clarifications on certain terms and aspects of the 2018 proposed rule. The public comment period was open from March 3, 2020, through May 18, 2020.
To read written comments posted to the docket, please visit: Regulations.gov: Docket ID No. EPA-HQ-OA-2018-0259.
The supplemental to the proposed rulemaking was published in the Federal Register on March 18, 2020, and is available here: Regulations.gov: Docket ID No. EPA-HQ-OA-2018-0259-9322
Questions and Answers
- What is the purpose of this rule?
The purpose of this action is to codify internal procedural requirements for how the EPA will consider the availability of the underlying dose-response data that it relies upon to promulgate significant regulatory actions and develop influential scientific information. EPA continues to believe that codifying internal procedures aimed at prioritizing transparency in significant regulatory actions and influential scientific information into regulation will improve the public’s access to EPA’s scientific analyses and resulting regulatory actions in a way that is beneficial to the scientific process, the Agency’s mission, and the public’s health and safety.
- What is the Agency’s legal authority for this rule?
EPA is authorized to issue this rule under its authority to promulgate housekeeping regulations governing its internal affairs.
- What Agency actions does this rule impact?
This rule has the potential to impact all future significant regulatory actions and influential scientific information that rely on dose-response data.
- Will this rule apply to other federal agencies?
No, this rulemaking does not regulate any entity outside of EPA; rather, it will only apply to EPA as it governs internal Agency procedures regarding the transparency of pivotal science underlying significant regulatory actions and influential scientific information.
- Does the rule regulate researchers whose science EPA uses?
No. The rule will only govern internal Agency procedures and will not regulate external researchers.
- Would this rule inhibit or otherwise impact the Agency’s ability to respond to emergencies (e.g. COVID, an oil spill or a natural disaster)?
EPA has the authority under its environmental statutes to issue emergency orders when necessary and respond to and address environmental emergencies to protect human health and the environment, and this rulemaking would not limit or impede EPA’s authority to undertake such responses.
Data and Privacy
- Will this rule require or allow the release of an individual’s PII or a company’s CBI?
No. The final rule does not require or allow the release of an individual’s PII or a company’s CBI.
- How will EPA protect personally identifiable information (PII)/confidential business information (CBI)/proprietary information that it makes publicly available?
The EPA will not make PII/CBI in its possession publicly available. This rulemaking does not require the release of PII/CBI nor does it require EPA to collect, store, or publicly disseminate any PII/CBI data underlying pivotal science. Rather, the rulemaking describes how EPA will identify pivotal science and the consideration to afford to studies based on whether the underlying data are available for independent validation. Owners or custodians of the PII/CBI are responsible for maintaining control and confidentiality.
- What data is the Agency required to make available as a result of this rule?
This rule does not impose additional requirements on EPA to make dose-response data available. Only to assess its availability and consider that availability when conducting its dose-response analysis.
- What is tiered or restricted access? What are some examples of tiered or restricted access?
Tiered access in this final rule means that the underlying dose-response data are available through a data sharing mechanism, such as through an agreement with the originating author or institution, access to a refined or redacted dataset that anonymizes the more sensitive portions of the analyzable dataset, a restricted access data repository or secure data enclave, or some other mechanism (e.g., Data Use Agreements) that allows a qualified subject matter expert access to enough data to support independent validation while still protecting sensitive information. CDC and NIH are two government agencies that have secure data enclaves.
- What is the effective date of this rule and how does it impact the ongoing development of significant regulatory actions and influential scientific information?
This rule will go into effect immediately upon publication in the federal register (January 6, 2021), but does not apply to significant regulatory actions for which a proposed rule was published in the Federal Register before January 6, 2021, and influential scientific information submitted for peer review before January 6, 2021.
- Does this rule apply to significant regulatory actions or influential scientific information already finalized?
No. This rule has no retrospective effect on existing significant regulatory actions or influential scientific information .
- May the Administrator grant exemptions? How will that work?
The Administrator may grant case-by-case exemptions to the requirements in proposed 40 CFR part 30 under specific conditions for which compliance with the requirements in proposed 40 CFR part 30 is impracticable. To ensure that the Administrator’s decision is appropriately transparent, EPA has included a provision in the final rule in 40 CFR 30.7 that requires the Agency to document the rationale for any exemptions granted by the Administrator in the significant regulatory action or influential scientific information. The Administrator may determine that greater consideration is warranted when:
- Technological or other barriers render sharing of the dose-response data infeasible;
- The development of the dose-response data was completed or updated before the effective date of this final rule;
- Making the dose-response data would conflict with laws and regulations governing privacy, confidentiality, CBI, or national security;
- Third-party independent validation of the study’s underlying dose-response data through reanalysis has been conducted; or
- The factors in 40 CFR 30.5 used in determining the consideration to afford to the pivotal science indicate full consideration is justified.
- What happens if the requirements to use best available science in an environmental statute conflicts with the transparency rule? Which takes precedence?
If there is a conflict with an environmental statute, this rulemaking will yield to the authority of existing EPA statutes (e.g., Clean Air Act; Clean Water Act; Comprehensive Environmental Response, Compensation, and Liability Act; Emergency Planning and Community Right-To-Know Act;Federal Insecticide, Fungicide, and Rodenticide Act; Resource Conservation and Recovery Act; Safe Drinking Water Act; Toxic Substances Control Act). In any cases where environmental statutes or their implementing regulations conflict with the rulemaking, EPA will first follow the requirements in the statutes and regulations.
- Did the Agency consider the benefits and costs of this rule? Why did the Agency not consider external costs?
Neither the 2018 proposed rule nor the 2020 SNPRM included a characterization of costs to the Agency since this is a rule of internal procedure promulgated under EPA’s housekeeping authority. However, EPA has identified some incremental costs that the Agency may incur as a result of this final rule (these are discussed in the preamble to the final rule.) Given the existing Agency process for identifying and reviewing scientific studies and documentation, as well as that the determination of dose-response data availability is limited to pivotal science underlying significant regulatory actions and influential scientific information, EPA anticipates that the incremental costs of this rule will be small. The Agency may also incur other administrative costs to perform analyses and evaluations to support activities such as exemption decisions made by the Administrator, and documenting these or other decisions made pursuant to the requirements of the final rule. This rule imposes no requirements on parties outside of EPA and thus no costs on researchers or their institutions.