EPA Proposes Rule to Strengthen the Transparency of Regulatory Science

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EPA has published a proposed regulation that is “intended to strengthen the transparency of EPA regulatory science.”   Specifically, the proposed regulation limits science used in regulatory actions to data that are publicly available “in a manner sufficient for validation and analysis.”  The Agency argues that the “proposal will help ensure that EPA is pursuing its mission of protecting public health and the environment in a manner that the public can trust and understand.” This proposed regulation is intended to apply prospectively to final regulations that are determined to be “significant regulatory actions” pursuant to E.O. 12866. Comments are due by May 30, 2018.

EPA argues that “enhancing the transparency and validity of the scientific information relied upon by EPA strengthens the integrity of EPA’s regulatory actions and its obligation to ensure the Agency is not arbitrary in its conclusions,”  “will lead to better outcomes, and [will] strengthen public confidence in the health and environmental protections underpinning EPA’s regulatory actions.”  The Agency explained in the Federal Register Notice that the “proposed rule is consistent with the principles underlying the Administrative Procedure Act and programmatic statutes that EPA administers to disclose to the public the bases for agency rules and to rationally execute and adequately explain agency actions.”

The proposed rule includes a provision allowing the Administrator to exempt significant regulatory decisions on a case-by-case basis if he or she determines that compliance is impracticable because it is not feasible to ensure that all dose response data and models underlying pivotal regulatory science are publicly available in a fashion that is consistent with law, protects privacy and confidentiality, and is sensitive to national and homeland security, or in instances where OMB’s Information Quality Bulletin for Peer Review provides for an exemption.

The proposal solicits comments on a number of issues including the following:

  • The effects of this proposed rule on individual EPA programs, including whether certain activities are appropriate to be excepted.
  • Should the proposal apply to other agency actions and promulgations in addition to “significant regulatory actions?”
  • The definitions of “pivotal regulatory science,” and “dose response data and models” and how to implement such definitions.
  • How to incorporate stronger data and model access requirements into the terms and conditions of cooperative agreements and grants.
  • Methodologies and technologies designed to provide protected access to identifiable and sensitive data.
  • How to balance appropriate protection for copyrighted or confidential business information with requirements for increased transparency of pivotal regulatory science.
  • Whether the disclosure requirements applicable to dose response data and models in the proposed rule should be expanded to cover other types of data and information, such as for example economic and environmental impact data.

EPA Updated the Pesticide Label Review Manual

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EPA has substantively updated the General Labeling Requirements, Precautionary Statements, and Net Contents/Net Weight Chapters of the Pesticide Label Review Manual, and made minor editorial changes throughout the rest of the manual. This manual is designed to help industry understand the pesticide labeling process and how labels should be drafted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The latest updates are as follows:

General Labeling Requirements — Chapter 3:

  • Web-distributed labeling section now includes container label language example;
  • Label submission requirements section now includes e-submission option;
  • Final printed labeling section now reflects current practices;
  • Updated mode of action symbol reference from PR Notice 2001-5 to PR Notice 2017-1; and
  • First aid statement location now reflects requirements of EPA’s guidance document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68.”

Precautionary Statements — Chapter 7:

  • Added dermal sensitization to acute toxicity categories table (Table 1);
  • Reinstated first aid statements per PR Notice 2001-1, and updated location of first aid statements per the Feb. 27, 2018, First Aid Guidance Document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68”;
  • Added Note to Physician statement for products containing zinc phosphide;
  • Updated National Pesticide Information Center NPIC information in first aid statements example in Table 9;
  •  Changed “Labeling Options” section to “Modified precautionary statements for diluted products (aqueous solutions only)”;
  • Removed redundant section on NPIC and referenced Chapter 15 for details; and
  • Removed “Optional Labeling/Deviations” section and moved directions under their respective sections.

Net Contents/Net Weight — Chapter 17:

  • Updated introduction section to include notes on declaring net contents information on application form 8570-1 and leaving net contents information blank on draft label for refillable containers; and
  • Updated labeling requirements for packages that use Bag on Valve technology to reflect 2018 NIST Handbook 130 regulations for net weight measurements.

TSCA Fees Rule — Release of Supplemental Information and Comment Period Extension

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On April 24, 2018, EPA released for public comment a supplemental analysis on the definitions of small business size and their effect on Toxic Substances Control Act (TSCA) user fee collection. In the proposed fees rule EPA released in February, small businesses can quality for reduced fee amounts. For the supplemental analysis, EPA requested comment on:

  • Whether an employee-based size standard (how many people are working there) would be more appropriate than a revenue-based size standard (how much revenue comes in), and what that employee level should be (note: the revenue level standard is already in the proposed rule);
  • Whether either size standard should vary from industry to industry for any reason;
  • What other factors and data sources the Agency should consider, besides inflation, when developing the size standard; and
  • What should the new TSCA section 5 fee amounts be if EPA changes the size standard?

EPA is also extending the comment period for the proposed TSCA fees rule until May 24, 2018. This is meant to give interested parties more time to comment on both the rule and the supplemental analysis.

EPA Issues Draft TSCA Inventory With “Active” Substance Designations

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Under the Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) Inventory Reset Rule, manufacturers and importers were required to report all chemical substances that were active in commerce in the ten year “look-back period” ending June 21, 2016. Based on the information it received, the EPA published a draft version of the TSCA Inventory that contains 38,304 substances with “active” designations.

The draft Inventory designates as active those substances:

  • Substances notified under the 2012 and 2016 Chemical Data Reporting (CDR) rule;
  • Those substances EPA received notices of commencement (NOCs) since June 21, 2006; and
  • Substances reported via notices of activity (NOAs) before the February 7, 2018 Inventory Reset reporting deadline.

Substances listed as “active” in the draft Inventory include 30,972 on the public inventory and 7,332 on the confidential inventory. There are approximately 48,000 substances that have not been reported as active.

“Active” designations may grow in the coming months. The Inventory Reset Rule allows processors to report any substances that did not get reported as active by manufacturers or importers until October 5, 2018. In addition EPA has established a process to “activate” substances that are designated inactive.

Download the draft “active” Inventory here.