SIGNIFICANT NEW USE RULES PROPOSED FOR 66 CHEMICALS

proposed rule

 

Title: Significant New Use Rules on Certain Chemical Substances

Docket ID: EPA-HQ-OPPT-2018-0650

Agency: Environmental Protection Agency

Comments Close: December 31, 2018

Summary Index:

  1. Purpose

  2. Regulatory Actions

  3. Context

 

e-PMN Form for submission of a Significant New Use Notice

Source: EPA webinar September 16, 2015

 
PURPOSE:

The Environmental Protection Agency ‘is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 66 chemical substances which were the subject of premanufacture notices.’ This is to achieve four objectives:

  1. Receive notice of any person's intent to manufacture or process a listed chemical substance before that activity begins.

  2. Have an opportunity to review and evaluate data submitted in the notice.

  3. Assess whether the prospective manufacture or processing is likely to present an unreasonable risk, and if so, take necessary regulatory action.

  4. Identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).

 

REGULATORY ACTIONS:

The Environmental Protection Agency proposes that persons who intend to manufacture (defined by statute to include import) or process any of these 66 chemical substances for an activity that is proposed as a “significant new use” to notify EPA at least 90 days before commencing that activity. A list of these 66 chemicals can be found in both the Federal Register website and 40 CFR part 721, subpart E. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.

CONTEXT:

Under the Toxic Substances Control Act Section 5(a)(2), EPA has the authority to determine that a use of a chemical substance is a “significant new use” (SNUR). Relevant information for EPA to consider includes the toxicity of chemical substances and potential human exposures and environmental releases that may be associated with the conditions of use of the substances. The notification required by an SNUR, a Significant New Use Notice, obligates EPA to assess risks that may be associated with the significant new use, and, if necessary,  regulate the proposed new use.

Regulatory responsibilities associated with chemicals included, or not included, in the TSCA inventory.

Source: Reach 24H Consulting Group

To establish a significant new use, EPA must determine that the use is not ongoing. In this proposed rule, November 15, 2018 was designated as the cutoff date for such determination.

EPA encourages those preparing SNUR submissions to include detailed information on human exposure and environmental release that may result from the significant new use of the chemical substances, and information on risks posed by the chemical substances compared to risks posed by potential substitutes.

 

 

 

 

 

Contributor: Post-Doctoral Fellow, Environmental Health

NATIONAL AMBIENT AIR QUALITY STANDARDS: CALL FOR INFORMATION

NOTICE

 

Title: Call for Information on Adverse Effects of Strategies for Attainment and Maintenance of National Ambient Air Quality Standards

Docket ID: EPA-HQ-OAR-2018-0365

Agency: Environmental Protection Agency

Comments Close: October 24, 2018

Summary Index:

  1. Purpose

  2. Notice Details

  3. Context

 

“Steps Associated with a Streamlined and Efficient Review of National Ambient Air Quality Standards

Source: Memorandum on ‘Back to Basics Process for reviewing NAAQs - Scott Pruitt, 5/9/2018

 
PURPOSE:

The Environmental Protection Agency is soliciting scientific input regarding ‘adverse public health, welfare, social, economic, or energy effects,’ which could result from setting and attaining national ambient air quality standards. The Environmental Protection Agency is specifically soliciting sources of peer-reviewed information regarding the impacts of strategy-setting for national ambient air quality standards. 

 

NOTICE DETAILS:

The Environmental Protection Agency (EPA) is calling for information to inform the review of national ambient air quality standards (NAAQS) and the strategies used to develop NAAQS. The EPA is particularly interested in:

  • Statements assessing strategies for attaining NAAQS, covering various sources of emissions (stationary, mobile, area)

  • Statements evaluating the effects of permitting requirements on economic growth, including new and preventative requirements

  • Statements examining the impacts of not achieving NAAQS and the effect on employment and economic growth

  • Statements evaluating the impacts of health, welfare, energy use and other social effects

  • Statements evaluating trade-offs between strategies for attaining NAAQS

CONTEXT:

The Clean Air Act mandates that the EPA facilitate the Clean Air Scientific Advisory Committee (Committee), which is charged with evaluating existing national ambient air quality standards (NAAQS) every five years. The Committee must review NAAQS criteria and recommend appropriate revisions or standards. The Committee is further charged with advising the EPA administrator of the process and necessity for further research, especially regarding anthropogenic (human-based) sources of air pollution.

The Clean Air Act distinguishes between primary and secondary standards for NAAQS. Primary standards are focused on protecting the human health, in particular for “sensitive” populations, including children, the sick and the elderly. Secondary standards are focused on protecting the public welfare and include “protection against decreased visibility and damage to animals, crops, vegetation, and buildings.” The EPA has set NAAQS for six criteria pollutants (listed in the table below), but has often failed to update and review the criteria pollutants every five years.  

 

 

 

Sources:

https://www.epa.gov/criteria-air-pollutants/naaqs-table

https://www.epa.gov/sites/production/files/2018-05/documents/image2018-05-09-173219.pdf

 

 

Contributor: Master's Candidate, Water Science and Governance

INFORMATION COLLECTION: Prenatal Assessment of Environmental Risk

NOTICE

 

Title: Proposed data collection for Prenatal Assessment of Environmental Risk

Docket ID: ATSDR-2018-0007

Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services

Comments Close: November 5, 2018

Summary Index:

  1. Purpose

  2. Notice Details - Stated Goals & Objectives, Main Themes

  3. Context

 

Workflow for the Agency for Toxic Substances and Disease Registry

Source: www.atsdr.cdc.gov

PURPOSE:

This notice invites public comment on a proposed information collection project titled “Prenatal Assessment of Environmental Risk”, or PAER. The long-term goal of PAER is to be widely adopted by reproductive health care professionals to provide informational resources and to facilitate reduction in harms associated with environmental chemical exposure to pregnant women and their babies (see CONTEXT below).

 

NOTICE DETAILS:

The Agency for Toxic Substances and Disease Registry is proposing a new information collection project called “Prenatal Assessment of Environmental Risk”, or PAER. Comments are being collected on the…

  1. Necessity of the proposed information collection

  2. Accuracy of the estimate of the burden of collection

  3. The quality, utility, and clarity of the information to be collected

  4. Collection techniques or information technology

  5. Collection cost

CONTEXT:

In response to call from the American College of Obstetricians and Gynecologists (ACOG) and other obstetrician-gynecologist professional societies for timely action to identify and reduce exposure to toxic environmental agents, the Agency for Toxic Substances and Disease Registry is requesting a three-year clearance for a new information collection, PAER. Federal agencies are required under the Paperwork Reduction Act of 1995 to obtain approval from the Office of Management and Budget for collection of information.

The long-term goal of PAER is to be widely adopted by reproductive health care professionals to provide informational resources and to facilitate reduction in harms associated with environmental chemical exposure to pregnant women and their babies. It also establishes a public health surveillance system that covers nationwide regions. Participation is voluntary. The Agency for Toxic Substances and Disease Registry will maintain anonymous patient PAER survey responses. The Agency will not receive any information from the electronic health records.

PAER is a web-based survey of 17 multiple-choice questions and one open-ended question. It covers five topic areas (“Lifestyle; home; food and water; cans, bottles, and containers; and getting ready for the baby”) and 11 common types of environmental exposures (“Air pollution, benzene, bisphenol A (BPA), flame retardants, lead, mercury, polychlorinated biphenyls (PCBs), pesticides, phthalates, smoking, and volatile organic compounds (VOCs)”). Respondents to PAER will include reproductive health care clinicians (RHCCs) and women of reproductive age who are seeking preconception or prenatal care.

In the next three years, the Agency for Toxic Substances and Disease Registry estimates that 5338 reproductive health care clinicians (clinician) and 66441 patients will adopt PAER. Online registration and training module components are estimated to take 30 minutes per clinician. Each clinician is estimated to have 12 patients participating in PAER each year and spend 30 minutes on each patient. Each patient is estimated to spend 10 minutes on answering the survey. The estimated annualized burden hours for the whole country is 45,722 hours.

 

 

 

 

 

Contributor: Post-doctoral Fellow, Environmental Health

EPA DRAFT STRATEGIC PLAN 2018-2022

NOTICE

 

Title: Draft Fiscal Year 2018-2022 Environmental Protection Agency Strategic Plan

Docket ID: EPA-HQ-OA-2017-0533

Agency: Environmental Protection Agency

Comments Close: October 31, 2017

Summary Index:

  1. Purpose
  2. Strategic Plan Details - Stated Goals & Objectives, Main Themes
  3. Context

 

Map of EPA Offices in the United States. 

Source: epa.gov/aboutepa

PURPOSE:

The Environmental Protection Agency (EPA) is notifying the public that they are currently taking comments on the EPA's Draft Strategic Plan for the 2018-2022 Fiscal Year period. The Strategic Plan establishes goals that are meant to fulfill the EPA’s core mission as a governmental agency. 

 

 

STRATEGIC PLAN DETAILS:

Goals and Objectives

The Draft Strategic Plan puts forward the following three goals, with more specific objectives listed underneath. The full text provides a more thorough explanation of each objective, along with strategic measures, strategies for achieving each objective, and external factors / emerging issues.

Goal 1 – Core Mission: Deliver real results to provide Americans with clean air, land and water.

  • Objective 1.1 – Improve Air Quality.
  • Objective 1.2 – Provide for Clean and Safe Water.
  • Objective 1.3 – Revitalize Land and Prevent Contamination.
  • Objective 1.4 – Ensure Safety of Chemicals in the Marketplace.

Goal 2 – Cooperative Federalism: Administer the law, as Congress intended, to refocus the Agency on its statutory obligations under the law.  

  • Objective 2.1 – Enhance Shared Accountability.
  • Objective 2.2 – Increase Transparency and Public Participation.

Goal 3 – Rule of Law and Process: Rebalance the power between Washington and the states to create tangible environmental results for the American people.

  • Objective 3.1 – Compliance with the Law.
  • Objective 3.2 – Create Consistency and Certainty.
  • Objective 3.3 – Prioritize Robust Science.
  • Objective 3.4 – Streamline and Modernize.
  • Objective 3.5 – Improve Efficiency and Effectiveness.

In addition, the Strategic Plan targets specific objectives as two-year agency priority goals for the strategic measures. These goals 'reflect the top near-term implementation performance improvement priorities of an agency’s leadership.' 

Main Themes

The explicit environmental goals that are explained within the plan include:

  1. Improved measurement of air quality and increase the areas of high air quality standards (p.6) ,
  2. Improving drinking water infrastructure (p. 9),
  3. Accelerating progress on Superfund sites to clean up contaminated sites (p. 12), and
  4. Effectively implement the Toxic Substances Control Act and the Federal Insecticide, Fungicide, and Rodenticide Act of 2016 (p. 15).

The Strategic Plans suggests that the EPA might be moving towards reducing regulatory burden (note: this is not explicitly written in the plan). The EPA does plan on:

  1. 'Accelerating permitting related-decisions.' (p. 34)
  2. 'Eliminate unnecessary or duplicative reporting burdens to the regulated community.' (p. 22)
  3. 'Reduce procurement processing time' and 'reduce unnecessary or unused office, warehouse, and lab space.' (p. 36)

The EPA plans to increase 'efficiency and effectiveness' in a variety of ways, as illustrated by the following Strategic Measures:

  1. 'Reduce the time between the identification of an environmental law violation and its correction.' and 'increase environmental law compliance rate.' (p. 26)
  2. 'Meet legal deadlines imposed on EPA.' (p. 29)
  3. 'Increase the percentage of decisions using EPA research and scientific analysis.' (p. 31)

As has been noted by a number of news outlets, the EPA Strategic Plan does not include any mention of climate change. This issue has been the focus of the vast majority of comments written by citizens and organizations on the plan.

 

 

CONTEXT:

Every 4 years, the EPA is required by the Government Performance and Results Act of 2010 to revise its Strategic Plan. As described in the full text of this draft Strategic Plan, senior managers at the EPA will 'use this Plan routinely as a management tool to guide the Agency’s path forward, tracking progress and assessing and addressing risks and challenges that could potentially interfere with the EPA’s ability to accomplish its goals.'

The EPA 'is also in the process of deploying a Lean management system specifically designed to deliver measurable results that align with this Plan. Lean is a set of principles and tools designed to identify and eliminate waste from processes while maximizing customer value and return on taxpayer investment. Under Administrator Scott Pruitt’s leadership, EPA will become a Lean organization.'

 

 

 

 

 

Contributor: M.S. Student, Quantitative Ecology