Home » Articles » Compliance Advisor

Perspective: Compliance Advisor

EPA Proposes New Use Rules

Proposal could limit the use of 14 nanoscale substances.

By Lynn L. Bergeson

The US Environmental Protection Agency (EPA) proposed on December 28, 2011, significant new use rules (SNURs) for 17 chemical substances that were the subject of premanufacture notices (PMN), including seven substances with the term carbon nanotube (CNT) and seven substances with the term fullerene in their respective names.  These 14 substances are subject to consent orders under Section 5(e) of the Toxic Substances Control Act (TSCA). This column provides background on, and the implications of, these proposed SNURs.

EPA has generously used its TSCA SNUR authority when reviewing PMN chemical substances that include nanoscale substances. Under TSCA Section 5, EPA can act cautiously and limit the opportunities for widespread release of new chemical substances — particularly where EPA determines the chemical or its use may present an unreasonable risk of injury to human health or the environment.

EPA states that the 14 nano substances at issue are subject to "risk-based" consent orders under TSCA Section 5(e)(1)(A)(ii)(I).  Under this provision, the limitations that apply to the notice submitters are memorialized in a consent order negotiated between EPA and the PMN submitter. Consent orders require protective measures intended to limit exposures or otherwise mitigate potential unreasonable risk, and related provisions designed to minimize risk and elicit additional information about potential risks. A consent order's limitations only apply to the notice submitter. EPA often thereafter issues a SNUR for substances subject to Section 5(e) consent orders to apply the limitations to all subsequent substance manufacturers by way of regulation.

Three observations are worth noting about the proposed rule. EPA states that because of a lack of established nomenclature for CNTs, the TSCA Inventory names for CNTs are currently in generic form, e.g., "carbon nanotube (CNT), multi-walled carbon nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube (SWCNT)." EPA uses the structural characteristics provided by the PMN submitter to characterize more specifically the TSCA Inventory listing for an individual CNT. 

According to EPA, all submitters of new chemical notices for CNTs have claimed those specific structural characteristics as confidential business information. The proposed rule includes the generic chemical name along with the PMN number to identify that a distinct chemical substance was the subject of the PMN without revealing the confidential chemical identity of the PMN substance. EPA states it's using the specific structural characteristics for all CNTs submitted to help develop standard nomenclature for placing these substances on the TSCA Inventory.

EPA compiled a generic list of those structural characteristics entitled "Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination & Nomenclature." A copy of the list is available under docket ID number EPA-HQ-OPPT-2010-0279.

Second, EPA designates a use as of the date of publication of a proposed SNUR, not the publication date of the final rule. EPA clarifies that persons who begin commercial manufacture, import or processing of the chemical substance that would be regulated would have to cease any such activity and resume them only after compliance with all applicable SNUR notice requirements and wait until the notice review period expires.

Third, EPA offers useful advice in the proposal to potential Significant New Use Notice (SNUN) submitters. A SNUN is simply a chemical with a significant new use designation. EPA notes that it's better able to evaluate a SNUN if detailed information is provided, including:  human exposure and environmental release that may result from significant new use of the substance; potential benefits of the substance; and information on risks posed by the substance compared to risks posed by potential substitutes. The first suggested set of data is the most challenging, and certainly the most costly to assemble. Nonetheless, a SNUN that includes this information has a significantly better chance of a favorable review than applications lacking such data.

The proposal offers useful insights into EPA's approach to the regulation under TSCA of nanoscale chemical substances. While the comment opportunity was very limited, it will be interesting to see if the public and other interested stakeholders weighed in and if so, whether any final rule will be appreciably different.

---

LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at Lbergeson@putman.net.
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on chemical industry issues. The views expressed herein are solely those of the author.

---

More From This Perspective

EPA Proposes New Use Rules
01/16/2012
Proposal could limit the use of 14 nanoscale substances.

EPA Registers Nanosilver As Active Ingredient
12/15/2011
Silver-based antimicrobial pesticide is first such product to gain conditional registration.

NTP Proposes to Revise RoC Review Process
11/15/2011
Suggested changes aim to address industry concerns.

EPA Issues Final Weight-of-Evidence Guidance
10/12/2011
Document addresses analysis for endocrine-disruptor Tier 1 screening assays.

EPA Issues Chemical Data Reporting Rule
09/08/2011
Companies must contend with significant changes.

EPA Moves Ahead With BPA Action Plan
08/10/2011
Agency seeks input on best approach to determine bisphenol A's risk to environment.

U.S. Issues Guidance for Regulating Nanotechnology
07/21/2011
Document recommends future regulation and oversight not inhibit trade or innovation.

U.S. Wants More Transparency in Trade
06/03/2011
New memorandum focuses on encouraging trade, coordination and public participation.

Could TSCA Reform Be Coming Soon?
05/09/2011
Proposal introduces significant new requirements and expansions in others

EPA Issues Final Rules for Boilers
04/19/2011
New subcategories place emission limits on different types of boilers.

OSHA Updates PPE Standards
03/15/2011
Several key changes help clarify the use of personal protective equipment

EPA Expands Endocrine Disruptor Testing
02/17/2011
Agency mandates screening of more chemicals and issues guidance

SCPA Delays Could Impact Industry
01/11/2011
Adoption and implementation of potentially "game changing" regulations are now unclear.

2010 Elections Could Impact EPA Programs
12/28/2010
Some new senators may take a hard line against EPA program expansion.

CPSC Moves Ahead on Harmful Products Database
11/11/2010
Online resource will allow consumers to report issues and manufacturers to respond.

New Inventory Update Rule Reporting Heads Our Way
10/19/2010
Proposed rule will significantly impact reporting functions.

Toxicity Testing Moves Ahead
09/01/2010
The Tox21 Partnership aims for far faster and less expensive screening.

Workplace Falls Get Fresh Attention
08/02/2010
Regulator proposes revised rules to prevent injury.

Transportation Revisions Are Coming Down the Pipeline
07/06/2010
Possible changes to rules for transporting combustible materials may eliminate confusion.

Regulation: Tiny Particles Get Big Attention
06/10/2010
Federal, state, international regulations target nanoscale materials.

EPA Seeks to Lift Stay
05/06/2010
Hydrogen sulfide reporting requirements get scrutiny.

Chemical Pollutants in Water Emerge
04/12/2010
High profile contaminants make for murky regulatory waters.

OSHA Aims to Harmonize Standards
03/10/2010
Aligning chemicals labeling with global rules involves major efforts.

Disclosure Protection May Narrow
02/09/2010
EPA targets confidential business information claims.

EPA Takes Unprecedented Action
01/12/2010
Agency targets several types of "Risk List" chemicals.

Prepare to Report Climate Risks
12/07/2009
Pressure mounts on companies to increase required disclosures.

EPA Targets Electric Utilities
11/04/2009
The agency steps up efforts to manage coal ash damage.

Expect More Inspections
10/23/2009
OSHA’s National Emphasis Program targets more facilities.

EPA Launches Online Discussion
09/08/2009
It’s your chance to impact National Enforcement Program priorities.

Compliance Advisor: Think Small for Water Management
08/05/2009
EPA hosts conference on decentralized wastewater treatment systems.

Safety Comes First for Nanotechnology
07/13/2009
Online guide provides innovative path to product stewardship.

Anti-Terrorism Mandates Face Major Revision
06/08/2009
Prospective legislation may put more emphasis on inherent safety.

Compliance: Vehicle Emissions May Prove Costly
05/11/2009
EPA proposes to find that GHGs endanger public health.

Program Targets Toxic "Hot Spots"
04/14/2009
EPA rolls out school monitoring air initiative.

Chemical Leasing is a Viable Option
03/13/2009
Use it to promote sustainable management of chemicals

Court Strikes Down Key Emissions Exemption
02/20/2009
Decision tightens hazardous air pollution emissions standards.

Legislators Set Agenda for Change
01/15/2009
Regulations are expected to target the chemical industry in 2009.

EPA/Corps Try to Clear Muddied Waters
12/11/2008
EPA and the U.S. Army Corps of Engineers issue joint guidance about Clean Water Act jurisdiction.

Expect More Water Regulation Everywhere
11/18/2008
EPA gets tough on arsenic levels in drinking water

EPA Finally Amends Definition of Solid Waste
10/22/2008
Rule provides exclusions for reclamation of hazardous secondary materials.

Compliance Advisor: New bills target chemicals
06/17/2008
Congress considers kid-safe chemicals legislation

Hazardous chemical shipments face rerouting
06/02/2008
DOT issues new railway rules to keep safety and security on right track

Biomonitoring continues to gain momentum
05/02/2008
CDC outlines criteria for removing chemicals from national report

Act before there’s not a drop to drink
02/13/2008
The Ground Water Protection Council is taking an active role.

Get the lead out
02/05/2008
EPA rethinks air quality standards, seeks comments.

Product stewardship grows globally
01/07/2008
Product stewardship is more essential today than ever before. Globally, stewardship initiatives, whether mandatory or voluntary, are emerging with regularity, and their significance should neither be ignored nor underestimated. Here’s why.

EPA clarifies position on ion-generating equipment
10/30/2007
Claims about a product’s ability to kill pests, including germs, can lead to EPA regulation, says Lynn Bergeson, regulatory editor.

EPA assesses link to greenhouse gases
09/27/2007
Steps taken during manufacturing can significantly impact landfill emissions, advises Lynn Bergeson, regulatory editor, in this month's Compliance Advisor column.

Tiny particles are drawing big interest
08/31/2007
Regulatory Editor Lynn Bergeson discusses how a voluntary program aims at responsible development of nanotechnology in this month's Compliance Advisor column.

Candidate contaminants get reprieve
08/01/2007
EPA decides not to regulate 11 materials in water. Read what Regulatory Editor Lynn Bergeson says about it in this month's Compliance Advisor column.

DHS aims to lock down security rules
07/06/2007
Expect a final ruling this summer on chemicals covered and some other key issues, warns Lynn Bergeson, regulatory editor.

Process safety is a good way to avoid bad consequences
06/06/2007
Process safety is an essential component of risk avoidance. The Occupational Safety and Health Administration (OSHA) has long recognized the critically important role for process safety awareness.

EPA must reconsider carbon dioxide
04/24/2007
Court rules that the agency has power to regulate greenhouse gases. Regulator Editor Lynn Bergeson how the ruling came to be and its impace on the industry.

Federal agencies really get the “green” light
03/28/2007
Executive Order creates opportunities for smart businesses, according to Lynn Bergeson, in April's Compliance Advisor column.

Chemicals transport faces worldly issues
03/01/2007
Global classification and labeling system aims to boost safety, Lynn Bergeson says in this month's Compliance Advisor column.

Chemical security rules edge forward
02/12/2007
Advance rulemaking was recently issued on anti-terrorism standards. Lynn Bergeson provides a summary in monthly Compliance Advisor column.

Exporters get reporting relief
01/08/2007
EPA eases annual reporting requirements and thresholds, and exporters are feeling relief, according to Lynn Bergeson in her monthly Compliance Advisor column.

Wal-Mart applies clout
12/05/2006
Wal-Mart Stores, Inc., previously committed to reduce by 5% the packaging used by its 60,000 suppliers by 2013. Now, a new initiative uses a scorecard to tackle wasteful packaging.

Get answers to your biomonitoring questions
10/24/2006
Guidance for chemical manufacturers, processors, and distributors about Section 8(e) of the Toxic Substances control act was issued on September 14, by the U.S. Environmental Protection Agency (EPA). Chemical Processing's Regulatory Editor Lynn Bergeson discusses the new regulation.

Expect tighter particulate matter standards
09/21/2006
Tighter particulate matter standards are in our future, according to Regulatory Editor Lynn Bergeson in this month's Compliance Advisor column on ChemicalProcessing.com

Biomonitoring gets a going-over
09/11/2006
The current state of biomonitoring is detailed in the much anticipated report issued July 24 by the Committee on Human Biomonitoring for Environmental Toxicants of the National Academies, Washington, D.C.

The impact of the European Union's directives on the U.S.
08/17/2006
The Restrictions of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (the RoHS Directive) is part of a growing wave of European Union product-based regulations that will profoundly impact global and United States product standards — and thus the chemical industry.

Small sensors promise big impact
06/28/2006
Because many environmental applications of nanotechnology will almost certainly revolutionize the science, law, and regulation of water pollution, readers are urged to keep abreast of this fast-changing area.

NIOSH makes big effort on small particles
06/20/2006
Many federal and international bodies are striving to identify and conduct research to fill data needs in connection with the health and safety implications of nanotechnology.

Develop an air-tight defense
04/24/2006
Chemical processors face significant challenges in controlling fugitive emissions. The emissions escape from valves, compressors, pumps, piping components, etc. It is a difficult task, but necessary to avoid penalties and other liability.

What does EPA have in store?
02/17/2006
Don’t expect any major changes in U.S. Environmental Protection Agency (EPA) regulations during 2006. Here’s a summary of trends and developments anticipated this year.

The importance of waste minimization
12/21/2005
It makes good environmental, economic, and business sense.

EPA seeks to reduce TRI reporting burden
11/27/2005
The EPA has proposed a new act in regards to reducing Toxics Release Inventory (TRI). Read here to get the details on how it might affect your plant.

Wade in on water pollutant detection
09/27/2005
An EPA initiative provides a mechanism for helping to shape pending actions.

EPA pushes material-management challenges
08/25/2005
The agency is striving to increase cooperative projects with industry to conserve resources.

Biomonitoring assumes growing significance
07/25/2005
Greater emphasis on chemicals uptake is raising the role of this safety tool.

Nanotechnology readies for a wastewater role
06/27/2005
The federal government strongly backs development of nanotechnology, seeking to ensure that the United States leads the way in developing and commercializing appropriate applications.

The essentiality of process-safety management
05/25/2005
The Chemical Safety and Hazard Investigation Board (CSB) says revision of the Process Safety Management standard is necessary, but OSHA disagrees.

Ultrafine Particles Come Under the Microscope
07/01/2004