EPA Issues Huge Batch of SNURs - 119 Chemicals in All

In a direct final rule issued today, the USEPA has issued significant new use rules (SNURs) for 119 new chemical substances.  Four of the chemical substances are already "subject to TSCA consent orders issued by EPA."  According to the Federal Register notice, "this action requires persons who intend to manufacture, import, or process any of these 119 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs."




While SNURs significantly restrict the ability for new companies to manufacture the substances - they are limited by the restrictions in the SNUR - they actually can provide a significant benefit to the original PMN submitter who already are being allowed to manufacture or import the substances listed. 


The four chemicals that are subject to consent orders are the only ones that are considered to be of significant risk, hence the consent order to control that risk. All four are perfluorinated substances.  The other 115 chemicals have more limited restrictions designed to ensure safe use.

The SNUR notice can be viewed in full here.

EPA Seeks Public Comment on Industry Petition for Guidance on Endocrine Disruptor Chemicals

The USEPA on August 10, 2011 published a notice in the Federal Register "seeking public comment on a June 21, 2011 petition" from three major trade associations requesting the Agency "develop and publish guidance explaining the criteria by which EPA will make its decisions on data received in response to the test orders issued under the Endocrine Disruptor Screening Program" (EDSP).

Almost two years ago EPA initiated the EDSP Tier 1 screening for a list of 67 chemicals for the potential of being endocrine disruptors.  Orders for testing were issued in the months following, with manufacturers of the initial list of chemicals being required to conduct eleven Tier I screening assays.  The goal of the suite of assays is to "determine the potential for a chemical to interact with estrogen, androgen and thyroid hormone systems."  Chemicals that were identified as possible disruptors could be subject to a second tier of assays designed to further evaluate and quantify endocrine effects. Last month the Inspector General faulted EPA for not moving fast enough to identify endocrine disruptor chemicals, and this response is unlikely to speed up the process.

Herein lies the reason for the industry petition.  Despite efforts to develop higher level assays, the exact assays to be required and the criteria for selecting them remains uncertain.  Crop Life America (CropLife), the Consumer Specialty Products Association (CSPA), and the Responsible Industry for a Sound Environment (RISE) filed the petition in an effort to better understand how EPA will use the Tier 1 screening data.  Particularly, the trade associations want EPA to "fully analyze the Tier 1 screening data received in response to the list 1 test orders and revise the guidance to be developed to reflect what is learned by the analysis in order to ensure scientifically sound determinations and to protect the public health and the environment."  In other words, what exactly are you going to do with the data received, and can you at least figure out what it all means before jumping into requiring the suite of tests for hundreds of other chemicals.  And definitely don't even think about requiring Tier 2 tests before you know whether the Tier 1 tests provided any reliable information.

The Federal Register notice can be downloaded as a PDF here.

More information on EPA's Endocrine Disruptor Screening Program can be found on their web site.

EPA Gives Advance Notice - Wants Input on Whether to Require Toxicity Testing on Bisphenol A

The USEPA is considering a rulemaking in which they would require additional toxicity testing on bisphenol-A, known commonly as BPA.  Yesterday EPA published an "Advanced Notice of Proposed Rulemaking" asking for public comment on whether and/or how they should require testing "to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations."  The notice is subject to a 60-day comment period.

According to the Federal Register notice, BPA is a high production volume (HPV) chemical and "is a reproductive, developmental, and systemic toxicant in animal studies and is weakly estrogenic."  The concern is that while there have been quite a few studies conducted, many of these have what some believe are significant flaws, thus calling into question their validity and/or ability to be used for regulatory purposes.  BPA is a common ingredient in plastics and has come under intense scrutiny for its potential to be an endocrine disruptor.  Given the disagreement over the scientific evidence and the significant ramifications of a BPA ban (and the similarly significant ramifications of a lack of BPA should the potential adverse effects be demonstrated), EPA is seeking to conduct definitive testing to settle the science.

In addition to toxicity testing, EPA is also considering environmental monitoring to determine the levels of BPA in "surface water, ground water, drinking water, soil, sediment, sludge, and landfill leachate in the vicinity of expected BPA releases."  At present, the advanced notice is focused "only  toward the environmental presence and environmental effects of BPA."  While EPA continues to work with the Department of Health and Human Services on potential human health issues, it "is not considering any additional testing specifically in regard to human health issues at this time."

The full Federal Register notice can be viewed here.  The deadline for public comment is September 26, 2011.

EPA Issues Notice to Deny Claims of Chemical Confidentiality Under TSCA

In its continuing quest to use its current authority under the Toxic Substances Control Act (TSCA), EPA has issued a notice in the Federal Register last week that outlines how it expects to "generally deny Confidential Business Information claims for the identity of chemicals in health and safety studies filed under TSCA."

This wouldn't apply if the chemical identity explicitly contains process information or discloses mixture information that would still be protected under TSCA, but basically it would require the chemical to be readily identifiable by the public. The health and safety studies themselves have never been considered CBI, but a lot of good that does if you can't figure out on what chemical the study was done.

The Federal Register Notice can be found here as a PDF. Additional information on EPA's efforts on increasing transparency on chemical information is available on the EPA existing chemicals web site. --------------------------------------------------------------------

USEPA Revising Enforceable Consent Agreement Procedures to Generate TSCA Chemical Test Data

On Friday, February 19, 2010, EPA published in the Federal Register a proposed rule to revise the procedures for developing Enforceable Consent Agreements (ECAs) to generate test data under TSCA. This seems to be yet another way that EPA is using the current TSCA authority to its fullest ability, as Administrator Lisa Jackson indicated she would do when she first took over the Agency.

According to the Federal Register notice, the main features of the ECA process that EPA is proposing to change include "when and how to initiate negotiations and inserting a firm deadline at which negotiations will terminate." There is also a proposal to amend several sections of 40 CFR part 790 to put all the ECA provisions in one section and the Interagency Testing Committee (ITC) information in a separate section.

ECAs are agreements between EPA and the manufacturers of chemicals to conduct specific testing on a particular chemical substance. They help provide data to EPA that then can be used to make assessments. But the key is that the ECA procedure gets data to the Agency without the Agency having to first make risk or exposure findings (which is hard to do without the data they can't request before they do it) or to promulgate a Section 4 test rule (which takes forever to do).

But the average time to negotiate an ECA has been two years, with negotiations for several chemicals taking much more than two years. And that is just to negotiate the ECA, after which the company would have several years to complete the testing, then another period of time for EPA to evaluate the data, then more negotiations to determine the remediation path forward if a concern is identfied. On top of this, many ECAs that begin negotiations never get finished. So the idea of this proposed change is to make the ECA negotiation process more efficient, more flexible, and more transparent.

As noted, the proposed rule was published in the Federal Register on Friday and the comment period is now open. Comments must be received on or before March 22, 2010. After that EPA will evaluate the comments, make any necessary adjustments in response, and then issue a final rule with a date in which it will go into effect.

So it seems there continue to be two roads that both lead to changes in how chemicals are regulated. On the current road EPA is trying to move from a crawl to a walk and maybe to a run. But it's clear that the old dirt road of the past will be replaced with a new paved road of the future. The question remains, however, whether the new road will be a superhighway at rush hour or one at off-peak hours with respect to efficiency and efficacy.

SURPRISE!! - US Government Asks for Public Input on Scientific Integrity

In a surprise move, the US government published in the Thursday, April 23rd Federal Register a "request for public comment" on a scientific integrity memo. This relates to the memorandum issued by President Obama on March 9, 2009, in which he required "the Director of the Office of Science and Technology Policy (OSTP)to craft recommendations for Presidential action to ensure scientific integrity in the executive branch." I discussed the memo in a previous post.

The Federal Register notice "solicits public input to inform the drafting of those recommendations." The notice asks "a series of questions to help guide the public in responding to this request."

As defined in the current Federal Register notice, the six principles of the President's March 3rd memorandum, and on which public comments are solicited are:

(a) The selection and retention of candidates for science and
technology positions in the executive branch should be based on the
candidate's knowledge, credentials, experience, and integrity;

(b) Each agency should have appropriate rules and procedures to
ensure the integrity of the scientific process within the agency;

(c) When scientific or technological information is considered in policy decisions, the information should be subject to well-established scientific processes, including peer review where appropriate, and each agency should appropriately and accurately reflect that information in complying with and applying relevant statutory standards.

(d) Except for information that is properly restricted from disclosure under procedures established in accordance with statute, regulation, Executive Order, or Presidential Memorandum, each agency should make available to the public the scientific or technological findings or conclusions considered or relied on in policy decisions;

(e) Each agency should have in place procedures to identify and
address instances in which the scientific process or the integrity of
scientific and technological information may be compromised; and

(f) Each agency should adopt such additional procedures, including any appropriate whistleblower protections, as are necessary to ensure the integrity of scientific and technological information and processes on which the agency relies in its decision-making or otherwise uses or prepares.

There is a 21 day period for public comment from April 23, 2009 to May 13, 2009.

The fact that this request for public comment relates to a presidential memorandum - which generally are edicts from the President without any public input - is a sign of a greater openness not just in providing the final results but also the underlying research and the process that went into developing the final outcome. It instills a greater degree of public confidence in the scientific process. It also gives all viewpoints - dissenting opinions as well as proponents - a chance to be heard. Which is likely to increase the chances of strong science-based policy decisions being made with less ideological manipulation.