Posted on July 15, 2016
Business groups largely supported the Toxic Substances Control Act (TSCA) Amendments recently signed into law by President Obama to address concerns about the emergence of varying state-by-state requirements regulating the chemicals used in consumer products. But for those wishing to avail themselves of California’s vast and lucrative marketplace, the TSCA Amendments and EPA’s June 29, 2016 plan to begin implementing them may prove to do little to alleviate business’s headaches. While the TSCA Amendments include a number of permanent and temporary federal preemption provisions, they are riddled with holes that may allow California’s activist requirements and plaintiffs’ lawyers to proceed largely unimpeded.
Potential Impact of the TSCA Amendments on California’s Safer Consumer Products (“Green Chemistry”) Program
The Amendment’s preemption provisions could halt or constrain the implementation of the California Safer Consumer Products (SCP) program. The statutory basis for California’s so-called “Green Chemistry Initiative” was enacted just after August 31, 2003 and its initial requirements for Priority Product-chemical pairings were not finalized prior to April 22, 2016 so at least certain types of requirements arising from the SCP program may be subject to TSCA preemption.
But whether these preemption provisions will have a meaningful effect on the future of the SCP program remains to be seen. For example, as long as EPA has not taken any regulatory action on a chemical, California will retain full authority to regulate a product that contains it. Moreover, if the use of the chemical does not fall under EPA’s TSCA jurisdiction, the SCP program’s actions concerning it will never be preempted. (For instance, TSCA does not cover personal care products or beauty products.)
Indeed, California’s requirement that manufacturers of products designated as Priority Products provide the state with data and conduct an Alternatives Analysis pursuant to the SCP program appears to be left unaltered by the new TSCA preemption provisions. Likewise certain forms of regulatory responses to an Alternatives Analysis on a Priority Product, such as mandating certain warnings or other information disclosure requirements, may well be found to survive TSCA preemption.
Potential Impact of the TSCA Amendments on California’s Proposition 65
Proposition 65 requires businesses to provide a “clear and reasonable” warning before knowingly and intentionally exposing a Californian to any detectable amount of a listed chemical unless the business can prove that the exposure level does not pose a significant risk of cancer or is at least 1,000 times below the level which causes no observable reproductive effect. Public prosecutors are meant to be the primary enforcers of Proposition 65, but the statute is most loathed because any individual claiming to act in the public interest also has the ability to enforce it by filing “bounty hunter” lawsuits against manufacturers, distributors, and retailers of consumer products.
California’s federal legislators, including retiring U.S. Senator Barbara Boxer, took pains to ensure that Proposition 65, which was enacted in 1986, remained fully shielded from TSCA preemption. Thus, California can continue to update its list of Proposition 65 chemicals “known” to that State to cause cancer and reproductive harm regardless of the outcome of EPA’s TSCA evaluation on the same chemical. Proposition 65 bounty-hunter lawsuits can also continue to be filed concerning even the most de minimis exposures to chemicals that EPA determines are safe.
That said, it still remains for the courts presiding over Proposition 65 cases to determine if EPA’s risk and safety determinations made pursuant to TSCA will have a significant evidentiary role in a business’s defense of a Proposition 65 claim on grounds other than preemption. California judges may also take EPA’s TSCA determinations about a chemical into account when it comes to assessing (or reducing) Proposition 65 penalties. And, perhaps at best, TSCA’s preemption provisions may also help convince courts that it is inappropriate to allow plaintiffs to continue to use Proposition 65 to obtain chemical “reformulation” of products made for a national or international market instead of just requiring Proposition 65 warnings for them when offered for sale in California.
Posted on July 7, 2016
Toxic Substances Control Act (TSCA) legal practitioners and every American interested in chemical safety celebrated President Obama’s signature Wednesday, June 22, 2016, of H.R. 2576, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The bill extensively amends TSCA, the federal chemical management law, and President Obama’s signature made the Act immediately effective. The amendments go a long and comforting way in fixing what was wrong with TSCA, and empower the U.S. Environmental Protection Agency (EPA) to identify and manage chemical risks more efficiently and effectively.
EPA wasted no time in beginning the challenging task of implementing the new law, and on June 22, rolled out a web page on the new law. EPA’s web page includes links for users to access: the text of the new law; answers to frequently asked questions (FAQ) on the new law; a brief summary of the provisions found in the new law; and Administrator McCarthy’s blog post -- TSCA Reform: A Bipartisan Milestone to Protect Our Health from Dangerous Chemicals.
On the whole, the new TSCA is vastly improved and, if implemented smartly, will make good on fulfilling the promise to make TSCA a truly muscular law that ensures chemical safety and public health. While there are many, many implications of the law’s enactment, its most immediate effect will be on the new chemicals review process. Under old TSCA, entities wishing to bring a new chemical or significant new use of an existing chemical (new chemical) to market submitted a notification and, if the 90-day review period lapsed without notice from EPA, commercialization could occur as permitted under the conditions of the notification. Speed to market and predictability are critical to innovation and business equilibrium. Under new TSCA, EPA must make one of three affirmative determinations: (1) that the new chemical presents an unreasonable risk; (2) that there is insufficient information on the new chemical to decide, or, in the absence of sufficient information, that it may present unreasonable risk, or that the substance is produced in substantial qualities and can be expected to enter the environment or pose substantial exposure risks; or (3) that the new chemical is not likely to present an unreasonable risk.
For new chemicals in the review process on June 22, TSCA Section 26 gives EPA discretion to apply old TSCA to pending notifications not yet “dropped” from EPA review. Importantly, EPA has interpreted this provision and notes on its new webpage “[f]or companies that submitted premanufacture notices (PMNs) prior to enactment and which are currently undergoing review, the new law effectively resets the 90-day review period. The agency will make every effort to complete its review and make a determination within the remaining time under the original deadline. EPA will be making additional information available on new chemical reviews in the very near future.”
EPA has the discretion to proceed in this way, but a preferred interpretation would have been to continue to apply the old TSCA provisions to pending cases for some time period into the future. While clarity is welcomed, the more flexible alternative reading would have allowed for a smoother and more measured transition. The take away here is that pending notifications will have their 90-day clocks reset (it is not entirely clear from what date the clock restarts), and submitters will need to recalibrate their delayed commercialization trajectory accordingly. More information is available in the Bergeson & Campbell, P.C. (B&C®) memorandum TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA and in the new B&C blog TSCAblog.com.
Posted on May 25, 2016
As divisive as Congress is, Members miraculously seem to agree that our chemical management law, the Toxic Substances Control Act (TSCA), needs modernizing. On May 6, the key Members of the Senate announced that they had reached agreement on draft TSCA reform legislation; the House is expected also to act soon, perhaps before Memorial Day. This means that TSCA, our chemical control law enacted almost 40 years ago, could be significantly modernized this year -- a goal that has proven to be uniquely elusive. Many believe that TSCA’s greatest failing, and the deficit that most undermined the public’s confidence in the U.S. Environmental Protection Agency’s (EPA) ability to assure chemical safety, is EPA’s limited authority under TSCA to regulate “existing” chemical substances believed to pose risks. Pending TSCA reform legislation that is supported by an unusually broad group of stakeholders would strengthen EPA’s authority and address this failing. Consensus on the contentious issue of preemption has proven especially challenging as many states are aggressively enacting chemical-specific measures, have been for years, and do not wish to cede authority to EPA. Now that the Senate has reached agreement, the hope is the House can also agree quickly as time is running out. TSCA reform is urgently needed. Congress has never been this close to making it happen, and while we are not there yet, Congress seems poised uncharacteristically to make the right choice. Tobacco products will still not be subject to TSCA jurisdiction, but celebrations will be in order if this elusive milestone is finally reached.
Posted on March 31, 2015
Way back around the turn of the decade from the ‘70s to the ‘80s I was invited by the International Joint Commission to attend a conference in Montreal to discuss whether the Canadians should adopt a statute similar to the Toxics Substances Control Act of 1976 (“TSCA”). The IJC is a largely advisory US-Canadian body whose primary area of interest is the Great Lakes. Also on that delegation was the principal author of the text of TSCA, Clarence (“Terry”) Davies. I did not win many friends on that trip when I argued that TSCA took the wrong approach to regulating chemicals in the stream of commerce and in the environment primarily because it used an inappropriate cost-benefit premised standard of review. I also argued that TSCA’s standards were simultaneously too vague and too complex. I suggested that the Canadians start afresh.
In the years following, Congress ignored repeated calls for significant amendment or replacement of TSCA, including a chorus of suggestions that it be replaced by a statute resembling the European Community’s chemical regulatory regime, REACH. In the meantime, EPA soldiered along, trying to make the best of enforcing an antiquated and fundamentally flawed regulatory statute.
Now after all these years we have two competing bills in the Senate, each of which purports to “reform” TSCA. On the one hand we have S.697, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act”, an allegedly “bipartisan” effort co-sponsored by Senators Mark Udall (D-N.M.) and David Vitter (R-La.), the first hearing on which was held on March 18th. And from another corner, we have S.725, the “Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act”, co-sponsored by Senators Barbara Boxer (D-Calif.) and Ed Markey (D.Mass.). At about 175 legislative pages, these bills aren’t capable of being thoroughly analyzed in a blog.
The Udall bill is tepidly supported by the chemical industry and by at least one environmental group, the Environmental Defense Fund. It is opposed by some other environmental and public safety advocacy groups. It would pre-empt state chemical regulatory programs like California’s Proposition 65 and other state-run chemical regulatory programs in California and Washington. The Boxer bill, predictably, because its principal sponsor is from California, preserves state programs. Both bills in one degree or another attempt to address the core problems with TSCA by changing the standard of review to a risk-based standard, overhauling and strengthening EPA’s information gathering authority on hazard, exposure and use data, and prioritizing chemicals for review. The Udall bill throws a bone to the chemical industry by exempting a wide variety of chemicals considered to be of low exposure potential or low risk.
I confess that, although I am not a policy wonk, I have an interest in these bills partly because if either — or a significant element of either — is enacted into law I will have to re-write an entire chapter of The Law of Chemical Regulation and Hazardous Waste. My guess is that, given Congress’s track record of doing little or nothing over the last few years, I won’t have to worry about getting writer’s cramp any time soon.
Posted on February 7, 2013
For Toxic Substances Control Act (TSCA) aficionados, a new federal legislative session holds the promise of long overdue legislative reform. Among the oldest environmental laws, it is also the most neglected. While hope springs eternal, the odds are against reform any time soon. A deeply divided Congress makes any environmental measure contentious. Pile on other Congressional priorities, including immigration reform, gun safety, and climate change, and we have the makings of more Congressional inaction and gridlock.
It is against this backdrop that we await introduction of Senator David Vitter’s (R-LA) TSCA reform bill, expected this month. As the new ranking Republican on the Senate Environment and Public Works Committee, Senator Vitter’s much-awaited bill marks the first Republican alternative to Senator Frank Lautenberg’s (D-NJ) long-standing TSCA reform measure, the Safe Chemicals Act.
Among many contentious issues is the TSCA safety standard. Senator Lautenberg’s bill contains a “reasonable certainty of no harm” standard to replace the current “unreasonable risk” standard. This language is found in the 1996 Food Quality Protection Act and defines the applicable standard for pesticide exposures in food. A key area of controversy is whether such a standard for food safety is appropriate for chemical exposures, or otherwise represents a “zero risk” standard that likely would inspire epic regulatory costs for questionable improvements in true risk reduction. In the void left by Congressional inaction, state measures are gaining ground. The California Safer Consumer Products Regulations are expected to be issued in final form sometime this year. This game-changing approach to assessing the safety of chemicals in consumer products by requiring chemical “alternative” assessments may well become the default safety standard in the absence of federal legislation.
2013 will be a watershed year for domestic chemical management initiatives. Even if federal inaction continues, a California initiative, like so many others in the past, may prevail and take domestic chemical product safety to places and levels Congress declines to go.
Posted on July 11, 2012
The Toxic Substances Control Act (TSCA) regulates chemicals. It also regulates chemicals in articles, a little known fact that gives rise to big headaches.
TSCA defines an article as a manufactured item that is formed to a specific shape or design. Articles include an enormous array of items, ranging from car bumpers to electronic devices. While the U.S. Environmental Protection Agency (EPA) has used its TSCA authority to regulate articles, it has done so sparingly.
As part of its Enhanced Chemical Management Program, EPA recently proposed Significant New Use Rules (SNUR) for five groups of chemicals (certain PBDEs, HBCD, benzidine-based chemical substances, a type of SCCPs, and DnPP). Three of the proposed SNURs would regulate the chemical substances and articles containing them.
Why is this big news? Well, when EPA issues a SNUR, it is designating a use of a chemical not already in commerce as “new” and subjecting that use to premarket EPA review. This means a manufacturer (including importers) wishing to make a product containing the SNUR substance must submit to EPA a significant new use notice (SNUN) at least 90 days before any commercial use. The uncertain outcome of any SNUN review is the bane of a company’s quest for commercial predictability. Reviews can take considerably longer than 90 days, and EPA’s TSCA authority can be expressed in the imposition of commercial restrictions or operating conditions, some of which may need to be communicated to downstream customers of the SNUN submitter.
There is also concern with the legal and policy implications of these proposals. The proposed rules would regulate SNUR chemicals in articles independent of whether any such article actually poses a risk. EPA notes its concern that if PBDEs contained in articles were exempt, there would be in increase in the amount of PBDEs in commerce in the United States without EPA review as to the implications. This observation, while accurate, falls short of describing any nexus between the presence of PBDEs in articles and risk.
EPA also places an enormous (and some would argue disproportionate) legal burden on commenters to explain existing uses, and to define terms and use applications with sufficient granularity to avoid being considered “new.” Given the complexity of imported articles, EPA’s “one size fits all” approach begs the question whether a more refined subset of articles, products that might actually pose risks, is a more fitting candidate for SNUR regulation.
Important threshold questions of whether EPA should even use its SNUR authority in this way, and the practical implications of doing so, are not framed in the proposals. Whether TSCA’s SNUR authority is the best or only way to address chemical risks, and whether all articles as defined in the proposals present risks worth regulating deserves greater stakeholder discussion. Comments on Federal Register notices that assume the legitimacy of EPA’s legal and policy approach are a poor surrogate for vigorous public debate.
Posted on September 22, 2010
EPA has issued an Advanced Notice of Proposed Rulemaking that broadly re-opens the question whether to authorize PCBs in caulk and under what conditions. EPA did not propose any new rules on the issue, but sought comments on what to do. This balance of this post reviews EPA’s regulatory efforts on this issue and the comments on the ANPRM, and then summarizes some options for building owners while the agency ponders.
Last year EPA announced that in “recent years” it had learned that many 1950 to 1978 buildings may contain caulking with PCB concentrations higher than 50 ppm, indeed often quite a bit higher. Linda Bochert’s post of November 3, 2009 linked to the EPA’s PCBs-in-caulk website, which the agency established to provide guidance for preventing exposures and conducting safe building renovations.
Last year’s guidance conspicuously avoided a central issue: EPA’s position on the legal status of PCB-containing caulk. EPA’s position actually is clear: PCBs at levels above 50 ppm in caulking are not authorized, hence are illegal to maintain. Yet EPA has never mounted a program to identify and remedy PCB-containing caulk, and last year’s guidance tacitly condones leaving PCBs in place indefinitely. So EPA de-emphasizes its legal interpretation. Quite possibly that is because EPA managers have not viewed PCB-containing caulking as causing actual health impacts whereas remediation certainly poses high costs and raises its own health risks.
The bottom line? Clear-cut and sensible regulatory answers remain far in the future. Meanwhile EPA is sending mixed messages – PCBs in caulk are unauthorized but don’t overreact while we ponder. Building owners, prospective purchasers and contractors must sort out their own answers about what to do or not do.
In truth, EPA long has had general awareness of PCBs in old caulk. If the concentrations are below 50 ppm, the caulk qualifies as an excluded PCB product and is not regulated by EPA. If the concentrations are higher, EPA considers the use to be illegal to maintain because EPA has never issued a use authorization for PCBs in building materials.
When over-50 ppm PCBs in caulk are reported to EPA, generally EPA has required remediation under TSCA’s rules. EPA New England (Region 1) has had a number of such matters. The Region also insists that cleanups must meet the requirements of the PCB spill regulations, which generally require cleanup in occupied buildings to levels well below 50 ppm.
Yet there is no obligation under TSCA for building owners to test for PCBs in caulk or to report exceedances to EPA. Many building owners ignore the issue, even if they are aware of the general possibility. So unauthorized caulk persists in many buildings, or goes away during renovations or demolition, awaiting potential discovery in unplanned circumstances.
That has led to a number of mini-crises, particularly for public school systems facing growing parental and school staff awareness. PCBs in schools have been much discussed in New York and elsewhere. In January 2010 the New York City schools and EPA entered into an extensive consent order to evaluate school buildings and study ways to encapsulate or treat PCBs over a period of several years.
In practice then, EPA has sent mixed messages. It has commendably - albeit tacitly -recognized that immediate and costly removal of unauthorized PCBs in caulk usually is not warranted. Yet the use remains unauthorized. Given the strictures of TSCA and the ill repute of PCBs, that remains unsettling for many building owners and prospective purchasers.
Efforts to authorize PCBs in caulk: the 1994 NOPR
The mixed messages from EPA and the issues of cost and health risks call out for clear cut regulatory answers, but also hamper EPA from issuing definitive regulations. It has already tried and retreated before.
Specifically, in 1994 as part of unrelated PCB rule changes, EPA proposed to authorize PCBs in pre-TSCA building materials, with conditions, similarly to intact asbestos containing materials. The NOPR included EPA’s conclusion that continued use at concentrations above 50 ppm did not pose a significant risk as long as the materials were in good condition. 59 Fed. Reg. 62788, 62810 (12/6/94).
The proposed conditions had many downsides from a building owner’s perspective, because leaving the materials in place, once discovered, would have then required:
· Notice within 30 days to EPA and potentially exposed individuals;
· Marking in a prominent location;
· Quarterly air monitoring and wipe sampling for one year and annually thereafter until removal of the material;
· Removal or containment (by encapsulation with a sealant) if wipe sampling or air monitoring showed exceedances of workplace standards;
· 24-hour notice to EPA of such exceedances;
EPA’s final rule issued deferred the issue while indicating EPA intended to issue a supplemental notice of proposed rulemaking and asking for further information on how much of a problem this is or not. 63 Fed. Reg. 35383, 35386 (6/29/98)
The 2010 ANPRM and Comments
Over a decade later, EPA has issued an ANRPM on unrelated PCB rule changes, and used it to request comments on whether EPA should reconsider the 50 ppm level for excluded PCB products. That request also specifically called for comment on whether EPA should issue a use authorization for PCBs in caulk. ANRPM, 75 Fed. Reg. 17645, 17664 (April 7, 2010). The ANPRM did not, however, describe any revised levels or conditions that EPA might propose for PCBs in caulk.
Many of the comments on the APNRM on this issue call for more study, but otherwise reflect an unsurprising range of recommendations. Comments from the Children’s Environmental Health Network urged EPA to cease any thought of authorizing an increase in the 50 ppm level. Comments from the American Federation of Teachers recommended a “suspension” of the allowance of PCB-containing caulk below 50 ppm while research is done. Massachusetts DPH comments tracked EPA’s position of 1994 by recommending leaving intact caulk alone, and included its own recent guidance to that effect. MIT’s comments proposed a facility-specific and detailed risk management approach. Comments from the National Association of College and University Business Officials recommended issuance of a use authorization for intact materials, perhaps conditioned on an I&M program.
Overall, the ANPRM attracted relatively few comments on this issue, by contrast with voluminous comments from the utility sector on other issues. The paucity of attention may mean that PCBs in caulk still have not reached a widespread awareness in the commercial real estate community, which provided exactly no comments. Or building owners just may prefer the status quo.
Continued Regulatory Uncertainty: Working Out Own Answers
It seems likely that EPA will not be providing any new rules on this issue in the foreseeable future. That leaves the regulated community to work out its own answers as best it can.
It appears that many building owners have determined not to look for PCBs in caulk, even in buildings where they might be expected. There is no requirement to do so and there have been no reports of actual health impacts due to PCBs in caulk.
Other building owners have chosen to test for PCBs in caulk in order to reduce regulatory risk, but only when renovations or demolition are undertaken for other reasons. Only if unauthorized PCBs are found then do they conduct remediation under the health and safety and disposal restrictions under the PCB rules.
Some prospective purchasers are including this issue in their due diligence, particularly if renovations are planned, and building attendant costs into the pricing. But some do not, relying on the absence to date of regulatory requirements, regulatory pressure or health impacts.
Some owners are writing requirements into construction contracts to make sure that contractors identify and handle any such caulking appropriately, similarly to contractual provisions for asbestos-containing materials.
Given EPA’s mixed message – PCBs in caulk are unauthorized but don’t overreact – each of those practices may be sensible. Building owners and prospective purchasers must choose their own paths based on their own policies and risk tolerance.
Posted on June 30, 2010
No one doubts that EPA’s war on lead-based paint serves the cause of mitigating an established health threat. With children being particularly at risk, the regulations to date have focused on lead-based paint in older homes and other “child-occupied facilities.” On May 6, 2010, however, EPA gave notice of its intent to take the battle to an undefined set of commercial and public buildings. Can a full-scale assault on commercial facilities, which will involve a more complex set of regulatory variables and which will venture farther from the core health risk concerns, succeed in achieving a proper balance of competing factors?
EPA’s May 6, 2010 Advance Notice of Proposed Rulemaking announcing the next step in the lead-based paint campaign was published only days after the April 22, 2010 effective date of the controversial Renovation, Repair and Painting Rule (“RRP Rule”). That rule regulates renovation and repair activities disturbing lead-based paint in older homes and child-occupied facilities. The RRP Rule affects contractors, landlords and others who perform RRP work for compensation.
The RRP Rule includes provisions for the required certification (for a fee) of firms performing covered RRP work, the training and certification (at a significant cost) of “Certified Renovators” through EPA-accredited classes, the required use of detailed RRP work practices when performing covered activities, the retention of compliance records, and the verification of compliance with work practice obligations. Even though the RRP Rule has a relatively narrow focus - residences and other child-occupied facilities - its requirements have generated substantial controversy.
Because the RRP Rule applies to numerous trades and contractors, as well as to certain landlords and other persons, issues related to obtaining the required training, safe implementation of the work practice requirements, costs of compliance and the possibility of a $37,500 per day, per violation penalty are only now being confronted by the regulated community as well as the regulators. Small contractors may be forced out of business, impacting competition. Needed RRP work may not be performed due to cost. Lead-contaminated waste disposal will create new environmental/health problems partially offsetting the benefits of the RRP Rule. Suffice it to say, EPA has not yet solved the numerous problems and complexities of implementing even these regulations focused on older homes and child-occupied facilities.
With this background, and setting aside for the moment legal mandates, one can reasonably question whether EPA is prepared to set its sights on a significantly more complex regulatory challenge- the renovation and repair of an estimated two to three million commercial and public facilities constructed prior to 1980. The ANPR includes no proposed language. Rather, the public is invited to respond to over 100 detailed questions and data requests.
At this time, the scope of EPA’s assault on the renovation and repair of commercial and public buildings is unknown. No current limitations on covered “commercial” and “public” buildings exist and both exterior and interior renovation and repair work are included in the ANPR. Unresolved questions include: What renovation and repair work should be covered? What activities create the most risk? Should exposure pathways be broadened to include nearby properties? How should the substantial amount of lead-contaminated waste be handled to avoid creating a different health and environmental hazard?
This much is known. The regulatory variables associated with extending the war on lead-based paint to commercial and public buildings are more numerous and the targeted health risks have expanded. I suggest that there is a real possibility that the regulations could fail to appropriately balance the legitimate interests of contractors, building owners and the public with the known and perceived health risks. Let us hope that the regulated community weighs-in on these issues and that the EPA gives careful thought to this next step in its campaign against lead-based paint.
The public comment period for this proposal ends July 6, 2010.