Archive for the 'CPSIA' Category

The Leap Year Effect at the CPSC

Leap year occurs every four years when an additional day is added to the calendar—February 29.  This is a corrective measure to account for a lack of precision in the earth’s orbit around the sun.   According to old folk traditions, during a leap year, role reversals are common, upsetting the usual norms of behavior.  We saw two examples of the leap year effect in operation last week when the CPSC considered its 2016 operating plan.

During last week’s meeting, Commissioner Mohorovic proposed that the agency adopt an enforcement policy to eliminate a costly and burdensome p impacting the apparel and footwear industry but that could set a useful precedent for other industries as well.  The 2008 Consumer Product Safety Improvement Act requires that manufacturers and importers certify that their products comply with safety regulations.  One of those regulations deals with the flammability characteristics of fabrics used in apparel, sets out testing criteria to determine flammability and exempts from testing those fabrics that, because of their weight and material, inherently do not present the risk that the rule is concerned with.  As the agency rushed to quickly (and somewhat thoughtlessly) implement the requirements of the CPSIA, a majority of commissioners determined that apparel manufacturers needed to certify that exempt fabrics were, indeed, exempt from testing—in other words, they were required to certify that they did not need to test and certify.  Talk about circuitous logic!

But this overreach by the agency is costing the apparel industry—and consumers–$250 million each year in paperwork costs.  These costs have nothing to do with assuring the safety of consumers and are totally related to wasteful paperwork requirements.  Commissioner Mohorovic was able to convince his colleagues to reverse their earlier position and adopt an enforcement policy that abrogates this process of “certifying that you do not need to test and certify.”

In a similar example of good judgment trumping regulatory excessiveness, at last week’s meeting, Commissioner Buerkle convinced her colleagues to agree to direct staff to prepare a briefing package on the attributes of the California revised rule (known as TB-117) addressing the smoldering hazards associated with upholstered furniture.  The flammability hazards associated with upholstered furniture have been flummoxing the agency since it was created.  The agency exacerbated the problem by insisting that any rulemaking address every ignition source for upholstered furniture fires —not only the vast majority of fires that are caused by smoldering cigarettes, but also those caused by open flames such as lighters and candles. This insistence made the process of writing a rule that much more difficult.  And since the majority of fires are caused by smoldering cigarettes, the agency’s approach meant that the risk of upholstered furniture fires went unaddressed while the regulators pursued unrealistic and uneconomical solutions.  Given this dithering on the federal level, California took the practical step of writing a standard that applied to smoldering fires, which account for the vast majority of fires.

Commissioner Buerkle’s proposal asking the staff to analyze the California regulation is a good first step in moving the agency toward a realistic and, hopefully, more timely effort to address this important issue.  After close to 40 years of analysis, it is time that the agency brought this rulemaking to a sensible resolution.  I hope that Commissioner Buerkle’s proposal has given the CPSC staff the latitude to accomplish this objective—one which advances consumer safety in a practice way.

Isn’t it too bad that leap year comes only every four years.

Saying Goodbye to Another CPSC Star

Several weeks ago, Neal Cohen, the CPSC small business ombudsman, called to tell me that he was leaving the agency.  Neal created the job of ombudsman and it turned out to be one of the most difficult and most under-appreciated but critically important positions at the CPSC.

The office of small business ombudsman was set up in 2010 in an effort to respond to the growing cries, especially from the small business community, that the agency’s regulations implementing the 2008 CPSIA statute were imposing a crushing burden on product sellers, notably small businesses.  When the office was set up, I argued that it should be a true ombudsman, bringing to the agency the concerns of small businesses as well as developing and advocating for solutions to the problems that community faced because of agency action.  Instead, the office was designed to be an outreach and education office—to help the small business community understand and comply with regulations.   While not fully meeting the true definition of an ombudsman, this still was a very important role, especially given the complexity of the rules the agency was in the midst of writing.  And Neal was just the right person to fill the position.

Over the past five years, Neal has worked tirelessly to make sure that businesses, especially small ones, understand their safety obligations as product sellers.  He has designed educational programs, given presentations throughout the country, answered thousands of emails and phone calls, and through that process, has helped the agency put a human and caring face on its work.  The latest achievement of his office, development of the Regulatory Robot, an on-line tool to help businesses understand what regulations they are subject to, will continue to be a testament to his dedication and hard work.

Whoever follows Neal in this role will have big shoes to fill but also a very good role model for how to get done a difficult but important job.  February 19, 2016 will be Neal’s final day at the agency. And as Neal leaves federal service to go into the private sector, no doubt he will come to understand even more the important public service he provided.

Phthalates NPR: Flawed Theory Supported by Flawed Data

risk_measurement_400_clr_5483-300x300On March 16, 2015, the comment period will close for the CPSC’s proposed rule banning specified concentrations of phthalates in children’s toys and child care articles.  While those who make and use phthalates are well aware of this proceeding, it has much broader implications for the entire regulated community.

The proposed rule is flawed not only in terms of substance but also of process.  The manner in which it used a cumulative risk assessment to justify banning products that contribute little, if any, exposure to phthalates has broad and troubling implications that extend well beyond this proceeding.

The proposed rule comes out the report of the Chronic Hazard Advisory Panel (CHAP), established by the CPSIA.  Using a cumulative risk assessment, the CHAP advised, and the Commission majority agreed, that concentrations of the phthalate DINP should be banned in all children’s toys and child care articles.  The CHAP found that “food, rather than children’s toys or child care articles, provides the primary source of exposure to both women and children….”  Nevertheless, the CHAP expressed its concern “that toys and child care articles may contribute to the overall exposure.” (See staff briefing package, “Prohibition of Children’s Toys and Child Care Articles Containing Phthalates”, page 13, emphasis added.)

Cumulative risk assessments can be a useful analytic tool in certain circumstances where risks come from identified multiple sources. However, in this instance, it is very clear that the CHAP had issues about how to do the risk assessment and then how to use it.  Cutting through the scientific jargon, the CHAP report and the CPSC’s proposed rule based on it address a potential health risk by proposing to ban a speculative contributor to the risk.  The notion that this rule will make the marketplace safer is belied by the fact that the CHAP report describes the many other and more primary exposure routes from the other products that contain phthalates—most of which are outside the jurisdiction of the CPSC and many of which are not being used by children.

I believe that the CHAP fell far short of carrying out its duties.  Since the CHAP believed that certain phthalates present health risks, it should have called upon those agencies with jurisdiction to initiate appropriate action rather than just issue its tepid call for more interagency study.   However, for the CHAP go on and “cya”  by recommending regulation of a product class that contributes little, if anything, to the hazard as a way to protect human health is akin to emptying a lake with a teaspoon—lots of effort; little results. And it is an intrusion into a policy area where it has no expertise.

These concerns are amplified by the fact that the CHAP based its findings on stale data, when there is ample evidence that had it used the most recent data available to it, the analysis may well have reached a different conclusion.  For the CPSC, which prides itself on being a “data-driven agency”, to acquiesce in such an inexplicable use of flawed data, much less base a proposed rule on it, is puzzling.  It might lead a cynic to wonder if this was a politically driven decision rather than a scientifically driven one.

Commissioner Beurkle has addressed the shortcomings of the CHAP report in a statement explaining why she could not support the NPR.  It is worth reading.

However, going forward, if the CPSC is going to use cumulative risk assessments to justify banning substances that contribute little if anything to a risk and do so based on stale data and flawed analysis, then all CPSC stakeholders should be concerned.  This is an issue that affects not just the chemical industry.  Those who make and sell products subject to the jurisdiction of the CPSC should weigh in on this troubling dumbing down of science in the name of science.

Shopping the Global E-Mall, Round 2

In my last post, I discussed the growing phenomenon of e-commerce sales directly to consumers from foreign (Chinese) manufacturers. My concern is that the regulatory stance of the CPSC—asserting that a foreign manufacturer is legally responsible for compliance with all U.S. safety standards when a U.S. consumer buys a product directly from that manufacturer—is both naïve and unenforceable.

Therefore, I was interested to see the announcement last week from the CPSC that it has entered into a voluntary agreement with Alibaba, the Chinese e-commerce direct sales company, to work with the agency to try to monitor its platforms for dangerous products.  Kudos to the agency for negotiating this agreement, as modest as it is.

According to press reports, Alibaba handles more e-commerce business than Amazon.com and eBay Inc. combined and, as a platform for third parties, it controls as much as 80 per cent of the Chinese e-commerce business.  Obviously, Alibaba can be a potent ally in policing the marketplace for unsafe products.

Looking at the reported details of the agreement, it is not clear whether it will prove to advance consumer safety in the global e-mall or merely serve as a fig leaf to which the parties can point to show they are doing something.  Alibaba has apparently agreed to block sales of up to 15 recalled products upon request from the CPSC.  Since a substantial number of the over-400 recalls the CPSC does each year are of products from China, there should be no problem finding candidates for this list.  All concede that this agreement is not enforceable. It remains to be seen how aggressive Alibaba will be carrying it out over time.

More interesting is the company’s agreement to make available information about safety requirements to importers into the United States.  U.S. safety requirements are not easily understood, especially those issued since 2009 in response to the CPSIA—see the labyrinthine regulations dealing with testing and certification for examples. Any way to get information to those who are honestly trying to comply can do nothing but help.

Whether this agreement is a modest, but effective first step or just another counterfeit product remains to be seen.  Stay tuned.

Happy (?) Birthday

Perhaps someone, somewhere celebrated the 6th birthday of the CPSIA 10 days ago, but it sure blew right by me.  It took the Product Safety Daily publication to remind me that it had occurred. ?????????????????????????????????????????????????????????????????????????????????

The American Apparel and Footwear Association posted a short, thoughtful blog about the significance of the CPSIA’s anniversary, noting that the law did achieve some important safety benefits but not without some very significant and unnecessary costs.  And it is my position, as a commissioner who lived through the internal debates at the agency, that the CPSC was complicit in exacerbating those unnecessary costs and complexities.  The good things in the law could have been achieved without the heavy toll extracted.  That the agency has not moved to reduce testing burdens as instructed by Congress is either regulatory incompetence or arrogance run amuck.  But I repeat myself.

Time for Doing the Work, Not Looking for Shortcuts

Those who follow the CPSC closely expect that the President’s new commission nominees will be confirmed soon.  The question is: will new leadership change either the tone or the direction of the agency?  Two exchanges during the confirmation hearings made my ears perk up since they went to that question.  Both exchanges addressed the regulatory approach of the nominees.

The first exchange dealt with testing burden reduction.  Remember that PL 112-28 directed the Commission to undertake actions to reduce the costs of third party testing or report back to Congress if it needed additional authorities.  Senator John Thune noted that the agency has done nothing to implement measures to reduce costs in any meaningful way.  Senator Thune asked each nominee, upon confirmation, to provide the Senate Committee with their plans for implementing efforts to reduce testing costs. Senator Thune has given the nominees a real opportunity to show leadership and provide actual relief from the agency’s overly-expansive and costly testing approach—which does not provide consumers with additional safety but does add additional costs to the products they buy.

So as the two nominees craft their plans in response to Senator Thune’s request, will those plans reflect business as usual, with the agency doing only enough to make it appear that it is doing its legal duty but still managing to avoid any real change?  Or will those plans show a thoughtful and creative approach to fixing a problem that Congress and members of the public have identified but which the leadership of the agency, up to this point, has sought to minimize?

Another interesting exchange during the hearing dealt with procedures for issuing regulations.  While addressing the five-year delay in issuing rules for recreational off-road vehicles, the nominee for Chairman, Mr. Kaye, bemoaned the lack of “express” rulemaking authority in the Consumer Product Safety Act.  He attributed regulatory delays to the findings the agency has to make before issuing a final rule and the cost-benefit analysis that he said was “unique” to the CPSC (implying that such analysis was overly burdensome).  But Mr. Kaye did not identify which findings and what aspects of cost-benefit analysis are overly burdensome to the agency. Having that information would provide the basis for a good discussion on regulatory policy at the agency.

Section 9 of the CPSA (15 U.S.C. 2058) spells out how the agency must go about issuing product safety rules or bans. The law states that before the agency initiates rulemaking it must make some preliminary effort to assure itself that the rule is indeed needed.  Those efforts include:

  • a first-cut at describing the potential costs and benefits of the proposed rule;
  • a discussion of why any existing voluntary standard is not adequate; and
  • a description of reasonable alternatives to the rule and why those alternatives should not be considered.

But which of these points of analysis do those advocating for express rulemaking want to eliminate?  Do we really want federal agencies beginning the rulemaking process without doing initial homework in the form of some upfront analysis to assure the public that the proposed direction is correct? To my ears, the complaint that doing your homework is too hard rings hollow.

But perhaps it is the cost benefit analysis that must been done during the rulemaking process that is the problem for those complaining about burdens and advocating express rulemaking.  The law states that the analysis must include a description of the potential benefits and potential costs of the rule and a description of the alternatives to the rule that the commission considered, the costs and benefits of those alternatives and a description of why they were not chosen.  But the law merely states explicitly what necessarily should be included in any competent regulatory analysis.  Unless we are willing to agree that the feds are always right in their regulatory approach, would we not want any agency to gather, write down and then actually consider that information before regulating?

I suspect that the real problem for those advocating for express rulemaking is the law’s expectation that the data will be used to inform results–that the agency actually will use the data to tailor or perhaps even change its preferred regulatory approach.  The law tells the agency that it may not issue a rule unless it finds, among other things, that

  • the benefits of the rule bear a reasonable relationship to its costs; and
  • the rule imposes the least burdensome requirement to adequately address the risk.

In other words, if the agency’s preferred regulatory approach is not the most efficient way to address a risk, then Congress expects the agency to change its approach.

Here are a couple of follow-up questions to the nominees.  Do we want the agency to be able to regulate without regard to costs and benefits? Should not the agency have to change its preferred approach if the costs and benefits are not reasonably related?  Do we want the agency to impose requirements that are more burdensome than they need to be and do so out of ignorance because it did not bother to consider alternatives?  I submit that we do not.  And I believe that experience over the past four years illustrates the importance of these requirements. Several extremely costly and burdensome rules were put into effect without the analysis described above since the CPSIA did not require that analysis.  Indeed, PL 112-28 was passed because the testing rule, not subjected to that analysis, resulted in costs that are excessive.

Regulation is not and should not be easy.  If data shows the need for a rule, then the agency should roll up its sleeves and get to work, not complain about how hard it is and look for shortcuts.  It will be interesting to see if the new leadership is up for doing the hard work.

Déjà Vu All Over Again

Yesterday the CPSC held an all-day meeting to again address ways to reduce the costs of third party testing.  Recall that three years ago, in Public Law 112-28, Congress told the agency of its concern that testing costs were imposing an undue burden and directed the agency to identify and implement opportunities to reduce that burden.  Over the past three years, the agency has asked for public comment on opportunities to reduce testing costs three, or is it four, times (but who’s counting).

Yesterday’s meeting focused on whether the agency should make “determinations” that certain substances do not and cannot contain phthalates and the various heavy metals listed in the toy standard, ASTM F-963. This inquiry is patterned after the action the agency took in 2009 when it determined that certain substances, such as natural fibers and untreated wood for example, did not and could not contain lead and so therefore there was no need to test for it.

Perhaps the agency will determine that the same substances that are exempt from lead testing should also be exempted from testing for phthalates and heavy metals.  If it does, then perhaps that action will provide a bit of relief for those companies that have been engaged in such useless testing.

But I have two questions for the agency:

(1)  What took you so long to reach such an obvious conclusion?

(2)  What more are you going to do to carry out Congress’ mandate or do you plan to stop there?

The agency was able to make its lead testing determinations very quickly and with a minimum of regulatory gyrations.  It has taken the current agency three years to even make an inquiry into questions that should have been very easy to answer.  What may come out of this exercise is very minimal relief with maximum patting oneself on the back for reducing testing costs.   I do hope the agency proves me wrong.

 


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