Archive for the 'Children’s Products' Category

Fighting the Magnet Wars

 

This morning I watched the oral arguments before the CPSC in the staff appeal of the ALJ’s decision in the Zen Magnets case.  I felt as if I was watching World War One trench warfare in modern dress.  And like trench warfare where the combatants refuse to give an inch, insisting on holding their positions, what we saw this morning was both wasteful and futile, made worse by a predetermined outcome.

To recap, this morning’s exercise was the latest in the long running battle between the CPSC and Zen Magnets which sells small rare earth magnets (“SREMs”).  The agency argues that the magnets are defective because small children can ingest them with resulting severe injuries.  In addition, the agency argues that the magnets are “toys” and violate the toy safety standard which prescribes how powerful magnets used in toys can be.  The agency brought an administrative action to recall the magnets but the administrative law judge who heard the case did not buy the CPSC’s arguments. Instead, he found that the magnets were not defective when accompanied with proper warnings and age restrictions and that the toy standard does not apply to such magnets. The agency staff does not accept this determination and instead appealed it to the Commission—the same body that voted to bring the administrative action in the first place.  I have not found even one person who believes that a majority of the Commissioners will not vote to overturn the ALJ’s decision and order a recall.  At that point, the order will be final agency action and ripe for judicial review.

The ALJ’s decision is not the only skirmish on this subject that the agency has lost.  At the end of last year, the Tenth Circuit U.S. Court of Appeals overturned a federal safety standard issued by the Commission which effectively banned the sale of SREMs by restricting the permissible strength and size of the magnets. The court found that the agency failed to properly address the degree of the risk posed by the product and also the utility of the product.  As a result of these shortcomings, the court overturned the rule. A majority of the Commissioners have now voted to re-propose the rule to correct the deficiencies identified by the court—in other words, beef up the record but still ban the product.

Today’s hearing covered a lot of ground.  For example, even though the agency put incident data into the administrative record, the staff sidestepped shortcomings found in the data (since the incidents could not be attributed to Zen), indicating that no injuries or incidents are needed to support a defect finding.  There was a great deal of discussion about the role of consumer misuse, and the adequacy of warnings and labels.  The Commission asked about the applicability of the toy standard to a general use product

While this all may be interesting to students of martial arts or administrative law, what should be of concern is that consumer safety has gotten lost in these protracted battles—and this must be laid at the doorstep of the agency.  Putting Zen Magnets out of business—which seems to be the objective of the exercise—will not stop SREMs from getting into the hands of consumers.  By shutting down the remaining U.S. company that has aggressive warnings and marketing practices that minimize children’s exposure to the product, the agency leaves the field open to the many other companies, based outside the U.S., that are now selling the product without warnings—and without any interference from the CPSC.

If the agency had spent the resources that it has devoted to this case to looking at what is now going on in the market, rather than seeking to stop the leading proponent of safe and responsible magnet use and who is seeking to bring better safety awareness to the industry, it would be fulfilling its safety mission.  If the agency had accepted the many offers that have been made to educate the public on magnet safety, it would be fulfilling its safety mission.  Instead, it just feels like the agency is fighting a grudge match—what a waste!

The futility of the agency’s position is also maddening.  The magnet recalls that have been done resulted in a dismal return rate.  In other words, the public likes the product—not just because it is very cool but also because it has high utility as an educational, creative and artistic product. While the agency discounts these uses, the public does not.  What the agency has not done and refuses to do is consider whether there are any ways to reconfigure the packaging, beef up the warnings, put in place marketing restrictions, and engage in education efforts so that the public can have access to the product with safety considerations part of the equation. It has done this with other products that present much greater risks to children—button batteries, for example. However, this would require the agency to get out of the trenches and this it refuses to do.  So the magnet wars continue into the future and real consumer safety is the main casualty.

 

 

 

 

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All I Want for Christmas Is . . .

A lifetime government job.  And if the commissioners at the CPSC grant tihe pending pettion to ban certain flame retardants, the staffers working on the ban will get that wish.

Earlier this month, the commission held a day-long hearing to consider a petition to ban all organohalogen flame retardants (OFT’s) used in children’s products, the plastic cases for electronics, mattresses and pads, and residential upholstered furniture.  Petitioners assert that the chemicals making up these flame retardants accumulate in the body and could cause cancer and other chronic diseases. Comments on whether to grant the petition will be accepted until mid-January.

So why does granting this petition guarantee lifetime employment for the staff working on it?  First, the breadth of the petition makes for an almost unmanageable task for those trying to write a regulation that would be upheld by a court.  The petition is not just asking for a ban of a single substance; instead it includes at least 83 different flame retardants, each somewhat different from the other, and would apply to substances for which risks are undemonstrated and entirely speculative. The product categories are also very broad and would include thousands and thousands of products where exposure to the OFR’s differ one from another.  Contrary to the assertions of the petitioners, the statute does not allow for regulation based on speculative harm. And like it or not, the statute does require that any regulation be based on risk and exposure.

In this regard, petitioners draw an analogy to the commission’s regulation of lead, a comparison that is entirely inapposite.  Prior to passage of the CPSIA, the agency regulated lead based how exposure contributed to risk of injury.  Congress changed that science-based approach and decreed that mere presence, not exposure, was the trigger for regulation of lead.  However, for other substances, the agency must still find the existence of a hazard and the mere presence of a substance does not necessarily indicate there is a risk of harm.

Establishing the extent of the risk for a wide class of chemicals as they are used in broad product categories is not the only statutory hurdle that must be addressed.  It is entirely unlikely that the ban requested by petitioners would satisfy the cost benefit analysis required both by the statute and by good administrative policy. For example, while barriers, rather than OFR’s, may be an option for upholstered furniture, the costs of implementing that option are extraordinary.  And the agency would need to consider the value of the lives saved from fires that were prevented by the OFR’s.

The statute also calls for the creation of a Chronic Hazard Advisory Panel (CHAP) when the agency seeks to regulate chronic hazards like those now under discussion.  As experience has shown, managing the work of a CHAP will keep a number of staffers working hard for the foreseeable future.

This is not to say that the health effects of OFR’s should not be examined.  On the contrary, the Environmental Protection Agency has the authority (soon-to-be enhanced under proposed amendments to the Toxic Substances Control Act), and has underway activities looking at these substances.  TSCA clearly gives the EPA the authority to regulate both these chemicals and their uses and the EPA is doing that.  If the pace or outcome of this activity does not satisfy the petitioners, then they should take action at EPA to change that, not go forum-shopping around the government.

This petition illustrates the quicksand the CPSC wanders into when it acts to regulate broad classes of chemicals that may present chronic hazards.  The agency is well equipped to address acute hazards but chronic hazards through chemical exposure present very different challenges.  Should the agency grant the petition and venture into the regulation of whole classes of chemicals, that action could sink the agency into a quagmire that will keep staff busy for years trying to claw out.

Defining “Wooden-Headedness”

In The March of Folly, historian Barbara Tuchman writes:

Wooden-headedness, the source of self-deception, is a factor that plays a remarkable large role in government.  It consists of assessing a situation in terms of preconceived fixed notions while ignoring or rejecting any contrary signs.  It is acting according to wish while not allowing oneself to be deflected by the facts.

Late last week the CPSC Commissioners voted to write Ms. Tuchman’s definition of “wooden-headedness”  into the Code Le_avventure_di_Pinocchio-pag046of Federal Regulations by issuing a direct final rule to give long-awaited “relief” from the burden imposed by its third party testing rules as directed by Congress way back in 2011[1].

The Commission has been promising relief from its burdensome testing requirements but has been doing everything it can to avoid doing anything since 2011 when Congress first directed it to take action.  Now after four years of study and promises to Congress (even as recently as last month), the Commission has found [INSERT LOUD DRUM ROLL HERE] that toys made from unfinished and untreated wood from the trunks of trees do not have to be tested for the presence of seven heavy metals regulated by the toy standard.

The Commission’s action last week is justified by a contractor’s study which is itself a study in the precautionary principle run amuck.  The contractor was tasked with doing a literature search looking at the same natural materials (untreated wood, fibers such as wool, linen, cotton or silk, bamboo and beeswax among other things) which the Commission exempted from testing for lead back in 2009.  Yet only for trunk wood was the contractor able to report sufficient data to show no presence of the suspect heavy metals in concentrations that violated the toy standard.  For most of the other materials there was insufficient evidence reported to show the absence of violative concentrations of the heavy metals. The contractor, however, did find that a report that wool from sheep dipped in arsenical pesticides (which are no longer used) had high concentrations of arsenic as did wool from sheep grazing next to a gold smelting mine.  In other words, if the contractor, in doing its literature search, found a study documenting a problem, then the material was disqualified.  If the contractor could not find a study documenting a problem, the material was also disqualified on the basis of insufficient information.

Back in 2009, the agency staff was able to make rather more expansive determinations quite quickly and efficiently, without expensive contractor studies, and to my knowledge, public health and safety has not been threatened by this action.  The current agency action seeks to take the smallest, most ineffectual step possible and then point to a constrained reading of the statute and an inconclusive contractor study to justify inaction.

Congress told the agency to take action to reduce testing burdens or report back if statutory impediments required Congressional action.  The agency has done neither.  Instead, the Commission, on several recent occasions, has promised Congress that action on test burden reduction will be forthcoming.  One hopes that limiting testing exemptions to toys made from tree trunks is not what the Commissioners had in mind when those statements were made.  It is hard to believe that Congress will find this a satisfactory response either.

So if you use bamboo or perhaps linen or beeswax in crafting your toy, you are out of luck because there is no evidence these materials are unsafe.  For those small businesses out there who might make a toy from a tree limb or decorate the toy with bark or twigs, you are also out of luck!  And if you are looking for clarity, too bad.  As one of my friends in the small business community said when she heard about this, “Is a branch 12 inches in diameter a trunk? Do I need to ask the lumber yard if the wood came from a trunk? Will they even know? Will I need to have proof the wood came from a trunk?  It just comes across as comical.  Is there value in this determination?  I suppose, but for many it is just too little, way too late. Four years late to be exact.”

The fact is that public health is not impacted by toys that include components of natural materials—the agency’s experience with lead has shown that.  Indeed, the natural materials exemption is a very narrow one and hardly opens the flood gates to testing avoidance. One must ask why the agency is so adverse to finding a workable solution to reducing testing burdens.  Wooden-headedness brings about wooden thinking.

[1] Direct final rules are reserved for those rules that are noncontroversial, and usually deal with routine, narrow or non-substantive matters. They go into effect unless someone objects.  In this case the rule, and the testing relief it proffers, could not be more narrow.

Phthalates NPR: A No-Win for CPSC

Assuming that the Commission does not vote to again extend it, the period for filing comments on its proposal to permanently ban certain phthalates closes in a few days.  At that point the monkey will be really on the back of the agency and none of its choices are very good.

Because the way the statute was written, the Chronic Hazard Advisory Panel (CHAP) that Congress directed the agency establish to study the health effects of phthalates, without strong direction from the management of the agency, easily could move into policy issues and this is what has happened with its recommendations.  If the agency holds with the recommendations of the CHAP, it faces sure, and probably successful, litigation at the end of the process.  If it tries to walk back the CHAP recommendations, it gets accused of disregarding “scientific” recommendations protecting children. A real no-win for the agency.

I have written before in this blog about the serious regulatory policy issues that the phthalates rulemaking raises.  For those who are interested in this issue and those who are concerned about the use of cumulative risk assessments, I wanted to bring to your attention an article I authored that appeared today in The Hill Congress Blog publication.  You can find it here.

Should Congress decide to do oversight of the CPSC, there are a number of issues that need examining.  This issue should be added to the list.

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.

Testing Assumptions

This week I had the pleasure of speaking to the leadership and staff of the American Association for Laboratory Accreditation.  The association accredits third party testing laboratories to a wide range of standards including, but not limited to those issued by the CPSC.  My presentation was an opportunity to discuss how the agency has implemented the CPSIA with a special focus on the agency’s testing requirements.  However, this was also an opportunity to have a free-wheeling conversation about the role that testing and testing laboratories play, and should play, in product safety.

I asked these experts whether third party testing of children’s products was the most effective way in all cases to assure regulatory compliance.  Interestingly, these representative of the testing laboratories agreed that while third party testing is the most expensive compliance tool, it is not always the most effective tool.  They pointed to the EPA’s green appliance regulations as an example of an effective regulatory regime that does not mandate third party testing. They pointed to NIST’s accreditation of first, second and third party testing laboratories to make the point that it is possible to oversee the integrity of in-house testing.

I pointed to the rule to require warning labels on slings—cloth infant carriers—that the agency plans to proposed next week, asking whether sending slings to a third party testing laboratory to “test” whether the label was correct was an efficient use of resources.  While the audible answer was “probably not”, judging by the body language of the folks in the room, the real answer was “are you kidding me?!”

I asked these experts about whether testing variability occurs among different labs or within the same lab.  The answer I got was “Of course it exists.  Everyone knows that.”  Apparently, everyone but the CPSC. This is an issue I tried to get the agency to address when I was a Commissioner but agency leadership was steadfast in refusing to even see lab variability as an issue.

We talked about the feasibility of laboratories discounting prices to small businesses who are suffering mightily under the burden of CPSC-required testing.  Commissioner Adler has suggested that laboratories do that since the testing requirements of the law and the CPSC regulations have provided laboratories with such a business windfall.  The conclusion of these experts was that this is not a workable option for a wide variety of reasons.

However, we did talk at some length about the role testing laboratories could play in assuring that testing resources are directed at those products that pose the greatest risk and are not wasted on unnecessary testing.  I challenged the industry to participate constructively in suggesting ways to reduce testing burdens beyond the rather unimaginative actions now being taken by the CPSC. While the industry may experience some short-terms gains by a system that requires excessive and burdensome third party testing, everyone, including testing laboratories, benefits from a system that deploys resources efficiently and reduces the costs that product sellers (and consumers) pay to assure safety in the marketplace.

 

Play at Your Own Risk

NO

Recently I was up in New York and met with two insightful and smart people I want to introduce if you do not already know them.

Phillip Howard is a lawyer, civic activist and the founder of an interesting organization, Common Good.  Part of the mission of the organization is to get back to a place where citizens can take responsibility for making sensible choices:  “Making choices for the common good is impossible if everyone is tied up in red tape. Reclaiming responsibility requires a basic shift—where law sets boundaries for free choice instead of dictating choices for the lowest common denominator. . .Common Good has developed practical solutions to bring reliability and balance to law in healthcare, education, and civil justice, as well as in areas such as children’s play. . .”.  With respect to this last item, the concern is that if all risk is taken out of play, our children will not be prepared for the risks that life inevitably throws at them as they mature.

This brings me to the second person I want to introduce—Lenore Skenazy.  Lenore is a journalist, mother, and the creator of Free Range Kids.  The (tongue-in-cheek) purpose of Free Range Kids is to fight “the belief that our children are in constant danger from creeps, kidnapping, germs, grades, flashers, frustration, failure, baby snatchers, bugs, bullies, men, sleepovers and/or the perils of a non-organic grape.” While Lenore’s writings are amusing, she does make the serious point that when the line between real and speculative risk becomes so blurred—which she contends is happening more and more—our children suffer as a result.

From my perspective as a former CPSC Commissioner, I do fear that the agency, when it is regulating, too often discounts the importance of personal responsibility on the part of consumers.  The result are regulations that try to address every possible risk, real or imagined, rather than actual risks that real-world data and science have demonstrated need addressing.   Imaging the worst-case scenario all the time cabins in our kids but gives government regulators a very wide swath indeed.


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