Posts Tagged 'phthalates'

Steps Forward; Steps Back

Now that August is over and Labor Day is but a memory, it is time to focus on how the twostepsforwardCPSC spent the closing days of summer.  On a positive note, the agency was able to push forward helpful initiatives that ease compliance costs without diluting safety.  Then they had to put a damper on this positive glow with threats of resurrecting the discredited and flawed proposals dealing with voluntary recalls and public information (the §6(b) rule).

Forward Steps

The recently published NPR interpreting the fireworks rule is one of those steps forward.  The fireworks regulation has been on the books for several decades and is sorely in need of updating.  Among many other things, the regulation is designed to address overloaded fireworks but does so in a less-than-straight-forward manner.  It bans fireworks “intended to produce audible effects” if those “audible effects” are produced by using more than 2 grains of pyrotechnic composition.  Rather than measure the pyrotechnic materials in the fireworks device to determine compliance, for years the staff has listened for the intensity of the sound produced by the device to determine if it was intended to produce audible effects or whether the sound produced was merely incidental to the operation of the device.  The staff’s determination as to how loud the device was, based on what a staffer heard, was hardly either objective or measurable and has resulted in compliance actions that have been criticized for lack of objectivity.

The American Pyrotechnic Association has a standard that actually measures the presence of materials that may be used to produce an audible effect.  The APA standard has been adopted by the Department of Transportation regulations that deal with the shipment of fireworks.  The proposal, which has been pushed by Commissioners Robinson and Mohorovic in particular, would adopt the APA standard as the testing measure for the CPSC as well. An objective standard would add clarity both for the staff who must make compliance decisions, and the industry which can stop worrying that compliance is dependent on a staffer’s ear.

Another example of a “step forward” is a proposal determining that four types of plastics used extensively in children’s products do not need to be tested for the presence of phthalates.  This proposal would put into action what product manufacturers have been telling the agency for some time—phthalates are not added to these substances and so testing for them both is unnecessary from the standpoint of safety and is costly and burdensome.  This proposal, which has been a long time in the making, compliments the flexibility found in the 2009 statement of policy on phthalates testing and, hopefully, should provide some relief to a number of manufacturers and importers.

Backward Steps

However, the Commissioners could not end the summer on a positive note.  Instead, on the last day of August, the Commissioners met to talk about their regulatory priorities for the upcoming fiscal year.  Observers of the agency are well aware of the controversy engendered by the agency proposal to significantly change the way voluntary recalls are negotiated and agreed to.  Similarly the proposed changes to §6(b) dealing with how information about individual products is made public would distort the statute and surely subject the agency to needless litigation. I have discussed the problems with these proposals in detail, and the Congress has told the agency to cease and desist.

Chairman Kaye has repeatedly expressed his lack of interest in moving forward with these two troublesome proposals.  However, each time he has been given the opportunity to vote to remove them from the agency’s regulatory priorities list, he has refused to do that.  At the recent priorities hearing he was given yet another chance to do that and he did not step up.  Instead, Commissioner Adler, a staunch foe of §6(b) and a supporter of the voluntary recall rule, announced that he would be trying to draft a “compromise” to offer at some unknown point in the future (and not specifying if that would be before or after the elections).  For those who thought that perhaps these two ill-conceived proposals were behind you, do not be so sure.  Commissioner Adler’s gambit may provide the excuse 3 Commissioners need to defy logic, good public policy and the Congress to promulgate these divisive and poorly thought-through rules.

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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.

Illusory Process = Diminished Results

The CPSC staff is now collecting and cogitating on information about how phthalates—substances added as plasticizers to make plastics soft and pliable—are used to manufacture children’s toys and child care articles.  This activity is part of the agency’s effort (perhaps its only effort?) to minimize the burdens of third party testing, as required by Congress in P.L. 112-28.  If the agency can conclude that certain substances do not and cannot contain illegal phthalates, then it can determine that products made up of those substances do not need to be tested for phthalates.

The problem is that the way the agency is going about its inquiry is almost guaranteed to result in very little relief.  And since phthalates testing is very costly, an illusory process that is structured to minimize any relief available does not reduce the testing burden Congress was trying to achieve, much less what responsible regulators should insist on.  The problem with the phthalates inquiry is that the agency is requiring that stakeholders not only show that phthalates are not now being used in the manufacturing process, but also to show that it is impossible that they will be so used any time in the future, in any place in the world.  In other words no matter how much real world data one supplies, it cannot proof the negative as is being asked by the CPSC staff.  Although we all know the moon is not made of green cheese, who can say what will happen in the future.

The outcome of this inquiry is pretty clear.  Certain predictable substances, such as natural wood and fibers, will eventually receive exclusions from testing (after how many years of costly and unnecessary testing?).  The bulk of products that do not use phthalates but whose makers cannot now predict the future in the absolute terms required by the agency will not get relief.  The agency will claim this as an accomplishment and close up shop on any real burden reduction.

I do not understand why the agency has taken the approach it has.  A real and honest effort to understand where phthalates are used, where they are not and then address its compliance efforts at where they are used and its burden reduction efforts at where they are not would result in significant relief.  Rather than ask stakeholders to prove a negative, they should ask stakeholders to help them understand where the agency should be looking for phthalates.

The response, no doubt, is that a collaborative approach does not guarantee that phthalates will not be added by some unscrupulous manufacturer at some point in the future.  However testing relief does not relieve anyone of complying with the underlying phthalates prohibition.  And the agency has plenty of tools to address that eventually if it were to occur.  Because the phthalates prohibition must be complied with regardless of testing, the agency cannot say that its current constrained approach is required to be consistent with assuring compliance with the existing law.  Denying testing relief to the vast majority of manufacturers who do not use phthalates because of some imagined future scenario which the agency can address should it occur does not carry out the spirit of the law Congress passed.


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