Archive for the 'Risk Analysis' Category



Question: When is Children’s Safety a Particular Concern?

It’s a sad day when the Consumer Product Safety Commission (CPSC) – charged with keeping consumers, especially children, safe from harmful products – can’t even agree that it will demonstrate “particular concern for the safety impacts on children” when it enforces its rules. Yesterday was that sad day.

Two weeks ago, when a majority of the Commission decided to impose a heavy-handed, indiscriminate lead requirement when there were plenty of reasons not to, I suggested that we direct staff to draft an enforcement policy to let people know how we would seek to enforce that rule.  What followed were two weeks of negotiations that resulted in a rather empty “statement” drafted at the Commission level that does little to help the community understand our goals.

I had hoped we could, at least, tell people we will enforce the limit with “particular concern for the safety impacts on children.” This would tell manufacturers of things kids actually use, touch, and mouth that they needed to be extra cautious. I was not able to reach agreement to include this phrase.  Apparently, enforcement with  “a particular concern for the safety impacts on children” isn’t a message we want getting out.

During yesterday’s debate, we heard that we can’t make our enforcement policy public or it will turn into a “How to” manual for getting around our rules. However, such a public policy is not an unusual idea.  Other agencies do it, and, indeed, our own agency has done it before, and we’re still able to enforce our regulations especially when companies get either sloppy or cheap and endanger consumers.

During the debate we also heard that kind of public enforcement policy would be “backdoor rulemaking.” I fail to see how it is anything other than the kind of open, transparent governing we should be doing. We are, after all, supposed to govern in the sunshine, so why not put our policies out front so people know just what it is we’re trying to do? It seems odd to me that it would be “backdoor rulemaking” to talk publicly about what we’re doing privately. It seems to me that, if governing openly is “backdoor rulemaking,” then governing in secret is “trapdoor rulemaking”, and that’s a style of governing I can’t support.*

Instead of a clear, open policy that would put manufacturers of the products most likely to cause harm on notice that they needed to adhere to very tight safety programs, we wound up with the statement we approved yesterday. I agreed to the statement because it does acknowledge that lead testing at the level we’re requiring is, at best, an inexact science, and it assures that staff will consider that fact as appropriate when bringing enforcement actions.

Nonetheless, when we can’t even agree to let people know our enforcement decisions embody “particular concern for the safety impacts on children,” then perhaps it’s time to re-think how we approach regulating.

Here is the statement that we did agree to:

The Consumer Product Safety Commission is cognizant of the claims that some manufacturers have made regarding their difficulty in consistently meeting the 100 ppm requirements because of the inherent variability in testing methods and the variability in materials they use in the manufacturing process.

The Commission always attempts to apply good judgment, common sense and fair and reasonable approaches when it enforces its regulations. The Commission staff will always consider documented claims made by manufacturers regarding their difficulty in consistently meeting the 100 ppm lead content requirements.

*In addition to my concerns on the limited value of the statement we passed, I also believe the majority, in opposing a more substantive policy, is misusing the term “backdoor rulemaking.” In real backdoor rulemaking, agencies establish new rules through procedures other than the familiar (and open) notice-and-comment process the law provides for rulemaking. An example of this would be using enforcement powers to force companies into complying with an agency’s demands, thereby setting a de facto rule without having to go through actual rulemaking.

A Conversation I Wish We Weren’t Having

When I started this blog, I wanted it to be an open conversation with consumers, companies and those who are impacted by what the CPSC does.  The feedback I have gotten has been very helpful in informing my thinking on the various issues we are called upon to address. 

Today a majority of commissioners decided to discount the concerns that a number of small retailers have raised about the effective date of our new crib standard.  I believe that the majority made the wrong decision.  I believe that a modest extension of the rule’s effective date will not impact safety but will help small retailers.  I want to share with you a note I received in response to this vote.  This note sums up the issue better than I ever could and makes fighting the good fight worth it.

Commissioner Nord, I just wanted to take a moment to thank you for your support of our family’s small business in this morning’s Commission meeting. The outcome is sad & will, without a doubt, have a significant impact on medium size specialty stores (with built up inventory) such as ourselves. It is a shame that one . . . competitor (in business 7 years & borrowing to buy cribs at all) was so vocally against helping other specialty retailers. We have been in business 40 years & pay upfront for all of our merchandise. I’m ashamed to be in the same market & category as this other retailer. Thank you for your efforts on our behalf. My family really does appreciate it. From the bottom of our hearts,

Cribs: Good Intentions, Bad Rulemaking

In December 2010, the CPSC unanimously approved a new safety standard for cribs.  The standard, in large part, builds on a voluntary standard that was updated in 2009 and for which there is significant compliance.  The new CPSC standard goes into effect on June 28, 2011 and (as required by the CPSIA) is retroactive, impacting all cribs being sold in the US regardless of when manufactured 

All of the Commissioners are committed to assuring a safe sleep environment for infants and the technical aspects of the new standard demonstrate this commitment.  Having said that, I believe that the Commission also has an obligation to roll out standards in such a way as to minimize disruption in the marketplace.  In that, we have again fallen down in our responsibilities.  The roll-out of the new crib standard has been unnecessarily chaotic. 

Besides the crib standard, there has been only one other major rule issued by this agency in its entire history.  (A major rule is defined as one with an impact on the economy of over $100 million.)  In spite of the crib rule’s significance, no cost benefit analysis was done so we did not have any real information in front of us when voting on the rule, about how the safety benefits of the rule compared to the economic impact of the rule, much less how to minimize that impact. 

The day care industry did protest that the rule, as proposed, would result in approximately a $1/2 billion hit to a group that could not immediately absorb costs of such magnitude, especially on the heels of having just bought new cribs to meet the standards of 2009.  As a result, at the last minute just before finalizing the rule, the Commission agreed to amend the proposed rule to delay the effective date for this group by 18 months.  There was no analysis behind this date; basically, it was pulled out of a hat.  Now, just two weeks before the rule goes into effect, we are hearing from those in the rental industry who cannot get cribs that comply with the new standard and ask that we delay the effective date at it applies to them.  We are also hearing from small retailers who are stuck with stranded inventory that they cannot sell, also asking for a delay. 

We are hearing that a significant number of small retailers will be facing substantial losses.  This is even though the briefing documents we got last December, and on which we relied in voting on this rule, stated that there would be no significant impact on retailers.  I am told that, in reaching this conclusion, no analysis was done on the impact of the rule on this segment of the market. 

At a public briefing this morning it was pretty clear that we do not know the true state of the marketplace.  We heard that some small retailers have been able to accommodate themselves to the effective date of the standard and that a number have not.  (It appears from reading the letters from some of those who believe they are in compliance that their beliefs may be somewhat misinformed.)  The magnitude of the problem is unknown.  An internal survey of 5 retailers found that those companies had at least 100,000 non-complying cribs in inventory.  A survey done by a trade association representing one part of the small retailer community found that 35 companies had 17,500 cribs that cannot legally be sold in two weeks.  The question of whether any of those cribs can be retrofitted is also unclear.  Only 72 hours ago did we finally post some guidance on that subject but the letters we are getting into the agency also show that there continues to be much confusion out there. 

I have no sympathy for those businesses who did not take the steps needed to get ready to comply with this new standard.  However, I have heard from many companies who have tried to comply but still find themselves with inventory valued in the thousands of dollars and soon to be worthless.  Consequently I believe that some relief is warranted. 

The whole crib standard saga is a good illustration of how not to regulate.  We rushed the standard out without doing the hard work upfront to understand the impact of the regulation.  A cost benefit analysis would have shown us how to get the maximum safety impact at the lowest cost.  At the time we finalized the rule we applied a band aid to stop the bleeding of one group – day care centers.  This morning we applied another band aid for those who rent out cribs.  We declined to staunch the bleeding of small retailers.

Our actions today may have the result of driving some retailers selling perfectly safe cribs out of business.  We will never know because we will never bother to find out.  Once again, I find I am repeating myself: this is no way to regulate and the public deserves better.

Reg Reform, No; Business as Usual, Yes

In my blog, I have repeatedly discussed both the need for this agency to do cost-benefit analysis as a part of our regulatory activities and the fact that this critical aspect of rulemaking is being regularly ignored by my colleagues.  Well, it’s happened again. 

During a review of our mid-year budget adjustments, I offered an amendment to do a cost benefit analysis of the testing and certification rule now under development.  Three of my colleagues rejected this amendment without even an explanation. It is inconceivable to me why a majority of the commissioners at this agency believe that it is acceptable to issue far-reaching regulations without knowing the economic impact of those regulations.  I know that I have said this before and I don’t want to sound like a broken record.  Nevertheless, it is important that the public understand that this kind of poor governance is occurring.  Here is my official statement  discussing my concerns.

Calling it Regulatory Reform Doesn’t Make It So

There have been a number of news stories in the last few days about the results of the President’s regulatory reform efforts.  The Wall Street Journal published an op-ed by Cass Sunstein, the director of the OMB Office of Information and Regulatory Affairs.  The accomplishments discussed in those stories do not comport to what is happening at this agency.  In response, I wrote a letter to the editor of the Wall Street Journal.  Here is the letter that was published today:

I read with interest Cass Sunstein’s assertion that federal agencies are working to eliminate excessively burdensome regulations (“21st-Century Regulation: An Update on the President’s Reforms,” op-ed, May 26). As a commissioner at the U.S. Consumer Product Safety Commission (CPSC), I can attest that no such activity is happening at this agency. We certainly have not combed through our regulations to eliminate those that are “out-of-date, unnecessary, [or] excessively burdensome,” as he suggests is being done across the government. Instead, we are regulating at an unprecedented pace and have pretty much abandoned any efforts to weigh societal benefits from regulations with the costs imposed on the public.

The CPSC is an independent regulatory agency and therefore, technically, it is not required to follow the president’s executive orders such as the one Mr. Sunstein refers to mandating a “cost-effective approach to regulation.” In past administrations, the agency has always followed the lead of the Office of Information and Regulatory Affairs, which Mr. Sunstein heads, in such matters. However, under this administration, we have ignored the recent direction to look for and eliminate burdensome regulations. We are just too busy putting out new regulations.

I have repeatedly requested that the agency do cost-benefit analysis on our various regulations only to have that request voted down by my fellow commissioners on a party-line basis. Consequently, we are issuing regulations without having done the necessary work to understand the impact of our actions both on those being regulated and on the public. As a result we have imposed regulatory burdens and caused people to lose their livelihoods without a real payback in terms of safety. At the CPSC, common sense regulation doesn’t even get a head-nod.

Nancy A. Nord

Commissioner

Consumer Product Safety Commission

Washington

Logjam Broken?

 I am glad to see that the House Subcommittee on Commerce, Manufacturing and Trade voted today to support a bill to enhance CPSC’s authorities to prioritize based on risk and thereby protect consumers while reducing some of the unintended consequences of the CPSIA. I hope that momentum for some real reform continues to pick up pace.

 Arguments being made against the bill do not stand up to scrutiny. For example, it is said that this bill will do away with third-party testing: not true. Mandatory third-party testing is preserved for the standards that CPSIA listed as priorities (i.e. lead paint, cribs, pacifiers, small parts, lead content in children’s metal jewelry, baby bouncers, walkers, jumpers and other durable nursery goods). In addition, CPSC is allowed to require third-party testing for other standards as it determines is needed for consumer safety, as well as continued compliance testing. The point is that the expert agency will decide what testing makes the most sense.

 It is said that this bill creates “common toy box” problems, i.e. children playing with older children’s toys. If the “common toy box” problem is the concern that children will use something beyond their age range, where does this theory stop when the child plays with things throughout the house?

Anyone who has raised children recognizes the silliness of the “common toy box” argument. Most parents remember sitting their baby on the kitchen floor with a pan and metal spoon to bang away with. Of course, the lead in these products – used for cooking and eating – is considerably higher than what is specified in the CPSIA. And parents know that 12-year-olds do not tolerate lightly toddlers getting into their stuff. But more importantly, the common toy box argument does not recognize the long standing practice of this agency to regulate products based on the hazard they pose as determined by the age of the child. For example, we recognize that small parts present a choking hazard to small children but that same hazard is not present for older children. Therefore we ban small parts in toys intended for toddlers. We do not take the position that a common toy box means that small parts are banned in all toys. We look at the risk and then regulate as appropriate. Lead exposure in children’s products should not be treated any differently.

Other arguments being made against the bill also do not stand up to examination. It’s good news that this bill is on its way to full committee consideration. The sooner CPSIA reforms are in place, the sooner CPSC can return to focusing its resources on consumer risks that matter most.

Finally Movement to Fix a Broken Law

I am pleased that today the House Subcommittee on Commerce, Manufacturing and Trade is holding a hearing to discuss the draft legislation to solve problems with the CPSIA that have been so evident.  The draft bill will go a long way to addressing many of the unintended consequences of the CPSIA.  It’s time to get our agency back on track and focusing on real safety issues, not imagined ones. 

I hope any final legislation will include the following necessary changes:

  • The lead exclusions need to be amended to give agency more flexibility to address unintended consequences.  The amendment needs to recognize the expertise of the agency to define what is an unacceptable risk based on whether the child’s interaction with the product results in measurable increase in blood lead levels.  Migration of lead limit from 300 ppm to 100 ppm (effective in 2011) should be repealed.  The agency can set an appropriate lower level if dictated by safety.  The scope of the lead provisions is too broad.  The law treats all children – from infants to preteens – the same even though product interaction is quite different and risks are different. The scope should be narrowed to apply to products intended for younger children (recognizing that the agency has inherent authority to deal with risks, regardless of source, to older children).

 

  • The lead and phthalates provisions need to be amended so that the law applies prospectively, rather than retroactively.  

 

  • Mandatory third party testing requirements for all children’s products impose a significant burden especially on small businesses.  Testing and labeling provisions need to be amended to minimize the damaging impact on product makers while protecting consumers.  Rather than requiring third party testing in every instance, the agency should be able to set reasonable and appropriate testing and labeling requirements to assure compliance with underlying safety standards.

 

  • Regulations should be subject to cost/benefit analysis.

 

  • The Public Database provisions should be amended to include only complaints from consumers who bought or used the product or relevant public health or other public agencies; enhance the ability of businesses to respond to complaints; and include the duty of the agency to assure accuracy of any information made public. 

 

The discussion draft would go a long way to solving the obvious problems with the CPSIA.  I hope that Congress will move swiftly to pass constructive legislation.

When is a Decision a Better Decision

In a public briefing this morning, the CPSC Commissioners received the agency staff’s recommendations for a CPSIA required final rule on another durable nursery product (toddler beds). 

This proposed rule provides a good example of a serious shortcoming of the CPSIA – that is, directing the agency to act without full information.  The incident data presented to the Commission today shows that there are very few serious injuries associated with the product under discussion.  We are also being told that, as a result of the rule, “…the price increase (as well as the increases in quality and safety) could be relatively high…It is possible that the draft final standard could have a significant impact on a substantial number of small entities…The extent of these costs is unknown…”. 

Although the statute does not require that we look at the costs and benefits of regulations, it is unacceptable for regulators to issue rules impacting both consumers and product sellers without understanding the effects of their actions.  It’s no excuse to say the statute doesn’t make us do this; responsible regulating requires it.

100 PPM: One More Bite at the Apple

The CPSIA requires that children’s products sold after August 14, 2011 contain no more than 100 parts per million of lead and that requirement applies retroactively to all products in inventory and on store shelves.  The retroactive nature of the law accounts in part for the economic devastation and mindless waste that has resulted over the last two years as companies tried to comply.  The 100 ppm requirement goes into effect unless the CPSC finds that for certain products or classes of products this requirement is not technologically feasible. 

Last month, the agency held a hearing on what constituted technological feasibility.  A webcast of that hearing can be found on our website.  In preparation for that hearing, we asked for comments from the public.  Because Commissioners and agency staff were given little time to ask questions of the witnesses at the hearing, the record of the hearing has been held open so that Commissioners can submit additional written questions to the witnesses.  In addition, any member of the public may submit additional information. 

The Commission voted yesterday to keep the record open for 15 days after the notice is published in the Federal Register. (Publication occurs about a week after the notice is submitted, so effectively you have only three weeks left to respond.)  Therefore, anyone with additional thoughts on the issue of how we manage the migration to 100 ppm needs to let us have your comments and suggestions  asap.

How Low Can We Go?

We have another big CPSIA decision looming on the horizon and therefore need your input and participation.

CPSIA provides that, as of August 14, 2011, children’s products may not contain more than 100 parts per million (ppm) of lead unless the Commission determines that such a limit is not technologically feasible.  The Commission may make this determination only after notice and a hearing and after analyzing the public health protections associated with substantially reducing lead in children’s products.

A hearing is scheduled for Wednesday, February 16th.   In order for me to act from an educated perspective, I need the evidence and data the public supplies, along with staff analysis.  I invite you to speak up and tell us how this lower lead limit will effect you. For details about participating, please refer to the Federal Register notice.  The deadline to sign up to present your remarks in person is February 10th.  You may also submit written comments and watch on webcast.

Last July, we solicited comments and information about manufacturers’ ability to meet the 100 ppm standard. Some commenters stated that source materials, including recycled materials for metal alloys, cannot comply consistently due to the variability of the materials and that plastics could comply only if  virgin plastics are used.  We heard about significant variability among test results due to variations in testing methodology and procedures.  Several people stated there were not demonstrable health effects reducing lead limits from 300 ppm to 100 ppm in light of the relative inaccessibility of lead that is bound in plastic or metal.  Others said there are children’s products in the market now that meet the 100 ppm lead limit, so that it is not only possible, but essential for public health to meet the lowest levels feasible.

The Federal Register notice outlines issues where staff is seeking new or additional information. Questions that are of particular interest to me include:

  • how do we evaluate whether a product that complies with the lower limit is ‘commercially available’;
  • what factors should be considered in an analysis of the public health protections associated with substantially reducing lead in children’s products, and
  • does consideration of technological feasibility include economic implications?

Before we vote to regulate, it is critically important that the Commission understand the practical and safety implications of lowering the lead levels in children’s products. We need your input so we can make an informed decision.

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