August 3, 2010
Todd A. Stevenson
Director, Office of the Secretary
Room 820
U.S. Consumer Product Safety Commission
4330 East West Highway
Bethesda, Maryland 20814
Agency: Consumer Product Safety Commission (CPSC)
Re: Docket No. CPSC–2010-0038 Testing and Labeling Pertaining to Product Certification.
Dear Mr. Stevenson:
I am hereby submitting comments in response to the Solicitation of Comments on Testing and Labeling Pertaining to Product Certification (Docket No. CPSC–2010–0038) published in the Federal Register on May 20, 2010 (the “Proposed Rule”).
The End of (Business) Life As We Know It:As I sit down to record my comments on this rule, I take comfort in knowing that the CPSC admits what it is doing here. In a section entitled “Caveats and Possible Market Reactions to Third Party Testing Requirements”, the agency acknowledges the severe impact of its new rule on manufacturers:
a. Significantly increased costs,
b. Incentive to redesign (presumably successful) products,
c. Incentive to reduce features on products,
d. Incentive to eliminate (presumably useful) components in finished goods,
e. Incentive to reduce product lines,
f. Exit the market altogether,
g. Go out of business,
h. Create barriers to entry for future business expansion, especially in specialty markets (non-mass market),
i. Devastate niche markets (noting particularly the “special needs” educational market – sorry, blind kids!), and
j. Incentive to delay or forgo product or manufacturing process improvements (to avoid testing costs).
Quite a stimulus program! Of course, the CPSC knows we can’t meet this challenge alone. In “The Potential Effects of the Proposed Rule”, the agency advises us to hire a few helpers:
a. Lawyers to review CPSC regulations,
b. Engineers and chemists to develop product specifications, conduct tests and design a program for production testing,
c. Statisticians or consultants to determine the frequency, sample size and collection method for production testing, and
d. Technicians, “perhaps working under the supervision of an engineer, chemist or similar professional”, to perform production tests.
This certainly is a Brave New World for us. Luckily we have the CPSC to tell us what to do. Unfortunately, we can’t afford an in-house legal department or teams of engineers, chemists or statisticians. We don’t even have technicians. Incredibly, somehow we bumble on in our blissful, almost charming ignorance, having had only one recall of 130 pieces (we recovered every unit) out of perhaps 1,000,000,000 units sold in the last 26 years. No doubt all the pain the CPSC is promising us will be worth it . . . gotta keep everyone so safe.
Seriously, Is Anyone Listening?On page 28338 of the Federal Register, the Proposed Rule reproduces the “reasonable testing program” as it stood before the December 10-11, 2009 workshop at the CPSC. The workshop (which we attended with three people who were each asked to appear as a panelist) was ostensibly for the purpose of giving “stakeholder feedback” on the so-called “15 Month Rule” (the Proposed Rule) and the component testing rule (also up for comment today, posted under separate cover). We gave detailed feedback on these rules – none positive – yet the Proposed Rule seems to have preserved the original, deeply-flawed concepts
intact.
It is difficult not to conclude that the process of providing feedback to this CPSC is a sham. While Chairman Tenenbaum has long touted her “policy” of seeking feedback from all stakeholders including industry, judging from this rule, the commitment to seeking feedback does not involve maintaining an open mind. It appears that the most likely feedback to be well-received is feedback that ratifies what the agency already plans to do. Other feedback is “wrong”, I guess. I doubt you will find this letter useful.
As time ebbs on and as the drumbeat of a CPSC bent on our destruction becomes more and more clear, the incentive to waste a few days preparing detailed comments also ebbs. Nevertheless, owing to the importance of this Proposed Rule, I am hereby submitting comments. I have no reason to be optimistic that you will consider my point of view with an open mind. This rule has all the earmarks of a fait accompli.
Deeply Flawed Economic Analysis.
The Proposed Rule devotes pages and pages to a tortured analysis of its purported compliance with the Regulatory Flexibility Act (“RFA”). This section of the Proposed Rule is a virtual admission of how unworkable the rule is (and the CPSIA testing scheme in general). As a starting point, the rule states: “
The objective of the rule is to reduce the risk of injury from consumer products, especially from products intended for children aged 12 years and younger.” In my recent study of CPSC recall data posted on its website, I have found exactly ONE DEATH and THREE ASSERTED INJURIES from lead or lead-in-paint from 1999-2010. Please keep this statistic in mind as I review the economics of your “injury reduction” effort.
The flaws in the RFA analysis are clear in its discussion of testing costs for toys. The analysis acknowledges that it only accounts for out-of-pocket testing costs, nothing else. Significant additional (and ignored) costs include samples destroyed or damaged in testing, transportation of samples, administrative costs for managing testing, administration costs for managing the testing data, administrative costs for managing recordkeeping, an allocation of general management time, legal expenses relating to testing and so on. Depending on the scale of the business, I estimate that these costs (and distractions) will add 15%-50% to the out-of-pocket testing costs.
The RFA analysis concludes that testing a typical toy will cost $1,262 per product. As an average, this might be a good number for our business. I would note, however, that the Proposed Rule posits that we will test multiple samples, sending in perhaps four separate samples per item to satisfy the bizarre “required high degree of assurance” standard. [The rule states clearly that testing one sample is never enough. Interestingly, we have never had the experience in the last 20 years that multiple safety tests of the same product reveals anything useful other than rapidly approaching poverty.] The rule’s four-sample regime takes the testing cost per toy up to $4,848 (by the calculation in the document) plus another $2,500 for mechanical tests (because the rule posits that we will submit FIFTY samples for mechanical tests). That brings us up to $7,348 per item, plus 54 destroyed samples. This implies a rough “all-in” cost of $10,000 per item. We have 1,500 catalog items in our product line. Without a “reasonable testing program” in place (see below), we will have to test each item annually. This is a cost of $15 million for our company EVERY YEAR. [We also sell custom items, a business that would presumably be terminated by this testing rule. That’s several jobs down the drain.]
Does it surprise you to know that $15 million in testing costs exceeds our annual profit? By far?
The RFA analysis is deeply flawed in other ways, too. The rule duly reports that “[a]ccording to a representative of a trade association, there are an estimated 50,000 to 60,000 individual toys on the market.” Oh, really? Perhaps the CPSC shouldn’t have consulted the International Hubcap Manufacturers Association for this information. A quick visit to the Amazon.com website reveals listings of 808,465 toys and games on August 3rd (
http://amzn.to/djtTVX). Amazon is a customer of ours – I estimate that they list about one-third of all toys and games sold in the consumer market. Call it 2.5 million toys and games available to consumers in the U.S. But that’s not all – the category also includes specialty items not present on consumer sites. For instance, our industry, the education industry, is largely invisible on consumer sites. I estimate that about one million SKUs are available to purchase at the annual convention of the International Reading Association. Millions of other SKUs are displayed at the national math show, the national science show and the national early childhood show. Add in special needs and other sub-markets – and you get well in excess of 4-5 million toys and games. So the RFA analysis might be off by 100x in its assessment of the toy market ALONE. That’s not close. . . .
The RFA analysis goes on to conclude that the ENTIRE MARKET of products affected by the rule is 100,000–150,000 products. This includes “wearing apparel, accessories, jewelry, juvenile products, children’s furniture, etc.”, plus non-children’s products and other children’s products like ATVs, bikes, bunk beds and so on. It is hard to dignify this ridiculous data with a retort, except to note that it is absurd on its face. The apparel industry ALONE offers as many as 8,000,000 different children’s SKUs for sale. The RFA analysis is fatally flawed.
At $10,000 per SKU, the projected children’s product testing costs will easily exceed $50 billion per year. Remember the 11-year CPSC statistic on lead deaths and injuries – one death and three ASSERTED injuries? [There are no recorded injuries from phthalates or cadmium, by the way.] The 11-year compliance cost will exceed $550 billion (in 2010 dollars), expended by U.S. companies to “reduce” this risk of injury. It would cost a lot less to wrap every American child in bubble wrap.
Small Businesses CANNOT SURVIVE THIS RULE.
Assuming we are supposed to take this rule seriously, the Proposed Rule is perhaps the best friend of the mass market yet invented by an agency seemingly bent on the destruction of the small business community. This letter documents again and again the unrealistic expectations and assumptions made by the authors of this rule with respect to businesses in general and small businesses in particular. Thousands of small businesses of every stripe and color will be affected by this rule. Are you seriously thinking that they will all hire statisticians, chemists and engineers to prepare the reams of data, plans and reports the CPSC expects? Once this massive, herculean effort is completed, who will be safer anyhow? I can think of someone – mass market companies who have been handed a game-ending cost advantage on a silver platter by the CPSC. This, combined with mass market companies’ ability to create certified firewalled in-house labs, favors the big guy dramatically. No wonder the rule states again and again how prejudicial this rule is to small business. The CPSC knows what it’s doing.
Small businesses will strain to even understand what is expected of them. The rule is obtuse, long-winded and full of arcania. Small business people may not have the time or skills to master this complex rule. When the CPSC turns to its attention to enforcement (as promised for 2011) and selects a few small businesses to whip into shape, the market will take note of the pain and a mass exit will result. I realize, however, that Cassandra-like predictions haven’t influenced the CPSC in recent times. One of the Commissioners has even been quoted as saying that “anecdotes aren’t evidence”. It feels like we have to die to prove we were right. A few small businesses might just do that, if the agency waits long enough.
The Commission has asked for feedback on how to address these issues. The complexity of the CPSIA safety rules proves that they are unworkable. To repair this damage, the Commission must ask Congress to restore its ability to assess risk. I am assuming that the Commission would exercise this discretion with more common sense than is embodied in this rule. CPSC rules should be trimmed back to things that MATTER, only. Second, the agency should build its rules and its enforcement activity around DATA. Injury statistics tell the agency what is important. If a particular hazard generates ONE DEATH AND THREE ASSERTED INJURIES OVER 11 YEARS, you can safely relax your rules quite a bit (there are worse problems out there). Education might make a difference, however.
Finally, the Commission should NOT take ANY step if there is EVEN A SHRED OF DOUBT about the impact on small business. Small business is the major jobs creator in America. When you promulgate rules that choke the life out of small business or sharply reduce their incentive to invest, you are killing our economy. You have a heavy responsibility to keep this place running, even if it’s an imperfect world. While it’s sad that a child ever dies, the pain and suffering imposed on countless families from lost jobs, lost capital, lost access to needed products, and so on likely far exceeds it.
Reasonable Testing Program – Busy Work to Keep Us From Running Our Businesses.
The “Reasonable Testing Program” (“RTP”) represents a choice presented to manufacturers of children’s products under this rule. If we endure the expense and disruption of a RTP, we can cut our testing frequency (read, testing costs) in half. A very tempting prospect but the cost of a RTP seems too high, leaving us with a Hobson’s Choice. We can’t afford annual testing and we cannot afford a RTP. What should we do? What will anyone do?
Owing to the burden and complexity of RTPs, I predict EVERY REGULATED COMPANY will violate these rules. Since Ms. Tenenbaum has promised to turn to enforcement in 2011, the CPSC regulators should have a pretty easy time finding juicy targets. Every company will provide wonderful enforcement opportunities.
Although our testing program has been highly-effective over the last 26 years, our program would never meet these standards. We do not maintain the volume of paperwork that the new CPSC rule now requires. We know what we’re doing, but we have not organized our files into a how-to manual. Perhaps the agency thinks every company in the country is an ISO 9001 company. They’re not, and this kind of documentation is rare and breathtakingly expensive to prepare.
Having endured the CPSIA spectacle for two years now, I do not trust the seemingly flexible definition of necessary documentation. The pattern is that these seemingly open-ended terms (which may or may not describe our current recordkeeping) will mature into something rigid down the line. Even if they don’t, we still face the risk that we will not measure up to the expectations of the CPSC enforcement officer at the time of reckoning. The feeling that we are being set up is inescapable. As noted above, given our record of performance, the agency should have NO concerns about how we go about our business. Nonetheless, I feel certain that these rules will bite me in the future.
Sample selection under the rule should not be based on any statistical formula (per the baffling presentation of Dr. Michael Greene at the December 2009 workshop). If the overall safety results of the company are strong, the choice of samples by the company or factories should be presumed compliant without further inquiry. Random selection (taking one off the shelf . . . without the assistance of a statistician) works just fine in our experience, and there is no evidence that testing multiple samples will accomplish anything but will certainly raise costs. Better sampling won’t lower injury rates that already approach zero.
We currently do not use production testing and have zero production testing plans in place. With one recall in 26 years, I would assert this kind of testing is superfluous in our business and basically useless from a safety standpoint. It will significantly raise costs, however. The tedious exercise of preparing a pallet load of production testing plans to meet the new requirements is just plain busy work. One must ask what the CPSC was thinking when it penned this description of a production testing plan: “A production testing plan may include recurring testing or the use of process management techniques such as control charts, statistical process control programs, or failure modes and effects analysis (FMEAs) designed to control potential variations in product manufacturing that could affect the product’s ability to comply with the applicable rules, bans, standards or regulations.” Fancy words but . . . what planet are they from?
The requirement to list all the tests applicable to our items, again and again, to satisfy the RTP requirements is typical of mindless busy work asked of us. Does the CPSC think this will make ANY difference? Most businesses confirm safety tests with their testing lab partners anyhow. More bureaucracy, taken to new heights.
We don’t have any remedial plans in place either. We are quite familiar with how to appropriately resolve compliance and quality issues, and have never had a problem with regulators in the exercise of our business judgment. The requirement to prepare a detailed written plan, just in case we have another recall in the next 26 years, is pure officiousness. This is yet another waste of our time, our money, our resources and our intellect.
The recordkeeping requirements of a RTP is well beyond our ability or interest to preserve for 1500 products produced in thousands of lots over the course of a year. Taking a “Dear Diary” approach to how we source, test, move, remediate, repair, investigate and otherwise manage children’s products is completely unreasonable. This is especially ridiculous given our track record.
The Commission has asked what a RTP might cost us. I have a hard time estimating it because all the fun in our business would be gone. If we had to endure the bureaucratic nightmare this rule envisions, if anyone actually expects us to do all this to make simple plastic toys for schools, I would have to seriously consider our alternatives. So it might cost us our entire company. That’s the whole enchilada, guys.
Remember, we don’t have to make children’s products, nor do we have to stick around for the next act of this tragedy. If the CPSC persists in ruining what was once a rather safe industry with a strong track record, the cost will be the entire market for children’s products.
Is that a high enough price to give you pause? I know, I know, more anecdotes . . . .
The Requirement to Document Procedures against Undue Influence is Unreasonable.The “Undue Influence Procedures” requirement (“UIP”) is essentially a requirement to document efforts to avoid fraud. If you’re not inclined to commit fraud, there’s little reason to set out your plan to not commit fraud. Here’s our current policy – “Don’t break the law or commit fraud”. This has worked well for us, as we have never exerted undue influence in the last 26 years and have no plans to start now.
I am really sorry that there are bad people in the world, some small number of which may have at one time attempted to exert undue influence over one or more test labs. Perhaps the CPSC should concern themselves with the bad guys and leave the rest of us alone.
Material Change Rules Place Too Much Risk on Manufacturers.The CPSC’s rule on when to test after a “material change” is sufficiently open-ended to render the judgment on when to test fairly obvious – ALWAYS TEST. Deep within the Proposed Rule, Section 1107.10(b)(2)(ii) instructs “A material change is any change in the product’s design, manufacturing process, or sourcing of component parts that a manufacturer
exercising due care knows,
or should know,
could affect the product’s ability to comply with the rules . . . .” “Due care” is defined as “the degree of care that a prudent and competent person engaged in the same line of business or endeavor would exercise under similar circumstances.”
In other words, the agency’s 20-20 hindsight can construct a case for testing for a material change for just about anything that “might” or “could” affect results or that a hypothetical “prudent person” might think of investigating. Of course, this issue only comes up in the context of an injury or a recall, so what are the odds that any judgment to NOT test would withstand inquiry by an angry CPSC? Zilch. So either you always test or you take a big risk. This is completely unfair and unreasonable.
Testing Frequency Must Be Left to the Manufacturer and to the Market.
A rule requiring manufacturers to test according to these standards every year is going to kill us and many other businesses. No one can afford the testing scheme outlined above, we least of all. If we must test according to these standards, we will be out of business quickly. It is equally unrealistic to imagine that testing cost savings from maintaining a RTP will hold much appeal since that project is so wasteful and gargantuan. Of course, a firewalled in-house lab would be nice for all of us small businesses, but that’s unrealistic, too (not to mention undesirable). We have no realistic way to moderate these costs. Please see my other August 3 comment letter for an explanation of why I believe component and composite testing will likewise provide no relief.
Testing is supposed to assure product quality and compliance. If we have a good, long term record of safety, why can’t we just carry on as we have, and deal with issues as they arise? That worked for 26 years. The new way is just unaffordable.
The “High Degree of Assurance” Standard is Unreasonable and Not Derived from the CPSIA.The rule seems to conclude that a “high degree of assurance” is a necessary element of any “reasonable testing program”. The importance of the “reasonable testing program” which was incorporated into the CPSIA as an alternative to third party testing for non-children’s products, has been imputed to the children’s product area as a way to reduce testing frequency, and with it, the “high degree of assurance” standard (“HDA”) was likewise imputed. Thus, sliding down this slippery slope, the HDA standard has become part and parcel of the “15 Month Rule”. Abracadabra.
The Commission has requested feedback on the meaning of the definition of HDA in Section 1107.2. Happily, the agency has rejected a strict statistical interpretation requiring “95% probability” of compliance. What should the definition be interpreted to mean? The “high degree of assurance” should be based on an overall assessment of the safety record of the company. It should NOT be based on the results of an individual product, even if recalled or deemed dangerous. In our case, we have done business for 26 years, had one recall of 130 pieces of out of about 1,000,000,000 pieces sold. All of these units were recovered. Thus, we believe there is zero probability that a recalled product is in the market. Our historical recall rate is approximately 130/1,000,000,000 or 0.00001% over a 26-year period.
With this record over so many years, our company should be deemed to have satisfied this HDA requirement and be endorsed as having a reasonable testing program without further inquiry. And if we DON’T deserve the HDA designation, then the CPSC should articulate what level of safety achievement would earn the designation.
Notably, the entire children’s product industry also meets this requirement. Of the 899 recalls of children’s products from 1999-2010, only one death and three asserted injuries from lead were recorded by the CPSC. Thus, the probability of being injured from lead by a children’s product is nearly zero, given that literally billions of children’s products are sold every year. [The apparel and footwear industry claims annual sales of about 4 billion units ALONE.] Industry recall rates are likewise well under 1% per annum. With injury statistics and recall rates in hand, the CPSC should GREATLY loosen the strictures of the “high degree of assurance” standard to focus its resources on activities that might actually injure someone.
One-to-One Product Testing Will Punish the Smallest Companies.The prophylactic approach to testing adopted by the CPSC will inevitably put many small or micro businesses into bankruptcy, or drive them into unregulated markets to avoid the CPSIA’s wasteful bureaucratic costs. If the law does not permit the agency to adopt sensible rules that allow businesses to manage their compliance risk as best they can (where the standards remain in place, but the government stops trying to tell businesses HOW to comply), then the Commission must finally tell Mr. Waxman what he doesn’t want to hear – that his law is broken and can’t be fixed. [Notably, these mini businesses most at risk have an exemplary record of safety and very low recall rates. NOTHING is gained by rules that crush the little guy.]
We in the small business community have suffered for two solid years while regulators have sought any possible way to avoid delivering this “unpleasant” message. I get the impression that the demise of our businesses would not be too great a cost for the agency to incur to avoid telling Congress what it doesn’t want to hear. If the Commission is genuinely interested in a fix, it must take action with Congress. I do not believe the agency can devise sensible regulations to fix this problem short of a legislative change.
Ban on Retesting Will Unnecessarily Create Crises at Small Businesses.
In our experience, test labs are neither infallible nor definitive in their understanding of U.S. safety laws and regulations. It is not unusual to experience failed test reports for reasons besides safety problems. In addition, children’s products are not so pure and perfect in their composition that every test produces the same result. The CPSC itself instructed manufacturers to audit their test labs in the ironically-dated April 1, 2010 version of the Proposed Rule in response to industry complaints that test results varied from test lab to test lab. By forbidding retesting, the Proposed Rule removes discretion and appropriate problem resolution techniques from a commonplace quality event. You don’t need to manage a very large portfolio of products before the probability of an ordinary course testing problem rises exponentially. This is a matter of mathematics. If retesting is banned, the CPSC is legislating a crisis of the week.
Again, CPSC injury data informs us that the nature of the problem is extremely modest. Historical injury rates are VERY low. This retesting rule is completely unnecessary and penal to all companies except perhaps mass market companies with greater resources. Small businesses won’t have teams of engineers or statisticians around to save the day. Many small businesses will naively call the CPSC for “help”, only to find out that they have created a worse crisis. Some small businesses may miss this point in the Proposed Rule and continue to retest, only to be punished later when the CPSC finds evidence of retesting at the time of a recall. Is this really how you want to regulate?
I would note that the justification for all this is bad acts: “[Retesting] may tempt unscrupulous parties to attempt to ‘test the product into compliance’. . . .” To my knowledge, this behavior has little precedence and even so, it is an abuse that can be dealt with other ways. If honorable and law-abiding companies use retesting to resolve honest problems, no harm is being done. Punishing good guys because you are afraid that otherwise bad guys might benefit is excessive and inappropriately harsh.
The 10,000 Piece Limit for One-Time Testing is Arbitrary and Unfair.The CPSC has failed to persuade that the 10,000 limit is an appropriate break point for testing. First of all, the limit is cumulative, not related to sales in a period or per annum. Second, the threshold bears no relationship to risk of injury. In other words, it’s completely arbitrary. Why 10,000? Why not? In my view, that’s not enough to justify this rule. Many of the micro businesses that might benefit from this rule have NEVER had a recall. These are the people this rule will restrict. And the logic of this is . . . what, exactly?
Even more remarkable is the rule’s insistence that these low volume items be tested annually after passing the 10,000 piece threshold. Small companies will never have a RTP so annual testing (or more frequently, if for instance the item is hand-assembled) will be mandated. Consider a product selling 2,000 piece per year. Under these rules, the incentive to drop it once it crosses the 10,000 threshold will be powerful. This reminds me of the incentive on small businesses to not hire a 26th employee to avoid an onslaught of Obamacare obligations. A tacit cap on sales will be imposed by this rule. Nice!
The solution to this problem is to require one-time testing before sale, and thereafter according to the business judgment of the manufacturer. Remember, the retailers that buy from the manufacturer will also have something to say about testing frequency, too. Not all solutions are better if imposed by the government.
Alternative Testing Technologies.The ability to test at low cost with XRF is attractive. For our business, it is tempting to use an XRF gun but for two reasons: (a) cost, and (b) health risk. XRF guns cost $30,000 each and have high annual maintenance costs (several thousand dollars a year). We might need several guns to manage our inventory volumes, a very costly prospect. XRF guns are portable x-ray machines. Notwithstanding the assurance of XRF gun manufacturers, I am quite reluctant to place an x-ray machine in the hands of a warehouse worker in our facility. This is an invitation to disaster. We likewise have no interest in hiring a highly-paid technician to wield the gun, or technicians to wield the guns. In any event, we cannot expose our employees to a possible risk of x-ray genetic damage. I am surprised that the CPSC doesn’t take this risk more seriously. Is lead a worse problem than x-rays?
In any event, I fail to understand what would be accomplished by a XRF solution for small businesses. The process of XRF testing may be inexpensive, but would be disruptive. In any event, I don’t see a connection to safety so I prefer a solution that restores sanity to our safety practices. Burning in a wasteful and disruptive process will only bog down our economy and our competitiveness. Until the CPSC can point to a risk factor relating to the little guys, one cannot rationally conclude that XRF makes this regulation better, just somewhat less worse.
In sum, the Proposed Rule is a dangerous rule with the acknowledged prospect of doing severe market damage. The CPSC knows this, having admitted it in writing in the text of the rule. There is no excuse to push forward with a defective rule on this scale. The Commission must talk honestly with Congress . . . before it’s too late.
Thank you for considering my views on this important subject.
Sincerely,
Richard Woldenberg
Chairman
Learning Resources, Inc.
380 North Fairway Drive
Vernon Hills, IL 60061
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