Monday, April 4, 2011

CPSIA - Analysis of Pending House CPSIA Amendment (Sections 1 and 2)

[This is a long essay - I apologize.  The subject is important.]

In anticipation of this week's hearing on the pending House CPSIA Amendment, I wanted to share my thoughts on the present draft.

But first, a little perspective:

The debate over the CPSIA amendment has propitious timing.  Fate has provided us with a new vantage point on lead mania.  In a sad parody of the junk science underlying the CPSIA, the EPA this week assured Americans that it's safe to feed mildly radioactive milk laced with bits of nuclear meltdown to infants.  What?!  In a March 30 press release (available on the EPA website), the EPA instructs us to keep it all in perspective:

"Results from a screening sample taken March 25 from Spokane, Wash. detected 0.8 pCi/L of iodine-131, which is more than 5,000 times lower than the Derived Intervention Level set by the U.S. Food and Drug Administration. These types of findings are to be expected in the coming days and are far below levels of public health concern, including for infants and children. Iodine-131 has a very short half-life of approximately eight days, and the level detected in milk and milk products is therefore expected to drop relatively quickly.  'Radiation is all around us in our daily lives, and these findings are a minuscule amount compared to what people experience every day. For example, a person would be exposed to low levels of radiation on a round trip cross country flight, watching television, and even from construction materials,' said Patricia Hansen, an FDA senior scientist."  [Emphasis added]

The CPSIA, on the other hand, is built around the idea that there is "no safe level for lead".  The CPSC has uniformly rejected exemption requests on the grounds that there is no proof that the products won't emit ANY lead - meaning one atom.  The CPSC staff has already acknowledged that there are no materials on Earth that can be relied upon to not emit a single atom of lead.  I would call that "limited" options.  Then again, perhaps space exploration will save us from this law . . . .

So the EPA blesses feeding milk infused with Japanese nuclear material to babies, but even a single atom of lead is intolerable to Congress and the CPSC.

Call me crazy, but they BOTH can't be right.  And it's obvious who knows what they're doing in this case - it's the EPA. 

It's time to drop the rhetoric and rebuild the CPSIA to provide appropriate protection WHERE IT'S ACTUALLY NEEDED and strip everything else away.  Period.  The Emperor has no clothes.

Section 1  Definition of Children's Product:  This open-ended section attempts to lay the groundwork for trimming the coverage of the CPSIA.  Notice that the age limits are blank.  This probably reflects internal divisions among the Republicans on how to set age limits or how to position this law for passage in the Senate and then into law.

Notably, an age limit of seven years of age passed the Senate back in 2008.  That seems to be the default age that may get penciled in, simply because some people believe it may be easier to get that age limit through the Senate.  I believe this is an untested hypothesis, unfortunately.  The consumer groups are going to scream no matter what - they hate most of this amendment, and will make it tough on the lefties in the House and particularly in the Senate to support any rational trimming of these limits.  Even seven years of age may find more than token resistance in the Senate.  Of course, that does not mean we shouldn't push for the right age limits.

Were it up to me alone, I would probably pick a range defined as products SUITABLE FOR children five years of age or younger.  Five years of age pretty much defines the outside limit of age inappropriate behavioral risks for normal children.  Injury statistics and human factors analysis do not identify substantial risks above this age.  [It provides a safe "margin of error", if one is actually needed.]  I think the definition must eliminate the concept of manufacturer's "intent" because the state of mind of the maker has nothing to do with safety.  The intrinsic attributes of the product are what defines risk.  In addition, the fact that we must GUESS as to the state of mind of the manufacturer makes it an unworkable standard.  An objective standard based on traditional notions of human factor analysis would work best.

Even more fundamentally, I question whether it is really the job of Congress to set these age limits.  As we know, Congress has already made a big mess as the self-appointed substitute for the CPSC.  Age limits for safety standards should be based on scientific inquiry, human factors analysis, risk assessment, and so on.  It is presumptuous for anyone to conclude that Congress can do it better than the Ph.D.s at the CPSC.  Of course, in this politicized environment, in which trust in the agency has been bruised beyond recognition, I am somewhat sympathetic to Republicans who feel more secure setting the rules in concrete. If, however, we want to get out of CPSIA hell, we need to restore order in the safety universe.  The CPSC should be given responsibility for making these determinations on a MANDATED RISK ASSESSMENT BASIS.
I hate to go down the path of one sizes fits all age limits, myself.  Is there ANY reason to set age ranges that apply equally to toys, books, t-shirts, dirt bikes and ATVs, CDs and DVDs and educational products?  Of course not.  Who should make this determination?  The agency with the experience and the professional staff trained to make these judgments - the CPSC.

PLEASE NOTE - this is a critical part of this amendment. This section defines who is subject to this awful law and who is not.  Don't misunderstand which provisions are driving this ship - this provisions controls your legal liability, your exposure to regulatory oversight, penalties, enforcement, government intrustion generally.  Testing relief in this amendment MUST BE seen in the context of the limitations here.
With that thought in mind, I would remind my readers of the scarcity of evidence of lead injuries from children's products and of lead-in-substrate victims in general.  I believe the entire basis of this law is a scam (or at a minimum, a hideous misunderstanding of the data) and CHALLENGE the zealots to PROVE a need for the suffocating regulation of lead-in-substrate in these products in these industries.  If lead victims cannot be identified and their lead injuries explained, then there is no demonstrated need for the legislative hammer - no one will benefit (no one will be safer because they weren't in danger in the first place).  The consumer groups and left wingers have had three years to trot out the victims.  There are NONE.  Shame on them for spreading fear.  I say put up . . . or shut up.

Section 2  Application of Lead Limit: 

Subsection (a) is a classic "kick the can down the road" compromise in which the 100 ppm lead standard will be implemented by the CPSC in four years, not three, pushing the prospective date of implementation out to August 2012.  Not good enough, guys!  The structure of this part of the law, requiring that the CPSC implement the new standard or a standard between 100 ppm and 300 ppm based on "technological feasibility" is a direct INSTRUCTION by Congress to the CPSC to reduce the standard.  The CPSC arguably has no choice in the matter.  [Now you know who to blame.]

You can see this issue discussed in gory detail in this snippet from my testimony on the 100 ppm in front of the CPSC Commission on February 16th.  Commissioner Bob Adler asks me if I want him to BREAK THE LAW by not implementing the new standard.  BREAK THE LAW, BOB! 

This is no way to regulate, no way to govern a country!  ALL references to the 100 ppm standard should be DROPPED from the law.  As noted above, and in countless blogposts here, there are no identified lead victims from children's products - so how is lowering the lead standard at enormous cost and economic risk of benefit to ANYONE?  The 112th Congress can do better than repeat the errors of the 110th Congress. 

Should there be a need for a lower standard based on real risk, the agency has sufficient regulatory authority under the CPSA and FHSA to lower standards to protect children in a rulemaking process.  Congress does not need to meddle further in this area.

Subsection (b) introduces a new and uncorrelated "standard" for risk under the CPSA:  "presents an unreasonable risk to children’s health".  This is bad draftsmanship.  There is a standard already in use in the CPSA and the FHSA, namely "substantial product hazard".  The amendment should MANDATE that this term ALONE should be the standard for all action by the agency. 

Subsection (c) makes the application of the lead standards prospective.  [In Section 6, the amendment makes the same change for phthalates.]  This is mainly intended to head off market disruption and distrust over the new 100 ppm standard.  Of course, in my formulation, this is unnecessary if the 100 ppm standard goes away.  I would point out that the entire idea of this kind of downward ratcheting of standards implies that what was safe yesterday is no longer safe today, which is crazy.

Subsection (d) relates to a revised exemption process.  The "any lead" standard would go away, in faver of some limited exceptions.  Ironically, this provision expands the application of the small parts rules to products for older children like youth model ATVs.  This seems like a big error to me (and a bad structure for the law).  If it's foreseeable that a cap on an ATV spark plug could come off and go through a small parts cylinder, it loses its eligibility for the exception.  Hmmm.  This may require some further thought . . . .

There would no longer be an exemption process under the CPSIA.  So if you are in, you are "in" and can't get out no matter what.  The drafters seem to have settled on small parts as the way lead poisoning is "transmitted" or may be transmitted.  I am not sure how this was determined, since there are no victim case histories to examine.  The presumption is that mouthing is how poisoning occurs, but then again, how many poisoning victims (from children's productrs, not from lead-in-paint) can be found?  Zero?  If we have never seen a victim, how can we be so sure there is ANY mechanism for this dreaded outcome?  Is chewing on ATVs, dirt bikes, the ink end of a pen, rocks, and so on, really such a big health risk that we must fight for years over it? 


The subsection also artciulates a new (presumably relaxed) standard for steel, copper and aluminum alloys.  The new standard is still blank.  I sure hope the definition of "steel, copper, and aluminum alloys" is crystal clear and I likewise hope that this covers the waterfront for metal used in all current products and future materials used in similar circumstances.  I guess we'll find out in time . . . .  It appears to me to be simply a better formulation of the originally defective legislative concept.  But still defective.  Remember, no victims . . . . 

The drafters have introduced doubt about what's in and what's out.  Is a grommet in or out?  Says the new provision:  you lose the exemption if "after any necessary assembly of the product and after the product has been subjected to reasonably foreseeable conditions of use and abuse, the part or any portion of the part becomes detached from the product and such part or portion of the part fits entirely within such cylinder."  How are you supposed to figure this out with confidence?  Your guess is as good as mine.  This kind of rule does NOT work in the real world.  Sorry. . . .

By the way, this provision seems to snag items incorporating metal balls.  While you may or may not like those products, this provision probably will give them no relief whatsoever.

I am even more hostile to their so-called "de minimus" exception.  "De minimus" ingestion of lead is okay under this rule (whatever that is - can't wait for the three year fight over "Congressional intent") BUT only if it does not fit into a small parts cylinder (same as the metals formulation).  This is patently ridiculous and will give no relief to anyone.  Why are the Republicans playing games here?  There is no safe level for over-compromised legislation . . . .

This is the mechanism that the House is providing to "save" rhinestones, btw.  To get rhinestones into the market, you will need a methodology to calculate the amount of lead a rhinestone emits and document it.  You are a "merchant of death", so you must keep records of how much of this "lethal" substance you subject children to.  Excessive regulation, perhaps???  As I have said, compromise is not always the way to build good legislation. The Republicans need to steel themselves to fix this law once and for all. 

The concept of the "de minimus" exception may be off-base.  It is worth noting that blood lead levels are CONCENTRATIONS (mass divided by volume).  In other words, different levels of lead ingestion will be required for a baby and a big child to develop the same blood lead levels.  The persistence of high blood lead levels also has a big impact on the likelihood of injury, so wouldn't daily lead ingestion rates be a better measure of the likelihood injury?  The "de minimus" standard seems to miss the point entirely.  I get the impression that this amendment was drafted entirely in the context of the (defective) CPSIA and thus carries froward some of its basic flaws and misconceptions.  Square pegs are not good fits for round holes. It may not be possible to "fix" the CPSIA by layering more and more rules on top of the underlying law.  Some things may be best left unregulated with a reliance on the substantial product hazard standard.

Perhaps John Dingell was onto something with the original conception of the CPSA in 1972.

Needless to say, this hyper-technical "de minimus" provision will not work for small business. None of us know how to make a "de minimus" assessment and besides, the requirement to document our methods is just an invitation for tort lawsuits.  If we will be made to create evidence to be used against us, I would rather be in another business. The crafters, the small toy merchants, the t-shirt vendors, the book printers, will also howl over the need to engage in silly and pointless technical evaluations of nonexistent risks by calculating the amount of lead ingested from use of their products.  This is just waste, waste, waste. Again, we should not compromise ourselves to hell in this amendment.  If Congress is going to try fix the damn thing, then fix it right.

As noted above, the substantial product hazard /standard is sufficient to empower the CPSC to do everything it needs to do. The legislative structure is in place and tested over decades.  Why not tell the CPSC to do its job, and stop telling us how to run our businesses? 

Finally, subsection (d)(2) entirely excludes used products from the CPSIA other than children's metal jewelry and products actually known by the sellers to violate the lead standards.  This relief is long overdue - I appreciate that the committee is prepared to do the right thing for this group of CPSIA victims.

Of course, this may beg the question.  If Congress is able to dispense mercy on used products, what about all the other absurd victms like bicycles, rhinestones, ATVs and dirt bikes, books, rhinestones, pens, educational products, CDs and DVDs and so on?  Why stop at used products?  Why even START at used products?  Of course, they deserve help but do they deserve it anymore than the rest of us?  They are senseless victims of this law, of course - but stand in line!  So why not keep the carving knife out and free some more corporate "unintended" victims?  I think the problem here is political, not policy.


No comments: