Archive for the 'Lead' Category

When Competing Policies Collide

Published September 17, 2013 Lead , Retailers 1 Comment

It is a basic premise of business that good managers do not allow short-range tactics, taken in response to immediate contingencies, to derail long-range strategies. This principle came to mind when I read a story in this week’s BNA Product Safety and Liability Reporter. The story discussed efforts by Wal-Mart Stores Inc. to put in place initiatives to reduce the environmental impact of the products it makes and sells. The story made clear that these efforts by Wal-Mart, and lauded by environmental activists, will be felt throughout the supply chain.

What especially caught my eye was the following portion of the story:

“Wal-Mart’s other environmentally friendly initiatives include:

• working with suppliers to increase the use of recycled content and to make packaging more recyclable. . .”

When I read this, I could not help but think back to the CPSC’s decision back in 2011 mandating the lead content of children’s products not be above 100 parts per million. You will recall that Congress set the limit at 300 ppm but allowed us to lower it to 100 ppm unless that level was not technologically feasible. The Commission decided to require the lower level even though this would drive many manufacturers to substitute more expensive materials in their products and even though our staff could not point to specific safety benefits (higher costs and consumer choice were certainly not factors in our thinking, of course).

However, more to the point, the staff specifically stated that, at the 100 ppm level, recycled materials would not be able to be used in children’s products and that virgin materials would need to be substituted. This is not because recycled materials do not necessarily meet the 100 ppm level, but because the testing we also require would not be predictive of what was actually in the product. In other words, because recycled materials, by their nature, are not necessarily consistent throughout, something could test at 90 ppm in one spot (passing our standard) but test at 120 ppm in another (failing our standard).

It is so unfortunate that the agency made no effort to try to reconcile the competing public policies—public health and environmental sustainability–at work here.  It would not have been hard for us to keep a lead content ceiling in place that was appropriately protective of health and still accommodate the government-wide policy to increase our use of recyclables. Exceptions for certain products that must and should be made out of virgin materials could easily have been integrated into such a policy. The commission clearly had, and has, the authority to do this, but in its regulatory exuberance, short-term reactive thinking trumped long-term creative problem solving.

So, kudos to Wal-Mart and other companies for their efforts to find environmentally friendly ways to make and sell products. It’s too bad that we have put up an unnecessary hurdle to that effort. Instead we could have come up with a solution that would have reconciled the important public policies of health and environmental stewardship. I wish we would have at least tried.

Exposing Exposure For What It Is

Published April 5, 2012 Children's Products , Lead 2 Comments
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Last Friday the Commission unanimously reached an important, eminently practical, and pretty obvious decision: there are children’s products that have more than 100 parts per million (ppm) of lead that should be allowed to be sold. That’s because removing lead at that trace level is not really feasible and that trace amount of lead will not cause a safety risk to a child.

That’s a lot to say, but it says a lot.

Although last summer the agency said there was no technological reason not to impose a 100 ppm lead-content limit on children’s products, thanks to Public Law 112-28 (also known as H.R. 2715), we now have found a way to provide realistic exceptions to that rule. Why? Because in that law Congress emphasized that exposure to lead, not just the mere presence, is the key to determining the true risk of harm. If reducing lead content is not practicable or technologically feasible, if the product isn’t likely to be mouthed, and if using the product won’t measurably increase blood lead levels, then the product can be over 100 ppm—and be okay. There’s no health risk.

There are other components of children’s products, beyond those dealt with in the petition spurring this decision, which may similarly qualify. I hope the Commission continues to use this reasonable approach, albeit long overdue.

The Song That Never Ends

Published November 21, 2011 Certification , Children's Products , Component Testing , Consumer Product Safety , CPSC , CPSIA , Lead , Small Business , Testing Leave a Comment

If you’re a close watcher of the CPSC Commissioner’s Statements page (and, really, who isn’t?) you may have noticed that my good friend and colleague Commissioner Adler and I have had another round on our perpetual motion statement ride. Back when we took the vote on our lead standard, we got a glimpse of this dynamic, as Commissioner Adler waited a couple weeks after the vote and my written statement explaining my vote, then issued a statement of his own, directly attempting to rebut the arguments I made in my statement.  He has done the same thing with respect to the recently-issued Testing Rule.  We are now on our third round of statements responding to each other.

As I have pointed out, I believe that the purpose of a commissioner’s written statement is to explain why a commissioner voted in a particular way.  If we use our statements as vehicles to respond to arguments made in other written statements, then the commissioner who writes last has the last word.  By using statements to explain ourselves, rather than directly to rebut others, we can guarantee that we do not find ourselves where we are now, trapped on a spinning merry-go-round.

Commissioner Adler does not share this view. In his most recent addition to the dialogue, he explained his rationale. He views these statements as an opportunity for “robust discussion and debate on the critical policy issues that come up before the Commission.” Discussion and debate are wonderful things, but, with all due respect, the time for them is before a vote. That way, the discussion actually has a chance to shape the policy issues. Statement after statement after the fact provides no such opportunity.  It risks becoming repetitive very quickly with the potential for descending into the petty.

The astute reader will no doubt be asking why I have responded to Commissioner Adler’s statements—both the Supplemental and the Further Supplemental—if I believe the entire exercise is such a misuse of the forum. The answer is simple: Unilateral disarmament may be noble, but it looks the same as surrender. If I don’t respond to Commissioner Adler’s arguments, no matter how fallacious they are, it will appear that I have conceded them. That is not so, and it would be inconsistent with my public policy role to allow such a misconception to exist.

That reality—that a Commissioner cannot let the conversation be one-sided, even if she feels it is hopelessly misplaced—is precisely why the CPSC statement format works best when it is kept to an explanation of the author’s perspective and decision. If we all stick to that approach, we give the public a clear, concise view of the arguments surrounding each CPSC action (or inaction) and an opportunity to provide informed comment on future debates on similar issues. If just one of us abandons this approach, we will all be inevitably sucked into a potentially endless exchange that leaves the reader confused, annoyed, or both.

I love Lambchop, but The Song That Never Ends is best sung on children’s television, not by the leadership of a Federal agency.

Regulatory Malpractice

Published October 19, 2011 Children's Products , Component Testing , Congress , Consumer Product Safety , CPSC , CPSIA , Jobs , Lead , Risk Analysis , Small Business , Testing 1 Comment

In a decision that surprised few, the CPSC voted today to ignore common sense and regulatory conscience. We witnessed a majority putting its last grasp of political power ahead of doing what was right.

In 2008, Congress required that we put in place a rule telling the regulated community how to test and certify that the products they make meet the relevant standards. The deadline Congress imposed has long since passed, but we all agreed that the details of the rule proved much harder to write than its basic idea did. Staff put much time and effort into a rule with some solid pieces that I could support. Then the majority, all behind closed doors, summarily dismissed these changes and determined they knew better than our experts. I cannot support their changes, and I cannot ignore their tactics.

The way the majority has handled this rule is, in my opinion, regulatory malpractice. They ultimately didn’t listen to staff, they really didn’t listen to Congress, they didn’t sincerely listen to the regulated community, and they certainly didn’t listen to their fellow Commissioners. All parties pointed in the direction of re-proposal so that we could hear and learn from public comment on the significantly changed rule and the new law surrounding it. Instead, the majority seemingly pushed this through because they soon would not be a majority.

Their reckless disregard for the value of public input in writing regulations is stunning. Other agencies have sought extra public comment when proposals or facts changed. Here, we had a new law change the framework supporting a rule, and, still the majority said we will listen to public comment only after we vote out the thing the public will be commenting on.

The majority is quick to suggest that seeking re-proposal is seeking delay. That’s pure fiction. I offered an amendment to re-propose this rule in light of the statutory changes Congress made, to make the rule better and more likely to stand up in court. Under my proposal, the rule still would have taken effect within the same timeframe as the rule passed today. The majority had a chance to get this done better and faster. Instead, they blew it.

My heart aches for any family who has lost a child due to a faulty consumer product. The pain they feel can never be dismissed or diminished. That pain, however, cannot justify irrational decision-making or misuse of power.

There’s an old lawyer adage: When you have the law on your side, pound the law; when you have the facts on your side, pound the facts; when you have neither the law nor the facts on your side, pound the table. The table-pounding by my colleagues today speaks for itself.

This arrogant dismissal of input from both peers and the public on such an important vote betrays the public trust we bear to implement statutes fairly, openly, and responsibly.

Major Rule, Major Costs

Published October 18, 2011 Children's Products , Congress , Consumer Product Safety , CPSC , CPSIA , Lead , Small Business , Testing 1 Comment

For those of you who aren’t experts in the field of administrative law, when an agency issues a significant new rule, it has to do what’s called a Regulatory Flexibility Act analysis, also known as “Reg Flex”. That’s not Calisthenics for Commissioners (though that’s not a bad idea). It’s a report that examines the impact a new rule will have on the economy, and specifically on small businesses.

The Reg Flex analysis for the testing rule we will vote on tomorrow looked at the costs of this rule, especially on small businesses.  Here is some of what our staff is telling us:

  •  This rule “will have a significant impact on all firms” making children’s products.  For example, the staff estimates that for large firms, increased testing costs will be approximately 1.2% of revenues.  For small firms, testing costs as a percent of revenues could be expected to increase to a staggering 11.7%. 
  •  The rule will have this financial impact on all manufacturers and importers of children’s products.  While we do not have a good handle on precisely how many firms this may be, it will be in the hundreds of thousands of firms.
  •  The testing rule “could be a barrier that inhibits new firms from entering . . . the market.”
  •  Impacted companies may “forgo or delay implementing improvement to products’ design or manufacturing processes in order to avoid the costs of third party testing.”
  •  Firms may be able to mitigate “the adverse impacts if they are able to raise their prices to cover their costs.”
  •  “The impact is expected to be disproportionate on small and low-volume manufacturers.”

At a recent briefing on this rule, one of my colleagues suggested that we already have done everything we can to reduce the costs of this rule.  What I believe he was saying is that we have done everything three Commissioners are willing to do to reduce the rule’s cost.  There are a number of things we could actually do to bring down the testing costs imposed by this rule.  Some of those things are even suggested in the Reg Flex analysis.  And we could still have a robust testing rule to address safety concerns. 

We know that this rule will burden our economy.  Our staff says so.  Because Congress was concerned about the high costs of testing, it recently told us to seek out ways to reduce the testing costs in this rule.  Therefore, before issuing this rule, we should do as Congress asked and look at ways to reduce the costs of testing consistent with assuring compliance with our safety standards. 

Unfortunately, politics often trumps good policy here at the CPSC, so tomorrow we will issue a final testing rule and then look for ways to reduce costs of the rule we are issuing.  Talk about putting the cart before the horse!  And this approach certainly raises the question of how sincere the effort to reduce costs will be. 

While we all agree on the goal of child product safety, I am convinced we can achieve that without incurring the staggering costs identified by our staff.

Solid Floor or Trap Door

Published October 17, 2011 Certification , Children's Products , Component Testing , Consumer Product Safety , CPSC , CPSIA , Lead , Small Business , Testing 1 Comment

Government shouldn’t be in the trap door business. The idea is to let people know what the law is, so that we have the moral ground to penalize violations. I’m worried the CPSC’s looming testing and certification rule has at least one giant trap door built in, and it creates opportunities for abuse. 

Along with initial and material change testing by an independent third party testing lab, this rule tells manufacturers to third-party test each product periodically for as long as it’s sold. What worries me is how we’ve structured the periodic testing.

Our rule tells manufacturers to third-party test at least once a year, or once every two years if they have production testing, or once every three years if they have their own lab certified by ISO. That sounds simple enough, but we’ve left a trap door.

Those intervals are ceilings, but the rule doesn’t have a floor. Manufacturers may have to test much more often than what is outlined above, but we’re going to put all the risk on them for making the right judgment call. What the rule actually says is that products need to be tested often enough to give a “high degree of assurance” of compliance, and then it gives ten factors – all of them judgment calls – we think manufacturers should consider.

This creates a situation where a well-intentioned manufacturer could set an interval it thinks is appropriate based on our factors. Then, when we step in to investigate an issue, we get to decide on our own with the benefit of 20/20 hindsight if that was good enough, with no limits on our discretion.

The obvious uncertainty that means for manufacturers is bad enough, but, worse, it’s an avenue for abuse. When a manufacturer – again, trying to do things the right way – is negotiating with us the remedies for a problem, including monetary penalties, we could stack on extra “violations” for its failure to read our minds accurately on the testing interval.

My colleagues have told me my fears aren’t real, and there’s no way we would use our rule like this. If that’s the case, why write it this way at all? Why not just make it clear: If you don’t do production testing and don’t have an ISO-certified lab and you third-party test at least once a year, you’re fine; if not, you’re in violation of this aspect of the rule. Period. No mind reading. No guessing games. No trap doors. Just a clear rule and clear enforcement, the way it’s supposed to be.

Majority’s Plan: Ram it through while we can

Published September 9, 2011 Certification , Children's Products , Component Testing , Congress , Consumer Product Safety , CPSC , CPSIA , Jobs , Lead , Risk Analysis , Small Business , Testing 2 Comments

The past three days in this blog I have discussed my disagreements with the three-member majority on the Commission about the pending testing and certification rule they plan to ram through in October.

  • The proposed rule applies a one-size-fits-all approach to third-party testing that is guaranteed to be a misfit rather than requiring third-party testing where it is the most necessary (i.e., where the risk is highest);
  • The proposal needlessly sets detailed definitions of a “reasonable testing program” in regulatory stone; and
  • The voluntary component part testing rule—which holds the promise of actually lowering costs and for which work was completed some time ago—has been needlessly held back while we work on the testing rule.

I also question the insistence on rushing this flawed product through. H.R. 2715, passed just weeks ago, expressly instructed us to consider the costs of our testing rules and get public feedback on how to mitigate those costs while still ensuring the safety of children’s products.  It would make sense to get that information before we issue the rule, but the three-member majority doesn’t want to do that. I have to ask: If we don’t have time to get it right the first time, when are we going to have time to fix it?

Congress addressed another problem that I had with our proposed testing rule. The CPSIA required companies to submit “random” samples of their products for testing, but didn’t define the term “random.” It would have been good for the Commission to interpret “random” to mean that manufacturers couldn’t rig the game by choosing “golden samples” they knew would comply.

Our proposal, however, did not take that plain-language approach. It read “random” in a much more technical, complicated sense that might have meant lots of money for statisticians but little or no safety benefits beyond those of a common-sense reading.

In H.R. 2715, Congress resolved this dispute. The new law makes clear that Congress intended to prevent the cherry picking of samples by striking the word “random” and replacing it with “representative.” We could have done this by interpretation, but we chose to let others clean up our mess after the fact. Sound familiar?

 So:

  • Congress has expressly informed us that the majority was mistaken on at least one key aspect of the testing rule.
  • The new law re-shapes the landscape to require us to look at ways to reduce costs. 
  • The proposed testing rule has serious flaws that will make it more burdensome than it has to be and less effective than it could be.

Given all this, prudence indicates the path forward. We should take a few moments to re-examine what we’re trying to accomplish and how we’re trying to accomplish it. If we do that openly and sincerely, we will arrive at a better product.

Instead, because three members of the Commission want to do all they can while they still have their majority, they are poised to foist a misguided, misconceived, and likely expensive regulation on an already fragile economy. All with the promise that sometime in the future it could be fixed.  Man up and fix it now.

Setting the Record Straight: the Crib Rule

Published August 3, 2011 Children's Products , Consumer Product Safety , CPSC , CPSIA , Lead , Recalls , Retailers , Small Business , Testing Leave a Comment

The Chairman has recently made several pointedly hostile, but grossly inaccurate, statements that warrant correction. One of the most egregious is her accusation that with our new crib rule, I have sought to put the interest of “a few retailers” over the interests of children. What utter nonsense!

This agency has always viewed children as a special constituency and has a long history of working to assure a safe sleep environment for them. That work intensified in 2007 when, as acting chairman, I established a cross-cutting, multidisciplinary team to do a comprehensive look-back at incidents involving children’s sleep environment to better determine hazard patterns. In 2008, while I was still chairman, the agency issued an Advanced Notice of Proposed Rulemaking informing the public that we were developing a new mandatory crib standard and seeking information. We were doing this work at the same time that the American Society for Testing and Materials (ASTM) was working to develop its new voluntary crib standard, and CPSC staff joined in that effort as well. ASTM issued its standard in 2009, and that provided much of the basis for the 2010 CPSC mandatory standard. The agency proposed to adopt the ASTM standard with two changes in mid-2010 and finalized the mandatory standard in December, 2010, to go into effect 6 months later. All this work was done with the full support of all the Commissioners.

So where is the problem that the Chairman alludes to? While I support what is in the new crib standard, I am very troubled by the chaotic manner in which we implemented it. Because we did not do a cost-benefit analysis that looked at regulatory impacts and alternatives, we did not even know that this was a major rule – having an impact on the economy of over $100 million – until literally days before the Commission was about to vote on the final rule. (The crib rule is only the second major rule in the history of the agency.) Only at that point did it become apparent that this rule would do major damage to the child care industry, which would be required to replace every single crib in every single child care center in this country. The hotel industry also told us that they would have to stop making cribs available to guests because of this rule. In response, we delayed the effective date for these two industries for two years – a date that was arbitrarily chosen by the Commissioners with no data behind it. For everyone else, it would be illegal to make or sell a crib that did not comply with the new standard (even if that crib did meet the 2009 ASTM standard) after June 28, 2011.

During the spring of 2011, we began to hear rumblings of trouble with respect to this rule. CPSC began accrediting labs only in late spring because the labs were having trouble doing the tests we required. Supply issues were starting to pop up. Although the scant economic analysis we had done prior to issuing the rule told us that retailers would not be impacted by it, we started to hear from retailers that the assurances they had received from manufacturers about the availability of retrofit kits for current inventory were not being met. (By the way, CPSC rushed to put out its guidelines on accepting retrofit kits only 72 hours before the crib standard was to go into effect.) In the late spring, we did a “quick and dirty” survey of five retailers and found at least 100,000 non complying cribs in inventory. We then heard from an association representing smaller retailers requesting an additional three months before the crib standard went into effect for retailers. At the same time we heard from the leasing industry also asking for a delay in the effective date.

The reaction of the various Commissioners is instructive. Commissioner Northup and I believed that the modest additional time the small retailers requested was reasonable, if the cribs in inventory complied with the new 2009 standard and were not the drop-side cribs that had created much of the concern. Among other things, this short extension would allow for retailers to get the retrofit kits manufacturers had promised so that they did not have to “trash” perfectly good cribs. While the majority of my colleagues were fine with giving the leasing industry an 18-month extension, they refused to give a 90-day extension to small retailers. Apparently the majority thinks that children in child care, in hotels and in leased cribs (regardless of whether they are drop side cribs or what the crib’s condition of repair is) do not warrant the extra protection, but a short extension so that thousands of perfectly good cribs do not have to be destroyed is not warranted. That is reasoning that I do not agree with.

It is unfortunate that the Chairman believes that anyone who does not agree with her is automatically “anti-consumer.” It is unfortunate that the Chairman sees “obstructionism” when constructive dissenting views are offered. It is unfortunate that the Chairman selectively interprets both facts and words and unfairly impugns her colleagues. Mostly, it is unfortunate that the Chairman cannot work with us to fashion rules that protect American families without imposing job-killing requirements on those same American families.

Click here for more information on the Chairman’s false accusations.

Democracy Means Debate

Published July 29, 2011 Children's Products , Congress , Consumer Product Safety , CPSC , CPSIA , Lead , Risk Analysis , Small Business , Testing 3 Comments

Today I was surprised to learn that our Chairman assumes any disagreement with her view of the world and rulemaking means, in her words, delay and distortion to circumvent the will of America.

I join with the Chairman and our talented, dedicated staff in seeking to remove genuine, unreasonable threats to consumer safety as our statute charges us to do. Life, unfortunately, doesn’t follow statutory rules, and always presents some risk. Falling off a bicycle will hurt even if it contains no lead whatsoever. As a mother, I would do anything in my power to change those realities. As a regulator, I know the CPSC does not have the power to change all those realities.  That’s why I advocate using our limited resources to address the greatest risks to consumers, particularly children.

The Chairman states that our excellent staff are “made up of parents and grandparents who are also consumers.” I guess I need to remind the Chairman we Commissioners and our staff are also made up of parents and grandparents who are also consumers. What’s her point?

I was struck by the number of baseless allegations by the Chairman. Among these was her imagining a “coordinated campaign” against her regulatory agenda. Two or more Commissioners expressing their sincere concerns about a regulatory approach does not a conspiracy make.

What the Chairman characterizes as “vigorous resistance” is actually my principled insistence on collaborative, participatory, democratic government. What does that mean?  That means the Chairman and the majority should not do what they just did on phthalates:  withhold information from the public and foreclose public debate. One virtue the Chairman does not and cannot claim here is transparency.

The “tactics” she accuses me of using are those of needless delay. Let’s see. The Chairman has repeatedly joined in votes to stay enforcement of a variety of CPSC mandates, and she has touted several of these votes as expressions of a spirit of cooperation. Apparently, when she agrees with a delay, it is merely wise bi-partisan restraint, but when I advocate for prudent restraint, it is merely dilatory.  

Additionally, the Chairman ignores the reality that I voted for many of the regulations she cites as CPSC’s latest achievements. In fact, she fails to mention that I took the lead in pursuing the new rules on drawstrings on children’s clothing, pressed the Chairman for months to bring it to a vote, and expanded the scope of that regulation to protect children more fully.

While the Chairman’s slogan “safety delayed is safety denied” may seem catchy, I prefer to focus on substantive language. For example, last week I tried to get regulatory language to focus our resources on our “particular consideration to the safety impacts on children.” I was voted down by the majority.

The message I get from the Chairman is clear: sit down, you’re rocking the boat.  It is unlikely her wish will come true.

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

Published July 28, 2011 Certification , Children's Products , Congress , Consumer Product Safety , CPSC , CPSIA , Jobs , Lead , Risk Analysis , Small Business , Testing Leave a Comment

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.

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