Prop 65

Is The Writing On The Wall For Prop 65?

Beverage, FDA, Federal Preemption, Food, Prop 65

                                                                                                                                                                                                       

By: Brent E. Johnson 

On October 12, 539 BC, Persian ruler Cyrus the Great conquered Babylon.  According to the Biblical Book of Daniel, on the night before the overthrow, the Babylonian king, Belshazzar, witnessed the appearance of a mysterious hand, which wrote on a palace wall, “Mene, Mene, Tekel, Upharsin.”  Belshazzar called for Daniel to interpret the mysterious inscription.  Daniel’s translation: “You have been weighed . . . and found wanting.”  Is the same writing on the wall for Prop 65?

First came “Roundup.”  As we’ve blogged about in the recent past, Monsanto, the manufacturer of the herbicide Roundup, filed a petition in Fresno County Superior Court to prevent the California Office of Environmental Health Hazard Assessment (“OEHHA”) from listing glyphosate (the principle ingredient in Roundup) as a Prop 65 chemical requiring a warning label.  Finding no success, Monsanto and several state agricultural associations moved to federal court seeking an order that they are not required to put a warning label on Roundup or food products containing glyphosate.  While the federal case is ongoing, the court granted a  preliminary injunction so that no warning is required during the pendency of the action.  The federal court gave particular credence to Monsanto’s first amendment argument that it was being required to engage in commercial speech with which it did not agree.  The court held that the State of California may only require commercial speakers to disclose “purely factual and uncontroversial information,” and the science before it was questionable regarding whether glyphosate is a carcinogen.  In 2015, the International Agency for Research on Cancer (“IARC”) – a division of the World Health Organization — issued a report finding that glyphosate is a “probable carcinogen.”  More recently, however, the Environmental Protection Agency issued a draft human health risk assessment that concluded that glyphosate is likely not carcinogenic.  The federal case will put on trial the science behind OEHHA’s glyphosate listing, which is predicated exclusively on the IARC study.

After Roundup came coffee.  As we’ve blogged about recently, in response to a ruling by the Los Angeles Superior Court that coffee must bear a Prop 65 cancer and reproductive harm warning, OEHHA announced, and opened a period for public comment on, a proposed regulation that would eliminate the need for cancer warnings on coffee products.  OEHHA’s reasoning is illuminating:   “In a review of more than 1,000 studies published this week, the World Health Organization’s International Agency for Research on Cancer (IARC) concluded that there is ‘inadequate evidence’ that drinking coffee causes cancer. IARC found that coffee is associated with reduced risk for cancers of the liver and uterus, and does not cause cancers of the breast, pancreas and prostate. IARC also found that coffee  “exhibits strong antioxidant effects related to reduced cancer risk.”  It seems that OEHHA is willing to look at coffee in its entirety — even though  the Los Angeles Superior Court opinion and Prop 65, itself, focuses on the chemical alone.  See Council for Education and Research on Toxics v. Starbucks Corp. et al., No. BC435759 (Cal. Super. Ct. L.A. County March 28, 2018)

And just this week, the California Court of Appeal (Second Appellate Division) ruled that breakfast cereal manufactures are not required to label their boxes with Prop 65 warnings based on the presence of acrylamide because federal law pre-empts Prop 65 when it comes to Fruity Pebbles.  Post Foods, LLC v. Superior Court, No. B284057, 2018 WL 3424800, at *6 (Cal. Ct. App. July 16, 2018).  The Court held that mandating a Prop 65 warning on cereals presented an “obstacle” to the Food and Drug Administration’s stated objective of encouraging the consumption of whole grains.

For those of us who practice in the food and beverage space, a finding of federal pre-emption of a state statute or regulation is the Holy Grail.  In this case, the Court of Appeal found “obstacle pre-emption” by citing to correspondence between FDA and OEHHA in the early and mid-2000s regarding the application of Prop 65 to food, in general, and acrylamide, in particular.  Specifically, in a July 14, 2003 letter from FDA Deputy Commissioner Lester Crawford to Joan Denton, Director of OEHHA, Commissioner Crawford stated:

“FDA is concerned that premature labeling of many foods with warnings about dangerous levels of acrylamide would confuse and could potentially mislead consumers, both because the labeling would be so broad as to be meaningless and because the risk of consumption of acrylamide in food is not yet clear. [¶] Furthermore, consumers may be misled into thinking that acrylamide is only a hazard in store-bought food. In fact, consumer exposure may be greater through home cooking. … In addition, a requirement for warning labels on food might deter consumers from eating foods with such labels. Consumers who avoid eating some of these foods, such as breads and cereals, may encounter greater risks because they would have less fiber and other beneficial nutrients in their diets. For these reasons, premature labeling requirements would conflict with FDA’s ongoing efforts to provide consumers with effective scientifically based risk communication to prevent disease and promote health.”

Post Foods, 2018 WL 3424800, at *2.

FDA’s letter should be read for what it is – a scathing indictment of Prop 65 as it pertains to food.  FDA essentially told OEHHA:  (1) Your Prop 65 labeling is so ubiquitous as to be “meaningless;” (2) Your science regarding acrylamide is suspect; and (3) Your labeling requirement is actually counterproductive because, to the extent consumers read the warnings, the labels might actually deter them from eating healthy foods, such as whole grains.  FDA followed up with OEHHA in 2006 reaffirming its earlier position and observing that an acrylamide warning on food might “create unnecessary and unjustified public alarm about the safety of the food supply; dilute overall messages about healthy eating; and mislead consumers into thinking that acrylamide is only a hazard in store-bought food.”

These recent developments go to the core of several long-standing criticisms of Prop 65:  (1) The science behind requiring a warning – in most cases, a study by IARC – is dubious; (2) The warning requirement is myopically focused on the presence of the accused chemical and does not take into account broader considerations of the value of the product as a whole or the actual risk posed by the presence of the chemical in the product; and (3) The “over-warning” engendered by Prop 65 dilutes the impact of consumer product warnings that are actually important.  While Prop 65 apologists often resort to the argument that the law is “just a warning statute — it doesn’t ban products,” this argument glosses over the fundamental issue of what the warning actually means.  Do the words “known to the State of California” mean that hard science supports the cancer or reproductive harm warning?  Does the very presence of the chemical in the product actually increase the risk of cancer or reproductive harm to the consumer who uses it or consumes it?  Does the product have benefits that outweigh any risks from exposure to the chemical?

These criticisms of Prop 65 finally have been heard by Congress, a group that was more than happy to legislate away Vermont’s GMO law, but heretofore has been disinclined to take on California.  On June 18, 2018, a bipartisan group of congressmen introduced H.R. 6022 (“The Accurate Labels Act”), a bill “[t]o amend the Fair Packaging and Labeling Act to require that Federal and State mandated information declarations and labeling requirements applicable to the chemical composition of . . . consumer products meet minimum scientific standards to deliver accurate and clear information . . . .”  Among the bill’s sponsors is Representative Jim Costa, a Democrat from California’s 16th Congressional District in the central San Joaquin Valley.  The bill prohibits departments and agencies of the federal government as well as states and political subdivision of states from requiring information — including warnings — on consumer commodities unless, among other things, the information/warning is:  (1) risk-based; (2) based on the best available science; and (3) based on an appropriate weight of the evidence review.  Therefore, to the extent a Prop 65 chemical listing is based on the mere presence of the chemical in a product (i.e., not based on the risk of a particular exposure); is made purely because a single health organization (read, IARC) has determined that the chemical may be a carcinogen or reproductive toxicant; or does not weigh the risk/benefits of the chemical in particular products, the listing would run afoul of H.R. 6022.  The bill also authorizes “[a]ny . . . person that is . . . required to display or communicate to a consumer covered information about a covered product, or is, or may be, subject to an enforcement action with respect to that requirement by a State or a political subdivision of a State, [to] bring a civil action in an appropriate district court of the United States against that State (or any private entity that is authorized to bring an enforcement action on behalf of that State) . . . if the requirement of the State or political subdivision does not comply with the requirements [of this Act].”  If the bill becomes law, Bounty Hunters in California may find themselves the subject of federal lawsuits for making Prop 65 claims.

H.R. 6022 has been referred to the House Committee on Energy and Commerce.  An analogous Senate bill, S 3109, is before the Committee on Commerce, Science and Transportation.  While these bills will have a difficult time making it out of committee because of timing issues and the likelihood of opposition from other California legislators in both houses, their very existence shows that Congress is paying attention.  When coupled with the recent Roundup and acrylamide decisions, the House and Senate bills – like the mysterious inscription given to Belshazzar – may be the writing on the wall for Prop 65?

OEHHA Flips on Coffee

Consumer Class Action, Food, Prop 65

** California Regulators Propose New Regulation That Excludes Coffee Makers from Acrylamide Prop 65 Warning **                                                                                                                                                                                                                                                                                                                                                              

By: Brent E. Johnson 

 

As we blogged about recently, Defendants in the blockbuster Prop 65 case, Council for Education and Research on Toxics v. Starbucks Corp. et al., No. BC435759 (Los Angeles County Superior Court), argued that although acrylamide was listed as a Prop 65 chemical – and although acrylamide was present in coffee (created as part of the roasting process) – consuming coffee, itself, has not been shown to cause cancer and, therefore, a Prop 65 warning was unwarranted.  Defendants went further, arguing that studies have actually shown that coffee reduces the risk of some cancers.  The court disagreed with Defendants analysis, holding that the relevant question was whether acrylamide causes cancer – not coffee as a whole. The court also rejected Defendants’ arguments touting the overall health benefits of coffee, which would have permitted the court to apply a “public health” exception to Prop 65 labeling.

The result: coffee sellers in California have no choice but to label their beverages with a Prop 65 warning.  With millions of coffee drinkers in California – most of them daily drinkers – the Prop 65 warning looks to become even more ubiquitous (and ignored).

But not so fast!  The California Office of Environmental Health Hazard Assessment (OEHHA) just proposed a new regulation providing that cancer warnings would not be required for coffee, stating (in effect) that the health benefits of consuming coffee outweigh the cancer risk posed by acrylamide.  OEHHA’s press release articulates that its proposed regulation is based on scientific evidence that drinking coffee has not been shown to increase the risk of cancer and may reduce the risk of some types of cancer: “In a review of more than 1,000 studies published this week, the World Health Organization’s International Agency for Research on Cancer (IARC) concluded that there is ‘inadequate evidence’ that drinking coffee causes cancer. IARC found that coffee is associated with reduced risk for cancers of the liver and uterus, and does not cause cancers of the breast, pancreas and prostate. IARC also found that coffee  “exhibits strong antioxidant effects related to reduced cancer risk.”  OEHHA’s Initial Statement of Reasons are linked here and make for interesting reading.  The proposed regulation, which would fit under § 25704 of the implementing regulations,  states: “Exposures to listed chemicals in coffee created by and inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer.”

OEHHA’s approach to this proposed regulation is identical to that rejected by the court in the Starbucks case when it denied the coffee sellers’ request that it consider the wider science on the cancer risks/benefits of coffee rather than the limited question of harm from acrylamide.  It is also an interesting development in so far as Prop 65 (Cal. Health & Safety Code § 25249.8 (a)) requires OEHHA to list chemicals that IARC identifies as carcinogenic but does not have a mechanism for exempting those products that IARC gives a green light.

OEHHA’s proposed regulation begs the question:  What about other products that are inherently healthy but contain a Prop 65 chemical?  For example, lead appears in trace amounts in dietary supplements that are made from botanicals.  Should these supplements also get their own product-specific exemption from Prop 65 labeling?

The proposed regulation has been posted, which initiates a public comment period that will run until August 30, 2018.

California Court Does Not Side With Coffee

Prop 65, Uncategorized, ,

** Starbucks and other Coffee Makers Lose Latest Phase of Prop 65 Acrylamide Warning Case **                                                                                                                                                                                                                                                                                          

By: Brent E. Johnson                                                                                                                                                                                                                        

Background: Acrylamide is a chemical compound first isolated in laboratories in the 1950’s.  Since its discovery, it has been used in many industrial applications, such as in the manufacture of polymers, in papermaking, ore processing, oil recovery, and in the manufacture of permanent press fabrics.

Acrylamide was listed by OEHHA as a chemical known to the State of California to cause cancer in 1990 based on studies that showed it produced cancer in laboratory rats and mice.  In 2011, it was added to the reproductive and developmental harm list following studies of laboratory animals that showed effects on the growth of offspring exposed in utero as well as genetic damage.

Apart from its industrial uses, in 2002 acrylamide was discovered in foods – in particular starchy, carbohydrate rich plant based foods.  The chemical appears to be created when these foods are roasted or fried at temperatures higher than 248 °F – but not in food that had been boiled or steamed.  Further, acrylamide levels seem to rise as food is heated for longer periods of time, although researchers are still unsure of the precise mechanisms by which acrylamide is formed.  It has been detected irrespective of whether the food is cooked at home, by a restaurant or by commercial food processors and manufacturers.  All the good stuff is implicated – french fries, potato chips, other fried and baked snack foods, coffee, roasted nuts, breakfast cereals, crackers, cookies and breads.  At present the Prop 65 No Significant Risk Level (NSRL)  for acrylamide is 0.2 µg/day.  Cal. Code Regs. tit. 27, § 25705 (c)(2).

In 2005, California attorney general Bill Lockyer filed a Prop 65 lawsuit against four makers of French fries and potato chips – H.J. Heinz Co., Frito-Lay, Kettle Foods Inc., and Lance Inc..  People of the State of California v. Frito-Lay, Inc. et al., Case No. BC338956 (Cal. Super. Ct. 2005).  The lawsuit was settled in 2008, with the food producers agreeing to reformulate, cutting acrylamide levels to 275 parts per billion (thereby avoiding a Prop 65 warning label).  The companies also agreed to pay a combined $3 million in civil penalties.

It was not until 2010 that a private attorney general filed a Prop 65 complaint against the major coffee sellers in California.  A number of similar cases were filed and ultimately consolidated in Los Angeles County Superior Court – Council for Education and Research on Toxics v. Starbucks Corp. et al., No. BC435759, and Council for Education and Research on Toxics v. Brad Barry Co. Ltd. et al., No. BC461182.  In all, the consolidated litigation involves more than 70 companies including grocery stores, coffee companies, food manufacturers and big-box retailers, such as Whole Foods Market, Trader Joe’s Co., Peet’s Coffee & Tea Inc., Nestle USA Inc., Costco Wholesale Inc. and Wal-Mart Stores.

The first phase of the trial took place in 2014, with a bench trial on several affirmative defenses, including whether acrylamide posed “no significant risk.” Judge Berle ruled in favor of Plaintiff at this phase, rejecting Defendants’ arguments that the level of acrylamide in their coffee products posed no significant risk because a multitude of studies show that coffee consumption does not increase the risk of cancer.  The court ruled that the studies assessed the effects of coffee generally, as opposed to the presence of acrylamide in the coffee and were therefore not persuasive.  Defendants’ argument that requiring them to post a Prop 65 warning amounted to unconstitutional forced speech was also rejected.

The second phase of the bench trial was held in September of 2017.  Several of the defendants settled on the eve of trial, among them were BP, which operates gas stations and convenience stores ($675,000 + warning label); Yum Yum Donuts Inc. ($250,000+ warning label) and 7-Eleven stores ($900,000 + warning label).  Starbucks did not settle, although it did begin posting Prop 65 notices in its stores, presumably to limit civil penalties were it unsuccessful at trial.

At the September 2017 trial, Defendants focused their trial strategy on:

  • Code Regs. tit. 27, § 25703 (b)(1), which exempts from the normal risk level circumstance where the “chemicals in food are produced by cooking necessary to render the food palatable or to avoid microbiological contamination.” At trial, experts for the defendants testified that there is no commercially viable way to reduce acrylamide in coffee by some other cooking method.
  • If § 25703 (b)(1) applies, the statute allows for a higher “alternative risk level” (i.e. not the NSRL of 0.2 µg/day) to apply to chemicals produced in the process of cooking foods if “sound considerations of public health” justify it. As to the appropriate risk level posed by drinking coffee, Defendants’ experts pegged it at up to 19 µg/day of acrylamide in coffee over a lifetime, and otherwise testified that the average person’s exposure to acrylamide in coffee is ten times less.  Defendants’ experts also testified that studies found no increased risk of cancer for coffee drinkers, and to the contrary, evidence suggested that moderate coffee consumption is associated with a reduced risk of certain chronic diseases, including certain cancers.

On March 28, 2018, Judge Berle issued a statement of decision under Rule 632 (akin to a preliminary ruling) rejecting the coffee makers’ arguments.  Council for Education and Research on Toxics v. Starbucks Corp. et al., No. BC435759 (Cal. Super. Ct. L.A. County March 28, 2018).  Judge Berle noted that Prop 65 contemplated an alternative risk level if “public health” justified it.  Id. ¶¶ at 75 – 81.  But he found that the expert evidence did not persuade him that drinking coffee was strictly speaking a “public health” concern, i.e. that coffee confers a particular benefit to human health.  On that basis, the alternative significant risk level defense failed as a threshold matter.  Under California procedure, the Defendants can object to these preliminary findings, but it is uncommon for a statement of decision to not ultimately be entered as the judgment.  The judge can now set another phase of trial to consider potential civil penalties – up to $2,500 per person exposed each day.  In the abstract, that could calculate out to be an astronomical sum, although this preliminary decision may push the parties to the settlement table.  We will see who the next target is – acrylamide is after all not just in coffee – but in many cooked and processed foods.

Updating Proposition 65 Warnings for the Online Era

Prop 65, ,

** California Law Makers Turn Their Attention to the Prop 65 Implications of Online Retailing **                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           

By: Brent E. Johnson                                                                                                                                                                                                                                                                                                             

California’s Proposition 65, requires any person who exposes a consumer to a listed chemical deemed to be either a carcinogen or a reproductive toxicant “in the course of doing business” to first provide a warning about that exposure (California Health & Saf. Code § 25249.5 et seq.).  As many of our readers are no doubt aware, particularly those who represent clients in California, Proposition 65 has generated a substantial amount of litigation since its enactment, largely due to “public interest” standing creating a private right of action to “any person” (§ 25249.7(d)).

California’s Office of Environmental Health Hazard Assessment (OEHHA) is tasked with updating the list of offending chemicals – there are almost a thousand currently on the list – and once a consumer product is shown to contain one of the listed chemicals a defendant has a heavy burden to show that the amount of exposure is within a safe harbor level or that the product is manufactured in such a way which precludes exposure.  The usual practice for consumer companies has been to rely on the warning provision – foreclosing on Prop. 65 litigation.  That said, the warning, in order to properly immunize the consumer company has to be “clear and reasonable” (§ 25249.11(f)).

What does this mean for manufacturers and retailers that deal with consumers online?  Bear in mind that the initial passage of Proposition 65 was in 1985 and unfortunately the implementing rules had not kept pace with changing trends in online retailing (not having been updated since 2008).  So internet sellers have been left somewhat to wonder.  OEHHA has released new regulations to take effect August 30, 2018, and for the first time they provide added specificity for internet sellers, and demonstrate when and how a Prop 65 warning should be provided.

New Reg. § 25600.1 provides a definition of “Retail seller” which means “a person or business that sells or otherwise provides consumer products directly to consumers by any means, including via the internet” (emphasis added).  The new rules do not upend the presumption that “[t]o the extent practicable, warning materials such as signs, notices, menu stickers, or labels shall be provided by the manufacturer, producer, or packager of the consumer product, rather than by the retail seller” (old § 25603) – they recognize that the new implementing rules are intended to minimize the burden on retail sellers of consumer products (see § 25249.11(f) of the Act).  As such it is primarily the burden of the “manufacturer, producer, packager, importer, supplier, or distributor” to provide the written notice of exposure to the retailer seller (Reg. § 25600.2 (b), (c)).

However, a retailer sellers is responsible for providing a Prop 65 warning in the following instances (§ 25600.2(e)):

  • The retail seller is selling the product under a brand or trademark that is owned or licensed by the retail seller or an affiliated entity;
  • The retail seller has knowingly introduced a listed chemical into the product, or knowingly caused a listed chemical to be created in the product;
  • The retail seller has covered, obscured or altered a warning label that has been affixed to the product by a manufacturer; or
  • Where the seller has “actual knowledge” from a “reliable source” of the potential of consumer product exposure to a listed chemical AND where the manufacturer, producer, packager, importer, supplier, or distributor of the product is: EITHER not “doing business” (because for example, they have less than 10 employees ” ( 25249.11(b))) OR has no registered agent or place of business in California. See Reg. § 25600.2 (e)(5).  In essence this broadens the reach of Prop 65 to retailers as a proxy for manufacturers who were not otherwise caught by Prop 65, either because they were too small or not connected to California.  “Actual knowledge” means specific knowledge of the consumer product exposure received by the retail seller from any reliable source.”  If the source of this knowledge is a notice served pursuant to Section 25249.7 (d)(1) of the Act (i.e. the 60 day notice required under Prop 65 before litigation can commence), the retail seller shall not be deemed to have actual knowledge of any consumer product exposure that is alleged in the notice until five business days after the notice.  This 5 day rule provides an important safe harbor for retailers – and begs the question as to whether there is any incentive for retailers to investigate products – or just wait until notice is provided. The fact that the provision also only applies to retailers when they are dealing with small (or out of state companies) also begs the question whether they’ll be a perhaps unintended consequence – retailers refusing to deal with these small businesses out of fear of the pass-along risk.

A retail seller can also be liable to provide Prop 65 warning where the manufacturer , importer, etc. provides notice and materials for the retailer to affix them, to shelves, products, or the text to provide on internet listings.  (Reg. § 25600.2 (b), (c)). The retailer’s correlative obligation is the “placement and maintenance of warning materials, including warnings for products sold over the Internet, that the retail seller receives” from the manufacture, producer etc.  (Reg. § 25600.2 (d)).  However, a retailer who agrees in writing with the manufacturer, importer, etc., that allocates legal responsibility to the latter will be binding and effective against Prop 65 liability (provided the consumer receives the relevant warning) (Reg. § 25600.2 (d)).  This provision provides another important safe harbor for retailers.  It will be interesting to see in which retail-manufacturer relationships the retailer has the bargaining power to demand this agreement.

The new regulations also provide guidance on how a Prop 65 warning should be given (Reg. § 25602 (b)): “For internet purchases, a . . .  must be provided by including either the warning or a clearly marked hyperlink using the word “WARNING” on the product display page, or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase.  If an on-product warning is provided pursuant to Section 25602(a)(4), the warning provided on the website may use the same content as the on-product warning. For purposes of this subarticle, a warning is not prominently displayed if the purchaser must search for it in the general content of the website.”  As many of you are aware, the new 2018 Regulations also provide new warning requirements, including a symbol, hyperlink and warning language more specific to the carcinogen, reproductive toxicant, etc. (Reg. § 25603).  There are also slightly different rules for specific products such as Food (Reg. § 25607.2), Raw Wood Products (Reg. § 25607.10), Furniture (Reg. § 25607.12), Products With Diesel Engines (Reg. § 25607.14), etc.

These new rules provide clarity . . . but also raise new questions.  For example, is an online platform which is merely connecting the ultimate seller and buyer, such as eBay (and to some extent Amazon) the actual “retail seller” or is the vendor who uses the site the “retail seller.”  See Tiffany (NJ) Inc. v. eBay Inc., 600 F.3d 93, 96–97 (2d Cir.2010) (eBay does not “does not itself sell the items listed for sale on the site nor does it ever take physical possession of them.”); Butler v. eBay, Inc., No. 5:06–cv–02704–JW (N.D.Cal. 12, 2006) (“[T]he seller is in control of the sale, not eBay…. Thus, the sale transaction is between the seller and the bidder.”); see also Cal. Att’y Gen. Op. No. 02–111 (2003) (“We have little doubt that eBay does not sell or offer to sell or buy or offer to buy, on behalf of another or others, any of the items.”). Should retailers, as discussed above, be required to be affirmative or have constructive knowledge of Prop 65 chemicals?  And if online retailers, as a practical matter, have to make the warning nationwide – does this trigger dormant commerce clause challenges?  These developments and more to follow as the rules begin implementation next year.