Ear To The Ground

And You Thought California's Proposition 65 Was A Pain Now

OEHHA PLANS MAJOR CHANGES TO PROPOSITION 65

WARNINGS AND REQUIRED INFORMATION FROM BUSINESS

 BACKGROUND

 In May of 2013, amid much publicity, Governor Brown of California released a general outline of a proposal to “reduce unnecessary litigation” and “require more useful information” related to the warnings required by Proposition 65.  See Sections 25249.5 to 25249.13 California Health & Safety Code (“H.&S.C.”).  These and other Proposition 65 related statutes may be found at http://www.oehha.ca.gov/prop65/law/P65law72003.html.  There was much optimism that the program would help address the rampant greenmail that is commonplace.  There was also hope that many of the flaws in Prop. 65 litigation would be addressed, such as those discussed at http://www.rmkb.com/tasks/sites/rmkb/assets/image/The_Flaws_of_Prop.65_TCH.pdf. 

The process has now undoubtedly become better for restaurants, parking garages, and bars facing a narrow range of claims (chemicals in food, alcohol, vehicle exhaust, and tobacco smoke) commonly exploited by an unfortunate coterie of plaintiffs who seemed more interested in generating revenue for themselves than in addressing important issues of public health.  See the amendments to Proposition 65 enacted through Assembly Bill 227 (2013; Assemblyperson Gattto):  http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201320140AB227&search_keywords=.  Unfortunately, for the rest of the business community, things are likely to get worse, not better.

The Office of Health Hazard Assessment (“OEHHA”), the administrative agency that oversees Prop. 65, has proposed changes to a) the warnings to be given, and b) additional information to be mandated of companies that is then to be posted on an OEHHA website.  For those interested in the regulatory agenda, notices, and explanations by OEHHA of its goals in these “reforms,” see http://oehha.ca.gov/prop65/warnings/030714warningworkshop.html.  Public hearings and receipt of written comments can be sent to OEHHA through May 14, 2014.  The breadth and scope of OEHHA’s changes are described in detail below.

PROPOSITION 65 WARNINGS

Warning Content

Gone will be the days of the “safe harbor” warnings, which can only mean much more litigation.  Warnings will now be required to specifically identify exposures to at least 12 chemicals (or combinations of these chemicals) “commonly found” in consumer products and food, assuming that these are present:

■ acrylamide

■ arsenic

■ benzene

■ cadmium

■ chlorinated tris

■ 1,4-dioxane

■ formaldehyde

■ lead

■ mercury

■ phthalates

■ tobacco smoke, and

■ toluene.

It is not clear how this list was developed, but OEHHA has noted that this list may grow. 

Obviously, warnings will grow longer, not shorter.  Warnings must include the following:

Pictogram.  The proposal would require the inclusion of the following standard (Globally Harmonized System) pictogram in many categories of warning:

 See https://www.flickr.com/photos/msds-online/4642776786/

 International Health Safety Hazard Symbol

“WARNING”.  The word “warning” must appear in all capital letters and bold print.  If the product contains one of the aforementioned 12 chemicals, these chemicals must be mentioned in the text of the warning.

 “Expose”.  The phrasing of the warning must make reference to exposing someone to the listed chemical.  This differs from the current safe harbor warning which uses the phrase “this [product, area] contains a chemical known to the State of California to cause [cancer, birth defects, reproductive harm].”  OEHHA has concluded that the word “contain” does not express the threat posed by the presence of the chemical, and thus the proposed switch to “expose.”

The use of the Pictogram makes no toxicological sense.  Warnings under Proposition 65 are triggered when exposures are to a very minute fraction of that which might cause or lead to harm.  The idea that this miniscule exposure is equivalent to some truly dangerous circumstances is truly without any scientific merit.

So, what might warnings look like?  Here are some possibilities.  But, note, in addition to the list of 12 [or so] chemicals, it may be the word “chemical” below will have to be replaced with the actual listed chemical that is found in the product, area exposure, etc.

•           Nonfood and nonmedical consumer product warnings:

“WARNING. This product will expose you to a chemical [or chemicals] known to the State of California to cause [cancer/birth defects or other reproductive harm]. For more information go to www.P65Warnings.ca.gov.”

•           Food warnings, other than those on a label:

“WARNING. Consuming this product will expose you to a chemical [or chemicals] known to the State of California to cause [cancer/birth defects or other reproductive harm]. For more information go to www.P65Warnings.ca.gov.”

•           Occupational exposures: Warning signs:

“WARNING. Entering this area will expose you to a chemical [or chemicals] known to the State of California to cause [cancer/birth defects or other reproductive harm]. For more information, ask your employer or go to www.P65Warnings.ca.gov.”

Remember that occupational warnings must also appear in the product’s M.S.D.S. sheet.

•           Product labels:

“WARNING. Using this product will expose you to a chemical [or chemicals] known to the State of California to cause [cancer/birth defects or other reproductive harm]. For more information, ask your employer or go to www.P65Warnings.ca.gov.”

•           General environmental-exposure warning signs:

“WARNING. Persons in [location] will be exposed to a chemical [or chemicals] known to the State of California to cause [cancer/birth defects or other reproductive harm]. For more information, ask your employer or go to www.P65Warnings.ca.gov.”

Warning Transmission

The proposed methods for transmission of a warning will now specifically include the following methods:

• Warnings on the product itself.
• For internet purchases, warnings that appear before the purchase is completed.
• For catalog purchases, warnings that are clearly associated with the item being purchased.
• Product specific shelf-tags or shelf signs.
• Warnings via an electronic device or process that automatically provides the warning during the purchasing process.  [This is a methodology that OEHHA intentionally keeps vague for now; an assessment of the “what” and “how” will be made in the future.]

The fundamental premise is that the consumer cannot be required to seek out the warning, but must see a warning in the appropriate format BEFORE a purchase is made. 

OEHHA has indicated that it will develop methods for transmission of warnings and warning language in specific contexts related to food, prescription drugs, medical devices, dental care, and alcoholic beverages, as well as for “environmental exposures” [e.g., for parking lots, apartments, lodging facilities (e.g., hotel, motel), amusement parks].

The OEHHA proposal also includes a provision that recognizes the validity of warning requirements set forth in existing lawsuit settlements.  While there is no question that a statute cannot undo settlements entered into as the result of litigation, the result is that there will be two warning regimes in effect, adding to confusion and undermining the understanding of the message being conveyed.

Special Categories of Warnings

OEHHA has noted that it will develop unique warnings for:

• Alcoholic beverage warnings;
• Restaurant warnings;
• Prescription drug and medical device warnings;
• New dental care warnings; and
• Warnings for the following specific environmental exposures: parking facilities, apartments/hotels/lodging facilities, and amusement parks.

For foods and nonmedical consumer goods, in recognition that package size may prevent the lengthy warnings noted, OEHHA is proposing simplified warnings.  For example:

• “WARNING: Cancer Hazard”
•  “WARNING: Reproductive Hazard”

Proposition 65 Website

The proposal would also require the display on the label of a link to a new OEHHA-hosted website (www.P65Warnings.ca.gov ) to allow the public to access more information relating to the warning, including additional chemicals, routes of exposure, and if applicable, any actions that individuals could take to reduce or avoid the exposure.

Companies would be required to provide the following information to OEHHA for use in the website within 30 days of presenting a warning to the public (e.g., initial sale of a consumer good in California; initial addition of a product to a website):

• The name and contact information for the person providing the warning.
•  The name and contact information for the manufacturer of any product the warning is intended to cover.
•  The specific products or category of products the warning is intended to cover, including barcodes, if any.
•  The type of occupational exposure to a listed chemical the warning is intended to cover, if any.
• The type of environmental exposures the warning is intended to cover, if any, and the affected area.
•  The name of the chemical or chemicals for which the warning is being provided.
•  Whether the warning is being provided for cancer, or birth defects or other reproductive harm, or both.
•  The anticipated route, routes, or pathways of exposure to the listed chemical for which the warning is being provided.
• Reasonably available information concerning the anticipated level of human exposure to the listed chemical, if known.
•  Information concerning actions a person can take to minimize or eliminate exposure to the listed chemical, if any.
•  Whether the warning is being provided in any language other than English and a copy of the translated warning, if any.

The information would have to be updated within 30 days of a business becoming aware that a) an additional chemical is required to be explicitly noted vis-à-vis the product or with reference to an environmental exposure, or b) any information provided earlier needs to be updated.

OEHHA has also noted that it may a) provide links to other authoritative sources (e.g., FDA, EPA) so that a consumer, for example, can obtain additional information about the product or the chemical, and b) develop additional information to supplement that information provided by business.

One of the problems that will obviously arise is over the toxicological characteristics of the chemical or chemicals being discussed.  Many of the listings are based on animal models that make sense when a regulatory program is seeking to avoid the potential for harm.  But, whether and to what extent such evidence may support a real and certain threat to human health is an entirely different question.  This has one among many issues that Proposition 65 has never addressed, but this dissonance will come to the forefront with the requirements being imposed for input for use on the OEHHA web site.

THE END GAME

Draft regulations are to be issued during the summer of 2014 and final regulations during the summer of 2015.

LITIGATION

There is nothing in the proposal that will decrease the likelihood of litigation.  Instead, entirely new areas will be open to litigation.  A few examples:

•  Has a company disclosed all chemicals to which an exposure may occur?
•  Are the levels of exposure accurate in the information provided to the OEHHA website?
•  Are the potential exposure pathways adequately assessed and defined in the information provided to the OEHHA website?
•  Are the area boundaries of environmental exposure properly identified (e.g., impacted zone from exhaust fumes generated in a parking lot)?

And of course all this litigation will contain the same $2,500/day penalty, the same attorney’s fees provision, and the same injunctive relief provisions contained in the current law.

PERSPECTIVE

After over two decades of experience with Proposition 65, it would appear that from a public policy perspective, the so-called Green Chemistry approach makes much more toxicological and risk assessment sense.  The bottom line in such a Green Chemistry program is that if there is a reasonable risk that a substance is bad for humans and humans are likely to be exposed, then the substance would be banned or at least exposure would be vastly decreased by engineering or design controls. 

Proposition 65’s reliance on litigation and greenmail more and more reflects a Rube Goldberg policy that in the real world does little in a meaningful manner to deal with real threats from real hazards. 

BEFORE YOU HIT SEND, CONSIDER -- IGNORANCE IS RISK: IMPACT OF NSA MONITORING TECHNOLOGIES ON ATTORNEY-CLIENT COMMUNICATIONS (PARTS 1&2)

Knew or should have known, a standard often applied in a myriad of legal context, could soon be the one applied to attorneys who ignore the risks associated with communicating with clients using modern technologies (i.e., text messaging, emails, telephone calls, and voice-mail) without appreciating the risk. “Ignorance is Bliss,” is a dangerous proposition in the practice of law when it comes to ignoring current technologies.  What obligations require attorneys to protect their client communications, and what practical steps can be taken to meet statutory and ethical obligations related to confidentiality? Is there a real risk, or is the risk limited to action movies?

Want to read more?  For Part 1, go to:  http://www.lexisnexis.com/legalnewsroom/litigation/b/litigation-blog/archive/2013/07/23/ignorance-is-risk-impact-of-nsa-monitoring-technologies-on-attorney-client-communications-part-1.aspx

For Part 2 go to:  http://www.lexisnexis.com/legalnewsroom/litigation/b/litigation-blog/archive/2013/07/24/ignorance-is-risk-response-options-to-nsa-monitoring-of-attorney-client-communications-part-2.aspx

Who literally profits from Proposition 65 litigation?

An interesting two-piece assessment has been published by KQED, the San Francisco PBS radio and television station.  They are succinct and informative.

Links to the two articles can be found at:

http://blogs.kqed.org/science/audio/who-profits-from-proposition-65-part-one/

http://blogs.kqed.org/science/audio/who-profits-from-proposition-65-part-two/

 

OEHHA proposes to list "emissions from coal combustion" under California's Proposition 65

OEHHA, the State regulatory agency overseeing the administration of Propositon 65, has announced its intent to list "emissions from the combustion of coal" as a carcinogen.  See http://www.oehha.ca.gov/prop65/CRNR_notices/admin_listing/intent_to_list/noil060713coal.html.  The emissions at issue are both from industrial facilities and residential settings.  According to the American Lung Association, these emissions include acid gases (hydrogen chloride, hydrogen fluoride, Dioxins & Furans (e.g., 2,3,7,8-TCDD), methylmercury, metals (arsenic, beryllium, cadmium, chromium, nickel, selenium, manganese, lead), Polynuclear Aromatic Hydrocarbons (PAH's), radioisotopes (radium, uranium), and volative organic compounds (e.g., benzene, toluene, ethylbenzene, xylene, aldehydes [including formaldehyde]).  See http://www.lung.org/assets/documents/healthy-air/coal-fired-plant-hazards.pdf.

OEHHA is citing to the "authoritative bodies" listing mechanism for the listing.  [For a discussion of Prop. 65 and the various listing mechanisms, see http://www.rmkb.com/tasks/sites/rmkb/assets/image/253.pdf as well as prior posts discussing the mechanism.]  The authoritative body is IARC, as manifest in its 2010 Publication Household Use of Solid Fuels and High Temperature Frying.  See http://apps.who.int/bookorders/anglais/detart1.jsp?sesslan=1&codlan=1&codcol=72&codcch=95, pp. 225, 226, 303, and 307.  The monograph notes that "[t]here is sufficient evidence in experimental animals for the carcinogenicity of emissions from combustion of coal."

OEHHA sent out requests for information relevant to the possible listing on March 26, 2013.  Input was requested by May 14, 2013.  There were no responses. 

OEHHA is providing a second opportunity to provide relevant information on the possible listing.  Comments are due by 5 PM on July 8, 2013.  See http://www.oehha.ca.gov/prop65/CRNR_notices/admin_listing/intent_to_list/noil060713coal.html.

 

AB 227, aimed at amending California's Proposition 65, continues through the legislative process, though with major amendments

A prior post noted the very substantial problems with AB 227.  If it was meant to be a universal cure, it was woefully inadequate.

However, it now appears that its scope has been limited substantially, which makes it somewhat more reasonable as a solution to the tactics used by some plaintiffs to "shakedown" small business owners.

At the initial hearing on the bill before the Assembly Environmental Safety and Toxic Materials Committee on April 16, 2013, the bill was opposed by various plaintiff groups.  Assemblyman Gatto noted that his intent was to prevent certain "shakedown" practices and that he would amend accordingly.  With that understanding, the bill passed out of Committee.

The next hearing was in the Assembly Judiciary Committee.  Apparently Gatto and the opponents struck a deal because there was no opposition that appeared at the hearing.  The changes have now become manifest:

The bill only applies to

• An exposure to alcoholic beverages or to a listed chemical resulting from the preparation of a food or beverage for immediate consumption at the alleged violator's premises;
• An exposure to environmental tobacco smoke by persons entering a premises where smoking is permitted at any location on the premises; or
• An exposure to a listed chemical found in engine exhaust if the exposure occurs in a facility primarily intended for parking noncommercial vehicles.

In order for the target of the Prop. 65 notice to be able to render the issue moot, it must:

• Cure the alleged violation within 14 days after service of the notice.
• Agree to pay a civil penalty of $500 (adjusted annually for inflation) with 75% of that amount going to state's Prop. 65 enforcement fund and 25% to the person sending the notice.
• Send the person who sent the notice a statement signed under penalty of perjury fully describing the actions it took to correct the alleged violation and sending a copy of any warning notice posted as part of that correction.

AB 227 also contains the following new provisions:

• Any 60-day notice alleging any of the three types of above exposures must include a description of the option to cure the violation set forth in the bill. The bill provides that OEHHA, as the Prop. 65 implementing agency, may adopt language stating what should be included in the notice.
• In the event of a dispute over whether a Prop. 65 enforcement action is barred by this cure provision, the notice target shall bear the burden of proving its application. If the trial court determines the notice target has prevailed, then the target can ask the judge to determine that there was no credible basis on which the notice sender could have assumed a liability. In that case the judge can find that the suit was "frivolous" and assess penalties allowed under the Code of Civil Procedure.
• The cure provision does not apply to an action brought by the attorney general, a district attorney, or a civil attorney given Prop. 65 enforcement authority. 

The history of the legislation, it changes in wording, and the votes as it moves through the legislative process can be found at:  http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201320140AB227&search_keywords=

Assembly Bill 227 – An Ineffective Attempt To Reform California's Proposition 65

The 60-day notice provision of Proposition 65 was allegedly modeled after several then existing (1986) Federal environmental statutes.  OEHHA: Final Statement of Reasons for Section 12903 (5/14/97) at http://oehha.ca.gov/prop65/law/903fsr.html.  Like Federal law, Proposition 65’s notice provision was and is meant to provide an opportunity for State or local prosecutors to undertake the legal action in lieu of “private enforcers.”

Proposition 65, like most environmental laws, provides for injunctive relief.  However, it is a long established general principle of equity that if the responsible party takes corrective action to cure the problem, then absent a showing of a likely continuance of the violation, injunctive relief will no longer be available.  Paul v. Milk Depots, Inc. (1964), 62 Cal. 2d 129, 133; Ratterree Land Co. v. Hutton (1935), 4 Cal. 2d 100, 101 & 102; § 3532 California Civil Code. 

However, one virtually never sees a case in which a Proposition 65 defendant contests a request for injunctive relief on the grounds that the alleged violation has become moot.  As noted in more detail hereinafter, the likely primary reason is that determining whether the potential for an exposure has been abated is, under the current legal framework, extraordinarily difficult, especially given some of the bizarre exposure scenarios that are so popular with plaintiffs.

Further, there is no case law that affirms this general principle in the context of either a public or private enforcement of Proposition 65.  Adding to the complexity of real world Prop. 65 actions, most private plaintiffs insist on some form of injunctive relief as the “price” of any settlement, often configured as a consent judgment, to be assured that the defendant will not engage in prohibited conduct in the future, even if there is no reason to so conclude.  One may speculate that one reason that plaintiffs insist on such injunctions is to provide a rationale for their attorney’s fees, which are part of any settlement that must be reviewed by the Court.  Section 25249.7(f)(4&5) California Health & Safety Code.

Into this void has stepped AB 227 (introduced Feb. 4, 2013).  See http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201320140AB227&search_keywords.  This bill would allow a person who receives a 60-day notice to correct the alleged violation within 14 days after receipt of the notice.  Further, to obtain such relief, the recipient must demonstrate within this 14-day period to a State or local prosecutor in whose jurisdiction the notice is filed that the violation has been corrected.  The bill would then prohibit an enforcement action from being commenced if the public prosecutor concurs that the violation has been corrected.  While the goal of the legislation is laudable, in the context of real-world Proposition 65 litigation, it does not provide a realistic remedy to what is a very significant problem. 

Proposition 65 has a lofty goal, incentivizing manufacturers, distributors, wholesalers and retailers to reformulate their product so that consumers are not needlessly exposed to listed chemicals. Beginning with the Notice and Certificate of Merit required to initiate an action, the question is exposure (what is the dose of a listed chemical from the consumer’s use of the product?).  The Office of Health Hazard Assessment regulations make plain that normal use by average consumers is the paradigm to be applied in assessing an exposure.  27 California Code of Regulations §§ 25602(b) & 25821(c)(2). 

But how is a business enterprise to know whether such an exposure may be taking place given that the 60-day Notice and Certificate of Merit create the illusion that often bizarre and unrealistic usage circumstances cause a violation of the law.  I have had plaintiff’s experts opine during deposition, without any relationship to the reality of how a product is used, that it would be lovingly held and used for many many hours on end (at least some of which would, of course, be by sweaty hands that will remove a listed chemical from a product and thereafter contaminate food, resulting in an
ingestion or inhalation), and even placed on the floor for a baby to lick like some precocious puppy. 

Again, normal use by the average consumer is the standard.  But without the assistance of legal counsel, a sophisticated analytical laboratory, and a toxicologist (and frequently other experts, such as statisticians), it takes time (certainly more than 14 days) to ascertain if normal use by the average
consumer results in an exposure than exceeds the warning threshold.  Even if such an assessment is made, what assurance does the business entity have that the specified enforcement authorities will concur with the evaluation?  The thesis that all this will happen in 14 days begs credulity.  The only realistic option for the business entity, if facing such a short deadline, is to offer to take the product off the California market, pay the “greenmail” demanded by the plaintiff to “settle” the case, or take the matter to trial. This is a brutally difficult choice when it is recognized that California is a huge market.  Using 2011 data, at least one study states that California has 12% of the U.S. population, and accounts for 13% of the nation’s output.  See http://www.lao.ca.gov/reports/2013/calfacts/calfacts_010213.aspx.  Depending on whom one believes, California is either the eighth or ninth largest economy in the world.

Thus, a legislative solution requires two separate components.  First, sufficient funding needs to be provided to OEHHA so that it can develop either regulations or guidance for ascertaining exposure to consumers from a product.  The second prong would be a program like that proposed in AB 227, but with a much more realistic time-frame to undertake the assessment and present it for evaluation.  In this day and age of tight budgets, there should be a fee charged for such an assessment so that the gate-keepers of the determination will deal with what is likely to be more than a few requests.

In the interim, business entities subject to a Proposition 65 60-day notice need to understand how the game is played, and what practical options are available to them to defend against such claims.

As a general rule, how do plaintiffs demonstrate exposure?  They have generally undertaken a lab test that takes a piece (or pieces) of the consumer product, dissolves them in an acid strong enough to extract a listed chemical from vitrified glass (which EPA wants used for the long-term storage of nuclear wastes), and then measures the presence of the listed chemical.  Plaintiffs claim that there is an association between the quantity of a listed chemical in a product and exposure.  This is not factually correct.  Material science makes plain that the matrix of substances composing the
product or its relevant parts within which the listed chemical is present determines whether the listed chemical can be “liberated” by consumer activities or not.  Yet, this fundamental fact of science is never addressed in nearly any Prop. 65 cases.  This twisted logic even shows up in
settlement agreements, where SOP is to have “standards” set at some seemingly arbitrary concentration number.  In the real world these numbers have little, if any, relationship to an actual exposure because the key element in determining whether an exposure will occur is the make-up and structure of the product (at the molecular level) and the quality of its creation and manufacture. 

Plaintiffs will also trot out their “NIOSH wipe test”, and allege that it mimics the handling of the product by a consumer, a claim allegedly supported by work done by the Federal Trade Commission.  Not true.   Not surprisingly, such proof is never produced at deposition.  Research has shown, in fact, that FTC studies have often found no correlation between wipe tests and what is removed by actual consumer handling.  In one assessment, the FTC study showed that a wipe removed between 5-times and 13-times more lead from the product than the actual handling of the product by people, depending on whether the wipe was wet or dry.  There is little or no truth to the allegation that wipe tests are the same as handling by people.

Let us assume that a prima facie case can be made and that challenges to the qualifications of plaintiff’s experts (another consideration that can often prove productive) have fallen short.  How does one show exposure?  Working with a variety of experts, we have developed a six step test methodology that in fact measures exposure. 

Step Number 1.  Identify the presence of the alleged listed chemical.  Because the distribution of a listed chemical is often not uniform, we put a strong acid on a cloth and rub it in discrete small sections of the product.  We then analyze the results in order to learn how the listed chemical is distributed over the product.  Sometimes it is uniformly present; sometimes, it is not.

Step 2.  With knowledge of how the product is handled or used and where the listed chemical is present on the product, we then develop a protocol for the handling of the product in a manner that mimics real world conditions. 

Step 3.  Using a variety of samples of the product (to reduce the likelihood that any one sample is an “outlier”), we have real people first clean their hands and thereafter handle the product to simulate a potential exposure.  We then remove the chemicals from their hands and determine the exposure to the listed substance.

Step 4.  After several days have passed so that the tester’s hands have recovered and are more au naturel, we repeat the exposure study and have samples of the product handled by different individuals.  We use the same group of individuals (though each will handle different products than the one done in the first round of testing).  We again analyze the result by removing the listed substance from their hands as a result of this second round of testing.

Step 5.  At this point we have a data set.  In some cases, the results show that the amount on the tester’s hands was less than the amount triggering the warning requirement.  For example, when we recently tested a “plastic” product that contained lead in the plastic, all the samples showed that the amount of lead on the hands of the testers was less than the 0.5 mcg. level.  With this result we could definitely state that there was no warning requirement triggered because even if 100 percent of the lead on the hands made it inside the body, the exposure level was less than that triggering the warning requirement. 

Step 6.  In some cases the amount present on the hands will be more than the warning threshold. At that point we engage in some sophisticated modeling, based on standard data sets, of how the listed substance might be transferred from the hands to (for example) the mouth where it would be ingested.  Since all such transfer actions are less than perfect, there are losses all along the way.  This transfer assessment may also result in the conclusion that the exposure is less than the warning threshold trigger.

This type of testing requires careful attention to detail and execution.  One must scope out potential confounding factors and address them with scientific measures to assure that the results are not skewed; attention to detail and QA/QC must be exquisite.  Complex statistical assessment of test design and results may also be necessary.  But, that is what it takes to actually measure whether an exposure (dose from use) will occur.  All the surrogates commonly used are very much flawed, especially those commonly employed by plaintiffs.

This process which is described herein also eliminates the use of extreme examples of hypothetical exposure scenarios as a basis for litigation.  Although such scenarios are popular with plaintiff’s experts, they are not part of the law.  As stated beforehand, the OEHHA regulations make plain that normal use by average consumers is the paradigm to be applied.  27 C.C.R. §§ 25602(b) & 25821(c)(2). 

Thus, AB 227 does not go nearly far enough in addressing the huge gaping hole in Proposition 65, standardization of exposure measurements. This hole is rather ironic since the literal language of Proposition 65 is all about exposure, not the concentration of a listed chemical within the components of a product.  Much more needs to be done than the limited agenda of AB 227.

An earlier version of this article was published in the March 19, 2013 issue of the California Daily Journal. Copyright 2013.

Study that found high lead levels in imported rice may have been faulty

At a conference in April 2013, researchers reported preliminary results that the lead level in rice was many times (20-40) above the FDA "provisional total tolerable intake" for adults.  The researchers sampled packaged rice from Bhutan, Italy, China, Taiwan, India, Israel, the Czech Republic and Thailand, which accounts for 65% of U.S. imports.  Their explanation was that rice fields are irrigated with raw sewage effluent and untreated industrial effluent in many countries.  The media was, of course, full of horror stories about lead and rice.

Preliminary checks on the findings have failed to replicate the test results.  The researchers originally used X-ray fluorescence; followup tests using a different technique produced much lower results.  The original equipment was sent to back to the manufacturer, who confirmed the presence of a calibration problem. 

Dutch regulators tested 26 samples of imported rice from various Asian nations and found lead present at 7 ppb, which is 1/1000 of the original test results.  The International Rice Institute weighed in, noting that a number of studies have shown that rice plants do not take up significant amounts of lead or move it to the grains. An earlier EU study of 612 rice samples found lead in the few tens of ppb range.  Consumer Reports sampled rice and rice-based products (e.g., rice cakes, rice drinks); a majority of the samples were under 5 ppb.

This episode is an excellent example of what is real in the environmental and toxic tort arena.  One is no better than a well executed laboratory method that accurate AND precisely measures that which one is seeking to ascertain.

Articles on this topic can be found at:  http://www.redorbit.com/news/health/1112829615/lead-in-rice-study-retracted-truth-about-heavy-metals-in/; http://www.bbc.co.uk/news/science-environment-22448696; http://www.prnewswire.com/news-releases/lead-in-rice-study-retracted-truth-about-heavy-metals-in-rice-revealed-204395941.html.          

 

Governor Brown says he wants to reform Proposition 65, but where's the beef?

Governor Brown has announced he intends to reform California's Proposition 65.  However, no detailed legislative language has been proposed, only an announcement about the California Environmental Protection Agency (the parent of the Office of Environmental Health Hazard Assessment which administers Proposition 65) working with the Legislature and "stakeholders" to achieve goals.  Of course those greedy lawyers are held up as one reason change needs to occur.  While there is no question that some folks have used Prop. 65 to their economic advantage, it is not really a widespread problem; terminate a few licenses to practice (as has been done in the past) and the problem is almost cured.  As will be noted in the next blog post on Prop. 65, the real tragedy of Prop. 65 is that the reality of how it is practiced and what the law are the material issues are miles apart.  See http://www.rmkb.com/tasks/sites/rmkb/assets/image/The_Flaws_of_Prop.65_TCH.pdf.

The outline of what goals are to be achieved have a nice ring, but reality is in the details.  The administration, stakeholders and the Legislature will discuss reforms to a) cap or limit attorney’s fees in Proposition 65 cases; b) require stronger demonstration by plaintiffs that they have information to support claims before litigation begins; c) require greater disclosure of plaintiff’s information; d) set limits on the amount of money in an enforcement case that can go into settlement funds in lieu of penalties; e) provide the State with the ability to adjust the level at which Proposition 65 warnings are needed for chemicals that cause reproductive harm; and, e) require more useful information to the public on what they are being exposed to and how they can protect themselves. 

It will be interesting to see how it all shakes out.  The last attempt at reform sounded good, but in reality made virtually no difference.  Stay tuned.

Are animal models a good analogy for humans? A recently published study of mice suggests that there may be problems

To set standards, animal models are frequently used.  Such use allows researchers to investigate disease and injury states in ways which would be considered unethical to inflict on humans.  For example, to determine some threshold injury or disease state, various groups of animals may be exposed to widely varying concentrations of the particular molecule being assessed.  It is assumed that because the animal commonly used is a mammal, as are we, that the biochemical and metabolic processes of the two different species have enough in common that useful data will be generated to, say, set standards of some sort (e.g., "no effects" levels, exposures that impact fertility or birth defects or cause cancer) or show the effectiveness of drugs.  But, is such data valid?  Recently published work on mice suggest there may be problems.

The study discussed in this blog grew out of a much larger effort to understand why nearly 150 clinical trials of drugs targeted at sepsis in humans failed.  Sepsis, a potentially deadly reaction that occurs as the body tries to fight an infection, afflicts 750,000 patients a year in the United States, kills one-fourth to one-half of them, and costs the nation $17 billion a year.  It is the leading cause of death in intensive-care units. 

These drugs were developed using mouse models and the drugs were all intended to control excessive immune responses.  Potentially deadly immune responses occur when a person’s immune system overreacts to what it perceives as danger signals, including toxic molecules from bacteria, viruses, fungi, or proteins released from cells damaged by trauma or burns.  Such immune system responses may also play a role in heart disease and cancer. 

The new study indicates that mouse models do not accurately reflect the genetic and proteomic responses to acute inflammatory stress in humans.  As noted, the research grew out of a larger project to characterize human inflammatory response to serious trauma (e.g., burns, car accidents, infection). The project was aimed at studying the multitude of genetic responses that result from these acute inflammatory stimuli in humans to ascertain the key biophysiologic response to such inflammation.  As often happens in science, serendipity intervened.

When reviewers rejected one of the group's papers because it failed to show that events in humans were reproduced in mice, the researchers began to question the relevance of mouse models.  So they decided to compare their data about human responses to that from corresponding murine (rodent) model systems.  The researchers compared changes in the expression of thousands of genes, the time course of those changes (using software designed to normalize the different time frames in which responses occur in mice and humans), and the regulation of major signaling pathways involved.

In humans, the genetic response was highly consistent even though patients were subjected to different inflammatory stimuli and different subsequent treatments, suggesting that the drugs targeting these molecular mechanisms could work for multiple inflammatory diseases. The common patterns seen in humans were not reproduced in mouse models, and the responses among the various mouse models varied widely.  The researchers also compared existing gene expression data from human patients and corresponding mouse models for several acute inflammatory diseases, including sepsis and acute respiratory distress syndrome, as well as response to injury.  Again, mouse models poorly mimicked the response among humans, which were highly consistent.  What was seen was that different conditions in mice — burns, trauma, sepsis — did not engender the same response.  Each condition used different groups of genes. In humans, though, similar genes were used in all three conditions. 

Learned commentary on the study were highly varied.  Some noted that the "commonality" alleged in various mouse models of humans was set too low, that there needs to be a higher degree to which a model reproduces human disease in terms of molecular mechanisms, rather than just phenotype (the observable physical or biochemical characteristics of an organism).  Critics noted that the research focused on one strain of mice, and that until data was in on other strains, it was too early to draw sweeping conclusions.  Other critics noted that the paper was correct insofar as the behavior of white blood cells goes, but that it was improper to draw any sweeping conclusions about other bodily organs (e.g., lungs, liver, heart, brain).

What does this mean, then, if anything, for litigators?  Now that Daubert has come to California, one has to think in terms of genes, RNA, molecular pathways etc.  It is not enough to allow an expert to waive his/her hands and say X causes Y without asking --- why is that?  Explain to me exactly how disease Z comes about in terms of genes being utilized or blocked, molecules conveying messages, modifications happening to normal pathways. 

The study can be found at http://www.pnas.org/content/110/9/3507.   

Have past blood tests for BPA been faulty? Recently published study so claims

Prior posts have noted in detail the results of various studies of the impacts of BPA on various test media (e.g., animals).  Prior posts have described the ongoing public debate over BPA and its listing and then delisting as a reproductive toxicant under California's Proposition 65.  A recent post described testing done on newborns in a neonatal ICU, and their substantially large exposure to BPA, as demonstrated by the sampling of urine.  Now a study challenges the accuracy of past human blood samples for BPA.  The study indicates that the amount attributed to the average general population is in error by perhaps three orders of magnitude.

In experiments rodents received 7 doses of BPA daily from conception through birth and subsequently into early adulthood.  Amounts ranged from "very low" (2.5 micrograms per kilogram of body weight, in the range of probable human exposure) to doses 100-times higher.  The researchers reported not seeing adverse effects in the low range, and that they detected none of the active form of the chemical in animals receiving less than 80 micrograms per kilogram of body weight per day.  Blood levels were below the limits of detection.

As yet unpublished studies have indicated that studies in rodents and monkeys demonstrate the rapid breakdown of ingested BPA into inactive substances.  However, as recently reported, infants have been shown to be much less efficient are breaking down BPA than adults. 

Researchers argue that because urine levels were at a particular point in the 28 thousand individuals sampled, the corresponding blood levels should be in the parts per trillion range.  Such levels are not detectable given current analytical capabilities.  Since they were not undetectable in various studies, the researchers state that the sampled population must have been exposed to unusually high amounts, or that the samples were contaminated during the sampling or analytical process. 

Critics point out that more than 25 studies have measured blood BPA levels, and thus it is unlikely all were wrong.  They state that just because the researchers state that urine/blood relationship must be of a particular sort does not mean that such an assertion is scientifically correct.

This debate will continue.  Stay tuned.

Studies and conference reports relevant to this issue can be found at:  http://aaas.confex.com/aaas/2013/webprogram/Paper8721.html; http://aaas.confex.com/aaas/2013/webprogram/Paper8728.html; http://aaas.confex.com/aaas/2013/webprogram/Paper8725.html; http://aaas.confex.com/aaas/2013/webprogram/Paper8720.html; http://toxsci.oxfordjournals.org/content/85/2/823.full; http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2944084/; http://endo.endojournals.org/content/early/2011/12/07/en.2011-1772.abstract; http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2920080/.