I think most (if not all) of us agree that the new law, regardless of what EPA regs are eventually promulagated, is like putting a band-aid on a skin lesion of a grossly metastatic

 malignant melanoma.  Perhaps well-meaning, but totally inadequate.  20 substances indeed (snort)!

Momona and I have been somewhat "worthy adversaries" for quite sometime.  Everyone needs at least one:  having one sharpens the senses, makes you look carefully at your own opinions and prejudices, and refines your arguments about points you feel strongly about.  THANX Momona!  Got a tablet I don't use and having bilateral trigger thumbs precludes being one of those who don't seem to smell the roses while there's something (anything?) on the small screen.  And I figured movie folks were more like the avatar of the Devil in the Garden of Eden, but of a much more venomous nature. Did play guitar, bass, and special effects in the pit band for a production of The Apple Tree sometime back. Doing so for Hair was infinitely more fun.

I rather like the idea of composing a list of chemicals that have caused problems we (collectively) are aware of.  That would be a start and something D-CHAS actually could do.  I wonder if we could interest the National Academies in such a list?  Very prestigious body often consulted by the Feds on various issues.   If anyone is interested, I did do a review of the daily listserve incidents reports fairly recently and tried to sort out the various types of bad outcomes and when possible identify the involved substance(s).  Could be a place to start?

If there is agreement on this, I could post it to the listserve for comments and suggestions.  Will not unless there is real interest.  Would this be an issue for the EC?  I  am a member-at-large, but some consensus would be needed.

Alan

Alan H.Hall, M.D.

Medical Toxicologist

On Sun, Jul 3, 2016 at 8:10 PM, Bruce Van Scoy <bvanscoy**At_Symbol_Here**twc.com> wrote:

Dr. Hall - I wanted to stay out of this discussion too. 

I couldn’t resist either.

You are correct, we should all be allowed one tirade on this list serve, I may have abused this “rule” over the years.

But, Monona is also right.  The fact that this legislation only requires testing of 20 of the ~30,000 high production volume chemicals over the next EIGHT years, reflects a true understanding of the potential hazards, especially when considering the total chemicals used in commerce is well above 100,000.  It is tragic.  Then consider that the 642 chemicals that OSHA regulates, it is abhorrent.  (Qualifier – I’m not a J.D., just a seasoned EHS professional who has seen many cases over the years of numerous chemical exposure scenarios related to the complete lack of regard for minimal due diligence.  Do we need to list?)  Maybe the list should start compiling a list of chemicals that have exhibited the characteristics from differing overexposures over the years from the various perspectives, environmental vs occupational. 

Maybe once we compile the list, we could prove through examples our collective wisdom and justify the need to develop a comprehensive corrective action program. 

But in order to do this, we must all recognize that we are dealing with different exposure levels, to different exposure groups.  The initial OSHA PELs were based upon TLVs developed upon a limited exposure group (working age males, no young, elderly or pregnant) based upon the exposed population at that time and economic considerations were not considered.  Which laws require the consideration of economic impact? 

If anyone on the list can inform me of when female or reproductive health was specifically mandated by law, other than the General Duty Clause, please let me know.  (Other than the new HazCom Standard.)

Harry is also right, the TLVs are NOT a fine line relative to the index of toxicity!

I think we must all recognize that we are defining different similar exposure groups (occupational which doesn’t reflect the hazards to elderly or young vs. environmental, compared to environmental, which by law, must consider sensitive populations.)  The group needs to recognize the variations and semantics and stick to the premise that Dr. Hall is applying,Paracelsus was right said it first:  "All substances are toxic.  There is none which is not. The difference between a treatment and a poison is the dose".  I think Paracelsus was wrong in one aspect, the susceptibility of the host makes a difference, as has been proven by numerous environmental exposures to susceptible individuals, e.g., the very young, old or pregnant.  Dr. Hall, where you and I disagree is not relying upon in vivo testing, until PROVEN ex vivo is as effective, we cannot and should not be discussing it as a possible alternative, right now there are simply to many unknowns and variables for us to begin considering as a viable consideration and I think our considering them for discussion considering what we do know is unprofessional – layman don’t know the differences and rely upon our opinions.  Once in vivo has been proven inequivalent, I’ll gladly jump on board, but currently that is a long way off.  I think we were all looking for significantly more improvement in TSCA than what was obtained with this law, and I’m more in line with what Manona suggested the results are disappointing to say the least. 

Meanwhile, other countries are well ahead of the U.S. in recognizing and dealing with recognizing chemical hazards, e.g., E.U. with REACH.  I think everyone can recognize that at least that has been a success. 

We have many professional, qualified and well respected opinions presented on this list and I appreciate and respect them all for due consideration,

Thank you for contributing!

BruceV

 

From: DCHAS-L Discussion List [mailto:dchas-l**At_Symbol_Here**med.cornell.edu]On Behalf Of Alan Hall
Sent: Sunday, July 3, 2016 5:27 PM
To: DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU
Subject: Re: [DCHAS-L] Today's Overview Webinar on New TSCA

 

Monona et al,

 

Everyone should be entitled to one tirade on this listserve.  This was mine, and with the hiccoughing computer I am currently using, it came out very poorly written.

 

However, no matter how bad the legislation is or whether I do or do not like the President that signed it into law--there it is.  It is the law of the land and EPA, whether or not it trips over its collective feet -- definition of a committee:  an organism with six or more feet and no brain -- will come up with something.  Either way, I don't do any lab testing of any kind and would derive no personal benefit from any such, other than that my personal environment and that of others might be a bit more safe if something were done right.  You will not find me becoming cyanotic from breathholding

 

Yes, better testing is a great idea and informing everyone who is a stakeholder first or downstream is also a good idea.  There's nothing wrong with wishing for such an outcome.

 

But there's the old "If wishes were horses..."

 

So what does anyone on the listserve propose we do about it (if anything) and how could something positive be acomplished?  Quite frankly, I do not have any idea.  Neither   

 D-CHAS nor ACS for that matter seem to me to have enough poliitical clout.  Once back when I was studying sociology and thought that's what I might make my career, I came up with a concept called "The Law of Conservation of Laws" whose basic premise was that it's far too derned easy to make a new law, and nearly impossible to get rid of a bad one. This is unquestionably a bad law. 

 

And, yes, Monona, I have been working with groups in France and other countries on the issue of ex vivo models and others to replace animal testing.  Not because I don't utterly despise the various freak organizations, but because I sincerely believe that a lot of animal testing is unnecessary and doesn't provide meaningful results that can be extrapolated reasonably and meaningfully (not with some formula -- choose whichever you want) to humans.  I also agree that in silico may eventually have its uses, it is still in its infancy and has a long way to go.  Living organisms such as humans have far too many variables, many of which still remain unknonwn at this time.  When was the last time anyone saw a human with a meibomian gland?  Personally, have not met one yet.

 

Again, any constructive ideas on what, if anything, can be done about it?

 

If all we can do at present is live with it, then how best to do so and still fulfill our basic safety mission?

 

Questions are easy, good answers, much less so.

 

Alan

Alan H.Hall, M.D.

Medical Toxicologist

 

 

 

 

 

 

 

On Sun, Jul 3, 2016 at 7:47 AM, Monona Rossol <0000012821515289-dmarc-request**At_Symbol_Here**listserv.med.cornell.edu> wrote:

Well, you misinterpret my aim.  I don't want everything to be safe. Hell, I'm in a risk taking business.  I just want there to be enough data to do a risk assessment and make the safest choices possible. So supporting legislation that mandates testing 20 chemicals over the next 8 years when there are 30,000 HPV chemicals on the market worldwide with no data is just plain dumb. 

 

And testing is not going to ruin the economy.  It is just going to put some money into the coffers of the labs and folks in your field.  If we've managed stave off a depression by becoming a service economy, this is just one more really good service that should be doing well.

 

And the more data we have, ultimately the less overall testing we will need to do.  Right now in silico (computer) testing is shaky because there is so much we don't know.  We are still occasionally finding new metabolic pathways so it is nuts of us to think computer modeling based on what we know at this point is a done deal.  Betcha there would be some surprises in the tests of those 30,000 HPVs. 

 

And it would do my heart good to see the cynical industry support of the animal rights crazies ended.

 

And how about letting the consumer know what we don't know?   Isn't that at the least the honest thing to do?   There is a company called Golden Artist Colors that does just that.  When this company's owners found out what the "nontoxic" label was really based on, they took it off their products and added a statement that there are "untested" ingredients in their product.  It hurt them a bit at first in the school market where the ignorant purchasing agents require "nontoxic" art supplies, but Golden is now one of the biggest and most respected of the art material manufacturers.

 

Done right, mandated testing and honest labeling is a win all around.  

 

Monona Rossol, M.S., M.F.A., Industrial Hygienist

President:  Arts, Crafts & Theater Safety, Inc.

Safety Officer: Local USA829, IATSE

181 Thompson St., #23

New York, NY 10012    212-777-0062

actsnyc**At_Symbol_Here**cs.com   www.artscraftstheatersafety.org

 

 

-----Original Message-----
From: Alan Hall <ahalltoxic**At_Symbol_Here**GMAIL.COM>
To: DCHAS-L <DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU>
Sent: Sun, Jul 3, 2016 7:24 am
Subject: Re: [DCHAS-L] Today's Overview Webinar on New TSCA

To all, but especially Harry and Monona, to label anything as "non-toxic"seems in my personal opinion to just plain be wrong.  Paracecelsus saif it plainly:  "All substances are toxic.  There is none which is not. The difference between a treatmen and a poison is the dose." I grant you, he was studying arsenic and antimony as poisons and therapeutics.  There is still an FDA approved trivalet arsenical medical used for some difficult to treat certain lukemias (Trisonox(R) and antimony has many beficial uses (but not medicinal). I was once one of the Occ docs at the old El Paso, TX ASARCO Smelter.  Lead, cadmium (before all the Scandanavian studies came ou), and antimon) and we did the best we could with the knowledge avaibale. Other various metal/metallois such as Iridium and Ytterium, I've only have experience (quite extensive) with the radioactive isotopes.

 

Dear Harry and Monona:

 

I respect you both, and let me throw my 2 cents in.

 

I had almost sworn a Mighty Oath to stay out of this.  Didn't work.

 

The retrospecrtoscope is 100% accurate and 0% useless.

 

When the EPA came out with the big Dioxin regs back when, and then said it was generated in abou 65 mg/year, mostly from municipal incineration?  Well, that's the same amount as a simple aspirin tablet, and according to the latest AAPCC NPDS data I reviewed, aspirin poisoning is still around or in the top 10 causes of death from overdose in that data set.  Then the infamous 313 toxis list (I know how the Belt-Way Bandits came about it and there was no more science than found in a bucket of pond slime -- I've never seem such an example of uninformed garbage from those who do not and could not know anything worthwile at all):  Bacitracin (topical antibiotic) was on the list and you could use it for your entire lifetime in recommended doses and even swim in a swimming pool full of it (if you didn't aspirate) and the only way to make it an "air toxic" was to heat it up to intolerable temperatures, and then the petrolatum base was a hades of a lot more toxic that the bacitracin. 

 

It hs always seemed to me that asking the government to fix anything is like creating a "positive feedback loop".. A "negative feedback loop" is how your furnace/AC works: you set the desired temperature, and the system reacts to raise or lower it as desired.  A "positive feedback loop" is when it's too hot, it turns the furnace on, and when it's too cold, the AC kicks in.  

 

I don't think D-CHAS or anyone else to petition the government to "fix" any law or regulation will accomplish diddly.

 

As to the so-called "Precautionary Principle", it comes back to the old NIMBY symdrome (Not In My Back Yard") with Edith Effrom (The Apolyptics) contention of BANANA syndrome (Build Nothing Anywhere Anything).  In other words, "Don't let there be any exposure to anything until it's proven entirely without risk or hazard (they are different). How could anything go forward?  How about air and water (the oxygen part of air).  Deprive a person of water, they die of dehydation.  Force feed themselves with water (as some perosn with psyshosis do in "water intoxication) and they die from dilution of essential electrolytes leading to cerbral edema and death after intractibe seizures.  Ddprive a person of oxygen for 5 minutes and breain death and other organ systems will occur.  Take the oxygen down to 4 atmospheres for say 40 minutes, and intractable seizures will also occur.

 

Some time back,I was invited to be the Token Medical Toxicologist at a meeting of the Association of Environmental Journalists).  I never knew such existed, but at least they did then.  I was to be the Token Medical Toxicologist in a panel discussion of Environmental Justice.  So I did my duty, thought seriously about it, made up a presentation.  Then I got there.  First was an impassioned presentation by a Sociologist that hazardous facilities were unproportionally placed near where certain ethic groups lived.  Then there were two presentation about energy exploration, mining, etc on NAtive American Tribal lands (to be honest, I had practiced medicine near some of these places), and then there me.  During other Q&A sessions,all I got from these journalists who had travelled quite far , some in private jets and rented limosines, and stayed in expensive hotels the simple questions of "How can we not have a (fill in the black).

 

I just tore up my notes and when it was my turn, I described what I had done to get there including a list of industries about 50 or so.  And then I said that if we didn't waht to have a (fill in the black) how life might have been in the Boulder/Denver Colorado area back when we didn't have a (fillin the blank).  Over 2 million folks lived there, then.  In the old days, maybe 5-10 thousand at the most.  Most children died before age 2 from now-preventable illnesses.  A man would like have 3-5 wives (in serial monogamy, because the first 2-4 died in childbirth.  A simple pneumonia would kill a person and an impacted tooth could very well do so.  And the village would have to move every few years as the midden filled with all manner of fith. So, if you want to live like that, just change history and go back to living like that.  I honestly didn't think I would get out of that room alive.  Such is telling the truth/

 

So which is more hazarous: cyainde or water?  You must consider the circumstnces as well as whatever "testing" has been done.  Scenario 1:  The cyanide is in a properly closed container (never been opened) and is in a laboratory in a properly operatinge laboratory exhaust hood.  Scenario two:  You are toseed "bare beam and buck naked" into the middle of LakeEerie off Cleveland in mid-January.  Now, which is most Hazardous?  The solution is left as a exercise for anyone who wants to attem.  Doing the best we can has to be as good as it can be done.

 

 

Conclusion:  Nothing can ever be completely safe.  Attempts to make things less hazarxous and more safe are up to all of us to work on.  Istead of what seems to be bickering.  an we not fins a common gound.  This is not a black/white area.  Like politics (which I detest), maybe it's the "Science of the Possible".  Well never know everything,not in any of our lifetimes.

 

Alan

Alan H. Hall, M.D.

Medical Toxicolgist

 

 

 

 

 

On Sat, Jul 2, 2016 at 4:55 PM, Monona Rossol <0000012821515289-dmarc-request**At_Symbol_Here**listserv.med.cornell.edu> wrote:

Who said TLVs were a measure of "relative toxicity?"  All I said is the stuff sure as hell is not "nontoxic" and if my workers are exposed to the powdered pigment I want personal monitoring for the metals. Don't stick words in my mouth.  I have enough trouble defending what I actually say.

 

And there are many chemicals out there for which there is not a scrap of toxicity data--not even acute in some cases.   Maybe the chemicals you use always have some data which, in your wisdom, you can extrapolate into some safe limits, but I'm constantly running into MSDSs and SDSs listing chemicals for which there is no data from which to assess risk.  

 

Again, I never said there is a requirement either in the U.S. or the E.U. to test or generate data.  But in the E.U., if one of the 10 tests tests has not been done, it is made clear that it hasn't with the "no data is available" statement.  If some testing has been done but not enough to characterize it, there is a phrase for that as well.  

 

Telling people what is not known with the "no data available" statement was not made mandatory by OSHA.  But their jurisdiction is over SDSs for products made and sold in the U.S.  But if you want to export, best do it.

 

Since Sigma Aldrich probably is a common source for you guys, take a look at the Section 11's in their newer SDSs. They do it right most of the time because they export.  Section 11 will have the the "no data available" listed for any of the 10 tests that are not done.  I love them. So nice to see someone doing it right without a lot of fuss.

 

 

Monona Rossol, M.S., M.F.A., Industrial Hygienist

President:  Arts, Crafts & Theater Safety, Inc.

Safety Officer: Local USA829, IATSE

181 Thompson St., #23

New York, NY 10012    212-777-0062

actsnyc**At_Symbol_Here**cs.com   www.artscraftstheatersafety.org

 

 

-----Original Message-----
From: Harry Elston <helston**At_Symbol_Here**MIDWESTCHEMSAFETY.COM>
To: DCHAS-L <DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU>
Sent: Sat, Jul 2, 2016 5:06 pm
Subject: Re: [DCHAS-L] Today's Overview Webinar on New TSCA

While it may be true that the individual TLVs for In, Y and Mn are based on toxicity, the TLV is not a measurement of relative toxicity and should not be used as such.  We are cautioned against such use by ACGIH in its Position Statement regarding the TLVs:

 

“The TLVs and BEIs represent conditions under which the ACGIH believes that nearly all workers may be repeatedly exposed without adverse health effects.  They are not a fine line between safe and dangerous exposures, nor are they are relative index of toxicity.”  (Emphasis added).

 

Individuals working with chemicals are not entitled to a “zero exposure” workplace; they are entitled to a “zero overexposure” workplace, and this is where the rub comes in.  It is rare that a chemical will have “unknown hazards.”  The hazards may be poorly or extremely poorly characterized, but rarely are the “unknown.”  There are usually always functional equivalents which can be used as the basis or starting point for our decisions regarding hazard.   For instance, even though the pigment you mention is marketed as “non-toxic” we already recognize that it may present workplace exposure issues, based on the known composition.  Likewise,  I also would advocate for personal air monitoring to establish a baseline exposure level.  If it can be sufficiently demonstrated that the total exposure is less than the lowest PEL or TLV, you’re on pretty solid footing that you’re not exceeding any of the occupational exposure limits.  I recognize that this approach does not take into account possible synergistic effects of the components of the mixture, or of the mixture with other workplace chemicals, but it’s a starting point – a basis for decision making.

 

The use of functional equivalents is not a new or novel concept.  EPA has been doing it for a long time.  For instance, if a manufacturer applying for a PMN (Pre-Manufacturing Notice) lists a “catch-all” CAS number (e.g. 64742-94-5, “Solvent naphtha (petroleum), heavy aromatic”) as a component in a PMN, EPA may choose a single component out of that description on which to make its requirements for environmental and personal protection on the manufacturer, regardless if that component is there or not.  Likewise, as an industrial hygienist I’ve used functional equivalents on a number of occasions for assigning changeout times on organic vapor cartridges for respirators.  (e.g. cadaverine and putresciene are just not listed in cartridge manufacturer databases).

 

Regarding the pigment in question there are many questions that need to be answered as to why it is being marketed as “non-toxic.”  Is it because that the concentrations of hazardous materials in the mixture are less than the cutoff values?  I don’t know, but that is the start of the line of questioning I would use to investigate the claim of “non-toxic.”  GHS/SDS requirements mandate the listing of hazardous materials in mixtures which are above cutoff concentrations.  That isnot the same as saying that the product is “non-toxic” or without hazard; it’s merely a statement of the requirements of writing SDSs which manufacturers must follow.  If the manufacturer is following the regulations as written regarding their SDS, it’s not the manufacturer’s fault if the regulation is poorly or insufficiently written.  It’s my experience that manufacturers will rarely go beyond what is required of them by regulation (and sometimes they don’t even get there either).  I am seeing an improvement in hazard communication now that SDSs are the requirement, however.

 

Regarding Section 11 on SDSs.  I’m under the impression (by Appendix D) that toxicological effects are required to be reported as data is available.  The mandate to report data is pretty clear; specific tests are not mentioned and there is no mandate under OSHA for the manufacturer to perform toxicity testing. 

 

H

 

From: DCHAS-L Discussion List [mailto:dchas-l**At_Symbol_Here**med.cornell.edu]On Behalf Of Monona Rossol
Sent: Saturday, July 02, 2016 8:42 AM
To: DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU
Subject: Re: [DCHAS-L] Today's Overview Webinar on New TSCA

 

Well, I happen to have those documents and the damage those TLVs are set to avoid are significant. So it is quite clear, this pigment should not be marketed as nontoxic.  And if I see it used in special effects or as a powered material on a job site, I'm going fight for air monitoring of all three metals since the TLVs apply to the inorganic compounds of all three metals.

 

Unlike you, I am FOR providing zero exposure to a chemical of unknown hazards. What would you rather do?  Make those workers the first lab rats?  Put your son or daughter on that factory floor in your mind and get over this feeling we have the right to put workers at risk like that.

 

As this PPE part of the rule goes, it is the only incidence of the exercise of the Precautionary Principle in our regulations.  We should jump on this as a starting point. Only with this policy underlying our rules will industry finally have an incentive to test chemicals.  They'll test just to reduce cost of the precautions.

 

But instead, we allow that chemical of unknown hazards made by these PPE protected workers out into the market where other workers and consumers are not protected or even informed that they might need protection.

 

And then, due to our insane CPSC regs, the downstream manufacturers of consumer products can legally label it "nontoxic" to completely hide the chemical's untested status.  

 

And while I personally like the current head of OSHA, what the hell was he thinking when OSHA did not require reporting of the 10 gold standard toxicity tests in Section 11 of the SDS?   Now U.S. workers have no chance of seeing that the tests have not been done--while E.U. workers and consumers can easily see both what is known and what is not known about the chemical.

 

And not content with scewing up our access to information, industry with the help of our U.S. Trade Representative, Michael Froman, are trying to use the TTIP treaty to force the E.U. to accept our untested and unlabeled products.  This action effectively voids REACH which requires disclosure on Section 11 of the SDS and has better labeling and restriction of chemicals they think are potentially toxic.

 

The CSA took away the states right to an opinion other than EPA's, and now we want to force that on the E.U.  It's already too late for the rest of the world due to the Pacific trade treaty. 

 

And the American public is deciding which candidate to back based on their attitude toward free trade without ever reading the F'n TTIP and seeing what is in that fine print that is going to screw them in the future.

 

Guess who the enemy is, Pogo.

 

 

Monona Rossol, M.S., M.F.A., Industrial Hygienist

President:  Arts, Crafts & Theater Safety, Inc.

Safety Officer: Local USA829, IATSE

181 Thompson St., #23

New York, NY 10012    212-777-0062

actsnyc**At_Symbol_Here**cs.com   www.artscraftstheatersafety.org

 

 

-----Original Message-----
From: Harry J. Elston <helston**At_Symbol_Here**MIDWESTCHEMSAFETY.COM>
To: DCHAS-L <DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU>
Sent: Sat, Jul 2, 2016 8:43 am
Subject: Re: [DCHAS-L] Today's Overview Webinar on New TSCA

"This pigment called YInMn Blue is made with the oxides of Indium (TLV-TWA = 0.1 mg/m3), yttrium (TLV-TWA = 1 mg/m3) and manganese (TLV-TWA = 0.1I and 0.02R).  But it's nontoxic, right?"

 

TLVs are not a measure of toxicity - one needs to get into the documentation of the TLVs to determine the basis of the occupational exposure level, e.g. irritation, toxicity or whatever.  

 

RE: 5(e) Order on Worker PPE:  I have some heartburn with EPA mandating PPE as my experience is that they seem to default to a "zero exposure/zero risk" posture unless the manufacturer can demonstrate otherwise, and even then, may not budge. Unfortunately we do not live in a zero exposure/zero risk world; we (should) live in a managed exposure/managed risk one.

 

"HAS THE WHOLE WORLD GONE NUTS?"

 

Pretty much, yeah.  Y'all need to come out to flyover country - it's somewhat saner out here. (Or the insanity progresses at slower pace).

 

H

 

On Fri, Jul 1, 2016 at 2:07 PM, Monona Rossol <0000012821515289-dmarc-request**At_Symbol_Here**listserv.med.cornell.edu> wrote:

Thanks.  That's pretty much what I think as well. I have been following the various House and Senate versions since I presented information on the chemical testing issue to a Senate Staff Briefing with Earthjustice in 2011 when my book, Pick Your Poison, came out?  

 

I also went through the outrageous CSA powerpoint discussed on the webinar. And while my major issue with the law is the piddling number of chemicals that will actually be tested and that they are the wrong chemicals and the wrong tests, I'd like to just look at one of those CSA webinar slides, The one that said:

 

New Chemicals

• New law requires EPA to make affirmative finding on new

chemicals or significant new uses of existing chemicals

 

• Before the chemical can enter the market, EPA must find

that the chemical:

– “presents an unreasonable risk” and issue a 5(f) order to

address such risk;

– “information…is insufficient to permit a reasoned

evaluation…” and issue a 5(e) order;

– “may present an unreasonable risk” and issue a 5(e) order;

or

– is “not likely to present an unreasonable risk” and publish

the determination

 

Someone should have asked what the provisions of the 5(e) and 5(f) orders are. Essentially, they are the same review procedure that has always been in place for PMN and SNURs that EPA has been using unsuccessfully for decades.  They still are asking EPA to determine risk in the absence of data.  And industry can still hold up the action by claiming that EPA did an unfair risk assessment.

 

I'm sure you know, but maybe others on the list re not familiar with these. Since 5(f) supposedly allows EPA ban production and to get a court injunction to stop manufacture (don't wait to see this happen), it make more sense to look at 5(e):

 

 

5(e) order   When a PMN is filed, EPA will decide if it poses a significant risk or not.  If they think it does, they do the following:

 

*  Testing for toxicity or environmental fate once a certain production volume or time period is reached   

NOTE:  nothing stopped production of the chemical.  Only after a certain volume does environmental testing even have to begin.  And this is not toxicity testing for human exposure, it is bioaccumulation, water quality, etc.

 

*  Use of worker personal protective equipment

NOTE: Since there is no data on the chemical, EPA takes a guess at respirator protection, gloves, etc. Again, the stuff is in production, and the only people being protected are the workers making it.

 

*  New Chemical Exposure Limits (NCELs) for worker protection

NOTE: Based on the same guesses about toxicity, EPA will set airborne limits only for those workers who manufacture the stuff.

 

*  Hazard communication language

NOTE: EPA expects manufacturers to tell their workers what those EPA guesses are about the toxicity.  That must be so reassuring.

 

*  Distribution and use restrictions

NOTE: This keeps the manufacturer from hurling the crap into the drains, out in the dumpster, or along a roadside in Tennessee. And they can say that something should not be used ultimately for certain purposes in the consumer or industrial markets. But this is rarely done and it is usually only restricted for uses that prevent environmental damage not human harm.

 

*  Restrictions on releases to water air and land, and

NOTE: Based on their guesses, they may set limits on how much of this stuff can be released.

 

*  Recordkeeping.

NOTE: the manufacturer keeps records of production

 

NOWanswer these questions:

 

1.  Did you see any testing requirement to find out what the stuff ACTUALLY does to the worker or other people?   Or is it still based on a risk assessment by analogy and without REAL data?

 

2.  Did you see any requirements for hazcom other than for the workers manufacturing the chemical?  Are workers using this chemical downstream included here?

 

3.  And WHERE does the chemical that these manufacturing workers have produced go?  Aha,  I've been watching the FR for years to figure it out. 

 

Now the chemical is sold to various jobbers and scattered to the wily winds of the market.  Does EPA's concern go on the label and the SDS that accompanies this stuff?  Maybe, maybe not.  But it certainly won't be on any document associated with this 5(e) chemical once it is part of a consumer or industrial product used by secondary industries or consumers.

 

And under the misguided rules of the CPSC, this chemical or products containing it can be labeled "nontoxic" since only chemicals proven by specific tests require labeling.  

 

I've watched this in particular with dyes in the 1980s and 1990 that are in classes we can assume are toxic.  They end up in the shops of my textile dyers and costume workers and on the clothes you and the actors wear. Unlike the E.U. that has a Dye Directive that prohibits use of any dye that can break down to release any of 22 known carcinogens next to the skin, we have no such law.

 

And no sense watching for this now, because manufacturers just send all this work to India, Bangladesh and China.  Notice that there is nothing in the bill about products made with any chemical in a foreign country that comes in as a consumer product.  There is no way not to police this that I've seen.

 

And DID YOU SEE the article in C&EN on the wonderful new blue inorganic pigment?  It is now being touted by the inventor and art organizations as nontoxic, art work using it can be seen on websites, and it will be coming to your neighborhood soon in some form.  Was there a PMN on this?  I no longer check the FR, but someone should. They'll probably just job it out.

 

This pigment called YInMn Blue is made with the oxides of Indium (TLV-TWA = 0.1 mg/m3), yttrium (TLV-TWA = 1 mg/m3) and manganese (TLV-TWA = 0.1I and 0.02R).  But it's nontoxic, right?  Why, because no one can prove if you combine three nasty things you might not get something really safe.  

 

HAS THE WHOLE WORLD GONE NUTS?

 

Monona Rossol, M.S., M.F.A., Industrial Hygienist

President:  Arts, Crafts & Theater Safety, Inc.

Safety Officer: Local USA829, IATSE

181 Thompson St., #23

New York, NY 10012    212-777-0062

 

Monona Rossol, M.S., M.F.A., Industrial Hygienist

President:  Arts, Crafts & Theater Safety, Inc.

Safety Officer: Local USA829, IATSE

181 Thompson St., #23

New York, NY 10012    212-777-0062

actsnyc**At_Symbol_Here**cs.com   www.artscraftstheatersafety.org

 

 

-----Original Message-----
From: Roger McClellan <roger.o.mcclellan**At_Symbol_Here**ATT.NET>
To: DCHAS-L <DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU>
Sent: Fri, Jul 1, 2016 6:03 am
Subject: Re: [DCHAS-L] Today's Overview Webinar on New TSCA

To all:
This bill has been moving through the system for years and with passage by the Congress and signature by the President it is the law of the line. I would be shocked if any substantive amendments will be made to the legislation in the next decade. Yes, there may be some minor clean up of legislative language next year as is customary for major legislation. However, I doubt the Congress will have any "stomach" for re-opening the legislation for major changes. The opportunity for addressing perceived short comings is now history.
This legislation as always has some latitude as to how it is implemented. Thus, I urge interested parties to closely follow the actions of EPA, especially over the next 1 to 2 years, as it implements the legislation. This is always challenging and time consuming. However, occasionally specific targeted efforts by interested persons and parties can influence EPA's actions on the first chemicals addressed which in turn can set the precedent for actions on future reviews on other chemicals.
It is my personal opinion that the legislation contains a lot of language, for example, frequent use of the phrase-- "unreasonable risk", that gives the EPA broad policy discretion in taking or not taking certain actions on specific chemicals. Finally, I would note my own personal view from following EPAs actions since its origins --- "Science needs to inform policy judgements and regulatory actions, however, science alone is not sufficient for dictating specific policy outcomes." It is important for scientists to make certain EPA gets the science right. If a scientist or group of scientists have difficulty with a particular agency decision it is important to critically examine the matter and determine whether the problem is with the science or the policy decisions leading to a particular regulatory outcome..
It is going to be interesting to follow the EPAs actions over the next several years. One thing the legislation does do is set some specific goals and time lines for the Agency to attempt to meet in the future. This is a clear response to the slow progress made by the EPA in moving chemicals through IRIS review over the last several decades.
Over past decades much time and energy has been expended in debating the relevance and role of data from laboratory animal studies in assessing human hazards and risks. Increasingly, attention will shift to interpreting the results of studies with experimental systems that do not use animals. The debate over emphasis on hazard characterization versus quantitative risk assessment will also continue. The recent debate over actions of IARC is a preview of what to expect. As an aside, did you note that IARC changed its classification of coffee consumption -its cancer hazard is no longer established. However, be careful what you drink, hot water is now on the IARC list of possible human carcinogens.
It is a wild, wild world at the interface between science and policy. I urge everyone to become engaged in the process, but, try to distinguish between whether your arguments are with how the science was used or with your own preference for a different policy outcome.
Regards to all.
Roger

Roger O. McClellan, DVM, MMS, DSc(Honorary)
Diplomate - ABVT and ABT; Fellow -ATS, SRA ,HPS, AAAR and AAAS
Member - National Academy of Medicine
Advisor, Toxicology and Human Health Risk Assessment
Albuquerque, NM 87111

On Thu, 6/30/16, Alvaldenio**At_Symbol_Here**verizon.net <alvaldenio**At_Symbol_Here**VERIZON.NET> wrote:

Subject: Re: [DCHAS-L] Today's Overview Webinar on New TSCA
To: DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU
Date: Thursday, June 30, 2016, 5:19 PM

Ralph,  In view of the
many shortcomings of the new law, should our Division start
proposing a series of amendments for the next session of
Congress?  Al Denio

Sent
from my iPad

> On Jun 30, 2016, at
6:23 PM, Secretary, ACS Division of Chemical Health and
Safety <secretary**At_Symbol_Here**DCHAS.ORG>
wrote:
>
> Note that
the slides from today's webinar are available at:
> https://urldefense.proofpoint.com/v2/url?u=https-3A__www.epa.gov_sites_production_files_2016-2D06_documents_june-5F30-5Fwebinar-5Fppt.pdf&d=DQIFaQ&c=lb62iw4YL4RFalcE2hQUQealT9-RXrryqt9KZX2qu2s&r=meWM1Buqv4IQ27AlK1OJRjcQl09S1Zta6YXKalY_Io0&m=U9vNbObAZcOW-J-qlR_zGLWOdaaGwrkOk0gi7wpP0T4&s=umayrGDMb8zbEq3RH7GE0MzaTJLRQ52FSgvCt_1IQV0&e=

>
> - Ralph
>
> From: "U.S. EPA
Office of Chemical Safety and Pollution Prevention"
<oppt.epa**At_Symbol_Here**public.govdelivery.com>
>
> Regarding Today's
webinar on the new TSCA, our sincere regrets that some
people were not able hear the audio or were not able to join
at the beginning of the presentation. Our conference lines
were overwhelmed by the large number of participants. We
plan to host another overview webinar in the near future.
Information for this future webinar will be sent out through
this Listserv and available at the new TSCA webpage. Please
accept our regrets.

 

--

+++++++
Harry J. Elston, Ph.D., CIH
Principal
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Twitter: **At_Symbol_Here**MidwestChemSafe