DCHAS-L Archives, Jul 02 2016 - 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 is not 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.

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).

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;

- 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

NOW answer 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
Company Information
Google+
Twitter: **At_Symbol_Here**MidwestChemSafe

About This Archive \|	DCHAS-L 2016 Index \|	DCHAS-L Yearly Index
Search All Posts: Advanced Search Disclaimer