Continuing my review of  Sen. Lautenberg’s Safe Chemicals Act bill, this blog covers the treatment of NEW CHEMICALS.  Today's PMNs will be converted to "safety declarations."  Any chemical not reported by a manufacturer or processor in the first round of the "current activity declarations" - see previous blog on the new TSCA Inventory -  will be "new" and require submission of:

1. information as required in the current activity declaration (chemical identity; facility name and location where the chemical is made, processed or distributed and where it will be shipped to; list of health and safety studies and copies not previously submitted to EPA; physical, chemical properties; toxicological properties; annual production; known uses; exposure and fate of the substance)

2. a minimum data set - essentially the same information as #1 and toxicity testing to be determined by rule within 1 year of passage of the Act [which means it will copy REACH because there won't be time to do anything too novel]

3. a statement that the chemical will meet "the safety standard"

So what is "the safety standard"?

There appears to be no specific definition in the Senate bill.  We'll assume this was to allow discussion under the House draft:

‘(1) SAFETY STANDARD.—The Administrator shall apply, as a safety standard under this title, a standard [that] takes into account aggregate and cumulative exposure to a chemical substance or mixture and that provides a reasonable certainty of no harm,  including to vulnerable populations, and protects the  public welfare from adverse effects, including effects on the environment."

The Senate bill does define  "REASONABLE CERTAINTY OF NO HARM.

The term ‘reasonable certainty of no harm’ means, in establishing whether a chemical substance or mixture meets the safety standard under this subchapter, that aggregate exposure and cumulative exposure of the general population or of any vulnerable population to the chemical substance or mixture presents a negligible risk of any adverse effect on the general population or a vulnerable population." §3(23)

['cumulative' and 'aggregate' is to capture the chemical used for anything, whether regulated as a TSCA/SCA "chemical substance" or not.  Usually moot for a new chemical.]

The bill emphatically says the burden is entirely on the manufacturer or processor to prove that the chemical is safe.  EPA's duty is to decide if the company met the burden of proof.  The agency can order the company to provide more information to support this proof.

EPA is supposed to make a positive or negative decision within 180 days of receipt of the information and can extend this up to 1 year to get more information from the submitter. If EPA fails to make a determination, the submitter cannot proceed to make or use the chemical in a new way. §5(a)(4)(D).  The company has no recourse to judicial review or challenge.

EPA could lickety-split come up with conditions under which manufacture and use  of a new chemical would constitute a "safety standard" with reasonable certainty of no harm.  In essence, this becomes equivalent to today's direct final SNUR with workplace, use and disposal restrictions - except these are orders and not rulemaking (or even "consent" orders as with current 5(e)).  EPA issues the safety standard loaded with "conditions" and the manufacturer of a new chemical takes it or leaves it.  These safety standards are not subject to judicial review.  EPA just has to be "transparent" and publish its decisions. (Even REACH authorization requires review!)

On the other hand, there is a default set of findings that the EPA can make to allow new chemical manufacture without doing a safety standard:  

If the new chemical substance, or a metabolite or degradation product of the chemical substance” is expected to

- be made at < 1 million lbs or released to environment < 100,000 lbs [pretty easy to  meet on a new chemical]

- present no potential for a long list of toxic endpoints including “other toxicological properties of concern[EPA's only requirement is to be "transparent" about its decision-making §6(b)(1)(B)(v).  EPA doesn't have to do a risk assessment. It just has to decide if the absolute negative has been proven.  Is that possible? ]

- not be persistent and bioaccumulative [the bill codifies EPA's policies, but allows a very rare authority to do rulemaking to update the definitions.]

- not be found in humans above natural levels [this makes no sense for a new chemical for which there are no natural levels] AND

- not be found in food, drinking water, ambient or indoor air, residential soil, or house dust above natural levels. [again, this makes no sense for a new chemical for which there are no natural levels]

the manufacturer can then make the new chemical.

Since failing any of these criteria will prohibit manufacture, it doesn't seem too applicable to new chemicals - unless they immediately degrade to whatever is deemed absolutely nontoxic. Water? Oxygen? Elemental carbon?  But even too much water or oxygen or carbon in the wrong place can cause adverse effects....  Plus, that kind of chemical is probably useless commercially as it doesn't stick around long enough to do anything!  If you can think of any new "green chemicals" that would survive this gauntlet, let me know.

Surely, a more reasonable set of "presumed safe enough" default criteria can be developed. Otherwise, there will be no new chemicals.  Even "green" ones. (Test marketing only has to prove it will "not endanger the health or the environment;" however, EPA can set any restrictions it wants to.)

On the off chance that EPA would let a new chemical be made under whatever safety standard conditions it had deemed appropriate, there is a non-rulemaking public process for petitioning for review of these positive safety findings.  Anyone can petition for "redetermination" of whether a chemical continues to meet the standard of "reasonable certainty of no harm." EPA publishes that a petition has been received, gets public comment and decides whether or not the chemical/use can continue within 180 days.

This system seems to guarantee no new chemicals will be developed and marketed in the US. If they are, they will be used in very limited niche markets - probably within a single company. Because, as SNUR'd chemical makers can attest to, potential customers don't want to deal with all the restrictions, recordkeeping and potential for major fines.

I don't have a big problem with a minimum data set if it is appropriately tiered and if sufficiently similar chemicals toxicity and exposure scenarios can be used (which appear possible under the bill).

I do have a major problem with absolute safety criteria and a demand to prove the "no harm."  Detection does not mean significant risk. A  transitory biological response is not necessarily adverse.  Nor can society afford to forgo the benefits of new chemicals to guarantee  protecting everyone with extreme health vulnerabilities.  We need reasonable, practical precautions mutually agreed upon to manage risk.

I also have a fairness problem with the cavalier dispensing of the rulemaking process and judicial review. EPA is given too much freedom in the bill to control chemical manufacture and use at the whim of bureaucrats and political appointees. Remember - it's taken over 30 years to even try to revise TSCA.  Don't give away due process because you didn't like the Bush EPA.

Next blog will be about NEW USES of existing chemicals and how they are treated.  The SCA opens a whole new Pandora's box for processors of chemicals.

Leave a reply