1 Pennington-Lawrenceville Rd., Pennington NJ 08534 ♦ afinkel@law.upenn.edu

Mr. John Schaefer U.S. EPA, Office of Air Quality Planning and Standa rds Sector Policies and Programs Division

VIA E-MAIL

Re: Docket ID No. EPA-HQ-OAR-2014-0471

May 19, 2015

Dear Mr. Schaefer:

The comments on the proposed listing of 1-bromopro pane (1-BP) as a Hazardous Air Pollutant (HAP) by Albemarle Corp. (and their c onsultants) and by Enviro Tech International are replete with legal, scientific, a nd policy misstatements. I trust that EPA will not deny the HSIA and NYSDEC petitions based o n misinformation and faulty logic, but in the interests of clarity, I will briefly enumera te my concerns in each of these areas.

Legal Standard:

All of the speculation contained in the recent comm ents about the exact magnitude of the individual risks to those exposed to 1-BP is only relevant upon a dubious interpretation of 42 USC §7412. Mr. Nestrud’s comments on behalf of Albemarle (p. 2) cite a personal communication with you (“John Shaefer” [sic]) as the source of the purported “requirement” that EPA cond uct the same full quantitative risk assessment under 7412(b)(3) that it would conduct u nder 7412(f) when it sets a NESHAP. I assume you made no such claim, as that would cont radict a plain reading of the Clean Air Act Amendments of 1990, and would confuse the well- understood distinction (dating back at least as far as the 1983 NAS “Red Book”) between hazard identification and risk characterization. Section 7412(b)(3)(B) is quite c lear: EPA must grant a petition to list a
substance as a HAP if “emissions... of the substance are known to cause or may reasonably be anticipated to cause adverse effects to human he alth.” Section (b)(2) above is even more clear that listing is a hazard-identification activity—here the Agency shall (emphasis2

added) add a substance to the list if it “may prese nt a threat of adverse human health effects,” with no mention of emissions.

I will not belabor here whether it is possible tha t a reviewing court would interpret “emissions” in (b)(3)(B) to mean “the substance mus t currently be emitted in quantities large enough that exposures somewhere in the U.S. a re above a biological threshold.” I think that is a much more tortured reading that thi s plain-English reading: “the substance, if emitted, is capable of causing adverse health ef fects.” Hopefully we will not have to hash this out in front of a judge (presumably one who kn ows well the recent Supreme Court cases confirming that EPA can, and sometimes must, not consider certain criteria when it makes findings, factors that it may or must conside r later when it sets regulatory limits). But even if (b)(3)(B), in contrast to (b)(2), requi res EPA to consider emissions when listing

, there is no evidence whatsoever in the record here that 1-BP can present itself in concentrations too small to cause (or reasonably be a nticipated to cause) cancer and neurological impairment (see below). Instead, the commenters have filled the record with risk estimates, but there is no mention of “it can cause adverse effects, but too few of them to matter” anywhere in 112(b). And even if the com menters had offered any evidence that
1-BP has a threshold below which no harm at all can occur, the burden would be on them to provide convincing evidence of this. EPA itself wrote in 2003 (68 Federal Register at 65651) that “Uncertainties concerning the risks of adverse health or environmental effects may be mitigated if we can determine that projected exposures are sufficiently low in relation to levels where adverse effects may occur to provide reasonable assurance that
such adverse effects will not occur ” (emphasis added). The commenters cannot possibl y provide such assurance; all they have tried to do ( quite unconvincingly, in my expert opinion as a risk assessor) is to suggest that thes e effects will occur too infrequently for the substance to be listed, and EPA is not permitted to accept such an irrelevant judgment even if it found the supporting arguments convincing.

I hope you will pardon this analogy, but the Amtra k derailment of the other day is fresh in my mind as I live near Philadelphia: if DO T was deliberating whether to “list” the Port Richmond curve as being dangerous enough to me rit a warning sign, imagine if someone objected to a sign on the grounds that “har dly any trains go by there anyway, and they have a lot of empty seats on them.” Hazard is hazard, and risk is risk: the hypothetical “listing decision” for the curve would be based on a determination that the curve was capable of causing a derailment, not on the frequen cy at which derailments might occur. Besides, I hope it is obvious to EPA (see below) th at emissions are almost wholly within the control of the very commenters who seek to dissuade you from listing! Their arguments amount to “we promise not to sell enough of this st uff to cause a big problem,” and I strongly caution against EPA accepting such an impl icit promise. How little or how much they sell (and others emit) affects the risk of 1-BP; the hazard

of 1-BP is your concern in3

this proceeding, and EPA cannot legally deny this p etition on the grounds that the risk might remain low, if the manufacturers respond to a ruli ng in their favor by selling less and less of a product now (incorrectly) not deemed to b e hazardous. The time to consider the quantitative “significance” of any risks is when th e Agency is contemplating actually regulating the hazard, not when it is deciding whether the ha zard exists 1

.

Scientific Claims:

Gradient Corp.’s risk assessment amounts to selecti ve “manufactured doubt.” I have no objection to a commenter demonstrating that unce rtainty in risk has been understated (it almost always is), other than to repeat my conc ern here that EPA should ignore claims that 1-BP is not a HAP because it’s not “risky enou gh” by someone’s judgment. But surely the uncertainty in 1-BP’s risk extends above as well as below the point estimate proffered by the petitioners; Gradient seems to have no inter est in that portion of the uncertainty distribution. Perhaps there should indeed (as Grad ient argues) be a slight downward adjustment of the IUR to account for interspecies d ifferences in dosimetry; perhaps also there should be a slight downward adjustment to gam ble on the possibility that by chance there were not “enough” tumors in the control anima ls compared to previous experiments
on the same strain of mouse. But what about the fa ilure to assess cumulative and aggregate risk, which would suggest looking at the total numb er of tumor-bearing animals in both the control and exposed groups? What about the recomme ndation of the National Academy of

Sciences Science and Decisions report, which urged EPA to adjust its animal-based cancer potency estimates upwards by a factor of from 10- to 50-fold to account for the known interindividual variability in susceptibility to ca ncer in the outbred human population? Like the cherry-picking in the Gradient report, the se objections to the point estimate are reasonable in light of uncertainty, but are one-sid ed. Again, I urge EPA to follow the statute
and assess the hazard

of 1-BP in this proceeding, but if it is going to incorrectly consider quantitative risk estimates, it must consider estim ates both below and above the point estimates the petitioners offered.

Secondly, as a former senior executive at OSHA I fi nd the recent comments offensive in their willful ignoring of worker exposures and r isks. As I demonstrated in my
unrebutted comments submitted to the record two mon ths before the (revised) end of the comment period, the best estimates of current occup ational exposure to 1-BP center at roughly 60 parts per million (300 mg/m 3 )—therefore, trying to “prove” that concentrations U.S. citizens are exposed to tend to fall below about 1 part per billion (the

1 As an expert in the litigation to which Mr. Morfor d refers on p. 7 of his (unnumbered) letter to the docket, I am privy to information contradicting several of hi s statements about that case, but I will not docume nt those misstatements in this public document.4

concentration needed to make the risk fall below 10 -6 ) is completely oblivious to the real risks posed by 1-BP.

Third, Gradient’s comments (pp. 5-8) about the poss ible nonlinearity, threshold, or species-specific mode of action for 1-BP are wildly speculative and incomplete. Their own conclusory statement on p. 6 says it all: “If indee d the mode of action is non-genotoxic, then the default linear threshold model used by the petitioners to estimate the IUR may not be appropriate, and a non-linear (threshold) approa ch may provide a more accurate representation of the dose-response relationship be tween nPB exposure and cancer endpoints.” The sentence is true as a logical prop osition, but note well the operative words: “If,” “may,” and “may.” Where is the eviden tiary support for these expressions of possible alternatives to linearity and human relevance?

• Female mice and rats showed tumorigenic responses, but not male animals (conveniently omitting mention of the excess skin c ancers in male rats)—if EPA wishes to analyze the 185 current HAPs for those th at show similar “inconsistent” results (or no positive cancer bioassay at all!), i t will find this is a common finding, including among substances already known via epidem iology to be carcinogenic in
male and female humans

.

• Mouse lung tumors may be caused by a species-specific pathway, causing “ an increase in mostly benign lung tumors”—this might b e interesting speculation, were it not for the fact (not mentioned in the Gradient report) that 7 of the 9 tumorbearing animals found in the 62.5 ppm exposed group had malignant neoplasms.

• No epidemiologic data are available to prove human carcinogenicity beyond doubt—again, this statement applies to the vast maj ority of all currently-listed HAPs. Epidemiology is to true cancer risk what Gal ileo’s telescope was to the enumeration of Jupiter’s moons—a good way to detect the obvious and to miss what

is there but is harder to see.

• Most of the in vitro tests on 1-BP did not show mutagenicity—if “weight of evidence” means nothing more than the number of studies on ea ch hand, perhaps this is a useful statement, but the report offers no refutati ons of the positive mutagenicity or DNA-damage tests, only to invoke a possible high-do se phenomenon.

• 1-BP caused immunosuppression in the test animals—N TP agrees with this observation, but Gradient’s inference that immunosuppression should decrease concern is bizarre, as this is a second and indepen dent risk factor for cancer in

humans.5

Again, I note with chagrin that every single refere nce in the Gradient report about “high dose” effects evidences utter disregard for U.S. wo rkers. I call particular attention to the statement (p. 8) that “the exposure concentrations used by NTP (62.5-500 ppm) are several orders of magnitude greater than those modeled for ambient air ... [and therefore] may be qualitative with regard to potential carcinogenic e ffects, but not reliable for quantitative extrapolation from animals to humans.” I have to a sk: what species are the U.S. workers for
whom no extrapolation from bioassay concentrations is needed because the y are currently being exposed above 62.5 ppm? EPA needs only to interpolate between the 62.5 and the 125 ppm exposures to see that the posi tive cancer bioassay is prima facie “relevant to humans”! (I also note that the Gradie nt statement immediately above acknowledges all EPA needs to know: the hazard iden tification step for 1-BP is complete, and it is “reasonably anticipated to cause cancer i n humans.”)

Finally, I note that nowhere does either manufactur er in its comments attempt to
cast doubt on the fact that 1-BP is a human neuroto xin at levels far below that used in the animal cancer bioassay. Although Albemarle does at tempt a partial refutation of the finding by Li et. al of diminished vibratory sense in workers at approximately 7 ppm (pp. 2- 4 of the January 2015 letter to Dr. Barone at OPPT) , nowhere does either manufacturer mention the 2004 study by Ichihara et al., which do cumented complete loss of vibratory sense in workers exposed to as little as 1.1 ppm 1- BP 2 . Therefore, in addition to being a reasonably-anticipated human carcinogen, 1-BP is a known human neurotoxin, and must
be listed as a HAP on that basis alone.

Policy Implications:

Enviro Tech would have EPA believe that its custom ers understand that 1-BP is not a “drop-in” replacement for perchloroethylene, and that for this and other reasons, its sales are declining. Perhaps EPA should accept Enviro Te ch’s own sales figures and future projections as accurate, even though the former are not verifia ble in the public record 3 and the latter are, of course, self-generated speculati on. But Enviro Tech is one of hundreds of suppliers, distributors, and traders of this chemic al (a search on the site www.molbase.com

2 That study examined 23 workers whose geometric mea n time-weighted average exposure was 2.92 ppm; 15 of the workers showed loss of vibratory sense in ei ther fingers, toes, or both.

3 Enviro Tech offers to help EPA obtain copyrighted r eports about 1-BP importation quantities, but provides no back-up for its domestic-production estimates.6

indicates at least 260 such suppliers), some of who m certainly do tout 1-BP as a drop-in replacement for Perc (see,. e.g., http://www.modelcleanersonline.com/solution.html ).

Enviro Tech would have EPA believe that IF domesti c use has indeed declined from 8.861 million pounds per year in 2012 to 8.159 mill ion pounds in 2014, and that IF that trend continues, that somehow the “out of date” inf ormation provided by petitioners renders 1-BP “not a HAP.” I suggest that EPA look at production figures for the 185 currently-listed HAPs, and see how many (or how few ...) of them are consumed in quantities above 8 million lbs/yr., before paying a ny attention to this non sequitur.

Enviro Tech would have EPA believe that listing 1- BP as a HAP would drive customers to use trichloroethylene. I suggest that EPA instead consider the market failure it has allowed to persist for at least the past sev eral years: customers currently are misled by the manufacturers of 1-BP to purchase what they prominently advertise as “EPAapproved and not considered [a] hazardous air pollu tant” (see p. 4 of my March 8 comments to this docket). If customers fail to app reciate quantitative differences in risk
within substances on the HAPs list, that is a problem, bu t surely that is far less of a problem than leaving one animal carcinogen and human neurot oxin on the list and leaving another one off, for no apparent reason other than that one was in production 25 years ago when Congress compiled the original list.

Conclusions:

The manufacturers of 1-BP are asking EPA to believ e that if the Agency does not list the substance as a HAP, exposures will decline. Th is proposition is unbelievable on its face (more likely, exposures will increase, which presum ably is the goal of thwarting this petition), but it is also irrelevant to the listing criteria.

Other than the affront of considering workers to be unworthy of mention, the most problematic statement in the recent comments is thi s one (p. 9 of the Enviro Tech comments): “little to no benefit will be achieved... should nPB be deemed a HAP.” Purportedly, Enviro Tech somehow knows that users o f 1-BP are already complying with
emissions limits that would be set in the future if EPA was first

to list 1-BP and then later to regulate it.

Instead, I offer the following truism, which follo ws directly from the Enviro Tech
statement: “little to no cost will be incurred... should nPB be deemed a HAP.” If Enviro Tech is correct, there is no reason not to follow NTP, ACGIH, and other expert bodies and summarize the science about 1-BPs hazard by listing it among the other 185 HAPs.7

But at this stage, EPA should not be concerned wit h either the benefits OR the costs of some hypothetical future regulation. It has bee n asked to render a science-policy opinion about whether a substance belongs on a list . The benefits of listing 1-BP as a HAP are simple: it amply meets the listing criteria in the Clean Air Act, and therefore citizens will no longer be misled that it is “non hazardous. ”

Thank you for the opportunity to comment on this im portant issue; I would be happy to provide any further information by request.

Sincerely,

Adam M. Finkel, Sc.D., CIH Senior Fellow and Executive Director, Penn Program on Regulation, University of Pennsylvania Law Schoo l and Clinical Professor of Environmental Health Sciences , Univ. of Michigan School of Public Health

(affiliations listed for purposes of identification only)