Denka Performance Elastomer LLC 560 Highway 44
LaPlace, LA 70068
June 26,2017
The Honorable Scott Pruitt Administrator IJ.S, Environmental Protection Agency Headquarters William Jefferson Clinton Building 1200 Pennsylvania Avenue, N,W, Mail Code: "i 101A Washington, D.C, 20460
Re: Request to Withdraw and Correct the 2010 IRIS Review of Chioroprene
Dear Administrator Pruitt:
l write on behalf o f Denka Performance Elastomer LLC (DPE) in support o f the request that the U.S. Environmental Protection Agency (EPA) withdraw and correct its Integrated Risk Information System (IRIS) Toxicological Review of Chioroprene (EPA/635/R-09/01OF, 2010} (the 2010 IRIS Review), The errors in the 2010 IRIS Review threaten the very survival of DPE'sNeoprene production facility in LaPiaee, Louisiana (Facility), In particular, based on those errors and EPA's subsequent flawed determinations concerning the risks caused by Facility emissions, ERA is making stringent ah' pollution control demands concerning the- Facility that: are technologically impossible to achieve, EPA must: expeditiously apply good science in this matter in order to alleviate the public's undue concerns about the risks associated with this Facility and to prevent further significant damage to DPE's business,
Key conclusions of the 2010 IRIS Review are not based on the best available science or sound scientific practices. First, the 2010 IRIS Review rejected the findings of the strongest available epidemiological study, which concluded that there is no increased risk o f cancer in workers exposed to chioroprene (some of the study cohorts actually exhibited a lower risk of cancer than the control population), Rather than accepting the overall study conclusions, the 2010 IRIS Review relied on select statistically non-significant comparisons of cancer incidence rates among subgroups o f the larger epidemiology study to bolster its classification of chioroprene as "likely to be carcinogenic to humans." Second, the 2010 IRIS Review is flawed because it relied on laboratory animal studies, and then used the results for the most sensitive laboratory animal - female mice - as the basis for a series o f overly conservative calculations to develop the human Inhalation unit risk (IUR). Contrary to sound scientific practice, the 2010 IRIS Review ignored the known differences between humans and a select strain of female laboratory mice, and relied on resuits in those female mice to estimate an IUR for humans, Third, the 2010 IRIS Review gives chioroprene, which EPA designates only as a "likely" and not a "known" human carcinogen, the fifth highest IUR estimate of any similar chemical, including known human carcinogens, in tire IRIS database, DuPont, the former Facility owner, provided similar information and analysis to EPA in comments on the draft IRIS Review, which comments were rejected in 2010, DPE's Request for Correction and the Raniboil Environ report provide new information and weight-of-evidence review not available in 2010.
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After EPA published the 2010 IRIS Review, the National Academies of Sciences'1 National Research Council (NRC) recommended major reforms in the IRIS process. Congress has repeatedly instructed EPA to implement the NRC's recommendations, and EPA has advised Congress that it is doing so. Tit 2010 IRIS Review ts plagued with flaws similar to those that gave rise to these reform initiatives, and it is extremely important that the 2010 IRIS Review now be corrected in light of its scientific and procedural deficiencies.
These issues are more fully explained in DPE's Request for Correction and in the supporting, toxieoiogieal and epidemiological expert review prepared by prominent scientists with the consulting firm of Ramhoii Environ: Drs. Kenneth Mundt. Robtnan Gently, and Sonja Sax, Their report is entitled Basis fo r Requesting Correction o f the U.S. EPA Toxicological Review o f Chloroprene. dated June 2017 ("the Ramboli Environ Report," and attached hereto), The Rambo.il Environ Report identifies multiple substantive errors in tire 2 0 1.0 IRIS Review and demonstrates that: if chloroprene is to be treated as a possible human carcinogen, the 2010 IRIS Review establishes an ItJR that is .156 times too high.
By way of background, DPE acquired the Neoprene Facility from DuPont on November 1, 2015, Neoprene is a synthetic rubber utilized in a. wide variety o f applications, including laptop sleeves, orthopedic braces, electrical insulation, and automotive fair belts, DPE is the only manufacturer o f Neoprene In the United States. The Facility is a commercial mainstay of LaPlace, Louisiana. With, an annual payroll o f $33 million, DPE directly employs 200-250 people in manufacturingjobs and regularly employs between 1.25 and 150 contractors. DPE also lias created 16 new corporate jobs. Additionally, DPE is investing and upgrading the Facility, including taking new measures to reduce its environmental footprint and improve its productivity and competitiveness.
The base feedstock for Neoprene is chloroprene. The Facility's air permits authorize it to emit chloroprene, and the Facility operates in compliance with those permit limits. However, shortly after DPE's acquisition of the Facility, on December 17, 2015, EPA publicly released its 2011 National Air Toxics Assessment (NATA), which identified the Facility as creating the greatest offsite risk o f cancer of arty manufacturing facility in the United States, The NATA findings concerning the Facility are based on the scientifically unwarranted and outdated 2010 IRIS Review and the emission profile o f the Facility,
Following the public release of the NATA, EPA and the Louisiana Department o f Environmental Quality (LDEQ) pressed DPE to reduce emissions to achieve an extraordinarily miniscule ambient air target concentration of 0.2 pg/m3 for chloroprene on an annual average basis (which is intended to reflect a 100 in 1,000,000 rate of potential excess cancers In a population exposed to such concentrations continuously for 70 years). The 0,2 pg/m3target is based on a risk assessment that applied the erroneous and scientifically unsubstantiated IUR from the 2010 IRIS Review, and the target reflects more than a four thousand-fold reduction in the applicable Louisiana 8-hour ambient standard for chloroprene. Ramboli Enviroifs expert scientific opinion is that the appropriate risk-based ambient target should be 156 times larger or 31,2 pg/m3. There is no agency rule or even proposed rule requiring the attainment o f the 0,2 pg/ra3target, yet EPA has advised DPE, LDEQ, and the public that 0.2 pg/m3 is the appropriate target.
As a result o f the flawed science embodied in the 2010 IRIS Review, and as a result of the NATA findings and the Facility's emission profile, DPE has suffered extraordinary hardship in a number o f ways.
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First, despite DPE's concerns about the science behind the 2010 IRIS Review,, DPE is currently spending more than $1.8 million on new pollution controls. On January 6, 2017, DPE entered into an Administrative Order on Consent with LDEQ to reduce chloroprene emissions by approximately 85% below the level o f the Facility's 2014 emissions, DPE estimates that the capital cost o f these emission reduction devices is approximately $18 million, and the devices will cost hundreds o f thousands of dollars per year to operate. Even though DPE is installing the most advanced air pollution controls available, it will still not he able to meet the stringent 0.2 pg/m3target.
Second, because the 2010 IRIS Review is flawed. EPA's very public announcements arising out of that Review and the NATA have created unnecessary public alarm. For example, after issuing the NATA, EPA created a public webpage specifically addressing DPE's chloroprene emissions.1 Moreover, environmental activists and plaintiffs' lawyers have had numerous meetings in the community about DPE, ail based on the faulty assumption that 0.2 pg/m3 is the "safe" level for chloroprene, Further, a local citizen's group has formed and has been handing out misleading flyers and protesting near DPE's Facility. The erroneous IUR in the 2010 IRIS Review and the resulting MATA findings have caused DPE enormous reputational damage.
Third, as a result of the NATA findings, EPA Region 6 asked the National Environmental Investigations Center (NEIC) to investigate the regulatory compliance status o f the Facility. NEIC sent a team of inspectors to the Facility from June 6-10, 2016, approximately seven months after DPE's acquisition. To he clear, DPE fully respects the important funct ion of the EPA in enforcing environmental requirements. It is sirnplv a fact, however, that as a result of the erroneous IUR and the NATA findings, EPA has initiated an enforcement proceeding against DPE and has devoted an extraordinary amount of resources from the Department of Justice, EPA headquarters, EPA Region 6, and NEIC to developing and pursuing the issues in the NEIC report,
Finally, since acquiring the Facility' in November of 2015, DPE's relatively small management team has been buffeted by continuous environmental regulatory demands resulting from the erroneous IUR and the NATA findings, in addition to Facility operation, DPE staff has been in non-stop meetings and negotiations with EPA and LDEQ. DPE's legal and consulting expenses have been enormous, in the millions of dollars. Underlying all of these expenses and burdens on DPE is the erroneous IUR in the 2010 IRIS Review, as applied in the NATA risk assessment.
DPE needs EPA's assistance in the expeditious application o f good science to this matter. In meetings with EPA in 2016 concerning the need to correct the 2010 IRIS Review, EPA officials advised DPE that EPA's "queue is full". DPE respectfully requests that EPA review the science underlying the 2010 IRIS Review, withdraw the erroneous IUR, and develop a more accurate toxicological review of chloroprene, We are confident that the Ramboli Environ Report: will lead you to these conclusions. Without
See https://www,epa.gov/la/!apiace-louisiana-background-infbrmation,
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this relief, it is uncertain whether DPE will he able to reduce emissions sufficiently to satisfy agency demands, or even continue operation,
Sincerely,
Kgkf'Tabiichi President and Chief Executive Offices' Denka Performance Elastomer LLC
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