1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

National Emission Standards for Hazardous Air Pollutants: Generic Maximum Achievable Control Technology Standards; and Manufacture of Amino/Phenolic Resins; Proposed Rule ) ) ) ) ) ) ) ) ) Docket No. EPA

– HQ

– OAR

– 2012

– 0133

Via regulations.gov and e

- mail March 10, 2014

COMMENTS OF S IERRA CLUB AND CALIFORNIA COMMUNITIES AGAINST TOXICS

Earthjustice submits these comments on behalf of Sierra Club and California C o mmunities Against Toxics. EPA’s proposed rule is not strong enough to protect people from the health hazards associated with the Generic MACT and Manufacture of Amino/Phenolic Resins source category. The record shows that this source has an environmental jus tice impact on African

- American and lower income communities. To satisfy the Clean Air Act (CAA or Act), EPA must finalize a rule that sets a leak prohibition and establishes up

- to

- date, stronger leak dete ction and repair requirements and must address and restrict flaring and f lared HAP emissions. E PA also must not finalize the unlawful and arbitrary affirmative defense. EPA must ensure that its risk assessment follows the best available current science to protect the most vulnerable and most exposed individuals, including chi ldren.

I. EPA MUST STRENGTHEN THE EMISSION STANDAR DS.

EPA refused to strengthen the existing standards to match developments that have occurred for many parts of these source categories based purely on its cost

- benefit analysis. Proposed Rule, 79 Fed. Reg. 1676 (Jan. 9, 2014). Yet EPA’s approach considered only the cost per ton of HAP emission reduction, without assessing relevant factors such as: the individual HAPs emitted and the impact those HAPs can have at a level below 1 ton; how many people would be affected by the potential emission reductions; where they live and if they are in a community containing multiple HAP sources, or whether they face a longstanding environmental justice impact. EPA also did not consider or address whether the standards wo uld provide any “margin of safety” to protect public health, much less whether the margin is “ample.” Thus, EPA ignored and violated the plain text of § 112(f)(2) of the Act, 42 U.S.C. § 7412(f)(2). EPA also did not fulfill the letter or purpose of § 112( d)(6) to ensure that EPA updates the standards when developments have occurred that would create stronger protection for public health. EPA’s2

refusal to strengthen the standards is also arbitrary and capricious. Although it is a positive step that EPA proposes to update the standards to s et MACT floor requirements for the first time pursuant to § 112(d)(2)

- (3) f or certain unregulated emissions, its proposed action w ould not do all that is necessary to fulfill these core legal directives, as discussed in these comme nts.

II. EPA MUST REMOVE ALL UNLAWFUL EXEMPTIONS FRO M THE STANDARDS , INCLUDING BY SETTI NG LIMITS ON LEAKS AND FLARING.

Commenters urge EPA to follow binding precedent in Sierra Club v. EPA

, 551 F.3d 1019 (D.C. Cir. 2008), and remove all unlawful exemptions from the rules. EPA is legally required to

remove all unlawful exemptions from the emission standards that have previously existed for startup, shutdown, and malfunction (SSM) periods, and not to set any new such exemptions. The agency recognizes this is necessary and that it is important for EPA to remo ve these exemptions in this rulemaking. EPA is taking comment on the requirements it must change to comply w ith the D.C. Circuit’s decision.

Commenters support EPA’s recognition of the need to remove all SSM exemptions, including to prohibit releases from pressure release devices (PRDs) and require monitoring of such devices. 79 Fed. Reg. at 17 11, 17 13.

However, EPA has not proposed to remove all such unlawful exemptions.

1. Equipment leaks are a kind of equipment malfunction.

EPA may not authorize any such leaks, because this violates Clean Air Act § 302(k) and D.C. Circuit precedent. 42 U.S.C. § 7602(k); Sierra Club v. EPA , 551 F.3d 1019 (D.C. Cir. 2008). Yet EPA has not set any limit on the amount of emissions that can occu r during the leak detection and l eak repair delay periods. And, EPA proposes to define “seal” to allow leaks up to 500 ppm, which would create another new unlawful exemption. 79 Fed. Reg. at 1715.

U ntil a leak is detected and a facility repair s it, EPA’ s rule allows an unlimited amount of HAP emissions to be released

. This also violates National Lime Association v. EPA , 233 F.3d 625 (D.C. Cir. 2000), in which the Court held that EPA must set an emission standard to limit all emitted HAPs. If a “seal” re gularly allows 500 ppm of emissions to escape, that is also an uncontrolled HAP release that violates § 112(d) of the Act and judicial precedent.

Allowing sources to leak HAP emissions as long as they are below the threshold ( e.g. , 10,000 or 500 ppm , as proposed ) , without setting any limit on these emissions, is equivalent to creating an exemption for “out of sight, out of mind” malfunctions. Thus, not setting a limit on leaks violates both the plain text and spirit of the Act, § 302(k), and judicial pre cedent.

In addition, EPA’s proposed definition for a “seal” is actually a new loophole, that would exempt leaks from open

- ended valves or lines below 500 ppm from the standards. That3

definition is another type of exemption similar to the SSM exemption the D.C. Circuit found unlawful, and EPA should not finalize the definition as proposed.

Instead of authorizing this unlawful exemption , EPA must prohibit all leaks and require the use of leak

- less valves and connectors to prevent and control them. EPA als o must require leak repair to occur, once detected, within the absolute minimum time needed to end each leak. All HAP leaks that occur in the intervening time period may cause or contribute to violations of the standards.

2. EPA must prohibit routine flari ng, set a cap to limit special flaring,

ensure its efficiency, and monitor flaring.

EPA is requesting comment on the performance of flares to control HAP emissions. 79 Fed. Reg. at 1715. But EPA states that it is “not at this time prepared to propose any changes to the currently applicable regulations pertaining to the performance of flares in the AMF, PC, and APR source categories, but we may revisit the issue in future notices.” Id. EPA is legally required to addr ess flares in this rulemaking under § 112(d)(6) and (f)(2). Further, the agency must prohibit routine flaring, cap allowable flaring in limited circumstances t o prevent emergencies, require best practices for use and mandate monitoring of flaring to assure compliance and protect communities’ ability to know what is in their air.

Since these emission standards were set, EPA now has substantial new information on flaring, how it works, problems with past flaring, and the impacts it can have. EPA’s 2012 peer

reviewed study, noted in the prea mble to the proposed rule, and other recent resting has showed that many flares are not combusting HAPs as efficiently as EPA has long assumed t o be the case. EPA, Parameters for Properly Designed and Operated Flares, www.epa.gov/ttn/atw/flare/2012flaretechreport.pdf

. 1 EPA’s enforcement division found the

same. EPA Enforcement Alert, EPA

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- 002 , at 1 (Aug. 2012) (“ Through its inspe ction and enforcement programs, EPA has identified many i nstances where flares have been improperly monitored and operated

. The consequences are lower combustion efficiency and potentially significant quantities of excess emissions of volatile organic chemicals, sometimes including hazardous ai r pollutants. ”).

As a result, EPA enforcement cases have led to dramatic reductions in flaring at individual facilities. Id. ; see, e.g. , Marathon and BP Whiting settlements,

1 S ee also “TCEQ 2010 Flare Study”, Texas Commission on Environmental Quality (Aug. 2011), http://www.tceq.texas.gov/assets/public/ implementation/air/rules/Flare/2010flarestudy/2010

- flare

- study

- final

report.pdf ; “Performance Test of a Steam

- Assisted Elevated Flare with Passive FTIR” for Texas City and Detroit, Marathon Petroleum Corporation (Sept. 2009 and July 2010), http://www.epa.gov/compliance/resources/publications/civil/programs/caa/texascity

- report.pdf ; http://www.epa.gov/compliance/resources/publications/civil/programs/caa/detroit

- report.pdf ; “PFTIR Tests of Steam

- Assisted Elevated Flares

- Port Arthur”, Flint Hills Resources Port Arthur, LLC (June 2011), http://www.epa.gov/compliance/resources/publications/civil/programs/caa/portarthur

- report.pdf

.4

http://www.epa.gov/compliance/resources/cases/civil/caa/marathonrefining.html ; http://www.epa.gov/compliance/resources/cases/civil/caa/bp

- whiting.html

. The impact on air quality is significant. “ Improper operation of an industri al flare can result in hundreds of tons of excess HAP emissions.” EPA, National Enforcement Initiative: Cutting Hazardous Air Pollutants

, http://www2.epa.gov/enforcement/national

- enforcement

initiative

- cutting

- hazardous

- air

- pollutants (last updated Feb. 7, 2014).

EPA must apply all of this new information in this rulemaking. It would be unlawful and arbitrary and capricious for the agency not to use the information showing significant new information on the combustion efficiency, best practices for the use of flares, and ways to
pr event, reduce, and monitor flaring

-- because they all dramatically reduce the amount of HAPs released

-- as part of the § 112(d)(6) and § 112(f)(2) rulemaking s here.

First, t hese changes in flaring use and knowledge about flaring are “developments” with in the meaning of § 112(d)(6)

, such that it is EPA is legally required to set stronger standards. 42 U.S.C. § 7412(d)(6). The existence of such “developments” makes it “necessary” under § 112(d)(6) to revise the existing standards. As EPA has recognize d, such “developments” include, at least “ [a] ny improvements in add

- on control technology or other equipment . . . that could result in additional emissions reduction,” as well as any new controls, work practices, operational procedures, process changes or pollution prevention alternatives. 79 Fed. Reg. at 1696. By EPA’s own definition, the new data on flaring qualifies as a “development.” Because the term “developments” points back to the list of methods to reduce pollution listed in § 112(d)(2), the ne w ways to prevent, reduce, improve, and monitor the efficiency of flaring also fully qualify as developments that EPA must address here. 42 U.S.C. § 7412(d)(2). Generally in its § 112(d)(6) rulemakings, EPA has recognized the need to consider factors lis ted in § 112(d)(2), even though it has often refused to set an updated MACT floor as required by § 112(d)(2)

- (3).

Second, that flares are releasing HAPs into the air, without appropriate § 112(d) limits violates National Lime Association

. This also violates the Court’s recognition that emission standards must apply at all times. When EPA’s standards are allowing HAP releases via badly performing flares, this is equivalent to the explicit malfunction exemption that the D.C. Circuit and EPA have both recognized as unlawful. 79 Fed. Reg. at 1711 (citing Sierra Club v. EPA ). These are critical issues for EPA to address in its rulemaking. EPA may not leave it up to the public to evaluate the extent to which there are uncontrolled HAP emission s coming from flares in this rulemaking. EPA must at least investigate this and ensure that it sets limits on all currently uncontrolled HAP emissions from flares, just as it has proposed to do for other currently uncontrolled HAP emission points in these source categories. See, e.g. , 79 Fed. Reg. at 1701

- 03.5

Third, § 112(f)(2) requires EPA to assess the health risk that remains, with the current emission standards in place , and decide whether stronger standards are required to provide an “ample margin of safety to protect public health

. ” 42 U.S.C. § 7412(f)(2); 79 Fed. Reg. at 1680. EPA may not fulfill this requirement without accounting for health risk caus ed by flares

- especially badly performing flares that have even higher emissions of HAPs . Treat ing the emissions and resulting health risk from flares

- whether performing normally or performing at low efficiency

- as zero is indefensible as a scientific matter, and thus both arbitrary and unlawful.

EPA must use the data it has on flaring in order to address this. If EPA believes it does not have enough direct information at present, then, at minimum, as EPA has acknowledged, the best available science recommends using “defaults,” in such circumstances

-- that is, where a risk is known to be prese nt but not fully measured . “[Default] options are generic approaches, based on general scientific knowledge and policy judgment, that are applied to various elements of the risk assessment process when the correct scientific model is unknown or uncertain.” Id. ; 79 Fed. Reg. at 1 693 n.22 (quoting National Academy of Sciences, NRC, Science and Judg ment in Risk Assessment (1994). EPA has chosen to use such defaults in some aspects of its risk assessment in this rulemaking, and must apply a similar approach here. Id. at 1693. The National Academy of Sciences has alerted EPA to the problem that it frequently ignores risk

-- calling this a problem of “missing defaults.” EPA must not allow flaring risk to qualify as such risk. See, e.g.

, NAS, Science and Decisions ( 2009 ) at 19 0

- 93, 19 6 , 203. EPA must either account for the health risk from flares directly using the best available data, or , at least, it must account for this using a default. It may not ignore the heal th risk from flared emissions, as it has proposed to do. Adding

t he health risk from flares is likely to increase the risk metrics EPA considers under § 112(f)(2), and require EPA to set stronger standards to protect public health under this provision.

Finally, a lthough EPA states that it does not currently have source

- category specific in formation on flaring, that does not provide an acceptable ground to avoid addressing flaring in the current rulemaking. EPA’s own preamble recognizes that fl aring is an issue for these sour ce categories, or it would not be taking comment and flagging possible future action on this issue.
EPA has provided no valid basis to distinguish between flares at facilities like refineries and chemical plants like the sources under review here. Indeed, such plants often collocated an d much of the information relevant to flares at refineries is fully relevant to chemical and plastics plants like those under review using many similar processes

. EPA has given no reasoned explanation based on the record to avoid applying the important ne w scientific and technological information on flares in this rulemaking. EPA may not lawfully delay action on f lares, and doing so would be arbitrary. It must apply the best available information it has, collect more, as needed, from industry and the stat es, and ensure that it sets standards in this rulemaking to satisfy its Clean Air Act legal duties and protect public health.

EPA should have sufficient available information to apply the new data on flaring in this rulemaking , including from past public submissions on flaring, and from its enforcement division6

and must investigate the issue in connection with staff who work on the flaring issue there . As Dow Chemical recognized, chemical and other companies must adopt the philosophy that “it is an unacceptable practice to flare.” Houston 2008, at 18

- 19 (quoting Steven Krietenstein, Dow Chemical Co., Flare Minimization Strategy During Plant Up sets: Freeport (Apr. 12, 2005)). In explaining how it is possible to reduce flaring, a Dow Chemical representative stated:

This philosophy had to be accepted at all levels. Management (Leadership) supported the project efforts by allowing operations the liberty to slow down the process of upset recovery if the efforts would result in less emissions. Und er these conditions, production rates were third in priority

— safety first, flare minimization second, and finally production rates. This allowed operations more freedom to think through upset situations and take more appropriate action in an effort to re duce flaring. This mindset also opened the doors to a larger group to generate further improvements. Even the smallest upset events are now managed to reduce flaring.

Id.

Flares should not be allowed to be routinely used as air control devices, as discus sed in the 2004 Environmental Integrity Project report. 2 As the Houston Report explained, flaring causes additional, harmful emissions, which are

– like fugitives

– likely to be underestimated and not taken seriously enough.

Regular flaring is a problem, not a solution, and so EPA must follow the data and prohibit or ensure less reliance on flaring for these source categories.

Flare emissions are generally calculated based on the assumption that flaring destroys 98 to 99 percent of the VOCs sent t o the flare. But, real

- world factors, like weather (e.g., high winds) or operating conditions (e.g., poor steam ratio) can result in significantly higher emissions. Because flares are significant sources of toxic emissions, they should be strictly limited. Their sole purpose should be treating large volumes of gases that are released as a result of emergency facility failures and cannot be recovered. Unfortunately, instead of using flares for emergencies, companies often use flares as a part of routine oper ations. In some cases, TCEQ has even permitted facilities to flare emissions during routine operation. California’s South Coast Air Quality Management District found that between 1999 and 2003, only 4 percent of flaring events could be attributed to emerge ncies. Similarly, EPA investigations found that flaring “frequently occurs in routine, non

- emergency situations or is used to bypass pollution

2 Envtl. Integrity Project, Gaming the System: How Off

- the

- B ooks Industrial Upset Emissions Cheat the Public Out of Clean Air 11 (Aug. 2004), http://www.environmentalintegrity.org/news_reports/Report_Gaming_System.php

.7 control equipment. This results in unacceptably high releases of sulfur dioxide and other noxious pollutants...” 3

Commenters believe that the Texas Petrochemicals Houston plant installed a flare gas recovery system that reduced its butadiene emissions dramatically, and EPA must investigate and consider this tremendous reduction. 4 The same plant also put in a remote s ensing laser system. The installation of this laser system demonstrates the value and need for EPA to require the use of remote sensing technology as a routine matter for all current sources. As discussed in a 2009 news report:

As a result of enhanced d etection by the fence line monitors and Texas Petrochemicals’ quicker response to emissions events, emissions from the flare decreased 90 percent. Volatile organic compounds, contributors to ozone, decreased from 230,000 pounds per year in 2004 to 26,000 pounds per year in 2007. Butadiene from the flare decreased from an average of 54,000 pounds per year to 5,300 pounds per year during the same period. 5

EPA must consider these data and collect other similar data to perform the current rulemaking.

Due to t he new information EPA now has that flares are less efficient and more harmful than previously understood, EPA should consider prohibiting the use of flaring, and requiring complete capture through flare gas recovery systems. 6 As example problems, a Marat hon 2010 report found that:

 A flare can be operated with greater than 300 BTU/scf vent

gas net heating value and with acceptable exit gas velocities and still be over

- steamed.

 Combustion efficiency becomes erratic and generally begins to decline sharply on ce the flame transitions from a clean, visible flame to one that is invisible. However, not all transparent flames have poor combustion efficiency.

3 Hou ston 2008, supra note 160, at 22 (quoting EPA, Enforcement Alert , Vol. 3, No.9 (Oct. 2000) and citing SCAQMD, E VALUATION R EPORT ON E MISSIONS FROM F LARING O PERATIONS AT R EFINERIES 2, tbl. 1 (2004)).
4 Id. at 17.
5 Env’t News Service, Texas Petrochemicals Must Spend $20M to Clean Houston Air (Apr. 22, 2009) (attached in Appendix), available at http://www.ens

- newswire.com/ens/apr2009/2009

- 04

- 22

- 092.html

. 6 See, e.g. , Cade et al.

, Marathon Petroleum Co., Steam Contribution to Combustion Zone Gas in Variable Wind Conditions (June 22, 2010); Marathon Petroleum Co., Performance Test of a Steam

- Assisted Elevated Flare With Passive FTIR, Final Report (May 2010); Marathon Petroleum Co., P erformance Test of a Steam

‐ Assisted Elevated Flare with Passive FTIR

‐ Detroit (Nov. 2010); The University of Texas at Austin, The Center for Energy and Environmental Resources, TCEQ 2010 Flare Study Final Report at 29 (Aug. 1, 2011) (“The most efficient f lare operation, as measured by the DRE and CE, for the flare operating conditions tested, was achieved at or near the incipient smoke point (ISP). Higher efficiencies could have been achieved with steam or air assist slightly less than the ISP assist value but this condition, i.e., a smoking flare, would not have been in compliance with 40 CFR § 60.18. Therefore, the minimum levels of steam or air assist that comply with the flare manufacturer’s recommendations should be used when possible.”).8  Combustion efficiency declines with increased steam to hydrocarbon ratios. The same general trends were obse rved in flare efficiency performance regardless of vent gas composition or turndown factors.

 The PFTIR measures a single point within the plume and not the composite.

 Variations in chemical composition within the plume itself may influence results. 7

EPA sh ould also consider requiring sources to develop flare minimization plans, conduct root cause analyses of flaring events, and improve flare monitoring, for all of the reasons discussed in the 2008 Houston Report. 8

As additional examples, from the Houston R eport:
California’s Bay Area Air Quality Management District prohibits flaring in non

- emergencies unless the flaring is consistent with a facility’s flare minimization plan, which must include all feasible flaring prevention measures. The district found th at adding compressor capacity and instituting better flare management practices resulted in an 85 percent reduction in VOC emissions between 2002 and 2005. California’s South Coast Air Quality Management District flaring rule requires: (1) improved monitor ing, (2) flaring only as a result of emergency, shutdown, startup, turnaround, or essential operational need, and (3) minimization of flare emissions during such events. The district estimates that its rule will reduce flare emissions, including VOC emissi ons, by more than 50 percent from 2003 levels, by 2010. 9

Like preventing equipment leaks, there is evidence that reducing flaring saves money for the industry itself. For example, in 2005, Dow reported that it had saved $2.5 million by capturing and rerou ting hydrocarbons for reprocessing and use. 10

Addressing and Controlling Flaring

At minimum, EPA has and could have no valid basis for not applying the best available information on restriction of flaring, such as the California standards, and the agency’s own settlements with facilities, to reduce and prevent the use of flaring here under § 112(d)(6) and (f )(2) . Because flaring creates an unlimited loophole for HAP releases, and has not worked the way the agency previously understood to reduce HAP emissions, EPA should prevent the routine

7 Marathon Ma y 2010 Report, id. at 3

- 45.
8 Id. at 22

- 23.
9 Id. at 23.
10 Id. (citing Steven Krietenstein, Dow Chemical Co., Flare Minimization Strategy During Plant Upsets: Freeport (April 12, 2005)).9

use of flaring as a control method. Instead, EPA should authorize on ly limited flaring, with a set limit or cap, in circumstances where data show this is essential to prevent accidents or explosions , and require necessary monitoring to assure compliance

. EPA also must set the proper parameters, e.g. , on mixing to avoid f lame quenching or oversteaming, and on heating value. Its own enforcement division has recognized specific practices needed to address these problems and EPA must review and apply the experience of recent enforcement inspections, evaluations, and settleme nts in this rulemaking. See, e.g. , EPA Enforcement Alert, EPA

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- 002, at 3 (Aug. 2012).

III. EPA MAY NOT PROMULGA TE AN AFFIRMATIVE DE FENSE TO CIVIL PENALTIES FOR MALFUN CTIONS.

EPA proposes to create an affirmative defense to civil penalties for the st andards. 79 Fed. Reg. at 1711 (proposing, e.g. , 40 C.F.R. §§ 631.1100(h), 63.1400(l))

. The affirmativ e defense provision is unlawful, arbitrary, and harmful and should not be finalized.

The statute makes clear how the courts are to assess civil penalties, whether a case is brought by EPA or a citizen. 42 U.S.C. § 7413(e). Congress plainly intended citizens to be able to enforce emission standards under the CAA using the full range of ci vil enforcement mechanisms available to the government, and, in the HAP context, subject only to the limitation that government not be “diligently prosecuting” its own civil enforcement action. CAA § 304 (a), (b)(1)(B), 42 U.S.C. § 7604 (a), (b)(1)(B). EPA ’s rule proposal, by shifting this careful balance and contravening these mandates, violates the CAA.

The affirmative defense that EPA proposes to allow in case of malfunctions violates the Act and goes directly against congressional intent in two ways. First, Congress expressed a clear intent that courts, not the agency, are responsible for determining the amount of civil penalties available, including by prescribing how judges determine the size of civil penalties whenever they are sought, and thus Con gress flatly barred EPA from limiting when a court can assess civil penalties for a violation of standards. See Chevron, U.S.A., Inc. v. Natural Res. Def. Council,
Inc ., 467 U.S. 837, 842

- 43 (1984); 42 U.S.C. §§ 7604(a), 7413(e). In this proposal, EPA ac ts outside of its delegated authority to limit civil penalties available in citizen suits or its own enforcement actions. See City of Arlington v. FCC , 133 S. Ct. 1863, 1871 n.3 (2013). Second, the proposal will impermissibly chill citizen participation, a nd the ability to win an effective, deterrent remedy in CAA enforcement actions.

The affirmative defense is fatally flawed because EPA does not have the authority to decide when civil penalties will not be allowed. The CAA itself spells out the only li mits that Congress intended to impose on citizens’ ability to seek and recover penalties in enforcement suits under CAA § 304, 42 U.S.C. § 7604. See 42 U.S.C. § 7413(e). By attempting to impose additional agency

- created limits, EPA exceeds its authority.10

Congressional intent on civil penalties is clear

— they are a remedy available for enforcement by citizen plaintiffs, and the Act gives judges a list of factors they must consider in assessing them. As such, EPA cannot interpret the statute to contravene that intent. 11 By attempting to rewrite these provisions, via regulation, EPA has done just that.

The CAA grants EPA discretion only with respect to the amount of administrative penalties the agency itself imposes, allowing EPA to “compromise, modify, or remit, with or without conditions, any administrative penalty which may be imposed under [subsection 113(d)].” 42 U.S.C. § 7413(d)(2)(B) (emphasis added). There is no similar grant of authority to EPA to compromise, modify or limit civil penalties that a court may impose under section 113(e) or section 304. The explicit reference to EPA’s ability to modify penalties in one subsection and its absence in the other subsection of the same provision can only be understood as an intentional decision by Congres s that EPA may not contravene by rule.

Congress’s intent to bar EPA from promulgating regulations like the affirmative defense is similarly apparent in CAA § 304. CAA § 304(a) gives EPA no functions to perform, thus barring it from supplanting district co urts’ jurisdiction. 42 U.S.C. § 7604(a). That provision only makes EPA the target of citizen suits. See id. By contrast, § 304(b) specifically requires EPA to promulgate regulations governing how citizens give notice of citizen suits. Id. § 7604(b). Again, the express grant of authority to EPA in one subsection and its absence in the other must be given effect: EPA has no authority to block district courts from providing the remedy Congress specifically made available.

A facility must not be able to evade civil penalties that apply when the congressionally mandated factors in the statute are met. 12 See 42 U.S.C. § 7413(e) (listing factors). It would be improper for a court to fail to consider these factors, or to override them based on its consideration o f different factors invented by EPA in the affirmative defense. Further, it would be improper for a court to fail to make its own determination of what civil penalties are

11 See Chevron , 467 U.S. at 842

- 43; see also Barnhart v. Sigmon Coal Co., Inc. , 534 U.S. 438, 462 (2002) (“We will not alter the text in order to satisfy the policy preferences of the Commissioner.”); North Carolina v. EPA , 531 F.3d 896, 910 (D.C. Cir. 2008) (“All the policy reasons in the world cannot justify reading a su bstantive provision out of a statute.”).
12 The proposed exemption would also be barred under Chevron step two or found to be arbitrary and capricious. Even if there exists some ambiguity, it is unreasonable to construe the statute as permitting EPA to sho rt

- circuit the consideration of specifically listed factors. See Chevron , 467 U.S. at 843 (explaining that if the statute does not answer the question at issue, “the question for the court is whether the agency’s answer is based on a permissible
construct ion of the statute”); S. Coast Air Quality Mgmt. Dist. v. EPA , 472 F.3d 882, 895 (D.C. Cir. 2006) (“We further hold that EPA’s interpretation of the Act in a manner to maximize its own discretion is unreasonable because the clear intent of Congress in enac ting the 1990 Amendments was to the contrary.”); see also Gen. Instrument Corp. v. F.C.C ., 213 F.3d 724, 732 (D.C. Cir. 2000) (explaining that “an arbitrary and capricious claim and a Chevron step two argument overlap”); Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co.

, 463 U.S. 29, 42

- 43 (1983) (explaining that agency acts in arbitrary and capricious manner if it fails to consider “relevant factors” or “entirely fail[s] to consider an important aspect of the problem”). By “upset[t ing] the statutory balance struck by Congress,” as discussed above, the affirmative defense is unreasonable under Chevron step two

. Int’l Alliance of Theatrical & Stage Employees v. N.L.R.B , 334 F.3d 27, 35 (D.C. Cir. 2003).11

“appropriate” under CAA § 304(a), regardless of whether the conditions invented by E PA in the affirmative defense have been satisfied. 13 A fortiori it is impermissible for EPA to attempt to displace the § 113(e) factors or in any way alter their significance by creating a bar to penalties if certain agency

- defined considerations are met i nstead.

The affirmative defense will chill and impede citizen participation in CAA enforcement also will be hindered, in violation of citizens’ rights to protect themselves from pollution and in direct conflict with congressional intent. The affirmative defense would likely be used on a routine basis by polluters seeking to avoid penalties, just as the malfunction exemption was. As a result, citizens who seek the assessment of civil penalties against polluters in order to protect themselves and achieve t he Act’s goals would be forced to engage in time consuming and expensive fact

- intensive disputes over the applicability of the affirmative defense regardless of whether a company has violated its emission standards. Congress did not intend or authorize any such barriers to enforcement. To the contrary, it provided that Courts may always impose penalties on companies that violate their emission standards and required only that courts consider the § 113(e) factors in deciding what penalty, if any, to apply. By superimposing an additional agency

- invented barrier to penalties, the affirmative defense would deter and impede citizen enforcement, limiting its effectiveness as a means to prevent and deter violations. As the Supreme Court explained: “To the extent that [civil penalties] encourage defendants to discontinue current violations and deter them from committing future ones, they afford redress to citizen plaintiffs who are injured or threatened with injury as a consequence of ongoing unlawful conduct.” Fri ends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc. , 528 U.S. 167, 186 (2000). 14

Thus, the affirmative defense also runs counter to Congressional intent to encourage citizen enforcement: (1) the burden it places on citizens makes it less likely th at they will enforce the Act, see, e.g. , Pennsylvania v. Del. Valley Citizens’ Council for Clean Air , 478 U.S. 546, 560 (1986); and (2) several of the factors at issue in the affirmative defense undercut Congress’s intent that citizen suit enforcement shou ld avoid re

- delving into “technological or other considerations.” Natural Res. Def. Council v. Train , 510 F.2d 692, 723

- 24 (D.C. Cir. 1974). Both result from the technical burden EPA imposes on affected citizens with the affirmative defense, and both rend er the defense impermissible.

Further, a violation of emission standards that occurs during a malfunction is just as much a violation as any other. Allowing only injunctive relief for such violations of emission standards is equivalent to providing no r emedy for such a violation, except future corrective action. This violates sections 302(k) and 112 of the Act, as explained in Sierra Club v. EPA , 551

13 It is also improper for EPA t o fail to consider the section 113(e)(1) factors in situations in which it is setting the penalty. CAA § 113(e)(1), 42 U.S.C. § 7413(e)(1); see also N.Y. Cross Harbor R.R. v. Surface Transp. Bd. , 374 F.3d 1177, 1184 (D.C. Cir. 2004) (holding that “Board’s failure to balance the competing interests . . . requires” vacatur of agency action).
14 S. Rep. No. 101

- 228, at 373 (1989), reprinted in 1990 U.S.C.C.A.N. 3385, 3756.12

F.3d 1019 (D.C. Cir. 2008), because it exempts malfunctions from the primary deterrent consequence of ha ving an emission standard established by the Act: paying a penalty for violating it. 42 U.S.C. §§ 7413(b), 7604(a). When the affirmative defense is used, all that is left is injunctive relief. But injunctive relief only applies prospectively, thereby al lowing past violations to occur as if there were no emission standard in force. Rather than ensure that the emission standards apply continuously, the affirmative defense creates an after

- the

- fact exemption that is equivalent to the exemption that the D.C . Circuit struck down as unlawful. Injunctive relief is still available to try to prevent further future violations, but that provides no remedy for a past violation. And, if polluting facilities know that they will face no civil penalties if they violat e the emission standards due to a malfunction, the deterrent power of enforcement actions will be severely limited, if not eliminated, even though there is an emission standard on the books. By nullifying the Act’s provision for civil penalties for malfun ctions, EPA has created an exemption from the emission standards for certain past violations that is unlawful and arbitrary.

EPA seeks to rely on a Fifth Circuit case that upheld EPA’s authority to partially approve an affirmative defense provision in a state implementation plan (“SIP”). 79 Fed. Reg. at 1711 (citing Luminant Generation Co. v. EPA

, 714 F.3d 841 (5th Ci r. 2013)). That decision does not affirm EPA’s action in all regards or in all jurisdictions. There is good reason why the D.C. Circuit should not follow the Fifth Circuit’s decision and why EPA should decide that it will not do so in this rulemaking

. It is the D. C. Circuit, not the Fifth Circuit, that will have jurisdiction over EPA’s final rule in this rulemaking.

First, Luminant does not even address § 304(a)’s grant of exclusive jurisdiction to district courts to hear enforcement cases and apply any civil pen alties. Second, the Fifth Circuit’s conclusion that § 113(e)(1) is “ambiguous” conflicts with binding D.C. Circuit case law. The Fifth Circuit held that § 113 was ambiguous because it “does not discuss whether a state may include in its SIP the availabilit y of an affirmative defense against civil penalties for unplanned [startup, shutdown, or malfunction] activity,” and thus deferred to EPA. 714 F.3d at 852

. That analysis assumes that so long as the Act does not explicitly say whether EPA has authority, th e Act is ambiguous. But such analysis is squarely foreclosed in the D.C. Circuit :

To suggest ... that Chevron step two is implicated any time a statute does not expressly negate the existence of a claimed administrative power (i.e. when the statute is not wr itten in “thou shalt not” terms), is both flatly unfaithful to the principles of administrative law ..., and refuted by precedent.

Rwy. Labor Executives’ Ass’n v. Nat’l Mediation Bd. , 29 F.3d 655, 671 (D.C. Cir. 1994) ( en banc ) (emphasis in original); accord

, e.g. , Shays v. FEC , 414 F.3d 76, 108 (D.C. Cir. 2005) ; Am. Petroleum Inst

. v. EPA , 52 F.3d 1113, 1120 (D.C. Cir. 1995) ; Ethyl Corp. v. EPA , 51 F.3d 1053, 1060 (D.C. Cir. 1995) ; see also Friends of the Earth v. EPA , 446 F.3d 140, 146 (D.C. Cir. 2006)13

(ref using EPA request to follow Second Circuit in rejecting plain meaning of Clean Water Act because D.C. Circuit’s case law on statutory interpretation differs from Second Circuit’s).

In addition to these problems, EPA has failed to demonstrate a rational justification for an affirmative defense to penalties to be written into the regulations and cause the harm that will result. In view of EPA’s prosecutorial discretion and the resulti ng harm to deterrence, the affirmative defense in a regulation is arbitrary and capricious. Importantly, EPA has discretion to decide what cases to prosecute, to consider settlements, and to request civil penalties in a case

by

- case manner, as long as it acts consistent with the Clean Air Act to protect clean air as its top priority, see 42 U.S.C. § 7401. EPA also has the authority to over

- file or start prosecuting a citizen enforcement matter, if it believes civil penalties should not be sought in a spec ific case. See 42 U.S.C. § 7604(b)(1)(B) (barring citizen suit if EPA or a State has commenced and is diligently prosecuting the case).

In the cases EPA chooses not to bring and which affected citizens bring instead, promulgating this affirmative defense is equivalent to giving polluters “get out of jail free” cards for serious emission exceedances and MACT violations. Polluters are likely to claim that any violation of the standard is due to a malfunction in order to evade the requirements. Allowing
po lluters to evade financial penalties

— which are the real teeth of the standards

— through this type of measure is likely to lead to polluters simply ignoring or factoring potential standard violations into their cost of doing business, rather than actually tr ying to prevent malfunctions and violations of the standards as a way to avoid financial losses from the application of penalties. EPA has provided no evidence that an affirmative defense for malfunctions would serve the purpose of section 112, to protect people from toxic air pollution. Instead, the defense contradicts the basic goal of section 112 to protect public health.

Assuming arguendo that EPA has authority to promulgate any type of affirmative defense to penalties for malfunctions, EPA should also promulgate the following provisions:

1. A specific amount of compensatory penalties should apply to each malfunction (consistent with the Act). These funds should be dedicated to enforcement, inspections, and monitoring in the local community around the specific facility, to create greater assurance that such malfunctions will not happen again.

2. A limitation on the affirmative defense so that it cannot be used by a specific facility or company more than once within a set period of time, such as 10 years. The affirmative defense should become automatically unavailable to a facility that has previo usly had a malfunction within the last 10 years, to ensure that this defense does not swallow the value of the standards.

3. Prompt public reporting and notification requirements for malfunctions, or any emission exceedance that occurs of which an opera tor is aware. Specifically, EPA must require that when a facility provides EPA with a notification of a malfunction or emission standard14

exceedance under the regulations, this notice will be made publicly available on EPA’s website within 7 days. In addi tion, EPA must promulgate the requirement that when such notification is made, the facility must also provide for same

- day community notification of the malfunction or emission standard exceedance, through an appropriate public forum that is designed to re ach residents who live near the facility, including but not limited to a notice on the facility’s own website (if it has one), a written notice to the local municipality and local school district, a press release to the local newspaper, radio, and TV news station that contains information community members may need to protect themselves and their families from the additional air pollution. It is important that malfunction reports be electronically reported, be made publicly available as soon as possible, a nd include all known information on emissions so that the public can evaluate associated health risks. Further, EPA should not allow facilities to wait until the next semiannual report to report malfunctions, as it has proposed to do.

Commenters urge EP A not to adopt an affirmative defense that undermines citizen rights and remedies under the Clean Air Act. People living near the facilities in the source categories under review are exposed to hazardous air pollution that no one should have to face simpl y because of where they live. Attempting to take away a right granted to citizens by Congress through an agency regulation sets a dangerous precedent. EPA must work to expand and protect the ability of people harmed by air pollution to seek all appropria te and available forms of relief in court. EPA must not retract or weaken citizen rights and remedies, as this proposal does, by making it more difficult for people to win meaningful relief from facilities releasing toxic air pollution into their communit ies in cases that EPA chooses not to bring.

IV. EPA MUST REQUIRE THE USE OF REMOTE SENSIN G DEVICES AND CONTINUOUS AIR TOXIC S MONITORING.

EPA needs to require remote sensing and continuous air toxics monitoring technologies to track and measure emissions. Rem ote sensing and continuous air toxics monitoring are the best ways to accurately measure air toxics emissions from all these facilities. All emissions data EPA currently has are primarily estimates subject to significant error in the estimation calculation s. Remote sensing and continuous monitoring are essential.
The 2008 Houston Report demonstrates the need for improved monitoring. It also provides information on technologies available to assess the emissions coming from a chemical plant. In particular, i t describes the use of example technologies that EPA should require here:

 Differential Absorption Light Detection and Ranging (DIAL)

— These systems are used extensively in Europe and are being used in Canada. The systems use ultraviolet and infrared lasers to measure pollutants, including criteria pollutant, light aromatics, methane and total hydrocarbons. The DIAL system has been validated in European studies for hydrocarbon emissions and its results, while generally found to be conservative, have
proven mo re accurate than prior estimates based on emission factors.15  Solar Occultation Flux (SOF)

— These systems can quantify pollutants, much like the DIAL system, and are used in Sweden to monitor whole plant emissions. SOF systems are less expensive than DIAL, but they are dependent on high sun and steady winds. 15

Available technology includes gas chromatography, and laser sensing. EPA must consider the CEREX UV Hound. EPA must consider Accusense. EPA has significant information on this type of technology an d cannot ignore its significant value for the current rulemaking.

EPA must require continuous emission monitoring as it has done for other sources, and should consult the Institute of Clean Air Companies regarding the available technology to perform con tinuous monitoring

– including for CO, CO2, H2S, NO, NO2, SO2, O2, THC, Hg, HCl, and opacity. 16 EPA has also recognized that CEMS should be used for lead. 17 In addition or in the alternative, EPA should also require performance tests at minimum every year, as it has required for other source categories. 18

V. EPA MUST FINALIZE AD DITIONAL MEASURES TO ASSURE COMPLIANCE.

The past history of the SSM exemption and compliance problems for these source categories demonstrate the need for strong and more frequent monit oring, testing, and reporting requirements described above, and additional enforcement provisions. EPA must implement strong enforcement provisions to prevent and remedy emission spikes, malfunctions and other violations in a way that will be enforceable by citizens in the Title V permits for these source categories. 19 Considering that the emissions from these source categories cause disproportionate risk in minority and economically disadvantaged communities, additional monitoring and stronger enforcement provisions would help provide environmental justice.

For these reasons, first, EPA must write standards that ensure prompt compliance, pursuant to the deadlines set by the Act. Section 112 includes strict compliance provisions for residual risk standar ds and all other section 112(d) standards. 20 EPA also must ensure that strict monitoring and enforcement provisions are part of its standards to enforce the permit condition

15 Houston 2008, supra note 160, at 19.
16 See, e.g. , 40 C.F.R. § 63.1350 (cement kilns

– requiring installation of CEMS for mercury, PM, HCl, THC, and more frequent monitoring tests for other pollutants); Inst. of Clean Air Companies, Continuous Emissions Monitoring Systems (CEMS), http://www.icac.com/i4a/pages/Index.cfm?pageID=3402.
17 See, e.g. , 40 C.F.R. § 63.543(l) (“Except as provided in paragraphs (l)(2) or (3) of this section, all new or reconstructed sources subject to the requirements under § 63.543 must install, calibrate, maintain, and operate a CEMS for measuring lead emissions.”).
18 See, e.g. , 40 C.F.R. § 63.543(g)(1), (i) (secondary lead

– requiring annual tests to ensure compliance with lead and THC standards).
19 See, e.g. , NYPIRG & Earth Day Coalition, The Proof Is In the Permit: How to Make Sure a Facility in Your Community Get s an Effective Title V Air Pollution Permit (June 19, 2000), available at http://www.epa.gov/oar/oaqps/permits/partic/proof.html

. 20 42 U.S.C. § 7412(f)(4) (prohibiting non

- compliance w ith a residual risk standard starting 90 days after promulgation); id. § 7412(i)(3) (requiring EPA to “provide for compliance as expeditiously as practicable, but in no event later than 3 years after the effective date of such standard” with narrow excepti ons).16

requirements of the Act. The Clean Air Act requires permits to contain “conditio ns as are necessary to assure compliance with applicable requirements of [the Act].” 21 40 C.F.R. Part 70 adds detail to this requirement. 40 C.F.R. § 70.6(a)(3) requires “monitoring sufficient to yield reliable data from the relevant time period that are r epresentative of the source’s compliance.” Section 70.6(c)(1) requires all Part 70 permits to contain “testing, monitoring, reporting, and recordkeeping requirements sufficient to assure compliance with the terms and conditions of the permit.” 22 EPA shoul d fully review the monitoring requirements it has proposed and ensure that they are stringent enough so that EPA, states, and citizens can easily assess whether a facility is in full compliance with the standards within a short period of time of any violat ion.

Second, EPA must promulgate specific public reporting and notification requirements for malfunctions, or any emission exceedance that occurs. EPA proposes to r equire malfunction reporting to EPA as part of a periodic compliance report, which may oc cur as long as 45 days after the alleged malfunction , if a source intends to take advantage of an affirmative defense. 23 EPA should require this reporting regardless whether a facility intends to try to take advantage of an affirmative defense (which EPA should not authorize). However, even EPA’s proposed reporting requirement provides only delayed, after

- the

- fact informat ion to the community. For people near the facility, a written r eport as long as 45 days later , is too late to find out about emission spikes and alleged malfunctions that may have threatened public health

. EPA must require telephone reporting by the fac ility no later than 24 hours after the malfunction or exceedance. EPA must require that when a facility provides EPA with telephone notification of a malfunction or emission exceedance under the regulations, this notice will be made publicly available on EPA’s website and through ECHO within 24 hours.

EPA should require that the EPA Administrator provide this information to its Regional office within 24 hours of receiving notification, and direct the Regional office to notify the local community on the Internet, by direct communication, and through all available means.

In addition, EPA must promulgate the requirement that when such notification is made, the facility must also provide for community notification of the malfunction or emission standard

e xceedance within 24 hours, through an appropriate public forum that is designed to reach residents who live near the facility, including but not limited to a notice on the facility’s own website (if it has one), a written notice to the local municipality a nd local school district and a press release to the local newspaper, radio, and TV news station that contains any information community members may need to try to protect themselves and their families from the additional air pollution. Commenters support EPA’s proposal to require reporting of malfunctions, but it is important that this information be reported more quickly, be electronically reported, be made publicly available, and include all known information on emissions so that the public can evaluate associated health risks.

EPA should also require a written report to be submitted within 7 days, and use the same distribution method as outlined above, including publication on ECHO, EPA’s Regional website,

21 42 U.S.C. § 7661c(a).
22 40 C.F.R. § 70.6(a)(3).
23 79 Fed. Reg. at 1720 (proposing 40 C.F.R. § 63.1100(h)(2)).17

and distribution to active local community memb ers who are interested (such as through setting up an email list, a local listserv, Twitter, and other media).

In the written report, EPA should require the facility to report: (1) the nature of the event; (2) the duration of the event; (3) estimate o f emissions released during the event; and (4) a description and timing of corrective actions that were taken and any planned to be taken.

Fourth and very importantly, reporting of malfunctions or other exceedances is not enough to protect the most expo sed people from the HAP emissions from the source categories under review in this rulemaking . EPA also must promulgate additional requirements that apply in the event of a malfunction or violation of the numerical emission standards. The Clean Air Act re quires continuous compliance with the emission standards. 24 The data from Texas demonstrate significant spikes in emissions and an unusual record of exceedances and violations that EPA cannot ignore for the chemical production industry. EPA must take actio n to protect local communities from health risk caused by these sources. Facilities must not be able to emit in an unlimited manner for an unlimited period of time.

In addition to requiring reporting of exceedances and malfunctions as described above, wh en such an event occurs:

1. EPA must require automatic shut

- off of the malfunctioning equipment or process for the time needed to take corrective action whenever an exceedance or malfunction occurs.

2. EPA must assign responsibility and liability to the plant manager or a high

- up staff member which allows only that person to restart the equipment or process.

3. EPA must require specific corrective measures to be taken immediately to remedy and prevent recurrence of the malfunction or violation.

4. For a facility that has had 1 or more malfunction, exceedance, or other violation incident in the prior month, written authorization by EPA must be required to restart equipment or processes. EPA should o nly authorize restart after making a public determination that provides information on the corrective measures that EPA is requiring. EPA should release this public determination on the Internet and require its Regional office to communicate this determin ation to all interested members of the public, including local community representatives.

5. If a facility has more than 4 exceedances or malfunctions during the same quarter, then EPA must require automatic shut down of the operation for a period of ti me needed to conduct and publish a full investigation and ensure systematic correction of the problem/s.

6. EPA should create a community complaint mechanism in the standards that ensures that citizen complaints of clouds, plumes, exceedances, odors, othe r air pollution incidents or health concerns receive an immediate response, in which EPA commits to initiate an investigation and provide a publicly available report of the result of the investigation, including whether it leads to an enforcement outcome f rom EPA’s enforcement division within 7 days.

24 See Sierra Club v. EPA , 551 F.3d 1019, 1028 (D.C. Cir. 2008).18

VI. EPA MUST FOLLOW THE BEST AVAILABLE SCIEN CE TO ASSESS AND REDUCE HEALTH RIS K FOR EXPOSED COMMUN ITY MEMBERS AS REQUIRED BY § 112(F)(2).

Although EPA states that it is taking a con servative, health

- protective approach, and it has made some progress in recent years, the agency still lags well behind the best available, current science to address the real

- world health risk for the individual most exposed to the current source categori es . EPA must finally act to apply this science in the current rulemaking and all other health risk rulemakings under the Clean Air Act under § 112(f)(2).
In particular, EPA has no valid excuse to avoid following the recommendations of the National Acade my of Sciences and its own Science Advisory Board on the below

- discussed key issues that affect the most

- exposed and most vulnerable populations, especially children and environmental justice communities.

EPA must consider the science, and update and str engt hen its risk assessment in, at least, each of the following ways before finalizing the rule:

 Account for individual

- level vulnerability in this risk assessment by better incorporating the vulnerability of children, early

- life exposures, and the develo ping fetus into risk assessment methods:

 Account for increased susceptibility by using age

- dependent adjustment factors for all carcinogens, not just known mutagens.

 Pre

- natal susceptibility: Account for increased susceptibility by using a
pre

- natal adjus tment factor for all carcinogens of at least 10X.

 For chronic non

- cancer risk, consult and apply child

- specific reference values (such as those created by California EPA scientists), where available.

 If child

- specific reference values are unavailable, co nsult science on early exposure impacts, and use an additional default factor of at least 10X

.

 Account for vulnerability due to residence in a community that is highly exposed, by including factors to account for increased vulnerability based on demograph ic differences, as part of the risk assessment. EPA also must fully integrate the findings of its environ mental justice analyses into this risk assessment and rulemaking , and set stronger pollution limits to provide environmental justice.

 Assess the cumul ative burden of exposures to multiple pollutants and sources via multiple pathways:

 Assess and aggregate exposure from multiple pathways

– including by adding inhalation and non

- inhalation

- based cancer risks.

 Include the interaction of multiple pollutants

.

 Account for exposure to multiple sources. Until EPA has a specific mechanism for estimating total exposures, a default or uncertainty factor of at least 10X should be used to provide overburdened19 communities with the protection they need now.

 Account for cumulative impacts of multiple exposures and vulnerabilities by shifting the level of risk which triggers policy action.

 Reduce EPA’s benchmark of what it considers acceptable lifetime cancer risk instead of relying on the outdated upper limit of 100

- in

- a

- million.

 Use a Margin of Exposure (MOE) framework for non

- c ancer impacts and adjust the target MOE according to known vulnerability factors.

 In the face of increasing evidence calling into question the assumption of a safe or acceptable level of exposure, EPA should also con sider changing its approach to risk
assessment to support reducing risks to the lowest possible level, to protect public health, rather than suggesting that there is always a safe or acceptable level. As EPA itself has reco gnized, there are many uncertainties suggesting its risk assessment is an underestimate and only address es part of the picture.

Each of the above

- listed risk issues is a factor that is relevant to EPA’s risk assessment, on which there is science that EPA should apply, and which EPA is legally required to address in order to fulfill its duty to assess health risk and provide the “ample margin of safety to protect public health” under § 112(f)(2). EPA has provided no reasoned explanation for not applying th e current science to address these risk factors. And, as shown in the additional information on these issues summarized below, EPA can have no valid basis for ignoring the science from experts such as the National Academy of Sciences, Science Advisory Boa rd, and other expert regulators, such as California EPA’s Office of Health Hazard Assessment (OEHHA). EPA must direct its scientists to apply each of the scientific bases and tools currently available that EPA is ignoring and must address.

It would be both unlawful under § 112(f)(2) for EPA to ignore the health risks outlined above, and arbitrary and capricious for EPA to avoid applying the best available science here. It also would be unacceptable and unfair for EPA to ignore the current scientific an d regulatory tools available for communities bombarded by toxic air pollution from the current source categories and many others.
If EPA wishes to act on its stated commitment to environmental justice, it will finally start using the science available no w to address these impacts and risks, while also working to continue to update its risk assessment approaches.

A. Account for individual

- level v ulnerability in risk assessment by better incorporating the vulnerability of children, early

- life exposures, and the developing fet us into risk assessment methods.

The National Academy of Sciences (“NAS”) reports and other new scientific and policy developments direct that EPA must better account for vulnerability and variability. See Appendix B

- C . In particular, t he science is now clear that “children are not ‘little adults’” when20

it comes to toxic chemicals. 25 They are both susceptible to greater harm from exposure to toxic chemicals, because they are still growing and developing, and they are exposed to such chem icals at a greater rate than adults because of age

- specific behaviors and physiological characteristics. Second, EPA must also better account for other types of human variability because some people exposed to the same amount of a pollutant experience gre ater health risk due to other factors, such as genetic s and baseline health status. Socioeconomic status has been shown to act as a proxy for other types of human variability to chemical risk that EPA has not adequately a ddressed in its risk assessment

. This section discusses key ways in which EPA must better address both the greater risk to children (including from early

- in

- life exposure to toxic chemicals), and other important types of human variability. Appendix B and C of this document summarize the significant body of scientific and policy developments on children’s health and environmental justice which illustrates the need for updates to EPA’s risk assessment approach.

1. Children’s Risk and Early

- Life Exposures

a. Account for increased early life sus ceptibility by using age

dependent adjustment factors for all carcinogens.

EPA’s cancer risk assessment in this rulemaking do es not adequately account for early

life exposure or the greater risk to and susceptibility of children. For cancer risk assessmen t, EPA should follow the science and account for increased early

- life susceptibility by applying
age

- dependent adjustment factors for all carcinogens emitted by a source category.

EPA has restricted its application of age

- dependent adjustment factors, a s discussed in the 2005 Guidelines and Supplemental Guidance for Assessing Susceptibility from Early

- Life Exposure to Carcinogens , to those hazardous air pollutants (“HAPs”) included in EPA’s list of carcinogens that act by a mutagenic mode of action. 26 It therefore has not applied age

- dependent adjustment factors to assess cancer risk from all of the carcinogens emitted by a source category. The NAS recognized this as a “missing” default in EPA’s approach that it should address and account for. 27

Instea d of taking the approach of the 2005 Guidelines and Supplemental Guidance to limit the use of age

- dependent adjustment factors to only some carcinogens, EPA must follow

25 National Research Council, “Pesticides in the Diets of Infants and C hildren” at 3 (1993).
26 See EPA, “Guidelines for Carcinogen Risk Assessment,” EPA/630/P

- 03/001F, at 1

- 19 to 1

- 20 (Mar. 2005), http://www.epa.gov/raf/publications/pdfs/CANCER_GUIDELINES_FINAL_3

- 25

- 05.PDF; EPA, “Supplemental Guidance for Assessing Susceptibility from Early

- Life Exposur e to Carcinogens,” EPA/630/R

- 03/003F (2005), http://www.epa.gov/raf/publications/pdfs/childrens_supplement_final.pdf; see, e.g. , EPA OAQPS, “National Emissions Standards for Hazardous Air Pollutants: Secondary Lead Smelters, Summary of Public Comments and Responses,” at 72

- 73 (11

- 14

- 11), EPA

- HQ

- OAR

- 2011

- 0344

- 0167.
27 NAS 2009 at 196 (Tbl. 6

- 3

- Examples of “Missing” Defaults in EPA “Default” Dose

- Response Assessments).21

the lead of OEHHA by using age

- dependent adjustment factors for all carcinogens. 28 Because OEHHA has provided robust scientific support for this approach, using these factors to assess cancer risk for all carcinogens would be consistent with the NAS recommendations. As the NAS explained: “EPA needs methods for explicitly considering i n cancer risk assessment

. . . chemicals that do not meet the threshold of evidence that the agency is considering for judging whether a chemical has a mutagenic mode of action . . . . Special attention should be given to hormonally active compounds and ge notoxic chemicals that do not meet the threshold of evidence requirements.” 29

The 2005 Guidelines recognized that updates would be needed if more data become available. 30 Now that such data are available, including from the NAS and OEHHA, the agency

must u pdate its approach promptly. EPA should immediately implement the OEHHA age

dependent adjustment factors for all carcinogens, and EPA should also update the 2005 Guidelines to fully reflect current science as described in OEHHA’s 2009 review of the scien tific literature on increased susceptibility to carcinogens from early life exposures. 31

b. Pre

- natal susceptibility: Account for increased susceptibility to
pre - natal exposures by using pre

- natal adjustment factors for all carcinogens.

EPA’s risk assessmen t also do es not take into account increased susceptibility to carcinogens due to pre

- natal exposures. The 2005 Supplemental Guidance recognized the scientific findings of increased susceptibility to carcinogens resulting from pre

- natal exposure, but did n ot develop adjustment factors to account for increased cancer risk resulting from pre

natal exposures. 32 For example, EPA recognized that “[e]xposures that are of concern extend from conception through adolescence and also include pre

- conception exposures of both parents.” 33 The NAS identified the lack of accounting for “ in utero periods” of exposure as a major omission in EPA’s 2005 cancer guidelines. 34

OEHHA conducted its own review of the scientific literature to account for pre

- natal

28 Cal. EPA, OEHHA, “Technical Support Document for Cancer Potency Factors: Methodologies f or Derivation, Listing of Available Values, and Adjustments to Allow for Early Life Stage Exposures ” 3

- 4, 50

- 51 (May 2009), http://www.oehha.ca.gov/air/hot_spots/2009/TSDCancerPotency.pdf, and http://oehha.ca.gov/air/hot_spots/tsd052909.html.
29 NAS 2009 at 112 (ch. 4) (describing the fact that “ in utero periods and nonmutagenic chemicals were not covered” by EPA’s 2005 guidelines, as significant omissions).
30 See EPA, 2005 Supp. Guidance at 21, 31 (“EPA expects to expand this Supplemental Guidance to specif ically address modes of action other than mutagenicity when sufficient data are available and analyzed.”).
31 Cal. EPA, OEHHA, TSD for Cancer Potency Factors, supra note 28

. 32 EPA, 2005 Supp. Guidance at 4

- 5, 14 & tbl. 1a (A

- 1) (discussing research on human and animal cancer risks from prenatal exposure).
33 EPA 2005 Guidelines for Carcinogen Risk Assessment, EPA/630/P

- 03/001F, at 1

- 16.
34 NAS 2009 at 112

- 13; see also id. at 112, 196 (noting that it is a “missing” default that EPA recognizes in utero carcinogenic activity, but fails to take account of it or calculate any risk for it as “EPA treats the prenatal period as devoid of sensitivity to carcino genicity”).22

susceptibility and exposures, which EPA should also consult and use. 35 It has also developed methods and adjustment factors to account for pre

- natal susceptibility and exposures that EPA should use. 36 In its new risk assessment guidelines, OEHHA includes procedures for expos ure assessment during fetal development, which EPA should evaluate. 37 OEHHA specifically discusses the use of a 10X adjustment factor for cancer risk due to pre

- natal to age 2 exposures, and EPA should consider using at least this same factor. 38

EPA shou ld consult the science OEHHA has used to develop this well

- supported factor, and should then use at least a 10X adjustment factor for all carcinogens to assess health risk due to pre

- natal exposure.

c. For chronic non

- cancer risk, consult and apply child

- specific reference values, where available.

Most of EPA’s IRIS toxicity threshold values (reference concentrations and reference doses) used for chronic non

- cancer risk assessment do not incorporate the latest science on increased susceptibility of children. 39 EPA needs to account for early exposure and the greater risk to and susceptibility of ch ildren in its risk assessment, including for cadmium and lead, which it has recognized are emitted by the source categories under review in this rulemaking

.

OEHHA child

- specific health values include reference doses for cadmium, chlordane, heptachlor, manganese, methoxychlor, nickel, and pentachlorophenol, and a benchmark for lead. A full list, with links to each scientific determination document, is ava ilable here: OEHHA, Table of all child

- chRDs Finalized to Date (last updated 06/22/09), http://oehha.ca.gov/public_info/public/kids/chrdtable.html. OEHHA has generated these child

specific reference values based on the latest science to take into account children’s greater exposure and greater vulnerability.

At least until the IRIS values fully account for the increased risk caused by early

- life

35 See Cal. EPA, OEHHA, “Technical Support,” supra note 28 , App. J: “In Utero and Early Life Susceptibility to Carcinogens: The Derivation of Age

- at

- Exposure Sensitivity Measures”

– conducted by OEHHA’s Reproductive and Cancer Hazard Assessment Branch,” .http://oehha.ca.gov/air/hot_spots/2009/AppendixJEarly.pdf.
36 Id. App. J at 7

- 8 & tbl. 1.
37 See Cal. EPA, OEHHA, Air Toxics Hot Sp ots Program Risk Assessment Guidelines, Technical Support Document for Exposure Assessment and Stochastic Analysis, Scientific Panel Review Draft at 1

- 6 to 1

- 7 (Feb. 2012) (“OEHHA 2012 Guidelines”).
38 See id.
39 OEHHA has explained why child

- specific refere nce doses or values are needed and provided a list of chemicals. See, e.g. , Cal. EPA, OEHHA, “Prioritization of Toxic Air Contaminants

- Children’s Environmental Health Protection Act” (Oct. 2001), http://oehha.ca.gov/air/toxic_contaminants/pdf_zip/SB25%20TAC%20prioritization.pdf ; Cal. EPA, OEHHA, “Development of Health Criteria for School Site Risk Assessment Pursuant to Health and Safety Code 901(g): Identi fication of Potential Chemical Contaminants of Concern at California School Sites, Final Report” (June 2002), http://oehha.ca.gov/public_info/public/kids/pdf/ChildHe althreport60702.pdf

.23

exposure to an emitted pollutant, EPA should use the OEHHA child

- specific reference doses or benchmarks availa ble to assess chronic non

- cancer health risk from ingestion for certain pollutants. EPA should also assess such risk from inhalation by using standard methods to translate these values into child

- specific reference concentrations to assess inhalation

- base d risk.

d. Where child

- specific reference values are unavailable, consult science on early exposure impacts and use an additional default or uncertainty factor.

The increased susceptibility of children, while known to exist, has not been quantified for

man y toxic chemicals. Until EPA has child

- specific or child

- based reference values available for a given pollutant, EPA should apply a default or uncertainty factor of at least 10 to account for increased risk from early

- life exposures for non

- cancer risk as sessment

.

This would be consistent with the NAS recommendation on the need for EPA to use default factors to account for greater risk, 40 with the science developed and considered by OEHHA, and with the 10X factor enacted by Congress in the Food Quality P rotection Act. Specifically, as the SAB report explained:

California EPA/OEHHA has determined that inhalation dosimetry for children is sufficiently different from adults to warrant a full 10

- fold intra

- individual pharmacokinetic uncertainty factor (i.e. , an extra 3

- fold PK uncertainty for children relative to the IRIS method) as a default approach. In setting non

- cancer reference exposure levels (RELs), Cal EPA/OEHHA also considers that children may be outliers in terms of chemical susceptibility and on

a case

- specific basis adds a children’s pharmacodynamic factor of 3

- fold, making the inhalation risk for children as much as 10 times greater than adults

. 41

In addition, Congress has recognized this science in its unanimous vote on toxics legislation passe d in 1996

– the Food Quality Protection Act (“FQPA”)

– in which Congress found the need to use and enacted a Ten

- fold Margin of Safety, or “10X factor.” Specifically, the Act provides that “an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre

- and post

- natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children.” 42 Congress’s recogniti on of the need to use this default factor provides a model that EPA should consider and incorporate into this and other residual risk assessments. It would be appropriate and within EPA’s authority under the Clean Air Act

40 NAS 2009 at 190

- 93, 203.
41 SAB May 2010 at 34 (May 2010) (citing Cal. EPA, OEHHA, “ Technical Support,” supra .)
42 21 U.S.C. § 346a(b)(2)(C) (requiring that, in establishing, modifying, leaving in effect, or revoking a tolerance or

e xemption for a pesticide chemical residue, “for purposes of clause (ii)(I) an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied” to protect infants and children).24

section 112(f)(2) to determine th at EPA must similarly use a children’s ten

- fold margin of safety factor here, consistent with the Clean Air Act’s “margin of safety” requirement. 43 In doing so, EPA may rely directly on the science itself, and also on the unanimous guidance from Congress, provided in the FQPA, that the existing evidence of increased harm requires significant action to protect children from toxic exposure.

Further, the child

- specific reference doses that OEHHA has created for some pollutants provide support for the use of an additional Ten

- fold Margin of Safety Factor. EPA’s current reference values are generally one order of magnitude less protective ( i.e. , larger) than the values that California has recognized as needed to protect children, based on the currently availa ble science and a specific assessment of research relevant to early life exposures, as shown in the chart attached as Appendix D.

2. Include factors to account for increased vulnerability based on demographic differences, as part of the risk assessment.

EPA found disparity in the risks created by the source categories under review, with more impact falling on African

- American and lower income communities.

The NAS report identified significant flaws in EPA’s assessment of individual variability in risk asse ssments that could result in significant underestimation of risk. In particular, EPA must fully account for the fact that people can be more vulnerable to toxic pollution due to various physiological, societal, demographic, and exposure history difference s and can therefore experience greater health risk from the same amount of a toxic chemical exposure. 44 As the NAS has observed, performing risk assessment that is meaningful for communities that already face a significant amount of pollution and communiti es concerned about environmental justice “requires an ability to evaluate multiple agents or stressors simultaneously

— to consider exposures not in isolation but in the context of other community exposures and risk factors.” 45 Addressing this issue is parti cularly important for EPA because of the need to consider and address environmental justice as mandated by Exec. Order 12898.

Communities that have minority and lower income populations and communities with higher than average levels of cancer, respirator y, and other health problems, as well as a lack of

43 42 U.S.C. § 7412(f)(2).
44 See, e.g. , NAS 2009 at 135

- 39, 145

- 51 (explaining that “[h]ow the population responds to chemical insults depends on individual responses, which vary among individuals”; and “[i]f the sensitive people constitute a distinct group either because of their numbers or b ecause of identifiable characteristics

— such as ethnicity, genetic polymorphism, functional or health status, or disease

— they should be considered for separate treatment in the overall risk assessment”); id. at 112 (noting that EPA’s guidelines do not addre ss variability due to factors “such as age, ethnic group, socioeconomic status, or other attributes,” and explaining that “there is a need for a nonzero default to address the variation in the population expected in the absence of chemical

- specific data”); see also id . at 134 (discussing various factors and recommending that “much more emphasis needs to be placed on describing the ranges of susceptibility and risk”); see also id. at 177

- 82, 196.
45 Id . at 214

- 15.25

access to health care, are likely to be more vulnerable to the impact of toxic air pollution. 46 Where a rule affects communities that are disproportionately minority or lower income, EPA cannot ignore this greater risk in its assessment. As a key starting point, EPA must assess the greater health risk based on socioeconomic status found in epidemi ological research studies. 47 As the NAS recognized, “there is growing epidemiologic evidence of interactions between environmental stressors and place

- based and individual

- based psychosocial stressors, driven in part by the spatial and demographic concorda nce between physical and chemical environmental exposures and socioeconomic stressors,” and there is also a growing field of information on social epidemiology, which addresses the relationship between social factors and disease in human populations. 48 Dat a describing these factors are available from the Center for Disease Control’s Environmental Public Health Tracking (“EPHT”) Program, the U.S. Agency for Toxic Substances and Disease Registry, state and local health agencies, and academic researchers, 49
and EPA must consider and use such inf ormation in its risk assessment

. Further, EPA must recognize and evaluate the need to consider socioeconomic factors not only as part of an environmental justice analysis, but also as part of EPA’s consideration of both vulnerability and variability, as core elements of the risk assessment itself. EPA has been assessing the demographics of affected communities, pursuant to CAA § 112(f) and the Environmental Justice Executive Order 12898. 50 This is necessary and important to continue. However, in addition to looking at the demographic census data on race, ethnicity, poverty level, and similar factors, EPA must also assess the starting point or baseline overall health status of the affected individuals and communities usin g the best available data at a local and national level, including the baseline cancer levels, respiratory problems, and health problems associated with the toxic chemicals emitted by a source category. Doing so would be consistent with the 1999 Residual Risk Report. 51 Further, EPA has significant research available on which it must draw to incorporate “overall h ealth” into its risk assessment . For example, the American Lung Association has published research showing that African Americans are at a much h igher risk of lung cancer than white Americans, and that African

- American men have a 37 percent higher risk

46 See, e.g. , Chari et al

., Integrating Suscep tibility , at 1078 & nn.5

- 10 (citing research); see also Cal. EPA, OEHHA, “Cumulative Impacts,” supra , at 6, 10, 12

- 17.
47 NAS 2009 at 109

- 10 & tbl. 4

- 1 (describing the need to consider increased susceptibility due to prior and concurrent exposures; and to “s ocial and economic factors”); id. at 220

- 21 (describing ways to assess cumulative risk including by consideration of “epidemiologic concepts” and information, and by considering “what the burden of disease is in the context of simultaneous exposure to a nu mber of stressors”); id. at 230 (discussing the role of epidemiology and surveillance data).
48 Id . at 230

- 33.
49 Id . at 232 (describing data available on health status, and patterns of diseases and exposures).
50 Exec. Order 12898, “Federal Actions To Addres s Environmental Justice,” supra

. 51 U.S. EPA, “Residual Risk Report to Congress” at 42, 67 (Mar. 1999), EPA

- 453/R

- 99

- 00 (discussing factor of “overall health” and recognizing the need to consider sensitive subpopulations that “consist of a specific set of i ndividuals who are particularly susceptible to adverse health effects because of physiological (e.g., age, gender, pre

existing conditions), socioeconomic (e.g., nutrition), or demographic variables, or significantly greater levels of exposure,” based on v arious demographic factors).26

of lung cancer than white men. 52 EPA must collect and consider this type of health information as part of each risk assessment that disproportionate ly affects particular minority groups and communities , like the one in the rulemaking now in progress.

Thus far, EPA has failed to adequately assess human variability, particularly the increased vulnerability of different socioeconomic groups, or to in corporate the information gained from the environmental justice analysis into its risk assessment. In this rulemaking, EPA has recognized that there are disproportionate impacts, e.g. , on African Americans and low income people (living below the poverty l evel)

, but EPA did not incorporate the additional vulnerability this represents at all into its risk assessment. As the NAS discussed, “EPA should compile relevant data related to socioeconomic status (SES), which may serve as a proxy for numerous individu al risk factors . . . and may be a more direct measure of vulnerability than could reasonably be assembled by looking at all relevant individual risk factors.” 53 EPA should follow the NAS recommendations and science to do so in its residual risk assessment

. In addition, EPA should simply use a default factor to account for socioeconomic and other community

- based stressors, just as it does to account for intrinsic biological factors. 54 For example, it traditionally uses a factor of 100 to account for the us e of animal studies, when translating such studies to assess human impacts. The Food Quality Protection Act directed EPA to use a factor of 10 to acc ount for in utero exposure. California’s Office of Environmental Health Hazard Assessment uses a similar factor to account for in utero exposure. EPA also uses
age

- dependent adjustment factors in other contexts. EPA should do the same to account for increased vulnerability based on socioeconomic factors or the presence of multiple sources to which a communi ty is exposed.

B. Assess the cumulative burden of exposures to multiple pollutants an d sources via multiple pathways

1. Perform multipathway assessment for all persistent and all bioaccumulative pollutants.

EPA must assess multipathway ( i.e. , non

- inhalation) r isk for all metals and all other pollutants with a persistent or bioaccumulative impact, as OEHHA does. Instead, EPA generally restricts its multipathway risk screening assessment to only those contaminants identified in the 2003 Risk Assessment Guidance as being both persistent and bioaccumulative in the

52 Am. Lung Ass’n, “Too Many Cases, Too Many Deaths: Lung Cancer in African Americans” at 1 (2010), http://www.lungusa.org/assets/documents/publications/lung

- disease

- data/ala

- lung

- cancer

- in

- african.pdf (explaining higher risk to African Americans even though primary factor for lung cancer, i.e. , cigarette smoke exposure, is lower than for whites); see also State of Lung Disease in Diverse Communities: 2010, available at www.LungUSA.org.
53 NAS 2009 at 226 (citing O’Neill et al . (2 003)).
54 Rachel Morello

- Frosch, Zuk, Jerrett, Shamasunder & Kyle, Understanding The Cumulative Impacts of Inequalities in Environmental Health: Implications for Policy , 30(5) Health Affairs 879, 883 (2011).27

environment ( i.e. , PB

- HAPs). 55 EPA’s 2003 list of 14 PB

- HAPs is incomplete, however, because it ignores other HAPs which present a multipathway risk. 56
EPA’s choice to restrict its analysis to only certain contaminants that bioaccumulate is not supported by the 2003 Guidance which states that “multipathway risk assessment may be appropriate generally when air toxics that persist and which also may bioaccumulate and/or biomagnify are present in releases.” 57 This guidance does not direct that the multipathway assessment be limited to only those contaminants listed as PB

- HAPs , but that is how EPA has applied it . The choice to exclude those contaminant s which persist and accumulate in soils underestimates risks from HAPs. The 2003 guidance document recognized deposition of persistent HAPs as a source of soil contamination presenting a potentially significant route of exposure, particularly for children

. 58

Based on EPA’s own guidance, and based on recent scientific information compiled by OEHHA, EPA must perform a full multipathway risk assessment for all metals. California OEHHA has recommended a multipathway assessment for metals based on scientific research. 59 EPA should consider and apply this science in its risk assessment

. EPA simply may not assume that the ingestion and other multipathway risks are zero for persistent pollutants when science shows otherwise. The failure to assess multipathway r isk from exposure to all PB

- HAPs, both individually and cumulatively, results in an underestimate of the health risks of HAP emissions.

The following is a list of top priority pollutants for EPA to add to its list of 14 chemicals for which multipathway ri sk should be evaluated , as well as all metals . These chemicals have been shown to have a significant potential for deposition and retention within the environment. Air emissions of these compounds therefore present a risk to nearby communities via dermal

, ingestion, and other non

- inhalation pathways that are currently not being considered in its residual risk assessment . For extensive documentation on the rationale for multipathway analysis for these compounds and multipathway exposure parameters please review the OEHHA 2012 Guidelines for Exposure Assessment. 60

i. Arsenic ii. Hexavalent chromium

55 See, e.g. , “Draft Residual Risk Assessment fo r the Ferroalloys Source Category” (Oct. 2011) at 10, EPA

- HQ

OAR

- 2010

- 0895

- 0046 (only analyzing multipathway risk for pollutants on EPA’s outdated PB

- HAP list even though arsenic is a persistent pollutant and is also emitted).
56 EPA, “PB

- HAP Compounds, Ris k Assessment and Modeling

– Air Toxics Risk Assessment Reference Library, Vol. I Tech. Resource Manual, Ch. 4 Air Toxics: Chemicals, Sources, and Emissions Inventories,” at 4

- 10, Exhibit 4

- 2 (2003), http://www.epa.gov/ttn/fera/risk_atra_vol1.html; http://w ww.epa.gov/ttn/fera1risk_atra_vol 1.html.
57 Id ., Part III, Ch. 14 “ Human Health Risk Assessment: Multipathway,” at 14

- 1(emphasis added).
58 Id. ch. 20.
59 OEHAA 2012 Guidelines, Appendix E, at E

- 5, E

- 10 to E

- 12, http://oehha.ca.gov/air/hot_spots/SRP/index.html.
60 Id. App. E.28 iii. Nickel iv. Diethylhexylphthalate

v. Beryllium vi. Selenium

In addition to these six listed by OEHHA, we also urge EPA to assess the persistent effects of manganese and naphthalene and add these to the PBT list for similar reasons. Manganese is a pollutant to which children have particular exposure and vulnerability, and there is evidence that it can pose a multipathway risk due to elevated levels in soils around major emission sou rces. 61 Naphthalene is a polycyclic aromatic hydrocarbon (PAH) and as such must be considered in the POM category which is listed as a PB HAP. Naphthalene has been demonstrated to be persistent and to bioaccumulate in biota, particularly shellfish. 62

2. Perf

orm multipathway assessment for all pathways of exposure, including those that particularly affect children.

EPA should recognize that the science shows additional pathways that it has not addressed for certain pollutants, for which it does recognize the n eed for a multipathway assessment. For example, OEHHA has recognized that breast milk exposure can be a pathway that creates health risk due to lead. 63 EPA should evaluate the research on various pathways of toxic exposure discussed by OEHHA.

In addition , science shows that EPA has been relying on outdated estimates of incidental soil ingestion exposures and EPA must update these values to ensure that it considers the urban child scenario in its multipathway risk assessment. 64 Risk assessment of exposure t o soil contaminants should evaluate both direct exposure, hand

- to

- mouth, and indirect, object

- to

- mouth exposure. Indirect hand

- to

- mouth activity is the exposure from young children who touch an

61 See, e.g. , ATSDR, “Draft Toxicological Profile for Manganese” at 12 (Sept. 2012) (“Manganese concentrations in soil may be elevat ed when the soil is in close proximity to a mining source or industry using manganese and may therefore pose a risk of excess exposure to children who ingest contaminated soil.”) http://www.atsdr.cdc.gov/ToxProfiles/tp151.pdf ; see also Cal. EPA, OEHHA, “D evelopment of Health Criteria for School Site Risk Assessment Pursuant to Health and Safety Code Section 901(g): Child

- Specific Reference Doses (chRDs) for School Site Risk Assessment: Manganese and Pentachlorophenol,” at 10 (June 2006) (discussing science showing that manganese can accumulate in the brain and showing that ingestion of high levels of manganese is associated with harm).
62 R. Yender et al. , NOAA, “Managing Seafood Safety after an Oil Spill

, ” (Nov. 2002).
63 OEHHA 2012 Guidelines, supra note 37 , App. E, at E

- 12, tbl. E3.
64 As an additional problem, California’s lead in soil standard is more stringent than EPA’s due to more recent scien ce on the harm of lead exposure. EPA has recognized that its standard is based on out

- dated information about lead, that previously assumed children’s blood

- lead levels below 10.0 ug/dL was safe. EPA now admits that number is not protective, but has not u pdated its soil standard. See, e.g. , “EPA fails to revise key lead

- poisoning hazard standards,” USA Today (Mar. 10, 2013), http://www.usatoday.com/story/news/nation/2013/03/10/epa

- has

- not

revised

- lead

- hazard

- standards

- for

- dust

- and

- soil/1971209 (“The EPA h as not revised key hazard standards that protect children from lead poisoning since 2001, despite science showing harms at far lower levels of exposure than previously believed.”); Children’s Health Advisory Protection Comm., Letter to Administrator Jackso n Regarding Childhood Lead Poisoning (Mar. 29, 2012), http://yosemite.epa.gov/ochp/ochpweb.nsf/content/chpac_childhood_lead_poison_letter.htm.29

object or food with soil contaminated hands and then put that object or food into their mouths. Published studies show that there is noticeable indirect hand

- to

- mouth activity in infants and children. In fact, one study found that, on average, a toddler will touch an object and then put that object into his or he r mouth 15 times in one hour. At the high end of the study’s distribution (90th percentile), that rate rises to 66 times per hour. 65 This same study found a statistically significant positive correlation between the frequency of object or food in mouth activity and blood lead levels. The 2011 update to EPA’s Exposure Factors Handbook includes more recent studies and estimates of hand

- to

- mouth behavior, which must be used to assess risks from exposures to contaminated soils. 66

3. Better account for the aggre gate impact of inhalation and multipathway cancer and chronic non

- cancer risk by adding each type of similar risk together for all pollutants.

The purpose of the multipathway assessment is to allow EPA to look overall at a person’s

exposure

– not just inh alation, and not just other exposure pathways, in isolation. To do so, EPA must add inhalation and multipathway risk. Failing to add up each type of risk in order to come up with a total cancer risk number and a total non

- cancer number, and then (as furt her discussed below), a cumulative burden metric makes EPA’s overall risk assessment incomplete.

A major problem is that EPA does a screening exercise for multipathway risk and then often decides not to do a full multipathway risk assessment. 67 This is problematic for two reasons. First, it withholds information from the public on the amount of non

- inhalation risk. Second, it hampers EPA’s ability to perform a full, cumulative analysis taking into account all the relevant exposures. EPA shou ld ensure that for each risk assessment it fully assesses multipathway or non

- inhalation risk, and that it also combines this with inhalati on risk, to come up with a cumulative risk level that EPA and the public can then analyze in the rulemaking
process.

C. Include Multiple Pollutants.

1. Assess the combined total of each type of risk for multiple pollutants.

EPA must assess the total and synergistic cancer risk and total chronic non

- cancer risk for different pollutants. For example, as OEHHA found, “[t] he potential neurotoxicity of arsenic in children, possibly in combination with other environmental agents, is also a concern. Studies in

65 Ko, S., Schaefer et al

., Relationships of Video Assessments of Touching and Mouthing Behaviors During Outdoor Play in Urban Residential Yards to Parental Perceptions of Child Behaviors and Blood Lead Levels , 17 J. of Exposure Science and Environ. Epidemiology 47 (2007).
66 EPA, Exposure Factors Handbook, 2011 Edition (http://cfpub.epa.gov/ncea/risk/recordisplay.cfm ?deid=236252).
67 “Draft Residual Risk Assessment for the Ferroalloys Source Category” (Oct. 2011) at 27

- 31, EPA

- HQ

- OAR

2010

- 0895

- 0046 (although the screening analysis showed mercury levels that were 4 times EPA’s screening threshold and POM levels that were 60 times EPA’ s screening threshold, EPA did not perform a full multipathway analysis or add the multipathway risks to the inhalation risks for POM, which EPA also identified as an inhalation

based cancer risk driver).30

mice (Meija et al., 1997) indicate combined effects of lead and arsenic on the central nervous system that were not o bserved with either metal alone.” 68

In addition, EPA evaluates total cancer risk (using the maximum individual risk or “MIR”) and chronic non

- cancer risk (using the target

- organ specific hazard index “TOSHI”) based on the combined exposure to pollutants with a common health impact. 69 EPA should apply these same principles to create a mechanism for assessing the total acute risk to chemical mixtures, such as a TOSHI, that aggregates the acute impacts on the same organ systems for all pollutants.

2. Assess t he total cumulative risk burden from all pollutants.

EPA must create a metric to assess the total and cumulative risk burden, rather than only looking at each type of risk in a discrete, separate way. 70 EPA should be integrating its assessments and performing a “comprehensive risk assessment” as the NAS has emphasized. 71 After first assessing the total cancer, chronic non

- cancer, and acute risks, for both inhalation and multipathway exposure, EPA also m ust create a metric to assess the total bundle of risks. 72 EPA must aggregate health risk for each pollutant, and each type of health risk, to create a cumulative risk determination for the individual “most exposed” to emissions as the Act requires. 73

Unl ess and until EPA creates a combined health risk metric, it is unclear how it can make

an ample margin of safety determination that is based on the full picture of health risk for a source category and that can be compared to other source categories. EPA must assess the full cumulative burden for public health. By failing to perform a full, cumulative risk assessment, EPA fails to gather the information needed to assess whether the risk to public health is acceptable under CAA § 112(f)(2).

D. Account for Mul tiple Sources.

EPA must assess and account for the cumulative impact and risk caused by exposure to multiple source categories’ toxic air emissions. In many communities containing sources of toxic air emissions, there are many other nearby sources of to xic air emissions within the 3, 5, 10, and the full 50 km radius of EPA’s residual risk assessment. Such exposures increase the

68 Cal. EPA, OEHHA, “Prioritization of Toxic Air Con taminants

- Children’s Environmental Health Protection Act, Arsenic and Arsenic Compounds” at Arsenic

- 2 (Part II) (Oct. 2001).
69 See, e.g. , EPA, OAQPS, “Residual Risk Assessment for the Secondary Lead Smelting Source Category” at 26 (Dec. 2011), EPA

- HQ

- OAR

- 2011

- 0344

- 0160.
70 See, e.g. , NAS 2009 at 177 (“The underlying scientific and risk

- management considerations point to the need for unification of cancer and noncancer approaches in which chemicals are put into a common analytic framework regardle ss of type of outcome.”).
71 Id. at 131; see also id. at 132

- 33 (discussing related issues).
72 Cal. EPA, OEHHA, “Cumulative Impacts,” supra at 19

- 21, 25 (describing total “pollution burden” as sum of exposures, public health effects, and environmental effec ts); EPA, “Concepts, Methods and Data Sources,” supra , at 4

- 42 to 4

- 46.
73 42 U.S.C. § 7412(f)(2).31

vulnerability of a community to new and additional toxic air emissions

. 74 Further, EPA’s own environmental justice analysis has found that the sources covered by the rulemaking under review here, like other sources of toxic air pollution listed under CAA section 112, such as lead smelters, chromium electroplaters, and many others frequently create disproportionate health risk for minority and lower income communities. This problem is exacerbated by the fact that multiple sources of pollution are more likely to be more concentrated in minority and lower income communities, creating a serious environmental justice problem. 75

There fore, in addition to performing a cumulative assessment from each source category alone, EPA also must perform a cumulative analysis that considers source categories’ individual impact and risk with that of other sources to which people are exposed. 76 EPA has acknowledged the importance of addressing multiple source exposures, by stating that it “understands the potential importance of considering an individual’s total exposure to HAP in addition to considering exposure to HAP emissions from the source cate gory and facility,” and that it is “interested in placing source category and facility

- wide HAP risks in the context of total HAP risks from all sources combined in the vicinity of each source.” 77 And, EPA has also recognized this need in its recent risk r eport. 78 Yet, so far EPA has failed to follow through on this. Although EPA has looked at all sources within a source category, it generally has not looked at other exposures. Although EPA has calculated what it calls “facility

- wide” risk for different sources collocated at the same address, it has not used that number to set standards, and it has ignored different sources across the street or in close proximity. 79 Fed. Reg. at 1691. 79
In this rulemaking, EPA recognized that there are sources contribut ing over 50% to the cancer risk above 1

- in

- 1 million and other health risk metrics. But it has provided no discussion

74 See, e.g. , NAS 2009 at 214.
75 See, e.g. , Cal. EPA, OEHHA, “Cumulative Impacts,” supra

. 76 We support EPA’s recognition of the need to assess whether the m aximum exposed individual is exposed to emissions from more than one source within each source category, as it does using the AERMOD modeling tool. We also appreciate that EPA has considered facility

- wide risk in this rulemaking . However, th at assessment offer s only part of the picture. And, even on both of these issues, EPA has provided very little information about what it included in such assessments. EPA often just states numbers found for facility

- wide risk, without explaining where those numbers ca me from, how they were calculated, or what emission sources they cover.

77 NESHAP: Mineral Wool Production and Wool Fiberglass Manufacturing, 76 Fed. Reg. 72,770, 72,786 (Nov. 25, 2011).
78 U.S. EPA, “Concepts, Methods and Data Sources,” supra, at xxxii (defining a cumulative risk assessment as including “aggregate exposures by multiple pathways, media and routes over time, plus combined exposures to multiple contaminants from multiple sources”).
79 The same problem has occurred in other similar rulemaking. See, e.g. , EPA, OAQPS, “Residual Risk Assessment for the Secondary Lead Smelting Source Category” (Dec. 2011), EPA

- HQ

- OAR

- 2011

- 0344

- 0160; “Draft Residual Risk Assessment for the Mineral Wool Prod uction and Wool Fiberglass Manufacturing Source Categories” at 23 tbl. 3.1

- 1; id . at 30 tbl. 4.1

- 1 (Sept. 2011), EPA

- HQ

- OAR

- 2010

- 1042

- 0086; “Residual Risk Assessment for the Chromic Acid Anodizing, Decorative Chromium Electroplating, and Hard Chromium Elec troplating Source Categories” (Aug. 2012), EPA

- HQ

- OAR

- 2010

- 0600

- 0630; “Draft Residual Risk Assessment for 7 Chemical Source Categories” (Nov. 2011), EPA

- HQ

- OAR

- 2011

- 0435

- 0018; “Draft Residual Risk Assessment for the Ferroalloys Source Category” at 27

- 31 (O ct. 2011) EPA

- HQ

- OAR

- 2010

- 0895

- 0046; “Residual Risk Assessment for the Oil and Gas Production and Natural Gas Transmission and Storage Source Categories,” (Apr. 2012) EPA

- HQ

- OAR

- 2010

- 0505

- 4558.32

of the collocated sources at a given facility or how it reached the percentages listed in the Tables in its risk assessment on facility

- w ide risk , to inform the public . I t has provided no reasoned justification for using 50% facility

- wide risk contribution as a relevant benchmark for action here

. Nor, did it discuss or consider the reductions in facility

- wide risk that would occur if it were to strengthen regulation of the source categories under review in this rulemaking. EPA’s failure to assess the combined, cumulative impact on health risk from multiple pollution source categ ories conflicts with the recommendation from the Scientific Advisory Board that in May 2010 urged EPA to incorporate cumulative risk into its residual risk analysis. The SAB stated that “RTR assessments will be most useful to decision makers and communiti es if results are presented in the broader context of aggregate and cumulative risks, including background concentrations and contributions from other sources in the area.” 80
To perform a cumulative risk or impact analysis, EPA should combine current bas eline emissions, exposures, and health impacts in addition to those of the specific source category EPA is reviewing. The NAS explained the need for “[i]ncorporation of background additivity to account for . . . [a]dditional sources of exposure to the sam e chemical or to similarly acting chemicals (including endogenous sources). . . .” 81 As part of this analysis, EPA should aggregate or add the emissions for the most

- exposed communities coming from: (1) the source category (including all individual sources within it); (2) facility

- wide risk from collocated sources outside of this category; and (2) all other sources of toxic air pollution in the area. Virtually all of the existing federal air toxics standards (under section 112(d)) require periodic testing an d monitoring, and this is something EPA must ensure is included in all rules as it updates them. Using these data, EPA can aggregate the community’s exposure and assess the full health threats faced by the affected community, including from the source und er review.

EPA must also consider the research that has already occurred to assess health risk from toxic air pollution in urban communities nationwide. 82 EPA should also draw on the OEHHA cumulative assessment approach. 83 EPA should consult with OEHHA and investigate the scientific approach it is using to address cumulative impacts, and consider and apply a similar science

- based appro ach in its residual risk assessment

. Further, the NAS has recommended that EPA evaluate “background exposures and vuln erability factors,” as well as use “epidemiologic and toxicologic e vidence” in its risk

80 SAB May 2010 at ii, supra note 41 , at 10.
81 NAS 2009 at 180 (explaining that this may require the use of default factors).

82 See, e.g. , Rachel Morello

- Frosch & Bill M. Jesdale, Envtl. Health Perspectives, Separate and Unequal: Residential Segregation and Estimated Cancer Risks Associated with Ambient Air Toxics in U.S. Metropolitan Areas , 114(3) Envtl. Health Perspectives 386 (2006) (assessing toxic air pollution cancer risk for 309 metropolitan

areas enco mpassing 45,710 tracts); “National Air Toxics Program: The Integrated Urban Strategy,” 64 Fed. Reg. 38,706, 38,738 (July 19, 1999).
83 See, e.g. , Cal. EPA, “Cumulative Impacts,” supra

.33

assessment

. 84 Rather than separating an environmental justice analysis and considerations of inequality from the risk assessment, considering these factors as part of t he cumulative risk

assessment

– because of the i ncreased vulnerability created

– would be a more effective, meaningful, and scientific approach.

EPA stated in this rulemaking that “we are interested in placing source category and facility

- wide HAP risks in the context of total HAP risks from all sources combined in the vicinity of each source,” but that “we are concerned about the uncertainties of doing so.” 79 Fed. Reg. at 1696. EPA has failed to explain why this would “make the assessments too unrelia ble,” rather than providing additional information on additional health risks that it is currently ignoring , so that EPA could then take a scientifically defensible approach to protect public health, with a more complete view of the most

- exposed person’s r isks. In assessing a source category’s emission contributions in affected communities and considering whether these contributions cause the most

- exposed people to experience an unacceptable level of public health risk when combined with the existing base line from past emissions, other HAP emissions, and the community’s health status, EPA can describe and manage uncertainties, as it does in other aspects of the risk assessment, 79 Fed. Reg. at 1691

- 95, and other federal agencies do for many other analyses. 85 Uncertainties do not justify refusing to assess and address the severe cumulative harm and risk to local commu nities from the source categories under review here (or other air toxics sources )

. Much of risk assessment is about managing uncertainties, an d that is not reason for EPA to avoid appropriately regulating sources under § 112(f)(2). Rather, there is no excuse for treating an unknown amount of additional risk as a missing default, to use the NAS term.
As a scientific and policy matter, where there is exposure to air toxic emissions beyond the individual source category, the level of total risk that is occurring, including the baseline health risk and the risk from other sources, is greater. Thus, the t otal risk that is unacceptable for the most

- exposed person must in fact be lower for each source category that person is exposed
to, because it combines with other risks to create a total risk from all regulated source categories

84 NAS 2009 at 221

- 23 (discussing Menzie et al. 2007 model); id. at 230 (discussing the role of epidemiology and surveillance data).
85 See, e.g. , 42 U.S.C. §§ 7475(a)(3), 7503(a)(1) (requiring a localized, cumulative assessment of whether or not a new or modified source’s additional emissions will cause an attainment area to deteriorate, or will make it difficult for a nonattainment area to make progress toward achieving the national ambient air quality standards); New York v. EPA , 443 F.3d 880, 883 n.1 (D.C. Cir. 2006) (citing New York v. EPA , 413 F.3d 3, 11

- 14 (D.C. Cir. 2005)); see also 40 C.F.R. § 1508.27(b)(7) (requiring a consideration of “[w]hether the action is related to other actions with individually insignificant but cumulatively significant impacts. Significance exists if it is r easonable to anticipate a cumulatively significant impact on the environment. Significance cannot be avoided by terming an action temporary or by breaking it down into small component parts”); see also 40 C.F.R. § 1508.7; Nat’l Wildlife Fed’n v. Nat’l Ma rine Fisheries Serv. , 524 F.3d 917, 930 (9th Cir. 2008) (applying 16 U.S.C. § 1536(a)(2) to enforce the Endangered Species Act duty to ensure against jeopardy which includes the requirement to assess a newly proposed action in the context of all other impa cts, and determine whether or not the specific action will “tip a species from a state of precarious survival into a state of likely extinction,” or, where baseline conditions already jeopardize a species, whether it will “deepen[] the jeopardy by causing additional harm”).34

which must be minimized. Looking at a source category’s contribution of risk in isolation is equivalent to ignoring the facts and pretending other health risks are not occurring. EPA may not decide that it is okay for a person to be exposed at a higher level simply because they l ive in a community where they are exposed to multiple sources of air pollution. That is the opposite of what EPA is required to do

– protect the people in local communities who are most exposed and most vulnerable to air pollution. It also conflicts with EPA’s own commitment to consider and provide environmental justice to overburdened communities.

At minimum, until EPA develops a data

- driven approach to comprehensively model cumulative risk or impacts from multiple sources, EPA must not treat multiple so urce exposure as a missing default, or ignored amount of health risk. EPA must incorporate an explicit default or uncertainty factor to adjust the degree to which each individual source category is contributing to the total risk experienced by the most

- ex posed individuals. For example, wherever there is evidence that the source category is contributing pollutants on top of a history of other exposures or is contributing pollutants in addition to other source categories, the “unacceptable” level of

cancer, non

- cancer chronic, and acute risk from the source category must be adjusted downward based on the number of other facilities contributing HAP exposure risks (such that no single source category could consume all of it, when the most

- exposed person is expo sed to many other source categories). For a source category in an area with up to 10 other HAP

- emitting facilities, this default or uncertainty factor should equal at least 10, consistent with the common scientific use of this factor for other kinds of vu lnerability. 86

E. Account for Additional Risk and Uncertainty.

In addition to and related to many of the issues already discussed, EPA must stop treating various types of risk as zero when the science shows risk is present; simply because EPA has not yet developed a risk function for a pollutant, type of exposure, or type of risk, does not mean risk does not exist and can be ignored. 87 As the NAS explained, EPA should use “explicitly stated defaults to take the place of implicit or missing defaults,” and “[k]ey priorities should be development of default approaches to support risk estimation for chemicals lacking chemical

specific information to characterize individual susceptibility to cancer . . . and to develop a dose

response relationship.” 88

1. EPA must not treat risk as zero for a pollutant for which it has no reference value.

As the NAS explained, it is a problem that “agents that have not been examined sufficiently in epidemiologic or toxicologic studies are insufficiently included in or even

86 For areas with more facilities, which cause an even greater level of health risk combined, the UF should be adjusted accordingly, i.e. , 11

- 20 facilities would result in an UF of 20, and more than 20 would result in an UF of 100, so the source category’s contribution is no higher than 1/100 of the threshold.
87 See, e.g. , NAS 2009 at 203

- 04, 207.
88 Id . at 207.35

excluded from risk assessments” by EPA. 89 Many chemicals have no cancer slope factor, RfD, RfC. 90 It is not appropriate to treat such compounds “as though they pose no risk that should be subject to regulation.” 91 The NAS has recommended that EPA develop “explici t defaults to use in place of missing defaults,” including for its “untested

- chemical assumption,” i.e. , that a chemical with no reference value poses no risk. 92

Where there is no reference value for a pollutant, EPA may not simply ignore health risks

asso ciated with these pollutants completely in its analysis by hiding behind uncertainty. Section 112 requires EPA to address and regulate all emitted HAPs. EPA states that the lack of reference values “ could r esult in quantitative estimates understating HAP risk

. ” 93 In fact, an understatement of risk for pollutants that are excluded from the analysis is certain because EPA has performed no quantitative assessment of health risk for those pollutants at all . The absence of a reference value means that EPA does not know by how much it is underestimating risk to human health, but it does know that its assessment is an underestimation.

Although EPA makes these general statements in the preamble, it does not advise the public as to which pollutants in this rulem aking are chemicals for which EPA has failed to assess risk at all quantitatively due to the lack of reference values, or pollutants for which EPA has only performed what it calls a qualitative assessment. 94 To inform the public and ful fill its notice and

c omment duty under the Clean Air Act , EPA must provide information on which chemicals these are, and seek additional information regarding these specific pollutants, before deciding not to assess health risk from them at all quantitatively.

In the absenc e of an available reference dose, EPA must, at minimum, add an uncertainty factor to account for the additional risk that a HAP likely causes, until such time as EPA does have a reference value to use. Using a protective uncertainty factor

– developed bas ed on the best available science

– would allow EPA to satisfy its legal duty under section 112(f)(2) to prevent unacceptable health risk, and ensure an “ample margin of safety to protect public health.” 95 The NAS has described an approach EPA can use to ac count for this risk, and explained that this approach “is based on the notion that for virtually all chemicals it is possible to say something about the uncertainty distribution regarding dose

- response relationships.” 96 For

89 Id . at 193.
90 Id . at 203.
91 Id. at 193

. 92 Id. at 203

. 93 79 Fed. Reg. at 1693.
94 Id. (“Further, HAP not included in the quantitative assessment are assessed qualitatively and considered in the risk characterization that informs the risk management decisions, including with regard to consideration of HAP reductions achieved by various control options.”)
95 42 U.S.C. § 7412(f) (2).
96 NAS 2009 at 203 (emphasis added).36

example, EPA can use information on chemical structure, available toxicologic tests and model or experimental data, and data on similar chemicals that have been s tudied. 97

Section 112(f)(2) of the CAA creates a critical duty and opportunity for EPA to conduct a comprehensive and protective analysis of risk to public health and the environment. In view of this, it is a serious problem for EPA’s analysis that some pollutants continue to have no reference values. 98 Over twenty years after the Clean Air Act was amended, sufficient stu dies for some pollutants have not been conducted to calculate reference doses, reference concentrations, or potency values. Moreover, the Integrated Risk Information System (“IRIS”) review process has been bogged down for many pollutants as the Government Accountability Office recently documented. 99 As the Center for Progressive Reform (“CPR”) has recognized, EPA should prevent the delay in this process from undermining its residual risk analysis for source categories under review. 100

For po llutants curre ntly under IRIS assessment, EPA must use the best available scientific information from the IRIS review during current rulemaking s

. 101 At minimum, EPA must account for the lack of reference values or the lack of an up

- to

- date final IRIS assessment rather th an just allowing important rulemakings to go by without any consideration of health risk due to such pollutants. 102

97 Id. at 204.
98 See, e.g.

, 79 Fed. Reg. at 1693.
99 U.S. Gov’t Accountability Office, GAO

- 12

- 42, Chemical Assessments: Challenges Remain with EPA’s Integrated Risk Information System Program 17

- 18 (2011).
100 See Rena Steinzor et al

., Setting Priorities for IRIS: 47 Chemicals that Should Move to the Head of the Risk

Assessment Line , Ctr. For Progressive Reform (Dec. 2010), (http://www.progressivereform.org/articles/IRIS_Priorities_1010.pdf. CPR’s analysis of IRIS offers a critical expose of these problems. EPA’s IRIS: A Database With Blind Spots , Ctr. For Progressive Reform, http://www.progressivereform.org/iris.cfm (last visited June 27, 2013). See also Gov’t Accountability Office, GAO

11

- 278, “High Risk Series : An Update” (2011); Gov’t Accountability Office, GAO

- 09

- 774T, http://www.gao.gov/new.items/d11278.pdf; Gov’t Accountability Office, “EPA Chemical Assessments: Process Reforms Offer the Potential to Address Key Problems,” (2009) ; Gov’t Accoun tability Office, GAO

- 08

- 743T, http://www.gao.gov/new.items/d09774t.pdf; Gov’t Accountability Office, “Toxic Chemicals: EPA’s New Assessment Process Will Increase Challenges EPA Faces in Evaluating and Regulating Chemicals” (2008); Gov’t Accountability Offi ce, GAO

- 08

- 440, 29, (2008), http://www.gao.gov/new.items/d08743t.pdf; Gov’t Accountability Office, “Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA’s Integrated Risk Information System” (2008), http://www.gao.gov/new.items/d08440.pdf.
101 Integrated Risk Information System (IRIS); Announcement of 2012 Program, 77 Fed. Reg. 26,751 (May 7, 2012).
102 See, e.g. , Draft Residual Risk Assessment for the Mineral Wool Production and Wool Fiberglass Manufacturing Source Categories at 23 tbl. 3.1

- 1; id. at 30 tbl. 4.1

- 1 (Sept. 2011), EPA

- HQ

- OAR

- 2010

- 1042

- 0086 (due to lack of reference value for hydrogen fluoride (HF), antimony, and other pollutants, EPA failed to account for any health risk from these pollutants). Similarly, there is no reference value for lead, and no safe level of lead exposure. Although information exists regarding how EPA could try to address this (such as using California’s benchmark for action of avoiding a blood

- lead level incr ease of 1.0 ug/dL), EPA regularly assesses only whether a source, alone, will cause an exceedance of the 2008 Lead National Ambient Air Quality Standards, instead of evaluating how to prevent har m from the lead emissions of a source category, in combinatio n with other pollutants and other sources. See, e.g.

, id. at 11; “Secondary Lead Smelting Residual Risk Assessment” at 12 (Dec. 2011), EPA

- HQ

- OAR

- 2011

- 0344

- 0160.37 2. EPA must account for the cumulative risk of upsets and malfunctions, instead of ignoring this risk.

As another example of the problem of ign oring health risk in its assessment, EPA ignores the higher emissions caused by malfunction or upset emissions, which can accumulate and combine to increase public health impacts and risk. Its acute risk assessment uses a factor of 10 (or only 2 for equip ment leaks), which fails to adequately account for additional health risk from malfunctions. “Upsets are a significant problem for many areas, including rural ones, but they are a particular problem for the predominantly lower income communities of color surrounding many refinery and chemical complexes.” 103 Malfunction or upset events increase emissions and thereby pose increased health risks which EPA must consider. Where control equipment fails, emissions could be at least 100 times greater ( e.g. , in t he circumstance where a control device has 99% efficiency, such that an uncontrolled release would cause 100 times the usual amount of emissions).

Failing to look at the true potential for spikes in emissions over a person’s lifetime may underestimate acut e risk, cancer risk and the amount of chronic risk based on pollutants that persist in the environment, such as PCBs, POM, lead, and cadmium. Ignoring these emission spikes is equivalent to treating additional health risk caused by exceedances as zero. EPA knows that there is additional risk from malfunctions and violations, and that this additional risk should not be ignored in its risk assessment

.
To assess the health risk from malfunctions, EPA has information available or can collect information o n major sources’ malfunction and violation histories. 104 Moreover, EPA regularly uses statistical methods and probability factors, which are readily available tools that EPA can also use to assess health risk due to malfunctions, to set clean air standards. Further, to calculate acute health risk, EPA uses what it calls a “worst case” scenario approach that attempts to account for some variability under the existing standard, which (although this does not fully do so) shows that the agency could similarly a dd a factor to account for malfunctions for acute and other types of health risk.

103 Envtl. Integrity Project, Gaming the System: How Off

- the

- Books Industrial Upset Emissions Cheat the Public Out of Clean Air at 1

- 2 (Aug. 2004) (finding significant likelihood of an upset at refineries, chemical plants, gas plants and a carbon black plant, and finding that the resulting emissions release is many times higher than the amount of otherwise

- reported annual emissions), http://www.environmentalintegrity.org/news_reports/Report_Gaming_System.php.

104 See, e.g. , EPA, Enforcement and Compliance History Online (ECHO), www.epa.gov/echo; Kelly Haragan, Envtl. Integrity Project, “ Gaming the System: How Off

- the

- Books Industrial Upset Emissions Cheat the Public Out of Clean Air” (Aug. 2004), 1

- 2, 5, http://www.environmentalintegrity.org/news_reports/Report_Gaming_System.php (finding significant likelihood of an upset at refineries, chemical pla nts, gas plants and a carbon black plant, and finding that the resulting emissions release is many times higher than the amount of otherwise

- reported annual emissions and that “releases from upsets actually dwarf a facility’s routine emissions.”).38

In addition, EPA must not underestimate acute health risk from equipment leaks as it has proposed to do in this rulemaking

. EPA found significant numbers for acute health ri sk from these source categories, often above 1. Yet, EPA also stated that it was only using a default factor of 2 to account for such health risk from equipment leaks, rather than the factor of 10 it used for all other such risk. 79 Fed. Reg. at 1688. W hen leaks can continue indefinitely and there is no limit on the amount of HAPs may come from such leaks, EPA has given no valid basis for using such a low factor to account for the risk from these sources.

F. Account for Cumulative Impacts of Multiple Expo sures and Vulnerabilities by Shifting the Level of Risk Which Triggers Policy Action.

EPA has a longstanding policy of assuming that it is possible to find a safe or acceptable level of cancer and other kinds of health risks. Currently available science debunks this assumption because there is so much uncertainty b uilt into EPA’s risk assessment , and because EPA lacks information on so many pollutants. For communities overburdened by pollution, this policy is especially problematic.
As a major example, EPA should recognize that cancer risk from a major industrial source category of toxic air pollution (listed under CAA § 112) that is 100

- in

- 1 million or less cannot be presumed safe or “acceptable.” Since 1990, however, EPA has made this assumption.
EPA based this assumption not on scientific information about cancer risk, but on an unusual study of people’s perceptions of their own risk from 1988, known as the Survey of Societal Risk (July 1988), to consider various types of health risks at that time. 105 Using a comparison of cancer risk to other kinds of hazards Americans then faced in their daily lives, EPA effectively chose a number out of a hat that it would consider acceptable. EPA looked at an odd collection of risks, such as dangers from driving a car, and found that “the presumptive level established for MIR [maximum individual risk of cancer] of approximately 1 in 10 thousand is within the range for individual risk in the survey, and provides health protection at a level lower than many other ris ks common ‘in the world in which we live.’” 106
EPA has failed to revisit or update this number for the decades since, even though scientists have made breakthroughs on early

- life exposure and children’s vulnerability; biomonitoring and other data on adult bo dy burdens of chemicals; the vulnerability of overburdened communities, including socioeconomic disparities; and on ways to analyze and control the impacts of pollutants on human health.

LANDMARKS SINCE 1990

105 Benzen e Rule Docket No. OAQPS 79

- 3, Part I, Docket Item X

- B

- 1, EPA Air Docket (cited at Nat’l Emission Standards for Hazardous Air Pollutants; Benzene Emissions from Maleic Anhydride Plants, Ethylbenzene/Styrene Plants, Benzene Storage Vessels, Benzene Equipment Leaks, and Coke By

- Product Recovery Plants, 53 Fed. Reg. 28,496, at 28,512

- 13 (July 28, 1988)).
106 54 Fed. Reg. 38,044, 38,046 (Sept. 14, 1989) (emphasis added) (quotation omitted).39

1990 Clean Air Act Amendments required techn ology

- based control for hazardous air pollutants and 8

- year review of residual health risk to ensure protection of communities.

1993 National Research Council published Pesticides in the Diets of Infants and Children , finding that children are n ot little adults, and have greater exposures and susceptibility.

1994 President Clinton signed Executive Order 12898 on Environmental Justice.

1996 Food Quality Protection Act passed unanimously with a 10

- Fold Children’s Safety Factor.

Safe Drin king Water Act amendments required attention to susceptibility of children.

EPA announced a new National Agenda to Protect Children’s Health.

1997 President Clinton signed the Children’s Environmental Health Executive Order 13045.

2000 EPA fir st published America’s Children and the Environment.

2009 National Academy of Science published Science and Decisions: Advancing Risk Assessment

.

2009 Then

- EPA Administrator Jackson declared environmental justice and children’s health priorities.

2011 EPA announced Plan EJ 2014 including rulemaking and science goals.

It is time for EPA scientists and science policymakers to revisit the outdated assumption EPA makes regarding what level of cancer risk triggers policy interventions. EPA’s own policy

reg arding carcinogens recognizes that they have no safe threshold of exposure. EPA has appropriately recognized that cancer risks add up to increase lifetime risk. EPA cannot reconcile what it knows

– and does not know

– about carcinogens with its out dated presumption that a cancer risk of 100

- in

- 1 million is acceptable. Importantly, EPA’s presumption regarding cancer risk ignores the experience of communities exposed to multiple sources and types of sources of pollution. Even if some level of risk might otherwise be acceptable, that cannot be assumed to be true for communities exposed to more than one source that is causing that level of health risk. EPA has a responsibility to address the science on cumulative impacts and risk and update its assumption s accordingly, to acknowledge that cancer risks below 100

- in

- 1 million cannot be presumed safe.40

EPA should also reform how it evaluates chronic and acute hazard indices, in which a risk number below 1 does not result in policy changes or standards. EPA sh ould instead factor in uncertainties and vulnerability factors that adjust the “acceptable level of risk.” This is currently done under FQPA when EPA uses factors to determine a Target Margin of Exposure and risks below this level warrant increased scruti ny and changes to allowable exposures. 107
In the face of increasing evidence which challenges the assumption of a safe or acceptable level of exposu re, EPA should also update its risk assessment approach to reduce risks to the lowest possible level, to prot ect public health, rather than suggesting that ther e is a safe or acceptable level. EPA must recognize that it does not know what, if any, would be a “safe” level. It has no valid basis for stating to the public that exposure to lifetime cancer health ri sks below 100

- in

- 1 million can be presumed safe, and it has failed to provide any evidence for this conclusion in connection with the current source categories under review.

* * *

Thank you for your consideration of these comments which EPA should adopt to follow the Clean Air Act and protect public health from the source categories under review in this rulemaking

. An accompanying CD

- ROM, sent by U.S. Mail, contains documents cited in these comments for EPA ’ s review.

For further information regarding these comments, please contact Emma Cheuse or Jim
Pew at Earthjustice (

jpew@earthjustice.org

, echeuse@earthjustice.org ) or (202) 667

- 4500.

107 See, e.g. , EPA, “Sulfuryl Fluoride; Proposed Order Granting Objections t o Tolerances and Denying Request for a Stay, Proposed Rule,” 76 Fed. Reg. 3422, 3427 (Jan. 19, 2011) (explaining use of MOE).41 APPENDIX A: ADDITIONAL SOURCES

In general, for further information on each of the topics discussed here, the agency should consult the following sources:

1. George Alexeef et al.

, A Screening Method for Assessin g Cumulative Impacts , 9 Int’l Journal of Envtl. Research and Pub. Health 648

- 659 (2012); doi:10.3390/ijerph9020648.

2. Ramya Chari et al ., Integrating Susceptibility into Environmental Policy: An Analysis of the National Ambient Air Quality Standard for Lead, 9 Int’l Journal of Envtl. Research Pub. Health1077

- 1096 (2012).

3. Peter L. deFur et al. , Vulnerability as a Function of Individual and Group Resources in Cumulative Risk Assessment, 115(5) Envtl. Health Perspectives 817

- 24 (2007).

4. Kelly Haragan, “ Gaming th e System: How Off

- the

- Books Industrial Upset Emissions Cheat the Public Out of Clean Air,” Envtl. Integrity Project (Aug. 2004), http://www.environmentalintegrity.o rg/news_reports/Report_Gaming_System.php

.

5. Sarah Janssen et al ., Strengthening Toxic Chemical Risk Assessments to Protect Human Health, NRDC, Sci. & Envtl. Health Network, Issue Paper, (Feb. 2012).

6. Kristen Lombardi, “‘Upset’ emissions: Flares in the air, worry on the ground,” The Ctr. for Pub. Integrity, (May 31, 2013, 11:57 AM), http://www.publicintegrity.org/2013/05/21/12654/upset

- emissions

- flares

- air

- worry

ground.

7. Paul Mohai, Byoung

- Suk Kweon, Sangyun Lee & Kerry Ard, Air Pollution Around Schools Is L inked to Poorer Student Health And Academic Performance , 30(5) Health Affairs 852 (published online May 4, 2011; 10.1377/hlthaff.2011.0077).

8. Rachel Morello

- Frosch et al., , Understanding the Cumulative Impacts of Inequalities In Environmental Health: Impli cations for Policy, 30(5) Health Affairs (2011).

9. Rachel Morello

- Frosch & Bill M. Jesdale, Separate and Unequal: Residential Segregation and Estimated Cancer Risks Associated with Ambient Air Toxics in U.S. Metropolitan Areas, 114(3) Envtl. Health Perspecti ves 386 (2006).

10. Nat’l Research Council, Nat’l Acad. of Sciences, Science and Decisions: Advancing Risk Assessment (2009).http://www.nap.edu/catalog.php?record_id=12209.

11. Nat’l Acad. of Sciences, Phthalates and Cumulative Risk Assessment: The Tasks Ahead (2 008).

12. Office of Envt’l Health Hazard Assessment, “ Air Toxics Hot Spots Risk Assessment Guidelines : Technical Support Document for Exposure Assessment and Stochastic42

Analysis, Scientific Review Panel Draft, ” Cal. EPA (June 20, 2012), http://oehha.ca.gov/air

/hot_spots/SRP/index.html.

13. Office of Envt’l Health Hazard Assessment, California Communities Environmental Health Screening Tool (CalEnviroScreen 1.0 ) , Cal. EPA (April 2013), http://oehha.ca.gov/ej/ces042313.html.

14. Office of Envt’l Health Hazard Assessment , Technical Support Document for Cancer Potency Factors: Methodologies for Derivation, Listing of Available Values, and Adjustments to Allow for Early Life Stage Exposures , Cal. EPA (May 2009), http://oehha.ca.gov/air/hot_spots/tsd052909.html

.
15. Office of Envt’l Health Hazard Assessment, Appendix J: “ In Utero and Early Life Susceptibility to Carcinogens: The Derivation of Age

- at

- Exposure Sensitivity Measures, ” Cal. EPA (May 2009), http://oehha.ca.gov/air/hot_spots/tsd052909.html,http://oehha.ca.gov/air/hot_ spots/2009/ AppendixJEarly.pdf.

16. Office of Envt’l Health Hazard Assessment, “ Cumulative Impacts: Building a Scientific Foundation, ” Cal. EPA (Dec. 31, 2010), http://oehha.ca.gov/ej/pdf/CIReport123110.pdf.

17. Office of Envt’l Health Hazard Assessment, Child

- spec ific Health Reference Doses, Cal. EPA (June 22, 2009), http://oehha.ca.gov/public_info/public/kids/chrdtable.html

18. Dawn Reeves, Sierra Club Calls For EPA To Address Cumulative Impacts Under NEPA

, Inside EPA, Vol. 33, No. 5 (Aug. 31, 2012).

19. James L. Sadd et al ., Playing It Safe: Assessing Cumulative Impact and Social Vulnerability through an Environmental Justice Screening Method in the South Coast Air Basin, California, 8 Int’l Journal of Envtl. Research and Pub. Health 1441

- 1459 (2011).

20. Elizabeth Shogren & Robert Bennincasa, “Baton Rouge’s Corroded, Overpolluting Neighbor: Exxon Mobil,” Nat’l Pub. Radio, (May 30, 2013, 4:29 PM), http://www.npr.org/2013/05/30/187044721/baton

- rouge

- s

- corroded

- overpolluting

neighbor

- exxon.

21. Letter from Pamela Shubat, Chair, Children’s Health Protection Advisory Committee, to Lisa Jackson, Administrator, EPA (Oct. 21, 2010), http://yosemite.epa.gov/ochp/ochpweb.nsf/content/CHPAC_NRC_Report.htm.

22. Sierra Club, “The State of Detroit’s Environment: An Initial Assessment Using the F ramework of Environmental Justice (2013).

23. Jason Su et al.

, An Index for Assessing Demographic Inequalities in Cumulative Environmental Hazards with Application to Los Angeles, California , 43(20) Envtl. Sci. Tech. 7626

– 7634 (2009) ).43

24. U.S. EPA, “ Report of the Task Group of the Children’s Health Protection Advisory Comm. on America’s Children & the Env’t, ” 3d Ed. (2010). (2010),

25. U.S. EPA, Sci. Advisory Bd., Review of EPA’s draft entitled, “Risk and Technology Review (RTR) Risk Assessment Methodologies: For Review by the EPA’s Science Advisory Board with Case Studies

– MACT I Petroleum Refining Sources and Portland Cement Manufacturing, ” EPA

- SAB

- 10

- 007 (May 2010).44 APPENDIX B : SCIENTIFIC AND POL ICY DEVELOPMENTS

Summary of Major Developments Relevant to

Ch ildren’s Health Risk and Environmental Justice

In recent decades, many major scientific and policy developments have occurred, all directing that the federal government

– and, in particular, EPA

– must fully account for health risk to children due to earl y

- in

- life exposure, and for the need to consider and provide environmental justice. Science now shows that “[e]nvironmental contaminants can affect children quite differently than adults, both because children may be more highly exposed to contaminants an d because they may be more vulnerable to the toxic effects of contaminants.” 108

 In 1993, the National Research Council published Pesticides in the Diets of Infants and Children , finding that children are not little adults, and have greater exposures and

su sceptibility. 109

 In 1994, President Clinton signed Executive Order 12898 on Environmental Justice. 110

 In 1996, Congress enacted the Food Quality Protection Act and the Safe Drinking Water Act amendments, which explicitly require consideration of the susceptibi lity of children and due to early exposure. 111 This same year, EPA announced a new National Agenda to Protect Children’s Health.

108 U.S. EPA, “America’s Children & the Env’t,” 3d Ed. at 8 (2013).
109 Nat’l Research Council, “Pesticides in the Diets of Infants an d Children” (1993); see also Hugh A. Barton et al.

, Assessing Susceptibility from Early

- Life Exposure to Carcinogens, 113(9) Envtl. Health Perspectives 1125 (2005); Dale Hattis et al.

, Age

- Related Differences in Susceptibility to Carcinogenesis: a Quantita tive Analysis of Empirical Animal Bioassay Data , 112(11) Envtl. Health Perspectives 1152 (2004).
110 Exec. Order No. 12898, 3 C.F.R. 859 (1995), reprinted as amended in 42 U.S.C. § 4321 (1998).
111 21 U.S.C. § 346a(b)(2)(C) (requiring that, in taking certain actions on pesticides “an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre

- and post

- natal toxicity and completeness of the dat a with respect to exposure and toxicity to infants and children ”) (emphasis added); 42 U.S.C. § 300g

- 1(b)(1)(C) (requiring that, in selecting unregulated contaminants for consideration, EPA “shall take into consideration, among other factors of public heal th concern, the effect of such contaminants upon subgroups that comprise a meaningful portion of the general population (such as infants, children, pregnant women , the elderly, individuals with a history of serious illness, or other subpopulations) that ar e identifiable as being at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population”) (emphasis added); id. § 300j

- 18(a)(1) (requiring EPA to “identify groups within the general population that ma y be at greater risk than the general population of adverse health effects from exposure to contaminants in drinking water. The study shall examine whether and to what degree infants, children, pregnant women , the elderly, individuals with a history of ser ious illness, or other subpopulations that can be identified and characterized are likely to experience elevated health risks, including risks of cancer, from contaminants in drinking water. . . .”) (emphasis added).45

 In 1997 the President issued the Children’s Environmental Health Executive Order (No. 13045) on the need to address risks to children. 112

 In 2000, EPA first published America’s Children and the Environment , which it has since updated. 113

 In 2006, EPA issued new guidance on protecting children from environmental health risks as part of the rulemaking process. 114 Among other things, t his Guide, at 8, recognize d the problem of disproportionate risk to children because they may be more sensitive to pollution and exposed at a higher rate than adults because of their developmental stage. This Guide also recognized the need “to think in ter ms of the broad range of early life, pre

- natal and post

- natal, environmental exposures that may affect the incidence of disease or alter development.” 115

 In 2008, EPA updated the Child

- Specific Exposure Factors Handbook. 116

 In 2008 and 2009, the major National Academy of Sciences reports

– Science and Decisions: Advancing Risk Assessment (“NAS 2009”), and Phthalates and Cumulative Risk Assessment: The Tasks Ahead (2008)

– were released, re

- emphasizing the importance of addres sing real

- world risk to children and cumulative health risk.

 In 2009, EPA Administrator Jackson declared environmental justice and children’s health priorities.

 In 2010, EPA Administrator Jackson issued EPA’s Action Development Process: Interim Guidance on Considering Environmental Justice During the Development of an Action

. 117

 In 2011, EPA Administrator Jackson announced Plan EJ 2014 including rulemaking and science goals to finally achieve the goals of the 1994 Environmental Justice Executive Order. 118 E PA continues to work to issue guidance that will advance these goals.

In addition, in recent years, EPA’s Children’s Health Protection Advisory Committee has recommended addressing the developmental origins of adult disease that come from childhood

112 Exec. Order 13045, 62 Fed. Reg. 19, 885 (Apr. 21, 1997).
113 U.S. EPA, “ American’s Children and the Env’t” (3d ed. 2013), http://www.epa.gov/opeedweb/children/publications/index.html.
114 U.S. EPA, “Guide to Considering Children’s Health When Developing EPA Actions: Implementing Executive Order 13045 and EPA’s Policy on Evaluating Health Risks to Children” (2006), http://yosemite.epa.gov/ochp/ochpweb.nsf/content/ADPguide.htm/$File/EPA_ADP_G uide_508.pdf.
115 Id.
116 U.S. EPA, Child

- Specific Exposure Factors Handbook (2008).
117 U.S. EPA, “EPA’s Action Development Process: Interim Guidance on Considering Environmental Justice During the Development of an Action” (2010). http://www.epa.gov/complia nce/ej/resources/policy/ej

rulemaking.html.
118 Plan EJ 2014, U.S. EPA, http://www.epa.gov/compliance/ej/plan

- ej/index.html.46

expo sure to air pollution and other environmental contaminants. 119 Similarly, the Committee has recommended that EPA incorporate a more robust analysis of childhood and pre

- natal exposure to environmental contaminants into its risk assessment method. 120

The Sci ence Advisory Board (SAB) has also urged EPA to address the greater risk to children from hazardous air pollution. 121 As the SAB further explained: “California’s Office of Environmental Health Hazard Assessment (OEHHA) has very recently updated its methodol ogy in ways that could affect the development of RfC and URE (unit risk estimate) values. EPA should examine these developments to make sure that the RTR process adequately covers children’s risks.” 122
Finally, during the last decade, OEHHA has also release d a number of groundbreaking scientific determinations and protocols to consider and address children’s health, early life exposure, and cumulative impacts, which are cited in this document, above, and are all available

at http://oehha.ca.gov/

.

119 U.S. EPA, Report of the Task Group of the Children’s Health Protection Advisory Comm. on America’s Children & the Env’t , 3d Ed. (2010).), http://yosemite.epa.gov/ochp/ochpweb.nsf/content/ACETask.htm/$file/ACE%20Task%20Group%20Report.pdf.
120 Letter from Pamela Shubat, Chair, Children’s Health Protection Advocacy Council, CHPAC to Lisa Jackson, Administrator, U.S. EPA, (Oct. 21, 2010) (“CHPAC recommends that EPA staff scientists participating in the upcoming discussions bring the concern of early life stage exposure and sensitivity to the conversations that will take place concerning optimizing risk assessment practice.”), ht tp://yosemite.epa.gov/ochp/ochpweb.nsf/content/CHPAC_NRC_Report.htm.
121 U.S. EPA, Sci. Advisory Bd., Review of EPA’s draft entitled, “Risk and Technology Review (RTR) Risk Assessment Methodologies: For Review by the EPA’s Science Advisory Board with Case S tudies

– MACT I Petroleum Refining Sources and Portland Cement Manufacturing, EPA

- SAB

- 10

- 007 (May 2010), at 7 (stating that “an overarching concern with the Agency’s chronic inhalation exposure estimates is that children’s exposures do not appear to have b een adequately addressed”); see also id. at 34 n.13 (“In particular is the question of whether the interindividual variability factor for non

- carcinogens and the standard cancer unit risk derivation adequately covers children. If it does not, it is a poten tially significant uncertainty given the greater intake rate of children via inhalation and sensitivity to carcinogens and other toxicants.”).
122 Id.47 APPENDIX C : CHILD

- SPECIFIC NON

- CANCER CHART

Non

- Cancer Health Risk: Comparison of Cal. EPA OEHHA Child

- specific health reference values

to U

. S

. EPA reference values

Chemical OEHHA

Child

health Reference Dose (chRD) or value* U

. S

. EPA

Chronic Oral Reference Dose (RfD) Difference

Between OEHHA and U.S. EPA Order of

Magnitude Difference between OEHHA and U.S. EPA

Atrazine 0.006 0.035 6 1

Cadmium 0.000011 0.0005 (water) 45 1 0.001(food) 91 2
Chlordane 0.000033 0.0005 15 1 Chlorpyrifos 0.0001 0.0003 3

- Deltamethrin 0.0001 0.01 100 2 Heptachlor 0.00003 0.0005 17 1 Heptachlor epoxide 0.000013 0.000013 1

-

Manganese 0.03 0.14 5 1 Methoxychlor 0.00002 0.005 250 2
Nickel 0.011 0.02 2

- Pentachlorophe nol 0.001 0.005 5

-

Lead OEHHA

action level * EPA has not updated its action

levels; CDC has reduced (2012). 1 (as a blood

- level increase) 10 (5

- as a total) 10 (5

- as a total) 1

* All units are in mg/kg

- day except lead which is in μg/dL blood. The lead value is not a dose. For lead this is a health benchmark indicating the increase in a child’s blood lead concentration showing protective action is needed.

Source: Office of Environmental Health Hazard Assessment ( OEHHA ), Cal. EPA (Table of all child

- specific reference doses finalized as of 06/22/09, http://oehha.ca.gov/public_info/public/kids/chrdtable.html )