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Chapter 3: Preventing Harm in the Face of Uncertainty

High Production Volume Chemical Challenge Program p. 197 (5th edition):

By the beginning of 2007, some 2200 chemicals had been tested, 1400 through the Challenge Program and another 630 through international efforts. So far, costs have proven to be much lower than industry and EPA originally projected, because chemical companies have been able to rely substantially on already existing data instead of original testing. At the same time, more than 600 "emerging" HPVs—chemicals newly qualified for the HPV list—had been identified. Industry has agreed to extend the voluntary testing program to approximately 500 of these. As of the end of 2006, there were still approximately 270 "orphan" chemicals—chemicals that satisfied the HPV volume threshold but for which no one had volunteered to provide testing information.  As for EPA’s own testing efforts, they have been starved for resources in recent years.  EDF has issued a report critical of the HPV effort.  EDF, High Hopes, Low Marks:  A Final Report Card on the High Production Volume Chemical Challenge (July 2007).  Noting that the Program was by then two and a half years beyond its own final deadline for completion,  ED concentrated on the fact that data for some 700 chemicals remained incomplete and that 10% -- the “orphans” – did not even have a sponsor.  For a discussion of the public and private steps needed to close the data gap, see John S. Applegate and Katherine Baer, Strategies for Closing the Chemical Data Gap, a CPR White paper, http://www.progressiveregulation.org/articles/Closing_Data_Gaps_602.pdf.

Voluntary Children’s Chemical Evaluation Program update p. 199 (5th edition):

In December 2000, EPA launched a Voluntary Children’s Chemical Evaluation Program to obtain health effects and exposure information on 23 pilot chemicals to which children are believed to be disproportionately exposed. If no companies agree to sponsor voluntary Tier I testing for a particular chemical, EPA will consider issuing a test rule for the chemical under Section 4 of TSCA.  As of June, 2008, 14 of the 23 chemicals have had Tier I data submitted.  EPA, VCCEP Chemicals:  VCCEP Pilot Chemicals, at www.epa.gov/oppt/vccep/pubs/chem22ltr.pdf.

EU’s REACH Program

p. 199 (5th edition): The European Union (EU) has decided to take a different approach to the problem of improving our knowledge of the hazards associated with commercial chemicals. Through the Registration, Evaluation and Authorization of Chemicals (REACH) program, the EU is pursuing a "no data, no market," approach. Enacted in 2003, the program entered into force on June 1, 2007, after going through the EU’s consultation process.  See  http://echa.europa.eu/reach_en.asp. Applicable to chemicals with sales over 1 ton/year (by comparison, the HPV Challenge Program’s 1 million pounds per year is equivalent to 454 metric tons/year).

Toxics Release Inventoryp. 200 (5th edition):

TRI reporting requirements have evolved over the years… In addition to providing current year data with regard to all the current reporting requirements, EPA’s annual reports also provide some data for comparative purposes that pertain just to the "original" industries and chemicals—those required to report and to be reported in 1988. For this original grouping, total releases of TRI chemicals stood at 1.901 billion pounds in 1995, 2.067 in 1997, 1.636 in 2000, and 1.240 in 2006. EPA, TRI Explorer. http://www.epa.gov/triexplorer/. Total releases in 2007 for all reporting industries stood at nearly 4.1 billion pounds, a reduction of 5 percent from the year before. Id. 

Toxicity Dose-Response Assessment p. 205 (5th edition):

For all toxic effects other than carcinogenicity, a threshold in the dose-response curve is assumed. The lowest NOAEL (no observed adverse effects level) from all available studies is assumed to be the approximate threshold for the groups of subjects (humans or animals) in which toxicity data were collected.  Alternatively, a benchmark does (BMD) may be estimated from the observed dose-response curve, and used as the point-of-departure for risk assessment.

The threshold for the human population is estimated by dividing the NOAEL (or, alternatively, the BMD)  by an uncertainty factor (UF), the size of which depends upon the nature and quality of the toxicity data and the characteristics of the human population. (The estimated human threshold dose has several different names, depending on the regulatory context.) For carcinogens a linear, no-threshold dose-response model is assumed to apply at low doses, unless data are available in specific cases to demonstrate that such a model is appropriate.  [J. Rodricks Calculated Risks (2d ed. 2007) at 229.

These seven assumptions are only the tip of the iceberg. Other important uncertainties concern “the relevance of effects observed in studies on males to females, adults to children, and ‘healthy’ works to the general population.  Similar uncertainties are important in all types of risk assessments.”  NAS, Science and Decisions:  Advancing Risk Assessment 39 (prepublication copy 2008).  The Red Book identified  50 data gaps that quantitative risk assessments can face, at which point default assumptions or "inferential bridges" must be employed to get across these gaps in our knowledge. National Research Council, Risk Assessment in the Federal Government: Managing the Process 33-37 (1983).  The content of each of those defaults raises a “science policy” question. 

In its work leading up to the Benzene litigation, OSHA concluded that the gaps that needed to be bridged in producing a quantitative risk assessment argued against trying to generate a QRA at all. After Benzene agencies generally have chosen the option of bridging the gaps with default assumptions.  Much of the controversy over whether agencies are employing "sound science" in their work focuses on the choice of defaults, but also on other decisions agencies must make in evaluating available data. Those who wish to see government being more preventative in its approach to exposures to toxic materials worry that quantitative risk assessments contribute to the problem of "paralysis by analysis" that agencies increasingly confront.

Mercury Regulation p. 216 (5th edition):

EPA’s approach to regulating mercury fell apart when the D.C. Circuit ruled that erred in removing mercury from the list of chemicals that must be regulated under the tough MACT standards.  New Jersey v. EPA, 517 F.3d 574 (D.C. Cir. 2008).

Asbestos Ban: International Developments p. 247 (5th edition):

While the Corrosion Proof Fittings decision derailed EPA’s efforts to ban asbestos in the United States, a growing number of countries throughout the world are enacting asbestos bans. In September 2000, the World Trade Organization (WTO) rejected a challenge by Canada to France’s decision to ban imports of chrysotile asbestos. As of March 2009, 46 countries had adopted, or were in the process of implementing, national asbestos bans, including the members of the European Union, Australia, Argentina, Chile, Japan and Saudi Arabia.  Brazilian cities and states accounting for 70 percent of Brazil’s market also have banned asbestos use. In the United States, Senator Patty Murray (D-WA) has since 2003 sponsored the Ban Asbestos in America Act, which would accomplish through legislation what EPA attempted to do under its TSCA authority.

Climate Change and the Safe Drinking Water Act: Carbon sequestration p. 253 (5th edition):

Efforts to address climate change will call into question many existing regulatory frameworks, some of them perhaps unanticipated.  The possibility that one means of reducing carbon dioxide emissions would come by pumping it into the earth – carbon sequestration – implicates safe drinking water issues.  Some sequestration sites involve underground aquifers that are currently too salty to be protected under the SDWA, because they are not anticipated to be sources of drinking water.  Environmentalists and water districts anticipate that advances in desalination technology and rising demand may in the future produce interest in utilizing such aquifers as drinking water sources.  When that time comes, they worry that accessing such aquifers may be impaired by sequestration activities, and so they are urging redefining the definition of protected underground water sources to preserve now to protect them from sequestration activities.  On the other hand, proponents of carbon sequestration want the law amended so that EPA can insulate them from future liability in the event sequestration interferes with water sources, something the SDWA does not currently allow EPA to do.  Groups Detail Drinking Water Act Fixes Needed for CO2 Sequestration, Inside EPA, October 10, 2008.  Which of these ideas seems like the better one to you?

Food Quality Protection Act pesticide registration process update p. 271 (5th edition):

The FQPA also provides for a less onerous, expedited registration process for "minor use" pesticides, defined as those that are used on commercial crops where the crop is smaller than 300,000 acres, for which no alternative pesticides are available, and where other requirements are met. It also establishes some tolerance setting flexibility for such pesticides, which expose a smaller population to risk than higher-volume pesticides do. As of August, 2006 – the statutory date established for EPA to finish its work --  the EPA had reassessed 9637 tolerances out of a total of 9,721. These reviews resulted in recommendations to revoke 3,200 tolerances, modify 1,200 and leave 5.237 unchanged.  http://www.epa.gov/pesticides/regulating/laws/fqpa/fqpa_accomplishments.htm (last viewed Dec. 5, 2008).

Section 112 of the Clean Air Act and MACT Standards: NRDC v. EPA p. 71 (5th edition):

EPA has also faced legal challenges when it has issued individual MACTS, including those for   industrial boilers, hazardous waste combustors, brick kilns and electric utilities. Several cases have litigated EPA’s decision to form subcategories.  Because of the MACT floor provision for existing sources, this is often a critical decision, affecting what plants will be included in the performance-based determination of the MACT for that subcategory.  In 2007, the D.C. Circuit decided Sierra Club v. EPA, 479 F.3d 875 (D.C. Cir. 2007) (“Brick MACT”), a challenge to EPA’s emission standards for brick and ceramics kilns.  EPA had initially proposed a subcategory  of kilns operating without any air pollution control technology,  with a  “no emissions reductions” MACT for them.  In the final rule, EPA replaced the “no emission reductions” floors with a “work practice standard” for use of clean-burning fuels – essentially the same as no emissions reductions, as the kilns were already operating with clean fuels.  The D.C. Circuit, rejecting the proposed standard, ruled that “EPA has a ‘clear statutory obligation to set emission standards for each listed HAP,’ which does not allow it to ‘avoid setting standards for HAPs not controlled with technology.’” The court further noted that work practice standards are a legitimate substitute for emission floors only if EPA determines that it is impracticable to measure emissions from the kilns, which it had not.  EPA has not abandoned efforts to use subcategories to create flexibility in the MACT systems.  Other standards, such as those for hazardous waste combustors, still have not been finalized because of controversy over subcategories.  E.g., 72 Fed Reg. 54875 (Sept. 27, 2007) (reopening hazardous waste combustor MACT.)

EPA has also tried to exempt some subcategories from MACT technology standards if they can be shown to be causing minimal risk. Consider the following case involving the plywood MACT.

Natural Resources Defense Council v. EPA
489 F.3d 1364 (D.C. Cir. 2007)

Rogers, Circuit Judge.

These are consolidated petitions for review of two final rules promulgated by the Environmental Protection Agency in 2004 and 2006 under Section 112 of the Clean Air Act (“CAA”), 42 U.S.C. §7412, to regulate hazardous air pollution from processing plywood and composite wood products (“PCWP”).  … As a result of the PCWP process, at least six primary hazardous air pollutants (“HAPs”) are released into the air. . . .

. . . . We hold that EPA lacked authority to create a low-risk subcategory and to extend the compliance deadline and therefore . . . vacate those provisions of the rules.

I. B

[EPA’s 2004 plywood MACT created a “low risk” subcategory, pursuant to §112(c)(9)(B) . . . .  Subject to acknowledged omissions, EPA determined that the sources in the low-risk subcategory did not emit carcinogens in excess of the statutory ceiling, namely, in amounts resulting in a lifetime cancer risk exceeding one in a million to the most-exposed individual; that they did not emit non-carcinogens in amounts exceeding a level adequate to provide an ample margin of safety to protect public health; and that no source emitted any HAP or combination of HAPs in amounts resulting in an adverse environmental effect as defined in subsection 112(a)(7).  Where site specific data was unavailable, EPA used standards ten times more protective of human health to analyze model emissions data for potentially low-risk facilities.  Eight sources met the criteria initially and EPA contemplated that others also would be relieved of all emission reduction requirements upon EPA approval of their low-risk eligibility. 

After the NRDC requested reconsideration of the low-risk subcategory and the delisting of sources under the 2004 Rule, EPA proposed amendments to the 2004 Rule.  EPA concluded that the changes to the emission testing requirements in the 2004 Rule had caused many sources to postpone emissions tests necessary to demonstrate eligibility for the low-risk subcategory and to identify their MACT compliance options. Therefore, EPA determined to allow PCWP sources additional time to comply with what it characterized as “substantial” changes to the 2004 Rule.

III. A

. . . .  In Sierra Club [“Brick MACT”], the court held that EPA's failure to set floors for existing small tunnel brick kilns and existing and new periodic brick kilns violated CAA Section 112(d)(3), 42 U.S.C. §7412(d)(3), noting that in National Lime, 233 F.3d at 633-34, the court had held unlawful EPA's “no control” emission floors for categories in which the best performers used no emission control technology.  Sierra Club, 479 F.3d at 878.  In the instant case, using the same rationale, the NRDC challenged EPA's failure to set emission standards for listed HAPs that PCWP plants emit.  EPA declined to do so on the rationale that these HAPs are not controlled with technology.  However, the fact that one form of control does not control emissions does not excuse EPA from finding other means to achieve that result. 

B.

The thrust of the NRDC challenge to EPA's establishment of a low-risk subcategory is based on the proposition that EPA cannot do an end-run around the statutory scheme enacted by Congress.  First, the low-risk subcategory contravenes the plain text of subsections 112(c)(2) and (d)(1), which indicate that Congress intended EPA to create categories and subcategories as a step toward establishing emission standards. . . .  Hence, the NRDC maintains, Congress never intended EPA to create a category or subcategory “whose defining characteristic is that its members will never be subject to emission standards.”  Second, EPA's authority under Section 112(d) (1) to establish categories and subcategories for sources does not authorize it to ignore subsection 112(c)(2)'s requirement that EPA establish emission standards for the low-risk subcategory; otherwise, the NRDC contends, emissions would be allowed that Congress has expressly prohibited. . . .

. . . .  Although finding no correlation between the facilities it identified as low-risk and the factors it had previously applied to subcategorize facilities, based on considerations such as technology, process, EPA maintains that its broad discretion allows it to consider other factors and that Congress recognized that in certain instances a risk-based approach can be appropriate.

That EPA may have broad subcategorization authority, however, does not authorize EPA to sidestep what Congress has plainly prohibited.  Whatever factors EPA might properly consider for subcategorization, it has no authority to create a low-risk subcategory scheme that allows harmful emissions in a manner contrary to Congress's statutory scheme.  Section 112(c)(9)(B) provides that EPA may delete from its source list “any source category.” (emphasis added)  Not only is the risk-based exemption for a subcategory contrary to the plain language of the statute, but EPA also failed to make the required statutory determination that no source in the category, rather than in the low-risk subcategory, emits HAPs “in quantities which may cause a lifetime risk of cancer greater than one in one million to the individual in the population who is most exposed to emissions . . . .”  42 U.S.C. §7412(c)(9)(B)(i).  EPA responds that Congress used the words “category” and “subcategory” interchangeably, but fails to demonstrate that Congress did not mean what it said in subsection 112(c)(9)(B)(i).  While neither word is defined in the statute, the absence of a statutory definition does not render a word ambiguous.  Goldstein v. SEC, 451 F.3d 873, 878 (D.C.Cir.2006).  The “words of the statute should be read in context, the statute's place in the overall statutory scheme should be considered, and the problem Congress sought to solve should be taken into account” to determine whether Congress has foreclosed the agency's interpretation.  PDK Labs. Inc. v. DEA, 362 F.3d 786, 796 (D.C.Cir.2004).

As a matter of the plain text, “subcategory” is a subset of “category,” as EPA has previously recognized.  Read in the context of subsection 112(c)(9), Congress's use of the words suggests that they have different meanings; in Section 112 at various points Congress specified both “category” and “subcategory” alone, and also used the combined phrase “category or subcategory” where appropriate.  Regardless of whether or not Congress may have used the two words interchangeably in other subsections-EPA cites subsections 112(e)(4) and (f)(2)(A)-does not necessarily show that in subsection 112(c)(9)(B), “as a matter of historical fact, Congress did not mean what it appears to have said, or that, as a matter of logic and statutory structure, it almost surely could not have meant it.”  New York v. EPA, 443 F.3d 880, 889 (D.C.Cir.2006).  As the NRDC point outs, because subsection 112(c)(9) involves carcinogens, limiting delistings to source “categories,” as distinct from “subcategories,” accords with Congress's tighter restrictions on carcinogenic HAPs.  By contrast, EPA's interpretation would make the words redundant and one of them “mere surplusage,” which is inconsistent with a court's duty to give meaning to each word used by Congress.  

Because EPA's interpretation of Section 112(c)(9) as allowing it to exempt the risk-based subcategory is contrary to the plain language of the statute, EPA's interpretation fails at Chevron step one. . . .

NOTES AND QUESTIONS

1.  What is the purpose of the low-risk delisting procedure of §112(c)(9)(B)?  Do you agree that EPA was misusing it here?

2.  Once the MACTs have been issued, EPA must move to the second phase of §112 implementation.  This requires it to make a “residual risk” determination to see if the emissions remaining after MACT has been applied warrant further regulation.  When EPA issued rules for the first six of the eight Phase I residual risk standards, it determined that no further controls were required, despite a finding that the most exposed individuals face more than a 1-in-a-million lifetime cancer risk.  Recall that in plywood MACT, the court had referred to 1-in-a-million as the statutory standard that could not be exceeded in order to delist a category.  Section 112(f)(2) also refers to this benchmark.  Environmental groups once again challenged EPA’s interpretation of 112, resulting in the following decision. 

Natural Resources Defense Council v. EPA
529 F.3d 1077 (D.C. Cir. June 6, 2008)

Silberman, Senior Circuit Judge.

Petitioners, the Natural Resources Defense Council and the Louisiana Environmental Action Network, challenge EPA's residual risk rulemaking under subsection 112(f) of the Clean Air Act for facilities that use or produce synthetic organic chemicals (“the industry”). We deny the petition.

I.

EPA initially promulgated technology-based emission standards for the industry in 1994 (there are 238 facilities in the United States that produce or use synthetic organic chemicals). Those standards required the use of control technologies such as recovery devices, thermal oxidizers, carbon absorbers, and steam strippers.  After submitting the required report to Congress in 1999, the agency commenced residual risk rulemaking, apparently because . . . the industry's emissions pose lifetime excess cancer risks of greater than one-in-one million.

EPA determined that under the existing technology-based standard, no individual would face an excess lifetime cancer risk of greater than 100-in-one million, which EPA regards as the “presumptively acceptable” level under its precedents.  … Petitioners . . .  contend that the statute obliged EPA, in the residual risk rulemaking, to tighten the standards for the industry so that the lifetime excess cancer risk to exposed persons would be no greater than one-in-one million.  


II. A

Petitioners contend that subsection 112(f)(2)(A) obliged EPA to revise industry standards to reduce lifetime excess cancer risk to one-in-one million.  Petitioners rely primarily on the last sentence of that subsection, whereas EPA looks to the whole subsection.  That provision states in full:

If Congress does not act on any recommendation submitted under paragraph (1), the Administrator shall, within 8 years after promulgation of standards for each category or subcategory of sources pursuant to subsection (d) of this section, promulgate standards for such category or subcategory if promulgation of such standards is required in order to provide an ample margin of safety to protect public health in accordance with this section (as in effect before November 15, 1990) or to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect.  Emissions standards promulgated under this subsection shall provide an ample margin of safety to protect public health in accordance with this section (as in effect before November 15, 1990), unless the Administrator determines that a more stringent standard is necessary to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect.  If standards promulgated pursuant to subsection (d) of this section and applicable to a category or subcategory of sources emitting a pollutant (or pollutants) classified as a known, probable or possible human carcinogen do not reduce lifetime excess cancer risks to the individual most exposed to emissions from a source in the category or subcategory to less than one in one million, the Administrator shall promulgate standards under this subsection for such source category.
42 U.S.C. §7412(f)(2)(A).


It is undisputed that facilities that produce or use synthetic organic chemicals emit carcinogens and are, therefore, within the reach of the last sentence.  It is also undisputed that, in light of the fact that existing technology-based standards do not reduce the risk to less than one-in-one million, EPA was obliged to “promulgate standards” under subsection 112(f).  Petitioners contend that the third sentence obviously means that residual risk standards must meet the threshold test- i.e., EPA must reduce such risks to one-in-one million.  That may well be a possible interpretation, but the sentence contains a glaring omission; it does not say what petitioners would like us to infer.  Rather, that sentence instructs the Administrator to “promulgate standards,” but it says nothing about the substantive content of those standards. If Congress had wished to set a “bright line” standard, it would have been rather easy for the draftsmen to say just that.  The failure to do so could not have been accidental. In light of the rest of the subsection's language (and other provisions), it seems to us that the subsection was drafted as a deliberately ambiguous compromise.

We reach that conclusion because the second sentence, which sets forth the substantive standard to be applied, simply calls for standards that “provide an ample margin of safety to protect public health” . . . .  No distinction is drawn between carcinogens and non-carcinogens.  The third sentence, on which petitioners rely, not only lacks the language that petitioners ask us to infer; it also specifically states that if the one-in-one million trigger is met, the Administrator must promulgate standards “under this subsection,” which, perforce, takes us back to the second sentence.

EPA's construction of the subsection is bolstered by another paragraph, 112(f)(2)(B), which states:

Nothing in subparagraph (A) or in any other provision of this section shall be construed as affecting, or applying to the Administrator's interpretation of this section, as in effect before November 15, 1990, and set forth in the Federal Register of September 14, 1989 (54 Federal Register 38044).
42 U.S.C. §7412(f)(2)(B). 

The cited item in the Federal Register is EPA's emission standard for benzene, which is a carcinogenic hazardous air pollutant. . . .  [T]he Benzene standard established a maximum excess risk of 100-in-one million, while adopting the one-in-one million standard as an aspirational goal.  This standard, incorporated into the amended version of the Clean Air Act, undermines petitioners' assertion that EPA must reduce residual risks to one-in-one million for all sources that emit carcinogenic hazardous air pollutants.


Petitioners respond that subsection 112(f)(2)(B) is a savings clause that only preserves EPA's specific regulations regarding benzene.  But the text belies this contention. . . .  The word “interpretation” indicates that the savings clause is not limited to EPA's benzene-specific determinations, but applies broadly to the agency's construction of the Clean Air Act in the Benzene standard. . . .

The parenthetical clause in the second sentence of subsection 112(f)(2)(A) lends further support to EPA's position. . . .  EPA interprets the parenthetical as a “shorthand reference” to the Benzene standard, given that subsection (B) uses almost identical language, incorporating “the Administrator's interpretation of this section, as in effect before November 15, 1990, and set forth in the Federal Register . . . .”  The phrase “this section (as in effect before November 15, 1990)” is certainly broad enough to encompass EPA's prior interpretations of “this section” as well as the text itself.  In fact, the operative provision of the pre-1990 version of section 112 uses the exact same “ample margin of safety” language as subsection 112(f)(2)(A) currently uses.  Thus, the parenthetical must refer to something more than the bare text of “this section,” or else it would be surplusage.

Petitioners insist that EPA's interpretation renders the third sentence effectively meaningless.  To be sure, the third sentence, as EPA interprets it, seems relatively anodyne; it lacks substantive force.  But, at least as EPA reads it, the word “promulgate” means the agency is obliged to conduct a rulemaking to consider residual risks for sources that emit carcinogens.  That extra procedural step is not a trivial obligation.  Congress often imposes procedural requirements without dictating substantive outcomes.  We also disagree with petitioners' argument that EPA did not “promulgate standards” under subsection 112(f)(2) because it simply readopted the initial standards.  This position finds no support in the text of the statute. Subsection 112(f)(2) only mandates that residual risk standards “provide an ample margin of safety to protect public health.”  If EPA determines that the existing technology-based standards already provide an “ample margin of safety,” then the agency is free to readopt those standards during a residual risk rulemaking.

Finally, petitioners argue that EPA unlawfully considered cost while setting the “ample margin of safety” in the residual risk standards.  Petitioners are correct that the Supreme Court has “refused to find implicit in ambiguous sections of the [Clean Air Act] an authorization to consider costs that has elsewhere, and so often, been expressly granted.”  Whitman v. Am. Trucking Ass'n, 531 U.S. 457, 467, 121 S.Ct. 903, 149 L.Ed.2d 1 (2001).  In this case, however, we believe the clear statement rule has been satisfied.  As explained above, subsection 112(f)(2)(B) expressly incorporates EPA's interpretation of the Clean Air Act from the Benzene standard, complete with a citation to the Federal Register.  In that rulemaking, EPA set its standard for benzene “at a level that provides ‘an ample margin of safety’ in consideration of all health information ... as well as other relevant factors including costs and economic impacts, technological feasibility, and other factors relevant to each particular decision.”  54 Fed.Reg. at 38,045 (emphasis added). . . .

In sum, we conclude that EPA's interpretation of subsection 112(f)(2), although not an inevitable one, certainly is, at least, a reasonable construction of the statute.  See Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837, 843, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984).

NOTES AND QUESTIONS

1.  At the same time as it issued its residual risk determination, EPA also determined that its statutorily-mandated review of the MACT standards did not require their revision at this time.  NRDC challenged that determination on the ground that EPA had impermissibly considered compliance costs, when the consideration of costs is impermissible in establishing the initial MACT floors.  The court ruled that it need not reach that issue because, although EPA did discuss costs, the record reflected that it had relied upon statutorily permissible criteria, and that its discussion of costs did not impermissibly “taint” that determination. 

2. Implementing the revised Section 112 has been controversial and slower than the ambitious statutory timeline, yet at the same time EPA has now finalized nearly all the required MACTS, which are being implemented.  In contrast,  EPA’s track record in implementing health-based standards is even less encouraging. Under the original section 112, EPA promulgated national emissions standards for only seven hazardous air pollutants in the first 20 years after enactment.

The “Sound Science” Debates p. 280 (5th edition):

A number of studies have also documented ways in which advocates seek to bend science to their own ends, trying to influence the outcome or credibility of scientific studies in order to influence the outcome of the regulatory decisions that rely upon that science.  When such efforts succeed, “instead of a process that has managed to insulate itself from the unruly world of policy, then, sacred scientific processes are contaminated by determined advocates who understand the power of supportive science in legal and policy proceedings.  Thomas McGarity and Wendy Wagner, Bending Science:  How Special Interests Corrupt Public Health Research 5 (2008).  See also David Michaels, Doubt is Their Product:  How Industry’s Assault on Science Threatens Your Health (2008).

Dioxin Risk Assessment update p. 283 (5th edition):

EPA has now been struggling with dioxin risk assessments and reassessments for about two decades.  It commissioned a NAS review, which resulted in a 2006 report criticizing EPA’s 2003 (third) reassessment for not adequately characterizing uncertainties.  National Academy of Sciences, Health Risks from Dioxin and Related Compounds:  Evaluation of EPA’s Reassessment. (2006).  EPA is still considering how to respond.  EPA Announces Plan to Reassess Key Portion of Dioxin Risk Study, Inside EPA, December 19, 2008. 

Toxics Release Inventory Emissions Threshold Reporting p. 307 (5th edition):

In 2006, EPA implemented a proposal easing facilities’ ability to use a less-detailed TRI form, known as Form A, by raising the emissions threshold from 500 to 2,000 pounds for the form.  71 Fed. Reg. 76932 (2006).  This rule was heavily criticized by the environmental justice community, who point out that “it is not uncommon for low-income communities or communities of color to be located near industrial parks, where multiple TRI facilities are clustered.”  Court’s Delay Opens Door to Obama Reversing Controversial TRI Rule, Clean Air Report, January 8, 2009.  They  argue that the cumulative effects of individually small emissions from multiple sources can pose serious health problems, and that the effect of the 2006 revisions was  to eliminate much of the reporting of individual emissions of concern to them.  On March 11, 2009 Congress reversed this rule change and returned TRI reporting to the rules previously in effect through legislation included in the Omnibus Appropriations Act of 2009.

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